(a) Scope. Except as otherwise specifically provided, this section applies to all persons who receive, possess, use, transfer, or acquire any radioactive material unless the person is subject to regulation by the United States Nuclear Regulatory Commission (NRC). This section does not apply to radioactive material in the possession of federal agencies. State regulation of source material, byproduct material, and special nuclear material in quantities not sufficient to form a critical mass is subject to the provisions of the agreement between the state and NRC and to Part 150 of NRC regulations (10 Code of Federal Regulations (CFR) Part 150). A person who receives, possesses, uses, owns, transfers, or acquires radioactive material before receiving a license is subject to the requirements of this chapter. (b) Definitions. The following words and terms when used in this chapter have the following meanings unless the context clearly indicates otherwise. (1) Absorbed dose--The energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad. (2) Accelerator-produced material--Any material made radioactive by exposing it to the radiation from a particle accelerator. (3) Access control--A system for allowing only approved individuals to have unescorted access to the security zone and for ensuring that all other individuals are subject to escorted access. (4) Act--Texas Radiation Control Act, Texas Health and Safety Code (HSC) Chapter 401. (5) Activity--The rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel (Bq) and the curie (Ci). (6) Adult--An individual 18 or more years of age. (7) Aggregated--Accessible by the breach of a single physical barrier that would allow access to radioactive material in any form, including any devices that contain the radioactive material, when the total activity equals or exceeds a category 2 quantity of radioactive material. (8) Agreement state--Any state with which NRC has entered into an effective agreement under Section 274 of the Atomic Energy Act of 1954, as amended. (9) Airborne radioactive material--Any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases. (10) Airborne radioactivity area--A room, enclosure, or area in which airborne radioactive materials exist in concentrations: (A) over the derived air concentrations (DACs) specified in Table I, Column 3 of §289.202(ggg)(2)(F) of this subchapter (relating to Standards for Protection Against Radiation from Radioactive Materials); or (B) to such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 percent of the annual limit on intake (ALI) or 12 derived air concentration-hours (DAC-hours). (11) Approved individual--An individual whom the licensee has determined to be trustworthy and reliable for unescorted access as specified in §289.252(ii)(2)-(8) of this chapter (relating to Licensing of Radioactive Material) and who has completed the training required by §289.252(ii)(10)(C) of this chapter. (12) As low as is reasonably achievable (ALARA)--Making every reasonable effort to maintain exposures to radiation as far below the dose limits in these regulations as is practical, consistent with the purpose for which the licensed activity is undertaken, taking into account the state of technology, the economics of improvements in relation to the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of ionizing radiation and licensed sources of radiation in the public interest. (13) Background investigation--The investigation conducted by a licensee or applicant to support the determination of trustworthiness and reliability. (14) Background radiation--Radiation from cosmic sources; non-technologically enhanced, naturally occurring radioactive material, including radon, except as a decay product of source or special nuclear material; and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents, such as Chernobyl, contributing to background radiation and not under the control of the licensee. "Background radiation" does not include radiation from sources of radiation regulated by the department. (15) Becquerel (Bq)--The International System of Units (SI) unit of activity. One becquerel is equal to one disintegration or transformation per second (dps or tps). Commonly used multiples of the becquerel are the kBq (kilobecquerel, 103 Bq), MBq (megabecquerel, 106 Bq), GBq (gigabecquerel, 109 Bq), and TBq (terabecquerel, 1012 Bq). 1 Ci = 37 GBq. (16) Bioassay--The determination of kinds, quantities, or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of this chapter, "radiobioassay" is an equivalent term. (17) Brachytherapy--A method of radiation therapy in which sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, or interstitial application. (18) Byproduct material--Byproduct material is defined as: (A) any radioactive material (except special nuclear material) yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear material; (B) the tailings or wastes produced by or resulting from the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute "byproduct material" within this definition; (C) any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity;(D) any material that has been made radioactive by use of a particle accelerator; and is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or (E) any discrete source of naturally occurring radioactive material, other than source material, that is extracted or converted after extraction before, on, or after August 8, 2005, for use in a commercial, medical, or research activity and that the United States NRC, in consultation with the Administrator of the United States Environmental Protection Agency (EPA), the United States Secretary of Energy, the United States Secretary of Homeland Security, and the head of any other appropriate federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security. (19) Category 1 quantity of radioactive material--A quantity of radioactive material meeting or exceeding the category 1 threshold in §289.252(jj)(9) of this chapter. This is determined by calculating the ratio of the total activity of each radionuclide to the category 1 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds one, the quantity would be considered a category 1 quantity. Category 1 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. (20) Category 2 quantity of radioactive material--A quantity of radioactive material meeting or exceeding the category 2 threshold but less than the category 1 threshold in §289.252(jj)(9) of this chapter. This is determined by calculating the ratio of the total activity of each radionuclide to the category 2 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds one, the quantity would be considered a category 2 quantity. Category 2 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. (21) Certificate of registration--A form of permission to engage in regulated activities given by the department to an applicant who has met the requirements for registration or mammography system certification set out in the Act and this chapter. (22) Certification of mammography systems (state certification)--A form of permission to engage in regulated activities given by the department to an applicant who has met the requirements for mammography system certification set out in the Act and this chapter. (23) Collective dose--The sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation. (24) Commercial--Having financial profit as the primary aim. (25) Committed dose equivalent (HT,50 ) --The dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake. (26) Committed effective dose equivalent (HE,50 )--The sum of the products of the weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (HE,50 = &SgrWT HT,50 ). (27) Consortium--An association of medical use licensees and a Positron Emission Tomography (PET) radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance costs of the PET radionuclide production facility. The PET radionuclide production facility produces radionuclides for production and noncommercial distribution of radioactive drugs among consortium members for medical use and is located at an educational institution or a medical facility. (28) Constraint (dose constraint)--A value above which specified licensee actions are required. (29) Critical group--The group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances. (30) Curie (Ci)--A unit of measurement of radioactivity. One curie (Ci) is the quantity of radioactive material that decays at the rate of 3.7 x 1010 disintegrations per second (dps). Commonly used submultiples of the curie are the millicurie (mCi) and the microcurie (µCi). One mCi = 1 x 10-3 Ci = 3.7 x 107 dps. One µCi = 1 x 10-6 Ci = 3.7 x 104 dps. One nanocurie (nCi) = 1 x 10-9 Ci = 3.7 x 101 dps. One picocurie (pCi) = 1 x 10-12 Ci = 3.7 x 10-2 dps. (31) Decommission--To remove a facility or site safely from service and reduce residual radioactivity to a level that permits the following: (A) release of the property for unrestricted use or termination of license; or (B) release of the property under alternate requirements for license termination. (32) Deep dose equivalent (Hd ), that applies to external whole body exposure--The dose equivalent at a tissue depth of 1 centimeter (cm) (1,000 milligrams per square centimeter (mg/cm2 )). (33) Department--The Department of State Health Services. (34) Depleted uranium--The source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material. (35) Discrete source--A radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities. (36) Distinguishable from background--The detectable concentration of a radionuclide is statistically different from the background concentration of that radionuclide in the vicinity of the site, or, in the case of structures or equipment, in similar materials using adequate measurement technology, survey, and statistical techniques. (37) Distribution--The physical conveyance and authorized transfer of commodities from producers to consumers and any intermediate persons involved in that conveyance. (38) Diversion--The unauthorized movement of radioactive material subject to §289.252(ii) of this chapter to a location different from the material's authorized destination inside or outside of the site at which the material is used or stored. (39) Dose--A generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of this chapter, "radiation dose" is an equivalent term. (40) Dose equivalent (HT )--The product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem. (41) Dose limits--The permissible upper bounds of radiation doses established as specified in this chapter. For purposes of this chapter, "limits" is an equivalent term.(42) Effective dose equivalent (HE )--The sum of the products of the dose equivalent to each organ or tissue (HT ) and the weighting factor (WT ) applicable to each of the body organs or tissues that are irradiated (HE = &SgrWT HT ). (43) Embryo/fetus--The developing human organism from conception until the time of birth. (44) Entrance or access point--Any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed sources of radiation. This includes portals of sufficient size to permit human access, irrespective of their intended use. (45) Escorted access--Accompaniment while in a security zone by an approved individual who maintains continuous direct visual surveillance, at all times over an individual who is not approved for unescorted access.(46) Exposure--The quotient of dQ by dm where "dQ" is the absolute value of the total charge of the ions of one sign produced in air when all the electrons and positrons liberated by photons in a volume element of air having mass "dm" are completely stopped in air. The SI unit of exposure is the coulomb per kilogram (C/kg). The roentgen is the special unit of exposure. For purposes of this chapter, this term is used as a noun.(47) Exposure rate--The exposure per unit of time.(48) External dose--That portion of the dose equivalent received from any source of radiation outside the body.(49) Extremity--Hand, elbow, arm below the elbow, foot, knee, and leg below the knee. The arm above the elbow and the leg above the knee are considered part of the whole body.(50) Fingerprint orders--The orders issued by the NRC or the legally binding requirements issued by agreement states that require fingerprints and criminal history records checks for individuals with unescorted access to category 1 and category 2 quantities of radioactive material or Safeguards Information-Modified Handling files. (51) Generally applicable environmental radiation standards--Standards issued by the EPA under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material. (52) Gray (Gy)--The SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (J/kg) or 100 rad. (53) High radiation area--An area, accessible to individuals, in which radiation levels from sources of radiation external to the body could result in an individual receiving a dose equivalent more than 0.1 rem (1 millisievert (mSv)) in one hour at 30 cm from any source of radiation or from any surface that the radiation penetrates. (54) Human use--The internal or external administration of radiation or radioactive material to human beings for healing arts purposes or research and development specifically authorized by the department. (55) Individual--Any human being. (56) Individual monitoring--The assessment of: (A) dose equivalent to an individual using individual monitoring devices; or (B) committed effective dose equivalent to an individual by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours. (See the definition for DAC-hours in §289.202(c) of this subchapter ); or (C) dose equivalent to an individual using survey data. (57) Individual monitoring device--Device designed to be worn by a single individual (such as a film badge, thermoluminescent dosimeter (TLD), optically stimulated luminescence dosimeter (OSL), or digital output personnel dosimeter) used for the assessment of dose equivalent. For purposes of this chapter, "personnel dosimeter" and "dosimeter" are equivalent terms. (58) Inspection--An official examination or observation, including records, tests, surveys, and monitoring to determine compliance with the Act and rules, orders, requirements, and conditions of the department. (59) Internal dose--That portion of the dose equivalent received from radioactive material taken into the body. (60) Ionizing radiation--Any electromagnetic or particulate radiation capable of producing ions, directly or indirectly, in its passage through matter. Ionizing radiation includes gamma rays and x-rays, alpha and beta particles, high-speed electrons, neutrons, and other nuclear particles. (61) Land disposal facility--The land, buildings, and equipment that are intended to be used for the disposal of low-level radioactive waste (LLRW) into the subsurface of the land. (62) Lens dose equivalent--The external dose equivalent to the lens of the eye at a tissue depth of 0.3 cm (300 mg/cm2 ). (63) License--A form of permission to engage in regulated activities given by the department to an applicant who has met the requirements for licensing set out in the Act and this chapter. (64) Licensed material--Radioactive material received, possessed, used, or transferred under a general or specific license issued by the department. (65) Licensee--Any person who is licensed by the department as specified in the Act and this chapter. (66) Local law enforcement agency (LLEA)--A public or private organization that has been approved by a federal, state, or local government to carry firearms and make arrests, and is authorized and has the capability to provide an armed response in the jurisdiction where the licensed category 1 or category 2 quantity of radioactive material is used, stored, or transported. (67) Lost or missing radioactive material--Radioactive material whose location is unknown. This definition includes licensed material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system. (68) Low-level radioactive waste (LLRW)--Radioactive material that meets the following criteria: (A) LLRW includes: (i) discarded or unwanted radioactive material not exempt by rule adopted under the Texas Radiation Control Act (Act), specifically, HSC, §401.106; (ii) waste, as that term is defined in 10 CFR §61.2; and (iii) radioactive material subject to: (I) concentration limits established in 10 CFR §61.55, or compatible rules adopted by the department or the Texas Commission on Environmental Quality (TCEQ), as applicable; and (II) disposal criteria established in