Historical Note

Former Rule Section A.1; Former Section R12-1-101 repealed, new Section R12-1-101 adopted effective June 30, 1977 (Supp. 77-3). Amended effective April 2, 1990 (Supp. 90-2). Amended effective August 10, 1994 (Supp. 94-3). Amended effective June 13, 1997 (Supp. 97-2). Amended by final rulemaking at 9 A.A.R. 1126, effective May 9, 2003 (Supp. 03-1).

R12-1-102. Definitions

Terms defined in A.R.S. § 30-651 have the same meanings when used in this Chapter. Additional subject-specific definitions are used in other Articles.

"A ₁ " means the maximum activity of special form radioactive material permitted in a Type A package.

"A ₂ " means the maximum activity of radioactive material, other than special form radioactive material, permitted in a Type A package. These values are either listed in 10 CFR 71.137, Appendix A, Table A-1, or may be derived in accordance with the procedure prescribed in 10 CFR 71.137, Appendix A, 2001 Edition, published January 1, 2001, incorporated by reference and on file with the Agency and the Office of the Secretary of State. This incorporation by reference contains no future editions or amendments.

"Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad.

"Accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 MeV. For purposes of this definition, "particle accelerator" is an equivalent term.

"Accelerator produced material" means any material made radioactive by irradiating it in a particle accelerator.

"Act" means A.R.S. Title 30, Chapter 4.

"Activity" means the rate of disintegration, transformation, or decay of radioactive material. The units of activity are the becquerel (Bq) and the curie (Ci).

"Adult" means an individual 18 or more years of age.

"Agency," or "ARRA" means the Arizona Radiation Regulatory Agency.

"Agreement State" means any state with which the United States Nuclear Regulatory Commission has entered into an effective agreement under Section 274(b) of the Atomic Energy Act of 1954, as amended (73 Stat. 689). Nonagreement State means any other state.

"Airborne radioactive material" means any radioactive material dispersed in the air in the form of aerosols, dusts, fumes, mists, vapors, or gases.

"Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed radioactive material, exist in concentrations:

In excess of the derived air concentrations (DACs) specified in Appendix B, Table I of Article 4 of these rules, or

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% of the annual limit on intake (ALI) or 12 DAC-hours.

"ALARA" means as low as is reasonably achievable, making every reasonable effort to maintain exposures to radiation as far below the dose limits in these rules as is practical, consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to 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 nuclear energy and licensed or registered sources of radiation in the public interest.

"Analytical x-ray equipment" means equipment used for x-ray diffraction or x-ray-induced fluorescence analysis.

"Analytical x-ray system" means a group of components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials.

"Annual" means done or performed yearly. For purposes of Chapter 1 any required activity done or performed within plus or minus two weeks of the annual due date is considered done or performed in a timely manner.

"Background radiation" means radiation from cosmic sources; not 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, that contribute to background radiation and are not under the control of a licensee. "Background radiation" does not include sources of radiation regulated by the Agency.

"Becquerel" (Bq) means the International System (SI) unit for activity and is equal to 1 disintegration per second (dps or tps).

"Bioassay" means 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 these rules, "radiobioassay" is an equivalent term.

"Brachytherapy" means a method of radiation therapy in which an encapsulated source or group of sources is utilized to deliver beta or gamma radiation at a distance of up to a few centimeters, by surface, intracavitary or interstitial application.

"Byproduct material" means:

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; and

The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium or thorium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute "byproduct material" within this definition.

"Calendar quarter" means not less than 12 consecutive weeks nor more than 14 consecutive weeks. The first calendar quarter of each year shall begin in January and subsequent calendar quarters shall be so arranged such that no day is included in more than one calendar quarter and no day in any one year is omitted from inclusion within a calendar quarter. A licensee or registrant shall not change the method of determining calendar quarters for purposes of this Chapter except at the beginning of a calendar year.

"Calibration" means the determination of:

The response or reading of an instrument relative to a series of known radiation values over the range of the instrument or

The strength of a source of radiation relative to a standard.

"Certifiable cabinet x-ray system" means an existing uncertified x-ray system that meets or has been modified to meet the certification requirements specified in 21 CFR 1020.40, 2001 Edition, published April 1, 2001, incorporated by reference and on file with the Agency and the Office of Secretary of State. This incorporation by reference contains no future editions or amendments.

"Certified cabinet x-ray system" means an x-ray system that has been certified in accordance with 21 CFR 1010.2, as being manufactured and assembled on or after April 10, 1975, in accordance with the provisions of 21 CFR 1020.40, both references 2001 Edition, published April 1, 2001, incorporated by reference and on file with the Agency and the Office of Secretary of State. These incorporations by reference contain no future editions or amendments.

"CFR" means Code of Federal Regulations.

"Chelating agent" means amine polycarboxylic acids, hydroxycarboxylic acids, gluconic acid, and polycarboxylic acids.

"Civil penalty" means the monetary fine which may be imposed on licensees by the Agency, pursuant to A.R.S. § 30-687, for violations of the Act, this Chapter, or license conditions.

"Collective dose" means 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.

"Committed dose equivalent" (H _T,50 ) means 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.

"Committed effective dose equivalent" (H _{E, 50} ) is 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 (H _E,50 = Σ w _T, H _T,50 ).

"Curie" means a unit of quantity of radioactivity. One curie (Ci) is that quantity of radioactive material which decays at the rate of 3.7E + 10 ¹⁰ transformations per second (tps).

"Current license or registration" means a license or registration issued by the Agency and for which the licensee has paid the license or registration fee for the current year according to R12-1-1304.

"Deep-dose equivalent" (H _d ), which applies to external whole body exposure, is the dose equivalent at a tissue depth of 1 centimeter (1000 mg/cm ² ).

"Depleted uranium" means 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.

"Dose" is 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 these rules, "radiation dose" is an equivalent term.

"Dose equivalent" (H _T ) means 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.

"Dose limits" means the permissible upper bound of radiation doses established in accordance with these rules. For purposes of these rules, "limits" is an equivalent term.

"Dosimeter" (see "Individual monitoring devices").

"Effective dose equivalent" (H _E ) means the sum of the products of the dose equivalent to each organ or tissue (H _T ) and the weighting factor (w _T ) applicable to each of the body organs or tissues that are irradiated (H _E = Σ w _T H _T ).

"Effluent release" means any disposal or release of radioactive material into the ambient atmosphere, soil, or any surface or subsurface body of water.

"Embryo/fetus" means the developing human organism from conception until the time of birth.

"Enclosed beam x-ray system" means an analytical x-ray system constructed in such a way that access to the interior of the enclosure housing the x-ray source during operation is precluded except through bypassing of interlocks or other safety devices to perform maintenance or servicing.

"Enclosed radiography" means industrial radiography conducted by using cabinet radiography or shielded room radiography.

"Cabinet radiography" means industrial radiography conducted by using an x-ray machine in an enclosure not designed for human admittance and which is so shielded that every location on the exterior meets the conditions for an "unrestricted area."

"Shielded room radiography" means industrial radiography conducted using an x-ray machine in an enclosure designed for human admittance and which is so shielded that every location of the exterior meets the conditions for an "unrestricted area."

"Entrance or access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

"Exhibit" for purposes of these rules, is equivalent in meaning to the word "Schedule" as found in previously issued rules, current license conditions, and regulation guide.

"Explosive material" means any chemical compound, mixture, or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

"Exposure" means:

Being subjected to ionizing radiation or radioactive materials.

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 special unit of exposure is the roentgen (R).

"Exposure rate" means the exposure per unit of time.

"External dose" means that portion of the dose equivalent received from any source of radiation outside the body.

"Extremity" means hand, elbow, arm below the elbow, foot, knee, and leg below the knee.

"Fail-safe characteristics" means a design feature which causes beam port shutters to close, or otherwise prevents emergence of the primary beam, upon the failure of a safety or warning device.

"Field radiography" means industrial radiography, utilizing a portable or mobile x-ray system, which is not conducted in a shielded enclosure.

"Field station" means a facility where radioactive sources may be stored or used and from which equipment is dispatched to temporary job sites.

"Former U.S. Atomic Energy Commission (AEC) or U.S. Nuclear Regulatory Commission (NRC) licensed facilities" means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where AEC or NRC licenses have been terminated.

"Generally applicable environmental radiation standards" means standards issued by the U.S. Environmental Protection Agency (EPA), 40 CFR 190 and 191, 2001 Edition, published July 1, 2001, incorporated by reference and on file with the Agency and the Office of the Secretary of State, 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. This incorporation by reference contains no future editions or amendments.

"Gray" (Gy) means the International System (SI) unit of absorbed dose and is equal to 1 joule per kilogram. One Gray equals 100 rad.

"Hazardous waste" means those wastes designated as hazardous in A.R.S. § 49-921(5).

"Healing arts" means the practice of medicine, dentistry, osteopathy, podiatry, chiropractic, and veterinary medicine.

"Health care institution" means every place, institution, or building which provides facilities for medical services or other health-related services, not including private clinics or offices which do not provide overnight patient care.

"High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 1 mSv (0.1 rem) in one hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates.

"Human use" means the internal or external administration of radiation or radioactive materials to human beings.

"Impound" means to abate a radiological hazard. Actions which may be taken by the Agency in impounding a source of radiation include seizing the source of radiation, controlling access to an area, and preventing a radiation machine from being utilized.

"Individual" means any human being.

"Individual monitoring" means the assessment of:

Dose equivalent

By the use of individual monitoring devices, or

By the use of survey data; or

Committed effective dose equivalent

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 of DAC-hours in Article 4).

"Individual monitoring device" means a device designed to be worn by a single individual for the assessment of dose equivalent. For purposes of this Chapter, "dosimeter" and "personnel dosimeter," are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescence dosimeters (TLDs), pocket ionization chambers, optical stimulation devices, and personal ("lapel") air sampling devices.

"Individual monitoring equipment" means one or more individual monitoring devices. For purposes of this Chapter, "personnel monitoring equipment" is an equivalent term.

"Industrial radiography" means the examination of the macroscopic structure of materials by non-destructive methods utilizing sources of ionizing radiation.

"Injection tool" means a device used for controlled subsurface injection of radioactive tracer material.

"Inspection" means an examination or observation by a representative of the Agency, including but not limited to tests, surveys, and monitoring to determine compliance with rules, orders, requirements and conditions of the License or certificate of registration.

"Interlock" means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.

"Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

"Irradiate" means to expose to radiation.

"Laser" (light amplification by the stimulated emission of radiation) means any device which can produce or amplify electromagnetic radiation with wave lengths in the range of 180 nanometers to 1 millimeter primarily by the process of controlled stimulated emission.

"Lens dose equivalent" (LDE) means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters (300 mg/cm ² ).

"License" means the grant of authority, issued pursuant to Article 3 and 14 of this Chapter and A.R.S. §§ 30-671, 30-672, and 30-721 et seq., to acquire, possess, transfer, and use sources of radiation. The types of licenses issued by the Agency are described in R12-1-1302.

"Licensed material" means radioactive material received, possessed, used, transferred, or disposed of under a general or specific license issued by the Agency.

"Licensed practitioner" means a person licensed or otherwise authorized by law to practice medicine, dentistry, osteopathy, chiropractic, podiatry, or naturopathy in this state.

"Licensee" means any person who is licensed by the Agency under this Chapter to acquire, possess, transfer, or use sources of radiation.

"Licensing State" means any state having regulations equivalent to this Chapter relating to, and an effective program for the regulation of, naturally occurring and accelerator-produced radioactive material (NARM).

"Limits" ("See Dose limits").

"Local components" means those parts of an analytical x-ray system that are struck by x-rays, including radiation source housings, port and shutter assemblies, collimator, sample holders, cameras, goniometer, detectors and shielding but not including power supplies, transformers, amplifiers, readout devices, and control panels.

"Logging supervisor" means the individual who provides personal supervision of the utilization of sources of radiation at the well site.

"Logging tool" means a device used subsurface to perform well logging.

"Lost or missing licensed or registered source of radiation" means licensed or registered source of radiation the location of which is unknown. Included are licensed radioactive material or a registered radiation source that has been shipped but has not reached its planned destination and whose location cannot be readily traced or ascertained in the transportation system.

"Low-level waste" means waste material which contains radioactive nuclides in concentrations or quantities which exceed applicable standards for unrestricted release but does not include:

High-level waste, such as irradiated reactor fuel, liquid waste from reprocessing irradiated reactor fuel, or solids into which any such liquid waste has been converted;

Waste material containing transuranic elements with contamination levels greater than 10 nanocuries per gram (370 kilobecquerels per kilogram) of waste material;

The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content.

"Major processor" means a user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material or exceeding four times Type B quantities as sealed sources but does not include nuclear medicine programs, universities, industrial radiographers, or small industrial programs. Type A and B quantities are defined in 10 CFR 71.4, 2001 Edition, published January 1, 2001, incorporated by reference and on file with the Agency and the Office of the Secretary of State. This incorporation by reference contains no future editions or amendments.

"Medical dose" means a radiation dose intentionally delivered to an individual for medical examination, diagnosis, or treatment.

"Member of the public" means any individual except when that individual is receiving an occupational dose.

"MeV" means Mega Electron Volt which equals 1 million volts (10 ⁶ eV).

"Mineral logging" means any well logging performed in a borehole drilled for the purpose of exploration for minerals other than oil or gas.

"Minor" means an individual less than 18 years of age.

"Monitoring" means the measurement of radiation, radio active material concentrations, surface area activities, or quantities of radioactive material, and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of these rules, "radiation monitoring" and "radiation protection monitoring" are equivalent terms.

"Multiplier" means a letter representing a number. The use of a multiplier is based on the code given below:

"NARM" means any naturally occurring or accelerator-produced radioactive material. It does not include byproduct, source, or special nuclear material. This term should not be confused with "NORM" which is defined as naturally occurring radioactive material.

"Normal operating procedures" means the entire set of instructions necessary to accomplish the intended use of the source of radiation. These procedures shall include, but are not limited to, sample insertion and manipulation, equipment alignment, routine maintenance by the licensee, and data recording procedures which are related to radiation safety.

"Natural radioactivity" means the radioactivity of naturally occurring radioactive substances.

"NRC" means Nuclear Regulatory Commission, the U.S. Nuclear Regulatory Commission, or its duly authorized representatives.

"Nuclear waste" means any highway route controlled quantity (defined in 49 CFR 173.403, 2001 Edition, published October 1, 2001, incorporated by reference and on file with the Agency and the Secretary of State, containing no future editions or amendments) of source, byproduct, or special nuclear material required to be in NRC-approved packaging while transported to, through, or across state boundaries to a disposal site, or to a collection point for transport to a disposal site. Additional requirements associated with transportation of radioactive material can be found in Article 15.

"Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to sources of radiation, whether in the possession of a licensee, registrant, or other person. Occupational dose does not include a dose received from background radiation, medical administration of radiation to the individual, exposure to an individual who has been administered radioactive material and released in accordance with R12-1-719, voluntary participation in a medical research program, or as a member of the public.

"Open beam system" means an analytical x-ray system in which an individual could place some body part in the primary beam path during normal operation.

"Package" means the packaging together with its radioactive contents as presented for transport.

"Particle accelerator" (see "Accelerator").

"Permanent radiographic installation" means a fixed, shielded installation or structure designed or intended for industrial radiography and in which industrial radiography is regularly performed.

"Personnel dosimeter" (see "Individual monitoring devices").

"Personnel monitoring equipment" (see "Individual monitoring devices").

"Personal supervision" means supervision in which the supervising individual is physically present at the site where sources of radiation and associated equipment are being used, watching the performance of the supervised individual and in such proximity that immediate assistance can be given if required.

"Pharmacist" means an individual licensed by this state to compound and dispense drugs, prescriptions, and poisons.

"Physician" means an individual licensed pursuant to A.R.S. Title 32, Chapters 13 or 17.

"Primary beam" means radiation which passes through an aperture of the source housing by a direct path from the x-ray tube or a radioactive source located in the radiation source housing.

"Public dose" means the dose received by a member of the public from radiation from radioactive material released by a licensee or registrant, or exposure to a source of radiation used in a licensed or registered operation. It does not include an occupational dose or a dose received from background radiation, medical administration of radiation to the individual, exposure to an individual who has been administered radioactive material and released in accordance with R12-1-719, or voluntary participation in a medical research program.

"Pyrophoric liquid" means any liquid that ignites spontaneously in dry or moist air at or below 130° F (54.4° C).

"Pyrophoric solid" means any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and, when ignited, burns so vigorously and persistently that it creates a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

"Qualified expert" means an individual certified in the appropriate field by the American Board of Radiology or the American Board of Health Physics, or having equivalent qualifications that provide the knowledge and training to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs; or an individual certified in Therapeutic Radiological Physics or X-ray and Radium Physics by the American Board of Radiology, or having equivalent qualifications that provide training and experience in the clinical applications of radiation physics to radiation therapy, to calibrate radiation therapy equipment. The detailed requirements for a particular qualified expert may be provided in the respective Articles of this Chapter. For clarification purposes, a qualified expert is not always an authorized medical physicist; however, an authorized medical physicist is included within the definition of "qualified expert."

"Quality Factor" (Q) means the modifying factor, listed in Tables I and II of this Article, that is used to derive dose equivalent from absorbed dose.

"Quarter" (see "calendar quarter").

"Rad" means the special unit of absorbed dose. One rad equals 100 ergs per gram, or 0.01 Gray.

"Radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. For purposes of these rules, this term is synonymous with ionizing radiation. Equivalent terminology for non-ionizing radiation is defined in Article 14.

"Radiation area" means any area accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in one hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.

"Radiation dose" (see "Dose").

"Radiation machine" means any device capable of producing radiation except those devices with radioactive material as the only source of radiation.

"Radiation safety officer" (RSO) means the individual designated by the licensee or registrant who has the knowledge, authority, and responsibility to apply appropriate radiation protection principles to ensure radiation safety and compliance with the Act, this Chapter and any license, or registration conditions.

"Radioactive marker" means radioactive material placed subsurface or on a structure intended for subsurface use for the purpose of depth determination or direction orientation.

"Radioactive material" means any solid, liquid, or gas which emits radiation spontaneously.

"Radioactivity" means emission of electromagnetic energy or particles or both during the transformation of unstable atomic nuclei.

"Radiographer" means any individual who performs or personally supervises industrial radiographic operations and who is responsible to the licensee or registrant for assuring compliance with the requirements of this Chapter and all conditions of the license or certificate of registration.

"Radiographer's assistant" means any individual who, under the personal supervision of a radiographer, uses sources of radiation, radiographic exposure devices, related handling tools, or survey instruments in industrial radiography.

"Registrant" means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to these rules and the Act.

"Registration" is the process by which a person becomes a registrant pursuant to Article 2 of this Chapter. With the exception of registration of persons who install or service radiation machines, the types of registrations issued by the Agency are described in R12-1-1302.

"Regulations of the U.S. Department of Transportation" means the federal regulations in 49 CFR 100 through 199, 1995 Edition, published October 1, 1995, incorporated by reference and on file with the Agency and the Office of the Secretary of State. This incorporation by reference contains no future editions or amendments.

"Rem" means the special unit of dose equivalent (see "Dose equivalent"). The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem - 0.01 sievert).

"Research and Development" means exploration, experimentation, or the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and Development does not include the internal or external administration of radiation or radioactive material to human beings.

"Restricted area" means any area where the licensee or registrant controls access for purposes of protecting individuals from exposure to radiation and radioactive material. A restricted area does not include any areas used for residential quarters, although a room or separate rooms in a residential building may be set apart as a restricted area.

"Roentgen" (R) means the special unit of exposure and is equal to the quantity of x or gamma radiation which causes ionization in air equal to 258 microcoulomb per kilogram (see "Exposure").

"Safety system" means any device, program, or administrative control designed to ensure radiation safety.

"Sealed source" means radioactive material that is permanently bonded or fixed in a capsule or matrix designed to prevent release and dispersal of the radioactive material under the most severe conditions which are likely to be encountered in normal use and handling.

"Sealed Source and Device Registry" means the national registry that contains all the registration certificates, generated by both the NRC and the Agreement States, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for each source or device.

"Shallow dose equivalent" (H _S ), which applies to the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm ² ).

"Shielded position" means the location within a radiographic exposure device or storage container which, by manufacturer's design, is the proper location for storage of the sealed source.

"Sievert" means the SI unit of dose equivalent (see "Dose equivalent"). The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 Sv = 100 rem).

"Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

"Source changer" means a device designed and used for replacement of sealed sources in radiographic exposure devices, including those also used for transporting and storage of sealed sources.

"Source holder" means a housing or assembly into which a radioactive source is placed for the purpose of facilitating the handling and use of the source in well-logging operations.

"Source material" means:

Uranium or thorium, or any combination of uranium or thorium, in any physical or chemical form; or

Ores that contain by weight 1/20 of 1% (0.05%) or more of uranium, thorium, or any combination of uranium and thorium.

Source material does not include special nuclear material.

"Source material milling" means any activity that results in the production of byproduct material as defined by the second subsection under the definition of "Byproduct material."

"Source of radiation" or "source" means any radioactive material or any device or equipment emitting, or capable of producing, radiation.

"Special form radioactive material" means radioactive material that satisfies all of the following conditions:

It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

The piece or capsule has at least one dimension not less than 5 millimeters (0.2 inch); and

It satisfies the test requirements specified in 10 CFR 71, 2000 Edition, published January 1, 2000, incorporated by reference in this rule and on file with the Agency and the Office of the Secretary of State. This incorporation by reference contains no future editions or amendments. A special form encapsulation designed in accordance with the U.S. Nuclear Regulatory Commission requirements in effect on June 30, 1983, and constructed prior to July 1, 1985, may continue to be used. A special form encapsulation constructed after June 30, 1985, shall meet requirements of this definition applicable at the time of its construction.

"Special nuclear material in quantities not sufficient to form a critical mass" means Uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235; Uranium-233 in quantities not exceeding 200 grams; Plutonium in quantities not exceeding 200 grams; or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed 1. For example, the following quantities in combination would not exceed the limitation and are within the formula:

"Storage area" means any location, facility, or vehicle which is used to store, transport, or secure a radiographic exposure device, storage container, sealed source, or other source of radiation when it is not in use.

"Storage container" means a device in which sealed sources are transported or stored.

"Subsurface tracer study" means the release of a substance tagged with radioactive material for the purpose of tracing the movement or position of the tagged substance in the well-bore or adjacent formation.

"Survey" means an evaluation of the production, use, release, disposal, or presence of sources of radiation or any combination thereof under a specific set of conditions to determine actual or potential radiation hazards. Such evaluations include, but are not limited to, tests, physical examination and measurements of levels of radiation or concentration of radioactive material present.

"TEDE" means Total Effective Dose Equivalent, the sum of the deep-dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.

"Teletherapy" means therapeutic irradiation in which the source of radiation is at a distance from the body.

"Temporary job site" means any location where sources of radiation are used other than the specified locations listed on a license document. Storage of sources of radiation at a temporary jobsite shall not exceed six months unless the Agency has granted an amendment authorizing storage at that jobsite.

"Test" means the process of verifying compliance with an applicable rule, order, or license condition.

"These rules" means all Articles of 12 A.A.C. 1.

"Total Effective Dose Equivalent" (TEDE) means total effective dose equivalent, the sum of the deep-dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.

"Total Organ Dose Equivalent" (TODE) means total organ dose equivalent, the sum of the deep-dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in R12-1-419(D)(1)(d) of these rules.

"Unrefined and unprocessed ore" means ore in its natural form prior to any processing, such as grinding, roasting, beneficiating, or refining.

"Unrestricted area" means any area access to which is not controlled by the licensee for purposes of protection of individuals from exposure to radiation and radioactive material. Any area used for residential quarters is an unrestricted area.

"U.S. Department of Energy" means the Department of Energy established by Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. 7101 et seq., to the extent that the Department exercises functions formerly vested in the U.S. Atomic Energy Commission, its Chairman, members, officers, and components; and transferred to the U.S. Energy Research and Development Administration and to the administrator of that agency under Sections 104(b), (c), and (d) of the Energy Reorganization Act of 1974 (Public Law 93-438, October 11, 1974, 88 Stat. 1233 at 1237, 42 U.S.C. 5814, effective January 19, 1975) and retransferred to the Secretary of Energy under Section 301(a) of the Department of Energy Organization Act (Public Law 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 U.S.C. 7151, effective October 1, 1977).

"Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose that exceeds 5 grays (500 rads) in one hour at one meter from a radiation source or one meter from any surface that the radiation penetrates.

"Waste" (see "Low-level waste").

"Waste handling licensees" means persons licensed to receive and store radioactive wastes prior to disposal and persons licensed to dispose of radioactive waste.

"Week" means seven consecutive days starting on Sunday.

"Well-bore" means a drilled hole in which wireline service operations and subsurface tracer studies are performed.

"Well-logging" means the lowering and raising of measuring devices or tools which may contain sources of radiation into well-bores or cavities for the purpose of obtaining information about the well and adjacent formations.

"Whole body" means, for purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee.

"Wireline" means an armored cable containing one or more electrical conductors which is used to lower and raise logging tools in the well-bore.

"Wireline service operation" means any evaluation or mechanical service which is performed in the well-bore using devices on a wireline.

"Worker" means any individual engaged in work under a license issued by the Agency and controlled by employment or contract with a licensee.

"WL" means working level, any combination of short-lived radon daughters in 1 liter of air that will result in the ultimate emission of 1.3E + 5 MeV of potential alpha particle energy. The short-lived radon daughters are -- for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212.

"WLM" means working level month, an exposure to one working level for 170 hours (2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours per month).

"Workload" means the degree of use of an x-ray or gamma-ray source per unit time.

"Year" means the period of time beginning in January used to determine compliance with the provisions of these rules. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

Historical Note

Former Rule Section A.2. Former Section R12-1-102 repealed, new Section R12-1-102 adopted effective June 30, 1977 (Supp. 77-3). Amended effective November 19, 1982 (Supp. 82-6). Amended effective February 25, 1985 (Supp. 85-1). Amended by adding a new paragraph (31), subparagraph (w) and renumbering the former paragraph (31), subparagraphs (w) through (z) accordingly effective November 28, 1986 (Supp. 86-6). Amended by adding a new paragraph (34) and renumbering the former paragraphs (34) through (68) accordingly effective June 26, 1987 (Supp. 87-2). Amended effective April 2, 1990 (Supp. 90-2). Amended effective November 5, 1993 (Supp. 93-4). Amended effective February 18, 1994 (Supp. 94-1). Amended effective August 10, 1994 (Supp. 94-3). Amended effective January 2, 1996 (Supp. 96-1). Amended effective June 13, 1997 (Supp. 97-2). Amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2). Amended by final rulemaking at 9 A.A.R. 1126, effective May 9, 2003 (Supp. 03-1). Amended by final rulemaking at 10 A.A.R. 2122, effective July 3, 2004 (Supp. 04-2). Amended by final rulemaking at 10 A.A.R. 4458, effective December 4, 2004 (Supp. 04-4). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4). Amended by final rulemaking at 13 A.A.R. 1217, effective May 5, 2007 (Supp. 07-1).

R12-1-103. Exemptions

A. Common and contract carriers, freight forwarders, and warehousemen who are subject to 49 CFR 107.109, 107.111, 107.113, 171.2, 171.3, 172.200, 173.1, 173.3, 173.4, 173.401, 175.3, 175.5, 175.10, 176.3, 176.5, 176.11, 176.24, 176.27, and 177.801, 2000 Edition, published October 1, 2000, of the U.S. Department of Transportation, or 39 CFR 111.1 of the U.S. Postal Service, 2001 Edition, published January 1, 2001, incorporated by reference and on file with the Agency and the Office of the Secretary of State, and if need be, store radioactive material, for periods of less than 72 hours, in the regular course of their carriage for another, are exempt from this Chapter. The above incorporation by reference contains no future editions or amendments.

B. Any U.S. Department of Energy contractor or subcontractor and any U.S. Nuclear Regulatory Commission contractor or subcontractor of the following categories operating within this state are exempt from this Chapter to the extent that such contractor or subcontractor under the contract receives, possesses, uses, transfers, or acquires sources of radiation:

1. Prime contractors performing work for the Department of Energy at U.S. Government-owned or controlled sites, including the transportation of sources of radiation to or from such sites and the performance of contract services during temporary interruptions of such transportation;

2. Prime contractors of the Department of Energy performing research or development, manufacture, storage, testing or transportation of nuclear weapons or components thereof;

3. Prime contractors of the Department of Energy using or operating nuclear reactors or other nuclear devices in a United States Government-owned vehicle or vessel; and

4. Any other prime contractor or subcontractor of the Department of Energy or of the Nuclear Regulatory Commission when the state and the Nuclear Regulatory Commission jointly determine:

a. That the exemption of the prime contractor or subcontractor is authorized by law; and

b. That under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.

C. Any licensee who delivers to a carrier for transport any package which contains radioactive material having a specific activity of 74 kBq/kg (2 nanocuries per gram) or less, is exempt from the provisions of this Chapter with respect to that package.

Historical Note

Former Rule Section A.3; Former Section R12-1-103 repealed, new Section R12-1-103 adopted effective June 30, 1977 (Supp. 77-3). Amended effective April 2, 1990 (Supp. 90-2). Amended effective August 10, 1994 (Supp. 94-3). Amended effective June 13, 1997 (Supp. 97-2). Amended by final rulemaking at 9 A.A.R. 1126, effective May 9, 2003 (Supp. 03-1). Amended by final rulemaking at 13 A.A.R. 1217, effective May 5, 2007 (Supp. 07-1).

R12-1-104. Prohibited Uses

A. A person shall not use the following fluoroscopic devices:

1. Hand-held fluoroscopic screens,

2. Shoe-fitting fluoroscopic devices.

B. Except as specifically authorized by law, a person shall not use sources of ionizing radiation for the purpose of screening an individual or inspecting an individual for:

1. Concealed weapons,

2. Hazardous materials,

3. Stolen property, or

4. Contraband.

C. Unless there is a medical or dental indication for the exposure and the exposure is prescribed by a licensed practitioner, a person shall not deliberately expose an individual to the useful beam from:

1. An ionizing radiation machine; or

2. A non-ionizing radiation source, having a radiation beam known to be harmful to human tissue.

Historical Note

Former Rule Section A.4; Former Section R12-1-104 repealed, new Section R12-1-104 adopted effective June 30, 1977 (Supp. 77-3). Former Section R12-1-104 repealed, new Section R12-1-104 renumbered from R12-1-112 and amended effective April 2, 1990 (Supp. 90-2). Amended effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 9 A.A.R. 1126, effective May 9, 2003 (Supp. 03-1).

R12-1-105. Quality Factors for Converting Absorbed Dose to Dose Equivalent

A. As used in these rules, the quality factors for converting absorbed dose to dose equivalent are shown in Table I.

TABLE I
QUALITY FACTORS AND ABSORBED DOSE EQUIVALENCIES
______________________________________________________

Quality Factor Absorbed Dose
(Q) Equal to a Unit
TYPE OF RADIATION Dose Equivalent ^a

X, gamma, or beta
radiation and high-
speed electrons 1

Alpha particles, multiple-
charged particles, fission
fragments, and heavy
particles of unknown
charge 20 0.05

Neutrons of unknown
energy 10 0.1

High-energy protons 10 0.1

B. If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in sievert per hour or rem per hour, 0.01 Sv (1 rem) of neutron radiation of unknown energies may, for purposes of these rules, be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee or registrant may use the fluence rate per unit dose equivalent or the appropriate Q value from Table II to convert a measured tissue dose in gray or rad to dose equivalent in sievert or rem.

^a Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-centimeter diameter cylinder tissue-equivalent phantom.

^b Monoenergetic neutrons incident normally on a 30-centimeter diameter cylinder tissue-equivalent phantom.

Historical Note

Former Rule Section A.5; Former Section R12-1-105 repealed, new Section R12-1-105 adopted effective June 30, 1977 (Supp. 77-3). Section repealed effective April 2, 1990 (Supp. 90-2). New Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 9 A.A.R. 1126, effective May 9, 2003 (Supp. 03-1).

R12-1-106. Units of Activity

For purposes of these rules, activity is expressed in the SI unit of becquerel (Bq) or in the special unit of curie (Ci), or their multiples, or disintegrations or transformations per unit of time. The definitions for these units are located in R12-1-102.

Historical Note

Former Rule Section A.6; Former Section R12-1-1-6 repealed, new Section R12-1-106 adopted effective June 30, 1977 (Supp. 77-3). Section repealed effective April 2, 1990 (Supp. 90-2). New Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 9 A.A.R. 1126, effective May 9, 2003 (Supp. 03-1).

R12-1-107. Misconduct

A. A licensee, registrant, applicant for a license or certificate of registration, or employee of a licensee, registrant, or applicant; or any contractor (including a supplier or consultant), subcontractor, or employee of a contractor or subcontractor of any licensee or certificate of registration holder who provides to any licensee, registrant, applicant, contractor, or subcontractor, any components, equipment, materials, or other goods or services that relate to a licensee's, registrant's, or applicant's activities in this Chapter, shall not:

1. Knowingly engage in conduct that violates or will result in a violation by a licensee, registrant, or applicant, of any statute, rule, regulation, or order; or any term, condition, or limitation of any license or registration issued by the Agency; or

2. Knowingly submit to the Agency, or a licensee, registrant, or applicant, or a licensee's, registrant's, or applicant's contractor or subcontractor, information that is incomplete or inaccurate.

B. The Board shall impose the applicable civil penalty listed in R12-1-1216 on a person who violates subsection (A)(1) or (A)(2). For this purpose the person is classified as a Division II licensee and the violation is classified as a Severity II violation.

C. For the purposes of this Section, "misconduct" means conduct prohibited under subsection (A).

D. A person who is not a licensee, registrant, or applicant and knowingly violates a rule for the safe use of radiation sources in 12 A.A.C.1 is subject to the enforcement actions in 12 A.A.C. 1, Article 12.

Historical Note

Former Rule Section A.7; Former Section R12-1-107 repealed, new Section R12-1-107 adopted effective June 30, 1977 (Supp. 77-3). Section repealed effective April 2, 1990 (Supp. 90-2). New Section made by final rulemaking at 10 A.A.R. 2122, effective July 3, 2004 (Supp. 04-2).

R12-1-108. Repealed

Historical Note

Former Rule Section A.8; Former Section R12-1-108 repealed, new Section R12-1-108 adopted effective June 30, 1977 (Supp. 77-3). Change of address (Supp. 85-6). Section repealed effective April 2, 1990 (Supp. 90-2).

R12-1-109. Repealed

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Section repealed effective April 2, 1990 (Supp. 90-2).

R12-1-110. Repealed

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Section repealed effective April 2, 1990 (Supp. 90-2).

R12-1-111. Repealed

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Section repealed effective April 2, 1990 (Supp. 90-2).

R12-1-112. Renumbered

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Former Section R12-1-112 renumbered to R12-1-104 effective April 2, 1990 (Supp. 90-2).

Appendix A. Repealed

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Repealed effective August 10, 1994 (Supp. 94-3).

Appendix B. Repealed

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Repealed effective August 10, 1994 (Supp. 94-3).

ARTICLE 2. REGISTRATION, INSTALLATION, AND SERVICE OF IONIZING RADIATION-PRODUCING MACHINES; AND CERTIFICATION OF MAMMOGRAPHY FACILITIES

R12-1-201. Exemptions

A. Electronic equipment that produces X-radiation incidental to its operation for other purposes is exempt from the registration and notification requirements of this Article, provided that an exposure rate, from any accessible surface, averaged over an area of 10 square centimeters (1.55 in.2) does not exceed 129µC/kg per hour (0.5 milliroentgen per hour) at 5 cm (2.0 in.). The production, testing, or factory servicing of electronic equipment that produces X-radiation incident to its operation is not exempt.

B. Radiation machines in storage or in transit to or from storage are exempt from the requirements of this Article.

C. Radiation machines rendered incapable of producing radiation are exempt from this Article.

Historical Note

Former Rule Section B.3. Former Section R12-1-203 repealed, new Section R12-1-203 adopted effective June 30, 1977 (Supp. 77-3). Former Section R12-1-201 repealed, former Section R12-1-203 renumbered as R12-1-201 and amended effective November 22, 1988 (Supp. 88-4). Amended effective January 2, 1996 (Supp. 96-1). Amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 9 A.A.R. 4302, effective November 14, 2003 (Supp. 03-3).

R12-1-202. Application for Registration of Ionizing Radiation Producing Machines

A. A person shall not use a radiation machine except as authorized in this Article.

B. A person possessing a nonexempt radiation machine shall apply for registration of the machine with the Agency within 30 days after its installation. The person applying for registration of a radiation-producing machine shall use the application forms provided by the Agency. The applicant shall provide the information identified in Appendix A of this Article.

C. In addition to the application form or forms, the applicant shall remit the appropriate registration or licensing fee in R12-1-1306 and provide other information required by R12-1-208.

D. Each applicant that applies for registration of a stationary x-ray system, with the exception of applicants from bone densitometry, cabinet radiography, podiatry, dental, bone mineral analyzer and mammography facilities, shall provide a scale drawing of the room in which the x-ray system is located, or provide measurements from the radiation source to the surrounding barrier surfaces. The drawing shall denote the type of materials and the thickness (or lead equivalence) of each barrier of the room (walls, ceilings, floors, doors, windows). The drawing shall also denote the type and frequency of occupancy in adjacent areas, including those above and below the x-ray room of concern (e.g., hallways, offices, parking lots, and lavatories). Estimates of workload shall also be provided with the drawing.

E. An applicant proposing to use a particle accelerator for medical purposes shall not use the particle accelerator until the Agency inspection required in R12-1-914 has been completed.

Historical Note

Former Rule Section B.4. Former Section R12-1-204 repealed, new Section R12-1-204 adopted effective June 30, 1977 (Supp. 77-3). Former Section R12-1-202 repealed, former Section R12-1-204 renumbered as R12-1-202 and amended effective November 22, 1988 (Supp. 88-4). Amended effective January 2, 1996 (Supp. 96-1). Amended effective June 13, 1997 (Supp. 97-2). Amended by final rulemaking at 5 A.A.R. 1817, effective June 11, 1999 (Supp. 99-2). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2). Amended by final rulemaking at 9 A.A.R. 4302, effective November 14, 2003 (Supp. 03-3).

R12-1-203. Application for Registration of Servicing and Installation

A. Each person who is engaged in the business of installing or offering to install radiation machines or is engaged in the business of furnishing or offering to furnish radiation machine servicing or services in this state shall apply for registration. If registration is required, any subsequent application shall be submitted before furnishing or offering to furnish any radiation machine service or installation.

B. Application for registration shall be completed on forms furnished by the Agency and shall contain all information required by A.R.S. § 30-672.01.

Historical Note

Former Rule Section B.5. Former Section R12-1-205 repealed, new Section R12-1-205 adopted effective June 30, 1977 (Supp. 77-3). Former Section R12-1-205 renumbered as R12-1-203 and amended effective November 22, 1988 (Supp 88-4). Amended by final rulemaking at 9 A.A.R. 4302, effective November 14, 2003 (Supp. 03-3).

R12-1-204. Issuance of Notice of Registration

A. Upon determining that the application meets the requirements of the Act and this Article, the Agency shall issue a Notice of Registration.

B. All radiation machines located at the same facility may be registered using one Notice of Registration.

Historical Note

Former Rule Section B.6. Former Section R12-1-206 repealed, new Section R12-1-206 adopted effective June 30, 1977 (Supp. 77-3). Former Section R12-1-206 renumbered as R12-1-204 and amended effective November 22, 1988 (Supp. 88-4). Amended effective January 2, 1996 (Supp. 96-1). Amended effective June 13, 1997 (Supp. 97-2).

R12-1-205. Expiration of Notice of Registration or Certification

A Notice of Registration, or certificate issued according to R12-1-208, expires at the end of the day on the date stated in the Notice of Registration or certificate unless the registrant or certificate holder, not less than 30 days prior to the expiration of the Notice of Registration or certificate, files a complete application for renewal. If a timely application for renewal is filed, the Notice of Registration or certificate does not expire until the application status is finally determined by the Agency.

Historical Note

Former Rule Section B.7. Former Section R12-1-207 repealed, new Section R12-1-207 adopted effective June 30, 1977 (Supp. 77-3). Former Section R12-1-207 renumbered as R12-1-205 and amended effective November 22, 1988 (Supp. 88-4). Amended effective January 2, 1996 (Supp. 96-1). Amended by final rulemaking at 9 A.A.R. 4302, effective November 14, 2003 (Supp. 03-3).

R12-1-206. Assembly, Installation, Removal from Service, and Transfer

A. A person who assembles, or installs ionizing radiation machines in this state shall notify the Agency in writing within 15 days of:

1. The name and address of the person possessing the machine that was assembled or installed;

2. The manufacturer, model, and serial number of each radiation machine with the tube housing model number and serial number, maximum kVp, and maximum mA, assembled or installed; and

3. The date each machine was assembled or installed, or the first clinical procedure is performed.

B. Any person who possesses a radiation machine registered by the Agency shall notify the Agency within 15 days of the machine being taken out of service. The written notification shall contain the name and address of the person receiving the machine, if it is sold, leased, or transferred to another person; the manufacturer, model, and serial number of the machine; and the date the machine was taken out of service.

C. In the case of diagnostic x-ray systems that contain certified components, an assembler shall submit to the Agency a copy of the assembler's report (FDA Report No. 2579) prepared in compliance with requirements in 21 CFR 1020.30(d)(1), April 1, 2004, published by the Office of the Federal Register, National Archives and Records Administration, incorporated by reference and on file with the Agency, containing no future editions or amendments, within 15 days following completion of the assembly. The report shall suffice in lieu of any other report by the assembler, if it contains the information required in subsection (A).

D. A person shall not make, sell, lease, transfer, lend, assemble, service, or install radiation machines or the supplies used in connection with radiation machines unless the supplies and equipment when properly placed in operation and used, meet the requirements of these rules.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Former Section R12-1-209 renumbered as Section R12-1-206 and amended effective November 22, 1988 (Supp. 88-4). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2). Amended by final rulemaking at 9 A.A.R. 4302, effective November 14, 2003 (Supp. 03-3). Amended by final rulemaking at 10 A.A.R. 4458, effective December 4, 2004 (Supp. 04-4).

R12-1-207. Reciprocal Recognition of Out-of-state Radiation Machines

A. If any radiation machine is to be brought into the state for temporary use, the person proposing to bring the radiation machine into the state shall provide written notice to the Agency at least three working days before the radiation machine is to be used in the State. The notice shall include the type of radiation machine; the nature, duration, and scope of use; and the exact location where the radiation machine is to be used. If, for a specific case, the three working-day period would impose an undue hardship, the person may upon application to the Agency, obtain permission to proceed sooner.

B. In addition, the owner of the radiation machine and the person possessing the machine while in the state shall:

1. Comply with all applicable rules of the Agency,

2. Upon request, supply the Agency with a copy of the machine's registration and other information regarding the safe operation of a machine while it is in the state; and

3. Upon request, supply the Agency with the work authorization from the Agency, machine registration, operating and emergency procedures, utilization log, survey instrument and associated calibration record, and training records for all users.

C. A radiation machine shall not be operated within the state on a temporary basis in excess of 180 calendar days per year.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Former Section R12-1-210 renumbered as Section R12-1-207 and amended effective November 22, 1988 (Supp. 88-4). Amended effective January 2, 1996 (Supp. 96-1). Amended by final rulemaking at 9 A.A.R. 4302, effective November 14, 2003 (Supp. 03-3).

R12-1-208. Certification of Mammography Facilities

An applicant seeking certification of a facility according to A.R.S. § 30-672(J) shall:

1. Provide evidence with the application that a quality assurance program has been established and is in use for the items listed in Appendix B of 12 A.A.C. 1, Article 6,

2. Provide evidence with the application that physicians reading mammographic images have the training and experience required in A.R.S. § 32-2842(A); and,

3. Provide evidence with the application that physicians reading mammographic images have met the minimum criteria established by their respective licensing boards, as required in A.R.S. § 32-2842(C).

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Repealed effective November 22, 1988 (Supp. 88-4). New Section adopted effective January 2, 1996 (Supp. 96-1). Amended by final rulemaking at 9 A.A.R. 4302, effective November 14, 2003 (Supp. 03-3).

R12-1-209. Notifications

A. A registrant shall notify the Agency within 30 days of any change to the information contained in the notice of registration or a certificate issued according to R12-1-208.

B. A person who possesses a radiation machine registered by the Agency shall notify the Agency within 15 days if the machine is discarded or transferred to another person. In the notice, the person shall provide the name and address of the person who receives the machine, if it is sold, leased, or transferred to another person; the manufacturer, model, and serial number of the machine; and the date the machine was taken out of service.

Historical Note

Adopted effective January 2, 1996 (Supp. 96-1). Section repealed; new Section made by final rulemaking at 11 A.A.R. 61, effective February 5, 2005 (Supp. 04-4).

Appendix A. Application Information

An application shall contain the following information as required in R12-1-202(B), before a registration will be issued. The Agency shall provide an application form to an applicant with a guide, if available, or shall assist the applicant to ensure that only correct information is provided on the application.

Historical Note

Appendix repealed; new Appendix made by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2). Amended by final rulemaking at 9 A.A.R. 4302, effective November 14, 2003 (Supp. 03-3).

ARRA-4. Repealed

Historical Note

Appendix A, Form ARRA-4 adopted effective November 22, 1988 (Supp. 88-4). Appendix A, Form ARRA-4 repealed, new Form ARRA-4 adopted effective April 17, 1996 (Supp. 96-2). Repealed by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

ARRA-4X. Repealed

Historical Note

Form ARRA-4X adopted effective April 17, 1996 (Supp. 96-2). Amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Repealed by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

ARRA-4XT. Repealed

Historical Note

Form ARRA-4XT adopted effective April 17, 1996 (Supp. 96-2). Amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Repealed by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

ARRA-4PAT. Repealed

Historical Note

Form ARRA-4PAT adopted effective April 17, 1996 (Supp. 96-2). Amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Repealed by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

ARRA-4IG. Repealed

Historical Note

Form ARRA-4IG adopted effective April 17, 1996 (Supp. 96-2). Amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Repealed by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

ARRA-4IR. Repealed

Historical Note

Form ARRA-4IR adopted effective April 17, 1996 (Supp. 96-2). Amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Repealed by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

ARRA-4PAR. Repealed

Historical Note

Form ARRA-PAR adopted effective April 17, 1996 (Supp. 96-2). Amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Repealed by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

ARRA-4PA. Repealed

Historical Note

Form ARRA-4PA adopted effective April 17, 1996 (Supp. 96-2). Amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2).

ARRA-13. Repealed

Historical Note

Form ARRA-13 adopted effective April 17, 1996 (Supp. 96-2). Repealed by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

ARRA-1004. Repealed

Historical Note

Form ARRA-1004 adopted effective April 17, 1996 (Supp. 96-2). Repealed by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

ARRA-1005. Repealed

Historical Note

Form ARRA-1005 adopted effective April 17, 1996 (Supp. 96-2). Repealed by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

ARRA-1030. Repealed

Historical Note

Form ARRA-1030 adopted effective April 17, 1996 (Supp. 96-2). Repealed by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

ARRA-1050. Repealed

Historical Note

Form ARRA-1050 adopted effective April 17, 1996 (Supp. 96-2). Repealed by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

ARRA-1070. Repealed

Historical Note

Form ARRA-1070 adopted effective April 17, 1996 (Supp. 96-2). Repealed by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

ARRA-1090. Repealed

Historical Note

Form 1090 adopted effective April 17, 1996 (Supp. 96-2). Repealed by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

ARTICLE 3. RADIOACTIVE MATERIAL LICENSING

R12-1-301. Ownership, Control, or Transfer of Radioactive Material

A. In addition to the requirements of this Article, all licensees are subject to the requirements of 12 A.A.C. 1, Article 1, Article 4, and Article 10. Licensees engaged in industrial radiographic operations are subject to the requirements of 12 A.A.C. 1, Article 5; licensees using radioactive material in the practice of medicine are subject to the requirements of 12 A.A.C. 1, Article 7; licensees transporting radioactive material are subject to the requirements contained in 12 A.A.C. 1, Article 15; and licensees using radioactive material in well logging operations are subject to the requirements in 12 A.A.C. 1, Article 17.

B. Notwithstanding any other provisions of this Article, any person may own radioactive material, provided that the ownership does not include the actual possession, custody, use, or physical transfer of radioactive material or the manufacture or production of any article that contains radioactive material without the applicable certification, license, or registration.

C. A manufacturer, processor, or producer of any equipment, device, commodity, or other product that contains source material or radioactive material whose subsequent possession, use, transfer, or disposal by all other persons is exempt from regulatory requirements may only obtain authority to transfer possession or control of the material from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

Historical Note

Former Rule Section C.1. Former Section R12-1-301 repealed, new Section R12-1-301 adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Former Section R12-1-301 renumbered to R12-1-322, new Section R12-1-301 adopted effective February 18, 1994 (Supp. 94-1). Former Section R12-1-301 repealed; new Section R12-1-301 renumbered from R12-1-302 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-302. Source Material; Exemptions

A. Any person is exempt from this Article to the extent the person receives, possesses, uses, or transfers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than 1/20th of 1 percent (0.05 percent) of the mixture, compound, solution, or alloy.

B. Any person is exempt from this Article to the extent the person receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material, provided that, the person does not refine or process the ore except as authorized in a specific license.

C. Any person is exempt from this Article if the person receives, possesses, uses, or transfers:

1. Any quantities of thorium contained in:

a. Incandescent gas mantles;

b. Vacuum tubes;

c. Welding rods;

d. Electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams of thorium;

e. Germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting, provided that each lamp does not contain more than 2 grams of thorium;

f. Rare earth metals, compounds, mixtures, or products containing not more than 0.25 percent by weight thorium, uranium, or any combination of thorium and uranium; or

g. Individual neutron dosimeters, provided that each dosimeter does not contain more than 50 milligrams of thorium;

2. Source material contained in the following products:

a. Glazed ceramic tableware, provided that the glaze contains not more than 20 percent source material by weight;

b. Glassware, glass enamel and glass enamel frit containing not more than 10 percent source material by weight, but not including commercially manufactured glass brick, pane glass, ceramic tile or other glass, glass enamel or ceramic used in construction; or

c. Piezoelectric ceramic containing not more than 2 percent source material by weight;

3. Photographic film, negatives, and prints containing uranium or thorium;

4. Any finished product or part fabricated of, or containing, tungsten-thorium or magnesium-thorium alloys, provided that the thorium content of the alloy does not exceed 4 percent by weight and that the exemption contained in this subsection does not authorize the chemical, physical, or metallurgical treatment or processing of the finished product or part;

5. Uranium contained in counterweights installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of counterweights, provided that:

a. The counterweights are manufactured in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission, authorizing distribution by the licensee according to 10 CFR 40;

b. Each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "DEPLETED URANIUM";

c. Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED";

d. The exemption contained in this item does not authorize the chemical, physical, or metallurgical treatment or processing of any counterweight other than repair or restoration of any plating or other covering; and

e. The requirements specified in subsections (C)(5)(b) and (c) do not apply to counterweights manufactured prior to December 31, 1969; provided, that these counterweights are impressed with the legend, "CAUTION -- RADIOACTIVE MATERIAL -- URANIUM."

6. Natural or depleted uranium metal used as shielding and constituting part of any shipping container; provided that:

a. The shipping container is conspicuously and legibly impressed with the legend "CAUTION -- RADIOACTIVE SHIELDING -- URANIUM," and

b. The uranium metal is encased in mild steel or equally fire resistant metal with minimum wall thickness of 1/8 inch (3.2 mm).

7. Thorium contained in finished optical lenses, provided that each lens does not contain more than 30 percent of thorium by weight, and that the exemption contained in this item does not authorize either

a. The shaping, grinding, or polishing of a thoriated lens or manufacturing processes other than the assembly of a thoriated lens into optical systems and devices without any alteration of the lens, or

b. The receipt, possession, use, or transfer of thorium contained in contact lenses, spectacles, or the eyepieces of binoculars or other optical instruments;

8. Uranium contained in detector heads of fire detection units, provided that each detector head contains not more than 5 nanocuries (185 Bq) of uranium; or

9. Thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that:

a. The thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide), and

b. The thorium content in the nickel-thoria alloy does not exceed 4 percent by weight.

D. The exemptions in subsection (C) do not authorize the manufacture of any of the products described.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Amended subsection (C) effective November 22, 1988 (Supp. 88-4). Former Section R12-1-302 renumbered to R12-1-303, new Section R12-1-302 renumbered from R12-1-301 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-302 renumbered to R12-1-301; new Section R12-1-302 renumbered from R12-1-303 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2).

R12-1-303. Radioactive Material Other than Source Material; Exemptions

A. Exempt concentrations

1. Except as provided in subsection (A)(2), a person is exempt from this Article if the person receives, possesses, uses, transfers or acquires products or materials containing radioactive material in concentrations not in excess of those listed in Exhibit A.

2. A person shall not introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under subsection (A)(1) or equivalent Regulations of the U.S. Nuclear Regulatory Commission or any Agreement State or Licensing State, except in accordance with a specific license issued under R12-1-311(A) or a general license prescribed in R12-1-320.

B. Exempt items

1. Except for persons who apply radioactive material to, or persons who incorporate radioactive material into the following products, a person is exempt from this Chapter to the extent that the person receives, possesses, uses, transfers or acquires the following products:

a. Timepieces, hands, or dials containing not more than the following specified quantities of material and not exceeding the following specified levels of radiation:

i. 925 MBq (25 millicuries) of tritium per timepiece,

ii. 185 MBq (5 millicuries) of tritium per hand,

iii. 555 MBq (15 millicuries) of tritium per dial (bezels are considered part of the dial),

iv. 3.7 MBq (100 microcuries) of promethium-147 per watch or 7.4 MBq (200 microcuries) of promethium-147 per any other timepiece,

v. 740 kBq (20 microcuries) of promethium-147 per watch hand or 1.48 MBq (40 microcuries) of promethium-147 per other timepiece hand,

vi. 2.22.MBq (60 microcuries) of promethium-147 per watch dial or 4.44 MBq (120 microcuries) of promethium-147 per other timepiece dial (bezels are considered part of the dial),

vii. The levels of radiation from hands and dials containing promethium-147 shall not exceed, when measured through 50 milligrams per square centimeter of absorber:

(1) For wrist watches, 1.0 μGy (0.1 millirad) per hour at 10 centimeters from any surface of the watch,

(2) For pocket watches, (0.1 millirad) per hour at 1 centimeter from any surface,

(3) For any other timepiece, 2.0 μGy (0.2 millirad) per hour at 10 centimeters from any surface,

viii. 37 kBq (1 microcurie) of radium-226 in time pieces manufactured prior to October 1, 1978;

b. Lock illuminators containing not more than 555 MBq (15 millicuries) of tritium or not more than 74 MBq (2 millicuries) of promethium-147 installed in automobile locks. The levels of radiation from each lock illuminator containing promethium-147 shall not exceed 10 μGy (1 millirad) per hour at 1 centimeter from any surface when measured through 50 milligrams per square centimeter of absorber;

c. Balances of precision containing not more than 37 Mbq (1 millicurie) of tritium per balance or not more than 18.5 MBq (0.5 millicurie) of tritium per balance part;

d. Automobile shift quadrants containing not more than 925 MBq (25 millicuries) of tritium;

e. Marine compasses containing not more than 27.75 GBq (750 millicuries) of tritium gas and other marine navigational instruments containing not more than 9.25 GBq (250 millicuries) of tritium gas;

f. Thermostat dials and pointers containing not more than 925 MBq (25 millicuries) of tritium per thermostat;

g. Electron tubes: Provided that each tube does not contain more than one of the following specified quantities of radioactive material:

i. 5.55 GBq (150 millicuries) of tritium per microwave receiver protector tube or 370 MBq (10 millicuries) of tritium per any other electron tube;

ii. 37 kBq (1 microcurie) of cobalt 60;

iii. 185 kBq (5 microcuries) of nickel 63;

iv. 1.11 MBq (30 microcuries) of krypton 85;

v. 185 kBq (5 microcuries) of cesium 137;

vi. 1.11 MBq (30 microcuries) of promethium-147;

And provided further, that the level of radiation due to radioactive material contained in each electron tube does not exceed 10 μGy (1 millirad) per hour) at 1 centimeter from any surface when measured through 7 milligrams per square centimeter of absorber. The term "electron tubes" includes spark gap tubes, power tubes, gas tubes, including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes, and any other completely sealed tube that is designed to conduct or control electrical current.

h. Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material provided that:

i. Each source contains no more than one exempt quantity set forth in Exhibit B of this Article, and

ii. Each instrument contains no more than 10 exempt quantities. For the purposes of this subsection, an instrument's source or sources may contain either one type or different types of radionuclide and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in Exhibit B of this Article, provided the sum of the fractions do not exceed unity.

iii. For the purposes of subsection (B)(1)(h) only, 185 kBq (50 nanocurie) of americium-241 is considered an exempt quantity under Exhibit B of this Article.

iv. Spark gap irradiators containing not more than 37 kBq (1 microcurie) of cobalt-60 per spark gap irradiator for use in electrically ignited fuel oil burners having a firing rate of at least 3 gallons per hour (11.4 liters/hr or 0.0114 m ³ /hr).

2. Resins containing scandium-46 and designed for sand consolidation in oil wells. A person is exempt from this Chapter if the person receives, possesses, uses, transfers, or acquires synthetic plastic resins containing scandium 46 which are designed for sand consolidation in oil wells. The described resins shall be manufactured or imported according to a specific license issued by the U.S. Nuclear Regulatory Commission, or shall be manufactured according to the specifications contained in a specific license issued by the Agency or any Agreement State to the manufacturer of the described resins according to licensing requirements equivalent to those in 10 CFR 32.16 and 10 CFR 32.17 of the U.S. Nuclear Regulatory Commission. This exemption does not authorize the manufacture of any resins containing scandium-46.

3. Self-luminous products

a. Except for persons who manufacture, process, or produce self-luminous products containing tritium, krypton-85, or promethium-147, a person is exempt from this Chapter if the person receives, possesses, uses, transfers or acquires tritium, krypton-85 or promethium-147 in self-luminous products manufactured, processed, produced, imported, or transferred under a specific license issued by the U.S. Nuclear Regulatory Commission and described in 10 CFR 32.22, and the license authorizes the transfer of the products to persons who are exempt from regulatory requirements. This exemption does not apply to tritium, krypton-85, or promethium-147 used in products for frivolous purposes or in toys or adornments.

b. A person is exempt from this Chapter if the person receives, possesses, uses, or transfers articles containing less than 3.7 kBq (100 nanocuries) of radium-226, manufactured prior to October 1, 1978.

4. Gas and aerosol detectors containing radioactive material

a. Except for persons who manufacture, process, or produce gas and aerosol detectors containing radioactive material, a person is exempt from this Chapter if the person receives, possesses, uses, transfers, or acquires radioactive material in gas and aerosol detectors designed to protect life or property from fires and airborne hazards, provided that detectors containing radioactive material shall be manufactured, imported, or transferred according to a specific license issued by the U.S. Nuclear Regulatory Commission and described in 10 CFR 32.26, or equivalent regulations of an Agreement or Licensing State, and the license authorizes the transfer of the detectors to persons who are exempt from regulatory requirements.

b. Gas and aerosol detectors previously manufactured and distributed to general licensees in accordance with a specific license issued by an Agreement State are exempt under subsection (B)(4)(a), provided that the device is labeled in accordance with the specific license authorizing distribution of the general licensed device, and that the detectors meet the requirements of R12-1-311(C).

C. Exempt quantities

1. Except as provided in subsections (C)(2) and (3), a person is exempt from these rules if the person receives, possesses, uses, transfers or acquires radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in Exhibit B of this Article.

2. This subsection does not authorize the production, packaging, or repackaging of radioactive material for purposes of commercial distribution, or the incorporation of radioactive material into products intended for commercial distribution.

3. Except as specified in this subsection, a person shall not, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in Exhibit B of this Article, knowing or having reason to believe the described quantities of radioactive material will be transferred to persons exempt under subsection (C) or equivalent Regulations of the U.S. Nuclear Regulatory Commission or any Agreement State or Licensing State. A person may transfer radioactive material for commercial distribution under a specific license issued by the U.S. Nuclear Regulatory Commission under 10 CFR 32.18, or by the Agency according to R12-1-311(B) which license states that the radioactive material may be transferred by the licensee to persons exempt under this subsection or the equivalent Regulations of the U.S. Nuclear Regulatory Commission or any Agreement State or Licensing State.

4. Sources containing exempt quantities of radioactive material shall not be bundled or placed in close proximity for the purpose of using the radiation from the combined sources in place of a single source, containing a licensable quantity of radioactive material.

5. Possession and use of bundled or combined sources containing exempt quantities of radioactive material in unregistered devices by persons exempt from licensing is prohibited.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Former Section R12-1-303 renumbered to R12-1-304, new Section R12-1-303 renumbered from R12-1-302 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-303 renumbered to R12-1-302; new Section R12-1-303 renumbered from R12-1-304 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

R12-1-304. License Types

Licenses for radioactive materials are of two types: general and specific.

1. A general license is provided by rule, grants authority to a person for certain activities involving radioactive material, and is effective without the filing of an application with the Agency or the issuance of a licensing document to a particular person. However, registration with the Agency may be required by the particular general license.

2. The Agency issues a specific license to a named person who has filed an application for a license under the applicable provision of this Chapter. A specific licensee is subject to all of the applicable rules in this Chapter and any limitation contained in the license document.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Former Section R12-1-304 renumbered to R12-1-305, new Section R12-1-304 renumbered from R12-1-303 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-304 renumbered to R12-1-303; new Section R12-1-304 renumbered from R12-1-305 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-305. General Licenses - Source Material

A. This subsection grants a general license that authorizes a person such as commercial and industrial firms; research, educational, and medical institutions; and state and local government agencies to use, and transfer not more than 6.8 kg (15 pounds) of source material at any one time for research, development, educational, commercial, or operational purposes. A person authorized under this subsection shall not receive more than 68.2 kg (150 pounds) of source material in one calendar year.

B. A person who receives, possesses, uses, or transfers source material under a general license granted under subsection (A) is exempt from the provisions of 12 A.A.C. 1, Article 4 and Article 10, provided the receipt, possession, use, or transfer is within the terms of the general license. This exemption does not apply to any person who is also in possession of source material under a specific license issued under this Article.

C. This subsection grants a general license that authorizes a person to receive acquire, possess, use, or transfer depleted uranium contained in industrial products and devices provided:

1. The depleted uranium is contained in the industrial product or device for the purpose of providing a concentrated mass in a small volume of the product or device;

2. The industrial products or devices have been manufactured or initially transferred in accordance with a specific license governed by R12-1-311(M), or a specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement State that authorizes manufacture of the products or devices for distribution to persons generally licensed by the U.S. Nuclear Regulatory Commission or an Agreement State;

3. The person files an ARRA 23 "Registration Certificate -- Use of Depleted Uranium Under General License" with the Agency. The person shall provide the information requested on the certificate and listed in Exhibit E. The person shall submit the information within 30 days after first receipt or acquisition of the depleted uranium, returning the completed registration certificate to the Agency. The person shall report in writing to the Agency any change in information originally submitted to the Agency on ARRA 23. The person shall submit the change report within 30 days after the effective date of the described change.

D. A person who receives, acquires, possesses, or uses depleted uranium according to the general license provided under subsection (C) shall:

1. Not introduce depleted uranium, in any form, into a chemical, physical, or metallurgical treatment or process, except a treatment or process for repair or restoration of any plating or other covering of the depleted uranium;

2. Not abandon the depleted uranium;

3. Transfer the depleted uranium as prescribed in R12-1-318. If the transferee receives the depleted uranium under a general license established by subsection (C), the transferor shall furnish the transferee with a copy of this Section and a copy of the registration certificate. If the transferee receives the depleted uranium under a general license governed by a regulation of the U.S. Nuclear Regulatory Commission or an Agreement State that is equivalent to subsection (C), the transferor shall furnish the transferee a copy of the equivalent rule and a copy of the registration certificate, accompanied by a letter explaining that use of the product or device is regulated by the U.S. Nuclear Regulatory Commission or an Agreement State under requirements substantially similar to those in this Section;

4. Within 30 days of any transfer, report in writing to the Agency the name and address of the person receiving the depleted uranium; and

5. Not export depleted uranium except under a license issued by the U.S. Nuclear Regulatory Commission in accordance with 10 CFR 110.

E. A person who receives, acquires, possesses, uses, or transfers depleted uranium in accordance with a general license granted under subsection (C) is exempt from the requirements of 12 A.A.C. 1, Articles 4 and 10 with respect to the depleted uranium covered by that general license.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Former Section R12-1-305 renumbered to R12-1-306, new Section R12-1-305 renumbered from R12-1-304 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-305 renumbered to R12-1-304; new Section R12-1-305 renumbered from R12-1-306 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-306. General License - Radioactive Material Other Than Source Material

A. This subsection grants a general license that authorizes a person such as a commercial or industrial firm, to transfer, receive, acquire, own, possess, and use radioactive material incorporated in the following devices or equipment manufactured, tested, and labeled by the manufacturer in accordance with a specific license issued to the manufacturer by the U.S. Nuclear Regulatory Commission under 10 CFR 31.3. The devices regulated by this subsection include:

1. Devices designed for use as static eliminators that contain, as a sealed source or sources, radioactive material, consisting of a total of not more than 18.5 MBq (500 microcuries) of polonium-210 per device; or

2. Devices designed for ionization of air that contain, as a sealed source or sources, radioactive material, consisting of a total of not more than 18.5 MBq (500 microcuries) of polonium-210 per device or 1.85 GBq (50 millicuries) of hydrogen-3 (tritium) per device.

B. Certain measuring, gauging or controlling devices

1. This subsection grants a general license that authorizes a person such as a commercial or industrial firm; a research, educational or medical institution; an individual conducting business; or a state or local government agency to receive, acquire, possess, use, or transfer radioactive material according to the provisions of 10 CFR 31.5(b) and (c), January 1, 2005, which are incorporated by reference, published by the Office of the Federal Register, National Archives and Records Administration, Washington, D.C. 20408, and on file with the Agency. The material incorporated by reference contains no future editions or amendments.

2. A general licensee shall receive a device from one of the specific licensees described in this Section or through a transfer made under subsection (4)(k).

3. A general license in subsection (B)(1) applies only to radioactive material contained in devices that have been manufactured or initially transferred and labeled in accordance with the requirements contained in:

a. A specific license issued under R12-1-311(D); or

b. An equivalent specific license issued by the NRC or another Agreement State.

4. A person who acquires, receives, possesses, uses, or transfers radioactive material in a device licensed under subsection (B)(1), shall:

a. Ensure that all labels and safety statements affixed to a device at the time of receipt are maintained and not removed, and comply with all instructions and precautions on the labels.

b. Ensure that the device is tested for leakage of radioactive material and proper operation of the on-off mechanism and indicator, if any, at no longer than six-month intervals or at other intervals as specified on the label.

i. A general licensee need not test a device that contains krypton for leakage of radioactive material, and

ii. A general licensee need not test a device for leakage of radioactive material if the device contains only tritium, not more than 3.7 Mbq (100 microcuries) of other beta or gamma emitting material, or 370 kBq (10 microcuries) of alpha emitting material, or the device is held in storage, in the original shipping container, before initial installation.

c. Ensure that the tests required by subsection (B)(4)(b) and other testing, installation, servicing, and removal from installation involving the radioactive material or its shielding or containment, are performed:

i. In accordance with the device label instructions; or

ii. By a person holding a specific license under R12-1-311(D) or in accordance with the provisions of a specific license issued by the NRC or an Agreement State which authorizes distribution of devices to persons generally licensed by the NRC or an Agreement State.

d. Maintain records of compliance with the requirements in subsections (B)(4)(b) and (c) that show the results of tests; the dates that required activities were performed, and the names of persons performing required activities involving radioactive material from the installation and its shielding or containment. The records shall be maintained for three years from the date of the recorded event or until transfer or disposal of the device.

e. Immediately suspend operation of a device if there is a failure of, or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of 185 Becquerel (0.005 microcurie) or more of removable radioactive material.

i. A general licensee shall not operate the device until it has been repaired by the manufacturer or another person holding a specific license to repair this type of device that was issued by the Agency under R12-1-311(D), the NRC, or an Agreement State which authorizes distribution of devices to persons generally licensed by the NRC or an Agreement State.

ii. If necessary the general licensee shall dispose of the device and any radioactive material from the device by transfer to a person authorized by a specific license to receive the radioactive material in the device or as otherwise approved by the Agency.

iii. Within 30 days of an event governed by subsection (B)(4)(e) the general licensee shall furnish a report that contains a brief description of the event and the remedial action taken and, in the case of detection of 185 Becquerel (0.005 microcurie) or more of removable radioactive material or failure of or damage to a source likely to result in contamination of the general licensee's facility or the surrounding area, if applicable, a plan for ensuring that the general licensee's facility and surrounding area, if applicable, are acceptable for unrestricted use. The radiological criteria for unrestricted use in R12-1-452 may be used to prepare the plan, as determined by the Agency, on a case-by-case basis.

f. Not abandon a device that contains radioactive material.

g. Not export a device that contains radioactive material except in accordance with 10 CFR 110, January 1, 2005, which is incorporated by reference, published by the Office of the Federal Register National Archives and Records Administration, Washington, D.C. 20408, and on file with the Agency. The material incorporated by reference contains no future editions or amendments.

h. Transfer or dispose of a device that contains radioactive material only by export as authorized in subsection (B)(4)(g), transfer to another general licensee as authorized in subsection (B)(4)(k) or a person who is authorized to receive the device by a specific license issued by the Agency, the NRC, or an Agreement State, or collection as waste if authorized by equivalent regulations of an Agreement State, or the NRC, or as otherwise approved under subsection (B)(4)(j).

i. Within 30 days after the transfer or export of a device to a specific licensee, furnish a report to the Agency. The report shall:

i. Identify the device by manufacturer's (or initial transferor's) name, model number, and serial number;

ii. Provide the name, address, and license number of the person receiving the device (license number not applicable if exported); and

iii. Provide the date of transfer or export.

j. Obtain written Agency approval before transferring a device to any other specific licensee that is not authorized in accordance with subsection (B)(4)(h).

k. Transfer a device to another general licensee only:

i If the device remains in use at a particular location. The transferor shall provide the transferee with a copy of this Section, a copy of R12-1-443, R12-1-445, and R12-1-448 and any safety documents identified on the device label. Within 30 days of the transfer, the transferor shall report to the Agency the manufacturer's (or initial transferor's) name; the model number and the serial number of the device transferred; the transferee's name and mailing address for the location of use; and the name, title, and telephone number of the responsible individual appointed by the transferee in accordance with subsection (B)(4)(n); or

ii. If the device is held in storage in the original shipping container at its intended location of use before initial use by a general licensee, and by a person that is not a party to the transaction.

l. Comply with the provisions of R12-1-443, R12-1-444, R12-1-445, R12-1-447, and R12-1-448 for reporting and notification of radiation incidents, theft or loss of licensed material, and is exempt from the other requirements of 12 A.A.C. 1, Articles 4 and 10.

m. Respond to written requests from the Agency to provide information relating to the general license within 30 days from the date on the request, or a longer time period specified in the request. If the general licensee cannot provide the requested information within the specified time period, the general licensee shall request a longer period to supply the information before expiration of the time period, providing the Agency with a written justification for the request.

n. Appoint an individual responsible for knowledge of applicable laws and possessing the authority to take actions required to comply with applicable radiation safety laws. The general licensee, through this individual, shall ensure the day-to-day compliance with applicable radiation safety laws. This provision does not relieve the general licensee of responsibility.

o. Register, in accordance with subsections (B)(4)(p) and (q), any device that contains at least 370 millibecquerel (10 millicuries) of cesium-137, 3.7 millibecquerel (0.1 millicuries) of strontium-90, 37 millibecquerel (1 millicurie) of cobalt-60, or 37 millibecquerel (1 millicurie) of americium-241 or any other transuranic (i.e., element with atomic number greater than uranium (92)), based on the activity indicated on the label. Each address for a location of use, as described under subsection (B)(4)(q)(iv), represents a separate general licensee and requires a separate registration and fee.

p. Register each device annually with the Agency and pay the fee required by R12-1-1306, Category D4, if in possession of a device that meets the criteria in subsection (B)(4)(o). The general licensee shall register by verifying, correcting, and adding to the information provided in a request for registration received from the Agency. The registration information shall be submitted to the Agency within 30 days from the date on the request for registration.

q. In registering a device, furnish the following information and any other registration information specifically requested by the Agency:

i Name and mailing address of the general licensee;

ii. Information about each device, including the manufacturer (or initial transferor), model number, serial number, radioisotope, and activity (as indicated on the label);

iii. Name, title, and telephone number of the responsible individual appointed by the general licensee under subsection (B)(4)(n);

iv. Address or location at which each device is used and stored. For a portable device, the address of the primary place of storage;

v. Certification by the responsible individual that the information concerning each device has been verified through a physical inventory and review of label information; and

vi. Certification by the responsible individual that the individual is aware of the requirements of the general license.

r. Report a change in mailing address for the location of use or a change in the name of the general licensee to the Agency within 30 days of the effective date of the change. For a portable device, a report of address change is only required for a change in the device's primary place of storage.

s. Not use a device if the device has not been used for a period of two years. If a device with shutters is not being used, the general licensee shall ensure that the shutters are locked in the closed position. The testing required by subsection (B)(4)(b) need not be performed during a period of storage. However, if a device is put back into service or transferred to another person, and has not been tested during the required test interval, the general licensee shall ensure that the device is tested for leakage before use or transfer and that the shutter is tested before use. A device kept in standby for future use is excluded from the two-year time limit in this subsection if the general licensee performs a quarterly physical inventory regarding the standby devices.

5. A person that is generally licensed by an Agreement State with respect to a device that meets the criteria in subsection (B)(4)(o) is exempt from registration requirements if the device is used in an area subject to Agency jurisdiction for a period less than 180 days in any calendar year. The Agency does not request registration information from a general licensee if the device is exempted from licensing requirements in subsection (B)(4)(o).

6. The general license granted under subsection (B)(1) is subject to the provisions of 12 A.A.C. 1, Articles 1, 3, 12, and 15, and A.R.S. §§ 30-654(B)(13), 30-657 (A) and (B), 30-681, and 30-685 through 30-689.

C. Luminous safety devices for aircraft

1. This subsection grants a general license that authorizes a person to receive, acquire, possess, and use tritium or promethium-147 contained in luminous safety devices for use in aircraft, provided that each device contains not more than 370 GBq (10 curies) of tritium or 11.1 GBq (300 millicuries) of promethium-147; and each device has been manufactured, assembled, or imported according to a specific license issued by the U.S. Nuclear Regulatory Commission, or each device has been manufactured or assembled according to the specifications contained in a specific license issued to the manufacturer or assembler of the device by the Agency or any Agreement State or Licensing State in accordance with licensing requirements equivalent to those in 10 CFR 32.53.

2. A person who receives, acquires, possesses, or uses a luminous safety device according to the general license granted in subsection (C)(1) is:

a. Exempt from the requirements of 12 A.A.C. 1, Article 4 and Article 10 except that the person shall comply with the reporting and notification provisions of R12-1-443, R12-1-444; R12-1-445, R12-1-447, and R12-1-448;

b. Not authorized to manufacture, assemble, or repair a luminous safety device that contains tritium or promethium-147;

c. Not authorized to own, receive, acquire, possess, or use radioactive material contained in instrument dials; and

d. Subject to the provisions of 12 A.A.C. 1, Articles 1, 3, 12, and 15 and A.R.S. §§ 30-654(B)(13), 30-657(A) and (B), 30-681, and 30-685 through 30-689.

D. This subsection grants a general license that authorizes a person who holds a specific license to receive, possess, use, and transfer radioactive material if the Agency issues the license; or special nuclear material if the NRC issues the license. For americium-241, radium-226, and plutonium contained in calibration or reference sources, this subsection grants a general license in accordance with the provisions of subsections (D)(1), (2), and (3). For plutonium, ownership is included in the licensed activities.

1. This subsection grants a general license for calibration or reference sources that have been manufactured according to the specifications contained in a specific license issued to the manufacturer or importer of the sources by the U.S. Nuclear Regulatory Commission under 10 CFR 32.57 or 10 CFR 70.39. This general license also governs calibration or reference sources that have been manufactured according to specifications contained in a specific license issued to the manufacturer by the Agency, an Agreement State, or a Licensing State, according to licensing requirements equivalent to those contained in 10 CFR 32.57 or 10 CFR 70.39, as applicable, January 1, 2004, which are incorporated by reference, published by the Office of the Federal Register, National Archives and Records Administration, Washington D.C. 20408, and on file with the Agency. The material incorporated by reference contains no future editions or amendments.

2. A general license granted under subsection (D) or (D)(1) is subject to the provisions of 12 A.A.C. 1, Articles 1, 3, 4, 10, 12, and 15 and A.R.S. §§ 30-654(B)(13), 30-657(A) and (B), 30-681, and 30-685 through 30-689. In addition, a person who owns, receives, acquires, possesses, uses, or transfers one or more calibration or reference sources under a general license granted under subsection (D) or (D)(1) shall:

a. Not possess at any one time, at any location of storage or use, more than 185 kBq (5 microcuries) of americium-241, plutonium, or radium-226 in calibration or reference sources;

b. Not receive, possess, use, or transfer a calibration or reference source unless the source, or the storage container, bears a label that includes one of the following statements, as applicable, or a substantially similar statement that contains the same information:

i. The receipt, possession, use and transfer of this source, Model _____, Serial No. _____, are subject to a general license and the regulations of the U.S. Nuclear Regulatory Commission or a State with which the Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

CAUTION -- RADIOACTIVE MATERIAL -- THIS SOURCE CONTAINS (name of the appropriate material) -- DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

________________________________

Name of manufacturer or importer

ii. The receipt, possession, use and transfer of this source, Model _____, Serial No. _____, are subject to a general license and the regulations of any Licensing State. Do not remove this label.

CAUTION -- RADIOACTIVE MATERIAL -- THIS SOURCE CONTAINS RADIUM-226. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

________________________________

Name of manufacturer or importer

c. Not transfer, abandon, or dispose of a calibration or reference source except by transfer to a person authorized to receive the source by a license from the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State;

d. Store a calibration or reference source, except when the source is being used, in a closed container designed, constructed, and approved for containment of americium-241, plutonium, or radium-226 which might otherwise escape during storage; and

e. Not use a calibration or reference source for any purpose other than the calibration of radiation detectors or the standardization of other sources.

3. The general license granted under subsections (D) or (D)(1) does not authorize the manufacture of calibration or reference sources that contain americium-241, plutonium, or radium-226.

E. This subsection grants a general license that authorizes a person to receive, possess, use, transfer, own, or acquire carbon-14 urea capsules, which contain one microcurie of carbon-14 urea for in vivo human diagnostic use.

Receipt, possession, use, transfer, ownership or acquisition of carbon-14 urea capsules containing 1 microcurie of carbon-14 urea for "in vivo" human diagnostic use:

1. Except as provided in subsections (E)(2) and (3), a physician is exempt from the requirements for a specific license, provided that each carbon-14 urea capsule for in vivo diagnostic use contains no more than 1 microcurie.

2. A physician who desires to use the capsules for research involving human subjects shall obtain a specific license issued according to the specific licensing requirements in this Article.

3. A physician who desires to manufacture, prepare, process, produce, package, repackage, or transfer carbon-14 urea capsules for commercial distribution shall obtain a specific license from the Agency, issued according to the requirements in 10 CFR 32, January 1, 2005, which is incorporated by reference, published by the Office of the Federal Register, National Archives and Records Administration, Washington, D.C. 20408, and on file with the Agency. The material incorporated by reference contains no future editions or amendments.

4. Nothing in this subsection relieves physicians from complying with applicable FDA and other federal and state requirements governing receipt, administration, and use of drugs.

F. This subsection grants a general license that authorizes any physician, clinical laboratory, or hospital to use radioactive material for certain in vitro clinical or laboratory testing.

1. The general licensee is authorized to receive, acquire, possess, transfer, or use, for any of the following stated tests, the following radioactive materials in prepackaged units:

a. Iodine-125, in units not exceeding 370 kBq (10 microcuries) each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or radiation from such material, to human beings or animals.

b. Iodine-131, in units not exceeding 370 kBq (10 microcuries) each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation from such material, to human beings or animals.

c. Carbon-14, in units not exceeding 370 kBq (10 microcuries) each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation from such material, to human beings or animals.

d. Hydrogen-3 (tritium), in units not exceeding 1.85 MBq (50 microcuries) each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation from such material, to human beings or animals.

e. Iron-59, in units not exceeding 740 kBq (20 microcuries) each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation from such material, to human beings or animals.

f. Cobalt-57, in units not exceeding 370 kBq (10 microcuries) each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation from such material, to human beings or animals.

g. Mock iodine-125 reference or calibration sources, in units not exceeding 1.85 kBq (50 nanocurie) of iodine-129 and 185 Bq (5 nanocurie) of americium-241 each, for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation from such material, to human beings or animals.

2. A person shall not acquire, receive, possess, use, or transfer radioactive material according to the general license established by this subsection until the person has filed with the Agency ARRA-9, "Certificate -- In Vitro Testing with Radioactive Material Under General License", provided the information listed in Exhibit E, and received a validated copy of ARRA-9, which indicates the assigned certification number. The physician, clinical laboratory, or hospital shall furnish on ARRA-9 the following information:

a. Name, telephone number, and address of the physician, clinical laboratory, or hospital; and

b. A statement that the physician, clinical laboratory, or hospital has radiation measuring instruments to carry out in vitro clinical or laboratory tests with radioactive material and that tests will be performed only by personnel competent to use the instruments and handle the radioactive material.

3. A person who receives, acquires, possesses, or uses radioactive material according to the general license granted under this subsection shall:

a. Not possess at any one time, in storage or use, a combined total of not more than 7.4 MBq (200 microcuries) of iodine-125, iodine-131, iron-59, or cobalt-57 in excess of 7.4 MBq (200 microcuries), or acquire or use in any one calendar month more than 18.5 MBq (500 microcuries) of these radionuclides.

b. Store the radioactive material, until used, in the original shipping container or in a container that provides equivalent radiation protection.

c. Use the radioactive material only for the uses authorized by subsection (F).

d. Not transfer radioactive material to a person who is not authorized to receive it according to a license issued by the Agency, the U.S. Nuclear Regulatory Commission, or any Agreement State or Licensing State, or in any manner other than in an unopened, labeled shipping container received from the supplier.

e. Not dispose of a mock iodine-125 reference or calibration source described subsection (F)(1) except as authorized by R12-1-434.

4. The general licensee shall not receive, acquire, possess, transfer, or use radioactive material according to subsection (F)(1):

a. Except as prepackaged units that are labeled according to the provisions of a specific license issued by the U.S. Nuclear Regulatory Commission, or any Agreement State that authorizes the manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), iron-59, cobalt-57, or mock iodine-125 for distribution to persons generally licensed under subsection (F) or its equivalent federal law, and

b. Unless one of the following statements, or a substantially similar statement that contains the same information, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure that accompanies the package:

i. This radioactive material may be acquired, received, possessed, and used only by physicians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation from such material, to human beings or animals. The acquisition, receipt, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a state with which the Commission has entered into an agreement for the exercise of regulatory authority.

____________________

Name of manufacturer

ii. This radioactive material shall be acquired, received, possessed, and used only by physicians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation from such material, to human beings or animals. The receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of a Licensing State.

____________________

Name of manufacturer

5. A physician, clinical laboratory or hospital that possesses or uses radioactive material under a general license granted by subsection (F):

a. Shall report to the Agency in writing, any change in the information furnished on the ARRA-9. The report shall be furnished within 30 days after the effective date of the change; and

b. Is exempt from the requirements of 12 A.A.C. 1, Article 4 and Article 10 with respect to radioactive material covered by the general license, except that a person using mock iodine-125 sources, described in subsection (F)(1)(g), shall comply with the provisions of R12-1-434, R12-1-443, and R12-1-444 of this Chapter.

6. For the purposes of subsection (F), a licensed veterinary care facility is considered a "clinical laboratory".

G. This subsection grants a general license that authorizes a person to receive, acquire, possess, use, and transfer strontium-90, contained in ice detection devices, provided each device contains not more than 1.85 Mbq (50 microcuries) of strontium-90 and each device has been manufactured or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission or each device has been manufactured according to the specifications contained in a specific license issued by the Agency or any Agreement State to the manufacturer of the device under licensing requirements equivalent to those in 10 CFR 32.61. A person who receives, acquires, possesses, uses, or transfers strontium-90 contained in ice detection devices under a general license in accordance with subsection (G):

1. Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating, discontinue use of the device until it has been inspected, tested for leakage, and repaired by a person who holds a specific license from the U.S. Nuclear Regulatory Commission or an Agreement State to manufacture or service ice detection devices; or dispose of the device according to the provisions of R12-1-434;

2. Shall assure that each label, affixed to the device at the time of receipt, which bears a statement that prohibits removal of the labels, maintained on the device; and

3. Is exempt from the requirements of 12 A.A.C. 1, Article 4 and Article 10, except that the user of an ice detection device shall comply with the provisions of R12-1-434, R12-1-443 and R12-1-444.

4. Shall not manufacture, assemble, disassemble, or repair an ice detection device that contains strontium-90.

5. Is subject to the provisions of 12 A.A.C. 1, Articles 1, 3, 12, and 15, and A.R.S. §§ 30-654(B), 30-657(A) and (B), 30-681, and 30-685 through 30-689.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Former Section R12-1-306 renumbered to R12-1-307, new Section R12-1-306 renumbered from R12-1-305 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-306 renumbered to R12-1-305; new Section R12-1-306 renumbered from R12-1-307 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-307. Repealed

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Repealed effective December 20, 1985 (Supp. 85-6). Former Section R12-1-307 renumbered to R12-1-308, new Section R12-1-307 renumbered from R12-1-306 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-307 renumbered to R12-1-306; new Section R12-1-307 renumbered from R12-1-308 and repealed by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2).

R12-1-308. Filing Application for Specific Licenses

A. An applicant for a specific license shall file an Agency application. The applicant shall prepare the application in duplicate, one copy for the Agency and the other for the applicant.

B. The Agency may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the Agency to determine whether the application should be granted or denied or whether a license should be modified or revoked.

C. Each application shall contain the information specified in Exhibit (E) of this Article and be signed by the applicant, licensee, or person duly authorized to act for the applicant or licensee.

D. Unless R12-1-1302 precludes combination with a license of another category, an application for a specific license may include a request for a license that authorizes more than one activity.

E. In the application, the applicant may incorporate by reference information contained in previous applications, statements, or reports filed with the Agency provided the references are clear and specific.

F. The Agency shall make applications and documents submitted to the Agency available for public inspection, but may withhold any document or part of a document from public inspection if disclosure of its content is not required in the public interest and would adversely affect the interest of a person concerned.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Former Section R12-1-308 renumbered to R12-1-309, new Section R12-1-308 renumbered from R12-1-307 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-308 renumbered to R12-1-307; new Section R12-1-308 renumbered from R12-1-309 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-309. General Requirements for Issuance of Specific Licenses

A license application shall be approved if the Agency determines that:

1. The applicant is qualified by reason of training and experience to use the material in question for the purpose requested according to these rules, in a manner that will minimize danger to public health and safety or property;

2. The applicant's proposed equipment, facilities, and procedures are adequate to minimize danger to public health and safety or property;

3. The issuance of the license will not be inimical to the health and safety of the public;

4. The applicant satisfies all applicable special requirements in R12-1-310, R12-1-311, R12-1-322, R12-1-323, 12 A.A.C. 1, Articles 5, 7, and 17; and

5. The applicant demonstrates that a letter has been sent, return receipt requested, to the Mayor's office of the city, town, or, if not within an incorporated community, to the County Board of Supervisors of the county in which the applicant proposes to operate which describes:

a. The nature of the proposed activity involving radioactive material; and

b. The facility, including use and storage areas.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Former Section R12-1-309 renumbered to R12-1-310, new Section R12-1-309 renumbered from R12-1-308 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-309 renumbered to R12-1-308; new Section R12-1-309 renumbered from R12-1-310 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-310. Special Requirements for Issuance of Specific Broad Scope Licenses

A. The Agency shall issue three classes of academic and industrial broad scope licenses, and only a single class A medical broad scope license.

1. A license is a broad scope class A license if it:

a. Contains the exact wording "Any radioactive material with Atomic Number 3 through 83" or "Any radioactive material with Atomic Number 84 through 92" in License Item 6, and

b. Contains the word "any" to authorize the chemical or physical form of the materials in License Item 7.

The license may authorize the radioactive materials in multi-curie quantities, and may authorize other radioactive materials and forms in addition to those listed in subsection (A)(1)(a).

2. A broad scope class B license is any specific license which authorizes the possession and use of the radioactive materials specified in Exhibit C of 12 A.A.C. 1, Article 3 in any chemical or physical form and in quantities determined as follows:

a. The possession limit, if only one radionuclide is possessed, is the quantity specified for that radionuclide in Exhibit C, Column I, or

b. The possession limit for multiple radionuclides is determined as follows: The sum of the ratios for all radionuclides possessed under the license shall not exceed unity (1). The ratio for each radionuclide is determined by dividing the quantity possessed by the applicable quantity in Exhibit C, Column I.

3. A broad scope class C license is any specific license authorizing the possession and use of the radioactive materials specified in Exhibit C of 12 A.A.C. 1, Article 3 in any chemical or physical form and in quantities determined as follows:

a. The possession limit, if only one radionuclide is possessed, is the quantity specified for that radionuclide in Exhibit C, Column II, or

b. The possession limit for multiple radionuclides is determined as follows: The sum of the ratios for all radionuclides possessed under the license shall not exceed unity (1). The ratio for each radionuclide is determined by dividing the quantity possessed by the applicable quantity in Exhibit C, Column II.

B. The Agency shall approve:

1. An application for a class A broad scope license if:

a. The applicant satisfies the general requirements specified in R12-1-309;

b. The applicant has engaged in a reasonable number of activities involving the use of radioactive material. For purposes of this subsection, the requirement of "reasonable number of activities" can be satisfied by showing that the applicant has five years of experience in the use of radioactive material. The Agency may accept less than five years of experience if the applicant's qualifications are adequate for the scope of the proposed license; and

c. The applicant has established administrative controls and provisions relating to organization, management, procedures, recordkeeping, material control, accounting, and management review that are necessary to assure safe operations, including:

i. Establishment of a radiation safety committee composed of a radiation safety officer, a representative of management, and persons trained and experienced in the safe use of radioactive material;

ii. Appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters; and

iii. Establishment of appropriate administrative procedures to assure:

Control of procurement and use of radioactive material;

Completion of safety evaluations of proposed uses of radioactive material which take into consideration matters such as the adequacy of facilities and equipment, training and experience of the user, and operating or handling procedures; and

Review, approval, and recording by the radiation safety committee of safety evaluations of proposed uses prepared in accordance with this subsection prior to use of the radioactive material.

2. An application for a class B broad scope license if:

a. The applicant satisfies the general requirements specified in R12-1-309; and

b. The applicant has established administrative controls and provisions relating to organization, management, procedures, recordkeeping, material control, accounting, and management review that are necessary to assure safe operations, including:

i. Appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and available for advice and assistance on radiation safety matters; and

ii. Establishment of appropriate administrative procedures to assure:

Control of procurement and use of radioactive material;

Completion of safety evaluations of proposed uses of radioactive material which take into consideration matters such as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

Review, approval, and recording by the radiation safety officer of safety evaluations of proposed uses prepared according to subsection (B)(2)(b)(ii) prior to use of the radioactive material.

3. An application for a class C broad scope license if:

a. The applicant satisfies the general requirements specified in R12-1-309;

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 material, the characteristics of ionizing radiation, units of 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, recordkeeping, material control and accounting, and management review necessary to assure safe operations.

C. Unless specifically authorized, broad-scope licensees shall not:

1. Conduct tracer studies in the environment involving direct release of radioactive material;

2. Acquire, receive, possess, use, or transfer devices containing 3.7 petabecquerel (100,000 curies) or more of radioactive material in sealed sources used for irradiation of materials;

3. Conduct activities for which a specific license is issued under R12-1-311, and 12 A.A.C. 1, Articles 5, 7, or 17; or

4. 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.

D. Radioactive material possessed under the class A broad scope license shall only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety committee.

E. Radioactive material possessed under the class B broad scope license shall only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety officer.

F. Radioactive material possessed under the class C broad scope license shall only be used by, or under the direct supervision of, individuals who satisfy the requirements of R12-1-310(B)(3)(b).

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Amended effective November 5, 1993 (Supp. 93-4). Former Section R12-1-310 renumbered to R12-1-311, new Section R12-1-310 renumbered from R12-1-309 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-310 renumbered to R12-1-309; new Section R12-1-310 renumbered from R12-1-311 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2).

R12-1-311. Special Requirements for a Specific License to Manufacture, Assemble, Repair, or Distribute Commodities, Products, or Devices that Contain Radioactive Material

A. Licensing the introduction of radioactive material into products in exempt concentrations.

1. The Agency shall grant a specific license to introduce radioactive material into a product or material, owned by or in the possession of the specific licensee or another that will be transferred to persons exempt under R12-1-303(A)(1), if the applicant satisfies the requirements of R12-1-309 and:

a. The applicant submits a description of the product or material into which the radioactive material will be introduced, intended use of the radioactive material and the product or material into which it is introduced, method of introduction, initial concentration of the radioactive material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material, and estimated concentration of the radioactive material in the product or material at the time of transfer; and

b. The applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in Exhibit A; reconcentration of the radioactive material in concentrations exceeding those in Exhibit A is not likely; use of lower concentrations is not feasible; and product or material is not likely to be incorporated in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

2. Each person licensed under subsection (A)(1) to initially transfer devices to generally licensed persons shall comply with the requirements of this subsection.

a. The specific licensee shall report to the Agency in writing any transfer of a device to a person for use under the general license in R12-1-306(B) and any receipt of a device from a person licensed under R12-1-306(B). The specific licensee shall submit the report on a quarterly basis and ensure that the report contains the following information:

i. The identity of each general licensee by name and mailing address for the location of use. If there is no mailing address for the location of use, the specific licensee shall submit an alternate address for the general licensee, along with information on the actual location of use;

ii. The name, title, and telephone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with applicable radiation safety laws;

iii. The date of transfer;

iv. The type, model number, and serial number of the device transferred; and

v. The quantity and type of radioactive material contained in the device.

b. If any person other than the intended user will temporarily possess the device at the place of use before its possession by the user, the specific licensee shall provide the same type of information provided under subsection (A)(2)(a) for the user and each person who will temporarily possess the device, clearly identifying each person.

c. For a device received from a R12-1-306(B) general licensee, the specific licensee shall provide the identity of the general licensee by name and address, type of device, model number, and serial number of the device received, the date of receipt, and, in the case of a device not initially transferred by the specific licensee, the name of the manufacturer or initial transferor.

d. If the specific licensee makes changes to a device possessed by a R12-1-306(B) general licensee that necessitate a label change, the specific licensee shall ensure that the report identifies the general licensee, the device, and the changes to information on the device label.

e. The specific licensee shall prepare a report that covers each calendar quarter. The report shall be filed within 30 days of the end of the calendar quarter, and clearly indicate the period covered by the report.

f. The report shall clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

g. If no transfers have been made to or from a person generally licensed under R12-1-306(B) during the reporting period, the specific licensee shall include this information in the report.

h. The specific licensee shall report any transfer of a device to a person for use under a general license in an Agreement State's regulations that is equivalent to R12-1-306(B) and any receipt of a device from any general licensee in the Agreement State's jurisdiction. The specific licensee shall submit a clear and legible report that contains all of the following information:

i. The identity of each general licensee by name and mailing address for the location of use. If there is no mailing address for the location of use, the specific licensee shall submit an alternate address for the general licensee, along with information on the actual location of use.

ii. The name, title, and telephone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with applicable radiation safety laws;

iii. The date of transfer;

iv. The type, model number, and serial number of the device transferred; and

v. The quantity and type of radioactive material contained in the device.

i. If any person other than the intended user will temporarily possess the device at the place of use before its possession by the user, the specific licensee shall record the same type of information provided for the user and for each person who will temporarily possess the device, clearly identifying each person.

j. For a device received from a general licensee, the specific licensee shall provide the identity of the general licensee by name and address, type of device, model number, and serial number of the device received, the date of receipt, and, in the case of a device not initially transferred by the specific licensee, the name of the manufacturer or initial transferor.

k. If the specific licensee makes changes to a device possessed by a general licensee that necessitate a label change to update required information, the specific licensee shall ensure that the report identifies the general licensee, the device, and the changes to information on the device label.

l. The specific licensee shall prepare a report that covers each calendar quarter, is filed within 30 days from the end of the calendar quarter, and clearly indicates the period covered by the report.

m. The report shall clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

n. If no transfers have been made to or from a general licensee in a particular Agreement State during the reporting period, the specific licensee shall report this information to the Agency, NRC, or responsible Agreement State agency at the request of the agency.

3. The specific licensee shall maintain all information concerning transfer and receipt of each device that supports the reports required by subsection (A). Records maintained in accordance with this subsection shall be maintained for a period of 3 years following the date of the recorded event.

B. Licensing the distribution of naturally occurring and accelerator-produced radioactive material (NARM) in exempt quantities.

1. The Agency shall grant a specific license to distribute naturally occurring and accelerator-produced radioactive material (NARM) to a person exempted from these rules according to R12-1-303(C) if the applicant satisfies the requirements of R12-1-309 and:

a. The radioactive material is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being;

b. The radioactive material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, identified as radioactive and to be used for its radioactive properties, but it is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and

c. The applicant submits copies of prototype labels and brochures and the Agency approves the labels and brochures.

2. The specific license issued under subsection (B)(1) is subject to the following conditions:

a. The licensee may sell or transfer 10 exempt quantities in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantities provided the sum of the fractions does not exceed unity.

b. The licensee shall individually package each exempt quantity. No more than 10 packaged exempt quantities shall be contained in any outer package for transfer to a person exempt according to R12-1-303(C). The licensee shall ensure that the dose rate at the external surface of the outer package does not exceed 5 microsieverts (0.5 millirem) per hour.

c. The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label that:

i. Identifies the radionuclide and the quantity of radioactivity, and

ii. Bears the words "Radioactive Material."

d. In addition to the labeling information required by subsection (B)(2)(c), the label affixed to the immediate container, or an accompanying brochure, shall:

i. State that the contents are exempt from Licensing State requirements;

ii. Bear the words "Radioactive Material -- Not for Human Use -- Introduction into Foods, Beverages, Cosmetics, Drugs, or Medicinals, or into Products Manufactured for Commercial Distribution is Prohibited -- Exempt Quantities Should Not Be Combined"; and

iii. Provide additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the radioactive material.

3. Each person licensed under subsection (B) shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under R12-1-303(C) or an equivalent rule of a Licensing State, and state the type and quantity of radioactive material transferred. The licensee shall file an annual report with the Agency stating the total quantity of each radionuclide transferred under the specific license. The annual report shall be provided to the Agency even if no transfers of radioactive material have been made according to this subsection during the reporting period. The report shall cover the year ending June 30 and be filed within 30 days after June 30.

C. The Agency shall grant a specific license to incorporate radioactive material, other than source or by-product material, into gas or aerosol detectors to be distributed to persons exempt under R12-1-303(B) if the applicant satisfies requirements contained in 10 CFR 32.26, January 1, 2006, which is incorporated by reference, published by the Office of the Federal Register, National Archives and Records Administration, Washington, D.C. 20408, and on file with the Agency, and contains no future editions or amendments, and provided:

1. The applicant satisfies the requirements of R12-1-309.

2. The licensee files annual reports required by 10 CFR 32.29, January 1, 2006, which is incorporated by reference, published by the Office of the Federal Register, National Archives and Records Administration, Washington, D.C. 20408 and on file with the Agency. The material incorporated by reference contains no future editions or amendments.

D. Licensing the manufacture and distribution of devices to persons generally licensed under R12-1-306(B).

1. The Agency shall grant a specific license to manufacture or distribute each device that contains radioactive material, excluding special nuclear material, to persons generally licensed under R12-1-306(B) or equivalent regulations of the U.S. NRC, an Agreement State, or the Licensing State if:

a. The applicant satisfies the requirements of R12-1-309;

b. The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that:

i. The device can be safely operated by persons not having training in radiological protection;

ii. Under ordinary conditions of handling, storage, and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive a dose in excess of 10% of the limits specified in R12-1-408; and

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

Whole body; head and trunk; active

blood-forming organs; gonads; or

lens of eye 150 mSv (15 rem)

Hands and forearms; feet

and ankles; localized areas

of skin averaged over areas

no larger than 1 square

centimeter 2 Sv (200 rem)

Other organs 500 mSv (50 rem)

c. Each device bears a durable, legible, clearly visible label or labels that contain in a clearly identified and separate statement:

i. Instructions and precautions necessary to assure safe installation, operating, 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 the testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and

iii. The information called for in one of the following statements in the same or substantially similar form:

The receipt, possession, use, and transfer of this device, Model _____, Serial No. _____, are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or a state with which the Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

CAUTION -- RADIOACTIVE MATERIAL

_____________________________________

(name of manufacturer or distributor)

The receipt, possession, use and transfer of this device, Model _____, Serial No. _____, are subject to a general license or the equivalent, and the regulations of a Licensing State. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

CAUTION -- RADIOACTIVE MATERIAL

_____________________________________

(name of manufacturer or distributor)

d. The model, serial number, and name of manufacturer or distributor may be omitted from the label if the information location is specified in labeling affixed to the device;

e. Each device with a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label that provides the device model number and serial number, the isotope and quantity, the words, "Caution-Radioactive Material," the radiation symbol described in R12-1-428, and the name of the manufacturer or initial distributor; and

f. Each device meets the criteria in 10 CFR 31.5(c)(13)(i), January 1, 2005, which is incorporated by reference, published by the Office of the Federal Register, National Archives and Records Administration, Washington, D.C. 20408, and on file with the Agency, and contains no future editions or amendments; and bears a permanent (e.g., embossed, etched, stamped, or engraved) label affixed to the source housing, if separable, or the device if the source housing is not separable, that includes the words, "Caution-Radioactive Material," and, if practicable, the radiation symbol described in R12-1-428.

2. In the event the applicant desires that the device undergo mandatory testing 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 application shall contain sufficient information to demonstrate that the longer interval is justified by performance characteristics of the device or similar devices and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the on-off mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the Agency shall consider information which includes, but is not limited to:

a. Primary containment (source capsule);

b. Protection of primary containment;

c. Method of sealing 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. In the event the applicant desires that the general licensee under R12-1-306(B), or under equivalent regulations of the NRC or an Agreement State or Licensing State, be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the on-off mechanism and indicator, or remove the device from installation, the application shall include written instructions to be followed by the general licensee, estimated calendar quarter doses associated with the activity or activities, and bases for the estimates. The submitted information shall demonstrate that performance of the activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a dose in excess of 10% of the limits specified in R12-1-408.

4. A licensee authorized under subsection (D) to distribute a device to a generally licensed person shall provide, if a device that contains radioactive material is to be transferred for use under the general license granted in R12-1-306(B), the name of each person that is licensed under R12-1-311(D) and the information specified in this subsection for each person to whom a device will be transferred. The licensee shall provide this information before the device may be transferred. In the case of transfer through another person, the licensee shall provide the listed information to the intended user before initial transfer to the other person.

a. The licensee shall provide:

i. A copy of the general license, issued under R12-1-306(B);

ii. A copy of R12-1-443 and R12-1-445;

iii. A list of the services that can only be performed by a specific licensee;

iv. Information on authorized disposal options, including estimated costs of disposal; and

v. A list of civil penalties for improper disposal.

b. The licensee shall:

i. Report on a quarterly basis to the responsible Agreement State or NRC all transfers of devices to persons for use under a general license in accordance with 10 CFR 32.52, January 1, 2006, which is incorporated by reference, published by the Office of the Federal Register, National Archives and Records Administration Washington, DC 20408, and on file with the Agency. This incorporated reference contains no future editions or amendments.

ii. Maintain all information concerning transfers and receipts of devices that supports the reports required by subsection (D)(4)(b).

iii. Maintain records required by subsection (D)(4)(b) for a period of three years following the date of the recorded event.

5. If radioactive material is to be transferred in a device for use under an equivalent general license of the NRC or another Agreement State, each person that is licensed under R12-1-304(B) shall provide the information specified in this subsection to each person to whom a device will be transferred. The licensee shall provide this information before the device is transferred. In the case of transfer through another person, the licensee shall provide the listed information to the intended user before initial transfer to the other person. The licensee shall provide:

a. A copy of the Agreement State's requirements that are equivalent to R12-1-306(A) and (B), and A.R.S. §§ 30-657, R12-1-443, and R12-1-445. If a copy of NRC regulations is provided to a prospective general licensee in lieu of the Agreement State's requirements, the licensee shall explain in writing that use of the device is regulated by the Agreement State. If certain requirements do not apply to a particular device, the licensee may omit the requirement from the material provided;

b. A list of the services that can only be performed by a specific licensee;

c. Information on authorized disposal options, including estimated costs of disposal; and

d. The name, title, address, and telephone number of the individual at the Agreement State regulatory agency who can provide additional information.

6. A licensee may propose to the Agency an alternate method of informing the customer.

7. If a licensee has notified the Agency of bankruptcy under R12-1-313(E) or is terminating under R12-1-319, the licensee shall provide, upon request, to the Agency, the NRC, or another Agreement State, records of the disposition as required under A.R.S. § 30-657.

8. A licensee authorized to transfer a device to a generally licensed person, shall comply with the following requirements:

a. The person licensed under subsection (D) shall report all transfers of devices to persons for use under a general license obtained under R12-1-306(B), and all receipts of devices from persons licensed under R12-1-306(B) to the Agency, NRC, or other affected Agreement State. The report shall be submitted on a quarterly basis, in a clear and legible form, and contain the following information:

i. The identity of each general licensee by name and mailing address for the location of use. If there is no mailing address for the location of use, the person licensed under subsection (D) shall submit an alternate address for the general licensee, along with information on the actual location of use;

ii. The name, title, and telephone number of a person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the applicable laws;

iii. The date of transfer;

iv. The type, model number, and serial number of the device transferred; and

v. The quantity and type of byproduct material contained in the device.

b. If one or more intermediaries will temporarily possess the device at the intended place of use before its possession by the intended user, the report shall include the information required of the general licensee in subsection (D)(4) for both the intended user and each intermediary, clearly identifying the intended user and each intermediary.

c. For devices received from a general licensee, licensed under R12-1-306(B), the report shall include:

i. The identity of the general licensee by name and address;

ii. The type, model number, and serial number of the device received;

iii. The date of receipt; and

iv. In the case of a device not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.

d. If the person licensed under subsection (D) makes a change to a device possessed by a general licensee so that the label must be changed to update required information, the report shall identify the general licensee, the device, and the changes to information on the device label.

e. The report shall cover a calendar quarter, be filed within 30 days of the end of each calendar quarter, and clearly indicate the period covered by the report.

f. The report shall clearly identify the person licensed under subsection (D) submitting the report and include the license number of the licensee.

g. If no transfers are made to or from persons generally licensed under R12-1-306(B) during a reporting period, the person licensed under subsection (D) shall submit a report indicating the lack of activity.

9. The licensee shall maintain records of all transfers for Agency inspection. Records shall be maintained for three years after termination of the license to manufacture the generally licensed devices regulated under R12-1-306(B).

E. The Agency shall grant a specific license to manufacture, assemble, or repair luminous safety devices that contain tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under R12-1-306(C), if the applicant satisfies:

1. The general requirements specified in R12-1-309; and

2. The requirements of 10 CFR 32.53 through 32.56 and 32.101, January 1, 2005, which are incorporated by reference, published by the Office of the Federal Register, National Archives and Records Administration, Washington, D.C. 20408, and on file with the Agency. The material incorporated by reference contains no future editions or amendments.

F. The Agency shall grant a specific license to manufacture calibration sources that contain americium-241 or plutonium for distribution to persons generally licensed under R12-1-306(D) if the applicant satisfies:

1. The general requirements of R12-1-309; and

2. The requirements of 10 CFR 32.57, 32.58, 32.59, 32.102, and 70.39, January 1, 2006, which are incorporated by reference, published by the Office of the Federal Register, National Archives and Records Administration, Washington, D.C. 20408, and on file with the Agency. The material incorporated by reference contains no future editions or amendments.

G. The Agency shall grant a specific license to distribute radioactive material for use by a physician under the general license in R12-1-306(E) if:

1. The applicant submits evidence that the radioactive material is to be manufactured, labeled, and packaged under a new drug application that the Commissioner of Food and Drugs, U.S. Food and Drug Administration has approved, or according to a license for a biologic product issued by the FDA; and

2. One of the following statements, or a substantially similar statement that contains the information called for in the following statements, appears on the label affixed to the container or appears in the leaflet or brochure that accompanies the package:

a. This radioactive drug may be received, possessed, and used only by physicians licensed to dispense drugs in the practice of medicine. Its receipt, possession, use and transfer are subject to the regulations and general license or its equivalent of the U.S. Nuclear Regulatory Commission or of a state with which the Commission has entered into agreement for the exercise of regulatory authority.

____________________

Name of Manufacturer

b. This radioactive drug may be received, possessed, and used only by physicians licensed (to dispense drugs) in the practice of medicine. Its receipt, possession, use and transfer are subject to the regulations and a general license or its equivalent of a Licensing State.

____________________

Name of Manufacturer

H. The Agency shall grant for a specific license to manufacture or distribute radioactive material for use under the general license of R12-1-306(F) if:

1. The applicant satisfies the general requirements specified in R12-1-309.

2. The radioactive material is to be prepared for distribution in prepackaged units of:

a. Iodine-125 in units not exceeding 370 kBq (10 microcuries) each;

b. Iodine-131 in units not exceeding 370 kBq (10 microcuries) each;

c. Carbon-14 in units not exceeding 370 kBq (10 microcuries) each;

d. Hydrogen-3 (tritium) in units not exceeding 1.85 MBq (50 microcuries) each;

e. Iron-59 in units not exceeding 740 kBq (20 microcuries) each;

f. Cobalt-57 in units not exceeding 370 kBq (10 microcuries) each;

g. Mock iodine-125 in units not exceeding 1.85 kBq (50 nanocuries) of iodine-129 and 185 Bq (5 nanocuries) of americium-241 each.

3. Each prepackaged unit bears a durable, clearly visible label:

a. Identifying the radioactive contents as to chemical form and radionuclide and indicating that the amount of radioactivity does not exceed 370 kBq (10 microcuries) of iodine-125, iodine-131, cobalt-57 or carbon-14; 1.85 MBq (50 microcuries) of hydrogen-3 (tritium), 740 kBq (20 microcuries) of iron-59; or mock iodine-125 in units not exceeding 1.85 kBq (50 nanocurie) of iodine-129 and 185 Bq (5 nanocuries) of americium-241 each; and

b. Displaying the radiation caution symbol described in R12-1-428, the words, "CAUTION, RADIOACTIVE MATERIAL," and the phrase "Not for Internal or External Use in Humans or Animals."

4. One of the following statements, or a substantially similar statement that contains the information called for in the following statements appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure that accompanies the package:

a. This radioactive material may be received, acquired, possessed, and used only by physicians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation from the radioactive material, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a state with which the Commission has entered into an agreement for the exercise of regulatory authority.

____________________

Name of Manufacturer

b. This radioactive drug may be received, acquired, possessed, and used only by physicians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation from the radioactive material, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of a Licensing State.

____________________

Name of Manufacturer

5. The label affixed to the unit, or the leaflet or brochure that accompanies the package, contains adequate information about the precautions to be observed in handling and storing the specified radioactive material. In the case of the mock iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements set out in R12-1-434.

I. The Agency shall grant for a specific license to manufacture and distribute ice detection devices to persons generally licensed under R12-1-306(G) if the applicant satisfies:

1. The general requirements of R12-1-309; and

2. The criteria of 10 CFR 32.61, 32.62, and 32.103, January 1, 2006, which are incorporated by reference, published by the Office of the Federal Register, National Archives and Records Administration, Washington, D.C. 20408, and on file with the Agency. The material incorporated by reference contains no future editions or amendments.

J. The Agency shall grant a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs that contain radioactive material for use by a person authorized in accordance with Article 7 of this Chapter, if the applicant meets all of the requirements in 10 CFR 32.72, January 1, 2006, which is incorporated by reference, published by the Office of the Federal Register, National Archives and Records Administration, Washington, D.C. 20408, and on file with the Agency. The material incorporated by reference contains no future editions or amendments.

K. The Agency shall grant a specific license to manufacture and distribute generators or reagent kits that contain radioactive material for preparation of radiopharmaceuticals by persons licensed according to 12 A.A.C. 1, Article 7 if:

1. The applicant satisfies the general requirements of R12-1-309;

2. The applicant submits evidence that:

a. The generator or reagent kit is to be manufactured, labeled and packaged according to the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act, a new drug application (NDA) approved by the Food and Drug Administration (FDA), a biologic product license issued by FDA, or a "Notice of Claimed Investigational Exemption for a New Drug" (IND) that has been accepted by the FDA; or

b. The manufacture and distribution of the generator or reagent kit are not subject to the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.

3. The applicant submits information on the radionuclide; chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material contained in the generator or reagent kit;

4. The label affixed to the generator or reagent kit contains information on the radionuclide, including quantity, and date of assay; and

5. The label affixed to the generator or reagent kit, or the leaflet or brochure that accompanies the generator or reagent kit, contains:

a. Adequate information, from a radiation safety stand point, on the procedures to be followed and the equipment and shielding to be used in eluting the generator or processing radioactive material with the reagent kit, and

b. A statement that this generator or reagent kit (as appropriate) is approved for use by persons licensed by the Agency under 12 A.A.C. 1, Article 7 or equivalent licenses of the U.S. Nuclear Regulatory Commission or an Agreement State or Licensing State. The labels, leaflets or brochures required by this subsection supplement the labeling required by FDA and they may be separate from or, with the approval of FDA, combined with the labeling required by FDA.

L. The Agency shall grant a specific license to manufacture and distribute sources and devices that contain radioactive material to a person licensed in accordance with Article 7 of this Chapter for use as a calibration or reference source or for medical purposes, if the applicant meets all of the requirements in 10 CFR 32.74, January 1, 2006, which is incorporated by reference, published by the Office of the Federal Register, National Archives and Records Administration, Washington, D.C. 20408, and on file with the Agency. The material incorporated by reference contains no future editions or amendments.

M. Requirements for license to manufacture and distribute industrial products containing depleted uranium for mass volume applications.

1. The Agency shall grant a specific license to manufacture industrial products and devices that contain depleted uranium for use under R12-1-305(C) or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State if:

a. The applicant satisfies the general requirements in R12-1-309;

b. The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards of the industrial product or device to provide reasonable assurance that possession, use, or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive a radiation dose in excess of 10 percent of the limits specified in R12-1-408.

c. The applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.

2. In the case of an industrial product or device whose unique benefits are questionable, the Agency shall approve an application for a specific license under 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 Agency may deny any application for a specific license under this subsection if the end use or uses of the industrial product or device cannot be reasonably foreseen.

4. Each person licensed under subsection (M)(1) shall:

a. Maintain the level of quality control required by the license in the manufacture of the industrial product or device and 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, the number of the license under which the product or device was manufactured, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and

ii. State that the receipt, possession, use, and transfer of the product or device are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or an Agreement State;

c. Assure that the depleted uranium, before being installed in each product or device, has been impressed with the following legend, clearly legible through any plating or other covering: "Depleted Uranium";

d. Furnish a copy of the general license contained in R12-1-305(C) and a copy of ARRA-23 to each person to whom depleted uranium in a product or device is transferred for use under a general license contained in R12-1-305(C); or

e. Furnish a copy of the general license contained in the U.S. Nuclear Regulatory Commission's or Agreement State's regulation equivalent to R12-1-305(C) and a copy of the U.S. Nuclear Regulatory Commission's or Agreement State's certificate, or alternatively, furnish a copy of the general license contained in R12-1-305(C) and a copy of ARRA-23 to each person to whom depleted uranium in a product or device is transferred for use under a general license of the U.S. Nuclear Regulatory Commission or an Agreement State, with a document explaining that use of the product or device is regulated by the U.S. Nuclear Regulatory Commission or an Agreement State under requirements substantially the same as those in R12-1-305(C);

f. Report to the Agency all transfers of industrial products or devices to persons for use under the general license in R12-1-305(C). The report shall identify each general licensee by name and address, an individual by name or position who serves as the point of contact person for the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which a product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under R12-1-305(C) during the reporting period, the report shall so indicate;

i. Report to the U.S. Nuclear Regulatory Commission all transfers of industrial products or devices to persons for use under the U.S. Nuclear Regulatory Commission general license in 10 CFR 40.25; or

ii. Report to the responsible state agency all transfers of devices manufactured and distributed under subsection (M)(4)(f) for use under a general license in that state's regulations equivalent to R12-1-305(C);

iii. The report required in subsection (M)(4)(f)(i) or (ii) shall identify each general licensee by name and address, an individual by name or position who serves as the contact person for the general licensee, the type and model number of the device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which a product or device is transferred to the generally licensed person;

iv. If no transfers have been made to U.S. Nuclear Regulatory Commission licensees during the reporting period, this information shall be reported to the U.S. Nuclear Regulatory Commission;

v. If no transfers have been made to general licensees within a particular Agreement State during the reporting period, this information shall be reported to the responsible Agreement state agency; and

vi. Keep records showing the name, address, and contact person for each general licensee to whom depleted uranium in industrial products or devices is transferred for use under a general license provided in R12-1-305(C) or equivalent regulations of the U.S. Nuclear Regulatory Commission or of an Agreement State. The records shall be maintained for a period of three years and show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the reporting requirements of this Section.

Historical Note

Former Rule Section C.101. Former Section R12-1-311 repealed, new Section R12-1-311 adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Former Section R12-1-311 renumbered to R12-1-312, new Section R12-1-311 renumbered from R12-1-310 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-311 renumbered to R12-1-310; new Section R12-1-311 renumbered from R12-1-312 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 10 A.A.R. 2122, effective July 3, 2004 (Supp. 04-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4). Amended by final rulemaking at 13 A.A.R. 1217, effective May 5, 2007 (Supp. 07-1).

R12-1-312. Issuance of Specific Licenses

A. Upon determination that a license application meets the requirements of the Act and Agency rules, the Agency shall grant a specific license that may contain conditions or limitations if the Agency has determined that additional requirements regarding the proposed activity will protect health and safety.

B. The Agency may incorporate in any license at the time of issuance, or thereafter by rule or order, additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of radioactive material in order to:

1. Minimize danger to public health and safety or property;

2. Require reports and recordkeeping, and provide for inspections of activities under the license as may be necessary to protect health and safety; and

3. Prevent loss or theft of material subject to this Article.

C. The Agency may verify information contained in an application and secure additional information necessary to make a determination on issuance of a license and whether any special conditions should be attached to the license. The Agency may inspect the facility or location where radioactive materials would be possessed or used, and discuss details of the proposed possession or use of the radioactive materials with the applicant or representatives designated by the applicant.

Historical Note

Former Rule Section C.102; Former Section R12-1-312 repealed, new Section R12-1-312 adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Former Section R12-1-312 renumbered to R12-1-313, new Section R12-1-312 renumbered from R12-1-311 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-312 renumbered to R12-1-311; new Section R12-1-312 renumbered from R12-1-313 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-313. Specific Terms and Conditions

A. Each license issued under this Article is subject to all provisions of A.R.S. Title 30, Chapter 4 and to all rules and orders of the Agency.

B. A licensee shall not transfer, assign, or in any manner dispose of a license issued or granted under this Article or a right to possess or utilize radioactive material granted by any license issued under this Article unless the Agency finds that the transfer is consistent with the Agency's statutes and rules, and gives its consent in writing.

C. Each person licensed by the Agency under this Article shall confine the use and possession of the material licensed to the locations and purposes authorized in the license.

D. Each person licensed under this Section and each general licensee that is required to register under R12-1-306(B)(4)(o) shall notify the Agency in writing if the licensee decides to permanently discontinue any or all activities involving materials authorized under the license. A specific licensee or general licensee shall notify the Agency, in writing:

1. Immediately following the filing of a petition for bankruptcy under any Chapter of Title 11 of the United States Code if the petition for bankruptcy is by or against:

a. The licensee;

b. An entity (as defined in the bankruptcy code) controlling the licensee or listing the license or licensee as property of the estate; or

c. An affiliate (as defined in the bankruptcy code) of the licensee.

2. Providing the following information:

a. The bankruptcy court in which the petition for bankruptcy was filed;

b. The bankruptcy case title and number; and

c. The date the petition was filed.

Historical Note

Former Rule Section C.103; Former Section R12-1-313 repealed, new Section R12-1-313 adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Amended effective June 20, 1990 (Supp. 90-2). Former Section R12-1-313 renumbered to R12-1-314, new Section R12-1-313 renumbered from R12-1-312 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-313 renumbered to R12-1-312; new Section R12-1-313 renumbered from R12-1-314 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-314. Expiration of License

Except as provided in R12-1-315(B), each specific license expires at the end of the day, in the month and year stated on the license.

Historical Note

Former Rule Section C.104; Former Section R12-1-314 repealed, new Section R12-1-314 adopted effective June 30, 1977 (Supp. 77-3). Former Section R12-1-314 renumbered to R12-1-315, new Section R12-1-314 renumbered from R12-1-313 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-314 renumbered to R12-1-313; new Section R12-1-314 renumbered from R12-1-315 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2).

R12-1-315. Renewal of License

A. An applicant shall file an application for renewal of a specific license according to R12-1-308.

B. If a licensee files a renewal application not less than 30 days before the license expiration date and the existing license and associated renewal application is in proper form, the existing license does not expire until a final renewal determination is made by the Agency.

Historical Note

Former Rule Section C.105; Former Section R12-1-315 repealed, new Section R12-1-315 adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Former Section R12-1-315 renumbered to R12-1-316, new Section R12-1-315 renumbered from R12-1-314 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-315 renumbered to R12-1-314; new Section R12-1-315 renumbered from R12-1-316 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-316. Amendment of Licenses at Request of Licensee

An applicant shall file an application for amendment of a specific license by complying with R12-1-308 and specifying the grounds for the amendment.

Historical Note

Former Rule Section C.106; Former Section R12-1-316 repealed, new Section R12-1-316 adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Former Section R12-1-316 renumbered to R12-1-317, new Section R12-1-316 renumbered from R12-1-315 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-316 renumbered to R12-1-315; new Section R12-1-316 renumbered from R12-1-317 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2).

R12-1-317. ARRA Action on Applications to Renew or Amend

In considering an application by a licensee to renew or amend a specific license, the Agency shall apply the criteria set forth in R12-1-309, R12-1-310, or R12-1-311 as applicable.

Historical Note

Former Rule Section C.107; Former Section R12-1-317 repealed, new Section R12-1-317 adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Former Section R12-1-317 renumbered to R12-1-318, new Section R12-1-317 renumbered from R12-1-316 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-317 renumbered to R12-1-316; new Section R12-1-317 renumbered from R12-1-318 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2).

R12-1-318. Transfer of Radioactive Material

A. A licensee shall not transfer radioactive material except as authorized under this Section.

B. Except as otherwise provided in the license and subject to the provisions of subsections (C) and (D), any licensee may transfer radioactive material:

1. To the Agency; after receiving prior approval from the Agency;

2. To the Department of Energy;

3. To any person exempt from the rules in this Article to the extent permitted under the exemption;

4. To any person authorized to receive radioactive material under terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the Agency, the U.S. Nuclear Regulatory Commission, or any Agreement State or Licensing State, or to any person otherwise authorized to receive radioactive material by the Federal Government or any agency of the Federal Government, the Agency, any Agreement State or Licensing State; or

5. As otherwise authorized by the Agency in writing.

C. Before transferring radioactive material to a specific licensee of the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State or Licensing State, or to a general licensee who is required to register with the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State or Licensing State prior to receipt of the radioactive material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred.

D. The transferor shall use one or more of the following methods for the verification required by subsection (C):

1. The transferor shall possess, and read, a current copy of the transferee's specific license or registration certificate;

2. The transferor shall possess a written certification by the transferee that the transferee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date;

3. For emergency shipments the transferor shall accept oral certification by the transferee that the transferee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date; provided the oral certification is confirmed in writing within 10 days;

4. The transferor shall obtain information equivalent to that in subsection (D)(1) to (3) compiled by a reporting service from official records of the Agency, the U.S. Nuclear Regulatory Commission, or the licensing agency of an Agreement State or Licensing State regarding the identity of any licensee and the scope and expiration date of any license, registration, or certificate; or

5. When none of the methods of verification described in subsections (D)(1) to (4) are readily available or when a transferor desires to verify that information received by one of the above methods is correct or up-to-date, the transferor shall obtain and record confirmation from the Agency, the U.S. Nuclear Regulatory Commission, or the licensing agency of an Agreement State or Licensing State that the transferee is licensed to receive the radioactive material.

E. A transferor shall prepare and transport radioactive material as prescribed in the provisions of 12 A.A.C. 1, Article 15.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Former Section R12-1-318 renumbered to R12-1-319, new Section R12-1-318 renumbered from R12-1-317 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-318 renumbered to R12-1-317; new Section R12-1-318 renumbered from R12-1-319 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2).

R12-1-319. Modification, Revocation, or Termination of a License

A. The terms and conditions of all licenses are subject to amendment, revision, or modification, and a license may be suspended or revoked by reason of amendments to the Agency's statutes or rules and orders issued by the Agency.

B. The Agency may revoke, suspend, or modify any license, in whole or in part, for any material false statement in the application; any omission or misstatement of fact required by statute, rule, or order, or because of conditions revealed by the application or any report, record, or inspection or other means that would cause the Agency to refuse to grant a license; or any violation of license terms and conditions, or the Agency's statutes, rules, or orders.

C. Except in cases of willfulness or those in which the public health, interest, or safety requires otherwise, the Agency shall not modify, suspend, or revoke a license unless, before the institution of proceedings, facts or conduct that may warrant action have been called to the attention of the licensee in writing and the licensee has been accorded an opportunity to demonstrate or achieve compliance.

D. The Agency may terminate a specific license upon a written request by the licensee that provides evidence the licensee has met the termination criteria in R12-1-451, R12-1-452, and the decommissioning requirements in R12-1-323.

E. Specific licenses, including expired licenses, continue in effect until terminated by written notice to the licensee, when the Agency determines that the licensee has:

1. Properly disposed of all radioactive material;

2. Made a reasonable effort to eliminate residual radioactive contamination, if present;

3. Performed an accurate radiation survey that demonstrates the premises are suitable for release in accordance with the criteria for decommissioning in R12-1-323;

4. Submitted other information that is sufficient to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning in R12-1-323.

5. Provided records to the Agency that detail the disposal of all radioactive material in unsealed form with a half-life greater than 120 days, and copies of the records required by 10 CFR 30.35(g), January 1, 2004, which is incorporated by reference and on file with the Agency. This incorporation by reference contains no future editions or amendments.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Former Section R12-1-319 renumbered to R12-1-320, new Section R12-1-319 renumbered from R12-1-318 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-319 renumbered to R12-1-318; new Section R12-1-319 renumbered from R12-1-320 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 10 A.A.R. 2122, effective July 3, 2004 (Supp. 04-2). Amended by final rulemaking at 10 A.A.R. 4458, effective December 4, 2004 (Supp. 04-4). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-320. Reciprocal Recognition of Licenses

A. This subsection grants a general license to perform specific licensed activities in Arizona for a period not to exceed 180 days in any calendar year to any person who holds a specific license for activity involving the use of radioactive material from the U.S. Nuclear Regulatory Commission, Licensing State, or any Agreement State, provided that:

1. The license does not limit the activity to specified installations or locations;

2. The out-of-state licensee notifies the Agency in writing at least three days before engaging in the licensed activity. The notification shall indicate the location, period, and type of proposed possession and use within the State, and be accompanied by a copy of the pertinent licensing document. If, for a specific case, the three-day period would impose an undue hardship on the out-of-state licensee, the licensee may, upon application to the Agency, obtain permission to proceed sooner. The Agency may waive the requirement for filing additional written notifications during the remainder of the calendar year, following receipt of the initial notification from a person engaging in activities under the general license provided in this Section;

3. The out-of-state licensee complies with all applicable statutes and rules of the Agency and with all the terms and conditions of the license, except those terms and conditions inconsistent with applicable statutes and rules of the Agency;

4. The out-of-state licensee supplies any other information the Agency requests; and

5. The out-of-state licensee does not transfer or dispose of radioactive material possessed or used under the general license provided in this Section except by transfer to a person:

a. Specifically licensed by the Agency, or by the U.S. Nuclear Regulatory Commission to receive the radioactive material; or

b. Exempt under R12-1-303(A).

B. Notwithstanding the provisions of subsection (A)(1), this subsection grants a general license to manufacture, install, transfer, demonstrate, or service a device described in R12-1-306(B)(1) to any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission, Licensing State, or an Agreement State authorizing the same activities within areas subject to the jurisdiction of the licensing body, provided that:

1. The person files a report with the Agency within 30 days after the end of each calendar quarter in which any device is transferred to or installed in this State. Each report shall identify the general licensee to whom the device is transferred by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device;

2. The device has been manufactured, labeled, installed, and serviced according to the applicable provisions of the specific license issued to the person by the U.S. Nuclear Regulatory Commission or an Agreement State;

3. The person entering the state ensures that any labels required to be affixed to the device under rules of the authority which licensed manufacture of the device bear the following statement: "Removal of this label is prohibited"; and

4. The holder of the specific license furnishes a copy of the general license contained in R12-1-306(B), or equivalent rules of the agency having jurisdiction over the manufacture or distribution of the device, to each general licensee to whom the licensee transfers the device or on whose premises the device is installed.

C. The Agency may withdraw, limit, or qualify the acceptance of any specific license or equivalent licensing document issued by another agency, or any product distributed under a license, upon determining that an action is necessary to prevent undue hazard to public health and safety, or property.

D. Before radioactive material can be used at a temporary job site within the state at any federal facility, a specific licensee shall determine the jurisdictional status of the job site. If the jurisdictional status is unknown, the specific licensee shall contact the controlling federal agency to determine whether the job site is under exclusive federal jurisdiction.

E. Before using radioactive material at a job site under exclusive federal jurisdiction, a specific licensee shall:

1. Obtain authorization from the NRC; and

2. Use the radioactive material in accordance with applicable NRC regulations and orders, and be able to demonstrate to the Agency that the correct license fee was paid to the NRC.

F. Before radioactive material can be used at a temporary job site in another state, a specific licensee shall obtain authorization from the state, if it is an Agreement State, or from the NRC for any non-Agreement State, either by filing for reciprocity or applying for a specific license.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Former Section R12-1-320 renumbered to R12-1-321, new Section R12-1-320 renumbered from R12-1-319 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-320 renumbered to R12-1-319; new Section R12-1-320 renumbered from R12-1-321 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-321. Repealed

Historical Note

Former Rule Section C.201; Former Section R12-1-321 repealed, new Section R12-1-321 adopted effective June 30, 1977 (Supp. 77-3). Amended effective December 20, 1985 (Supp. 85-6). Former Section R12-1-321 renumbered to R12-1-322, new Section R12-1-321 renumbered from R12-1-320 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-321 renumbered to R12-1-320; new Section R12-1-321 renumbered from R12-1-322 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Section repealed by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-322. The Need for an Emergency Plan for Response to a Release of Radioactive Material

A. For purposes of this rule, "Emergency Plan" means a procedure that will be followed when an accident occurs involving licensed radioactive materials for which an offsite response may be needed from organizations, such as police, fire, or medical organizations.

B. Each application to possess radioactive materials in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities in Exhibit D, "Radioactive Material Quantities Requiring Consideration for an Emergency Plan" shall contain either:

1. An evaluation showing that the maximum dose to a person off-site due to a release of radioactive materials would not exceed 1 rem effective dose equivalent or 5 rems to the thyroid; or

2. An emergency plan for responding to a release of radioactive material.

C. One or more of the following factors may be used to support an evaluation submitted under subsection (B)(1):

1. The radioactive material is physically separated so that only a portion could be involved in an accident.

2. All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;

3. The release fraction in the respirable size range would be lower than the release fraction shown in Exhibit D due to the chemical or physical form of the material;

4. The solubility of the radioactive material would reduce the dose received;

5. Facility design or engineered safety features in the facility would cause the release fraction to be lower than shown in Exhibit D;

6. Operating restrictions or procedures would prevent a release fraction as large as that shown in Exhibit D; or

7. Other factors appropriate for the specific facility.

D. An emergency plan for responding to a release of radioactive material submitted under subsection (B)(2) shall include the following information:

1. A brief description of the licensee's facility and areas near the site that could expose a member of the public to a dose equal to or greater than the levels expressed in subsection (B)(1).

2. An identification of each type of radioactive materials accident for which protective actions may be needed.

3. A classification system for classifying accidents as alerts or site area emergencies.

4. Identification of the means of detecting each type of accident in a timely manner.

5. 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.

6. A brief description of the methods and equipment to assess releases of radioactive materials.

7. A brief description of the responsibilities of licensee personnel responsible for promptly notifying offsite response organizations and the Agency; also responsibilities for developing, maintaining, and updating the plan.

8. A commitment to and a brief description of the means to promptly notify offsite response organizations and request off-site assistance, including medical assistance for the treatment of contaminated and injured onsite workers when appropriate. A control point shall be established. The notification and coordination shall be planned so that unavailability of some personnel, parts of the facility, and some equipment will not prevent the notification and coordination. The licensee shall also commit to notify the Agency immediately after notification of the appropriate off-site response organizations and not later than one hour after the licensee declares an emergency.

9. A brief description of the types of information on facility status, radioactive releases, and recommended protective actions, if necessary, to be given to off-site response organizations and to the Agency.

10. A brief description of the frequency, performance objectives, and plans for the training that the licensee will provide workers on how to respond to an emergency including any special instructions and orientation tours the licensee would offer to fire, police, medical, and other emergency personnel. The training shall familiarize personnel with site-specific emergency procedures. Also, the training shall thoroughly prepare site personnel for their responsibilities in the event of accident scenarios postulated as most probable for the specific site, including the use of team training for such scenarios.

11. A brief description of the means of restoring the facility to a safe condition after an accident.

12. Provisions for conducting quarterly communications checks with off-site response organizations and biennial onsite exercises to test response to simulated emergencies. Quarterly communications checks with off-site response organizations shall include the verifying and updating of all necessary telephone numbers. The licensee shall invite off-site response organizations to participate in the biennial exercises. Their participation is not required. Exercises shall use accident scenarios postulated as most probable for the specific site and the scenarios shall not be known to most exercise participants. The licensee shall critique each exercise, using individuals without direct implementation responsibility for the plan. Critiques of exercises shall evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and overall effectiveness of the response. Deficiencies found by the critiques shall be corrected.

13. A certification that the applicant has met its responsibilities in A.R.S. §§ 26-341 through 26-353 (emergency Planning and Community Right-to-Know Act of 1986), if applicable to the applicant's activities at the proposed place of use of the radioactive material.

E. The licensee shall allow 60 days for the off-site response organizations, expected to respond in case of an accident, to comment on the licensee's emergency plan before submitting it to the Agency. The licensee shall provide any comments received within the 60 days to the Agency with the emergency plan.

Historical Note

Former Section R12-1-322 repealed effective June 30, 1977 (Supp. 77-3). New Section R12-1-322 renumbered from R12-1-321 effective February 18, 1994 (Supp. 94-1). Former Section R12-1-322 renumbered to R12-1-321; new Section R12-1-322 renumbered from R12-1-323 and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2).

R12-1-323. Financial Assurance and Recordkeeping for Decommissioning

A. For purposes of terminating specific licensed activities:

1. "Decommissioning" means to remove a radioactive material use facility safely from service and to reduce residual radioactivity to a level that permits release of the property for unrestricted use and termination of the radioactive material use license.

2. "Byproduct material" as used in 10 CFR 30, means "radioactive material" which is defined in A.R.S. § 30-651.

3. "Facility" means the entire site of radioactive material use, or any separate building or outdoor area where it is used.

4. "Appendix B to Part 30" as used in 10 CFR 30, means Appendix E in 12 A.A.C. 1, Article 4.

5. "Financial security" means having a net worth of not less than $10,000.

B. When applying, each nongovernment applicant for a specific license that authorizes the possession and use of radioactive material, and each nongovernment holder of a license to possess and use radioactive material issued before the effective date of this Section, shall submit to the Agency a certification of financial security, as required in A.R.S. § 30-672(H). A licensee required to meet the requirement in subsection (C) is exempt from the requirements in this subsection.

C. When applying, each applicant for a specific license that authorizes the possession and use of radioactive material, and each holder of a license to possess and use radioactive material issued before the effective date of this Section, shall submit to the Agency a decommissioning funding plan or certification of financial assurance that meets the requirements in 10 CFR 30.35, 40.36, and 70.25, January 1, 2005, which are incorporated by reference, published by the Office of the Federal Register, National Archives and Records Administration, Washington, D.C. 20408, and on file with the Agency. The material incorporated by reference contains no future editions or amendments.

D. Each licensee required to provide financial assurance for decommissioning a radioactive material facility under this Section shall maintain records of information important to the safe and effective decommissioning of the facility in an identified location until the license is terminated by the Agency. The licensee shall maintain the following records during the decommissioning process:

1. Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, and site. The licensee shall keep records identifying the involved radionuclides and associated quantities, forms, and concentrations.

2. As-built drawings showing modifications of structures and equipment in restricted areas where radioactive materials are used and stored, and locations of possible inaccessible contamination. If drawings are not available, the licensee shall provide appropriate records describing each location of possible contamination.

3. Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.

E. Decommissioning procedures:

1. Upon expiration or termination of principal activities a licensee shall notify the Agency in writing whether the licensee is discontinuing licensed activities. The licensee shall begin decommissioning its facility within 60 days after the Agency receives notice of the decision to permanently terminate principal activities, or within 12 months after receipt of notice, submit to the Agency a decommissioning plan, as prescribed in 10 CFR 30.36(g)(1), January 1, 2005, which is incorporated by reference, published by the Office of the Federal Register, National Archives and Records Administration, Washington, D.C. 20408, and on file with the Agency. The material incorporated by reference contains no future editions or amendments. The licensee shall begin decommissioning upon approval of the plan if the license has expired or no licensed activities have been conducted at the licensee's facility for a period of 24 months.

2. In addition to the notification requirements in subsection (E)(1), the licensee shall maintain in effect all decommissioning financial assurances required by this Section. The financial assurances shall be increased or may be decreased as appropriate to cover the cost estimate established for decommissioning in subsection (E)(1). The licensee may reduce the amount of the financial assurance following approval of the decommissioning plan, provided the radiological hazard is decreasing and the licensee has the approval of the Agency.

3. The Agency shall extend the time periods established in subsection (E)(1) if a new time period is in the best interest of public health and safety.

a. The licensee shall submit a request for an extension no later than 30 days after the Agency receives the notice required in subsection (E)(1).

b. If a licensee has requested an extension, the licensee is not required to commence decommissioning activities required in subsection (E)(1), until the Agency has made a determination on the request submitted to the Agency under subsection (E)(3)(a).

4. Except as provided in subsection (E)(5), the licensee shall complete decommissioning of a facility as soon as practicable but no later than 24 months following the initiation of decommissioning; and except as provided in subsection (E)(5), when decommissioning involves the entire facility, the licensee shall request license termination as soon as practicable but no later than 24 months following initiation of decommissioning.

5. The Agency shall approve a request for an alternate schedule for completion of decommissioning and license termination if the Agency determines that the alternative is warranted by consideration of the conditions specified in 10 CFR 30.36(i), January 1, 2005, which are incorporated by reference, published by the Office of the Federal Register, National Archives and Records Administration, Washington, D.C. 20408, and on file with the Agency. The material incorporated by reference contains no future editions or amendments.

6. As a final step in decommissioning, the licensee shall meet the requirements specified in 10 CFR 30.36(j), January 1, 2005, which are incorporated by reference, published by the Office of the Federal Register, National Archives and Records Administration, Washington, D.C. 20408, and on file with the Agency. The material incorporated by reference contains no future editions or amendments.

Historical Note

Former Section R12-1-323 repealed effective June 30, 1977 (Supp. 77-3). New Section R12-1-323 adopted effective February 18, 1994 (Supp. 94-1). Former Section R12-1-323 renumbered to R12-1-322; new Section adopted by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-324. Public Notification and Public Participation

Upon the receipt of a license termination plan (LTP) or decommissioning plan from a licensee, or a proposal by a licensee for decommissioning of a site in accordance with R12-1-451 and R12-1-452, or for other events when the Agency deems a notice to be in the public interest, the Agency shall:

1. Notify and solicit comments from:

a. State and local governments and any Indian Nation or other indigenous people who have legal rights that could be affected by the decommissioning; and

b. The Arizona Department of Environmental Quality for cases in which the licensee proposes to decommission a site in accordance with R12-1-452.

2. Publish the notice in the Arizona Administrative Register and use other methods of publication such as local newspapers, letters to local organizations, or any other method that is reasonably calculated to provide notice, and solicit comments from affected parties.

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3). New Section made by final rulemaking at 10 A.A.R. 4588, effective December 4, 2004 (Supp. 04-4).

R12-1-325. Timeliness in Decommissioning Facilities

A. "Principal activities," as used in this Section, means activities authorized by the license that are essential to achieving the purposes for which the license was issued or amended. Storage, during which licensed material is not accessed for use, or disposal and other activities incidental to decontamination or decommissioning are not principal activities.

B. Each specific license revoked by the Agency expires at midnight on the date of the Agency's final determination to revoke the license, the expiration date stated in the determination, or as otherwise provided by Agency order.

C. Each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of radioactive material, until the Agency notifies the licensee in writing that the license is terminated. During this time, the licensee shall:

1. Limit actions involving radioactive material to those related to decommissioning;

2. Continue to control entry to restricted areas until they are suitable for release in accordance with NRC requirements; and

3. Pay the applicable annual fee for the license category listed in R12-1-1306.

D. Within 60 days of the occurrence of any of the following, each licensee shall notify the Agency in writing of the occurrence and either begin decommissioning its site, or any separate building or outdoor area that contains residual radioactivity, so that the building or outdoor area is suitable for release in accordance with Agency requirements, or submit within 12 months of notification a decommissioning plan, if required by R12-1-323, and begin decommissioning upon approval of that plan if:

1. The license expires in accordance with subsection (B) or R12-1-314, unless the licensee submits a renewal application in accordance with R12-1-315;

2. The licensee decides to permanently terminate principal activities at the entire site or in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with Agency requirements;

3. No principal activities under the license have been conducted for a period of 24 months; or

4. No principal activities have been conducted for a period of 24 months in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with Agency requirements.

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3). New Section made by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-326. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-327. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-328. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-329. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-330. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-331. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-332. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-333. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-334. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-335. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-336. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-337. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-338. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-339. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-340. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-341. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-342. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-343. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-344. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-345. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-346. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-347. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

R12-1-348. Repealed

Historical Note

Repealed effective June 30, 1977 (Supp. 77-3).

Exhibit A. Exempt Concentrations

Column I Column II

Gas Liquid and Solid

Element (atomic Concentration Concentration

number) Isotope (μCi/ml) ¹ / (μCi/ml) ² /

________________________________________________________________________________________________________________

Antimony (51) Sb-122 3X10 ^-4

Sb-124 2X10 ^-4

Sb-125 1X10 ^-3

Argon (18) Ar-37 1X10 ^-3

Ar-41 4X10 ^-7

Arsenic (33) As-73 5X10 ^-3

As-74 5X10 ^-4

As-76 2X10 ^-4

As-77 8X10 ^-4

Barium (56) Ba-131 2X10 ^-3

Ba-140 3X10 ^-4

Beryllium (4) Be-7 2X10 ^-2

Bismuth (83) Bi-206 4X10 ^-4

Bromine (35) Br-82 4X10 ^-7 3X10 ^-3

Cadmium (48) Cd-109 2X10 ^-3

Cd-115m 3X10 ^-4

Cd-115 3X10 ^-4

Calcium (20) Ca-45 9X10 ^-5

Ca-47 5X10 ^-4

Carbon (6) C-14 1X10 ^-6 8X10 ^-3

Cerium (58) Ce-141 9X10 ^-4

Ce-143 4X10 ^-4

Ce-144 1X10 ^-4

Cesium (55) Cs-131 2X10 ^-2

Cs-134m 6X10 ^-2

Cs-134 9X10 ^-5

Chlorine (17) Cl-38 9X10 ^-7 4X10 ^-3

Chromium (24) Cr-51 2X10 ^-2

Cobalt (27) Co-57 5X10 ^-3

Co-58 1X10 ^-3

Co-60 5X10 ^-4

Copper (29) Cu-64 3X10 ^-3

Dysprosium (66) Dy-165 4X10 ^-3

Dy-166 4X10 ^-4

Erbium (68) Er-169 9X10 ^-4

Er-171 1X10 ^v

Europium (63) Eu-152 6X10 ^-4

(T _r =9.2 h)

Eu-155 2X10 ^-3

Fluorine (9) F-18 2X10 ^-6 8X10 ^-3

Gadolinium (64) Gd-153 2X10 ^-3

Gd-159 8X10 ^-4

Gallium (31) Ga-72 4X10 ^-4

Germanium (32) Ge-71 2X10 ^-2

Gold (79) Au-196 2X10 ^-3

Au-198 5X10 ^-4

Au-199 2X10 ^-3

Hafnium (72) Hf-181 7X10 ^-4

Hydrogen (1) H-3 5X10 ^-6 3X10 ^-2

Indium (49) In-113m 1X10 ^-2

In-114m 2X10 ^-4

Iodine I-126 3X10 ^-9 2X10 ^-5

I-131 3X10 ^-9 2X10 ^-5

I-132 8X10 ^-8 6X10 ^-4

I-133 1X10 ^-8 7X10 ^-5

I-134 2X10 ^-7 1X10 ^-3

Iridium (77) Ir-190 2X10 ^-3

Ir-192 4X10 ^-4

Ir-194 3X10 ^-4

Iron (26) Fe-55 8X10 ^-3

Fe-59 6X10 ^-4

Krypton (36) Kr-85m 1X10 ^-6

Kr-85 3X10 ^-6

Lanthanum (57) La-140 2X10 ^-4

Lead (82) Pb-203 4X10 ^-3

Lutetium (71) Lu-177 1X10 ^-3

Manganese (25) Mn-52 3X10 ^-4

Mn-54 1X10 ^-3

Mn-56 1X10 ^-3

Mercury (80) Hg-197m 2X10 ^-3

Hg-197 3X10 ^-3

Hg-203 2X10 ^-4

Molybdenum (42) Mo-99 2X10 ^-3

Neodymium (60) Nd-147 6X10 ^-4

Nd-149 3X10 ^-3

Nickel (28) Ni-65 1X10 ^-3

Niobium (Columbium) (41) Nb-95 1X10 ^-3

Nb-97 9X10 ^-3

Osmium (76) Os-185 7X10 ^-4

Os-191m 3X10 ^-2

Os-191 2X10 ^-3

Os-193 6X10 ^-4

Palladium (46) Pd-103 3X10 ^-3

Pd-109 9X10 ^-4

Phosphorus (15) P-32 2X10 ^-4

Platinum (78) Pt-191 1X10 ^-3

Pt-193m 1X10 ^-2

Pt-197m 1X10 ^-2

Pt-197 1X10 ^-3

Potassium (19) K-42 3X10 ^-3

Praseodymium (59) Pr-142 3X10 ^-4

Pr-143 5X10 ^-4

Promethium (61) Pm-147 2X10 ^-3

Pm-149 4X10 ^-4

Rhenium (75) Re-183 6X10 ^-3

Re-186 9X10 ^-4

Re-188 6X10 ^-4

Rhodium (45) Rh-103m 1X10 ^-1

Rh-105 1X10 ^-3

Rubidium (37) Rb-86 7X10 ^-4

Ruthenium (44) Ru-97 4X10 ^-3

Ru-103 8X10 ^-4

Ru-105 1X10 ^-3

Ru-106 1X10 ^-4

Samarium (62) Sm-153 8X10 ^-4

Scandium (21) Sc-46 4X10 ^-4

Sc-47 9X10 ^-4

Sc-48 3X10 ^-4

Selenium (34) Se-75 3X10 ^-3

Silicon (14) Si-31 9X10 ^-3

Silver (47) Ag-105 1X10 ^-3

Ag-110m 3X10 ^-4

Ag-111 4X10 ^-4

Sodium (11) Na-24 2X10 ^-3

Strontium (38) Sr-85 1X10 ^-3

Sr-89 1X10 ^-4

Sr-91 7X10 ^-4

Sr-92 7X10 ^-4

Sulfur (16) S-35 9X10 ^-8 6X10 ^-4

Tantalum (73) Ta-182 4X10 ^-4

Technetium (43) Tc-96m 1X10 ^-1

Tc-96 1X10 ^-3

Tellurium (52) Te-125m 2X10 ^-3

Te-127m 6X10 ^-4

Te-127 3X10 ^-3

Te-129m 3X10 ^-4

Te-131m 6X10 ^-4

Te-132 3X10 ^-4

Terbium (65) Tb-160 4X10 ^-4

Thallium (81) Tl-200 4X10 ^-3

Tl-201 3X10 ^-3

Tl-202 1X10 ^-3

Tl-204 1X10 ^-3

Thulium (69) Tm-170 5X10 ^-4

Tm-171 5X10 ^-3

Tin (50) Sn-113 9X10 ^-4

Sn-125 2X10 ^-4

Tungsten (Wolfram) (74) W-181 4X10 ^-3

W-187 7X10 ^-4

Vanadium (23) V-48 3X10 ^-4

Xenon (54) Xe-131m 4X10 ^-6

Xe-133 3X10 ^-6

Xe-135 1X10 ^-6

Ytterbium (70) Yb-175 1X10 ^-3

Yttrium (39) Y-90 2X10 ^-4

Y-91m 3X10 ^-2

Y-91 3X10 ^-4

Y-92 6X10 ^-4

Y-93 3X10 ^-4

Zinc (30) Zn-65 1X10 ^-3

Zn-69m 7X10 ^-4

Zn-69 2X10 ^-2

Zirconium (40) Zr-95 6X10 ^-4

Zr-97 2X10 ^-4

(See notes at end of appendix)

Beta and/or gamma emitting

radioactive material not

listed above with half-life

less than three years 1X10 ^-10 1X10 ^-6

NOTE 1: Many radioisotopes disintegrate into isotopes which are also radioactive. In expressing the concentrations in Schedule A the activity stated is that of the parent isotope and takes into account the daughters.

____________________________________

^1/ Values are given in Column I only for those materials normally used as gases

^2/ μCi/gm are for solids

NOTE 2: For purposes of Section 303 where there is involved a combination of isotopes, the limit for the combination should be derived as follows: Determine for each isotope in the product the ratio between the concentration present in the product and the exempt concentration established in Schedule A for the specific isotope when not in combination. The sum of such ratios may not exceed "1" (i.e., unity).

EXAMPLE:

Concentration of Isotope A in Product + Concentration of Isotope B in Product ≤ 1

Exempt concentration of Isotope A Exempt concentration of Isotope B

Historical Note

Adopted effective December 20, 1985 (Supp. 85-6). Former Schedule D renumbered to Exhibit C; new Exhibit D renumbered from Schedule E and amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2).

Exhibit E. Application Information

1. Radioactive Material (RAM) Specific License Application Information

An applicant shall provide the following information in a specific license application before a license is issued to the applicant. The Agency shall provide an application form to an applicant with a guide, when possible, to ensure that correct information is provided in the application:

Name and mailing address of applicant Use location

Contact person Telephone number

Users of RAM Training of users

Radiation Safety Officer identity (RSO) Duties of RSO

Description of RAM and uses Description of radia-
tion detection/mea-
surement instru-
ments and their
calibration

Personnel monitoring Bioassay program

Facility description Survey program

Leak test program Records manage-
ment program

Instruction to personnel Waste disposal
program

Emergency procedures Procedures for

ordering, receiving,

and opening packages

Description of animal use Licensing fee

provided with
application

Copy of letter-of-intent Description of
to local governing body ALARA

and quality

management

programs

Description of transportation
procedures Certifying signature

Legal structure of licensee's
operation

Other licensing requirements listed in: R12-1-310, R12-1-311, R12-1-312, R12-1-511, R12-1-703, and R12-1-1721

2. Radioactive Material (RAM) General License Application Information

An applicant shall provide the following information on a registration certificate. The certificate will be validated and returned to the applicant if the information provided is complete.

Name and address Telephone number

Where will the radioactive
material be used Address of use location

Description of radioactive
material use Date

Authorizing signature and
printed name Position of person signing
the form

Historical Note

Adopted effective February 18, 1994 (Supp. 94-1). Former Schedule E renumbered to Exhibit D; new Exhibit adopted by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2).

ARTICLE 4. STANDARDS FOR PROTECTION AGAINST IONIZING RADIATION

R12-1-401. Purpose

A. Article 4 establishes standards for protection against ionizing radiation resulting from activities conducted according to licenses or registrations issued by the Agency. These rules are issued according to A.R.S. Title 30, Chapter 4, as amended.

B. The requirements of Article 4 are designed to control the receipt, possession, use, transfer, and disposal of sources of radiation by any licensee or registrant so the total dose equivalent to an individual, including radiation exposure resulting from all sources of radiation other than radiation prescribed by a physician in the practice of medicine, radiation received while voluntarily participating in a medical research program, and background radiation, does not exceed the standards for protection against radiation prescribed in this Article. However, this Article does not limit actions that may be necessary to protect health and safety.

Historical Note

Former Rule Section D.1; Former Section R12-1-401 repealed, new Section R12-1-401 adopted effective June 30, 1977 (Supp. 77-3). Amended effective February 25, 1985 (Supp. 85-1). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

R12-1-402. Scope

Except as specifically provided in other Articles of these rules, Article 4 applies to persons licensed or registered by the Agency to receive, possess, use, transfer, or dispose of sources of ionizing radiation.

Historical Note

Former Rule Section D.2; Former Section R12-1-402 repealed, new Section R12-1-402 adopted effective June 30, 1977 (Supp. 77-3). Amended effective February 25, 1985 (Supp. 85-1). Amended subsection (A) effective June 26, 1987 (Supp. 87-2). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

R12-1-403. Definitions

"Air-purifying respirator" means respiratory protective equipment with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

"ALI" means annual limit on intake, the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the Reference Man that would result in a committed effective dose equivalent of 0.05 Sv (5 rem) or a committed dose equivalent of 0.5 Sv (50 rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Appendix B, Table I, Columns 1 and 2.

"Assigned protection factor (APF)" means the expected workplace level of respirator protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

"Atmosphere-supplying respirator" means respiratory protective equipment that supplies the equipment user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SARs) and self-contained breathing apparatus (SCBA) units.

"Class" means a classification scheme for inhaled material according to the material's rate of clearance from the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for Class D, days, of less than 10 days, for Class W, weeks, from 10 to 100 days, and for Class Y, years, of greater than 100 days (See Introduction, Appendix B). For purposes of these rules, "lung class" and "inhalation class" are equivalent terms.

"Constraint" or "dose constraint" means a value above which specified licensee or registrant actions are required.

"Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

"DAC" means derived air concentration, the concentration of a given radionuclide in air which, if breathed by Reference Man for a working year of 2,000 hours under conditions of light work, results in an intake of one ALI. For purposes of these rules, the condition of light work is an inhalation rate of 1.2 cubic meters of air per hour for 2,000 hours in a year. DAC values are given in Appendix B, Table I, Column 3.

"DAC-hour" means derived air concentration-hour, the product of the concentration of radioactive material in air, expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take 2,000 DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (5 rem).

"Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant in writing of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

"Decommission" means to remove a facility or site safely from service and reduce residual radioactivity to a level that permits release of the property for unrestricted use and termination of the license or release of the property under restricted conditions and the termination of the license.

"Demand respirator" means an atmosphere-supplying respiratory protective equipment that admits breathing air to the face piece only when a negative pressure is created inside the face piece by inhalation.

"Deterministic effect" [see "Nonstochastic effect"].

"Disposable respirator" means respiratory protective equipment for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent depletion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of device include a disposable half-mask respirator or a disposable, escape-only, self-contained breathing apparatus (SCBA).

"Distinguishable from background" means that the detectable concentration of a radionuclide is statistically greater than the background concentration of that radionuclide in the vicinity of a site or, in the case of structures, in similar materials using accepted measurement, survey, and statistical techniques.

"Dosimetry processor" means an individual or an organization that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

"Filtering face piece (dust mask)" means a particulate respirator that operates under a negative pressure with a filter as an integral part of the face piece or with the entire face piece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

"Fit factor" means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

"Fit test" means the use of protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

"Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

"Hood" means a respiratory inlet covering that completely covers the head, neck, and may also cover portions of the shoulders and torso.

"Inhalation class" [see "Class"].

"Loose-fitting face piece" means a respiratory inlet covering that is designed to form a partial seal with the face.

"Lung class" [see "Class"].

"Negative pressure respirator (tight fitting)" means respiratory protective equipment in which the air pressure inside the face piece is negative during inhalation with respect to the ambient air pressure outside the respirator.

"Nonstochastic effect" means a health effect, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect. For purposes of these rules, "deterministic effect" is an equivalent term and "threshold" means that which if not exceeded, poses no risk or likelihood of an effect to occur.

"Planned special exposure" means an infrequent exposure to radiation received while employed, but separate from and in addition to the annual occupational dose limits.

"Positive pressure respirator" means respiratory protective equipment in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

"Powered air-purifying respirator (PAPR)" means an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.

"Pressure demand respirator" means a positive pressure, atmosphere-supplying respirator that admits breathing air to the face piece when the positive pressure is reduced inside the face piece by inhalation.

"Probabilistic effect" [see "Stochastic effect"].

"Qualitative fit test (QLFT)" means a pass or fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

"Quantitative fit test (QNFT)" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

"Reference Man" means a hypothetical aggregation of human physical and physiological characteristics determined by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base. A description of Reference Man is contained in the International Commission on Radiological Protection report, ICRP Publication 23, "Report of the Task Group on Reference Man," published in 1975 by Pergammon Press, incorporated by reference and on file with the Agency and the Office of the Secretary of State. This incorporation by reference contains no future editions or amendments.

"Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, or other media at a site, resulting from activities under a licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials that remain at the site because of routine or accidental release of radioactive material at the site or a previous burial at the site, even if the licensee complied with reagent provisions of A.A.C. Title 12, Chapter1.

"Respiratory protective equipment" means an apparatus, such as a respirator, used to reduce an individual's intake of airborne radioactive materials.

"Sanitary sewerage" means a system of public sewers for carrying off waste water and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee or registrant.

"Self-contained breathing apparatus (SCBA)" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

"Stochastic effect" means a health effect that occurs randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without a threshold. Hereditary effects and cancer incidence are examples of stochastic effects. For purposes of these rules, "probabilistic effect" is an equivalent term.

"Supplied-air respirator (SAR) or airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user

"Tight-fitting face piece" means a respiratory inlet covering that forms a complete seal with the face.

"User seal check (fit check)" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

"Very-high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to an individual's body could result in the individual receiving an absorbed dose in excess of 5 Gy (500 rad) in one hour at one meter from a radiation source or one meter from any surface that the radiation penetrates. (At very high doses received at high dose rates, units of absorbed dose, the gray and rad should be used, rather than units of dose equivalent, the sievert and rem)

"Weighting factor" w _T for an organ or tissue (T) means the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of w _T are:

Historical Note

Former Rule Section D.3, Former Section R12-1-403 repealed, new Section R12-1-403 adopted effective June 30, 1977 (Supp. 77-3). Amended effective February 25, 1985 (Supp. 85-1). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2). Amended by final rulemaking at 9 A.A.R. 1126, effective May 9, 2003 (Supp. 03-1). Amended by final rulemaking at 10 A.A.R. 2122, effective July 3, 2004 (Supp. 04-2).

R12-1-404. Units and Quantities

A. Each licensee or registrant shall use the Standard International (SI) units becquerel, gray, sievert, and coulomb per kilogram, or the special units curie, rad, rem, and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by this Article.

B. The licensee or registrant shall make a clear distinction among the quantities entered on the records required by this Article, such as, total effective dose equivalent, total organ dose equivalent, shallow dose equivalent, lens dose equivalent, deep dose equivalent, or committed effective dose equivalent.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective February 25, 1985 (Supp 85-1). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

R12-1-405. Form of Records

A. A licensee or registrant shall ensure that each record required by this Article is legible throughout the specified retention period. The record shall be the original, a reproduced copy, or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. As an alternative the record may be stored in electronic media capable of producing legible records during the required retention period. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. A licensee or registrant shall maintain adequate safeguards against tampering with and loss of records.

B. In the records required by this Article, a licensee or registrant may record quantities in SI units in parentheses following each of the required units, curie, rad, and rem, and include multiples and subdivisions.

C. Notwithstanding subsection (B), the licensee or registrant shall ensure that information is recorded in the International System of Units (SI) or in SI and the units specified in subsection (B) on each shipment manifest as required in R12-1-439(A).

D. A licensee or registrant shall make a clear distinction among the quantities entered on the records required by this Section (e.g., total effective dose equivalent, shallow-dose equivalent, lens dose equivalent, deep-dose equivalent, committed effective dose equivalent).

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective February 25, 1985 (Supp. 85-1). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-406. Implementation

Any existing license or registration condition that is more restrictive than this Article remains in force until amendment or renewal of the license or registration.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective February 25, 1985 (Supp. 85-1). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

R12-1-407. Radiation Protection Programs

A. Each licensee or registrant shall develop, document, and implement a radiation protection program sufficient to ensure compliance with the provisions of Article 4.

B. The licensee or registrant shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and public doses that are as low as is reasonably achievable (ALARA).

C. The licensee or registrant shall, at intervals not to exceed 12 months, review the radiation protection program content and implementation.

D. To implement the ALARA requirements in subsection (B), and notwithstanding the requirements in R12-1-416, each licensee or registrant governed by A.A.C. Title 12, Chapter 1, Article 3 shall limit air emissions of radioactive material to the environment so that individual members of the public likely to receive the highest dose will not receive a total effective dose equivalent in excess of 0.1mSv (10 mrem) per year from the emissions. If a licensee or registrant subject to this requirement exceeds this limit, the licensee or registrant shall report the incident to the Agency, in accordance with R12-1-444, and take prompt corrective action to prevent additional violations.

E. Records.

1. Each licensee or registrant shall maintain records of the radiation protection program, including:

a. The provisions of the program; and

b. Audits and other reviews of program content and implementation.

2. A licensee or registrant shall retain the records required by subsection (E)(1)(a) for three years after the termination of the license or registration. The licensee or registrant shall retain the records required by subsection (E)(1)(b) for three years after the record is made.

3. The following licensees and registrants are exempt from the record requirements contained in this subsection:

B6-General Medical

C9-Gas Chromatograph

C10-General Industrial

D15-Possession Only

E2-X-ray Machine class B

E3-X-ray Machine class C

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective February 25. 1985 (Supp. 85-1). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 5 A.A.R. 1812, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2). Amended by final rulemaking at 10 A.A.R. 2122, effective July 3, 2004 (Supp. 04-2).

R12-1-408. Occupational Dose Amounts for Adults

A. Each licensee or registrant shall control the occupational dose to individual adults, except for planned special exposures required in R12-1-413, to the following dose limits:

1. An annual limit, which is the more limiting of:

a. The total effective dose equivalent being equal to 0.05 Sv (5 rem): or

b. The sum of the deep-dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 0.5 Sv (50 rem).

2. The annual limits to the lens of the eye, to the skin, and to the extremities which are:

a. A lens dose equivalent of 0.15 Sv (15 rem), and

b. A shallow dose equivalent of 0.5 Sv (50 rem) to the skin of the whole body or to the skin of any extremity.

B. Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current year and during the individual's lifetime. See R12-1-413.

C. The assigned deep-dose equivalent and shallow-dose equivalent are, for the portion of the body receiving the highest exposure, determined as follows:

1. The deep-dose equivalent, lens dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable.

2. If a protective apron is worn and monitoring is conducted as specified in R12-1-419(B)(6), the effective dose equivalent for external radiation shall be determined as follows:

a. If only one individual monitoring device is used and it is located at the neck outside the protective apron, and the reported dose exceeds 25% of the limit specified in R12-1-408(A), the reported deep-dose equivalent value multiplied by 0.3 is the effective dose equivalent for external radiation; or

b. When individual monitoring devices are worn, both under the protective apron at the waist and outside the protective apron at the neck, the effective dose equivalent for external radiation is assigned the value of the sum of the deep-dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep-dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by 0.04.

3. The assigned deep-dose equivalent shall be determined for the part of the body that receives the highest exposure. The assigned shallow-dose equivalent is the dose averaged over the contiguous 10 square centimeters of skin that receives the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable.

D. Derived air concentration (DAC) and annual limit on intake (ALI) values are presented in Table I of Appendix B and may be used to determine the individual's dose and to demonstrate compliance with the occupational dose limits.

E. Notwithstanding the annual dose limits, the licensee shall limit the soluble Uranium intake by an individual to 10 milligrams in a week in consideration of chemical toxicity. See footnote 3 of Appendix B.

F. The licensee or registrant shall reduce the dose that an individual may receive in the current year by the amount of occupational dose received while employed occupationally as a radiation worker by all previous employers. See R12-1-412.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective February 25, 1985 (Supp. 85-1). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 5 A.A.R. 1812, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-409. Summation of External and Internal Doses

A. If a licensee or registrant is required to monitor according to both R12-1-419(B) and (C), the licensee or registrant shall add external and internal doses, and use the sum to demonstrate compliance with dose limits. If the licensee or registrant is required to monitor only according to R12-1-419(B) or only according to R12-1-419(C), summation is not required to demonstrate compliance with dose limits. The licensee or registrant may demonstrate compliance with the requirements for summation of external and internal doses according to subsections (B), (C), and (D). The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation but are subject to separate limits (See R12-1-408(A)(2)).

B. If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep-dose equivalent divided by the total effective dose equivalent limit, and one of the following, does not exceed unity (1):

1. The sum of the fractions of the inhalation ALI for each radionuclide, or

2. The total number of derived air concentration-hours (DAC-hours) for all radionuclides divided by 2,000, or

3. The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using applicable biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, W _T , and the committed dose equivalent, H _T,50 , per unit intake is greater than 10% of the maximum weighted value of H _T,50 , that is, w _T H _T,50 , per unit intake for any organ or tissue.

C. If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than 10% of the applicable oral ALI, the licensee or registrant shall account for this intake and include it in demonstrating compliance with the limits.

D. The licensee or registrant shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for Hydrogen-3 and does not need to be evaluated or accounted for according to this subsection.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective February 25, 1985 (Supp. 85-1). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 5 A.A.R. 1812, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

R12-1-410. Determination of External Dose from Airborne Radioactive Material

A. Each licensee shall, when determining the dose from airborne radioactive material, include the contribution to the deep-dose equivalent, lens dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud. See Appendix B, footnotes 1 and 2.

B. Airborne radioactivity measurements and DAC values shall not be used as the primary means to assess the deep-dose equivalent when the airborne radioactive material includes radionuclides other than noble gases or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep-dose equivalent to an individual shall be based upon measurements using instruments or individual monitoring devices.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective February 25, 1985 (Supp. 85-1). Amended effective June 20, 1990 (Supp. 90-2). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

R12-1-411. Determination of Internal Exposure

A. For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, each licensee or registrant shall, when required according to R12-1-419, take suitable and timely measurements of:

1. Concentrations of radioactive materials in air in work areas,

2. Quantities of radionuclides in the body,

3. Quantities of radionuclides excreted from the body, or

4. Combinations of these measurements,

B. Unless respiratory protective equipment is used, as provided in R12-1-425, or the assessment of intake is based on bioassays, the licensee or registrant shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

C. When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee or registrant may:

1. Use that information to calculate the committed effective dose equivalent, and, if used, the licensee or registrant shall document that information in the individual's record;

2. Upon prior approval of the Agency, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and

3. Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent. See Appendix B.

D. If the licensee or registrant chooses to assess intakes of Class Y material using the measurements given in subsection (A)(2) or (3), the licensee or registrant may delay the recording and reporting of the assessments for periods up to seven months, unless otherwise required by R12-1-444 or R12-1-445. This delay permits the licensee or registrant to make additional measurements basic to the assessments.

E. If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours is either:

1. The sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y from Appendix B for each radionuclide in the mixture; or

2. The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.

F. If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture is the most restrictive DAC of any radionuclide in the mixture.

G. If a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if:

1. The licensee uses the total activity of the mixture to demonstrate compliance with the dose limits in R12-1-408 and complies with the monitoring requirements in R12-1-419;

2. The concentration of any radionuclide disregarded is less than 10% of its DAC; and

3. The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed 30%.

H. When determining the committed effective dose equivalent, the following information may be considered:

1. In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of 1 ALI, or an exposure of 2,000 DAC-hours, results in a committed effective dose equivalent of 0.05 Sv (5 rem) for radionuclides that have their ALls or DACs based on the committed effective dose equivalent.

2. For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 0.5 Sv (50 rem), the intake of radionuclides that would result in a committed effective dose equivalent of 0.05 Sv (5 rem), that is, the stochastic ALI, is listed in parentheses in Table I of Appendix B. The licensee may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee or registrant uses the stochastic ALI, the licensee shall also demonstrate that the limit in R12-1-408(A)(1)(b) is met.

Historical Note

Former Rule Section D.101; Former Section R12-1-411 repealed, new Section R12-1-411 adopted effective June 30, 1977 (Supp. 77-3). Amended effective February 25, 1985 (Supp. 85-1). Amended subsection (F) effective June 26, 1987 (87-2). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 5 A.A.R. 1812, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

R12-1-412. Determination of Prior Occupational Dose

A. For each individual who is likely to receive in a year an occupational dose that requires monitoring according to R12-1-419 the licensee shall:

1. Determine the occupational radiation dose received during the current year, and

2. Attempt to obtain the records of lifetime cumulative occupational radiation dose.

B. Before permitting an individual to participate in a planned special exposure, the licensee or registrant shall determine:

1. The internal and external doses from all previous planned special exposures; and

2. All doses in excess of the limits received during the lifetime of the individual, including doses received during accidents and emergencies; and

3. All lifetime, cumulative, occupational radiation doses.

C. In complying with the requirements of subsection (A), a licensee or registrant shall:

1. Accept, as a record of the occupational dose that the individual received during the current year, a written and signed statement from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual received during the current year; and

2. Accept, as the record of lifetime cumulative radiation dose, an up-to-date Agency Form Y (available from the Agency) or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant; and

3. Obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant, by telephone, telegram, facsimile, or letter. The licensee or registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.

D. Records.

1. The licensee or registrant shall record the exposure history, as required by subsection (A), on Agency Form Y (available from the Agency) or a similar clear and legible record of all the information required by this subsection. The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant shall use the dose shown in the report for preparing Agency Form Y or its equivalent. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on Agency Form Y or its equivalent indicating each period of time for which there is no data.

2. The licensee or registrant is not required to reevaluate the separate external dose equivalents and internal committed dose equivalents or intakes of radionuclides assessed according to the rules in Article 4 in effect before January 1, 1994. Occupational exposure histories obtained and recorded on Agency Form Y or its equivalent before January 1, 1994, would not have included effective dose equivalent but may be used in the absence of specific information on the intake of radionuclides by the individual.

3. If the licensee or registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee or registrant shall:

a. In establishing administrative controls under R12-1-408(F) for the current year, reduce the allowable dose limit for the individual by 12.5 mSv (1.25 rem) for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and

b. Not subject the individual to planned special exposures.

4. The licensee or registrant shall retain current and prior records on Agency Form Y or its equivalent for three years after the Agency terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing Agency Form Y or its equivalent for three years after the record is made.

Historical Note

Former Rule Section D.102; Former Section R12-1-412 repealed, new Section R12-1-412 adopted effective June 30, 1977 (Supp. 77-3). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-413. Planned Special Exposures

A. A licensee or registrant may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in R12-1-408, provided that each of the following conditions is satisfied:

1. The licensee or registrant authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the dose estimated from the planned special exposure are unavailable or impractical.

2. The licensee or registrant, and employer if the employer is not the licensee or registrant, specifically authorizes the planned special exposure, in writing, before the exposure occurs.

3. Before a planned special exposure, the licensee or registrant ensures that each individual involved is:

a. Informed in writing of the purpose of the planned special exposure;

b. Informed in writing of the estimated doses, associated potential risks, and specific radiation levels or other conditions that might be involved in performing the task; and

c. Instructed in the measures to be taken to keep the dose ALARA, considering other risks that may be present.

4. Before permitting an individual to participate in a planned special exposure, the licensee or registrant shall ascertain prior doses as required by R12-1-412(B) for each individual involved.

5. Subject to R12-1-408(B), the licensee or registrant shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses that exceed:

a. The numerical value of any of the dose limits in R12-1-408(A) in any year, and

b. Five times the annual dose limits in R12-1-408(A) during the individual's lifetime.

6. The licensee or registrant shall maintain records of a planned special exposure in accordance with subsections (B) and (C) and submit a written report to the Agency within 30 days after the date of any planned special exposure conducted in accordance with this Section, informing the Agency that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by subsection (B).

7. The licensee or registrant shall record the best estimate of the dose resulting from the planned special exposure in the individual's record and inform the individual, in writing, of the dose within 30 days after the date of the planned special exposure. The dose from a planned special exposure shall not be considered in controlling future occupational dose of the individual according to R12-1-408(A) but shall be included in evaluations required by subsections (A)(4) and (A)(5).

B. Records.

1. For each planned special exposure, the licensee or registrant shall maintain records that describe:

a. The exceptional circumstances requiring the use of a planned special exposure,

b. The name of the management official who authorized the planned special exposure and a copy of the signed authorization,

c. What actions were necessary,

d. Why the actions were necessary,

e. What precautions were taken to assure that doses were minimized in accordance with R12-1-407(B),

f. What individual and collective doses were expected,

g. The doses actually received in the planned special exposure, and

h. The process through which the employee involved in the planned special exposure has been informed in writing of the information contained in subsection (A)(3).

2. The licensee or registrant shall retain the records for three years after the Agency terminates each pertinent license or registration.

C. A licensee shall submit a report to the Agency no later than 30 days after a planned special exposure conducted in accordance with subsection (A). The report shall contain the date of the planned exposure and the information required by subsection (B).

Historical Note

Former Rule Section D.103. Former Section R12-1-413 repealed, new Section R12-1-413 adopted effective June 30, 1977 (Supp. 77-3). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2). Amended by final rulemaking at 10 A.A.R. 2122, effective July 3, 2004 (Supp. 04-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-414. Occupational Dose Limits for Minors

The annual occupational dose limits for minors are 10% of the annual occupational dose limits specified for adult workers in R12-1-408.

Historical Note

Former Rule Section D. 104; Former Section R12-1-414 repealed, new Section R12-1-414 adopted effective June 30, 1977 (Supp. 77-3). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3).

R12-1-415. Dose Equivalent to an Embryo or Fetus

A. A licensee or registrant shall ensure that the dose equivalent to an embryo or fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed 5 mSv (0.5 rem). Records shall be maintained according to R12-1-419(D)(4) and (5).

B. The licensee or registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman to satisfy the limit in subsection (A).

C. For purposes of this Section, the dose equivalent to the embryo or fetus is the sum of:

1. The deep-dose equivalent to the declared pregnant woman; and

2. The dose equivalent to the embryo or fetus resulting from radionuclides in the embryo or fetus and radionuclides in the declared pregnant woman.

D. If the dose equivalent to the embryo or fetus is found to have exceeded 5 mSv (0.5 rem) or is within 0.5 mSv (0.05 rem) of this dose by the time the woman declares the pregnancy to the licensee or registrant, the licensee or registrant shall be deemed to be in compliance with subsection (A) if the additional dose equivalent to the embryo or fetus does not exceed 0.5 mSv (0.05 rem) during the remainder of the pregnancy.

Historical Note

Former Rule Section D. 105; Former Section R12-1-415 repealed, new Section R12-1-415 adopted effective June 30, 1977 (Supp. 77-3). Amended effective February 25, 1985 (Supp. 85-1). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 5 A.A.R. 1812, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-416. Dose Limits for Individual Members of the Public

A. Each licensee or registrant shall conduct operations so that:

1. The total effective dose equivalent to any individual member of the public from the licensed or registered operation does not exceed 1 mSv (0.1 rem) in a year, excluding the dose contribution from background radiation, medical administration of radiation, exposure to an individual who has been administered radioactive material and released in accordance with R12-1-719, voluntary participation in a medical research program, and the licensee's or registrant's disposal of radioactive material into sanitary sewerage in accordance with R12-1-436; and

2. The dose in any unrestricted area from an external source excluding the dose contribution from an individual who has been administered radioactive material and released in accordance with R12-1-719, does not exceed 0.02 mSv (0.002 rem) in any one hour.

B. Registrants possessing radiation machines in operation before August 10, 1994, are exempt from the requirement in subsection (A)(1). Operation of these machines shall be conducted so that the total effective dose equivalent to any individual member of the public does not exceed 5 mSv (0.5 rem) in a year.

C. A licensee, registrant, or an applicant for a license or registration may apply for Agency authorization to operate with an annual dose limit of 5 mSv (0.5 rem) for an individual member of the public. The application shall include the following information:

1. An explanation of the need for and the expected duration of operations in excess of the limit in subsection (A), and

2. The licensee's or registrant's program to assess and control dose within the 5 mSv (0.5 rem) annual limit; and

3. The procedures to be followed to maintain the dose in accordance with R12-1-407(B).

D. A licensee or registrant shall comply with the U.S. Environmental Protection Agency's applicable environmental radiation standards in 40 CFR 190, 2003 edition, published July 1, 2003, by the Office of the Federal Register, National Archives and Records Administration, Washington, D.C. 20408, which are incorporated by reference, on file with the Agency and contain no future editions or amendments.

E. The Agency may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee or registrant may release in effluents in order to restrict the collective dose.

F. Each licensee or registrant shall make or cause to be made surveys of radiation levels in unrestricted areas and radioactive materials contained in effluents released to unrestricted areas.

G. Each licensee or registrant shall:

1. Demonstrate by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed or registered operation does not exceed the annual dose limit; or

2. Demonstrate that:

a. The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in Appendix B, Table II; and

b. If an individual were continually present in an unrestricted area, the dose from external sources would not exceed 0.02 mSv (0.002 rem) in an hour and 0.5 mSv (0.05 rem) in a year.

H. Upon approval from the Agency, the licensee or registrant may adjust the effluent concentration values in Appendix B, Table II for members of the public, to take into account the actual physical and chemical characteristics of the effluents, such as aerosol size distribution, solubility, density, radioactive decay equilibrium, and chemical form.

I. Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public and shall retain the records for three years after the Agency terminates each pertinent license or registration.

Historical Note

Former Rule Section D. 106; Former Section R12-1-416 repealed, new Section R12-1-416 adopted effective June 30, 1977 (Supp. 77-3). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2). Amended by final rulemaking at 10 A.A.R. 2122, effective July 3, 2004 (Supp. 04-2).

R12-1-417. Testing for Leakage or Contamination of Sealed Sources

A. A licensee in possession of any sealed source shall ensure that:

1. Each sealed source, except as specified in subsection (B), is tested for leakage or contamination and the test results are received before the sealed source is put into use unless the licensee has a certificate from the transferor indicating that the sealed source was tested within six months before transfer to the licensee or registrant.

2. Each sealed source that is not designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed six months or at alternative intervals approved by the Agency, after evaluation of information specified by R12-1-311(D)(2) and (D)(3), or equivalent information specified by an Agreement State, a Licensing State, or the U.S. Nuclear Regulatory Commission.

3. Each sealed source that is designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed three months or at alternative intervals approved by the Agency, after evaluation of information specified by R12-1-311(D)(2) and (D)(3), or equivalent information specified by an Agreement State, a Licensing State, or the Nuclear Regulatory Commission.

4. Each sealed source suspected of damage or leakage is tested for leakage or contamination before further use.

5. Tests for leakage for all sealed sources, except brachytherapy sources manufactured to contain radium, are capable of detecting the presence of 185 Bq (0.005 μCi) of radioactive material on a test sample. The person conducting the test shall take test samples from the sealed source or from the surfaces of the container in which the sealed source is stored or mounted on which contamination could accumulate. For a sealed source contained in a device, the person conducting the test shall obtain test samples when the source is in the "off" position.

6. The test for leakage from brachytherapy sources containing radium is capable of detecting an absolute leakage rate of 37 Bq (0.001 μCi) of Radon-222 in a 24-hour period when the collection efficiency for Radon-222 and its daughters has been determined with respect to collection method, volume, and time.

7. Tests for contamination from radium daughters are taken on the interior surface of brachytherapy source storage containers and are capable of detecting the presence of 185 Bq (0.005 μCi) of a radium daughter which has a half-life greater than four days.

B. A licensee need not perform tests for leakage or contamination on the following sealed sources:

1. Sealed sources containing only radioactive material with a half-life of less than 30 days;

2. Sealed sources containing only radioactive material as a gas;

3. Sealed sources containing 3.7 MBq (100 μCi) or less of beta or photon-emitting material or 370 kBq (10 μCi) or less of alpha-emitting material;

4. Sealed sources containing only Hydrogen-3;

5. Seeds of Iridium-192 encased in nylon ribbon; and

6. Sealed sources, except teletherapy and brachyherapy sources, which are stored, not being used, and identified as in storage. The licensee shall test each sealed source for leakage or contamination and receive the test results before any use or transfer unless it has been tested for leakage or contamination within six months before the date of use or transfer.

C. Persons specifically authorized by the Agency, an Agreement State, a Licensing State, or the U.S. Nuclear Regulatory Commission shall perform tests for leakage or contamination from sealed sources.

D. A licensee shall maintain for Agency inspection test results in units of becquerel or microcurie.

E. The following is considered evidence that a sealed source is leaking:

1. The presence of 185 Bq (0.005 μCi) or more of removable contamination on any test sample.

2. Leakage of 37 Bq (0.001 μCi) of Radon-222 per 24 hours for brachytherapy sources manufactured to contain radium.

3. The presence of removable contamination resulting from the decay of 185 Bq (0.005 μCi) or more of radium.

F. A licensee shall immediately withdraw a leaking sealed source from use and shall take action to prevent the spread of contamination. The leaking sealed source shall be repaired or disposed of in accordance with this Article.

G. A licensee shall file a report with the Agency within five days if the test for leakage or contamination indicates a sealed source is leaking or contaminated. The report shall include the equipment involved, the test results, and the corrective action taken.

H. A licensee shall maintain records of the tests for leakage required in subsection (A) for three years after the records are made.

Historical Note

Former Rule Section D. 107; Former Section R12-1-417 repealed, new Section R12-1-417 adopted effective June 30, 1977 (Supp. 77-3). Amended effective February 25, 1985 (Supp. 85-1). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

R12-1-418. Surveys and Monitoring

A. Each licensee or registrant shall make, or cause to be made, surveys if surveys are:

1. Necessary for the licensee or registrant to comply with Article 4, and

2. Reasonable under the circumstances to evaluate:

a. The magnitude and extent of radiation levels,

b. Concentrations or quantities of radioactive material, and

c. The potential radiological hazards.

B. All personnel dosimeters, except for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to any extremity, that require processing to determine the radiation dose and that are used by licensees and registrants to comply with R12-1-408, with other applicable provisions of these rules, or with conditions specified in a license or registration shall be processed and evaluated by a dosimetry processor:

1. Holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology, according to NVLAP procedures published March 1994 as NIST Handbook 150, and NIST Handbook 150-4, published August 1994, which is incorporated by reference, published by the U.S. Government Printing Office, Washington D.C. 20402-9325, and on file with the Agency. The material incorporated by reference contains no future editions or amendments; and

2. Approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored.

C. The licensee or registrant shall ensure that adequate precautions are taken to prevent a deceptive exposure of an individual monitoring device and that personnel monitoring devices are issued to, and used by only the individual to whom the monitoring device has been first issued during any reporting period.

D. A licensee shall ensure that survey instruments and personnel dosimeters that are used to make quantitative measurements are calibrated in accordance with R12-1-449.

E. Records.

1. Each licensee or registrant shall maintain records showing the results of surveys required by this Section and R12-1-433(B). The licensee or registrant shall retain these records for three years after the record is made.

2. The licensee or registrant shall retain each of the following records for three years after the Agency terminates the license or registration:

a. Records of the survey results used to determine the dose from external sources of radiation, in the absence of or in combination with individual monitoring data, and provide an assessment of individual dose equivalents;

b. Records of the results of measurements and calculations used to determine individual intakes of radioactive material and to assess an internal dose;

c. Records showing the results of air sampling, surveys, and bioassays required according to R12-1-425(A)(3)(a) and (b); and

d. Records of the measurement and calculation results used to evaluate the release of radioactive effluents to the environment.

Historical Note

Former Rule Section D. 108; Former Section R12-1-418 repealed, new Section R12-1-418 adopted effective June 30, 1977 (Supp. 77-3). Amended effective February 25, 1985 (Supp. 85-1). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended effective June 13, 1997 (Supp. 97-2). Amended by final rulemaking at 5 A.A.R. 1812, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2). Amended by final rulemaking at 10 A.A.R. 2122, effective July 3, 2004 (Supp. 04-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-419. Conditions Requiring Individual Monitoring of External and Internal Occupational Dose

A. Each licensee or registrant shall monitor exposures from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of this Article.

B. At minimum each licensee or registrant shall supply and require the use of individual monitoring devices by the following personnel:

1. Adults likely to receive, in one year, an intake in excess of 10% of the applicable ALI in Table I, Columns 1 and 2, of Appendix B;

2. Minors and declared pregnant women likely to receive, in one year, a committed effective dose equivalent in excess of 0.5 mSv (0.05 rem);

3. Adults likely to receive, in one year from radiation sources external to the body, a dose in excess of 10 percent of the limits in R12-1-408(A);

4. Minors likely to receive, in one year, from radiation sources external to the body, a deep dose equivalent in excess of 1 mSv (0.1 rem), a lens dose equivalent in excess of 1.5 mSv (0.15 rem), or a shallow dose equivalent to the skin or to the extremities in excess of 5mSv (0.5 rem);

5. Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 1 mSv (0.1 rem) (Note: All of the occupational doses in R12-1-408 continue to be applicable to the declared pregnant worker as long as the embryo/fetus dose limit is not exceeded.); and

6. Individuals entering a high or very high radiation area;

7. Individuals operating mobile x-ray equipment; except dental intraoral systems, as described in R12-1-608;

8. Individuals holding animals for diagnostic x-ray procedures, as described in R12-1-613;

9 Individuals servicing enclosed beam x-ray systems with bypassed interlocks, as described in R12-1-803;

10. Individuals operating open beam fluoroscopic systems and ancillary personnel working in the room when the fluoroscopic system is in use, except when relieved of this requirement by registration condition; and

11. Individuals performing well logging, as described in Article 17.

C. Each licensee shall monitor the occupational intake of radioactive material by and assess the committed effective dose equivalent to:

1. Adults likely to receive, in one year, an intake in excess of 10% of the applicable ALI in Table 1, Columns 1 and 2, of Appendix B;

2. Minors likely to receive, in one year, a committed effective dose equivalent in excess of 1 mSv (0.1 rem); and

3. Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of 1 mSv (0.1 rem).

D. Records.

1. Each licensee or registrant shall maintain records of doses received by all individuals for whom monitoring is required according to this Section, and records of doses received during planned special exposures, accidents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before January 1, 1994, need not be changed. These records shall include, when applicable:

a. The deep-dose equivalent to the whole body, lens dose equivalent, shallow-dose equivalent to the skin, and shallow-dose equivalent to the extremities;

b. The estimated intake of radionuclides;

c. The committed effective dose equivalent assigned to the intake of radionuclides;

d. The specific information used to assess the committed effective dose equivalent according to R12-1-411(A) and (C), and when required R12-1-419.

e. The total effective dose equivalent when required by R12-1-409: and

f. The total of the deep-dose equivalent and the committed dose to the organ receiving the highest total dose;

2. The licensee or registrant shall make entries of the records specified in subsection (D)(1), at intervals not to exceed one year;

3. The licensee or registrant shall maintain at the inspection site the records specified in subsection (D)(1), on Agency Form Z (available from the Agency), in accordance with the instructions for Agency Form Z, or in clear and legible records containing all the information required by this subsection;

4. The licensee or registrant shall maintain the records of dose to an embryo or fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy, including the estimated date of conception, shall also be kept on file but may be maintained separately from the dose records;

5. The licensee or registrant shall retain each required form or record for three years after the Agency terminates each pertinent license or registration requiring the record.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective February 25, 1985 (Supp. 85-1). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended effective June 13, 1997 (Supp. 97-2). Amended by final rulemaking at 5 A.A.R. 1812, effective May 12, 1999 (Supp. 99-2). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2). Amended by final rulemaking at 9 A.A.R. 1126, effective May 9, 2003 (Supp. 03-1). Amended by final rulemaking at 10 A.A.R. 2122, effective July 3, 2004 (Supp. 04-2). Amended by final rulemaking at 12 A.A.R. 75, effective February 7, 2006 (Supp. 05-4).

R12-1-420. Control of Access to High Radiation Areas

A. A licensee or registrant shall ensure that each entrance or access point to a high radiation area has one or more of the following features:

1. A control device that, upon entry into the area, causes the level of radiation to be reduced below the level at which an individual might receive a deep-dose equivalent of 1 mSv (0.1 rem) in one hour at 30 centimeters from the source from any surface that the radiation penetrates;

2. A control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of the entry; or

3. Entryways that are locked, except during periods when access to the areas is required, with positive control over each individual entity.

B. In place of the controls required by subsection (A) for a high radiation area, the licensee or registrant may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.

C. The licensee or registrant may apply to the Agency for approval of alternative methods for controlling access to high radiation areas.

D. The licensee or registrant shall establish the controls required by subsections (A) and (C) in a way that does not prevent individuals from leaving a high radiation area.

E. The licensee or registrant is not required to control each entrance or access point to a room or other area that is a high radiation area solely because of the presence of radioactive materials prepared for transport and packaged and labeled in accordance with the regulations of the U.S. Department of Transportation, provided that:

1. The packages do not remain in the area longer than three days, and

2. The dose rate at 1 meter from the external surface of any package does not exceed 0.1 mSv (0.01 rem) per hour.

F. The licensee or registrant is not required to control entrance or access to rooms or other areas in hospitals solely because of the presence of patients containing radioactive material, provided that there are personnel in attendance who are taking the necessary precautions to prevent the exposure of individuals to radiation or radioactive material in excess of the established limits in Article 4 and operate in accordance with R12-1-407(B) and the provisions of the licensee's or registrant's radiation protection program.

G. The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a high radiation area if the registrant has met all the specific requirements for access and control specified in other applicable Articles of these rules, such as Article 5 for industrial radiography, Article 6 for x-rays in the healing arts, and Article 9 for particle accelerators.

Historical Note

Adopted effective June 30, 1977 (Supp. 77-3). Amended effective February 25, 1985 (Supp. 85-1). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

R12-1-421. Control of Access to Very-high Radiation Areas

A. In addition to the requirements in R12-1-420, a licensee or registrant shall institute measures to ensure that an individual is not able to gain unauthorized or inadvertent access to areas in which radiation levels could be encountered at 5 Gy (500 rad) or more in one hour at 1 meter from a source or from any surface that the radiation penetrates. This requirement does not apply to rooms or areas in which diagnostic x-ray systems are the only source of radiation or non-self-shielded irradiators.

B. The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a very high radiation area, described in subsection (A), if the registrant has met all requirements for access and control specified in other applicable Articles of these rules, such as Article 5 for industrial radiography, Article 6 for x-rays in the healing arts, and Article 9 for particle accelerators.

C. Each licensee or registrant shall maintain records of tests made according to R12-1-422(B)(9) on entry control devices for very-high radiation areas. These records shall include the date, time, and results of each test of function.

D. The licensee or registrant shall retain the records required by this Section for three years after the record is made.

Historical Note

Former Rule Section D.201; Former Section R12-1-421 repealed, new Section R12-1-421 adopted effective June 30, 1977 (Supp. 77-3). Amended effective February 25, 1985 (Supp. 85-1). Section repealed, new Section adopted effective August 10, 1994 (Supp. 94-3). Amended by final rulemaking at 7 A.A.R. 2584, effective June 8, 2001 (Supp. 01-2).

R12-1-422. Control of Access to Irradiators (Very-high Radiation Areas)

A. This Section applies to licensees or registrants with sources of radiation in non-self-shielded irradiators. This Section does not apply to sources of radiation that are used in teletherapy, industrial radiography, or completely self-shielded irradiators in which the source of radiation is both stored and operated within the same shielding radiation barrier and, in the designed configuration of the irradiator, is always physically inaccessible to any individual and cannot create high levels of radiation in an area that is accessible to any individual.

B. A licensee or registrant shall ensure that each area in which radiation levels may exceed 5 Gy (500 rad) in one hour at 1 meter from a source that is used to irradiate materials meets the following requirements:

1. Each entrance or access point shall be equipped with entry control devices that:

a. Function automatically to prevent any individual from inadvertently entering a very high radiation area;

b. Permit deliberate entry into the area only after a control device is actuated that causes the radiation level within the area, from the source of radiation, to be reduced below that at which it would be possible for an individual to receive a deep-dose equivalent in excess of 1 mSv (0.1 rem) in one hour; and

c. Prevent operation of the source of radiation if it would produce radiation levels in the area that could result in a deep-dose equivalent to an individual in excess of 1 mSv (0.1 rem) in one hour.

2. If the control devices required in subsection (B)(1) fail to function, additional control devices shall be provided so that:

a. The radiation level within the area, from the source of radiation, is reduced below that at which it would be possible for an individual to receive a deep-dose equivalent in excess of 1 mSv (0.1 rem) in one hour; and

b. Conspicuous visible and audible alarm signals are generated so that an individual entering the area is aware of the hazard. The individual who enters the very-high radiation area after an alarm signals shall be familiar with the process and equipment. Before entering, the individual shall ensure that a second individual is present and aware of the first person's actions.

3. The licensee or registrant shall provide control devices so that, upon failure or removal of physical radiation barriers other than the sealed source's shielded storage container:

a. The radiation level from the source of radiation is reduced below that at which it would be possible for an individual to receive a deep-dose equivalent in excess of 1 mSv (0.1 rem) in one hour; and

b. Conspicuous visible and audible alarm signals are generated so that potentially affected individuals are aware of the hazard. Potentially affected individuals shall notify the licensee or registrant of the failure or removal of the physical barriers.

4. When the shield for stored sealed sources is a liquid, the licensee or registrant shall provide means to monitor the integrity of the shield and to signal, automatically, loss of adequate shielding.

5. Physical radiation barriers that comprise permanent structural components, such as walls, that have no credible probability of failure or removal in ordinary circumstances need not meet the requirements of subsections (B)(3) and (B)(4).

6. The licensee or registrant shall equip each area with devices that will automatically generate conspicuous visible and audible alarm signals to alert personnel in the area before the source of radiation can be put into operation and in time for any individual in the area to operate a clearly identified control device, installed in the area, and which can prevent the source of radiation from being put into operation.

7. The licensee or registrant shall control each area by use of administrative procedures and devices necessary to ensure that the area is cleared of personnel before each use of the source of radiation.

8. The licensee or registrant shall check each area by radiation measurement to ensure that, before the first individual's entry into the area after any use of the source of radiation, the radiation level from the source of radiation in the area is below that at which it would be possible for an individual to receive a deep-dose equivalent in excess of 1 mSv (0.1 rem) in one hour.

9. The licensee or registrant shall test the entry control devices required in subsection (B)(1) for proper functioning and keep records according to R12-1-421.

a. Testing shall be conducted before initial operation with the source of radiation on any day, unless operations were continued uninterrupted from the previous day;

b. Testing shall be conducted before resumption of operation of the source of radiation after any unintentional interruption: and

c. The licensee or registrant shall submit to the Agency and adhere to a schedule for periodic tests of the entry control and warning systems.

10. The licensee or registrant shall not conduct operations, other than those necessary to place the source of radiation in a safe condition or effect repairs on controls, unless control devices are functioning properly.

11. The licensee or registrant shall control entry and exit portals that are used in transporting materials to and from the irradiation area, and that are not intended for use by individuals, with devices and administrative procedures necessary to physically protect and warn against inadvertent entry by any individual through these portals. Exit portals for irradiated materials shall be equipped to detect and signal the presence of any uncontained radioactive material that is carried toward an exit and automatically prevent contained radioactive material from being carried out of the area.

C. A licensee, registrant, or applicant seeking a