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RULE §289.231 General Provisions and Standards for Protection Against Machine-Produced Radiation

Published: 2015

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(a) Purpose.   (1) This section establishes standards for protection against ionizing radiation resulting from the use of radiation machines.   (2) The requirements in this section are designed to control the receipt, possession, use, and transfer of radiation machines by any person so the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in this section. However, nothing in this section shall be construed as limiting actions that may be necessary to protect health and safety in an emergency. A person who receives, possesses, uses, owns, or acquires radiation machines prior to receiving a certificate of registration is subject to the requirements of this chapter. (b) Scope.   (1) Except as specifically provided in other sections of this chapter, this section applies to persons who receive, possess, use, or transfer radiation machines. The dose limits in this section do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released in accordance with this chapter, or to voluntary participation in medical research programs. However, no radiation may be deliberately applied to human beings except by or under the supervision of an individual authorized by and licensed in accordance with Texas' statutes to engage in the healing arts.   (2) Registrants who are also licensed by the agency to receive, possess, use, and transfer radioactive materials must also comply with the requirements of §289.201 of this title (relating to General Provisions for Radioactive Material) and §289.202 of this title (relating to Standards for Protection Against Radiation from Radioactive Material). (c) Definitions. The following words and terms when used in this section shall have the following meaning, 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) Act--Texas Radiation Control Act, Health and Safety Code, Chapter 401.   (3) Adult--An individual 18 or more years of age.   (4) Agency--The Department of State Health Services.   (5) Agreement State--Any state with which the United States Nuclear Regulatory Commission (NRC) has entered into an effective agreement under §274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689).   (6) As low as is reasonably achievable (ALARA)--Making every reasonable effort to maintain exposures to radiation as far below the dose limits in this chapter as is practical, consistent with the purpose for which the registered 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 radiation machines in the public interest.   (7) 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 including global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents, such as Chernobyl, that contribute to background radiation and are not under the control of the registrant. "Background radiation" does not include radiation from sources of radiation regulated by the agency.   (8) Certificate of registration--A form of permission given by the agency to an applicant who has met the requirements for registration or mammography system certification set out in the Texas Radiation Control Act (Act) and this chapter.   (9) Certification of mammography systems (state certification)--A form of permission given by the agency to an applicant who has met the requirements for mammography system certification set out in the Act and this chapter.   (10) Chiropractor--An individual licensed by the Texas Board of Chiropractic Examiners.   (11) 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.   (12) Declared pregnant woman--A woman who has voluntarily informed the registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman voluntarily withdraws the declaration in writing or is no longer pregnant.   (13) Deep dose equivalent (DDE), that applies to external whole body exposure--The dose equivalent (DE) at a tissue depth of 1 centimeter (cm) (1,000 milligrams per square centimeter (mg/cm 2 )).   (14) Dentist--An individual licensed by the Texas State Board of Dental Examiners.   (15) Dose--For external exposure to x-ray radiation from radiation machines, a generic term that means absorbed dose, DE, or total effective dose equivalent. For purposes of this chapter, "radiation dose" is an equivalent term.   (16) Dose equivalent (DE)--The product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of DE are the sievert (Sv) and rem.   (17) Dose limits--The permissible upper bounds of radiation doses established in accordance with this chapter. For purposes of this chapter, "limits" is an equivalent term.   (18) Dosimetry processor--A person that processes and evaluates personnel monitoring devices in order to determine the radiation dose delivered to the monitoring devices.   (19) Embryo/fetus--The developing human organism from conception until the time of birth.   (20) Entrance or access point--Any opening through which an individual or extremity of an individual could gain access to radiation areas or to radiation machines. This includes portals of sufficient size to permit human access, irrespective of their intended use.   (21) 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 (negatrons and positrons) liberated by photons in a volume element of air having mass "dm" are completely stopped in air. The International System of Units (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.   (22) Exposure rate (air kerma rate)--The exposure per unit of time.   (23) External dose--That portion of the DE received from any source of radiation outside the body.   (24) 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.   (25) 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.   (26) 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 DE in excess of 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.   (27) Human use--For exposure to x-ray radiation from radiation machines, the external administration of radiation to human beings for healing arts purposes or research and/or development specifically authorized by the agency.   (28) Individual--Any human being.   (29) Individual monitoring--The assessment of DE to an individual by the use of:     (A) individual monitoring devices; or     (B) survey data.   (30) Individual monitoring devices--Devices designed to be worn by a single individual for the assessment of DE. For purposes of this chapter, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples of individual monitoring devices include, but are not limited to, film badges, thermoluminescence dosimeters (TLDs), optically stimulated luminescence dosimeters (OSLs), pocket ionization chambers (pocket dosimeters), and electronic personal dosimeters.   (31) Inspection--An official examination and/or observation including, but not limited to, records, tests, surveys, and monitoring to determine compliance with the Act and rules, orders, requirements, and conditions of the agency.   (32) 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.   (33) Lens dose equivalent (LDE)--The external DE to the lens of the eye at a tissue depth of 0.3 cm (300 mg/cm2 ).   (34) License--A form of permission given by the agency to an applicant who has met the requirements for licensing set out in the Act and this chapter.   (35) Licensed material--Radioactive material received, possessed, used, or transferred under a general or specific license issued by the agency.   (36) Licensee--Any person who is licensed by the agency in accordance with the Act and this chapter.   (37) Licensing state--Any state with rules equivalent to the Suggested State Regulations for Control of Radiation relating to, and having an effective program for, the regulatory control of naturally occurring or accelerator-produced radioactive material (NARM) and has been designated as such by the Conference of Radiation Control Program Directors, Inc.   (38) Lost or missing radiation machine(s)--A radiation machine(s) whose location is unknown.   (39) Machine-produced radiation--A stimulated emission of radiation from a manufactured product or device or component part of a manufactured product or device that has an electronic circuit that during operation can generate or emit a physical field of radiation.   (40) Manufacture--To fabricate or mechanically produce.   (41) Member of the public--Any individual, except when that individual is receiving an occupational dose.   (42) Minimal threat radiation machines--Those radiation machines capable of generating or emitting fields of radiation that, during the operation of which:     (A) no deliberate exposure of an individual occurs;     (B) the radiation is not emitted in an open beam configuration; and     (C) no physical injury to an individual has occurred and is known by the agency.   (43) Minor--An individual less than 18 years of age.   (44) Monitoring--The measurement of radiation and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of this chapter, "radiation monitoring" and "radiation protection monitoring" are equivalent terms.   (45) Occupational dose--The dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to sources of radiation from licensed/registered and unlicensed/unregistered sources of radiation, whether in the possession of the licensee/registrant or other person. Occupational dose does not include dose received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with this chapter, from voluntary participation in medical research programs, or as a member of the public.   (46) Particle accelerator--Any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and designed to discharge the resultant particulate or other associated radiation at energies usually in excess of 1 MeV.   (47) Person--Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, local government, any other state or political subdivision or agency thereof, or any other legal entity, and any legal successor, representative, agent, or agency of the foregoing, other than the NRC, and other than federal government agencies licensed or exempted by the NRC.   (48) Personnel monitoring equipment--(See definition for individual monitoring devices.)   (49) Physician--An individual licensed by the Texas Medical Board.   (50) Podiatrist--An individual licensed by the Texas State Board of Podiatric Medical Examiners.   (51) Public dose--The dose received by a member of the public from exposure to sources of radiation released by a licensee, or to any other source of radiation under the control of a licensee/registrant. It does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with this chapter, or from voluntary participation in medical research programs.   (52) Quarter--A period of time equal to one-fourth of the year observed by the registrant, approximately 13 consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters. Cont'd...