25 TAC § 289.252. Licensing of Radioactive Material

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Texas Administrative Code › Title 25 HEALTH SERVICES › Part 1 DEPARTMENT OF STATE HEALTH SERVICES › Chapter 289 RADIATION CONTROL › 25 TAC § 289.252

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(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);

(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.

(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

(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

(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

(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;

(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 Title 10 Code of Federal Regulations (10 CFR) §32.18.

(2) Licenses issued under this subsection do not authorize:

(A) the combining of exempt quantities of radioactive material in a single device;

(B) any program advising a person to combine exempt quantity sources and providing devices for them to do so; and

(C) the possession and use of combined exempt sources, in a single unregistered device, by a person exempt from licensing under §289.251(e)(2) of this subchapter.

(k) Specific licenses for incorporating byproduct material or NARM into gas and aerosol detectors. A specific license authorizing the incorporation of byproduct material or NARM into gas and aerosol detectors to be distributed to a person exempt from this chapter must only be issued by the NRC under

10 CFR §32.26

(l) Specific licenses for the manufacture and commercial distribution of devices to a person generally licensed under §289.251(f)(4)(H) of this subchapter.

(1) In addition to the requirements in subsection (e) of this section, a specific license to manufacture or commercially distribute devices containing radioactive material to a person generally licensed under §289.251(f)(4)(H) of this subchapter or equivalent requirements of the NRC or any agreement state will be issued if the department approves the following information submitted by the applicant:

(A) 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 a person 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 any person will receive, in any period of one year, a dose in excess of ten percent of the limits as specified in §289.202(f) of this chapter; and

(iii) under accident conditions (such as fire and explosion) associated with handling, storage, and use of the device, it is unlikely any person would receive an external radiation dose or dose commitment in excess of the following organ doses:

(I) 15 rem to the whole body; head and trunk; active blood-forming organs; gonads; or lens of eye;

(II) 200 rem to the hands and forearms; feet and ankles; or localized areas of skin averaged over areas no larger than 1 square centimeter (cm

); or

(III) 50 rem to other organs;

(B) procedures for disposition of unused or unwanted radioactive material;

(C) each device bears a durable, legible, clearly visible label or labels approved by the department containing the following 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 in one of the following statements, as appropriate, in the same or substantially similar form:

(I) For radioactive materials other than NARM, the following statement is appropriate:

Attached Graphic

(II) For NARM, the following statement is appropriate:

Attached Graphic

(III) The model and 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.

(D) Each device having a separable source housing providing the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial numbers, the isotope and quantity, the words, "Caution-Radioactive Material," the radiation symbol described in §289.202(z) of this chapter, and the name of the manufacturer or initial distributor.

(E) Each device meeting the criteria of §289.251(g)(1) of this subchapter, bears a permanent (for example, embossed, etched, stamped, or engraved) label affixed to the source housing if separable, or the device if the source housing is not separable, including the words, "Caution-Radioactive Material," and, if practicable, the radiation symbol described in §289.202(z) of this chapter.

(F) The device has been registered in the Sealed Source and Device Registry.

(2) If the applicant desires the device 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 must include in the application sufficient information to demonstrate the longer interval is justified by performance characteristics of the device or similar devices and by design features having 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 department considers information, including:

(A) primary containment (sealed source capsule);

(B) protection of primary containment;

(D) containment construction materials;

(E) form of contained radioactive material;

(F) maximum temperature withstood during prototype tests;

(G) maximum pressure withstood during prototype tests;

(H) maximum quantity of contained radioactive material;

(I) radiotoxicity of contained radioactive material; and

(J) operating experience with identical devices or similarly designed and constructed devices.

(3) If the applicant desires the general licensee under §289.251(f)(4)(H) of this subchapter or equivalent regulations of the NRC or any agreement state, be authorized to install the device, collect the sample to be analyzed by a specific licensee for radioactive material leakage, service the device (i.e., replace labels, perform rust and corrosion prevention, or perform repair and maintenance of fixed gauge sealed source holder mounting brackets), test the "on-off" mechanism and indicator, or remove the device from installation, the applicant must include in the application written instructions to be followed by the general licensee, estimated annual doses associated with these activities, and bases for the estimates. The submitted information must demonstrate performance of these activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices as authorized by the general license, is unlikely to cause that individual to receive an annual dose in excess of ten percent of the limits as specified in §289.202(f) of this chapter.

(4) Before the device may be transferred, each person licensed under this subsection to commercially distribute devices to generally licensed persons must furnish to each person to whom a device is transferred for use under the general license in §289.251(f)(4)(H) of this subchapter or equivalent NRC or agreement state general license:

(A) a copy of the general license in §289.251(f)(4)(H) of this subchapter;

(B) a copy of the general license in the NRC's or any agreement state's regulation equivalent to §289.251(f)(4)(H) of this subchapter, or alternatively, a copy of the general license in §289.251(f)(4)(H) of this subchapter;

(i) if certain requirements of the regulations do not apply to the device, those requirements may be omitted; and

(ii) if a copy of the general license in §289.251(f)(4)(H) of this subchapter is furnished to such a person, it must be accompanied by an explanation that use of the device is regulated by the NRC or any agreement state under requirements substantially the same as those in §289.251(f)(4)(H) of this subchapter;

(D) a list of the services that can only be performed by a specific licensee;

(E) information on acceptable disposal options, including estimated costs of disposal;

(F) the name or position, address, and phone number of a contact person at the department, the NRC, or any agreement state, from which additional information may be obtained; and

(G) a statement that it is the NRC's policy to issue high civil penalties for improper disposal if the device is commercially distributed to a general licensee of the NRC.

(5) An alternative approach to informing customers may be submitted by the licensee for approval by the department.

(6) In the case of a transfer through an intermediate person, each licensee who commercially distributes radioactive material in a device for use under the general license in §289.251(f)(4)(H) of this subchapter, must furnish the information in paragraph (4) of this subsection to the intended user before the initial transfer to the intermediate person.

(7) Each person licensed under this subsection to commercially distribute devices to generally licensed persons must:

(A) report to the department all commercial distributions of devices to any person for use under the general license in §289.251(f)(4)(H) of this subchapter and all receipts of devices from general licensees licensed under §289.251(f)(4)(H) of this subchapter.

(i) The report must:

(I) cover each calendar quarter;

(II) be filed within 30 days of the end of each calendar quarter;

(III) be submitted on a form prescribed by the department or in a clear and legible report containing all the data required by the form;

(IV) clearly indicate the period covered by the report;

(V) clearly identify the specific licensee submitting the report and include the license number of the specific licensee;

(VI) identify each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee must be submitted along with information on the actual location of use;

(VII) identify an individual by name, title, and phone number who has knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements;

(VIII) identify the type, model and serial number of the device, and serial number of the sealed source commercially distributed;

(IX) identify the quantity and type of radioactive material contained in the device; and

(X) include the date of transfer.

(ii) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must also include the information as specified in paragraph (7)(A)(i) of this subsection for both the intended user and each intermediate person and clearly designate the intermediate person.

(iii) If no commercial distributions have been made to a person generally licensed under §289.251(f)(4)(H) of this subchapter during the reporting period, the report must so indicate.

(iv) For devices received from a general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.

(B) report the following to the NRC to include covering each calendar quarter to be filed within 30 days thereafter, clearly indicating the period covered by the report, the identity of the specific licensee submitting the report, and the license number of the specific licensee:

(i) all commercial distributions of such devices to a person for use under the NRC general license in

10 CFR §31.5

and all receipts of devices from general licensees in areas under NRC jurisdiction, including:

(I) the identity of each general licensee by name and address;

(II) the type, model and serial number of the device, and serial number of sealed source commercially distributed;

(III) the quantity and type of radioactive material contained in the device; and

(IV) the date of transfer; or

(ii) if the licensee makes changes to a device possessed under the general license in §289.251(f)(4)(H) of this subchapter, and the label must be changed to update required information, the report must identify the licensee, the device, and the changes to information on the device label;

(iii) the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor;

(iv) if no commercial distributions were made to the NRC licensees during the reporting period; the report must so indicate;

(C) report to the department or any agreement state all transfers of devices manufactured and commercially distributed under this subsection for use under a general license in the state's requirements equivalent to §289.251(f)(4)(H) of this subchapter and all receipts of devices from general licensees.

(i) The report must:

(I) be submitted within 30 days after the end of each calendar quarter in which the device is commercially distributed to the generally licensed person;

(II) clearly indicate the period covered by the report;

(III) clearly identify the specific licensee submitting the report and include the license number of the specific licensee;

(IV) identify each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use an alternate address for the licensee must be submitted along with the information on the actual location of use;

(V) identify an individual by name, position, and phone number who has knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements;

(VI) include the type, model and serial number of the device, and serial number of the sealed source commercially distributed;

(VII) include the quantity and type of radioactive material contained in the device; and

(VIII) include the date of receipt.

(ii) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must also include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person.

(iii) If no commercial distributions have been made to persons in the agreement state during the reporting period, the report shall so indicate.

(D) make, maintain, and retain records required by this paragraph for inspection by the department as specified in subsection (mm) of this section, including the name, address, and the point of contact for each general licensee to whom the licensee directly or through an intermediate person commercially distributes radioactive material in devices for use under the general license provided in §289.251(f)(4)(H) of this subchapter, or equivalent requirements of the NRC or any agreement state.

(i) The records must include:

(I) the date of each commercial distribution;

(II) the isotope and the quantity of radioactivity in each device commercially distributed;

(III) the identity of any intermediate person; and

(IV) compliance with the reporting requirements of this subsection.

(ii) The records must indicate when no commercial distributions have been made to a person generally licensed under §289.251(f)(4)(H) of this subchapter during the reporting period.

(8) If a notification of bankruptcy has been made as specified in subsection (x)(6) of this section or the license is to be terminated, each person licensed under this subsection must provide, upon request, to the NRC and to any appropriate agreement state, records of final disposition required under subsection (y)(16)(A) of this section.

(9) Each device transferred after February 19, 2002, must meet the labeling requirements as specified in paragraph (1)(C) - (E) of this subsection.

(m) Specific licenses for the manufacture, assembly, repair, or initial transfer of luminous safety devices containing tritium or promethium-147 for use in aircraft for distribution to a person generally licensed under §289.251(f)(4)(B) of this subchapter. In addition to the requirements in subsection (e) of this section, a specific license to manufacture, assemble, repair, or initially transfer luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to a person generally licensed under §289.251(f)(4)(B) of this subchapter, is issued if the department approves the information submitted by the applicant. The information must satisfy the requirements of

10 CFR §§32.53

, 32.54, 32.55, and 32.56, or their equivalent.

(n) Specific licenses for the manufacture or initial transfer of calibration sources containing americium-241 or radium-226 for commercial distribution to a person generally licensed under §289.251(f)(4)(D) of this subchapter.

(1) In addition to the requirements in subsection (e) of this section, a specific license to manufacture or initially transfer calibration sources containing americium-241, or radium-226 to a person generally licensed under §289.251(f)(4)(D) of this subchapter will be issued if the department approves the information submitted by the applicant. The information must satisfy the requirements of

10 CFR §§32.57

, 32.58, 32.59, and §70.39 or their equivalent.

(2) Each person licensed under this subsection must perform a dry wipe test on each source containing more than 0.1 microcurie (µCi) (3.7 kilobecquerels (kBq)) of americium-241 or radium-226 before transferring the source to a general licensee under §289.251(f)(4)(D) of this subchapter or equivalent regulations of the NRC or any agreement state. This test must be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the filter paper must be measured by using radiation detection instrumentation capable of detecting 0.005 µCi (0.185 kBq) of americium-241 or radium-226. If a source has been shown to be leaking or losing more than 0.005 µCi (0.185 kBq) of americium-241 or radium-226 by methods described in this paragraph, the source must be rejected and may not be transferred to a general licensee under §289.251(f)(4)(D) of this subchapter or equivalent regulations of the NRC or any agreement state.

(o) Specific licenses for the manufacture and commercial distribution of sealed sources or devices containing radioactive material for medical use. In addition to the requirements in subsection (e) of this section, a specific license to manufacture and commercially distribute sealed sources and devices containing radioactive material to a person licensed under §289.256 of this subchapter for use as a calibration, transmission, or reference source or for use of sealed sources listed in §289.256(q), (rr), (bbb), and (ddd) of this subchapter will be issued if the department approves the following information submitted by the applicant:

(1) an evaluation of the radiation safety of each type of sealed source or device, including:

(A) the radioactive material contained, its chemical and physical form, and amount;

(B) details of design and construction of the sealed source or device;

(C) procedures for, and results of, prototype tests to demonstrate the sealed source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents;

(D) for devices containing radioactive material, the radiation profile of a prototype device;

(E) details of quality control procedures to assure production sources and devices meet the standards of the design and prototype tests;

(F) procedures and standards for calibrating sealed sources and devices;

(G) instructions for handling and storing the sealed source or device from the radiation safety standpoint. These instructions are to be included on a durable label attached to the sealed source or device or attached to a permanent storage container for the sealed source or device; instructions too lengthy for the label may be summarized on the label and printed in detail on a brochure referenced on the label; and

(H) a legend and methods for labeling sources and devices as to their radioactive content;

(2) documentation that the label affixed to the sealed source or device, or to the permanent storage container for the sealed source or device, contains information on the radionuclide, quantity, and date of assay, and a statement that the name of the sealed source or device is licensed by the department for commercial distribution to a person licensed for use of sealed sources in the healing arts or by equivalent licenses of the NRC or any agreement state;

(3) documentation that in the event the applicant desires that the sealed source or device be tested for radioactive material leakage at intervals longer than six months, the applicant must include in the application sufficient documentation to demonstrate the longer interval is justified by performance characteristics of the sealed source or device or similar sources or devices and by design features having a significant bearing on the probability or consequences of radioactive material leakage from the sealed source;

(4) documentation considered in determining the acceptable interval for testing radioactive material leakage, includes:

(A) primary containment (sealed source capsule);

(B) protection of primary containment;

(D) containment construction materials;

(E) form of contained radioactive material;

(F) maximum temperature withstood during prototype tests;

(G) maximum pressure withstood during prototype tests;

(H) maximum quantity of contained radioactive material;

(I) radiotoxicity of contained radioactive material; and

(J) operating experience with identical sealed sources or devices or similarly designed and constructed sealed sources or devices; and

(5) the source or device has been registered in the national Sealed Source and Device Registry.

(p) Specific licenses for the manufacture and commercial distribution of radioactive material for certain in vitro clinical or laboratory testing under the general license. In addition to the requirements in subsection (e) of this section, a specific license to manufacture or commercially distribute radioactive material for use under the general license in §289.251(f)(4)(G) of this subchapter will be issued if the department approves the following information submitted by the applicant:

(1) documentation the radioactive material will be prepared for distribution in prepackaged units of:

(A) iodine-125 in units not exceeding 10 µCi (0.37 megabecquerel (MBq)) each;

(B) iodine-131 in units not exceeding 10 µCi (0.37 MBq) each;

(D) hydrogen-3 (tritium) in units not exceeding 50 µCi (1.85 MBq) each;

(E) iron-59 in units not exceeding 20 µCi (0.74 MBq) each;

(F) cobalt-57 in units not exceeding 10 µCi (0.37 MBq) each;

(G) selenium-75 in units not exceeding 10 µCi (0.37 MBq) each; or

(H) mock iodine-125 in units not exceeding 0.05 µCi (1.85 kBq) of iodine-129 and 0.005 µCi (0.185 kBq) of americium-241 each;

(2) evidence each prepackaged unit will bear a durable, clearly visible label:

(A) identifying the radioactive contents as to chemical form and radionuclide, and indicating the amount of radioactivity does not exceed 10 µCi (0.37 MBq) of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 50 µCi (1.85 MBq) of hydrogen-3 (tritium); 20 µCi (0.74 MBq) of iron-59; or mock iodine-125 in units not exceeding 0.05 µCi (1.85 kBq) of iodine-129 and 0.005 µCi (0.185 kBq) of americium-241; and

(B) displaying the radiation caution symbol as specified in §289.202(z) of this chapter and the words, "CAUTION, RADIOACTIVE MATERIAL," and "Not for Internal or External Use in Humans or Animals";

(3) one of the following statements, as appropriate, or a substantially similar statement appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure accompanying the package:

(A) option 1:

Attached Graphic

(B) option 2:

Attached Graphic

(4) the label affixed to the unit, or the leaflet or brochure accompanying the package, contains adequate information as to the precautions to be observed in handling and storing the 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 §289.202(ff) of this chapter.

(q) Specific licenses for the manufacture and commercial distribution of ice detection devices. In addition to the requirements of subsection (e) of this section, a specific license to manufacture and commercially distribute ice detection devices to a person generally licensed under §289.251(f)(4)(E) of this subchapter will be issued if the department approves the information submitted by the applicant. This information must satisfy the requirements of

10 CFR §32.61

and §32.62.

(r) Specific licenses for the manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing radioactive materials for medical use under §289.256 of this subchapter.

(1) In addition to the requirements in subsection (e) of this section, a specific license to manufacture, prepare, or transfer for commercial distribution, radioactive drugs containing radioactive material for use by a person authorized under §289.256 of this subchapter will be issued if the department approves the following information submitted by the applicant:

(A) evidence the applicant is at least:

(i) registered with the United States Food and Drug Administration (FDA) as the owner or operator of a drug establishment engaging in the manufacture, preparation, propagation, compounding, or processing of a drug under Title

21 CFR §207.17

(a); or

(ii) registered or licensed with a state agency as a drug manufacturer; or

(iii) licensed as a pharmacy by the Texas State Board of Pharmacy; or

(iv) operating as a nuclear pharmacy within a federal medical institution; or

(v) a positron emission tomography (PET) drug production facility registered with a state agency;

(B) radionuclide data relating to:

(i) chemical and physical form;

(ii) maximum activity per vial, syringe, generator, or other container of the radioactive drug; and

(iii) shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees;

(i) each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution must include:

(I) the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL";

(II) the name of the radioactive drug or its abbreviation; and

(III) the quantity of radioactivity at a specified date and time (the time may be omitted for radioactive drugs with a half-life greater than 100 days); and

(ii) each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution must include:

(I) radiation symbol and the words, "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; and

(II) an identifier ensuring the syringe, vial, or other container can be correlated with the information on the transport radiation shield.

(2) A licensee must possess and use instrumentation to measure the radioactivity of radioactive drugs and must have procedures for the use of the instrumentation. The licensee must measure, by direct measurement or by a combination of measurements and calculations, the amount of radioactivity in dosages of alpha, beta, or photon-emitting radioactive drugs before transfer for commercial distribution. In addition, the licensee must:

(A) perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary;

(B) check each instrument for constancy and proper operation at the beginning of each day of use; and

(C) make, maintain, and retain records of the tests and checks required in this paragraph for inspection by the department as specified in subsection (mm) of this section.

(3) A licensee described in paragraph (1)(A)(iii) or (iv) of this subsection may prepare radioactive drugs for medical use as defined in §289.256 of this subchapter with the following provisions.

(A) Radioactive drugs must be prepared by either an authorized nuclear pharmacist, as specified in subparagraphs (B) and (D) of this paragraph, or an individual under the supervision of an authorized nuclear pharmacist as specified in §289.256(s) of this subchapter.

(B) A pharmacist may be allowed to work as an authorized nuclear pharmacist if:

(i) the individual qualifies as an authorized nuclear pharmacist as defined in §289.256 of this subchapter;

(ii) the individual meets the requirements as specified in §289.256(k)(2) and (m) of this subchapter, and the licensee has received from the department, an approved license amendment identifying the individual as an authorized nuclear pharmacist; or

(iii) the individual is designated as an authorized nuclear pharmacist under subparagraph (D) of this paragraph.

(C) The actions authorized in subparagraphs (A) and (B) of this paragraph are permitted despite more restrictive language in license conditions.

(D) A licensee may designate a pharmacist, as defined in §289.256 of this subchapter, as an authorized nuclear pharmacist if:

(i) the individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material; and

(ii) the individual practiced at a pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the NRC or the department.

(E) The licensee must provide the following to the department:

(i) a copy of each individual's certification by a specialty board whose certification process has been recognized by the NRC, the department, or an agreement state as specified in §289.256(k)(1) of this subchapter; or

(ii) the department, NRC, or another agreement state license; or

(iii) NRC master materials licensee permit; or

(iv) the permit issued by a broad scope licensee or the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist; or

(v) documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC or the department; and

(vi) a copy of the Texas State Board of Pharmacy licensure or registration, no later than 30 days after the date the licensee allows, under subparagraph (B)(i) and (iii) of this paragraph, the individual to work as an authorized nuclear pharmacist.

(F) The radiopharmaceuticals for human use must be processed and prepared according to instructions furnished by the manufacturer on the label attached to or in the FDA-accepted instructions in the leaflet or brochure accompanying the generator or reagent kit.

(G) If the authorized nuclear pharmacist elutes generators or processes radioactive material with the reagent kit in a manner deviating from written instructions furnished by the manufacturer, a complete description of the deviation must be made and maintained for inspection by the department as specified in subsection (mm) of this section.

(4) A licensee must satisfy the labeling requirements in subsection (r)(1)(C) of this section.

(5) Nothing in this subsection relieves the licensee from complying with applicable FDA, or other federal and state requirements governing radioactive drugs.

(s) Specific licenses for the manufacture and commercial distribution of products containing depleted uranium for mass-volume applications.

(1) In addition to the requirements in subsection (e) of this section, a specific license to manufacture products and devices containing depleted uranium for use under §289.251(f)(3)(D) of this subchapter or equivalent regulations of the NRC or an agreement state, will be issued if the department approves the following information submitted by the applicant:

(A) 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 the 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 ten percent of the limits as specified in §289.202(f) of this chapter; and

(B) reasonable assurance is provided that unique benefits will accrue to the public because of the usefulness of the product or device.

(2) In the case of a product or device whose unique benefits are questionable, the department will issue a specific license under paragraph (1) of this subsection 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.

(3) The department may deny any application for a specific license under this subsection if the end use or uses of the product or device cannot be reasonably foreseen.

(4) Each person licensed under paragraph (1) of this subsection must:

(A) 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;

(B) 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 the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and

(ii) state the receipt, possession, use, and commercial distribution of the product or device are subject to a general license or the equivalent and the requirements of the NRC or of an agreement state;

(C) 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";

(D) furnish a copy of the following:

(i) the general license in §289.251(f)(3)(D) of this subchapter to each person to whom the licensee commercially distributes depleted uranium in a product or device for use under the general license in §289.251(f)(3)(D) of this subchapter;

(ii) the NRC's or agreement state's requirements equivalent to the general license in §289.251(f)(3)(D) of this subchapter and a copy of the NRC's or agreement state's certificate; or

(iii) alternately, a copy of the general license in §289.251(f)(3)(D) of this subchapter to each person to whom the licensee commercially distributes depleted uranium in a product or device for use under the general license of the NRC or an agreement state;

(E) report to the department all commercial distributions of products or devices to a person for use under the general license in §289.251(f)(3)(D) of this subchapter.

(i) The report must be submitted within 30 days after the end of each calendar quarter in which a product or device is commercially distributed to the generally licensed person and must include the following:

(I) the identity of each general licensee by name and address;

(II) the identity of an individual by name and position who may constitute a point of contact between the department and the general licensee;

(III) the type and model number of devices commercially distributed; and

(IV) the quantity of depleted uranium contained in the product or device.

(ii) If no commercial distributions have been made to a person generally licensed under §289.251(f)(3)(D) of this subchapter during the reporting period, the report must indicate this;

(F) report to the NRC and each responsible agreement state agency all commercial distributions of industrial products or devices to a person for use under the general license in the NRC's or agreement state's equivalent requirements to §289.251(f)(3)(D) of this subchapter. The report must meet the provisions of subparagraph (E)(i) and (ii) of this paragraph; and

(G) make, maintain, and retain records, including the name, address, and point of contact for each general licensee to whom the licensee commercially distributes depleted uranium in products or devices for use under the general license provided in §289.251(f)(3)(D) of this subchapter or equivalent requirements of the NRC or any agreement state. The records must be maintained for inspection by the department as specified in subsection (mm) of this section and must include 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.

(t) Specific licenses for the processing of loose radioactive material for manufacture and commercial distribution. In addition to the requirements in subsection (e) of this section, a license to process loose radioactive material for manufacture and commercial distribution of radioactive material to a person authorized to possess such radioactive material under this chapter will be issued if the department approves the following information submitted by the applicant:

(1) the radionuclides to be used, including the chemical and physical form and the maximum activity of each radionuclide;

(2) the intended use of each radionuclide and the sealed sources or other products to be manufactured, including:

(A) receipt of radioactive material;

(B) chemical or physical preparations;

(D) final assembly or processing;

(E) quality assurance testing;

(F) quality control program;

(G) leak testing;

(H) American National Standards Institute (ANSI) testing procedures;

(I) transportation containers;

(J) shipping procedures; and

(K) disposition of unwanted or unused radioactive material;

(3) scaled drawings of the facility to include:

(A) air filtration;

(B) ventilation system;

(D) radioactive material handling systems and, when applicable, remote handling hot cells;

(4) details of the environmental monitoring program; and

(5) documentation of training as specified in subsection (jj)(1) of this section for all personnel who handle radioactive materials.

(u) Specific licenses for other manufacture and commercial distribution of radioactive material. In addition to the requirements in subsection (e) of this section, a license to manufacture and commercially distribute radioactive material to a person authorized to possess such radioactive material under these requirements will be issued if the department approves the following information submitted by the applicant:

(1) the radionuclides to be used, including the chemical and physical form and the maximum activity of each radionuclide;

(2) the intended use of each radionuclide and the sealed sources or other products to be manufactured, including:

(A) receipt of radioactive material;

(B) chemical or physical preparations;

(D) final assembly or processing;

(E) quality assurance testing;

(F) quality control program;

(G) leak testing;

(H) ANSI testing procedures;

(I) transportation containers;

(J) shipping procedures; and

(K) disposition of unwanted or unused radioactive material;

(3) scaled drawings of radioactive material handling systems; and

(4) documentation of training as specified in subsection (jj)(1) of this section for all personnel who handle radioactive material.

(v) Sealed source or device evaluation.

(1) Any manufacturer or initial distributor of a sealed source or device containing a sealed source may submit a request to the department for evaluation of radiation safety information about its product and for its registration.

(2) The request for review must be sent to the department as specified in §289.201(k) of this chapter and must be submitted in duplicate accompanied by the appropriate fee as specified in §289.204 of this chapter.

(3) In order to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property, the request for evaluation of a sealed source or device must include sufficient information about the:

(A) design;

(B) manufacture;

(D) quality control program;

(E) labeling;

(F) proposed uses; and

(G) leak testing.

(4) The request for evaluation of a device must also include sufficient information about:

(A) installation;

(B) service and maintenance;

(D) its potential hazards.

(5) The department normally evaluates a sealed source or a device using radiation safety criteria within accepted industry standards. If these standards and criteria do not readily apply to a particular case, the department formulates reasonable standards and criteria with the help of the manufacturer or distributor. The department must use criteria and standards sufficient to ensure the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property. Section 289.251(e)(1) - (3) of this subchapter includes specific criteria applying to certain exempt products and §289.251(f) of this subchapter includes specific criteria applying to certain generally licensed devices. This section includes specific provisions applying to certain specifically licensed items.

(6) After completion of the evaluation, the department issues a sealed source and device (SS & D) certificate of registration to the person making the request. The SS & D certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product, or concerning use under an exemption from licensing or general license as applicable for the category of SS & D certificate of registration.

(7) The person submitting the request for evaluation and SS & D certificate of registration of safety information about the product must manufacture and distribute the product as specified in:

(A) the statements and representations, including the quality control program, contained in the request; and

(B) the provisions of the SS & D certificate of registration.

(8) Authority to manufacture or initially distribute a sealed source or device to specific licensees must be provided in the license without the issuance of a SS & D certificate of registration in the following cases:

(A) calibration and reference sources must contain no more than:

(i) 1 millicurie (mCi) (37 MBq) for beta or gamma emitting radionuclides; or

(ii) 10 µCi (0.37 MBq) for alpha emitting radionuclides; or

(B) the intended recipients are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in any form in the case of unregistered sources or, for registered sealed sources contained in unregistered devices, are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unshielded form, as specified in their licenses; and

(i) the intended recipients are licensed under subsection (h) of this section, §289.256(o) of this subchapter, or equivalent regulations of the NRC or any agreement state; or

(ii) the recipients are authorized for research and development; or

(iii) the sources and devices are to be built to the unique specifications of the particular recipient and contain no more than 20 curie (Ci) (740 gigabecquerel (GBq)) of tritium or 200 mCi (7.4 GBq) of any other radionuclide.

(9) After the SS & D certificate of registration is issued, the department may conduct an additional review as it determines is necessary to ensure compliance with current regulatory standards. In conducting its review, the department will complete its evaluation according to criteria specified in this section. The department may request additional information it considers necessary to conduct its review and the SS & D certificate of registration holder must provide the information requested.

(10) Inactivation of SS & D certificates of registration.

(A) An SS & D certificate of registration holder no longer manufacturing or initially transferring any of the sealed sources or devices covered by a particular SS & D certificate of registration issued by the department must request inactivation of the SS & D certificate of registration. Such a request must be made to the department by an appropriate method under §289.201(k) of this chapter and must be made no later than two years after initial distribution of all of the sources or devices covered by the SS & D certificate of registration have ceased. However, if the SS & D certificate of registration holder determines an initial transfer was in fact the last initial transfer more than two years after that transfer, the SS & D certificate of registration holder must request inactivation of the SS & D certificate of registration within 90 days of this determination and briefly describe the circumstances of the delay.

(B) If a distribution license is to be terminated under subsection (y) of this section, the licensee must request inactivation of its SS & D certificate of registration associated with that distribution license before the department will terminate the license. A request for inactivation of the SS & D certificate of registration must indicate the license is being terminated and include the associated specific license number.

(C) A specific license to manufacture or initially transfer a source or device covered only by an inactivated SS & D certificate of registration no longer authorizes the licensee to initially transfer such sources or devices for use. Servicing of devices must comply with any conditions in the SS & D certificate of registration, including in the case of an inactive SS & D certificate of registration.

(w) Issuance of specific licenses.

(1) When the department determines an application meets the requirements of the Act and the rules of this chapter, the department issues a specific license authorizing the proposed activity in such form and containing the conditions and limitations as the department deems appropriate or necessary.

(2) The department may incorporate in any license at the time of issuance, or by amendment, additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of radioactive material subject to this section as the department deems appropriate or necessary to:

(A) minimize danger to occupational and public health and safety and the environment;

(B) require reports and the keeping of records, and provide for inspections of activities under the license as may be appropriate or necessary; and

(3) The department may request, and the licensee must provide, additional information after the license has been issued to enable the department to determine whether the license should be modified as specified in subsection (dd) of this section.

(x) Specific terms and conditions of licenses.

(1) Each license issued under this section is subject to the applicable provisions of the Act and to applicable rules in effect and orders of the department.

(2) No license issued or granted under this section and no right to possess or utilize radioactive material granted by any license issued under this section may 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 department, after securing full information, finds the transfer complies with the Act, applicable rules in effect, and orders of the department. The department provides its consent in writing.

(3) An application for transfer of license must include:

(A) the identity, technical and financial qualifications of the proposed transferee; and

(B) financial assurance for decommissioning information required by subsection (gg) of this section.

(4) Each person licensed by the department under this section must confine use and possession of the radioactive material licensed to the locations and purposes authorized in the license. Radioactive material must not be used or stored in residential locations unless specifically authorized by the department.

(5) The licensee must notify the department in writing within 15 calendar days of any of the following changes:

(A) name;

(B) mailing address; or

(6) Each licensee must notify the department, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy by the licensee or its parent company, if the parent company is involved in the bankruptcy.

(7) The notification in paragraph six of this subsection must include:

(A) the bankruptcy court in which the petition for bankruptcy was filed; and

(B) the date of the filing of the petition.

(8) A copy of the petition for bankruptcy must be submitted to the department along with the written notification.

(9) In deciding whether to grant, deny, amend, renew, revoke, suspend, or restrict a license, the department may consider the technical competence and compliance history of an applicant or holder of a license. After an opportunity for a hearing, the department may deny an application for a license, an amendment to a license, or an application for renewal of a license if the applicant's compliance history reveals three or more disciplinary actions have been issued against the applicant within the previous six years. Disciplinary actions include those assessing administrative or civil penalties against the applicant or revoking or suspending the applicant's license.

(10) Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators must test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, under §289.256 of this subchapter.

(A) The licensee must make, maintain, and retain a record of the results of each test for inspection by the department, as specified in subsection (mm) of this section.

(B) The licensee must report the results of any test exceeding the permissible concentration listed in §289.256(ii) of this subchapter at the time of generator elution, as specified in §289.256(www) of this subchapter.

(11) Licensees must not hold radioactive waste, sources, or devices not authorized for disposal by decay in storage, and not in use for longer than 24 months following the last principal activity use. Sources and devices kept in standby for future use may be excluded from the 24-month time limit if the department approves a plan for future use. A plan for an alternative disposal timeframe may be submitted by the licensee if the 24-month time limit cannot be met. Licensees must submit plans to the department at least 30 days before the end of the 24 months of nonuse.

(y) Expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas.

(1) Except as provided in paragraph (2) of this subsection and subsection (z)(2) of this section, each specific license expires at the end of the day, in the month and year stated in the license.

(2) Expiration of the specific license does not relieve the licensee of the requirements of this chapter.

(3) All license provisions continue in effect beyond the expiration date, with respect to possession of radioactive material until the department notifies the former licensee in writing the provisions of the license are no longer binding. During this time, the former licensee must:

(A) be limited to actions involving radioactive material to those related to decommissioning; and

(B) continue to control entry to restricted areas until each location is suitable for release for unrestricted use, as specified in §289.202(ddd) of this chapter.

(4) Within 60 days of the occurrence of any of the following, each licensee must provide notification to the department in writing and either begin decommissioning a site, or any separate building or outdoor area containing residual radioactivity, so the building and outdoor area is suitable for release under §289.202(eee) of this chapter, or submit within 12 months of notification a decommissioning plan, if required by paragraph (7) of this subsection, and begin decommissioning upon approval of that plan if:

(A) the license has expired or has been revoked, as specified in this subsection or subsection (dd) of this section;

(B) the licensee has decided to permanently cease principal activities, as defined in §289.201(b) of this chapter, at the entire site or in any separate building or outdoor area containing residual radioactivity and the building or outdoor area is unsuitable for release, as specified in department requirements;

(C) no principal activities at an entire site as specified in the license have been conducted for a period of 24 months; or

(D) no principal activities have been conducted for a period of 24 months in any separate building or outdoor area containing residual radioactivity such that the building or outdoor area is unsuitable for release under §289.202(eee) of this chapter.

(5) Coincident with the notification required by paragraph (4) of this subsection, the licensee must maintain in effect all decommissioning financial assurances established by the licensee, as specified in subsection (gg) of this section in conjunction with a license issuance or renewal or as required by this section. The amount of the financial assurance must be increased, or may be decreased, as appropriate, with department approval, to cover the detailed cost estimate for decommissioning established under paragraph (10)(E) of this subsection.

(A) Any licensee who has not provided financial assurance to cover the detailed cost estimate submitted with the decommissioning plan must do so as specified in subsection (gg) of this section.

(B) Following approval of the decommissioning plan, a licensee may reduce the amount of the financial assurance as decommissioning proceeds and radiological contamination is reduced at the site, with the approval of the department.

(6) The department may grant a request to delay or postpone initiation of the decommissioning process if the department determines such relief is not detrimental to the occupational and public health and safety and is otherwise in the public interest. The request must be submitted no later than 30 days before notification under paragraph (4) of this subsection. The schedule for decommissioning set forth in paragraph (4) of this subsection must not commence until the department has decided on the request.

(7) A decommissioning plan must be submitted if required by license condition or if the procedures and activities necessary to carry out decommissioning of the site or separate building or outdoor area have not been previously approved by the department and these procedures 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) The department may approve an alternate schedule for submittal of a decommissioning plan required under paragraph (4) of this subsection if the department determines the alternative schedule is necessary to the effective conduct of decommissioning operations and presents no undue risk from radiation to the occupational and public health and safety and is otherwise in the public interest.

(9) The procedures listed in paragraph (7) of this subsection must not be carried out before approval of the decommissioning plan.

(10) The proposed decommissioning plan for the site or separate building or outdoor area must include the following:

(A) a description of the conditions of the site or separate building or outdoor area sufficient to evaluate the acceptability of the plan;

(B) a description of planned decommissioning activities;

(C) a description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning;

(D) a description of the planned final radiation survey;

(E) an updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning; and

(F) for decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, a justification for the delay based on the criteria in paragraph (15) of this subsection.

(11) The proposed decommissioning plan will be approved by the department if the information in the plan demonstrates the decommissioning will be completed as soon as practicable and the health and safety of workers and the public will be adequately protected.

(12) Except as provided in paragraph (14) of this subsection, licensees must complete decommissioning of the site or separate building or outdoor areas as soon as practicable but no later than 24 months following the initiation of decommissioning.

(13) Except as provided in paragraph (14) of this subsection, when decommissioning involves the entire site, the licensee must request license termination as soon as practicable but no later than 24 months following the initiation of decommissioning.

(14) The department may approve a request for an alternate schedule for completion of decommissioning of the site or separate building or outdoor area, and license termination if appropriate, if the department determines the alternative is warranted by consideration of the following:

(A) whether it is technically feasible to complete decommissioning within the allotted 24-month period;

(B) whether sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted 24-month period;

(C) whether a significant volume reduction in wastes requiring disposal is achieved by allowing short-lived radionuclides to decay;

(D) whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and

(E) other site-specific factors the department may consider appropriate on a case-by-case basis, such as the regulatory requirements of other government agencies, lawsuits, groundwater treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.

(15) As the final step in decommissioning, the licensee must:

(A) certify the disposition of all licensed material, including accumulated wastes; and

(B) conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey unless the licensee demonstrates the premises are suitable for release according to the radiological requirements for license termination as specified in §289.202(ddd) of this chapter. The licensee must, as appropriate:

(i) report the following levels:

(I) gamma radiation in units of microroentgen per hour (µR/hr) (millisieverts per hour (mSv/hr)) at 1 meter (m) from surfaces;

(II) radioactivity, including alpha and beta, in units of disintegrations per minute (dpm) or microcuries (µCi) (megabecquerels (MBq)) per 100 square centimeters (cm

) for surfaces;

(III) µCi (MBq) per milliliter for water; and

(IV) picocuries (pCi) (becquerels (Bq)) per gram (g) for solids such as soils or concrete; and

(ii) specify the manufacturer's name and model and serial number of each survey instrument used and certify each instrument is properly calibrated, as specified in §289.202(p) of this chapter, and tested.

(16) The department will provide written notification to specific licensees, including former licensees with provisions continued in effect beyond the expiration date under paragraph (3) of this subsection, that the provisions of the license are no longer binding. The department provides such notification when the department determines:

(A) radioactive material has been properly disposed;

(B) reasonable effort has been made to eliminate residual radioactive contamination, if present;

(C) a radiation survey has been performed demonstrating the premises are suitable for release according to the radiological requirements for license termination as specified in §289.202(ddd) of this chapter, or other information submitted by the licensee is sufficient to demonstrate the premises are suitable for release according to the radiological requirements for license termination as specified in §289.202(ddd) of this chapter; and

(D) any outstanding fees under §289.204 of this chapter are paid and any outstanding notices of violations of this chapter or of license conditions are resolved.

(17) Each licensee must submit to the department all records required by §289.202(nn)(3) of this chapter before the license is terminated.

(z) Renewal of licenses.

(1) Requests for renewal of specific licenses must be filed as specified in subsection (d)(1) - (4) and (6) - (8) of this section. In any application for renewal, the applicant may incorporate drawings by clear and specific reference (for example, title, date, and unique number of drawing), if no modifications have been made since previously submitted.

(2) In any case in which a licensee, not less than 30 days before expiration of an existing license, has filed a request in proper form for renewal or for a new license authorizing the same activities, the existing license will not expire until the request has been finally determined by the department. In any case in which a licensee, not more than 90 days after the expiration of an existing license, has filed a request in proper form for renewal or for a new license authorizing the same activities, the department may reinstate the license and extend the expiration until the request has been finally determined by the department. The requirements in this subsection are subject to the provisions of Texas Government Code, §2001.054.

(3) An application for technical renewal of a license will be approved if the department determines the requirements of subsection (e) of this section are satisfied.

(aa) Amendment of licenses at request of licensee.

(1) Requests for amendment of a license must be filed as specified in subsection (d)(1) - (4) of this section, must be signed by management or the RSO, and must specify the respects in which the licensee desires a license to be amended and the grounds for the amendment.

(2) Requests for amendments to delete a subsite from a license must be filed as specified in subsections (d)(1) and (2) and (y)(13) and (15) of this section.

(bb) Department action on requests to renew or amend. In considering a request by a licensee to renew or amend a license, the department applies the criteria in subsection (e) of this section as applicable.

(cc) Transfer of material.

(1) A licensee must not transfer radioactive material except as authorized under this chapter. This subsection does not include transfer for commercial distribution.

(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 department, only after receiving approval from the department;

(B) to the United States Department of Energy (DOE);

(D) to any person authorized to receive such material under the terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the department, the NRC, or any agreement state, or to any person otherwise authorized to receive such material by the federal government or any agency of the federal government, the department, or any agreement state; or

(E) as otherwise authorized by the department in writing.

(3) Before transferring radioactive material to a specific licensee of the department, the NRC, or any agreement state, or to a general licensee who is required to register with the department, the NRC, or any agreement state before receipt of the radioactive material, the licensee transferring the material must verify 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 possesses and has read a current copy of the transferee's specific license.

(B) When a current copy of the transferee's specific license described in subparagraph (A) of this paragraph is not readily available or when a transferor desires to verify the information received is correct or up-to-date, the transferor may obtain and record confirmation from the department, the NRC, or any agreement state the transferee is licensed to receive the radioactive material.

(5) Preparation for shipment and transport of radioactive material must be performed as specified in the provisions of subsection (ff) of this section.

(6) Requirements for a specific license to initially transfer source material to a person generally licensed under §289.251(f)(3) of this subchapter.

(A) An application for a specific license to initially transfer source material for use under §289.251(f)(3) of this subchapter;

10 CFR §40.22

; or equivalent regulations of any agreement state, will be approved if:

(i) the applicant satisfies the general requirements as specified in subsection (e) of this section; and

(ii) the applicant submits adequate information on, and the department approves, the methods to be used for quality control, labeling, and providing safety instructions to recipients.

(B) Quality control, labeling, safety instructions, and records and reports. Each person licensed under subparagraph (A) of this paragraph must:

(i) label the immediate container of each quantity of source material with the type of source material and quantity of material and the words, "radioactive material";

(ii) ensure the quantities and concentrations of source material are as labeled and indicated in any transfer records;

(iii) provide the information as specified in this clause to each person to whom source material is transferred for use under §289.251(f)(3) of this subchapter;

10 CFR §40.22

; or equivalent regulations of any agreement state. This information must be provided before the source material is transferred for the first time in each calendar year to the recipient. The required information includes:

(I) a copy of this subsection, and as applicable, §289.251(f)(3) of this subchapter;

10 CFR §40.22

; or the equivalent agreement state regulation; and

10 CFR §40.51

; or the equivalent agreement state regulations; and

(II) appropriate radiation safety precautions and instructions relating to handling, use, storage, and disposal of the material; and

(iv) report transfers as follows:

(I) File a report with the department and the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555. The report must include the following information:

(-a-) the name, address, and license number of the person who transferred the source material;

(-b-) for each general licensee under §289.251(f)(3) of this subchapter;

10 CFR §40.22

; or equivalent regulations of any agreement state to whom greater than 50 grams (0.11 pounds (lb)) of source material has been transferred in a single calendar quarter, the name and address of the general licensee to whom source material is distributed; a responsible agent, by name or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred; and

(-c-) the total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients.

(II) File a report with each responsible agreement state agency that identifies all persons operating under §289.251(f)(3) of this subchapter;

10 CFR §40.22

; or equivalent regulations of any agreement state to whom greater than 50 grams (0.11 lb) of source material has been transferred within a single calendar quarter. The report must include the following information specific to those transfers made to the agreement state being reported to:

(-a-) the name, address, and license number of the person who transferred the source material; and

(-b-) the name and address of the general licensee to whom source material was distributed; a responsible agent, by name or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred; and

(-c-) the total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients within the agreement state.

(III) The following are to be submitted to the department by January 31 of each year:

(-a-) each report required by subclauses (I) and (II) of this clause covering all transfers for the previous calendar year;

(-b-) if no transfers were made during the current period to a person generally licensed under §289.251(f)(3) of this subchapter;

10 CFR §40.22

; or equivalent regulations of any agreement state, a report to the department indicating so; and

(-c-) if no transfers have been made to general licensees in a particular agreement state during the reporting period, this information must be reported to the responsible agreement state upon request of that agency.

(i) The licensee must maintain all information supporting the reports required by this paragraph concerning each transfer to a general licensee for inspection by the department, as specified in subsection (mm) of this section.

(ii) The licensee transferring the material must retain each record of transfer of radioactive material until the department terminates each license authorizing the activity subject to the recordkeeping requirement.

(dd) Modification, suspension, and revocation of licenses.

(1) The terms and conditions of all licenses are subject to revision or modification. A license may be modified, suspended, or revoked due to amendments to the Act or rules in this chapter, or orders issued by the department or a court.

(2) Any license may be revoked, suspended, or modified, in whole or in part, for any of the following:

(A) any material false statement in the application or any statement of fact required under provisions of the Act;

(B) conditions revealed by such application or statement of fact or any report, record, or inspection, or other means warranting department refusal to grant a license on an original application;

(C) violation of, or failure to observe any of the terms and conditions of the Act, this chapter, the license, or order of the department or court; or

(D) existing conditions constituting a substantial threat to the public health or safety or the environment.

(3) Each specific license revoked by the department ends at the end of the day on the date of the department's final determination to revoke the license, or on the revocation date stated in the determination, or as otherwise provided by the department order.

(4) Except in cases in which the occupational and public health or safety requires otherwise, no license will be suspended or revoked unless, before the institution of proceedings, facts or conduct warranting such action is called to the attention of the licensee in writing and the licensee has been given an opportunity to demonstrate compliance with all lawful requirements.

(ee) Reciprocal recognition of licenses.

(1) Subject to this section, any person who holds a specific license from the NRC or any agreement 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 granted a general license to conduct the activities authorized in such licensing document within the State of Texas provided:

(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 department in writing at least three working days before 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 department, obtain permission to proceed sooner. The department 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 under the general license provided in this subsection. Such notification must include:

(i) the exact location, start date, duration, and type of activity to be conducted;

(ii) the identification of the radioactive material to be used;

(iii) the name and in-state address of each individual performing the activity;

(iv) a copy of the applicant's pertinent license;

(v) a copy of the licensee's operating, safety, and emergency procedures;

(vi) a fee as specified in §289.204 of this chapter; and

(vii) a copy of the completed RC Form 252-1 (Business Information Form);

(C) the out-of-state licensee complies with all applicable rules of the department and with all the terms and conditions of the licensee's licensing document, except any such terms and conditions inconsistent with applicable rules of the department;

(D) the out-of-state licensee supplies such other information as the department may request;

(E) the out-of-state licensee must not transfer or dispose of radioactive material possessed or used under the general license provided in this subsection except by transfer to a person:

(i) specifically licensed by the department, the NRC, or any agreement state to receive such material, or

(ii) exempt from the requirements for a license for such material under §289.251(e)(1) of this subchapter; and

(F) the out-of-state licensee must always have the following documents in their possession when conducting work in Texas, and make them available for department review upon request:

(i) a copy of the department letter granting the licensee reciprocal recognition of their out-of-state license;

(ii) a copy of the licensee's operating and emergency procedures;

(iii) a copy of the licensee's radioactive material license;

(iv) a copy of all applicable sections of this chapter; and

(v) a copy of the completed RC Form 252-3 notifying the department of the licensee's intent to work in Texas.

(2) In addition to the provisions of paragraph (1) of this subsection, any person who holds a specific license issued by the NRC or any agreement state authorizing the holder to manufacture, transfer, install, or service the device described in §289.251(f)(4)(H) of this subchapter or in

10 CFR §150.20

, within areas subject to the jurisdiction of the licensing body, is granted a general license to install, transfer, demonstrate, or service the device in the State of Texas provided that:

(A) the person files a report with the department 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 report must identify by name and address, each general licensee to whom the device is transferred, the type of device transferred by manufacturer's name, model and 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 as specified in applicable provisions of the specific license issued to the person by the NRC or any agreement state;

(C) the person assures any labels required to be affixed to the device according to requirements of the authority licensing the manufacture of the device, bear a statement that "Removal of this label is prohibited"; and

(D) the holder of the specific license furnishes to each general licensee to whom the holder of the specific license transfers the device, or on whose premises the holder of the specific license installs the device, a copy of the general license contained in §289.251(f)(4)(H) of this subchapter.

(3) The department may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by another agency, or any product distributed under the licensing document, upon determining the action is necessary to prevent undue hazard to occupational and public health and safety and the environment.

(ff) Preparation of radioactive material for transport. Requirements for the preparation of radioactive material for transport are specified in §289.257 of this subchapter.

(gg) Financial assurance and record keeping for decommissioning.

(1) The applicant for a specific license or renewal of a specific license, or holder of a specific license, authorizing the possession and use of radioactive material must submit and receive written authorization for a decommissioning funding plan as described in paragraph (4) of this subsection in an amount sufficient to allow the department to engage a third party to decommission each site specified on the license for the following situations:

(A) when unsealed radioactive material requested or authorized on the license, with a half-life greater than 120 days, is in quantities exceeding 10

times the applicable quantities set forth in subsection (jj)(2) of this section;

(B) when a combination of the unsealed radionuclides requested or authorized on the license, with a half-life greater than 120 days, results in the R of the radionuclides divided by 10

being greater than 1 (unity rule), where R is defined as the sum of the ratios of the quantity of each radionuclide to the applicable value in subsection (jj)(2) of this section;

(C) when sealed sources or plated foils requested or authorized on the license, with a half-life greater than 120 days and in quantities exceeding 10

times the applicable quantities set forth in subsection (jj)(2) of this section (or when a combination of isotopes is involved if R, as defined in this subsection, divided by 10

is greater than 1), must submit a decommissioning funding plan as described in paragraph (4) of this subsection; or

(D) when radioactive material requested or authorized on the license is in quantities more than 100 mCi (3.7 GBq) of source material in a readily dispersible form.

(2) The applicant for a specific license or renewal of a specific license or the holder of a specific license authorizing possession and use of radioactive material as specified in paragraph (3) of this subsection must either:

(A) submit a decommissioning funding plan as described in paragraph (4) of this subsection in an amount sufficient to allow the department to engage a third party to decommission each site specified on the license; or

(B) submit financial assurance for decommissioning in the amount specified in paragraph (3) of this subsection, using one of the methods described in paragraph (6) of this subsection, in an amount sufficient to allow the department to engage a third party to decommission each site specified on the license.

(3) The required amount of financial assurance for decommissioning is determined by the quantity of material authorized by the license and is determined as follows:

(A) readtac$ext.TacPage?sl=T&app=9&p_dir=F&p_rloc=221280&p_tloc=127978&p_ploc=118040&pg=14&p_tac=&ti=25&pt=1&ch=289&rl=252,125,000 for quantities of material greater than 10

but less than or equal to 10

times the applicable quantities in subsection (jj)(2) of this section in unsealed form. (For a combination of radionuclides, if R, as defined in paragraph (1) of this subsection, divided by 10

is greater than 1 but R divided by 10

is less than or equal to 1);

(B) $225,000 for quantities of material greater than 10

but less than or equal to 10

times the applicable quantities in subsection (jj)(2) of this section in unsealed form. (For a combination of radionuclides, if R, as defined in paragraph (1) of this subsection, divided by 10

is greater than 1 but R divided by 10

if less than or equal to 1);

but less than or equal to 10

times the applicable quantities in subsection (jj)(2) of this section in sealed sources or plated foils. (For a combination of radionuclides, if R, as defined in paragraph (1) of this subsection, divided by 10

is greater than 1, but R divided by 10

is less than or equal to 1); or

(D) $225,000 for quantities of source material greater than 10 mCi (0.37 GBq) but less than or equal to 100 mCi (3.7 GBq) in a readily dispersible form.

(4) Each decommissioning funding plan must:

(A) be submitted for review and approval and must contain the following:

(i) a detailed cost estimate for decommissioning in an amount reflecting:

(I) the cost of an independent contractor to perform all decommissioning activities;

(II) the cost of meeting the criteria of §289.202(ddd)(2) of this chapter for unrestricted use provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of §289.202(ddd)(3) of this chapter, then the cost estimate may be based on meeting the criteria of §289.202(ddd)(3) of this chapter;

(III) the volume of onsite subsurface material containing residual radioactivity requiring remediation to meet the criteria for license termination; and

(IV) an adequate contingency factor;

(ii) identification of and justification for using the key assumptions contained in the detailed cost estimate;

(iii) a description of the method of assuring funds for decommissioning from paragraph (6) of this subsection, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;

(iv) a certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and

(v) a signed original of the financial instrument obtained to satisfy the requirements of paragraph (6) of this subsection (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning); and

(B) be resubmitted at the time of license renewal and at intervals not to exceed three years with adjustments as necessary to account for changes in costs and the extent of contamination. If the amount of financial assurance is adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:

(i) spills of radioactive material producing additional residual radioactivity in onsite subsurface material;

(ii) waste inventory increasing above the amount previously estimated;

(iii) waste disposal costs increasing above the amount previously estimated;

(iv) facility modifications;

(v) changes in authorized possession limits;

(vi) actual remediation costs exceeding the previous cost estimate;

(vii) onsite disposal; and

(viii) use of a settling pond.

(5) Financial assurance in conjunction with a decommissioning funding plan must be submitted as follows:

(A) for an applicant for a specific license, financial assurance as described in paragraph (6) of this subsection, may be obtained after the application has been approved and the license issued by the department, but must be submitted to the department before receipt of licensed material; or

(B) for an applicant for renewal of a specific license, or a holder of a specific license, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (6) of this subsection must be submitted with the decommissioning funding plan.

(6) Financial assurance for decommissioning must be provided by one or more of the following methods. The financial instrument obtained must be continuous for the term of the license in a form prescribed by the department. The applicant or licensee must obtain written approval of the financial instrument or any amendment to it from the department.

(A) Prepayment is the deposit 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 decommissioning costs will be paid. 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 (jj)(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. For commercial corporations issuing bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in subsection (jj)(4) of this section. For commercial companies not issuing bonds, a guarantee of funds by the applicant or licensee for decommissioning costs may be used if the guarantee and test are as contained in

subsection (jj)(5) of this section. For nonprofit entities, such as colleges, universities, and nonprofit hospitals, a guarantee of funds by the applicant or licensee may be used if the guarantee and test are as contained in subsection (jj)(6) of this section. A guarantee by the applicant or licensee may not be used in combination with any other financial methods to satisfy the requirements of this section or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company. 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 before the renewal date, the issuer notifies the department, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide the full face amount be paid to the beneficiary automatically before the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the department within 30 days after receipt of notification of cancellation.

(ii) The surety method or insurance must be payable in the State of Texas to the Radiation and Perpetual Care Account.

(iii) The surety method or insurance must remain in effect until the department 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 comply 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 as specified in paragraph (3) of this subsection, and indicating funds for decommissioning will be obtained when necessary.

(E) When a governmental entity is assuming custody and ownership of a site, there must be an arrangement deemed acceptable by such governmental entity.

(7) Each person licensed under this section must make, maintain, and retain records of information important to the safe and effective decommissioning of the facility in an identified location for inspection by the department, as specified in subsection (mm) of this section. If records of relevant information are kept for other purposes, reference to these records and their locations may be used. Information the department considers important to decommissioning consists of the following:

(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 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 or stored, and of locations of possible inaccessible contamination such as buried pipes subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee must substitute appropriate records of available information concerning these areas and locations;

(C) except for areas containing only sealed sources (provided the sealed sources have not leaked or no contamination remains after any leak) or byproduct materials having only half-lives of less than 65 days, a list contained in a single document and updated every two years of:

(i) all areas designated and formerly designated as restricted areas as defined in §289.201(b) of this chapter;

(ii) all areas outside of restricted areas requiring documentation under subparagraph (A) of this paragraph; and

(iii) all areas outside of restricted areas containing material where, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in §289.202(ddd) of this chapter, or meet the requirements for approval of disposal under §289.202(ff) - (kk) of this chapter; and

(D) 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.

(hh) Emergency plan for responding to a release.

(1) A new or renewal 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 (jj)(7) of this section, must contain either:

(A) an evaluation showing the maximum dose to a person offsite due to a release of radioactive material would not exceed 1 rem effective dose equivalent or 5 rem 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 under paragraph (1)(A) of this subsection:

(A) the radioactive material is physically separated so 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 (jj)(7) 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 (jj)(7) of this section;

(F) operating restrictions or procedures would prevent a release fraction as large as that in subsection (jj)(7) 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 under 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. Identification of each radioactive materials accident type for which protective actions may be needed.

(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 department; 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 unavailability of some personnel, parts of the facility, and some equipment will not prevent the notification and coordination. The licensee must also commit to notify the department 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 from 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) 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 department.

(J) Training. A brief description of the frequency, performance objectives, and plans for the training 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 must familiarize personnel with site-specific emergency procedures. Also, the training must comprehensively prepare site personnel to effectively respond to accidents considered as most probable for the specific site and include the use of team training for such events.

(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 at intervals not to exceed three months and biennial onsite exercises to test response to simulated emergencies. Communications checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee must 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 must not be known to most exercise participants. The licensee must 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 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 use of the radioactive material.

(4) The licensee must 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 department. The licensee must provide any comments received during the 60 days to the department with the emergency plan.

(ii) Physical protection of category 1 and category 2 quantities of radioactive material.

(1) Specific exemptions. A licensee possessing radioactive waste containing category 1 or category 2 quantities of radioactive material is exempt from the requirements of paragraphs (2) - (23) of this subsection, except any radioactive waste containing discrete sources, ion-exchange resins, or activated material weighing less than 2,000 kilograms (kg) (4,409 lb) is not exempt from the requirements of this subsection. The licensee must implement the following requirements to secure the radioactive waste:

(A) use continuous physical barriers allowing access to the radioactive waste only through established access control points;

(B) use a locked door or gate with monitored alarm at the access control point;

(C) assess and respond to each actual or attempted unauthorized access to determine whether an actual or attempted theft, sabotage, or diversion occurred; and

(D) immediately notify the local law enforcement agency (LLEA) and request an armed response from the LLEA upon determination there was an actual or attempted theft, sabotage, or diversion of the radioactive waste containing category 1 or category 2 quantities of radioactive material.

(2) Personnel access authorization requirements for category 1 or category 2 quantities of radioactive material.

(A) General.

(i) Each licensee possessing an aggregated quantity of radioactive material at or above the category 2 threshold must establish, implement, and maintain its access authorization program, as specified in the requirements of this paragraph and paragraphs (3) - (8) of this subsection.

(ii) An applicant for a new license and each licensee that would become subject to the requirements of this paragraph and paragraphs (3) - (8) of this subsection upon application for modification of its license, must implement the requirements of this paragraph and paragraphs (3) - (8) of this subsection, as appropriate, before taking possession of an aggregated category 1 or category 2 quantity of radioactive material.

(iii) Any licensee that has not previously implemented the security orders or been subject to this paragraph and paragraphs (3) - (8) of this subsection must implement the provisions of these paragraphs before aggregating radioactive material to a quantity equaling or exceeding the category 2 threshold.

(B) General performance objective. The licensee's access authorization program must ensure individuals specified in subparagraph (C)(i) of this paragraph are trustworthy and reliable.

(i) Licensees must subject the following individuals to an access authorization program:

(I) any individual whose assigned duties require unescorted access to category 1 or category 2 quantities of radioactive material or to any device containing the radioactive material; and

(II) reviewing officials.

(ii) Licensees need not subject the categories of individuals listed in paragraph (6)(A)(i) - (xiii) of this subsection to the investigation elements of the access authorization program.

(iii) Licensees must approve for unescorted access to category 1 or category 2 quantities of radioactive material only those individuals with job duties requiring unescorted access to category 1 or category 2 quantities of radioactive material.

(iv) Licensees may include individuals needing access to safeguards information-modified handling under

10 CFR Part 73

, in the access authorization program under this paragraph and paragraphs (3) - (8) of this subsection.

(3) Access authorization program requirements.

(A) Granting unescorted access authorization.

(i) Licensees must implement the requirements of paragraph (2), this paragraph, and paragraphs (4) - (8) of this subsection for granting initial or reinstated unescorted access authorization.

(ii) Individuals who have been determined to be trustworthy and reliable must also complete the security training required by paragraph (10)(C) of this subsection before being allowed unescorted access to category 1 or category 2 quantities of radioactive material.

(B) Reviewing officials.

(i) Reviewing officials are the only individuals who may make trustworthiness and reliability determinations allowing individuals to have unescorted access to category 1 or category 2 quantities of radioactive materials possessed by the licensee.

(ii) Each licensee must name one or more individuals to be reviewing officials. After completing the background investigation on the reviewing official, the licensee must provide to the department under oath or affirmation, a certification the reviewing official is deemed trustworthy and reliable by the licensee. The fingerprints of the named reviewing official must be taken by a law enforcement agency, federal or state agencies providing fingerprinting services to the public, or commercial fingerprinting services authorized by a state to take fingerprints. The licensee must recertify the reviewing official is deemed trustworthy and reliable every 10 years, as specified in paragraph (4)(C) of this subsection.

(iii) Reviewing officials must be permitted to have unescorted access to category 1 or category 2 quantities of radioactive materials or access to safeguards information or safeguards information-modified handling if the licensee possesses safeguards information or safeguards information-modified handling.

(iv) Reviewing officials cannot approve other individuals to act as reviewing officials.

(v) A reviewing official does not need to undergo a new background investigation before being named by the licensee as the reviewing official if:

(I) the individual has undergone a background investigation, including fingerprinting and a Federal Bureau of Investigation (FBI) criminal history records check and has been determined to be trustworthy and reliable by the licensee; or

(II) the individual is subject to a category listed in paragraph (6)(A) of this subsection.

(i) Licensees may not initiate a background investigation without the informed and signed consent of the subject individual. This consent must include authorization to share personal information with other individuals or organizations as necessary to complete the background investigation. Before a final adverse determination, the licensee must provide the individual with an opportunity to correct any inaccurate or incomplete information developed during the background investigation. Licensees do not need to obtain signed consent from those individuals meeting the requirements of paragraph (4)(B) of this subsection. A signed consent must be obtained before any reinvestigation.

(ii) The subject individual may withdraw his or her consent at any time. Licensees must inform the individual that:

(I) if an individual withdraws his or her consent, the licensee may not initiate any elements of the background investigation not in progress at the time the individual withdrew his or her consent; and

(II) the withdrawal of consent for the background investigation is sufficient cause for denial or termination of unescorted access authorization.

(D) Personal history disclosure. Any individual who is applying for unescorted access authorization must disclose the personal history information required by the licensee's access authorization program for the reviewing official to determine the individual's trustworthiness and reliability. Refusal to provide, or the falsification of, any personal history information required by paragraph (2), this paragraph, and paragraphs (4) - (8) of this subsection is sufficient cause for denial or termination of unescorted access.

(E) Determination basis.

(i) The reviewing official must determine whether to permit, deny, unfavorably terminate, maintain, or administratively withdraw an individual's unescorted access authorization based on an evaluation of all the information collected to meet the requirements of paragraph (2), this paragraph, and paragraphs (4) - (8) of this subsection.

(ii) The reviewing official may not permit any individual to have unescorted access until the reviewing official has evaluated all the information collected to meet the requirements of paragraph (2), this paragraph, and paragraphs (4) - (8) of this subsection and determined the individual is trustworthy and reliable. The reviewing official may deny unescorted access to any individual based on information obtained at any time during the background investigation.

(iii) The licensee must document the basis for concluding whether there is reasonable assurance an individual is trustworthy and reliable.

(iv) The reviewing official may terminate or administratively withdraw an individual's unescorted access authorization based on information obtained after the background investigation has been completed and the individual granted unescorted access authorization.

(v) Licensees must maintain a list of persons currently approved for unescorted access authorization. When a licensee determines a person no longer requires unescorted access or meets the access authorization requirement, the licensee must:

(I) remove the person from the approved list as soon as possible, but no later than seven working days; and

(II) take prompt measures to ensure the individual is unable to have unescorted access to the material.

(F) Procedures. Licensees must develop, implement, and maintain written procedures for implementing the access authorization program. The procedures must:

(i) include provisions for the notification of individuals who are denied unescorted access;

(ii) include provisions for the review, at the request of the affected individual, of a denial or termination of unescorted access authorization; and

(iii) contain a provision to ensure the individual is informed of the grounds for the denial or termination of unescorted access authorization and allow the individual an opportunity to provide additional relevant information.

(G) Right to correct and complete information.

(i) Before any final adverse determination, licensees must provide each individual subject to paragraph (2), this paragraph, and paragraphs (4) - (8) of this subsection with the right to complete, correct, and explain information obtained resulting from the licensee's background investigation. Confirmation of receipt by the individual of this notification must be maintained by the licensee for inspection by the department as specified in subsection (mm) of this section.

(ii) If, after reviewing his or her criminal history record, an individual believes it is incorrect or incomplete in any respect and wishes to change, correct, update, or explain anything in the record, the individual may initiate challenge procedures. These procedures include direct application by the individual challenging the record to the law enforcement agency contributing the questioned information or a direct challenge as to the accuracy or completeness of any entry on the criminal history record to the Federal Bureau of Investigation, Criminal Justice Information Services (CJIS) Division, ATTN: SCU, Mod. D-2, 1000 Custer Hollow Road, Clarksburg, WV 26306 as set forth in

28 CFR §§16.30

- 16.34. In the latter case, the FBI will forward the challenge to the agency submitting the data and will request the agency verify or correct the challenged entry. Upon receipt of an official communication directly from the agency contributing the original information, the FBI Identification Division makes any changes necessary according to the information supplied by that agency. Licensees must provide at least 10 days for an individual to initiate action to challenge the results of an FBI criminal history records check after the record being made available for his or her review. The licensee may make a final adverse determination based upon the criminal history records only after receipt of the FBI's confirmation or correction of the record.

(H) Records. The licensee must make, maintain, and retain the following records/documents for inspection by the department as specified in subsection (mm) of this section. The licensee must maintain superseded versions or portions of the following records/documents for inspection by the department as specified in subsection (mm) of this section:

(i) documentation regarding the trustworthiness and reliability of individual employees;

(ii) a copy of the current access authorization program procedures; and

(iii) the current list of persons approved for unescorted access authorization.

(4) Background investigations.

(A) Initial investigation. Before allowing an individual unescorted access to category 1 or category 2 quantities of radioactive material or to the devices containing the material, licensees must complete a background investigation of the individual seeking unescorted access authorization. The scope of the investigation must encompass at least the seven years preceding the date of the background investigation or since the individual's eighteenth birthday, whichever is shorter. The background investigation must include at a minimum:

(i) fingerprinting and an FBI identification and criminal history records check as specified in paragraph (5) of this subsection;

(ii) verification of true identity. Licensees must:

(I) verify the true identity of the individual who is applying for unescorted access authorization to ensure the applicant is who the individual claims to be;

(II) review official identification documents (e.g., driver's license; passport; government identification; certificate of birth issued by the state, province, or country of birth) and compare the documents to personal information data provided by the individual to identify any discrepancy in the information;

(III) document the type, expiration, and identification number of the identification document, or maintain a photocopy of identifying documents on file as specified in paragraph (7) of this subsection;

(IV) certify in writing the identification was properly reviewed; and

(V) maintain the certification and all related documents for inspection by the department as specified in subsection (mm) of this section;

(iii) employment history verification. Licensees must:

(I) complete an employment history verification, including military history; and

(II) verify the individual's employment with each previous employer for the most recent seven years before the date of application;

(iv) verification of education. Licensees must verify the individual participated in the education process during the claimed period;

(v) character and reputation determination. Licensees must complete reference checks to determine the character and reputation of the individual applying for unescorted access authorization. Unless other references are not available, reference checks may not be conducted with any person who is known to be a close member of the individual's family, including the individual's spouse, parents, siblings, or children, or any individual who resides in the individual's permanent household. Reference checks as specified in paragraphs (2) and (3), this paragraph, and paragraphs (5) - (8) of this subsection must be limited to whether the individual has been and continues to be trustworthy and reliable;

(vi) the licensee must also, to the extent possible, obtain independent information to corroborate information provided by the individual (e.g., seek references not supplied by the individual); and

(vii) if a previous employer, educational institution, or any other entity with which the individual claims to have been engaged fails to provide information or indicates an inability or unwillingness to provide information within a time frame deemed appropriate by the licensee, but at least after 10 business days of the request, or if the licensee is unable to reach the entity, the licensee must document the refusal, unwillingness, or inability in the record of investigation and attempt to obtain the information from an alternate source.

(B) Grandfathering.

(i) Individuals who have been determined to be trustworthy and reliable for unescorted access to category 1 or category 2 quantities of radioactive material as specified in the fingerprint orders may continue to have unescorted access to category 1 and category 2 quantities of radioactive material without further investigation. These individuals are subject to the reinvestigation requirement.

(ii) Individuals determined to be trustworthy and reliable under

10 CFR Part 73

, or the security orders for access to safeguards information, safeguards information-modified handling, or risk-significant material may have unescorted access to category 1 and category 2 quantities of radioactive material without further investigation. The licensee must document the individual was determined to be trustworthy and reliable under

10 CFR Part 73

, or a security order. Security order, in this context, refers to any order issued by the NRC requiring fingerprints and an FBI criminal history records check for access to safeguards information, safeguards information-modified handling, or risk significant material such as special nuclear material or large quantities of uranium hexafluoride. These individuals are subject to the reinvestigation requirement.

(C) Reinvestigations. Licensees must conduct a reinvestigation every 10 years for any individual with unescorted access to category 1 or category 2 quantities of radioactive material. The reinvestigation must consist of fingerprinting and an FBI identification and criminal history records check as specified in paragraph (5) of this subsection. The reinvestigations must be completed within 10 years of the date on which these elements were last completed.

(5) Requirements for criminal history records checks of individuals granted unescorted access to category 1 or category 2 quantities of radioactive material.

(A) General performance objective and requirements.

(i) Except for those individuals listed in paragraph (6) of this subsection and those individuals grandfathered under paragraph (4)(B) of this subsection, each licensee subject to the requirements of paragraphs (2) - (4), this paragraph, and paragraphs (6) - (8) of this subsection must:

(I) fingerprint each individual who is to be permitted unescorted access to category 1 or category 2 quantities of radioactive material;

(II) transmit all collected fingerprints to the NRC for transmission to the FBI; and

(III) use the information received from the FBI as part of the required background investigation to determine whether to grant or deny further unescorted access to category 1 or category 2 quantities of radioactive materials for that individual.

(ii) The licensee must notify each affected individual their fingerprints will be used to secure a review of their criminal history record and must inform the individual of the procedures for revising the record or adding explanations to the record.

(iii) Fingerprinting is not required if a licensee is reinstating an individual's unescorted access authorization to category 1 or category 2 quantities of radioactive materials if:

(I) the individual returns to the same facility granting unescorted access authorization within 365 days of the termination of the individual's unescorted access authorization; and

(II) the previous access was terminated under favorable conditions.

(iv) Fingerprints do not need to be taken if an individual who is an employee of a licensee, contractor, manufacturer, or supplier has been granted unescorted access to category 1 or category 2 quantities of radioactive material, access to safeguards information, or safeguards information-modified handling by another licensee, based upon a background investigation conducted under paragraphs (2) - (4), this paragraph, and paragraphs (6) - (8) of this subsection, the fingerprint orders, or

10 CFR Part 73

. An existing criminal history records check file may be transferred to the licensee asked to grant unescorted access as specified in the requirements of paragraph (7)(C) of this subsection.

(v) Licensees must use the information obtained as part of a criminal history records check solely for the purpose of determining an individual's suitability for unescorted access authorization to category 1 or category 2 quantities of radioactive materials, access to safeguards information, or safeguards information-modified handling.

(B) Prohibitions.

(i) Licensees may not base a final determination to deny an individual unescorted access authorization to category 1 or category 2 quantities of radioactive material solely on the basis of information received from the FBI involving:

(I) an arrest more than one year old for which there is no information of the disposition of the case; or

(II) an arrest resulting in dismissal of the charge or an acquittal.

(ii) Licensees may not use information received from a criminal history records check obtained under paragraphs (2) - (4), this paragraph, and paragraphs (6) - (8) of this subsection in a manner infringing on the rights of any individual under the First Amendment to the Constitution of the United States, nor may licensees use the information in any way discriminating among individuals on the basis of race, religion, national origin, gender, or age.

(i) For the purpose of complying with paragraphs (2) - (4), this paragraph, and paragraphs (6) - (8) of this subsection, licensees must use an appropriate method listed in

10 CFR §37.7

, to submit to the U.S. Nuclear Regulatory Commission, Director, Division of Physical and Cyber Security Policy, 11545 Rockville Pike, ATTN: Criminal History Program/Mail Stop T-07D04M, 11545 Rockville Pike, Rockville, Maryland 20852, one completed, legible standard fingerprint card (Form FD-258, ORIMDNRCOOOZ), electronic fingerprint scan, or, where practicable, other fingerprint record for each individual requiring unescorted access to category 1 or category 2 quantities of radioactive material. Copies of these forms may be obtained by emailing

MAILSVS.Resource@nrc.gov

. Guidance on submitting electronic fingerprints can be found at

https://www.nrc.gov/security/chp.html

(ii) Fees for the processing of fingerprint checks are due upon application. Licensees must submit payment with the application for the processing of fingerprints through corporate check, certified check, cashier's check, money order, or electronic payment, made payable to "U.S. NRC." (For guidance on making electronic payments, contact the Division of Physical and Cyber Security Policy by emailing

Crimhist.Resource@nrc.gov.

) Combined payment for multiple applications is acceptable. The NRC publishes the amount of the fingerprint check application fee on the NRC's public website. (To find the current fee amount, go to the Licensee Criminal History Records Checks & Firearms Background Check information page at

https://www.nrc.gov/security/chp.html

and see the link for How do I determine how much to pay for the request?).

(iii) The NRC will forward to the submitting licensee all data received from the FBI as a result of the licensee's application for criminal history records checks.

(6) Relief from fingerprinting, identification, and criminal history records checks and other elements of background investigations for designated categories of individuals permitted unescorted access to certain radioactive materials.

(A) Fingerprinting, the identification and criminal history records checks required by Section 149 of the Atomic Energy Act of 1954, as amended, and other elements of the background investigation are not required for the following individuals before granting unescorted access to category 1 or category 2 quantities of radioactive materials:

(i) an employee of the NRC or of the Executive Branch of the U.S. Government who has undergone fingerprinting for a prior U.S. Government criminal history records check;

(ii) a member of Congress;

(iii) an employee of a member of Congress or Congressional committee who has undergone fingerprinting for a prior U.S. Government criminal history records check;

(iv) the governor of a state or his or her designated state employee representative;

(v) federal, state, or local law enforcement personnel;

(vi) state radiation control program directors and state homeland security advisors or their designated state employee representatives;

(vii) agreement state employees conducting security inspections on behalf of the NRC under an agreement executed as specified in section 274.i. of the Atomic Energy Act;

(viii) representatives of the International Atomic Energy Agency (IAEA) engaged in activities associated with the U.S./IAEA Safeguards Agreement who have been certified by the NRC;

(ix) emergency response personnel who are responding to an emergency;

(x) commercial vehicle drivers for road shipments of category 1 and category 2 quantities of radioactive material;

(xi) package handlers at transportation facilities such as freight terminals and railroad yards;

(xii) any individual having an active federal security clearance, if the individual makes available the appropriate documentation. Written confirmation from the agency/employer granting the federal security clearance or reviewed the criminal history records check must be provided to the licensee. The licensee must maintain and retain this documentation for inspection by the department as specified in subsection (mm) of this section; and

(xiii) any individual employed by a service provider licensee for which the service provider licensee has conducted the background investigation for the individual and approved the individual for unescorted access to category 1 or category 2 quantities of radioactive material. Written verification from the service provider must be provided to the licensee. The licensee must maintain and retain the documentation for inspection by the department as specified in subsection (mm) of this section.

(B) Fingerprinting, and the identification and criminal history records checks required by Section 149 of the Atomic Energy Act of 1954, as amended, are not required for an individual who has had a favorably adjudicated U.S. Government criminal history records check within the last five years, under a comparable U.S. Government program involving fingerprinting and an FBI identification and criminal history records check, provided the individual makes available the appropriate documentation. Written confirmation from the agency/employer reviewing the criminal history records check must be provided to the licensee. The licensee must maintain and retain this documentation for inspection by the department as specified in subsection (mm) of this section. These programs include:

(i) National Agency Check;

(ii) Transportation Worker Identification Credentials (TWIC) under

49 CFR Part 1572

;

(iii) Bureau of Alcohol, Tobacco, Firearms, and Explosives background check and clearances under

27 CFR Part 555

;

(iv) Health and Human Services security risk assessments for possession and use of select agents and toxins under

42 CFR Part 73

;

(v) Hazardous Material security threat assessment for hazardous material endorsement to commercial driver's license under

49 CFR Part 1572

; and

(vi) Customs and Border Protection's Free and Secure Trade (FAST) Program.

(7) Protection of information.

(A) Each licensee who obtains background information on an individual under paragraphs (2) - (6), this paragraph, or paragraph (8) of this subsection must establish and maintain a system of files and written procedures for protection of the record and the personal information from unauthorized disclosure.

(B) The licensee may not disclose the record or personal information collected and maintained to any person other than the subject individual, the individual's representative, or to those having a need to access to the information in performing assigned duties in the process of granting or denying unescorted access to category 1 or category 2 quantities of radioactive material, safeguards information, or safeguards information-modified handling. No individual authorized to have access to the information may disseminate the information to any other individual who does not have a need to know.

(C) The personal information obtained on an individual from a background investigation may be provided to another licensee:

(i) upon the individual's written request to the licensee holding the data to disseminate the information contained in his or her file; and

(ii) provided the recipient licensee verifies information such as name, date of birth, social security number, gender, and other applicable physical characteristics.

(D) The licensee must make background investigation records obtained under paragraphs (2) - (6), this paragraph, and paragraph (8) of this subsection available for examination by an a

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