Part I
General Provisions

12VAC5-481-10. Definitions.

As used in these regulations, these terms have the definitions set forth below.

"A₁" means the maximum activity of special form radioactive material permitted in a Type A package. This value is listed in Table 1 of 12VAC5-481-3770.

"A₂" means the maximum activity of radioactive material, other than special form radioactive material, LSA, and SCO material, permitted in a Type A package. This value is listed in Table 1 of 12VAC5-481-3770.

"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.

"Absorbed dose rate" means absorbed dose per unit time, for machines with timers, or dose monitor unit per unit time for linear accelerators.

"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 one MeV. For purposes of this definition, "particle accelerator" is an equivalent term.

"Accelerator-produced material" means any material made radioactive by a particle accelerator.

"Accessible surface" means the external surface of the enclosure or housing of the radiation producing machine as provided by the manufacturer. It also means surface of equipment or of an equipment part that can be easily or accidentally touched by persons without the use of a tool.

"Act" means §§32.1-227 through 32.1-238 of the Code of Virginia.

"Active maintenance" means any significant activity needed during the period of institutional control to maintain a reasonable assurance that the performance objectives in 12VAC5-481-2490 and 12VAC5-481-2500 are met. Such active maintenance includes ongoing activities such as the pumping and treatment of water from a disposal unit or one-time measures such as replacement of a disposal unit cover. Active maintenance does not include custodial activities such as repair of fencing, repair or replacement of monitoring equipment, revegetation, minor additions to soil cover, minor repair of disposal unit covers, and general disposal site upkeep such as mowing grass.

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

"Acute" means a single radiation dose or chemical exposure event or multiple radiation dose or chemical exposure events occurring within a short time (24 hours or less).

"Added filtration" means any filtration that is in addition to the inherent filtration.

"Address of use" means the building or buildings that are identified on the license and where radioactive material may be produced, prepared, received, used, or stored.

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

"Agency" means the Radiological Health Program of the Virginia Department of Health.

"Agreement state" means any state with which the Nuclear Regulatory Commission NRC or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954, as amended (73 Stat. 689).

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

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

1. In excess of the derived air concentrations (DACs) specified in Appendix B to 10 CFR Part 20 12VAC5-481-3690; or

2. To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6% of the annual limit on intake (ALI) or 12 DAC-hours.

"Air kerma (K)" means the kinetic energy released in air by ionizing radiation. Kerma is determined as the quotient of De by Dm, where De is the sum of the initial kinetic energies of all the charged ionizing particles liberated by uncharged ionizing particles in air of mass Dm. The SI unit of air kerma is joule per kilogram and the special name for the unit of kerma is the gray (Gy).

"Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

"Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by offsite response organizations to protect persons offsite.

"Aluminum equivalent" means the thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question. The nominal chemical composition of type 100 aluminum is 99.00% minimum aluminum, 0.12% copper.

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

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

"Annual limit on intake" (ALI) means 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 Tables 1 and 2 in Appendix B of 10 CFR 20 12VAC5-481-3690.

"Annual refresher safety training" means a review conducted or provided by the licensee or registrant for its employees on radiation safety aspects of industrial radiography. The review shall include, as a minimum, any results of internal inspections, new procedures or equipment, new or revised regulations, and accidents or errors that have been observed. The review shall also provide opportunities for employees to ask safety questions.

"Annually" means at intervals not to exceed one year.

"ANSI" means the American National Standards Institute.

"Area of use" means a portion of a physical structure that has been set aside for the purpose of producing, preparing, receiving, using, or storing radioactive material.

"Assigned protection factor (APF)" means the expected workplace level of respiratory 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.

"As low as is reasonably achievable" (ALARA) means making every reasonable effort to maintain exposures to radiation as far below the dose limits in these regulations as is practical, consistent with the purpose for which the licensed 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.

"Assembler" means any person engaged in the business of assembling, replacing, or installing one or more components into an X-ray system or subsystem. The term includes the owner of an X-ray system or his or her employee or agent who assembles components into an X-ray system that is subsequently used to provide professional or commercial services.

"Associated equipment" means equipment that is used in conjunction with a radiographic exposure device to make radiographic exposures that drive, guide, or come in contact with the source.

"Atmosphere-supplying respirator" means a respirator that supplies the respirator 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.

"Attenuation block" means a block or stack, having dimensions 20 centimeters by 20 centimeters by 3.8 centimeters, of type 1100 aluminum alloy or other materials having equivalent attenuation. The nominal chemical composition of type 100 aluminum is 99.00% minimum aluminum, 0.12% copper.

"Authorized medical physicist" means an individual who:

1. Meets the requirements in 12VAC5-481-1760 and 12VAC5-481-1790; or

2. Is identified as an authorized medical physicist or teletherapy physicist on:

a. A specific medical use license issued by the NRC or another agreement state;

b. A medical use permit issued by an NRC master material licensee;

c. A permit issued by an NRC or another agreement state broad scope medical use licensee; or

d. A permit issued by an NRC master material license broad scope medical use permittee.

"Authorized nuclear pharmacist" means a pharmacist who:

1. Meets the requirements in 12VAC5-481-1770 and 12VAC5-481-1790;

2. Is identified as an authorized nuclear pharmacist on:

a. A specific license issued by the NRC or another agreement state that authorizes medical use or the practice of nuclear pharmacy;

b. A permit issued by an NRC master material licensee that authorizes medical use or the practice of nuclear pharmacy;

c. A permit issued by an NRC or another agreement state broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or

d. A permit issued by an NRC master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy;

3. Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or

4. Is designated as an authorized nuclear pharmacist in accordance with 12VAC5-481-440 I 2.

"Authorized user" means a practitioner of the healing arts who is identified as an authorized user on an agency, agreement state, licensing state or the Nuclear Regulatory Commission license that authorizes the medical use of radioactive material.

"Authorized user" means a practitioner of the healing arts who:

1. Meets the requirements in 12VAC5-481-1790 and any of the following:

a. 12VAC5-481-1910;

b. 12VAC5-481-1940;

c. 12VAC5-481-1980;

d. 12VAC5-481-1990;

e. 12VAC5-481-2000;

f. 12VAC5-481-2010;

g. 12VAC5-481-2030;

h. 12VAC5-481-2040; or

2. Is identified as an authorized user on:

a. A specific license issued by the NRC or another agreement state that authorizes medical use;

b. A permit issued by an NRC master material licensee that authorizes medical use;

c. A permit issued by an NRC or another agreement state broad scope medical use licensee that authorizes medical use; or

d. A permit issued by an NRC master material license broad scope medical use permittee that authorizes medical use.

"Automatic exposure control (AEC)" means a device that automatically controls one or more technique factors in order to obtain, at a preselected location(s), a required quantity of radiation (includes devices such as phototimers and ion chambers).

"Background radiation" means radiation from cosmic sources;, naturally occurring radioactive materials, that have not been technologically enhanced, including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices, or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee or registrant. "Background radiation" does not include sources of radiation from radioactive materials regulated by the agency.

"Barrier" (See "Protective barrier").

"Beam axis" means a line from the source through the centers of the X-ray fields.

"Beam-limiting device" means a device that provides a means to restrict the dimensions of the X-ray field.

"Beam monitoring system" means a system designed and installed in the radiation head to detect and measure the radiation present in the useful beam.

"Beam scattering foil" means a thin piece of material (usually metallic) placed in the beam to scatter a beam of electrons in order to provide a more uniform electron distribution in the useful beam.

"Becquerel" (Bq) means the SI unit of activity. One becquerel is equal to one disintegration or transformation per second (dps or tps).

"Beneficial attribute" means, as used in Part XVI (12VAC5-481-3460 et seq.) of this chapter, the radioactivity of the product necessary to the use of the product.

"Beneficial to the product" see "Beneficial attribute."

"Bent beam linear accelerator" means a linear accelerator geometry in which the accelerated electron beam must change direction by passing through a bending magnet.

"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 regulations, "radiobioassay" is an equivalent term.

"Board" means the State Board of Health.

"Brachytherapy" means a method of radiation therapy in which sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, or interstitial application.

"Buffer zone" means a portion of the disposal site that is controlled by the licensee and that lies under the disposal units and between the disposal units and the boundary of the site.

"Byproduct material" means:

1. 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 using special nuclear material; and

2. 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. ;

3. a. Any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or

b. Any material that:

(1) Has been made radioactive by use of a particle accelerator; and

(2) Is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; and

4. Any discrete source of naturally occurring radioactive material, other than source material, that:

a. The NRC, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and

b. Before, on, or after August 8, 2005, is extracted or converted after extraction for use in a commercial, medical, or research activity.

"C-arm X-ray system" means an X-ray system in which the image receptor and X-ray tube housing assembly are connected by a common mechanical support system in order to maintain a desired spatial relationship. This system is designed to allow a change in the projection of the beam through the patient without a change in the position of the patient.

"Cabinet radiography" means industrial radiography conducted in an enclosure or cabinet so shielded that every location on the exterior meets the dose limits for individual members of the public as specified in 12VAC5-481-720.

"Cabinet X-ray system" means an X-ray system with the X-ray tube installed in an enclosure independent of existing architectural structures except the floor on which it may be placed. The cabinet X-ray system is intended to contain at least that portion of a material being irradiated, provide radiation attenuation, and exclude personnel from its interior during generation of radiation. Included are all X-ray systems designed primarily for the inspection of carry-on baggage at airline, railroad, and bus terminals, and in similar facilities. An X-ray tube used within a shielded part of a building, or X-ray equipment that may temporarily or occasionally incorporate portable shielding, is not considered a cabinet X-ray system.

"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. The method observed by the licensee or registrant for determining calendar quarters shall only be changed at the beginning of a year.

"Calibration" means the determination of (i) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument or (ii) the strength of a source of radiation relative to a standard.

"Camera" (See "Radiographic exposure device").

"Carrier" means a person engaged in the transportation of passengers or property by land or water as a common, contract, or private carrier, or by civil aircraft.

"Cephalometric device" means a device intended for the radiographic visualization and measurement of the dimensions of the human head.

"Certifiable cabinet X-ray system" means an existing uncertified X-ray system that has been modified to meet the certification requirements specified in 21 CFR 1020.40.

"Certificate holder" means a person who has been issued a certificate of compliance or other package approval by the NRC.

"Certificate of compliance (CoC)" means the certificate issued by the NRC that approves the design of a package for the transportation of radioactive material.

"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 pursuant to the provisions of 21 CFR 1020.40.

"Certified components" means components of X-ray systems that are subject to regulations promulgated under Pub.L. 90-602, the Radiation Control for Health and Safety Act of 1968 of the Food and Drug Administration.

"Certified system" means any X-ray system which has one or more certified component(s).

"Certifying entity" means an independent certifying organization meeting the agency's requirements for documenting applicant's training in topics set forth in 12VAC5-481-1320 or equivalent state or Nuclear Regulatory Commission NRC regulations.

"CFR" means Code of Federal Regulations.

"Changeable filters" means any filter, exclusive of inherent filtration, that can be removed from the useful beam through any electronic, mechanical, or physical process.

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

"Class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of 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. For purposes of these regulations, "lung class" and "inhalation class" are equivalent terms.

"Closed transport vehicle" means a transport vehicle equipped with a securely attached exterior enclosure that during normal transportation restricts the access of unauthorized persons to the cargo space containing the radioactive material. The enclosure may be either temporary or permanent but shall limit access from top, sides, and ends. In the case of packaged materials, it may be of the "see-through" type.

"Coefficient of variation (C)" means the ratio of the standard deviation to the mean value of a set of observations. It is estimated using the following equation:

where:

s = Standard deviation of the observed values;

 = Mean value of observations in sample;

x_i = i_th observation in sample;

n = Number of observations in sample.

"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.

"Collimator" means a device used to limit the size, shape, and direction of the primary radiation beam. For industrial radiography it means a radiation shield that is placed on the end of the guide tube or directly onto a radiographic exposure device to restrict the size of the radiation beam when the sealed source is cranked into position to make a radiographic exposure.

"Commencement of construction" means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a land disposal facility. The term does not mean disposal site exploration, necessary roads for disposal site exploration, borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the disposal site or the protection of environmental values.

"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 (w_T) 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 = ? (w_T H_T,50)).

"Computed tomography" means the production of a tomogram by the acquisition and computer processing of X-ray transmission data.

"Computed tomography dose index" means the integral from -7T to +7T of the dose profile along a line perpendicular to the tomographic plane divided by the product of the nominal tomographic section thickness and the number of tomograms produced in a single scan, that is:

where:

z = Position along a line perpendicular to the tomographic plane;

D(z) = Dose at position z;

T = Nominal tomographic section thickness;

n = Number of tomograms produced in a single scan.

This definition assumes that the dose profile is centered around z = 0 and that, for a multiple tomogram system, the scan increment between adjacent scans is nT.

"Consignment" means each shipment of a package or groups of packages or load of radioactive material offered by a shipper for transport.

"Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a federal facility or a medical facility.

 "Constraint" means each shipment of a package or groups of packages or load of radioactive material offered by a shipper for transport.

"Constraint (dose constraint)" means a value above which specified licensee actions are required.

"Contact therapy system" means a therapeutic radiation machine with a short target to skin distance (TSD), usually less than five centimeters.

"Contrast scale" means the change in the linear attenuation coefficient per CTN relative to water, that is:

where:

 = Linear attenuation coefficient of the material of interest;

 = Linear attenuation coefficient of water;

 = of the material of interest;

 = of water.

"Control (drive) cable" means the cable that is connected to the source assembly and used to drive the source to and from the exposure location.

"Control drive mechanism" means a device that enables the source assembly to be moved into and out of the exposure device.

"Control panel" means that part of the X-ray control upon which are mounted the switches, knobs, pushbuttons, and other hardware necessary for manually setting the technique factors.

"Control tube" means a protective sheath for guiding the control cable. The control tube connects the control drive mechanism to the radiographic exposure device.

"Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason.

"Conveyance" means:

1. For transport by public highway or rail any transport vehicle or large freight container;

2. For transport by water any vessel, or any hold, compartment, or defined deck area of a vessel including any transport vehicle on board the vessel; and

3. For transport by any aircraft.

"Cooling curve" means the graphical relationship between heat units stored and cooling time.

"Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

"Criticality safety index (CSI)" means the dimensionless number (rounded up to the next tenth) assigned to and placed on the label of a fissile material package, to designate the degree of control of accumulation of packages containing fissile material during transportation. Determination of the criticality safety index is described in Part XIII (12VAC5-481-2950 et seq.).

"CS" (See "Contrast scale").

"CT" (See "Computed tomography").

"CT conditions of operation" means all selectable parameters governing the operation of a CT X-ray system including, but not limited to, nominal tomographic section thickness, filtration, and the technique factors as defined in these regulations.

"CTDI" (See "Computed tomography dose index").

"CT gantry" means the tube housing assemblies, beam-limiting devices, detectors, and the supporting structures and frames which hold these components.

"CTN" (See "CT number").

"CT Number" means the number used to represent the X-ray attenuation associated with each elemental area of the CT image.

where:

 = A constant, a normal value of 1,000 when the Houndsfield scale of CTN is used;

 = Linear attenuation coefficient of the material of interest;

 = Linear attenuation coefficient of water.

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

"Custodial agency" means an agency of the government designated to act on behalf of the government owner of the disposal site.

"Dead-man switch" means a switch so constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator.

"Declared pregnant woman" means a woman who has voluntarily informed her employer the licensee, 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 termination of the license.

"Dedicated check source" means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years. This source may also be used for other purposes.

"Deep dose equivalent" (H_d), which applies to external whole body exposure, means the dose equivalent at a tissue depth of one centimeter (1000 mg/cm²).

"Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

"Department of Energy" means the Department of Energy established by Pub. L. 95-91, August 4, 1977, 91 Stat. 565, 42 USC §7101 et seq., to the extent that the Department exercises functions formerly vested in the Atomic Energy Commission, its Chairman, members, officers and components and transferred to the Energy Research and Development Administration and to the Administrator thereof pursuant to sections 104(b), (c) and (d) of the Energy Reorganization Act of 1974 (Pub. L. 93-438, October 11, 1974, 88 Stat. 1233 at 1237, 42 USC §5814, effective January 19, 1975) and retransferred to the Secretary of Energy pursuant to section 301(a) of the Department of Energy Organization Act (Pub. L. 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 USC §7151, effective October 1, 1977.)

"Depleted uranium" means the source material uranium in which the isotope uranium-235 is less than 0.711 weight percentage of the total uranium present. Depleted uranium does not include special nuclear material.

"Derived air concentration" (DAC) means the concentration of a given radionuclide in air which, if breathed by the 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 regulations, 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 Table I, Column 3, of Appendix B to 10 CFR Part 20 12VAC5-481-3690.

"Derived air concentration-hour" (DAC-hour) means 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).

"Detector" (See "Radiation detector").

"Deuterium" means, for the purposes of Part XIII (12VAC5-481-2950 et seq.) deuterium and any deuterium compounds, including heavy water, in which the ratio of deuterium atoms to hydrogen atoms exceeds 1:5000.

"Diagnostic clinical procedures manual" means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures, where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

"Diagnostic source assembly" means the tube housing assembly with a beam-limiting device attached.

"Diagnostic X-ray system" means an X-ray system designed for irradiation of any part of the human or animal body for the purpose of diagnosis or visualization.

"Diagnostic X-ray imaging system" means an assemblage of components for the generation, emission and reception of X-rays and the transformation, storage and visual display of the resultant X-ray image.

"Direct scattered radiation" means that scattered radiation that has been deviated in direction only by materials irradiated by the useful beam (See "Scattered radiation").

"Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

"Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).

"Disposal" means the isolation of wastes from the biosphere inhabited by man and his food chains by emplacement in a land disposal facility.

"Disposal site" means that portion of a land disposal facility that is used for disposal of waste. It consists of disposal units and a buffer zone.

"Disposal unit" means a discrete portion of the disposal site into which waste is placed for disposal. For near-surface disposal, the unit is usually a trench.

"Distinguishable from background" means that the detectable concentration of a radionuclide is statistically different from the background concentration of that radionuclide in the vicinity of the site or, in the case of structures, in similar materials using adequate measurement technology, survey, and statistical techniques.

"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 regulations, "radiation dose" is an equivalent term.

"Dose commitment" means the total radiation dose to a part of the body that will result from retention in the body of radioactive material. For purposes of estimating the dose commitment, it is assumed that from the time of intake the period of exposure to retained material will not exceed 50 years.

"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 bounds of radiation doses established in accordance with these regulations. For purposes of these regulations, "limits" is an equivalent term.

"Dose monitor unit (DMU)" means a unit response from the beam monitoring system from which the absorbed dose can be calculated.

"Dose profile" means the dose as a function of position along a line.

"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.

"Doubly encapsulated sealed source" means a sealed source in which the radioactive material is sealed within an inner capsule and that capsule is sealed within an outer capsule.

"Drive cable" (See "Control cable").

"Effective dose equivalent (H_E)" means the sum of the products of the dose equivalent (H_T) to each organ or tissue and the weighting factor (w_T) applicable to each of the body organs or tissues that are irradiated (H_E = ? w_TH_T).

"Elemental area" means the smallest area within a tomogram for which the X-ray attenuation properties of a body are depicted. (See also "Picture element").

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

"Energy compensation source (ECS)" means a small sealed source, with an activity not exceeding 3.7 MBq (100 ?Ci), used within a logging tool, or other tool components, to provide a reference standard to maintain the tool's calibration when in use.

"Engineered barrier" means a manmade structure or device that is intended to improve the land disposal facility's ability to meet the performance objectives in these regulations.

"Enriched uranium" (See "Uranium – natural, depleted, enriched").

"Entrance exposure rate" means the exposure free in air per unit time at the point where the center of the useful beam enters the patient.

"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 or registered radioactive materials. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

"Equipment" (See "X-ray equipment").

"Exclusive use" means the sole use by a single consignor of a conveyance for which all initial, intermediate, and final loading and unloading are carried out in accordance with the direction of the consignor or consignee. The consignor and the carrier must ensure that any loading or unloading is performed by personnel having radiological training and resources appropriate for safe handling of the consignment. The consignor must issue specific instructions, in writing, for maintenance of exclusive use shipment controls, and include them with the shipping paper information provided to the carrier by the consignor.

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

"Exposure" means being exposed to ionizing radiation or to radioactive material.

"Exposure" means 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 SI unit of exposure is the coulomb per kilogram (C/kg). See 12VAC5-481-240 Units of Exposure and Dose for the special unit.

"Exposure head" means a device that locates the gamma radiography sealed source in the selected working position.

"Exposure rate" means the exposure per unit of time, such as roentgen per minute and milliroentgen per hour.

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

"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.

"Eye dose equivalent" means the external dose equivalent to the lens of the eye at a tissue depth of 0.3 centimeter (300 mg/cm²).

"Facility" means the location, building, vehicle, or complex under one administrative control, at which one or more radiation machines are installed, located and/or used.

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

"Field emission equipment" means equipment that uses an X-ray tube in which electron emission from the cathode is due solely to the action of an electric field.

"Field-flattening filter" means a filter used to homogenize the absorbed dose rate over the radiation field.

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

"Filter" means material placed in the useful beam to preferentially absorb selected radiations. It also means material placed in the useful beam to change beam quality in therapeutic radiation machines subject to Part XV (12VAC5-481-3380 et seq.) of this chapter.

"Filtering facepiece (dusk mask)" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

"Fissile material" means any special nuclear material consisting of or containing one or more fissile radionuclides. Fissile radionuclides are plutonium-238, plutonium-239, plutonium-241, uranium-233, and uranium-235. Neither natural nor depleted uranium is fissile material. Agency jurisdiction extends only to special nuclear material if quantities are not sufficient to form a critical mass as defined in Part I (12VAC5-481-10 et seq.) of this chapter the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. "Fissile material" means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium, that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in 10 CFR 71.15.

1. Fissile Class I: A package that may be transported in unlimited numbers and in any arrangement, and that requires no nuclear criticality safety controls during transportation. A transport index is not assigned for purposes of nuclear criticality safety but may be required because of external radiation levels.

2. Fissile Class II: A package that may be transported together with other packages in any arrangement but, for criticality control, in numbers that do not exceed an aggregate transport index of 50. These shipments require no other nuclear criticality safety control during transportation. Individual packages may have a transport index not less than 0.1 and not more than 10.

"Fissile material package" means a fissile material packaging together with its fissile material contents.

"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 a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

"Fluoroscopic imaging assembly" means a subsystem in which X-ray photons produce a visible image. It includes the image receptor(s) such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.

"Focal spot (actual)" means the area projected on the anode of the X-ray tube bombarded by the electrons accelerated from the cathode and from which the useful beam originates.

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

"Gantry" means that part of a radiation therapy system supporting and allowing movements of the radiation head about a center of rotation.

"Generally applicable environmental radiation standards" means standards issued by the Environmental Protection Agency 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.

"General environment" means, as used in Part XVI (12VAC5-481-3460 et seq.) of this chapter, the total terrestrial, atmospheric, and aquatic environments outside the site boundary within which any activity, operation, or process authorized by a general or specific license issued under Part XVI, is performed.

"General purpose radiographic X-ray system" means any radiographic X-ray system which, by design, is not limited to radiographic examination of specific anatomical regions.

"Gonad shield" means a protective barrier for the testes or ovaries.

"Gray (Gy)" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (100 rad).

"Guide tube (protection sheath)" means a flexible or rigid tube, or "J" tube, for guiding the source assembly and the attached control cable from the exposure device to the exposure head. The guide tube may also include the connections necessary for attachment to the exposure device and to the exposure head.

"Half-value layer (HVL)" means the thickness of a specified material that attenuates X-radiation or gamma radiation to an extent such that the air kerma rate, exposure rate or absorbed dose rate is reduced to one-half of the value measured without the material at the same point.

"Hands-on experience" means experience in all of those areas considered to be directly involved in the radiography process, and includes taking radiographs, calibration of survey instruments, operational and performance testing of survey instruments and devices, film development, posting of radiation areas, transportation of radiography equipment, posting of records and radiation area surveillance, etc., as applicable. Excessive time spent in only one or two of these areas, such as film development or radiation area surveillance, should not be counted toward the 2,000 hours of hands-on experience required for a radiation safety officer in 12VAC5-481-1310 A 2 or the hands-on experience for a radiographer as required by 12VAC5-481-1320 A.

"Hazardous waste" means those wastes designated as hazardous by the Environmental Protection Agency regulations in 40 CFR Part 261.

"Healing arts" means the art or science or group of arts or sciences dealing with the prevention and cure or alleviation of ailments, diseases or infirmities, and has the same meaning as "medicine" when the latter term is used in its comprehensive sense.

"Healing arts screening" means the testing of human beings using X-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such X-ray tests for the purpose of diagnosis or treatment.

"Heat unit" means a unit of energy equal to the product of the peak kilovoltage, milliamperes, and seconds, such as (kVp) times (mA) times (seconds).

"Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

"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 one mSv (0.1 rem) in one hour at 30 centimeters from any source of radiation or 30 centimeters from any surface that the radiation penetrates.

"Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

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

"HVL" (See "Half-value layer").

"Hydrogeologic unit" means any soil or rock unit or zone which by virtue of its porosity or permeability, or lack thereof, has a distinct influence on the storage or movement of groundwater.

"Image intensifier" means a device, installed in its housing, that instantaneously converts an X-ray pattern into a corresponding light image of higher intensity.

"Image receptor" means any device, such as a fluorescent screen or radiographic film, that transforms incident X-ray photons either into a visible image or into another form that can be made into a visible image by further transformations.

"Image receptor support" means, for mammographic systems, that part of the system designed to support the image receptor during mammography.

"Inadvertent intruder" means a person who might occupy the disposal site after closure and engage in normal activities, such as agriculture, dwelling construction, or other pursuits in which an individual might be unknowingly exposed to radiation from the waste.

"Independent certifying organization" means an independent organization that meets the agency's criteria for documenting applicant's training in topics set forth in 12VAC5-481-1320 or equivalent agreement state or Nuclear Regulatory Commission NRC regulations.

"Individual" means any human being.

"Individual monitoring" means the assessment of:

1. Dose equivalent (i) by the use of individual monitoring devices or (ii) by the use of survey data; or

2. Committed effective dose equivalent (i) by bioassay or (ii) by determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours. (See the definition of DAC)

"Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of these regulations, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescent dosimeters (TLDs), pocket ionization chambers, optically stimulated luminescence (OSL) dosimeters and personal air sampling devices.

"Industrial radiography" means an examination of the structure of materials by the nondestructive method of utilizing ionizing radiation to make radiographic images.

"Inhalation class" (See "Class").

"Inherent filtration" means the filtration of the useful beam provided by the permanently installed components of the tube housing assembly.

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

"Inspection" means an official examination or observation including, but not limited to, tests, surveys, and monitoring to determine compliance with rules, regulations, orders, requirements, and conditions of the agency.

"Institutional controls" means: (i) permanent markers placed at a disposal site, (ii) public records and archives, (iii) government ownership and regulations regarding land or resource use, and (iv) other methods of preserving knowledge about the location, design, and contents of a disposal system.

"Instrument traceability" (for ionizing radiation measurements) means the ability to show that an instrument has been calibrated at specified time intervals using a national standard or a transfer standard. If a transfer standard is used, the calibration must be at a laboratory accredited by a program that requires continuing participation in measurement quality assurance with the National Institute of Standards and Technology or other equivalent national or international program.

"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.

"Interruption of irradiation" means the stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.

"Intruder barrier" means a sufficient depth of cover over the waste that inhibits contact with waste and helps to ensure that radiation exposures to an inadvertent intruder will meet the performance objectives set forth in these regulations, or engineered structures that provide equivalent protection to the inadvertent intruder.

"Irradiation" means the exposure of matter to ionizing radiation.

"Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (500 rads) per hour exist at one meter from the sealed radioactive sources in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

"Irradiator operator" means an individual who has successfully completed the training and testing described in 12VAC5-481-2830 and is authorized by the terms of the license to operate the irradiator without a supervisor present.

"Irradiator operator supervisor" means an individual who meets the requirements for an irradiator operator and who physically oversees operation of the irradiator by an individual who is currently receiving training and testing described in 12VAC5-481-2830.

"Isocenter" means the center of the sphere through which the useful beam axis passes while the gantry moves through its full range of motions.

"kBq" means kilabecquerels.

"Kilovolt (kV) (kilo electron volt (keV))" means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of 1,000 volts in a vacuum. Current convention is to use kV for photons and keV for electrons.

"Kilovolts peak" (See "Peak tube potential").

"kV" means kilovolts.

"kVp" (See "Peak tube potential").

"kWs" means kilowatt second.

"Land disposal facility" means the land, buildings, structures and equipment that is intended to be used for the disposal of wastes into the subsurface of the land. For purposes of this chapter, a "geologic repository" as defined in 10 CFR Part 60 or 10 CFR Part 63 is not considered a land disposal facility.

"Lay-barge radiography" means industrial radiography performed on any water vessel used for laying pipe.

"Lead equivalent" means the thickness of the material in question affording the same attenuation, under specified conditions, as lead.

"Leakage radiation" means radiation emanating from the diagnostic source assembly except for:

1. The useful beam; and

2. Radiation produced when the exposure switch or timer is not activated.

"Leakage technique factors" means the technique factors associated with the diagnostic source assembly that are used in measuring leakage radiation. They are defined as follows:

1. For diagnostic source assemblies intended for capacitor energy storage equipment, the maximum-rated peak tube potential and the maximum-rated number of exposures in an hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being 10 millicoulombs, i.e., 10 milliampere seconds, or the minimum obtainable from the unit, whichever is larger;

2. For diagnostic source assemblies intended for field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum-rated number of X-ray pulses in an hour for operation at the maximum-rated peak tube potential;

3. For all other diagnostic source assemblies, the maximum-rated peak tube potential and the maximum-rated continuous tube current for the maximum-rated peak tube potential.

"Lens dose equivalent (LDE)" applies to the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 cm (300 mg/cm²).

"License" means a license issued by the agency in accordance with the regulations adopted by the agency board.

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

"Licensee" means any person who is licensed by the agency in accordance with these regulations and the Act.

"Licensing state" means any state that has been finally designated as such by the Conference of Radiation Control Program Directors, Inc., that reviews state regulations to establish equivalency with the Suggested State Regulations and ascertains whether a state has an effective program for control of natural occurring or accelerator produced radioactive material (NARM). The conference will designate as licensing states those states with regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM.

"Light field" means that area of the intersection of the light beam from the beam-limiting device and one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the illumination is one-fourth of the maximum in the intersection.

"Limits" (See "Dose limits").

"Line-voltage regulation" means the difference between the no-load and the load line potentials expressed as a percentage of the load line potential. It is calculated using the following equation:

Percent line-voltage regulation = 100 (V_n-V_l)/V_l

where:

V_n = No-load line potential; and

V_l = Load line potential.

"Lixiscope" means a portable light-intensified imaging device using a sealed source.

"Local components" mean part of an analytical X-ray system and include areas that are struck by X-rays such as radiation source housings, port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors, and shielding, but do not include power supplies, transformers, amplifiers, readout devices, and control panels.

"Logging assistant" means any individual who, under the personal supervision of a logging supervisor, handles sealed sources or tracers that are not in logging tools or shipping containers or who performs surveys required by Part XIV (12VAC5-481-3140 et seq.) of this chapter.

"Logging supervisor" means the individual who uses sources of radiation or 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.

"Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

"Lost or missing source of radiation licensed material" means licensed (or registered) source of radiation whose location is unknown. This definition includes, but is not limited to, radioactive material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.

"Lot tolerance percent defective" means, expressed in percent defective, the poorest quality in an individual inspection lot that should be accepted.

"Low specific activity (LSA) material" means radioactive material with limited specific activity that is nonfissile or is excepted under 12VAC5-481-2970 C, and that satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA material must be in one of three groups:

1. LSA-I

a. Ores containing only naturally occurring radionuclides (for example, uranium or thorium decay series radionuclides) and uranium or thorium concentrates of such ores Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclide that are not intended to be processed for the use of these radionuclides; or

b. Solid unirradiated natural uranium or depleted uranium or natural thorium or their solid or liquid compounds or mixtures; or

c. Radioactive material, other than fissile material, for which the A₂ value is unlimited; or

d. Mill tailings, contaminated earth, concrete, rubble, other bulk debris, and activated material in which the radioactive material is essentially uniformly distributed, and the average specific activity does not exceed 1.0 E-06 A₂/g Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed 30 times the value for exempt material activity concentration determined in accordance with 12VAC5-481-3720.

2. LSA-II

a. Water with tritium concentration up to 0.8 terabecquerel per liter (20.0 Ci/L); or

b. Material Other material in which the radioactive material activity is distributed throughout, and the average specific activity does not exceed 1.0 E-04 A₂/g for solids and gases, and 1.0 E-05 A₂/g for liquids.

3. LSA-III

Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 CFR 71.77) in which:

a. The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (for example: concrete, bitumen, or ceramic); and

b. The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that, even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed 0.1 A₂; and

c. The estimated average specific activity of the solid does not exceed 2.0 E-03 A₂/g.

"Low toxicity alpha emitters" means natural uranium, depleted uranium, natural thorium; uranium-235, uranium-238, thorium-232, thorium-228 or thorium-230 when contained in ores or physical or chemical concentrates or tailings; or alpha emitters with a half-life of less than 10 days.

"Lung class" (See "Class").

"mA" means milliampere.

"mAs" means milliampere second.

"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 this section.

"Maximum line current" means the root-mean-square current in the supply line of an X-ray machine operating at its maximum rating.

"Management" means the chief executive officer or that individual's designee.

"MBq" means megabecquerels.

"Medical event" means an event that meets the criteria in 12VAC5-481-2080.

"Medical institution" means an organization in which several medical disciplines are practiced.

"Medical use" means the intentional internal or external administration of radioactive material or the radiation from radioactive material to patients or human research subjects under the supervision of an authorized user.

"Megavolt (MV) (mega electron volt (MeV))" means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one million volts in a vacuum. (Note: current convention is to use MV for photons and MeV for electrons.)

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

"Medical use" means the intentional internal or external administration of radioactive material, or the radiation therefrom, to humans in the practice of the healing arts.

"Mineral logging" means any logging performed for the purpose of mineral exploration other than oil or gas.

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

"Misadministration" means the administration of:

1. A radiopharmaceutical dosage greater than 1.11 megabecquerels (30 mCi) of either sodium iodide I-125 or I-131:

a. Involving the wrong patient or wrong radiopharmaceutical; or

b. When both the administered dosage differs from the prescribed dosage by more than 20% of the prescribed dosage and the difference between the administered dosage and prescribed dosage exceeds 1.11 megabecquerels (30 mCi);

2. A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-131:

a. Involving the wrong patient, wrong radiopharmaceutical, or wrong route of administration; or

b. When the administered dosage differs from the prescribed dosage by more than 20% of the prescribed dosage;

3. A gamma stereotactic radiosurgery radiation dose:

a. Involving the wrong patient or wrong treatment site; or

b. When the calculated total administered dose differs from the total prescribed dose by more than 10% of the total prescribed dose;

4. A teletherapy radiation dose:

a. Involving the wrong patient, wrong mode of treatment, or wrong treatment site; or

b. When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than 10% of the total prescribed dose; or

c. When the calculated weekly administered dose exceeds the weekly prescribed dose by 30% or more of the weekly prescribed dose; or

d. When the calculated total administered dose differs from the total prescribed dose by more than 20% of the total prescribed dose;

5. A brachytherapy radiation dose:

a. Involving the wrong patient, wrong radionuclide, or wrong treatment site (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site); or

b. Involving a sealed source that is leaking; or

c. When, for a temporary implant, one or more sealed sources are not removed upon completion of the procedure; or

d. When the calculated administered dose differs from the prescribed dose by more than 20% of the prescribed dose;

6. A diagnostic radiopharmaceutical dosage, other than quantities greater than 1.11 megabecquerels (30 mCi) of either sodium iodide I-125 or I-131, both:

a. Involving the wrong patient, wrong radiopharmaceutical, wrong route of administration, or when the administered dosage differs from the prescribed dosage; and

b. When the dose to the patient exceeds 50 millisieverts (5 rem) effective dose equivalent or 500 millisieverts (50 rem) dose equivalent to any individual organ.

"Mobile nuclear medicine service" means the transportation and medical use of radioactive material.

"Mobile X-ray equipment" (See "X-ray equipment").

"Monitor unit (MU)" (See "Dose monitor unit").

"Monitoring" means the measurement of radiation, radioactive 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 regulations, "radiation monitoring" and "radiation protection monitoring" are equivalent terms. For Part XI (12VAC5-481-2330 et seq.) of this chapter, it means observing and making measurements to provide data to evaluate the performance and characteristics of the disposal site.

"Moving beam radiation therapy" means radiation therapy with any planned displacement of radiation field or patient relative to each other, or with any planned change of absorbed dose distribution. It includes arc, skip, conformal, intensity modulation and rotational therapy.

"Multiple tomogram system" means a computed tomography X-ray system that obtains X-ray transmission data simultaneously during a single scan to produce more than one tomogram.

"NARM" means any naturally occurring or accelerator-produced radioactive material. It does not include byproduct, source, or special nuclear material.

"Nationally tracked source" means a sealed source containing a quantity equal to or greater than Category 1 or Category 2 levels of any radioactive material listed in 12VAC5-481-3780. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and that is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 1 threshold. Category 2 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold.

"Natural radioactivity" means radioactivity of naturally occurring nuclides.

"Natural thorium" means thorium isotopes with a the naturally occurring distribution of thorium isotopes, which is essentially 100 weight percent thorium-232.

"Natural uranium" (See "Uranium – natural, depleted, enriched").

"Near-surface disposal facility" means a land disposal facility in which waste is disposed of within approximately the upper 30 meters of the earth's surface.

"Negative pressure respirator (tight fitting)" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

"Noise" means the standard deviation of the fluctuations in CTN expressed as a percentage of the attenuation coefficient of water. Its estimate (S_n) is calculated using the following expression:

where:

 = Linear attenuation coefficient of the material of interest.

 = Linear attenuation coefficient of water.

 = Standard deviation of the CTN of picture elements in a specified area of the CT image.

"Nominal tomographic section thickness" means the full width at half-maximum of the sensitivity profile taken at the center of the cross-sectional volume over which X-ray transmission data are collected.

"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 regulations, "deterministic effect" is an equivalent term.

"NORM" means any naturally occurring radioactive material. It does not include accelerator produced, byproduct, source, or special nuclear material.

"Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

"Normal operating procedures" mean step-by-step instructions necessary to accomplish the analysis. These procedures shall include sample insertion and manipulation, equipment alignment, routine maintenance by the registrant (or licensee), and data recording procedures, which are related to radiation safety.

"Nominal treatment distance" means:

1. For electron irradiation, the distance from the scattering foil, virtual source, or exit window of the electron beam to the entrance surface of the irradiated object along the central axis of the useful beam.

2. For X-ray irradiation, the virtual source or target to isocenter distance along the central axis of the useful beam. For nonisocentric equipment, this distance shall be that specified by the manufacturer.

"Nuclear Regulatory Commission (NRC)" means the Nuclear Regulatory Commission NRC or its duly authorized representatives.

"Nuclear waste" means a quantity of source, byproduct or special nuclear material (the definition of nuclear waste in this part is used in the same way as in 49 CFR 173.403) required to be in United States Nuclear Regulatory Commission-approved NRC-approved specification packaging while transported to, through or across a state boundary to a disposal site, or to a collection point for transport to a disposal site.

"Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties for the licensee or registrant involve exposure to sources of radiation, whether or not the sources of radiation are in the possession of the licensee, registrant, or other person. Occupational dose does not include doses received: from background radiation, or from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with 12VAC5-481-1870, or from voluntary participation in medical research programs, or as a member of the public.

"Offshore platform radiography" means industrial radiography conducted from a platform over a body of water.

"Offshore waters" means that area of land and water, beyond the Commonwealth of Virginia's jurisdiction, on or above the U.S. Outer Continental Shelf.

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

"Output" means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions.

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

1. Fissile material package or Type AF package, Type BF package, Type B(U)F package, or Type B(M)F package means a fissile material packaging together with its fissile material contents.

2. Type A package means a Type A packaging together with its radioactive contents. A Type A package is defined and must comply with the DOT regulations in 49 CFR Part 173.

3. Type B package means a Type B packaging together with its radioactive contents. On approval, a Type B package design is designated by NRC as B(U) unless the package has a maximum normal operating pressure of more than 700 kPa (100 lbs/in²) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 CFR 71.73 (hypothetical accident conditions), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see DOT regulations in 49 CFR Part 173. A Type B package approved before September 6, 1983, was designated only as Type B. Limitations on its use are specified in 10 CFR 71.19.

"Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of these regulations. It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system, and auxiliary equipment may be designated as part of the packaging.

"Panoramic dry-source-storage irradiator" means an irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored in shields made of solid materials. The term includes beam-type dry-source-storage irradiators in which only a narrow beam of radiation is produced for performing irradiations.

"Panoramic irradiator" means an irradiator in which the irradiations are done in air in areas potentially accessible to personnel. The term includes beam-type irradiators.

"Panoramic wet-source-storage irradiator" means an irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored under water in a storage pool.

"Particle accelerator" (See "Accelerator").

"Patient" means an individual or animal subjected to healing arts examination, diagnosis, or treatment.

"PBL" (See "Positive beam limitation").

"Peak tube potential" means the maximum value of the potential difference across the X-ray tube during an exposure.

"Periodic quality assurance check" means a procedure that is performed to ensure that a previous calibration continues to be valid.

"Permanent radiographic installation" means an enclosed shielded room, cell, or vault, not located at a temporary jobsite, in which radiography is performed.

"Person" means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency department of the Commonwealth other than the Department of Health, political subdivision of this state the Commonwealth, any other state or political subdivision or agency department thereof, and any legal successor, representative, agent, or agency department of the foregoing, (but shall not include including federal government agencies).

"Personal monitoring equipment" (See "Individual monitoring devices").

"Personal supervision" means guidance and instruction by the supervisor who is physically present at the jobsite and watching the performance of the operation in such proximity that contact can be maintained and immediate assistance given as required. In radiography it means guidance and instruction provided to a radiographer trainee by a radiographer instructor who is present at the site, in visual contact with the trainee while the trainee is using sources of radiation, and in such proximity that immediate assistance can be given if required.

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

"Phantom" means a volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation. This requires that both the atomic number (Z) and the density of the material be similar to that of tissue.

"Pool irradiator" means any irradiator at which the sources are stored or used in a pool of water including panoramic wet-source-storage irradiators and underwater irradiators.

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

"Physician" means an individual licensed by this state to dispense prescribe drugs in the practice of medicine.

"Picture element" means an elemental area of a tomogram.

"PID" (See "Position indicating device").

"Pigtail" (See "Source assembly").

"Pill" (See "Sealed source").

"Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual occupational dose limits.

"Portable X-ray equipment" (See "X-ray equipment").

"Position indicating device" means a device on dental X-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.

"Positive beam limitation" means the automatic or semi-automatic adjustment of an X-ray beam to the size of the selected image receptor, whereby exposures cannot be made without such adjustment.

"Primary beam" means radiation that 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.

"Primary dose monitoring system" means a system that will monitor the useful beam during irradiation and that will terminate irradiation when a preselected number of dose monitor units have been delivered.

"Primary protective barrier" (See "Protective barrier").

"Positive emission tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

"Positive pressure respirator" means a respirator 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.

"Practical examination" means a demonstration through application of the safety rules and principles in industrial radiography including use of all procedures and equipment to be used by radiographic personnel.

"Practical range of electrons" corresponds to classical electron range where the only remaining contribution to dose is from bremsstrahlung X-rays. A further explanation may be found in "Clinical Electron Beam Dosimetry: Report of AAPM Radiation Therapy Committee Task Group 25" (Medical Physics 18(1): 73-109, Jan/Feb. 1991) and ICRU Report 35, "Radiation Dosimetry: Electron Beams with Energies Between 1 and 50 MeV", International Commission on Radiation Units and Measurements, September 15, 1984.

"Preceptor" means an individual who provides, directs, or verifies training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, or a radiation safety officer.

"Prescribed dosage" means the quantity of radiopharmaceutical activity as documented:

1. In a written directive; or

2. Either in the diagnostic clinical procedures manual or in any appropriate record in accordance with the directions of the authorized user for diagnostic procedures.

"Prescribed dose" means:

1. For gamma stereotactic radiosurgery, the total dose as documented in the written directive; or

2. For teletherapy, the total dose and dose per fraction as documented in the written directive; or

3. For brachytherapy, either the total source strength and exposure time, or the total dose, as documented in the written directive.

"Pressure demand respirator" means a positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

"Primary beam" means radiation that 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.

"Primary dose monitoring system" means a system that will monitor the useful beam during irradiation and that will terminate irradiation when a preselected number of dose monitor units have been delivered.

"Primary protective barrier" (See "Protective barrier").

"Principal activities," as used in this chapter, means activities authorized by the license that are essential to achieving the purpose(s) for which the license was issued or amended. Storage during which no licensed material is accessed for use or disposal and activities incidental to decontamination or decommissioning are not principal activities.

"Private inspector" means an individual who meets the requirements set forth in 12VAC5-481-340 and who has demonstrated to the satisfaction of the agency that such individual possesses the knowledge, training and experience to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs.

"Product" means, as used in Part XVI (12VAC5-481-3460 et seq.) of this chapter, something produced, made, manufactured, refined, or benefited.

"Product conveyor system" means a system for moving the product to be irradiated to, from, and within the area where irradiation takes place.

"Projection sheath" (See "Guide tube").

"Projector" (See "Radiographic exposure device").

"Protective apron" means an apron made of radiation-attenuating or absorbing materials used to reduce exposure to radiation.

"Protective barrier" means a barrier of radiation absorbing material(s) used to reduce radiation exposure. The types of protective barriers are as follows:

1. "Primary protective barrier" means the material, excluding filters, placed in the useful beam;

2. "Secondary protective barrier" means the material that attenuates stray radiation.

"Protective glove" means a glove made of radiation absorbing materials used to reduce radiation exposure.

"Public dose" means the dose received by a member of the public from exposure to sources of radiation released by the licensee or registrant, or to any other source of radiation under the control of the licensee or registrant. Public dose does not include occupational dose, or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with 12VAC5-481-1870, or from voluntary participation in medical research programs.

"Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 130°F (54.4°C) or 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 that can be ignited readily and, when ignited, burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

"Qualitative fit test (QLFT)" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

"Quality factor" (Q) means the modifying factor, that is referenced in 12VAC5-481-240, that is used to derive dose equivalent from absorbed dose.

"Quantitative fit test (QNFT)" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

"Quarter" means a period of time equal to one-fourth of the year observed by the licensee, approximately 13 consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

"Rad" means the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram (0.01 gray).

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

"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 regulations, ionizing radiation is an equivalent term. Radiation, as used in these regulations, does not include nonionizing radiation, such as radiowaves or microwaves, visible, infrared, or ultraviolet light.

"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 detector" means a device which in the presence of radiation provides a signal or other indication suitable for use in measuring one or more quantities of incident radiation.

"Radiation dose" (See "Dose").

"Radiation field" (See "Useful beam").

"Radiation head" means the structure from which the useful beam emerges.

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

"Radiation room" means a shielded room in which irradiations take place. Underwater irradiators do not have radiation rooms.

"Radiation safety officer (RSO)" means an individual who has the knowledge and responsibility to apply appropriate radiation protection regulations and has been assigned such responsibility by the licensee or registrant.

"Radiation safety officer for industrial radiography" means an individual with the responsibility for the overall radiation safety program on behalf of the licensee or registrant and who meets the requirements of 12VAC5-481-1310.

"Radiation safety officer for medical" means an individual who meets the requirements of 12VAC5-481-1750 and 12VAC5-481-1790 and is identified as an RSO on: a medical use license issued by the agency, NRC or another agreement state, or a medical use permit issued by an NRC masters material licensee.

"Radiation therapy physicist" means an individual qualified in accordance with 12VAC5-481-340.

"Radiation therapy simulation system" means a radiographic or fluoroscopic X-ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.

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

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

"Radioactivity" means the transformation of unstable atomic nuclei by the emission of radiation.

"Radiobioassay" (See "Bioassay").

"Radiograph" means an image receptor on which the image is created directly or indirectly by an X-ray pattern and results in a permanent record.

"Radiographer" means any individual who performs or who, in attendance at the site where the sources of radiation are being used, personally supervises industrial radiographic operations and who is responsible to the licensee or registrant for assuring compliance with the requirements of the agency's regulations and the conditions of the license or registration.

"Radiographer certification" means written approval received from a certifying entity stating that an individual has satisfactorily met the radiation safety, testing, and experience criteria in 12VAC5-481-1320.

"Radiographer instructor" means any radiographer who has been authorized by the agency to provide on-the-job training to radiographer trainees in accordance with Part V (12VAC5-481-1170 et seq.) of this chapter.

"Radiographer trainee" means any individual who, under the personal supervision of a radiographer instructor, uses sources of radiation, related handling tools, or radiation survey instruments during the course of his instruction.

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

"Radiographic exposure device" means any instrument containing a sealed source fastened or contained therein, in which the sealed source or shielding thereof may be moved, or otherwise changed, from a shielded to unshielded position for purposes of making a radiographic exposure.

"Radiographic imaging system" means any system whereby a permanent or semi-permanent image is recorded on an image receptor by the action of ionizing radiation.

"Radiographer instructor" means any radiographer who has been authorized by the agency to provide on-the-job training to radiographer trainees in accordance with Part V (12VAC5-481-1170 et seq.) of this chapter.

"Radiographic operations" means all activities performed with a radiographic exposure device, or with a radiation machine. Activities include using, transporting except by common or contract carriers, or storing at a temporary job site, performing surveys to confirm the adequacy of boundaries, setting up equipment, and any activity inside restricted area boundaries. Transporting a radiation machine is not considered a radiographic operation.

"Radiographer trainee" means any individual who, under the personal supervision of a radiographer instructor, uses sources of radiation, related handling tools, or radiation survey instruments during the course of his instruction.

"Radiographic exposure device" means any instrument containing a sealed source fastened or contained therein, in which the sealed source or shielding thereof may be moved, or otherwise changed, from a shielded to unshielded position for purposes of making a radiographic exposure.

"Radiographic personnel" means any radiographer, radiographer instructor, or radiographer trainee.

"Radiography" (See "Industrial radiography").

"Rating" means the operating limits as specified by the component manufacturer.

"Reasonably maximally exposed individual" means, as used in Part XVI (12VAC5-481-3460 et seq.) of this chapter, a representative of a population who is exposed to TENORM at the maximum TENORM concentration measured in environmental media found at a site along with reasonable maximum case exposure assumptions. The exposure is determined by using maximum values for one or more of the most sensitive parameters affecting exposure, based on cautious but reasonable assumptions, while leaving the others at their mean value.

"Recordable event" means the administration of:

1. A radiopharmaceutical or radiation without a written directive where a written directive is required;

2. A radiopharmaceutical or radiation where a written directive is required without daily recording of each administered radiopharmaceutical dosage or radiation dose in the appropriate record;

3. A radiopharmaceutical dosage greater than 1.11 megabecquerels (30 mCi) of sodium iodide I-125 or I-131 when both the administered dosage differs from the prescribed dosage by more than 10% of the prescribed dosage, and the difference between the administered dosage and the prescribed dosage exceeds 555 kilobecquerels (15 mCi);

4. A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-131, when the administered dosage differs from the prescribed dosage by more than 10% of the prescribed dosage;

5. A teletherapy radiation dose when the calculated weekly administered dose exceeds the weekly prescribed dose by 15% or more of the weekly prescribed dose; or

6. A brachytherapy radiation dose when the calculated administered dose differs from the prescribed dose by more than 10% of the prescribed dose.

"Recording" means producing a permanent form of an image resulting from X-ray photons.

"Redundant beam monitoring system" means a combination of two dose monitoring systems in which each system is designed to terminate irradiation in accordance with a preselected number of dose monitor units.

"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 employees to standardize results of experiments and to relate biological insult to a common base. A description of the reference man is contained in the International Commission on Radiological Protection report, ICRP Publication 23, "Report of the Task Group on Reference Man."

"Reference plane" means a plane that is displaced from and parallel to the tomographic plane.

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

"Registration" means registration with the agency in accordance with the regulations adopted by the agency.

"Regulations of the United States Department of Transportation" means the regulations in 49 CFR Parts 100-189.

"Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem rems is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 Sv).

"Research and development" means (i) theoretical analysis, exploration, or experimentation; or (ii) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstrative 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 mater material to human beings.

"Residential location" means any area where structures in which people lodge or live are located, and the grounds on which such structures are located including, but not limited to, houses, apartments, condominiums, and garages.

"Residual radioactive material" means (i) waste (that the Secretary of Energy determines to be radioactive) in the form of tailings resulting from the processing of ores for the extraction of uranium and other valuable constituents of the ores and (ii) other waste (that the Secretary of Energy determines to be radioactive) at a processing site that relates to such processing, including any residual stock of unprocessed ores or low-grade materials. This term is used only with respect to materials at sites subject to remediation under Title I of the Uranium Mill Tailings Radiation Control Act of 1978, as amended.

"Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the 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 remaining at the site as a result of routine or accidental releases of radioactive materials at the site and previous burials at the site, even if those burials were made in accordance with the provisions of Part IV (12VAC5-481-600 et seq.) of this chapter.

"Respiratory protective equipment device" means an apparatus, such as a respirator, used to reduce an individual's intake of airborne radioactive materials.

"Restricted area" means an area, access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation and radioactive materials. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

"Roentgen" means the special unit of exposure. One roentgen (R) equals 2.58E-4 coulombs per kilogram of air (see "Exposure" and 12VAC5-481-240).

"S-tube" means a tube through which the radioactive source travels when inside a radiographic exposure device.

"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.

"Scan" means the complete process of collecting X-ray transmission data for the production of a tomogram. Data can be collected simultaneously during a single scan for the production of one or more tomograms.

"Scan increment" means the amount of relative displacement of the patient with respect to the CT X-ray system between successive scans measured along the direction of such displacement.

"Scan sequence" means a preselected set of two or more scans performed consecutively under preselected CT conditions of operation.

"Scan time" means the period of time between the beginning and end of X-ray transmission data accumulation for a single scan.

"Scattered radiation" means ionizing radiation emitted by interaction of ionizing radiation with matter, the interaction being accompanied by a change in direction of the radiation. Scattered primary radiation means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam.

"Sealed source" means any container of radioactive material that has been constructed in such a manner as radioactive material that is encased in a capsule designed to prevent the leakage or escape of any radioactive material.

"Sealed Source and Device Registry (SSD)" means the national registry that contains the registration certificates, maintained by the Nuclear Regulatory Commission (NRC) NRC, that summarize the radiation safety information for sealed sources and devices, and describes the licensing and use conditions approved for the product.

"Secondary dose monitoring system" means a system which will terminate irradiation in the event of failure of the primary dose monitoring system.

"Secondary protective barrier" (See "Protective barrier").

"Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in 250 years is greater than 10%, as designated by the United States Geological Survey.

"Self-contained breathing apparatus (SCBA)" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

"Shadow tray" means a device attached to the radiation head to support auxiliary beam blocking material.

"Shallow dose equivalent (H_s)," which applies to the external exposure of the skin or an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2) averaged over an area of one square centimeter.

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

"Shielded-room radiography" means industrial radiography conducted in a room shielded so that radiation levels at every location on the exterior meet the limitations specified in 12VAC5-481-640.

"Shutter" means a device attached to the tube housing assembly which can intercept the entire cross sectional area of the useful beam and which has a lead equivalency not less than that of the tube housing assembly.

"SI" means the abbreviation for the International System of Units.

"SID" (See "Source-image receptor distance").

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

"Simulator (radiation therapy simulation system)" means any X-ray system intended for localizing the volume to be exposed during radiation therapy and reproducing the position and size of the therapeutic irradiation field.

"Single tomogram system" means a CT X-ray system that obtains X-ray transmission data during a scan to produce a single tomogram.

"Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by offsite response organizations to protect persons offsite.

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

"Site closure and stabilization" means those actions that are taken upon completion of operations that prepare the disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

"Source" means the focal spot of the X-ray tube.

"Source assembly" means an assembly that consists of the sealed source and a connector that attaches the source to the control cable. The source assembly may include a ballstop to secure the source in the shielded position.

"Source changer" means a device designed and used for replacement of sealed sources in radiographic exposure devices, including those source changers 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-image receptor distance" means the distance from the source to the center of the input surface of the image receptor.

"Source material" means:

1. Uranium or thorium, or any combination thereof, in any physical or chemical form; or

2. Ores that contain by weight one-twentieth of 1.0% (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 definition (2) of "byproduct material."

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

"Source-skin distance (SSD)" (see "Target-skin distance") means the distance between the source and the skin entrance plane of the patient.

"Source traceability" means the ability to show that a radioactive source has been calibrated either by the national standards laboratory of the National Institute of Standards and Technology, or by a laboratory that participates in a continuing measurement quality assurance program with National Institute of Standards and Technology or other equivalent national or international program.

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

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

2. The piece or capsule has at least one dimension not less than five millimeters (0.2 in.); and

3. It satisfies the test requirements specified by the Nuclear Regulatory Commission NRC. A special form encapsulation designed in accordance with the Nuclear Regulatory Commission NRC requirements in effect on June 30, 1983, and constructed prior to July 1, 1985, may continue to be used. A special form encapsulation either designed or constructed after April 1, 1998, must meet requirements of this definition applicable at the time of its design or construction.

"Special nuclear material" means:

1. Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material the Nuclear Regulatory Commission NRC, pursuant to the provisions of section 51 of the Atomic Energy Act of 1954, as amended, determines to be special nuclear material, but does not include source material; or

2. Any material artificially enriched by any of the foregoing but does not include source material.

"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:

"Specific activity" of a radionuclide means the radioactivity of a radionuclide per unit mass of that nuclide. The specific activity of a material in which the radionuclide is essentially uniformly distributed is the radioactivity per unit mass of the material.

"Spot film" means a radiograph that is made during a fluoroscopic examination to permanently record conditions that exist during that fluoroscopic procedure.

"Spot-film device" means a device intended to transport and/or position a radiographic image receptor between the X-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette over the input end of an image intensifier for the purpose of making a radiograph.

"SSD" means the distance between the source and the skin entrance plane of the patient.

"Stability" means structural stability.

"State inspector" means an employee of the Virginia Department of Health designated to perform those duties or functions assigned the Radiological Health Program.

"Stationary beam radiation therapy" means radiation therapy without displacement of one or more mechanical axes relative to the patient during irradiation.

"Stationary X-ray equipment" (See "X-ray equipment").

"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 threshold. Hereditary effects and cancer incidence are examples of stochastic effects. For purposes of these regulations, "probabilistic effect" is an equivalent term.

"Storage" means a condition in which a device or source is not being used for an extended period of time, and has been made inoperable.

"Storage area" means any location, facility, or vehicle that is used to store and secure a radiographic exposure device, a radiation machine, or a storage container when it is not used for radiographic operations. Storage areas are locked or have a physical barrier to prevent accidental exposure, tampering, or unauthorized removal of the device, machine, or container.

"Storage container" means a device in which sealed sources or radiation machines are secured and stored.

"Stray radiation" means the sum of leakage and scattered radiation.

"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.

"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.

"Surface contaminated object" (SCO) means a solid object that is not itself classed as radioactive material, but that has radioactive material distributed on any of its surfaces. An SCO must be in one of two groups with surface activity not exceeding the following limits:

1. SCO-I: A solid object on which:

a. The nonfixed contamination on the accessible surface averaged over 300 cm², or the area of the surface if less than 300 cm², does not exceed four becquerel per cm² (1 E-04 ?Ci/cm²) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerel per cm² (1 E-05 ?Ci/cm²) for all other alpha emitters;

b. The fixed contamination on the accessible surface averaged over 300 cm², or the area of the surface if less than 300 cm², does not exceed 4 E+04 becquerel per cm² (1.0 ?Ci/cm²) for beta and gamma and low toxicity alpha emitters, or 4 E+03 becquerel per cm² (0.1 ?Ci/cm²) for all other alpha emitters; and

c. The nonfixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm², or the area of the surface if less than 300 cm², does not exceed 4 E+04 becquerel per cm² (1 ?Ci/cm²) for beta and gamma and low toxicity alpha emitters, or 4 E+03 Becquerel per cm² (0.1 ?Ci/cm²) for all other alpha emitters.

2. SCO-II: A solid object on which the limits for SCO-I are exceeded and on which:

a. The nonfixed contamination on the accessible surface averaged over 300 cm², or the area of the surface if less than 300 cm², does not exceed 400 becquerel per cm² (1 E-02 ?Ci/cm²) for beta and gamma and low toxicity alpha emitters or 40 becquerel per cm² (1 E-03 ?Ci/cm²) for all other alpha emitters;

b. The fixed contamination on the accessible surface averaged over 300 cm², or the area of the surface if less than 300 cm², does not exceed 8 E+05 becquerel per cm² (20 ?Ci/cm²) for beta and gamma and low toxicity alpha emitters, or 8 E+04 becquerel per cm² (2 ?Ci/cm²) for all other alpha emitters; and

c. The nonfixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm², or the area of the surface if less than 300 cm², does not exceed 8 E+05 becquerel per cm² (20 ?Ci/cm²) for beta and gamma and low toxicity alpha emitters, or 8 E+04 becquerel per cm² (2 ?Ci/cm²) for all other alpha emitters.

"Surveillance" means monitoring and observation of the disposal site for purposes of visual detection of need for maintenance, custodial care, evidence of intrusion, and compliance with other license and regulatory requirements.

"Survey" means a test or procedure done by a private or state inspector to determine if the equipment or procedures comply with the requirements of these regulations. Documentation, at a minimum, shall consist of completing forms approved by the agency in their entirety if such forms exist an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

"Target" means that part of an X-ray tube or accelerator onto which a beam of accelerated particles is directed to produce ionizing radiation or other particles.

"Technologically Enhanced Naturally Occurring Radioactive Material (TENORM)" means, as used in Part XVI (12VAC5-481-3460 et seq.) of this chapter, naturally occurring radionuclides whose concentrations are increased by or as a result of past or present human practices. TENORM does not include background radiation or the natural radioactivity of rocks or soils. TENORM does not include uranium or thorium in "source material" as defined in the AEA and US NRC regulations.

"Technique factors" means the following conditions of operation:

1. For capacitor energy storage equipment, peak tube potential in kV and quantity of charge in mAs;

2. For field emission equipment rated for pulsed operation, peak tube potential in kV, and number of X-ray pulses;

3. For CT X-ray systems designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in Ma, X-ray pulse width in seconds, and the number of X-ray pulses per scan, or the product of tube current, X-ray pulse width, and the number of X-ray pulses in mAs;

4. For CT X-ray systems not designed for pulsed operation, peak tube potential in kV, and either tube current in Ma and scan time in seconds, or the product of tube current and exposure time in mAs and the scan time when the scan time and exposure time are equivalent; and

5. For all other equipment, peak tube potential in kV, and either tube current in Ma and exposure time in seconds, or the product of tube current and exposure time in mAs.

"Teletherapy physicist" means an individual identified as a qualified teletherapy physicist on an agency license.

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

"Temporary job site" means any location where industrial radiography, wireline service, well-logging, portable gauge or XRF use is performed other than the location(s) listed in a specific license or certificate of registration. It also means a location where radioactive materials are present for the purpose of performing wireline service operations or subsurface tracer studies and where licensed material may be stored other than those location(s) of use authorized on the license.

"Tenth-value layer (TVL)" means the thickness of a specified material that attenuates X-radiation or gamma radiation to an extent such that the air kerma rate, exposure rate, or absorbed dose rate is reduced to one-tenth of the value measured without the material at the same point.

"Termination of irradiation" means the stopping of irradiation in a fashion that will not permit continuance of irradiation without the resetting of operating conditions at the control panel.

"Test" means the process of verifying compliance with an applicable regulation.

"Therapeutic radiation machine" means X-ray or electron-producing equipment designed and used for external beam radiation therapy.

"These regulations" mean all parts of these regulations.

"Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

"Tomogram" means the depiction of the X-ray attenuation properties of a section through the body.

"Tomographic plane" means that geometric plane which is identified as corresponding to the output tomogram.

"Tomographic section" means the volume of an object whose X-ray attenuation properties are imaged in a tomogram.

"Total effective dose equivalent" (TEDE) means the sum of the deep effective dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.

"Total organ dose equivalent" (TODE) means the sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in 12VAC5-481-1040.

"Traceable to a National Standard" (See "Instrument traceability" or "Source traceability").

"Transfer" means, as used in Part XVI (12VAC5-481-3460 et seq.) of this chapter, the physical relocation of NORM containing materials not directly associated with commercial distribution within a business's operation or between general or specific licensees. This term does not include a change in legal title to NORM containing materials that does not involve physical movement of those materials.

"Transport container" means a package that is designed to provide radiation safety and security when sealed sources are transported and which meets all applicable requirements of the United States Department of Transportation.

"Transport index (TI)" means the dimensionless number, rounded up to the next tenth, placed on the label of a package to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number expressing the determined by multiplying the maximum radiation level in millisievert (mSv) per hour at one meter (3.3 feet) from the external surface of the package in millisievert (mSv) per hour multiplied by 100, which is thus (equivalent to the maximum radiation level in millirem per hour at one meter (3.3 ft)).

"Treatment site" means the correct anatomical description of the area intended to receive a radiation dose, as described in a written directive.

"Tritium neutron generator target source" means a tritium source used within a neutron generator tube to produce neutrons for use in well-logging applications.

"Tube" means an X-ray tube, unless otherwise specified.

"Tube housing assembly" means the tube housing with tube installed. It includes high-voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing.

"Tube rating chart" means the set of curves which specify the rated limits of operation of the tube in terms of the technique factors.

"Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material or A₂ for normal form radioactive material, where A₁ and A₂ are given in Appendix L Table A-1 of 12VAC5-481-3770 or may be determined by procedures described in Appendix L Table A-1 of 12VAC5-481-3770.

"Type B package" means a Type B packaging together with its radioactive contents. A Type B package design is designated as B(U) or B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, refer to 49 CFR Part 173. A Type B package approved prior to September 6, 1983, was designated only as Type B. Limitations on its use are specified in 12VAC5-481-3010.

"Type B packaging" means a packaging designed to retain the integrity of containment and shielding when subjected to the normal conditions of transport and hypothetical accident test conditions set forth in 10 CFR Part 71.

"Type B quantity" means a quantity of radioactive material greater than a Type A quantity.

"Underwater irradiator" means an irradiator in which the sources always remain shielded under water and humans do not have access to the sealed sources or the space subject to irradiation without entering the pool.

"Underwater radiography" means radiographic operations performed when the radiographic exposure device or radiation machine and/or related equipment are beneath the surface of the water.

"Underwater irradiator" means an irradiator in which the sources always remain shielded under water and humans do not have access to the sealed sources or the space subject to irradiation without entering the pool.

"Unirradiated uranium" means uranium containing not more than 2 x 10³ Bq of plutonium per gram of uranium-235, not more than 9 x 10⁶ Bq of fission products per gram of uranium-235, and not more than 5 x 10^-3 g of uranium-236 per gram of uranium-235.

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

"Unrestricted area" means an area, access to which is neither limited nor controlled by the licensee or registrant. For purposes of these regulations, "uncontrolled area" is an equivalent term.

"Uranium—natural, depleted, enriched"

1. "Natural uranium" means uranium isotopes with the naturally occurring distribution of uranium isotopes, which is approximately 0.711 weight percent uranium-235, and the remainder by weight essentially uranium-238.

2. "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

3. "Enriched uranium" means uranium containing more uranium-235 than the naturally occurring distribution of uranium isotopes.

"Uranium sinker bar" means a weight containing depleted uranium used to pull a logging tool down toward the bottom of a well.

"Useful beam" means the radiation emanating from the tube housing port or the radiation head and passing through the aperture of the beam limiting device when the exposure controls are in a mode to cause the system to produce radiation.

"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.

"Variable-aperture beam-limiting device" means a beam-limiting device which has capacity for stepless adjustment of the X-ray field size at a given SID.

"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 in excess of five Gy (500 rad) in one hour at one meter from a source of radiation or one meter from any surface that the radiation penetrates.

"Virtual source" means a point from which radiation appears to originate.

"Visible area" means that portion of the input surface of the image receptor over which incident X-ray photons are producing a visible image.

"Visiting authorized user" means an authorized user who is not identified on the license of the licensee being visited.

"Waste" means those low-level radioactive wastes that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level waste has the same meaning as in the Low-Level Radioactive Waste Policy Act, Pub. L. 96-573, as amended by Pub. L. 99-240, effective January 15, 1986; that is, radioactive waste (i) not classified as high-level radioactive waste, spent nuclear fuel, or byproduct material as defined in Section 11e.(2) of the Atomic Energy Act (uranium or thorium tailings and waste) and (ii) classified as low-level radioactive waste consistent with existing law and in accordance with (a) by the Nuclear Regulatory Commission those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in subdivisions 2, 3, and 4 of the definition of byproduct material.

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

"Wedge filter" means a filter that effects continuous change in transmission over all or a part of the useful beam.

"Week" means seven consecutive days starting on Sunday.

"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:

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

"Well-logging" means all operations involving the lowering and raising of measuring devices or tools that may contain sources of radiation into well-bores or cavities for the purpose of obtaining information about the well or 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 a cable containing one or more electrical conductors that is used to lower and raise logging tools in the well-bore.

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

"Worker" means an individual engaged in work under a license or registration issued by the agency and controlled by a licensee or registrant but does not include the licensee or registrant.

"Working level (WL)" means any combination of short-lived radon daughters in one 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 of radon-222 are polonium-218, lead-214, bismuth-214, and polonium-214; and those of radon-220 are polonium-216, lead-212, bismuth-212, and polonium-212.

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

"Written directive" means an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation, except as specified in subdivision 6 below, containing the following information:

1. For any administration of quantities greater than 1.11 megabecquerels (30 mCi) of sodium iodide I-125 or I-131: the radionuclide, and dosage; or

2. For a therapeutic administration of a radiopharmaceutical other than sodium iodide I-125 or I-131: the radiopharmaceutical, dosage, and route of administration; or

3. For gamma stereotactic radiosurgery: target coordinates, collimator size, plug pattern, and total dose; or

4. For teletherapy: the total dose, dose per fraction, treatment site, and overall treatment period; or

5. For high-dose-rate remote afterloading brachytherapy: the radionuclide, treatment site, and total dose; or

6. For all other brachytherapy,

a. Prior to implantation: the radionuclide, number of sources, and source strengths; and

b. After implantation but prior to completion of the procedure: the radionuclide, treatment site, and total source strength and exposure time (or, equivalently, the total dose).

"X-ray exposure control" means a device, switch, button or other similar means by which an operator initiates and/or terminates the radiation exposure. The X-ray exposure control may include such associated equipment as timers and back-up timers.

"X-ray equipment" means an X-ray system, subsystem, or component thereof. Types of X-ray equipment are as follows:

1. "Mobile X-ray equipment" means X-ray equipment mounted on a permanent base with wheels and/or casters for moving while completely assembled.

2. "Portable X-ray equipment" means X-ray equipment designed to be hand-carried.

3. "Stationary X-ray equipment" means X-ray equipment that is installed in a fixed location.

"X-ray field" means that area of the intersection of the useful beam and any one of the sets of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the exposure rate is one-fourth of the maximum in the intersection.

"X-ray high-voltage generator" means a device which transforms electrical energy from the potential supplied by the X-ray control to the tube operating potential. The device may also include means for transforming alternating current to direct current, filament transformers for the X-ray tube(s), high-voltage switches, electrical protective devices, and other appropriate elements.

"X-ray system" means an assemblage of components for the controlled production of X-rays. It includes minimally an X-ray high-voltage generator, an X-ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. Additional components that function with the system are considered integral parts of the system.

"X-ray table" means a patient support device with its patient support structure (tabletop) interposed between the patient and the image receptor during radiography and/or fluoroscopy. This includes, but is not limited to, any stretcher equipped with a radiolucent panel and any table equipped with a cassette tray (or bucky), cassette tunnel, image intensifier, or spot-film device beneath the tabletop.

"X-ray tube" means any electron tube that is designed for the conversion of electrical energy into X-ray energy.

"Year" means the period of time beginning in January used to determine compliance with the provisions of these regulations. 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. If a licensee or registrant changes in a year, the licensee or registrant shall assure that no day is omitted or duplicated in consecutive years.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-20. Scope.

Except as otherwise specifically provided, these regulations apply to all persons who receive, possess, use, transfer, own, or acquire any source of radiation; provided, however, that nothing in these regulations shall apply to any person to the extent such person is subject to regulation by the Nuclear Regulatory Commission NRC. Attention is directed to the fact that regulation by the state of source material, byproduct material, and special nuclear material in quantities not sufficient to form a critical mass is subject to the provisions of the agreement between the state and the Nuclear Regulatory Commission NRC and to 10 CFR Part 150 of the commission's regulations.

To reconcile differences between this chapter and the incorporated sections of federal regulations and to effectuate their joint enforcement, the following words and phrases shall be substituted for the language of the federal regulations:

1. A reference to "NRC" or "Commission" means agency.

2. A reference to "NRC or agreement state" means agency, NRC or another agreement state.

3. The definition of "sealed source" includes NARM.

4. A reference to "byproduct material" includes NARM.

5. Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the agency and, for NRC licenses, to the NRC until agreement state status is in effect.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-30. [Reserved] Deliberate misconduct.

A. No person may do any of the following:

1. Engage in deliberate misconduct that causes or would have caused, if not detected, a licensee, registrant or applicant under this chapter to be in violation of any rule or order of the agency; or any term, condition or limitation of any license or registration issued by the agency under this chapter.

2. Deliberately submit to the agency, a licensee, registrant or applicant under this chapter; or a contractor or subcontractor of a licensee, registrant or applicant under this chapter; any information that the person knows to be incomplete or inaccurate.

B. Deliberate misconduct by a person means an intentional act or omission that the person knows:

1. Would cause a licensee, certificate of registration holder or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation, of any license issued by the agency; or

2. Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a licensee, certificate of registration holder, applicant, contractor, or subcontractor.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Reserved, Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-90. Exemptions from regulatory requirements.

A. The agency may, upon application or upon its own initiative, grant such exemptions or exceptions from the requirements of these regulations as it determines are authorized by law and will not result in undue hazard to public health and safety or property.

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

1. Prime contractors performing work for the Department of Energy at United States 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 in, or development, manufacture, storage, testing, or transportation of, atomic 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 NRC when the state and the Nuclear Regulatory Commission NRC 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.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-100. Records.

A. Each licensee and registrant shall maintain records showing the receipt, transfer, and disposal of all sources of radiation as follows:

1. As long as the material is possessed and for three years following transfer or disposition of the radioactive material.

2. Until the agency terminates the license for the licensee who transferred the material.

3. Until the agency terminates the license for the licensee who disposes the material.

B. If radioactive material is combined or mixed with other licensed material and subsequently treated in a manner that makes direct correlation of a receipt record with a transfer, export, or disposition record impossible, the licensee may use evaluative techniques (such as first-in-first-out) to make the records that are required by this section account for 100% of the material received.

C. Additional record requirements are specified elsewhere in these regulations. If the record retention period is not specified, the record shall be maintained for a period of three years.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-110. Inspections and enforcement.

A. Each licensee and registrant shall afford the agency at all reasonable times opportunity to inspect sources of radiation and the premises and facilities wherein such sources of radiation are used or stored.

B. Each licensee and registrant shall make available to the agency for inspection, upon reasonable notice, records maintained pursuant to these regulations.

C. Enforcement: The following provisions of Article 4 (§32.1-24) of Chapter 1 of Title 32.1 of the Code of Virginia, shall apply:.

1. Right of entry to inspect, etc.: warrants.—Upon presentation of appropriate credentials and upon consent of the owner or custodian, the commissioner or his designee shall have the right to enter at any reasonable time onto any property to inspect, investigate, evaluate, conduct tests or take samples for testing as he reasonably deems necessary in order to determine whether the provisions of this chapter, any order of the board or commissioner or any conditions in a permit, license or certificate issued by the board or commissioner are being complied with. If the commissioner or his designee is denied entry, he may apply to an appropriate circuit court for an inspection warrant authorizing such investigation, evaluation, inspection, testing or taking of samples for testing as provided in Chapter 24 (§19.2-393) of Title 19.2 §19.2-393 of the Code of Virginia.

2. Orders.—The board is authorized to issue orders to require any person to comply with the provisions of any law administered by the commissioner or the agency or any regulations promulgated by the board or to comply with any case decision, as defined in §2.2-4001 of the Code of Virginia, of the board or commissioner.

3. Penalties, injunctions, civil penalties and charges for violations.

a. Any person willfully violating or refusing, failing or neglecting to comply with any regulation or order of the board or commissioner or any provision of this title shall be guilty of a Class 1 misdemeanor unless a different penalty is specified.

b. Any person violating or failing, neglecting, or refusing to obey any lawful regulation or order of the board or commissioner or any provision of this title, may be compelled in a proceeding instituted in an appropriate court by the board or commissioner to obey such regulations, order or provision of this title and to comply therewith by injunction, mandamus, or other appropriate remedy.

c. Without limiting the remedies that may be obtained in subdivision 2 of this section, any person violating or failing, neglecting or refusing to obey any injunction, mandamus or other remedy obtained pursuant to subdivision 2 of this section shall be subject, in the discretion of the Court, to a civil penalty not to exceed 10,000 25,000 dollars for each violation. Each day of violation shall constitute a separate offense.

d. With the consent of any person who has violated or failed, neglected or refused to obey any regulation or order of the board or commissioner or any provision of this title, the board may provide, in an order issued by the board against such person, for the payment of civil charges for past violations in specific sums, not to exceed the limit specified in subdivision 3 of this section. Such civil charges shall be instead of any appropriate civil penalty which could be imposed under subdivision 3 of this section.

1. Whenever the department finds, following inspection and examination, that a source of radiation as constructed, operated or maintained results in a violation of this article or of any rules promulgated under this article, the department shall:

a. Notify the person in control of the source of radiation as to the nature of the violation; and

b. Specify a time frame for termination or abatement of the violation, including a deadline by which the source of the violation shall be reconstructed, operated, or maintained in compliance with this article and any regulations promulgated pursuant to this article.

2. Upon failure to comply within the time frame specified by the department for termination or abatement of the violation, the department may revoke the license, and pursue penalties or enforcement in accordance with §32.1-27 of the Code of Virginia.

3. Whenever, in the judgment of the department, any person has engaged in or is about to engage in any acts or practices that constitute or will constitute an emergency, hazard to health and safety, or a violation of any provision of this article, or any rule, regulation or order issued thereunder, and at the request of the commissioner, the Attorney General may make application to the appropriate court for an order enjoining such acts or practices, or for an order directing compliance, and upon a showing by the department that such person has engaged or is about to engage in any such acts or practices, a permanent or temporary injunction, restraining order, or other order may be granted.

4. In addition to the provisions of §32.1-27 of the Code of Virginia, any person who violates any provisions of this article or any order or regulation adopted pursuant thereto shall, upon such finding by a court of competent jurisdiction, be assessed a civil penalty of not more than $10,000 for each day of such violation. All penalties under this section shall be recovered in a civil action brought by the Attorney General in the name of the Commonwealth. Civil penalties collected pursuant to this section shall be paid into the state treasury and credited to the Radioactive Material Perpetual Care Trust Fund created pursuant to §32.1-232 of the Code of Virginia.

5. In addition to the provisions of §32.1-25 of the Code of Virginia, the department shall have the power to enter at all reasonable times, or in cases of an emergency, upon any private or public property for the purpose of determining whether or not there is compliance with or violation of the provisions of this article and rules and regulations issued thereunder, except that entry into areas under the jurisdiction of the federal government shall be effected only with the concurrence of the federal government or its duly designated representative.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-130. Impounding.

Sources of radiation shall be subject to impounding pursuant to Article 8 (§32.1-227 et seq.) of Chapter 6 §32.1-238 of the Code of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-150. Communications.

All communications and reports concerning this chapter, and applications filed thereunder, should be addressed to the agency at the following address: Virginia Department of Health, Radiological Health Radioactive Materials Program, 109 Governor Street, Room 730, P.O. Box 2448, Richmond, VA 23218 23219.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-200. Violations. (Repealed.)

An injunction or other court order may be obtained prohibiting any violation of any provision of the Act or any regulation or order issued thereunder. Any person who violates any provision of the Act or any regulation or order issued thereunder may be guilty of a crime and, upon conviction, may be punished by fine or imprisonment or both, as provided by law. The agency may also apply the Administrative Process Act. Permits may be revoked for violations of this regulation.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-230. Appeal.

A. Any appeal from a denial of a license or certification must be made in writing and received by the department agency within 30 days of the date of receipt of notice of the denial.

B. Any request for hearing on the findings on a Notice of Violation pursuant to this regulation must be made in writing and received within 30 days of receipt of the final Notice of Violation.

C. Pursuant to the Administrative Process Act (§2.2-4000 et seq. of the Code of Virginia), an aggrieved licensee or registrant may appeal a final decision of the commissioner to an appropriate circuit court.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-240. Units of exposure and dose.

The following regulation, Units of radiation dose (10 CFR 20.1004, January 1, 2003) (10 CFR 20.1004) is applicable and identical in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-250. Units of activity radioactivity.

The following regulation, Units of radioactivity (10 CFR 20.1005, 56 FR 61352, December 3, 1991) (10 CFR 20.1005) is applicable and identical in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Part II
Registration of Radiation Machine Facilities and Services

12VAC5-481-260. Purpose and scope.

A. This part provides for the registration of ionizing radiation machine facilities.

B. In addition to the requirements of this part, all registrants are subject to the applicable provisions of the General Provisions (Part I), Standards for Protection (Part IV) and Notices, Instructions and Reports (Part X) of this chapter. In addition, some registrants are subject to provisions of the regulations for Industrial Radiography (Part V), Healing Arts (Part VI), Analytical Equipment (Part VIII) or Particle Accelerators (Part IX) Part 1 (12VAC5-481-10 et. seq.), Part IV (12VAC5-481-600 et. seq.) and Part X (12VAC5-481-2250 et. seq.) of this chapter. In addition, some registrants are subject to provisions of the regulations for Part V (12VAC5-481-1170 et. seq.), Part VI (12VAC5-481-1580 et. seq.), Part VIII (12VAC5-481-2090 et. seq.) and Part IX (12VAC5-481-2140 et. seq.) of this chapter.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-270. Exemptions.

A. Electronic equipment that produces radiation incidental to its operation is exempt from the registration and notification requirements of this part, provided that the dose equivalent rate averaged over an area of 10 square centimeters does not exceed 5 ?Sv (0.5 millirem) (0.5 mrem) per hour at five centimeters from any accessible surface of such equipment. The production, testing, or factory servicing of such equipment shall not be exempt.

B. Radiation machines while in transit or storage incident thereto are exempt from the requirements of this part.

C. Domestic television receivers are exempt from the requirements of this part.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-340. Private inspector qualifications.

Any person desiring designation as a private inspector for diagnostic X-ray, mammographic or therapeutic X-ray and teletherapy machines must be qualified by training and experience to perform surveys inspections or calibrations according to the following criteria and must submit to the commissioner agency a statement on the appropriate form certifying his specific qualifications. In order to maintain designation as a private inspector, the individual must maintain satisfactory performance of work performed in that capacity. The commissioner agency shall disqualify individuals from this designation for just cause provided that a show-cause hearing has been held and the commissioner agency has determined that the individual has demonstrated unsatisfactory performance as a private inspector.

A. Private inspector, diagnostic X-ray (except mammography). The person must have adequate knowledge, training and experience to measure ionizing radiation, evaluate safety techniques, and advise regarding radiation protection needs to assure compliance with Virginia Rules and Regulations for Ionizing Radiation as evidenced by all of the following:

1. Initial qualifications: evidenced by one or more of the following:

a. Certification by one of the following: American Board of Radiology either in diagnostic or radiological physics, American Board of Health Physics in comprehensive practice, or the American Board of Medical Physics in diagnostic imaging physics.

b. Bachelor's degree in one of the physical sciences or engineering and three years of full-time experience in radiation safety including at least one year in diagnostic X-ray safety. Advanced degrees in related areas may be substituted for experience on an equal time basis, except that no substitution shall be allowed for the required one year of experience in diagnostic X-ray safety.

c. Those individuals listed as private inspectors immediately prior to September 20, 2006, shall be considered grandfathered.

2. Continuing qualifications:

a. Continuing education. Private inspectors must participate in continuing education programs relating to diagnostic X-ray, either by teaching or completing at least 15 continuing education units (CMEs) every three years.

b. Continuing experience. The private inspector must have surveyed inspected at least 10 diagnostic X-ray machines within the preceding 12 months.

3. Reestablishing qualifications. Private inspectors who fail to maintain the required continuing qualifications of this section may not perform the surveys inspections without the supervision of a qualified private inspector. Before independently surveying inspecting another facility, private inspectors must reestablish their qualifications, as follows:

a. Private inspectors who fail to meet the continuing educational requirements of this section shall obtain a sufficient number of continuing education units to bring their total units up to five continuing education units during the preceding 12 months.

b. Private inspectors who fail to meet the continuing experience requirement of this section shall complete a satisfactory survey inspection of a sufficient number of facilities and machines under the direct supervision of a private inspector who meets the qualifications of this section to bring the number to the required level.

B. Private inspector, therapeutic X-ray and teletherapy machines. The person must have adequate knowledge, training, and experience to calibrate a therapeutic X-ray machine or teletherapy machine, performing radiation protection surveys perform inspections and to establish procedures for (and review the results of) spot-check measurements as evidenced by all of the following:

1. Initial qualifications: evidenced by one or more of the following:

a. Be certified by the American Board of Radiology in:

(1) Therapeutic radiological physics;

(2) Roentgen-ray and gamma-ray physics;

(3) X-ray and radium physics;

(4) Radiological physics;

b. Be certified by the American Board of Medical Physics in Radiation Oncology Physics;

c. Be certified by the Canadian College of Medical Physics; or

d. Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and have completed one year of full time training in therapeutic radiological physics and also one year of full time work experience under the supervision of a radiation therapy physicist at a medical institution. To meet this requirement, the individual shall have performed the tasks listed in 12VAC5-481-3400 A; 12VAC5-481-3420 P; 12VAC5-481-3430 T; 12VAC5-481-3420 Q; and 12VAC5-481-3430 U under the supervision of a radiation therapy physicist during the year of work experience.

e. Notwithstanding the provisions of 12VAC5-481-3390 D;, certification pursuant to subdivisions B 1 a, b or c of this section shall be required on or before July 1, 2007, for all persons currently qualifying as a radiation therapy physicist pursuant to subdivision B 1 d of this section.

2. Continuing qualifications.

a. Continuing education: Private inspectors must participate in continuing education programs relating to therapeutic X-ray and teletherapy machines, either by teaching or completing at least 15 continuing education units (CEUs) every three years.

b. Continuing experience: The private inspector must have surveyed inspected at least one therapeutic X-ray or teletherapy facilities and at least one therapeutic X-ray or teletherapy machine within the preceding 12 months.

3. Reestablishing qualifications. Private inspectors who fail to maintain the required continuing qualifications of this section may not perform the surveys an inspection without the supervision of a qualified private inspector. Before independently surveying inspecting another facility, private inspectors must reestablish their qualifications, as follows:

a. Private inspectors who fail to meet the continuing educational requirements of this section shall obtain a sufficient number of continuing education units to bring their total units up to five continuing education units during the preceding 12 months.

b. Private inspectors who fail to meet the continuing experience requirement of this section shall complete a satisfactory survey inspection of a sufficient number of facilities and machines under the direct supervision of a private inspector who meets the qualifications of this section to bring the number to the required level.

C. Private inspector, mammography. The person must have adequate knowledge, training, and experience to inspect mammography X-ray machines and facilities. All mammography private inspector conducting surveys inspections of mammography facilities and providing oversight of the facility quality assurance program must meet one of the following tracks, either through the initial master's degree of higher route or the alternative initial bachelor's degree route:

1. Initial qualifications:

Master Route:

a. Be certified by the American Board of Radiology (ABR) or the American Board of Medical Physics (ABMP) in:

(1) Diagnostic radiological physics;

(2) Radiological physics; or

(3) Diagnostic imaging physics;

b. A master's degree or higher in a physical science with at least 20 semester hours or equivalent of graduate or undergraduate physics; and

c. Twenty contact hours of mammography facility training; and

d. The experience of conducting surveys inspections of at least one mammography facility and a total of at least 10 mammography units.

Bachelor Route (must have been qualified before April 28, 1999):

a. A bachelor's degree in a physical science with at least 10 semester hours or equivalent of college level physics;

b. Forty contact hours of documented specialized training in conducting surveys inspections of mammography facilities; and

c. The experience of conducting surveys inspections of at least one mammography facility and a total of at least 20 mammography units. The training and experience requirements must be met after fulfilling the degree requirement.

2. Continuing qualifications.

a. Continuing education. At all times after the third anniversary of completion of the initial requirements of this section, the private inspector shall have taught or completed at least 15 continuing education units in mammography during the preceding three years.

b. Continuing experience. At all times after the first anniversary of the completion of the initial requirements of this section, the private inspector shall have surveyed inspected at least two mammography facilities and six machines in 24 months.

c. Before a private inspector may begin independently performing mammographic examinations using a new modality, that is, a modality other than one for which the physicist received training to qualify under this section, the inspector must receive at least eight hours of training in surveying inspecting units with the new modality.

3. Reestablishing qualifications. Private inspectors who fail to maintain the required continuing qualifications of this section may not perform the mammography surveys inspections without the supervision of a qualified private inspector. Before independently surveying inspecting another facility, private inspectors must reestablish their qualifications as follows:

a. Private inspectors who fail to meet the continuing educational requirements of this section shall obtain a sufficient number of continuing education units to bring their total units up to the required 15 in the previous three years.

b. Private inspectors who fail to meet the continuing experience requirement of this section shall complete a satisfactory survey inspection of three mammography facilities under the direct supervision of a private inspector who meets the qualifications of this section.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-370. Certification of X-ray systems.

A. Every owner or operator of an X-ray machine shall:

1. Have the machine certified by the agency within 60 days of the date of installation and thereafter according to the inspection survey schedule in Part VI (12VAC5-481-1580 et seq.) of this chapter; and

2. Have the machine inspected whenever the machine is moved to a new location or according to the schedule in Part VI (12VAC5-481-1580 et seq.) of this chapter, whichever occurs first, by a private or state inspector; and

3. Submit to the agency one copy of each radiation survey inspection or calibration report for which records are required to be maintained pursuant to Part VI (12VAC5-481-1580 et seq.) of this chapter and if. If the survey inspection was performed by a state inspector and the survey inspection was not initiated by the agency pay the appropriate fee as established by the Board of Health board.

B. Certification may be denied if any noncompliances are not corrected within 45 days from the date of inspection.

C. The agency shall issue a certificate when the data indicates the machine meets the board's standards. A copy of the certificate shall be displayed by the registrant in a conspicuous place in close proximity to the X-ray machine.

D. Certification may be denied if the machine does not meet the standards set forth in these regulations. If the certification is denied, the machine shall not be used for treatment, diagnosis, or evaluation of patients, whether human or animal, until the standards of the board have been met.

E. Final disposition of the machine, including electrical disconnection or storage, will be made within 90 days of agency review.

F. For facilities providing mammography services, the agency may conduct scheduled and random unannounced inspections, to ensure compliance with laws, regulations, or conditions specified by the board.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Part III
Licensing of Radioactive Material

Article 1
Purpose and Scope

12VAC5-481-380. Purpose and scope.

A. This part, and Parts V (12VAC5-481-1170 et seq.), VII (12VAC5-481-1660 et seq.), XI (12VAC5-481-2330 et seq.), and XIII (12VAC5-481-2950 et seq.), XIV (12VAC5-481-3140 et seq.) and XVI (12VAC5-481-3460 et seq.) of this chapter, provide for the licensing of radioactive material. No person shall receive, possess, use, transfer, own, or acquire radioactive material except as authorized pursuant to this part or Parts V (12VAC5-481-1170 et seq.), VII (12VAC5-481-1660 et seq.), XI (12VAC5-481-2330 et seq.), and XII (12VAC5-481-2660 et seq.), XIII (12VAC5-481-2950 et seq.), XIV (12VAC5-481-3140 et seq.) and XVI (12VAC5-481-3460 et seq.) of this chapter, or as otherwise provided in these parts.

B. In addition to the requirements of this part, all licensees are subject to the requirements of Parts I (12VAC5-481-10 et seq.), IV (12VAC5-481-600 et seq.), X (12VAC5-481-2250 et seq.), and XIII (12VAC5-481-2950 et seq.) of this chapter. Furthermore, licensees engaged in industrial radiographic operations are subject to the requirements of Part V (12VAC5-481-1170 et seq.) of this chapter, licensees using radionuclides in the healing arts are subject to the requirements of Part VI (12VAC5-481-1580 et seq.) VII (12VAC5-481-1660 et seq.) of this chapter, licensees engaged in land disposal of radioactive material are subject to the requirements of Part XI (12VAC5-481-2330 et seq.) irradiator operations are subject to the requirements of Part XII (12VAC5-481-2660 et seq.) of this chapter, and licensees engaged in wireline and subsurface tracer studies are subject to the requirements of Part XIV (12VAC5-481-3140 et seq.) of this chapter.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 2
Exemptions from the Regulatory Requirements

12VAC5-481-390. Source material.

The following regulations, Carriers (10 CFR 40.12) and Unimportant quantities of source material (10 CFR 40.13, 26 FR 284, January 14, 1961) and Definitions (10 CFR 40.4, 26 FR 284, January 14, 1961) (10 CFR 40.13) are applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-400. Radioactive material other than source material.

A. Exempt concentrations. The following regulations regulation, Exempt concentrations (10 CFR 30.14, 58 FR 7736, February 9, 1993) and Definitions (10 CFR 30.4, 65 FR 54950, September 12, 2000) are (10 CFR 30.14) is applicable in the Commonwealth of Virginia and include the regulation of natural occurring and accelerator produced radioactive materials (NARM).

B. Exempt quantities. The following regulations regulation, Exempt quantities (10 CFR 30.18, 58 FR 7736, February 9, 1993) and Definitions (10 CFR 30.4, 65 FR 54950, September 12, 2000) are (10 CFR 30.18) is applicable in the Commonwealth of Virginia and include the regulation of natural occurring and accelerator produced radioactive materials NARM. The exemption stated in paragraph (b) of 10 CFR 30.18 does not apply for radium-226.

C. Exempt items. 1. The following regulations regulation, Exempt quantities (10 CFR 30.15, 58 FR 7736, February 9, 1993) and Definitions (10 CFR 30.4, 65 FR 54950, September 12, 2000) are Certain items containing byproduct material (10 CFR 30.15) is applicable in the Commonwealth of Virginia and include the regulation of natural occurring and accelerator produced radioactive materials NARM. The following item is specifically included: one microcurie (37 kBq) 37 kBq (1?Ci) of radium-226 per timepiece in timepieces acquired prior to September 1, 1980.

2. D. Self-luminous products containing radioactive material. The following regulations regulation, Self-luminous products containing tritium, krypton-85, or promethium-147 (10 CFR 30.19, 58 FR 7736, February 9, 1993) and Definitions (10 CFR 30.4, 65 FR 54950, September 12, 2000) are (10 CFR 30.19) is applicable in the Commonwealth of Virginia and include includes the regulation of natural occurring and accelerator produced radioactive materials NARM. In addition, any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers, or owns articles containing less than 0.1 microcurie (3.7 kBq) 3.7 kBq (0.1 ?Ci) of radium-226 that were acquired prior to September 1, 1980.

3. E. Gas and aerosol detectors containing radioactive material.

a. 1. The following regulations regulation, Gas and aerosol detectors containing byproduct material (10 CFR 30.20, 58 FR 7736, February 9, 1993) and Definitions (10 CFR 30.4, 65 FR 54950, September 12, 2000) are (10CFR 30.20) is applicable in the Commonwealth of Virginia and include the regulation of natural occurring and accelerator produced radioactive materials NARM.

b. 2. Gas and aerosol detectors previously manufactured and distributed to general licensees in accordance with a specific license issued by an agreement state shall be considered exempt under subdivision 3 a 1 of this subsection, provided that the device is labeled in accordance with the specific license authorizing distribution of the generally licensed device, and provided further that they meet the requirements of 12VAC5-481-480 C.

c. 3. Gas and aerosol detectors containing NARM previously manufactured and distributed in accordance with a specific license issued by a licensing state shall be considered exempt under subdivision 3 a 1 of this subsection, provided that the device is labeled in accordance with the specific license authorizing distribution, and provided further that they meet the requirements of 12VAC5-481-480 C.

4. F. Resins containing Scandium-46 and designed for sand consolidation in oil wells.

The following regulations, Resins containing Scandium-46 and designed for sand consolidation in oil wells (10 CFR 30.16, 58 FR 7736, February 9, 1993) and Definitions (10 CFR 30.4, 65 FR 54950, September 12, 2000) are (10 CFR 30.16) is applicable in the Commonwealth of Virginia.

G. Radioactive drug: Capsules containing carbon-14 urea for "in-vivo" diagnostic use for humans. The following regulation, Capsules containing carbon-14 urea for "in-vivo" diagnostic use for humans (10 CFR 30.21) is applicable in the Commonwealth of Virginia.

H. Special nuclear material. The following regulations, Carriers (10 CFR 70.12) and Department of Defense (10 CFR 70.13) are applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 3
Licenses

12VAC5-481-410. Types of licenses.

The following regulations, Types of licenses (10 CFR 30.31, 65 FR 79187, December 18, 2000) and Definitions (10 CFR 30.4, 65 FR 54950, September 12, 2000) (10 CFR 30.31, 10 CFR 40.20(a) and 10 CFR 70.18) are applicable in the Commonwealth of Virginia, and include the regulation of natural occurring and accelerator produced radioactive materials NARM.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-420. General licenses -- source material.

A. Small quantities of source material. The following regulations regulation, Small quantities of source material (10 CFR 40.22, 45 FR 55420, August 20, 1980) and Definitions (10 CFR 40.4, 26 FR 284, January 14, 1961) are (10 CFR 40.22) is applicable in the Commonwealth of Virginia.

B. General license to receive title to source or byproduct material. The following regulations regulation, General license to receive title to source or byproduct material (10 CFR 40.21, 45 FR 65531, October 3, 1980) and Definitions (10 CFR 40.4, 26 FR 284, January 14, 1961) are (10 CFR 40.21) is applicable in the Commonwealth of Virginia.

C. Depleted uranium in industrial products and devices. The following regulations regulation, General license for use of certain industrial products or devices (10 CFR 40.25, 60 FR 24551, May 9, 1995) and Definitions (10 CFR 40.4, 26 FR 284, January 14, 1961) are (10 CFR 40.25) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-430. General licenses -- radioactive material other than source material.

A. Certain devices and equipment. The following regulations, Certain devices and equipment (10 CFR 31.3, 35 FR 3982, March 3, 1970) (10 CFR 31.3) and Terms and Conditions (10 CFR 31.2, 65 FR 79187, December 18, 2000) (10 CFR 31.2) are applicable in the Commonwealth of Virginia.

B. Certain detecting, measuring, gauging or controlling devices and certain devices for producing light or an ionized atmosphere. The following regulations, Certain devices and equipment (10 CFR 31.5, 68 FR 58804, October 10, 2003) Certain detecting, measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere (10 CFR 31.5) and Terms and Conditions (10 CFR 31.2, 65 FR 79187, December 18, 2000) (10 CFR 31.2) are applicable in the Commonwealth of Virginia. In addition, any person who owns, receives, acquires, possesses, uses, or transfers radioactive material in a device pursuant to the general license in this subsection, shall comply with the provisions of 12VAC5-481-1090 and 12VAC5-481-1100 for reporting radiation incidents, theft, or loss of licensed material, but shall be exempt from the other requirements of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter. The registration required by 10 CFR 31.5(c)(13)(i) shall be made to the agency. A registration invoice will be provided by the agency. The registration fee will be $50 per device.

C. The general license provided in 12VAC5-481-420 B is subject to the provisions of 12VAC5-481-100 through 12VAC5-481-210, 12VAC5-481-500, 12VAC5-481-570, 12VAC5-481-580 and Part XIII (12VAC5-481-2950 et seq.) of this chapter.

D. Luminous safety devices for use in aircraft. The following regulations, Luminous safety devices for use in aircraft (10 CFR 31.7, 58 FR 67659, December 22, 1993) (10 CFR 31.7) and Terms and Conditions (10 CFR 31.2, 65 FR 79187, December 18, 2000) (10 CFR 31.2) are applicable in the Commonwealth of Virginia. In addition, this general license is subject to the provisions of 12VAC5-481-100 through 12VAC5-481-210, 12VAC5-481-500, 12VAC5-481-570, 12VAC5-481-580, and Part XIII (12VAC5-481-2950 et seq.) of this chapter.

E. Ownership of radioactive General license to own byproduct material. The following regulations, Ownership of radioactive material (10 CFR 31.9, 30 FR 8189, June 26, 1965) and General license to own byproduct material (10 CFR 31.9), Terms and Conditions (10 CFR 31.2, 65 FR 79187, December 18, 2000) (10 CFR 31.2) and General license to own special nuclear material (10 CFR 70.20) are applicable in the Commonwealth of Virginia and includes natural occurring and accelerator produced radioactive materials NARM.

F. Calibration and reference sources.

1. The following regulations, Americium-241 in the form of calibration and or reference sources (10 CFR 31.8, 56 FR 40767, August 16, 1991) and (10 CFR 31.8), Terms and Conditions (10 CFR 31.2, 65 FR 79187, December 18, 2000) (10 CFR 31.2) and General license for calibration or reference sources (10 CFR 70.19) are applicable in the Commonwealth of Virginia and includes natural occurring and accelerator produced radioactive materials include NARM.

2. A general license is hereby issued to own, receive, possess, use, and transfer plutonium in the form of calibration or reference sources in accordance with the provisions of subdivisions 4 and 5 of this subsection to any person who holds a specific license issued by the agency that authorizes him to receive, possess, use, and transfer radioactive material.

3. A general license is hereby issued to own, receive, possess, use, and transfer radium-226 in the form of calibration or reference sources in accordance with the provisions of subdivisions 4 and 5 of this subsection to any person who holds a specific license issued by the agency which authorizes him to receive, possess, use, and transfer radioactive material.

4. The general licenses in subdivisions 1 through 3 of this subsection apply only to calibration or reference sources that have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer or importer of the sources by the Nuclear Regulatory Commission NRC pursuant to 10 CFR 32.57 or 10 CFR 70.39, or that have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer by the agency, any agreement state or licensing state pursuant to licensing requirements equivalent to those contained in 10 CFR 32.57 or 10 CFR Part 70.39.

5. The general licenses provided in subsection G subdivisions 1 through 3 of this section subsection are subject to the provisions of 12VAC5-481-100 through 12VAC5-481-210, 12VAC5-481-500, 12VAC5-481-570, 12VAC5-481-580 and Parts IV (12VAC5-481-600 et seq.); X (12VAC5-481-2250 et seq.); and XIII (12VAC5-481-2950 et seq.) of this chapter. In addition, persons who own, receive, acquire, possess, use, or transfer one or more calibration or reference sources pursuant to these general licenses:

a. Shall not possess at any one time, at any one location of storage or use, more than five microcuries (185 kBq) 185 kBq ( 5 ?Ci) of americium-241, five microcuries (185 kBq) 185 kBq ( 5 ?Ci) of plutonium, or five microcuries (185 kBq) 185 kBq (5 ?Ci) of radium-226 in such sources;

b. Shall not receive, possess, use, or transfer such source unless the source, or the storage container, bears a label that includes one of the following statements, as appropriate, or a substantially similar statement that contains the information called for in one of the following statements, as appropriate:

(1) The receipt, possession, use and transfer of this source, ______________________________

Model __________, Serial No. __________, are subject to a general license and the regulations of the Nuclear Regulatory Commission or of a state with which the Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

CAUTION—RADIOACTIVE MATERIAL

THIS SOURCE CONTAINS (AMERICIUM-241).

(PLUTONIUM) (Showing only the name of the appropriate material.)

DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

____________________Name of manufacturer or importer

(2) The receipt, possession, use and transfer of this source, Model __________, Serial No. __________, are subject to a general license and the regulations of a 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. Shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license from the agency, the Nuclear Regulatory Commission NRC, an or another agreement state or a licensing state to receive the source;

d. Shall store such source, except when the source is being used, in a closed container adequately designed and constructed to contain americium-241, plutonium, or radium-226 that might otherwise escape during storage; and

e. Shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.

11. 6. These general licenses do not authorize the manufacture of calibration or reference sources containing americium-241, plutonium, or radium-226.

G. General license for use of radioactive material for certain in vitro clinical or laboratory testing.

The following regulations, General license for use of byproduct material for certain in vitro clinical or laboratory testing (10 CFR 31.11, 68 FR 58804, October 10, 2003) (10 CFR 31.11) and Terms and Conditions (10 CFR 31.2, 65 FR 79187, December 18, 2000) (10 CFR 31.2) are applicable in the Commonwealth of Virginia and includes natural occurring and accelerator produced radioactive materials include NARM. The agency form equivalent to the Form NRC-483 is designated RH-F-14, "Certificate—In Vitro Testing with Radioactive Material Under General License."

H. Ice detection devices. The following regulations, General license for use strontium-90 in ice detection devices (10 CFR 31.10, 58 FR 67659, December 22, 1993) (10 CFR 31.10) and Terms and Conditions (10 CFR 31.2 65 FR 79187, December 18, 2000) (10 CFR 31.2) are applicable in the Commonwealth of Virginia. This general license is subject to the provisions of 12VAC5-481-100 through 12VAC5-481-210, 12VAC5-481-500, 12VAC5-481-570, 12VAC5-481-580 and Part XIII (12VAC5-481-2950 et seq.) of this chapter.

I. Certain items and self-luminous products containing radium-226. The following regulations, General license for certain items and self-luminous products containing radium-226 (10 CFR 31.12) and Terms and Conditions (10 CFR 31.2) are applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 4
Specific Licenses

12VAC5-481-440. Filing application for specific licenses.

A. Applications for specific licenses shall be filed on a form prescribed by the agency.

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 be signed by the applicant or licensee or a person duly authorized to act for and on his behalf.

D. An application for a license may include a request for a license authorizing one or more activities.

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

F. E. Applications and documents submitted to the agency may be made available for public inspection except that the agency may withhold any document or part thereof 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 in accordance with the Virginia Freedom of Information Act (§2.2-3700 et seq. of the Code of Virginia). The agency may withhold records in accordance with specific exemptions in the Virginia Freedom of Information Act or as otherwise specified by law.

F. An application for a specific license to use radioactive material in the form of a sealed source or in a device that contains the sealed source must either:

1. Identify the source or device by manufacturer and model number as registered with the NRC under 10 CFR 32.210 or an agreement state under equivalent regulations;

2. Contain the information in 10 CFR 32.210(c); or

3. For sources or devices containing NARM manufactured prior to November 30, 2007, that are not registered with the NRC under 10 CFR 32.210 or with an agreement state, and for which the applicant is unable to provide all categories of information specified in 10 CFR 32.210(c), the applicant must provide:

a. All available information identified in 10 CFR 32.210(c) concerning the source, and, if applicable, the device; and

b. Sufficient additional information to demonstrate that there is reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Such information must include a description of the source or device, a description of radiation safety features, the intended use and associated operating experience, and the results of a recent leak test.

G. Each application to possess radioactive material in unsealed form, on a foil or plated source, or sealed in glass in excess of the quantities in 12VAC5-481-3740 shall contain one of the following:

1. An evaluation showing that the projected dose to a person offsite due to a release of radioactive material would not exceed 0.01 Sv (1 rem) total effective dose equivalent or 0.05 Sv (5 rem) to the thyroid; or

2. An emergency plan, reviewed and commented on by offsite response organizations expected to respond in the event of an accident that contains the following information:

a. Facility description. A brief description of the licensee or applicant's facility and surroundings.

b. Types of accidents. An identification of each type of radioactive materials accident for which actions by licensee staff or offsite response organizations will be needed to protect members of the public.

c. Classification of accidents. A method for classifying and declaring an accident as alert or site area emergency.

d. Detection of accidents. Identification of the means for detecting each type of alert or site area emergency in a timely manner.

e. Mitigation of consequences. A brief description of the means and equipment that are available for mitigating the consequences of each type of accident, including those provided to protect workers onsite, and a description of the program for maintaining the equipment.

f. Assessment of releases. A brief description of the methods and equipment available to assess releases of radioactive material.

g. Responsibilities. A brief description of the responsibilities of the licensee or applicant's personnel who will respond if an accident occurs, including identification of personnel responsible for promptly notifying offsite response organizations, including the agency.

h. Plan maintenance. A brief description of the positions assigned and methods to develop, maintain and update the plan.

i. A list of offsite response organizations, description of their responsibilities and anticipated actions, and copy of formal commitments, if any.

j. Notification and coordination. A brief description of the means to promptly notify the offsite response organizations and request offsite assistance including medical assistance for the treatment of contaminated injured onsite workers. The notification and coordination must include alternate provisions in case key personnel, parts of the facility, or some equipment are unavailable. The licensee shall also commit to notify the agency immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency.

k. Information to be communicated. A brief description of the types of information on facility status, radioactive releases and recommended protective actions, if necessary, to be given to offsite response organizations and the agency. A licensee shall allow the offsite response organizations expected to respond in case of an accident 60 days to comment on the licensees emergency plan before submitting it to the agency. A licensee shall provide any comments received within the 60 days to the agency with the emergency plan.

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

m. Drills and exercises. Provisions for conducting quarterly communications checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. The licensee or applicant shall invite offsite response organizations to participate in biennial exercises. The exercises shall use accident scenarios postulated as the most probable for the specific site and the scenarios may not be known to most exercise participants. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel and overall effectiveness of the response. Deficiencies found by the critiques must be corrected.

n. Safe condition. A brief description of the means of restoring the facility and surroundings to a safe condition after an accident.

o. Hazardous chemicals. A certification that the applicant has met its responsibilities under the Emergency Planning and Community Right-To-Know Act of 1986, Title III, P.L. 99-499, if applicable to the applicant's activities at the proposed place of use of the radioactive material.

H. An application from a medical facility or educational institution to produce PET radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under Part VII (12VAC5-481-1660 et seq.) of this chapter shall include:

1. A request for authorization for the production of PET radionuclides or evidence of an existing license issued under Part III (12VAC5-481-380 et. seq.) of this chapter for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.

2. Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in 12VAC5-481-480 I.

3. Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an ANP as specified in 12VAC5-481-480 I 2.

4. Information identified in 12VAC5-481-480 I 1 c on the PET drugs to be noncommercially transferred to members of its consortium.

I. Manufacture, preparation, or transfer for commercial distribution of drugs containing radioactive material for medical use under Part VII (12VAC5-481-1660 et seq.).

1. An application for a specific license to manufacture, prepare, or transfer for commercial distribution drugs containing radioactive material for use by persons authorized pursuant to Part VII (12VAC5-481-1660 et seq.) will be approved if:

a. The applicant satisfies the general requirements specified in 12VAC5-481-450;

b. The applicant submits evidence that the applicant is at least one of the following:

(1) Registered or licensed with the U.S. Food and Drug Administration (FDA) as a drug manufacturer;

(2) Registered or licensed with a state agency as a drug manufacturer;

(3) Licensed as a pharmacy by the Virginia Board of Pharmacy;

(4) Operating as a nuclear pharmacy within a federal medical institution; or

(5) A PET drug production facility registered with a state agency.

c. The applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees; and

d. The applicant satisfies the following labeling requirements:

(1) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half life greater than 100 days, the time may be omitted.

(2) A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

2. A licensee authorized to manufacture, prepare or transfer for commercial distribution radioactive drugs shall ensure that any individual preparing the drugs is one of the following:

a. An authorized nuclear pharmacist (ANP) as defined in 12VAC5-481-10;

b. An individual that meets the requirements specified in 12VAC5-481-1770 and 12VAC5-481-1790, and the licensee has received an approved license amendment identifying this individual as an ANP;

c. A pharmacist, as defined in 12VAC5-481-10, designated as an ANP if:

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

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

d. An individual under the supervision of an ANP as specified in 12VAC5-481-1710.

3. Shall provide to the agency no later than 30 days after the date that the licensee allows, under subdivision 2 a or c of this subsection, the individual to work as an ANP:

a. The individual's certification by a specialty board whose certification process has been recognized by the NRC with the written attestation signed by a preceptor as required by 12VAC5-481-1770;

b. An NRC or another agreement state license;

c. NRC master materials licensee permit;

d. The permit issued by a licensee or NRC master materials permittee of broad scope or the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist; or

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

f. The Virginia Board of Pharmacy's license.

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

a. Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and

b. Check each instrument for constancy and proper operation at the beginning of each day of use.

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

6. Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/ryubidium-82 generators shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination in accordance with 12VAC5-481-1930. The licensee shall record the results of each test and retain each record for three years after the record is made.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-450. General requirements for the issuance of specific licenses.

A. A license application will 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 in accordance with these regulations in such a manner as to 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; and

4. The applicant has described in the application how facility design and procedures for operation will minimize, to the extent practicable, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practicable, the generation of radioactive waste; and

4. 5. The applicant satisfies any applicable special requirements in 12VAC5-481-460, 12VAC5-481-470, 12VAC5-481-480, Part V (12VAC5-481-1170 et seq.), Part VII (12VAC5-481-1660 et seq.), Part XI (12VAC5-481-2330 et seq.), or Part XII (12VAC5-481-2660 et seq.), Part XIV (12VAC5-481-3140 et seq.) or Part XVI (12VAC5-281-3460 et seq.) of this chapter.

B. Environmental report, commencement of construction. In the case of an application for a license to receive and possess radioactive material for commercial waste disposal by land burial, or for the conduct of any other activity that the agency determines will significantly affect the quality of the environment, the agency, before commencement of construction of the plant or facility in which the activity will be conducted, has concluded, after weighing the environmental, economic, technical and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion shall be grounds for denial of a license to receive and possess radioactive material in such plant or facility. As used in this subsection the term "commencement of construction" means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a site. The term does not mean site exploration, necessary roads for site exploration, borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the site or the protection of environmental values.

C. Financial surety arrangements for site reclamation.

1. Pursuant to §32.1-231 of the Code of Virginia, and as otherwise provided, financial surety arrangements for site reclamation that may consist of surety bonds, cash deposits, certificates of deposit, deposits of government securities, letters or lines of credit, or any combination of the above for the categories of licensees listed in subdivision 4 of this subsection shall be established to ensure the protection of the public health and safety in the event of abandonment, default, or other inability of the licensee to meet the requirements of the Act and this chapter.

a. The amount of funds to be ensured by such surety arrangements shall be based on agency-approved cost estimates.

b. Self insurance, or any arrangement that essentially constitutes self insurance, will not satisfy the surety requirement since this provides no additional assurance other than that which already exists through license requirements.

2. The arrangements required in subdivision 1 of this subsection shall be established prior to issuance of the license to assure that sufficient funds will be available to carry out the decontamination and decommissioning of the facility.

3. Amendments to licenses in effect on September 20, 2006, may be issued providing that the required surety arrangements are established within 90 days after September 20, 2006.

4. The following specific licensees are required to make financial surety arrangements:

a. Major processors;

b. Waste handling licensees;

c. Former United States Atomic Energy Commission or Nuclear Regulatory Commission licensed facilities; and

d. All others except persons exempt pursuant to subdivision 5 of this subsection.

5. The following persons are exempt from the requirements of subdivision 1 of this subsection:

a. All state, local, or other government agencies, unless they are subject to subdivision 4 b of this subsection;

b. Persons authorized to possess no more than 1,000 times the quantity specified in Appendix C or combination of radioactive material listed therein as given in Appendix C, Note 1;

c. Persons authorized to possess hydrogen-3 contained as hydrogen gas in a sealed source; or

d. Persons authorized to possess radioactive noble gases in sealed sources with no radioactive daughter product with half-life greater than 30 days.

C. Financial assurance and records for decommissioning.

1. A person applying for a specific license authorizing the possession and use of unsealed radioactive material shall submit a decommissioning funding plan as described in subdivision 6 of this subsection with the license application for any of the following types of materials:

a. Unsealed radioactive material with a half-life greater than 120 days and in quantities greater than 10⁵ times the applicable quantities listed in 12VAC5-481-3750.

b. Unsealed radioactive material involving a combination of isotopes with R divided by 10⁵ being greater than one, where R is defined as the sum of the ratios of the quantity of each isotope to the applicable value in 12VAC5-481-3750.

2. A person applying for a specific license authorizing the possession and use of radioactive material not covered by subdivision 1 of this subsection with a half-life greater than 120 days and in quantities specified in subdivision 5 of this subsection shall do either of the following:

a. Submit a decommissioning funding plan as described in subdivision 6 of this subsection.

b. Submit a written certification, signed by the chief financial officer or other individual designated by management to represent the licensee, that financial assurance has been provided in the amount prescribed in subdivision 5 of this subsection using one of the methods described in subdivision 6 of this subsection and a signed original of the financial instrument obtained to satisfy the requirements of subdivision 7 of this subsection. The written certification may state that the appropriate assurance will be obtained after the application has been approved and the license issued by the agency but before receipt of radioactive material by the applicant. If the applicant defers execution of the financial instrument until after the license has been issued, the applicant shall submit to the agency a signed original of the financial instrument obtained before receipt of licensed material.

3. The following are exempt from the requirements of this subsection:

a. A state, local or other government agency, except for a government agency licensed to handle or process radioactive waste.

b. A person authorized to possess only radioactive materials with a half-life of 65 days or less.

c. Other persons exempted by the agency based on a review of the license application.

4. Implementation.

a. A person who possesses a specific license authorizing the possession and use of radioactive material issued on or after the effective date as stated in 12VAC5-481-160 that is of a type described in subdivision 1 of this subsection, shall provide financial assurance for decommissioning under this section.

b. A person who possesses a specific license issued before the effective date as stated in 12VAC5-481-160 shall do one of the following:

(1) For a license authorizing the use of radioactive material meeting the criteria of subdivision 1 of this subsection, submit a decommissioning funding plan as described in subdivision 6 of this subsection and a certification of financial assurance for at least $1,125,000, under the criteria in subdivision 5 of this subsection, with any application for license renewal.

(2) For a license authorizing the use of radioactive material meeting the criteria of subdivision 2 of this subsection, submit a decommissioning funding plan as described in subdivision 6 of this subsection or a certification of financial assurance for decommissioning according to the criteria of subdivision 5 of this subsection with any application for license renewal.

c. The term of the financial assurance shall be from the issuance or renewal of the license until the agency terminates the license.

d. A licensee's financial assurance arrangements may be reviewed annually by the agency to recognize any increases or decreases resulting from inflation or deflation, changes in engineering plans, activities performed or any other condition affecting costs for decommissioning to ensure that sufficient funding is available to cover liability that remains until license termination.

5. Required amounts for financial assurance.

a. A licensee shall provide the following minimum amounts of financial assurance for decommissioning, unless otherwise specified by the agency:

(1) $1,125,000 if the quantity of material is greater than 10⁴ but less than or equal to 10⁵ times the applicable quantities of 12VAC5-481-3750 in unsealed form. For a combination of isotopes, R divided by 10⁴ is greater than one but R divided by 10⁵ is less than or equal to one.

(2) $225,000 if the quantity of material is greater than 10³ but less than or equal to 10⁴ times the applicable quantities of 12VAC5-481-3750 in unsealed form. For a combination of isotopes, R divided by 10³ is greater than one but R divided by 10⁴ is less than or equal to one.

(3) $113,000 if the quantity of material is greater than 10¹⁰ times the applicable quantities of 12VAC5-481-3750 in sealed sources or plated foils. For a combination of isotopes, R divided by 10¹⁰ is greater than one.

b. The agency may eliminate, reduce or raise the required amount of financial assurance under subdivision 5 a of this subsection for an individual applicant or licensee based on the cost estimate for decommissioning included in the decommissioning funding plan required under subdivision 6 a of this subsection.

6. Decommissioning funding plan.

a. A decommissioning funding plan shall include all the following information:

(1) A cost estimate for decommissioning that considers all of the following:

(a) Probable extent of contamination through the use or possession of radioactive material at the facility or site and the projected cost of removal of the contamination to a level specified by the agency. The evaluation shall encompass probable contaminating events associated with the licensee's or applicant's operation and shall be based on factors such as quantity, half-life, radiation hazard, toxicity and chemical and physical forms.

(b) The extent of possible offsite property damage caused by operation of the facility or site.

(c) The cost of removal and disposal of radiation sources that are or would be generated, stored, processed or otherwise present at the licensed facility or site.

(d) The costs involved in reclaiming the property on which the facility or site is located and all other properties contaminated by radioactive material authorized under the license.

(2) A description of the method of assuring funds for decommissioning according to subdivision 7 of this subsection.

(3) A description of the method for adjusting cost estimates and associated funding levels periodically over the life of the facility.

b. The decommissioning funding plan shall also contain the licensee's certification that financial assurance has been provided in the amount of the cost estimate for decommissioning and a signed original of the financial instrument obtained to satisfy the requirements of subdivision 7 of this subsection.

7. A licensee may use any of the following methods to provide financial assurance for decommissioning:

a. Prepayment. Prepayment is the deposit prior to operation into an account segregated from licensee assets and outside the licensee's administrative control of cash or liquid assets in an amount sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit or deposit of government securities.

b. Surety method, insurance or other guarantee. Payment of future decommissioning costs shall be guaranteed by a surety method, insurance or other guarantee. A surety method may be in the form of a surety bond, letter of credit or line of credit. Self insurance, or any method that essentially constitutes self-insurance, may not be used as a method of providing financial assurance. Any surety method or insurance used to provide financial assurance for decommissioning must meet all of the following criteria:

(1) The surety method or insurance shall be open-ended or, if written for a specified term, renewed automatically unless 90 days or more prior to the renewal date, the issuer notifies the agency, the beneficiary and the licensee of its intention not to renew. The surety method or insurance shall also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the agency within 30 days after receipt of notification of cancellation.

(2) The surety method or insurance shall be payable to a trust established for decommissioning costs. The agency shall approve the trustee and the trust.

(3) The surety method or insurance shall remain in effect until the agency terminates the license.

c. External sinking fund. An external sinking fund may be used in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit or deposit of government securities. The surety or insurance provisions shall meet the requirements of subdivision 7 b of this subsection.

d. Statement of intent. A state or local government licensee exempt under subdivision 3 of this subsection shall submit a written statement of intent containing a cost estimate for decommissioning or an amount based on subdivision 5 of this subsection. The cost estimate shall indicate that funds for decommissioning will be obtained when necessary.

8. A licensee shall keep the following records of information related to decommissioning of a facility in an identified location until the site is released for unrestricted use:

a. Records of spills or other unusual occurrences involving the spread of radioactive contamination in and around the facility, equipment or site. The records may be limited to instances where contamination remains after any cleanup procedures or when there is reasonable likelihood that radioactive contaminants may have spread to inaccessible areas or into porous materials such as concrete. The records shall include any known information on identification of involved nuclides, quantities, forms and concentrations.

b. As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used or stored, and of locations of possible inaccessible contamination such as buried pipes that may contain radioactive contaminants. If required drawings are referenced, each relevant document does not need to be indexed individually. If drawings are not available, a licensee shall substitute appropriate records of available information concerning the areas and locations of inaccessible contamination.

Note: As-built architectural and engineering drawings need to reflect the final details of the structures and equipment as they were constructed.

c. Except for areas containing only sealed sources that have not leaked or where no contamination remains after a leak, or byproduct materials with half-lives of less than 65 days, a list containing all the following:

(1) All areas currently and formerly designated as restricted areas.

(2) All areas outside of restricted areas that require documentation under subdivision 8 (c) 1 of this subsection.

(3) All areas outside of restricted areas where current and previous wastes have been buried as documented under 12VAC5-481-1060.

(4) All areas outside of restricted areas that contain radioactive material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in 12VAC5-481-510 or apply for approval for disposal under 12VAC5-481-920.

d. Records of the cost estimate performed for the decommissioning funding plan or the amount certified for decommissioning and records of the funding method used for assuring funds.

9. A licensee shall keep the records in subdivision 8 of this subsection until the site is decommissioned and approved by the agency for unrestricted use.

10. Prior to a licensed activity being transferred to another licensee under 12VAC5-481-500 B, the original licensee shall transfer all records under subdivision 8 of this subsection to the new licensee. The new licensee shall be responsible for maintaining the records until their license is terminated by the agency.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-460. Special requirements for issuance of certain specific licenses for radioactive material. (Repealed.)

A. Reserved.

B. Reserved.

C. Reserved.

D. Reserved.

E. Use of sealed sources in industrial radiography. In addition to the requirements set forth in 12VAC5-481-450, a specific license for use of sealed sources in industrial radiography will be issued if:

1. The applicant will have an adequate program for training radiographic personnel and submits to the agency a schedule or description of such program that specifies the:

a. Initial training,

b. Periodic training,

c. On-the-job training, and

d. Means to be used by the licensee to determine the radiographic personnel's knowledge and understanding of and ability to comply with agency regulations and licensing requirements, and the operating and emergency procedures of the applicant.

2. The applicant has established and submits to the agency satisfactory written operating and emergency procedures described in 12VAC5-481-1330;

3. The applicant will have an internal inspection system adequate to assure that these regulations, license provisions, and the applicant's operating and emergency procedures are followed by radiographic personnel; the inspection system shall include the performance of internal inspections at intervals not to exceed three months and the retention of records of such inspections for two years;

4. The applicant submits to the agency a description of the overall organizational structure pertaining to the industrial radiography program, including specified delegations of authority and responsibility for operation of the program;

5. The applicant who desires to conduct his own leak tests has established adequate procedures to be followed in testing sealed sources for possible leakage and contamination and submits to the agency a description of such procedures including:

a. Instrumentation to be used,

b. Method of performing tests, and

c. Pertinent experience of the individual who will perform the test; and

6. The licensee shall conduct a program for inspection and maintenance of radiographic exposure devices and storage containers to assure proper functioning of components important to safety.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-470. Special requirements for specific licenses of broad scope.

This section prescribes requirements for the issuance of specific licenses of broad scope for radioactive material and certain regulations governing holders of such licenses. (Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the Nuclear Regulatory Commission, Washington, D.C. 20555-0001.)

A. The different types of broad scope licenses are set forth below:

1. A "Type A specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license, for any authorized purpose. The quantities specified are usually in the multicurie range.

2. A "Type B specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in Appendix D 12VAC5-481-3760, for any authorized purpose. The possession limit for a Type B license of broad scope, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Appendix D 12VAC5-481-3760, Column I. If two or more radionuclides are possessed thereunder, the possession limit for each is determined as follows: for each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in Appendix D 12VAC5-481-3760, Column I, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

3. A "Type C specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in Appendix D 12VAC5-481-3760, for any authorized purpose. The possession limit for a Type C license of broad scope, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Appendix D 12VAC5-481-3760, Column II. If two or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: for each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in Appendix D 12VAC5-481-3760, Column II, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

B. An application for a Type A specific license of broad scope will be approved if:

1. The applicant satisfies the general requirements specified in 12VAC5-481-450;

2. The applicant has engaged in a reasonable number of activities involving the use of radioactive material; and

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

a. The establishment of a radiation safety committee composed of such persons as a radiation safety officer, a representative of management, and persons trained and experienced in the safe use of radioactive material;

b. The 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

c. The establishment of appropriate administrative procedures to assure:

(1) Control of procurement and use of radioactive material;

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

(3) Review, approval, and recording by the radiation safety committee of safety evaluations of proposed uses prepared in accordance with subdivision 3 c (2) of this subsection prior to use of the radioactive material.

C. An application for a Type B specific license of broad scope will be approved if:

1. The applicant satisfies the general requirements specified in 12VAC5-481-450; and

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

a. The 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

b. The establishment of appropriate administrative procedures to assure,

(1) Control of procurement and use of radioactive material,

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

(3) Review, approval, and recording by the radiation safety officer of safety evaluations of proposed uses prepared in accordance with subdivision 2 b (2) of this subsection prior to use of the radioactive material.

D. An application for a Type C specific license of broad scope will be approved if:

1. The applicant satisfies the general requirements specified in 12VAC5-481-450;

2. The applicant submits a statement that radioactive material will be used only by, or under the direct supervision of, individuals who have received:

a. A college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering, and

b. At least 40 hours of training and experience in the safe handling of radioactive material, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used; and

3. 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.

E. Specific licenses of broad scope are subject to the following conditions:

1. Unless specifically authorized, persons licensed pursuant to 12VAC5-481-470 shall not:

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

b. Receive, acquire, own, possess, use, or transfer devices containing 100,000 curies (3.7 PBq) 3.7 PBq (100,000 Ci) or more of radioactive material in sealed sources used for irradiation of materials;

c. Conduct activities for which a specific license issued by the agency under 12VAC5-481-460, 12VAC5-481-480 Part III (12VAC5-481-380 et. seq.), Part V (12VAC5-481-1170 et. seq.) or Parts Part VII (12VAC5-481-1660 et seq.) and XI (12VAC5-481-2330 et seq.) of this chapter is required; or

d. 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.

2. Each Type A specific license of broad scope issued under this part shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety committee.

3. Each Type B specific license of broad scope issued under this part shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety officer.

4. Each Type C specific license of broad scope issued under this part shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals who satisfy the requirements of subsection D of this section.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-480. 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. Reserved.

1. In addition to the requirements set forth in 12VAC5-481-450, a specific license authorizing the introduction of radioactive material into a product or material owned by or in the possession of the licensee or another to be transferred to persons exempt under 12VAC5-481-400 A will be issued if:

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 Appendix C , that reconcentration of the radioactive material in concentrations exceeding those in Appendix C is not likely, that use of lower concentrations is not feasible, and that the 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. Appendix C refers to Appendix C to Part 20—Quantities of Licensed Material Requiring Labeling (10 CFR 20, Appendix C, 60 FR 20186, April 25, 1995).

2. Each person licensed under this subsection shall file an annual report with the agency that shall identify the type and quantity of each product or material into which radioactive material has been introduced during the reporting period; name and address of the person who owned or possessed the product or material, into which radioactive material has been introduced, at the time of introduction; the type and quantity of radionuclide introduced into each such product or material; and the initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the licensee. If no transfers of radioactive material have been made pursuant to this subsection during the reporting period, the report shall so indicate. The report shall cover the year ending June 30, and shall be filed within 30 days thereafter.

B. Licensing the distribution of radioactive material in exempt quantities. (Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct radioactive material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the Nuclear Regulatory Commission, Washington, D.C. 20555-0001.)

1. An application for a specific license to distribute NARM to persons exempted from these regulations pursuant to 12VAC5-481-400 B will be approved if:

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 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 such labels and brochures.

2. The license issued under this subdivision 1 of this subsection is subject to the following conditions:

a. No more than 10 exempt quantities shall be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantity provided the sum of the fractions shall not exceed unity.

b. Each exempt quantity shall be separately and individually packaged. No more than 10 such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to 12VAC5-481-400 B. The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem (?Sv) per hour.

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

(1) Identifies the radionuclide and the quantity of radioactivity, and

(2) Bears the words "Radioactive Material."

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

(1) State that the contents are exempt from licensing state requirements,

(2) 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

(3) Set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the radioactive material.

3. Each person licensed under this subsection shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under 12VAC5-481-400 B or the equivalent regulations of a licensing state, and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the agency. Each report shall cover the year ending June 30, and shall be filed within 30 days thereafter. If no transfers of radioactive material have been made pursuant to 12VAC5-481-400 B during the reporting period, the report shall so indicate.

C. Licensing the incorporation of naturally occurring and accelerator-produced radioactive material into gas and aerosol detectors. An application for a specific license authorizing the incorporation of NARM into gas and aerosol detectors to be distributed to persons exempt under 12VAC5-481-400 C 3 will be approved if the application satisfies requirements equivalent to those contained in 10 CFR 32.26. The maximum quantity of radium-226 in each device shall not exceed 0.1 microcurie (3.7 kBq).

D. C. Licensing the manufacture and distribution or initial transfer of devices to persons generally licensed under 12VAC5-481-430 D B.

1. An application for a specific license to manufacture or distribute initially transfer devices containing radioactive material, excluding special nuclear material, to persons generally licensed under 12VAC5-481-430 D B or equivalent regulations of the Nuclear Regulatory Commission NRC, an or another agreement state, or a licensing state will be approved if:

a. The applicant satisfies the general requirements of 12VAC5-481-450;

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:

(1) The device can be safely operated by persons not having training in radiological protection,

(2) 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 in any period of one calendar quarter a dose in excess of 10% of the limits specified in the table in 12VAC5-481-640, and

(3) 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 dose to the appropriate organ as specified in 12VAC5-481-3580, Column IV; and

and

c. Each device bears a durable, legible, clearly visible label or labels approved by the agency, which contain in a clearly identified and separate statement:

(1) Instructions and precautions necessary to assure safe installation, operation, and servicing of the device; documents such as operating and service manuals may be identified in the label and used to provide this information;

(2) The requirement, or lack of requirement, for leak testing, or for testing any "on-off" mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity, and

(3) The information called for in one of the following statements, as appropriate, in the same or substantially similar form:

(a) 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 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 initial transferor

(b) 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. (The model, serial number, and name of the manufacturer or distributor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device.)

CAUTION—RADIOACTIVE MATERIAL

____________________Name of manufacturer or distributor initial transferor

2. In the event the applicant desires that the device be required to be tested at intervals longer than six months, either for proper operation of the "on-off" mechanism and indicator, if any, or for leakage of radioactive material or for both, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features that 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 will consider information that includes, but is not limited to:

a. Primary containment or 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 12VAC5-481-430 D B, or under equivalent regulations of the Nuclear Regulatory Commission NRC, an or another agreement state, or a 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 applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and basis for such estimates. The submitted information shall demonstrate that performance of such 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 calendar quarter dose in excess of 10% of the limits specified in the table in 12VAC5-481-640.

4. Each person licensed under 12VAC5-481-430 D this subsection to distribute devices to generally licensed persons shall:

a. Furnish a copy of the general license contained in 12VAC5-481-430 D B to each person to whom he directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license contained in 12VAC5-481-430 D B;

b. Furnish a copy of the general license contained in the Nuclear Regulatory Commission's NRC's, or another agreement state's, or licensing state's regulation equivalent to 12VAC5-481-430 D B, or alternatively, furnish a copy of the general license contained in 12VAC5-481-430 D B to each person to whom he directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license of the Nuclear Regulatory Commission NRC, the or another agreement state, or the licensing state. If a copy of the general license in 12VAC5-481-430 D B is furnished to such a person, it shall be accompanied by a note explaining that the use of the device is regulated by the Nuclear Regulatory Commission NRC, or another agreement state, or licensing state under requirements substantially the same as those in 12VAC5-481-430 D B;

c. Report to the agency all transfers of such devices to persons for use under the general license in 12VAC5-481-430 D B. Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type and model number of device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. If no transfers have been made to persons generally licensed under 12VAC5-481-430 D B during the reporting period, the report shall so indicate. The report shall cover each calendar quarter and shall be filed within 30 days thereafter;

d. Furnish reports to other agencies.

(1) Report to the Nuclear Regulatory Commission NRC all transfers of such devices to persons for use under the Nuclear Regulatory Commission NRC's general license in regulation entitled Certain detecting, measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere (10 CFR 31.1, 68 FR 58804, October 10, 2003) that is applicable in the Commonwealth in 10 CFR 31.5.

(2) Report to the responsible state agency all transfers of devices manufactured and distributed pursuant to this subsection for use under a general license in that state's regulations equivalent to 12VAC5-481-430 D B.

(3) Such reports shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type and model of the device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. The report shall be submitted within 30 days after the end of each calendar quarter in which such a device is transferred to the generally licensed person.

(4) If no transfers have been made to Nuclear Regulatory Commission NRC general licensees during the reporting period, this information shall be reported to the Nuclear Regulatory Commission NRC.

(5) If no transfers have been made to general licensees within a particular state during the reporting period, this information shall be reported to the responsible state agency upon request of that agency; and

e. Keep records showing the name, address, and the point of contact for each general licensee to whom he directly or through an intermediate person transfers radioactive material in devices for use pursuant to the general license provided in 12VAC5-481-430 D B, or equivalent regulations of the Nuclear Regulatory Commission, an NRC or another agreement state, or a licensing state. The records shall show the date of each transfer, the radionuclide and the quantity of radioactivity in each device transferred, the identity of any intermediate person, and compliance with the report requirements of subdivision 4 of this subsection.

f. If a notification of bankruptcy has been made under 12VAC5-481-500 E or the license is to be terminated, each person licensed under this section shall provide, upon request, to the agency, the NRC and to any appropriate agreement state, records of final disposition required under subdivision 4 e of this subsection.

g. The licensee shall maintain all information concerning transfers and receipts of devices that supports the reports required by this section. Records required by this section must be maintained for a period of three years following the date of the recorded event.

E. D. Special requirements for the manufacture, initially transfer, assembly, or repair of luminous safety devices for use in aircraft. An application for a specific license to manufacture, assemble, or repair luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under 12VAC5-481-430 E D will be approved if:

1. The applicant satisfies the general requirements specified in 12VAC5-481-450; and

2. The applicant satisfies the requirements of §§ 10 CFR 32.53, 32.54, 32.55, 32.56, and 32.101 and 32.110 of 10 CFR Part 32, or their equivalent.

F. E. Special requirements for license to manufacture or initially transfer calibration sources containing americium-241, plutonium or radium-226 for distribution to persons generally licensed under 12VAC5-481-430 G F. An application for a specific license to manufacture calibration and reference sources containing americium-241, plutonium or radium-226 to persons generally licensed under 12VAC5-481-430 G F will be approved if:

1. The applicant satisfies the general requirement of 12VAC5-481-450; and

2. The applicant satisfies the requirements of §§ 10 CFR 32.57, 32.58, 32.59, and 32.102 of 10 CFR Part 32 and § 10 CFR 70.39 of 10 CFR Part 70 or their equivalent.

G. F. Reserved.

H. G. Manufacture and distribution of radioactive material for certain in vitro clinical or laboratory testing under general license. An application for a specific license to manufacture or distribute radioactive material for use under the general license of 12VAC5-481-430 G will be approved if:

1. The applicant satisfies the general requirements specified in 12VAC5-481-450.

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

a. Carbon-14 in units not exceeding 10 microcuries (370 kBq) 370 kBq (10 ?Ci) each.

b. Cobalt-57 in units not exceeding 10 microcuries (370 kBq) 370 kBq (10 ?Ci) each.

c. Hydrogen-3 (tritium) in units not exceeding 50 microcuries (1.85 MBq) 1.85 MBq (50 ?Ci) each.

d. Iodine-125 in units not exceeding 10 microcuries (370 kBq) 370 kBq (10 ?Ci) each.

e. Mock iodine-125 in units not exceeding 0.05 microcurie (1.85 kBq) 1.85 kBq (0.05 ?Ci) of iodine-129 and 0.005 microcurie (185 Bq) 185 Bq (0.005 ?Ci) of americium-241 each.

f. Iodine-131 in units not exceeding 10 microcuries (370 kBq) 370 kBq (10 ?Ci) each.

g. Iron-59 in units not exceeding 20 microcuries (740 kBq) 740 kBq (20 ?Ci) each.

h. Selenium-75 in units not exceeding 10 microcuries (370 kBq) 370 kBq (10 ?Ci) 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 10 microcuries (370 kBq) 370 kBq (10 ?Ci) of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 50 microcuries (1.85 MBq) 1.85 MBq (50 ?Ci) of hydrogen-3 (tritium); 20 microcuries (740 kBq) 740 kBq (20 ?Ci) of iron-59; or mock iodine-125 in units not exceeding 0.05 microcurie (1.85 kBq) 1.85 kBq (0.05 ?Ci) of iodine-129 and 0.005 microcurie (185 Bq) 185 Bq (0.005 ?Ci) of americium-241 each; and

b. Displaying the radiation caution symbol described in 12VAC5-481-850 and the words, "CAUTION, RADIOACTIVE MATERIAL," and "Not for Internal or External Use in Humans or Animals."

4. One of the following statements, as appropriate, or a substantially similar statement that contains the information called for in one of 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, veterinarians, 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 therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the Nuclear Regulatory Commission or of a state with which the Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority.

____________________ Name of manufacturer

b. This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians, 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 therefrom, 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 which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such 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 12VAC5-481-910.

I. H. Licensing the manufacture and distribution of ice detection devices. An application for a specific license to manufacture and distribute ice detection devices to persons generally licensed under 12VAC5-481-430 H will be approved if:

1. The applicant satisfies the general requirements of 12VAC5-481-450; and

2. The criteria of §§ 10 CFR 32.61, 32.62, and 32.103 of 10 CFR Part 32 and 32.110 are met.

J. Manufacture and distribution of radiopharmaceuticals containing radioactive material for medical use under group licenses. An application for a specific license to manufacture and distribute radiopharmaceuticals containing radioactive material for use by persons licensed pursuant to this part for the uses listed in 12VAC5-481-1940, 12VAC5-481-1960 and 12VAC5-481-2000 will be approved if:

1. The applicant satisfies the general requirements specified in 12VAC5-481-450;

2. The applicant submits evidence that:

a. The radiopharmaceutical containing radioactive material will be manufactured, labeled, and packaged in accordance with the federal Food, Drug and Cosmetic Act or the Public Health Service Act, such as a new drug application (NDA) approved by the Food and Drug Administration (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 radiopharmaceutical containing radioactive material is 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 that is appropriate for safe handling and storage of radiopharmaceuticals by group licensees; and

4. a. The label affixed to each package of the radiopharmaceutical contains information on the radionuclide, quantity, and date of assay and the label affixed to each package, or the leaflet or brochure which accompanies each package, contains a statement that the radiopharmaceutical is licensed by the agency for distribution to persons licensed pursuant to this part for the uses listed in 12VAC5-481-1940, 12VAC5-481-1960 and 12VAC5-481-2000 or under equivalent licenses of the Nuclear Regulatory Commission, an agreement state, or a licensing state.

b. The labels, leaflets, or brochures required by subdivision 4 a of this subsection are in addition to the labeling required by the Food and Drug Administration (FDA) and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA.

K. Manufacture and distribution of generators or reagent kits for preparation of radiopharmaceuticals containing radioactive material. An application for a specific license to manufacture and distribute generators or reagent kits containing radioactive material for preparation of radiopharmaceuticals by persons licensed. (Although the agency does not regulate the manufacture and distribution of reagent kits that do not contain radioactive material, it does regulate the use of such reagent kits for the preparation of radiopharmaceuticals containing radioactive material as part of its licensing and regulation of the users of radioactive material. Any manufacturer of reagent kits that do not contain radioactive material who desires to have his reagent kits approved by the agency for use by persons licensed pursuant to 12VAC5-481-1960 may submit the pertinent information specified in this subsection pursuant to this part for the uses listed in 12VAC5-481-1960 will be approved if:

1. The applicant satisfies the general requirements specified in 12VAC5-481-450;

2. The applicant submits evidence that:

a. The generator or reagent kit is to be manufactured, labeled and packaged in accordance with the federal Food, Drug and Cosmetic Act or the Public Health Service Act, such as a new drug application (NDA) approved by the Food and Drug Administration (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, 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 standpoint, 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 pursuant to 12VAC5-481-1960 or under equivalent licenses of the Nuclear Regulatory Commission, an agreement state, or a licensing state. The labels, leaflets, or brochures required by this section are in addition to the labeling required by the Food and Drug Administration (FDA) and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA.

I. Manufacture, preparation, or transfer for commercial distribution of drugs containing radioactive material for medical use under Part VII (12VAC5-481-1660 et seq.).

1. An application for a specific license to manufacture, prepare, or transfer for commercial distribution drugs containing radioactive material for use by persons authorized pursuant to Part VII (12VAC5-481-1660 et seq.) will be approved if:

a. The applicant satisfies the general requirements specified in 12VAC5-481-450;

b. The applicant submits evidence that the applicant is at least one of the following:

(1) Registered or licensed with the U.S. Food and Drug Administration (FDA) as a drug manufacturer;

(2) Registered or licensed with a state agency as a drug manufacturer;

(3) Licensed as a pharmacy by the Virginia Board of Pharmacy;

(4) Operating as a nuclear pharmacy within a federal medical institution; or

(5) A PET drug production facility registered with a state agency.

c. The applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees; and

d. The applicant satisfies the following labeling requirements:

(1) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half life greater than 100 days, the time may be omitted.

(2) A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

2. A licensee authorized to manufacture, prepare or transfer for commercial distribution radioactive drugs shall ensure that any individual preparing the drugs is one of the following:

a. An authorized nuclear pharmacist (ANP) as defined in 12VAC5-481-10;

b. An individual that meets the requirements specified in 12VAC5-481-1770 and 12VAC5-481-1790, and the licensee has received an approved license amendment identifying this individual as an ANP;

c. A pharmacist, as defined in 12VAC5-481-10, designated as an ANP if:

(1) The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material, and

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

d. An individual under the supervision of an ANP as specified in 12VAC5-481-1710.

3. Shall provide to the agency no later than 30 days after the date that the licensee allows, under subdivision 2 a or c in this subsection, the individual to work as an ANP:

a. The individual's certification by a specialty board whose certification process has been recognized by the NRC with the written attestation signed by a preceptor as required by 12VAC5-481-1770;

b. An NRC or another agreement state license;

c. NRC master materials licensee permit;

d. The permit issued by a licensee or NRC master materials permittee of broad scope or the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist; or

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

f. The Virginia Board of Pharmacy's license.

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

a. Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and

b. Check each instrument for constancy and proper operation at the beginning of each day of use.

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

6. Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/ryubidium-82 generators shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination in accordance with 12VAC5-481-1930. The licensee shall record the results of each test and retain each record for three years after the record is made.

L. J. Manufacture and distribution of sources or devices containing radioactive material for medical use. An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to Part VII (12VAC5-481-1660 et seq.) of this chapter for use as a calibration or reference source or for the uses listed in 12VAC5-481-2010, 12VAC5-481-2020, 12VAC5-481-2040 and 12VAC5-481-2060 will be approved if:

1. The applicant satisfies the general requirements in 12VAC5-481-450;

2. The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

a. The radioactive material contained, its chemical and physical form, and amount,

b. Details of design and construction of the source or device,

c. Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents,

d. For devices containing radioactive material, the radiation profile of a prototype device,

e. Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests,

f. Procedures and standards for calibrating sources and devices,

g. Legend and methods for labeling sources and devices as to their radioactive content, and

h. Instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device provided, that instructions that are too lengthy for such label may be summarized on the label and printed in detail on a brochure that is referenced on the label;

3. The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, and date of assay, and a statement that the source or device is licensed by the agency for distribution to persons licensed pursuant to Part VII (12VAC5-481-1660 et seq.) of this chapter and 12VAC5-481-2040 and 12VAC5-481-2060 12VAC5-481-1830, 12VAC5-481-2010, 12VAC5-481-2020 and 12VAC5-481-2040 or under equivalent licenses of the Nuclear Regulatory Commission NRC, an or another agreement state, or a licensing state, provided that such labeling for sources that do not require long term storage may be on a leaflet or brochure that accompanies the source;

4. In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months, he the applicant shall include in his application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source; and

5. In determining the acceptable interval for test of leakage of radioactive material, the agency will consider information that includes, but is not limited to:

a. Primary containment or 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 sources or devices or similarly designed and constructed sources or devices.

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

1. An application for a specific license to manufacture industrial products and devices containing depleted uranium for use pursuant to 12VAC5-481-420 B C or equivalent regulations of the Nuclear Regulatory Commission NRC or an another agreement state will be approved if:

a. The applicant satisfies the general requirements specified in 12VAC5-481-450;

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 in any period of one calendar quarter a radiation dose in excess of 10% of the limits specified in 12VAC5-481-640; and

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 will 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(s) of the industrial product or device cannot be reasonably foreseen.

4. Each person licensed pursuant to subdivision 1 of this subsection shall:

a. Maintain the level of quality control required by the license in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device;

b. Label or mark each unit to:

(1) Identify the manufacturer or initial transferor of the product or device and the number of the license under which the product or device was manufactured or initially transferred, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and

(2) 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 Nuclear Regulatory Commission NRC or an another 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. Do the following:

(1) Furnish a copy of the general license contained in 12VAC5-481-420 B C and a copy of agency form RH-F-13 "Certificate - Use of Depleted Uranium under a General License" to each person to whom he transfers depleted uranium in a product or device for use pursuant to the general license contained in 12VAC5-481-420 B C is transferred, or

(2) Furnish a copy of the general license contained in the Nuclear Regulatory Commission's NRC's or another agreement state's regulation equivalent to 12VAC5-481-420 B and a copy of the Nuclear Regulatory Commission's NRC's or another agreement state's certificate, or alternatively, furnish a copy of the general license contained in 12VAC5-481-420 B C and a copy of agency form RH-F-13 "Certificate - Use of Depleted Uranium under a General License" to each person to whom he transfers depleted uranium in a product or device for use pursuant to the general license of the Nuclear Regulatory Commission NRC or an another agreement state is transferred, with a note explaining that use of the product or device is regulated by the Nuclear Regulatory Commission NRC or an another agreement state under requirements substantially the same as those in 12VAC5-481-420 B C;

e. Report to the agency all transfers of industrial products or devices to persons for use under the general license in 12VAC5-481-420 B C. Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and 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 such a product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under 12VAC5-481-420 B C during the reporting period, the report shall so indicate;

f. Do the following:

(1) Report to the Nuclear Regulatory Commission NRC all transfers of industrial products or devices to persons for use under the Nuclear Regulatory Commission NRC general license in 10 CFR 40.25,

(2) Report For devices transferred to another agreement state, report to the responsible state agency all transfers of devices manufactured and distributed pursuant to this subsection for use under a general license in that state's regulations equivalent to 12VAC5-481-420 B C,

(3) Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and 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 such product or device is transferred to the generally licensed person,

(4) If no transfers have been made to Nuclear Regulatory Commission NRC licensees during the reporting period, this information shall be reported to the Nuclear Regulatory Commission NRC, and

(5) If no transfers have been made to general licensees within a particular another agreement state during the reporting period, this information shall be reported to the responsible state agency upon the request of that agency; and keep records showing the name, address, and point of contact for each general licensee to whom he transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in 12VAC5-481-420 B C or equivalent regulations of the Nuclear Regulatory Commission NRC or an another agreement state. The records shall be maintained for a period of two years and shall show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the report requirements of this section.

L. An application for a specific license to manufacture, or initially transfer for sale or distribution, synthetic plastic resins containing scandium-46 for use pursuant to 12VAC5-481-400 F will be approved if:

1. The applicant satisfies the general requirements specified in 12VAC5-481-450 of this chapter;

2. The product is designed to be used only for sand-consolidation in oil wells;

3. The applicant submits the following information:

a. The general description of the product to be manufactured or initially transferred.

b. A description of control procedures to be used to assure that the concentration of scandium-46 in the final product at the time of distribution will not exceed 1.4 x 10^-3 ?Ci/ml.

4. Each container of such product will bear a durable, legible label approved by the agency, which contains the following information:

a. The product name;

b. A statement that the product contains radioactive scandium and is designed and manufactured only for sand-consolidation in oil wells;

c. Instructions necessary for proper use; and

d. The manufacturer's name.

M. Serialization of nationally tracked sources. Each licensee who manufactures a nationally tracked source shall assign a unique serial number to each nationally tracked source. Serial numbers must be composed only of alpha-numeric characters.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-500. Specific terms and conditions of licenses.

A. Each license issued pursuant to this part shall be subject to all the provisions of the Act, now or hereafter in effect, and to all rules, regulations, and orders of the agency.

B. No license issued or granted under this part and no right to possess or utilize radioactive material granted by any license issued pursuant to this part shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person unless the agency shall, after securing full information find that the transfer is in accordance with the provisions of the Act, now or hereafter in effect, and to all valid rules, regulations, and orders of the agency, and shall give its consent in writing.

C. Each person licensed by the agency pursuant to this part shall confine use and possession of the material licensed to the locations and purposes authorized in the license.

D. Each licensee shall notify the agency in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license.

E. Each licensee shall notify the agency in writing immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 (Bankruptcy) of the United States Code by or against:

1. The licensee;

2. An entity (as that term is defined in 11 USC §101(14)) 11 USC §101(15)) controlling the licensee or listing the license or licensee as property of the estate; or

3. An affiliate (as that term is defined in 11 USC §101(2)) of the licensee.

F. The notification specified in subsection E of this section shall indicate the bankruptcy court in which the petition for bankruptcy was filed and the date of the filing of the petition.

G. PET Distribution.

1. Authorization under 12VAC5-481-440 H to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable FDA, other state or local requirements governing radioactive drugs.

2. Each licensee authorized under 12VAC5-481-440 H to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall:

a. Satisfy the labeling requirements in 12VAC5-481-480 I 1 d for each PET radioactive drug transport radiation shield and each syringe, vial, or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of its consortium.

b. Possess and use instrumentation to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of its consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in 12VAC5-481-480 I 3.

3. A licensee that is a pharmacy authorized under 12VAC5-481-440 H to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall require that any individual that prepares PET radioactive drugs shall be:

a. An ANP that meets the requirements in 12VAC5-481-480 I 2; or

b. An individual under the supervision of an ANP as specified in 12VAC5-481-1710.

4. A pharmacy, authorized under 12VAC5-481-440 H to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium that allows an individual to work as an ANP, shall meet the requirements of 12VAC5-481-480 I 2.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-510. Expiration and termination of licenses and decommissioning of sites and separate building or outdoor areas.

A. Except as provided in 12VAC5-481-520 B, each a specific license shall expire at the end of the specified day in the month and year stated therein in the license. If an application for license renewal has been filed at least 30 days prior to the expiration date stated in the existing license and the agency denies the renewal application, the license shall expire on the date as stated in the determination of denial. If an application for license renewal is filed less than 30 days from the expiration date stated in the existing license, the agency may deny the renewal application and the license shall expire on the expiration date stated in the license.

B. Each licensee shall notify the agency immediately, in writing, and request termination of the license when the licensee decides to terminate all activities involving radioactive material authorized under the license. This notification and request for termination of the license must include the reports and information specified in subsection D 1 d and e of this section.

C. No less than 30 days before the expiration date specified in the license, the licensee shall either:

1. Submit an application for license renewal under 12VAC5-481-520; or

2. Notify the agency, in writing, if the licensee decides not to renew the license.

D. Do the following:

1. If a licensee does not submit an application for license renewal under 12VAC5-481-520, the licensee shall, on or before the expiration date specified in the license:

a. Terminate use of radioactive material;

b. Remove radioactive contamination to the extent practicable;

c. Properly dispose of radioactive material;

d. Submit a completed appropriate agency form; and

e. Submit a radiation survey report to confirm the absence of radioactive material or to establish the levels of residual radioactive contamination, unless the licensee demonstrates the absence of residual radioactive contamination in some other manner. The licensee shall, as appropriate:

(1) Report levels of radiation in units of microrads per hour of beta and gamma radiation at one centimeter and gamma radiation at one meter from surfaces and report levels of radioactivity, including alpha, in units of transformations per minute (or microcuries) per 100 square centimeters removable and fixed on surfaces, microcuries per milliliter in water, and picocuries per gram in contaminated solids such as soils or concrete; and

(2) Specify the instrumentation used and certify that each instrument was properly calibrated and tested.

2. If no residual radioactive contamination attributable to activities conducted under the license is detected, the licensee shall submit a certification that no detectable radioactive contamination was found. The agency will notify the licensee, in writing, of the termination of the license.

3. Do the following:

a. If detectable levels of residual radioactive contamination attributable to activities conducted under the license are found, the license continues in effect beyond the expiration date, if necessary, with respect to possession of residual radioactive material present as contamination until the agency notifies the licensee in writing that the license is terminated. During this time the licensee is subject to the provisions of subsection E of this section.

b. In addition to the information submitted under subdivision 1 d and e of this subsection, the licensee shall submit a plan for decontamination, if required, as regards residual radioactive contamination remaining at the time the license expires.

E. Each licensee who possesses residual radioactive material under subdivision D 3 of this subsection, following the expiration date specified in the license shall:

1. Limit actions involving radioactive material to those related to decontamination and other activities related to preparation for release for unrestricted use; and

2. Continue to control entry to restricted areas until they are suitable for release for unrestricted use and the agency notifies the licensee in writing that the license is terminated.

B. A specific license revoked by the agency expires at the end of the day on the date of the agency's final determination, or on the expiration date stated in the determination, or as otherwise provided by an agency order.

C. A specific license remains valid, with respect to possession of radioactive material, until the agency notifies the licensee in writing that the license is terminated. While the license is valid, the licensee shall do all of the following:

1. Limit actions involving radioactive material to those related to decommissioning and other activities related to preparation for release for unrestricted use.

2. Continue to control entry to restricted areas until they are suitable for release for unrestricted use and the agency notifies the licensee in writing that the license is terminated.

D. A licensee shall do all of the following:

1. Notify the agency within 60 days of any of the following:

a. Expiration of the license pursuant to subsections A or B of this section.

b. The licensee's deciding to permanently cease 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.

c. The absence of conduct of any principal activities under the license for a period of 24 months.

d. The absence of conduct of any principal activities 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.

2. If any separate building or outdoor area contains residual radioactivity so that the building or outdoor area is unsuitable for release, do one of the following:

a. Begin decommissioning its site, separate building or outdoor area if a decommissioning plan has been previously approved by the agency.

b. Submit a decommissioning plan within 12 months if required by subsection F of this section and begin decommissioning upon approval of that plan.

E. Concurrent with the notification required by subsection D of this section, the licensee shall maintain in effect all decommissioning financial assurances established by the licensee pursuant to 12VAC5-481-450 C in conjunction with a license issuance or renewal or as required by this section. The amount of the financial assurance shall be increased, or may be decreased, as appropriate, to cover the detailed cost estimate for decommissioning established pursuant to subdivision H 5 of this section. Following approval of the decommissioning plan and with the agency's approval, a licensee may reduce the amount of the financial assurance as decommissioning proceeds and radiological contamination is reduced at the site.

F. A licensee shall submit a decommissioning plan to the agency if required by license condition or if the procedures and activities necessary to carry out decommissioning of the site, separate building or outdoor area have not been previously approved by the agency and the procedures and activities may adversely effect the health and safety of workers or the public. The procedures may not be carried out prior to the agency's approval of the decommissioning plan. Examples of applicable procedures and activities include any of the following cases:

1. Procedures that would involve techniques not applied routinely during cleanup or maintenance operations.

2. Procedures by which workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation.

3. Procedures that could result in significantly greater airborne concentrations of radioactive materials than are present during operation.

4. Procedures that could result in significantly greater releases of radioactive material to the environment than those associated with operation.

G. The agency may approve an alternate schedule for submittal of a decommissioning plan required pursuant to subsection D of this section if the agency determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and presents no undue risk from radiation to the public health and safety and is otherwise in the public interest.

H. The proposed decommissioning plan for the site or separate building or outdoor area shall include all of the following elements:

1. A description of the conditions of the site, separate building or outdoor area sufficient to evaluate the acceptability of the plan.

2. A description of planned decommissioning activities.

3. A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning.

4. A description of the planned final radiation survey.

5. An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning.

6. For decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, a justification for the delay based on the criteria in subsection J of this section.

I. Except as provided in subsection H of this section, a licensee shall complete decommissioning of the site or separate building or outdoor area no later than 24 months following the initiation of decommissioning. When decommissioning involves the entire site, a licensee shall request license termination no later than 24 months following the initiation of decommissioning.

J. The agency may approve a request for an alternative schedule for completion of decommissioning of the site, separate building or outdoor area, and license termination if appropriate, if the agency determines that the alternative is warranted after consideration of all the following:

1. Whether it is technically feasible to complete decommissioning within the allotted 24-month period.

2. Whether sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted 24-month period.

3. Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay.

4. Whether a significant reduction in radiation exposure to workers may be achieved by allowing short-lived radionuclides to decay.

5. Other site-specific factors which the agency may consider appropriate on a case-by-case basis, such as the regulatory requirements of other government agencies, court decisions, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.

K. As the final step in decommissioning, a licensee shall do all the following:

1. Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed agency form for disposition of radioactive materials or equivalent information.

2. Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning in 12VAC5-481-1161.

3. Report levels of gamma radiation in units of millisieverts (microroentgen) per hour at one meter from surfaces, and report levels of radioactivity, including alpha and beta, in units of megabecquerels per 100 square centimeters, disintegrations per minute per 100 square centimeters or microcuries per 100 square centimeters - removable and fixed - for surfaces, megabecquerels (microcuries) per milliliter for water, and becquerels (picocuries) per gram for solids such as soils or concrete.

4. Specify the survey instruments used and certify that each instrument is properly calibrated and tested.

L. The agency shall terminate a specific license, including an expired license, by written notice to the licensee when the agency determines all of the following have occurred:

1. Radioactive material has been properly disposed of.

2. Reasonable effort has been made to eliminate residual radioactive contamination, if present.

3. The licensee has filed with the agency sufficient information, including a radiation survey, to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning in 12VAC5-481-1161.

4. The licensee has submitted records required under 12VAC5-481-571 to the agency.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-530. Amendment of licenses at request of licensee.

Applications for amendment of Amendment requests for a license shall be filed in accordance with 12VAC5-481-440 and shall specify the respects in which the licensee desires the license to be amended and the grounds for such amendment.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-540. Agency action on applications to renew or amend.

In considering an application by a licensee to renew or amend the license, the agency will apply the criteria set forth in 12VAC5-481-450 through 12VAC5-481-480 and in Parts V (12VAC5-481-1170 et seq.), VII (12VAC5-481-1660 et seq.), XI (12VAC5-481-2330 et seq.), or XII (12VAC5-481-2660 et seq.), XIV (12VAC5-481-3140 et seq.), or XVI (12VAC5-481-3460 et seq.) of this chapter, as applicable.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 5
Licenses Held at the Time of the Effective Date of These Regulations

12VAC5-481-550. Persons possessing a license for source, byproduct, or special nuclear material in quantities not sufficient to form a critical mass on effective date of these regulations.

Any person who, on September 20, 2006 the effective date as stated in 12VAC5-481-160, possesses a general or specific license for source, byproduct, or special nuclear material in quantities not sufficient to form a critical mass, issued by the Nuclear Regulatory Commission NRC, shall be deemed to possess a like license issued under this part and the Act, such license to expire either 90 days after receipt from the agency of a notice of expiration of such license, or on the date or expiration specified in the Nuclear Regulatory Commission NRC license, whichever is earlier.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-560. Persons possessing naturally occurring and accelerator-produced radioactive material (NARM) NARM on effective date of these regulations.

Any person who, on September 20, 2006, possesses NARM for which a specific license is required by the Act or this part shall be deemed to possess such a license issued under the Act and this part. Such license shall expire 90 days after September 20, 2006; provided, however, that if within the 90 days the person possessing such material files an application in proper form for a license, such existing license shall not expire until the application has been finally determined by the agency.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 6
Transfer of Material

12VAC5-481-570. Transfer of material.

A. No licensee shall transfer radioactive material except as authorized pursuant to this section.

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

1. To the agency only after receiving prior approval from the agency.

2. To the United States Department of Energy;

3. To any person exempt from these regulations to the extent permitted under such exemption;

4. To any person authorized to receive such material under terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the agency, the Nuclear Regulatory Commission NRC, any or another agreement state or any licensing state, or to any person otherwise authorized to receive such material by the federal government or any agency thereof, the agency, an or another agreement state, or a 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 Nuclear Regulatory Commission NRC, an or another agreement state or a licensing state, or to a general licensee who is required to register with the agency, the Nuclear Regulatory Commission NRC, an or another agreement state or a 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. Any of the following methods for the verification required by subsection C of this section is acceptable:

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

2. The transferor may 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 may 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 that the oral certification is confirmed in writing within 10 days.

4. The transferor may obtain other information compiled by a reporting service from official records of the agency, the Nuclear Regulatory Commission NRC, an or another agreement state, or a licensing state regarding the identity of licensees and the scope and expiration dates of licenses and registration.

5. When none of the methods of verification described in subdivisions 1 through 4 of this subsection are readily available or when a transferor desires to verify that information received by one of such methods is correct or up to date, the transferor may obtain and record confirmation from the agency, the Nuclear Regulatory Commission NRC, or an another agreement state, or a licensing state that the transferee is licensed to receive the radioactive material.

E. Shipment and transport of radioactive material shall be in accordance with the provisions of Part XIII (12VAC5-481-2950 et seq.) of this chapter.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 7
Records

12VAC5-481-571. Receipt, transfer and disposal records.

A. Record retention. A licensee shall retain records required by 12VAC5-481-100 or by license condition. If a retention period is not otherwise specified by this chapter or license condition, the record shall be retained until the agency terminates each license.

B. Transfer of records to the agency. Prior to license termination, a licensee authorized to possess radioactive material, in an unsealed form, with a half-life greater than 120 days, shall forward to the agency all records of disposal of licensed material made under 12VAC5-481-910 to 12VAC5-481-950, including burials authorized before January 28, 1981, and the results of measurements and calculations required by 12VAC5-481-1000.

C. Transfer of records to new licensee.

1. If licensed activities are transferred or assigned in accordance with 12VAC5-481-570, each licensee authorized to possess radioactive material in unsealed form, with a half-life greater than 120 days, shall transfer the following records to the new licensee:

a. Records of disposal of licensed material made under 12VAC5-481-910 to 12VAC5-481-950, including burials authorized before January 28, 1981.

b. Records of the results of measurements and calculations required by12VAC5-481-1000.

2. The new licensee shall be responsible for maintaining the records required in subdivision C 1 of this section until the license is terminated.

D. Transfer of records of decommissioning activities. A licensee shall forward the records required by 12VAC5-481-450 C to the agency prior to license termination.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 7 8
Modification and Revocation of Licenses

12VAC5-481-580. Modification and revocation of licenses.

A. The terms and conditions of all licenses shall be subject to amendment, revision, or modification or the license may be suspended or revoked by reason of amendments to the Act, or by reason of rules, regulations, and orders issued by the agency.

B. Any license may be revoked, suspended, or modified, in whole or in part, for any false statement in the application or any statement of fact required under provisions of the Act, or because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means that would warrant the agency to refuse to grant a license on an original application, or for violation of, or failure to observe any of the terms and conditions of the Act, or of the license, or of any rule, regulation, or order of the agency.

C. No Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, no license shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefor, facts or conduct that may warrant such action shall have been called to the attention of the licensee in writing and the licensee shall have been accorded an opportunity to demonstrate or achieve compliance with all lawful requirements.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 8 9
Reciprocity

12VAC5-481-590. Reciprocal recognition of licenses.

A. Licenses of byproduct, source, and special nuclear material in quantities not sufficient to form a critical mass.

1. Subject to these regulations, any person who holds a specific license from the Nuclear Regulatory Commission NRC or an another agreement state, and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within this state for a period not in excess of 180 days in any calendar year provided that:

a. The licensing document does not limit the activity authorized by such document to specified installations or locations;

b. The out-of-state licensee notifies the agency in writing at least three days prior to engaging in such activity. Such notification shall indicate the location, period, and type of proposed possession and use within the state, and shall 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 the receipt of the initial notification from a person engaging in activities under the general license provided in this subdivision;

c. The out-of-state licensee complies with all applicable regulations of the agency and with all the terms and conditions of the licensing document, except any such terms and conditions that may be inconsistent with applicable regulations of the agency;

d. The out-of-state licensee supplies such other information as the agency may request; and

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

(1) Specifically licensed by the agency, or by the Nuclear Regulatory Commission NRC or another agreement state to receive such material, or

(2) Exempt from the requirements for a license for such material under 12VAC5-481-400 A.

2. Notwithstanding the provisions of subsection subdivision A 1 of this section, any person who holds a specific license issued by the Nuclear Regulatory Commission NRC or an another agreement state authorizing the holder to manufacture, transfer, install, or service a device described in 12VAC5-481-430 B within areas subject to the jurisdiction of the licensing body is hereby granted a general license to install, transfer, demonstrate, or service such a device in this state provided that:

a. Such person shall file 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 such report shall identify each general licensee to whom such device is transferred by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device;

b. The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by the Nuclear Regulatory Commission NRC or an another agreement state;

c. Such person shall assure that any labels required to be affixed to the device under regulations of the authority which licensed manufacture of the device bear a statement that "Removal of this label is prohibited"; and

d. The holder of the specific license shall furnish to each general licensee to whom he transfers such device or on whose premises he installs such device a copy of the general license contained in 12VAC5-481-430 D B or in equivalent regulations of the agency having jurisdiction over the manufacture and distribution of the device.

3. The agency may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by the Nuclear Regulatory Commission NRC or an another agreement state, or any product distributed pursuant to such licensing document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property.

B. Licenses of naturally occurring and accelerator-produced radioactive material NARM.

1. Subject to these regulations, any person who holds a specific license from a licensing state the NRC or another agreement state, and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within this state for a period not in excess of 180 days in any calendar year provided that:

a. The licensing document does not limit the activity authorized by such document to specified installations or locations;

b. The out-of-state licensee notifies the agency in writing at least three days prior to engaging in such activity. Such notification shall indicate the location, period, and type of proposed possession and use within the state, and shall 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 the receipt of the initial notification from a person engaging in activities under the general license provided in subdivision 1 of this subsection;

c. The out-of-state licensee complies with all applicable regulations of the agency and with all the terms and conditions of the licensing document, except any such terms and conditions which may be inconsistent with applicable regulations of the agency;

d. The out-of-state licensee supplies such other information as the agency may request; and

e. The out-of-state licensee shall not transfer or dispose of radioactive material possessed or used under the general license provided in subdivision 1 of this subsection except by transfer to a person:

(1) Specifically licensed by the agency, or by another licensing state the NRC or another agreement state to receive such material, or

(2) Exempt from the requirements for a license for such material under 12VAC5-481-400.

2. Notwithstanding the provisions of subdivision 1 of this subsection, any person who holds a specific license issued by a licensing state the NRC or another agreement state authorizing the holder to manufacture, transfer, install, or service a device described in 12VAC5-481-430 B 1 within areas subject to the jurisdiction of the licensing body is hereby granted a general license to install, transfer, demonstrate or service such a device in this state provided that:

a. Such person shall file 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 such report shall identify each general licensee to whom such device is transferred by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device;

b. The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by a licensing state the NRC or another agreement state;

c. Such person shall assure that any labels required to be affixed to the device under regulations of the authority which licensed manufacture of the device bear a statement that "Removal of this label is prohibited"; and

d. The holder of the specific license shall furnish to each general licensee to whom he transfers such device or on whose premises he installs such device a copy of the general license contained in 12VAC5-481-430 D B or in equivalent regulations of the agency having jurisdiction over the manufacture and distribution of the device.

3. The agency may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by a licensing state the NRC or another agreement state, or any product distributed pursuant to such licensing document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 2
Radiation Protection Programs

12VAC5-481-630. Radiation protection programs.

The following regulations regulation, Radiation protection programs (10 CFR 20.1101, 63 FR 39482, July 23, 1998) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1101) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 3
Occupational Dose Limits

12VAC5-481-640. Occupational dose limits for adults.

The following regulations regulation, Occupational dose limits for adults (10 CFR 20.1201, 67 FR 16304, April 5, 2002) and Definitions (10 CFR 20.1003, 67 FR 62872, October 9, 2002) are (10 CFR 20.1201) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-650. Compliance with requirements for summation of external and internal doses.

The following regulations regulation, Compliance with requirements for summation of external and internal doses (10 CFR 20.1202, 57 FR 5787, December 8, 1992) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1202) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-660. Determination of external dose from airborne radioactive material.

The following regulations regulation, Determination of external dose from airborne radioactive material (10 CFR 20.1203, 63 FR 39482, July 23, 1998) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1203) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-670. Determination of internal exposure.

The following regulations regulation, Determination of internal exposure (10 CFR 20.1204, 60 FR 20185, April 25, 1995) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1204) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-680. Determination of prior occupational dose.

A. For each individual who may enter the licensee's or registrant's restricted area and is likely to receive, in a year, an occupational dose requiring monitoring pursuant to 12VAC5-481-660 12VAC5-481-760, the licensee or registrant shall: determine the occupational radiation dose received during the current year.

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. Prior to 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, including doses received during accidents and emergencies, received during the lifetime of the individual.

C. In complying with the requirements of subsection A or B of this section, a licensee or registrant may:

1. Accept, as a record of the occupational dose that the individual received during the current year, a written 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;

2. Accept, as the record of lifetime cumulative radiation dose, an up-to-date occupational radiation exposure form provided by the agency form Y 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. Do the following:

1. The licensee or registrant shall record the exposure history, as required by this section on an occupational radiation exposure form provided by the agency form Y, or other clear and legible record, of all the information required on that form. 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 in preparing the occupational radiation exposure form provided by the agency form Y or equivalent. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on the occupational radiation exposure form provided by the agency form Y or equivalent indicating the periods of time for which data are not available.

2. Licensees or registrants are not required to partition historical dose between external dose equivalent(s) and internal committed dose equivalent(s). Further, occupational exposure histories obtained and recorded on the occupational radiation exposure form provided by the agency form Y or equivalent before September 20, 2006, might not have included effective dose equivalent, but may be used in the absence of specific information on the intake of radionuclides by the individual.

E. 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 assume:

1. In establishing administrative controls pursuant to 12VAC5-481-640 for the current year, that the allowable dose limit for the individual is reduced 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

2. That the individual is not available for planned special exposures.

F. The licensee or registrant shall retain the records on an occupational radiation exposure form provided by the agency form Y or equivalent until the agency terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing the occupational radiation exposure form provided by the agency form Y or equivalent for three years after the record is made.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-690. Planned special exposures.

The following regulations regulation, Planned special exposures (10 CFR 20.1206, 63 FR 39482, July 23, 1998) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1206) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-700. Occupational dose limits for minors.

The following regulations regulation, Occupational dose limits for minors (10 CFR 20.1207 as amended January 1, 2003) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1207) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-710. Dose to an embryo/fetus.

The following regulations regulation, Dose to an embryo/fetus (10 CFR 20.1208, 63 FR 39482, July 23, 1998) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1208) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 4
Radiation Dose Limits for Individual Members of the Public

12VAC5-481-720. Dose limits for individual members of the public.

The following regulations regulation, Dose limits for individual members of the public (10 CFR 20.1301, 67 FR 62872, October 9, 2002) and Definitions (10 CFR 20.1003, 67 FR 62872, October 9, 2002) are (10 CFR20.1301) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-730. Compliance with dose limits for individual members of the public.

The following regulations regulation, Compliance with dose limits for individual members of the public (10 CFR 20.1302, 60 FR 20185, April 25, 1995) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1302) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 5
Testing for Leakage or Contamination of Sealed Sources

12VAC5-481-740. Testing for leakage or contamination of sealed sources.

A. The licensee or registrant in possession of any sealed source shall assure that:

1. Each sealed source, except as specified in subsection B of this section, is tested for leakage or contamination and the test results are received before the sealed source is put into use unless the licensee or registrant 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 12VAC5-481-480 L J 4 and 5, an agreement state, a licensing state, or the Nuclear Regulatory Commission NRC or another agreement state;

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 12VAC5-481-480 L J 4 and 5, an agreement state, a licensing state, or the Nuclear Regulatory Commission NRC or another agreement state;

4. For each sealed source that is required to be tested for leakage or contamination, at any other time there is reason to suspect that the sealed source might have been damaged or might be leaking, the licensee or registrant shall assure that the sealed source is tested for leakage or contamination before further use;

5. Tests for leakage for all sealed sources, except brachytherapy sources manufactured to contain radium, shall be capable of detecting the presence of 185 Bq (0.005 ?Ci) of radioactive material on a test sample. Test samples shall be taken from the sealed source or from the surfaces of the container in which the sealed source is stored or mounted on which one might expect contamination to accumulate. For a sealed source contained in a device, test samples are obtained when the source is in the "off" position;

6. The test for leakage for brachytherapy sources manufactured to contain radium shall be capable of detecting an absolute leakage rate of 37 Bq (0.001 ?Ci) 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 shall be taken on the interior surface of brachytherapy source storage containers and shall be capable of detecting the presence of 185 Bq (0.005 ?Ci) of a radium daughter which has a half-life greater than four days.

B. A licensee or registrant need not perform test 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 ?Ci) or less of beta or photon-emitting material or 370 kBq (10 ?Ci) or less of alpha-emitting material;

4. Sealed sources containing only hydrogen-3;

5. Seeds of iridium-192 encased in nylon ribbon; and

6. The following regulation, Tritium neutron generator target source (10 CFR 359.35, 68 FR 75390, December 31, 2003), is applicable in the Commonwealth of Virginia. Sealed sources that are stored, not being used and identified as in storage. The licensee or registrant shall, however, test each such sealed source for leakage or contamination and receive the test results at intervals not to exceed five years and within six months before the date of use or transfer.

C. Tests for leakage or contamination from sealed sources shall be performed by persons specifically authorized by the agency, an agreement state, a licensing state, or the Nuclear Regulatory Commission NRC or another agreement state to perform such services.

D. Test results shall be kept in units of becquerel or microcurie and maintained for inspection by the agency. Records of test results for sealed sources shall be made pursuant to 12VAC5-481-1010.

E. The following shall be considered evidence that a sealed source is leaking:

1. The presence of 185 Bq (0.005 ?Ci) or more of removable contamination on any test sample;

2. Leakage of 37 Bq (0.001 ?Ci) 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 ?Ci) or more of radium.

F. The licensee or registrant 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 part.

G. Reports of test results for leaking or contaminated sealed sources shall be made pursuant to 12VAC5-481-1150.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 6
Surveys and Monitoring

12VAC5-481-750. General.

The following regulations regulation, General (10 CFR 20.1501, 63 FR 39482, July 23, 1998) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1501) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-760. Conditions requiring individual monitoring of external and internal occupational dose.

The following regulations regulation, Conditions requiring individual monitoring of external and internal occupational dose (10 CFR 20.1502, 63 FR 39482, July 23, 1998) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1502) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 7
Control of Exposure from External Sources in Restricted Areas

12VAC5-481-780. Control of access to high radiation areas.

A. The following regulations regulation, Control of access to high radiation areas (10 CFR 20.1601, 56 FR 23398, May 21, 1991) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1601) is applicable in the Commonwealth of Virginia.

B. The licensee or 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 as described in this section if the licensee or registrant has met all the specific requirements for access and control specified in other applicable parts of this chapter, such as Part V (12VAC5-481-1170 et seq.) for industrial radiography, Part VI (12VAC5-481-1580 et seq.) for X-rays in the healing arts, and Part IX (12VAC5-481-2140 et seq.) for particle accelerators and Part XII (12VAC5-481-2660 et seq.) for irradiators.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-790. Control of access to very high radiation areas.

A. In addition to the requirements in 12VAC5-481-780, the 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 five 5 Gy (500 rad) or more in one hour at one meter from a source of radiation or any surface through which 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 to nonself-shielded irradiators.

B. The licensee or 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 as described in subsection A of this section if the registrant has met all the specific requirements for access and control specified in other applicable parts of these regulations, such as Part V (12VAC5-481-1170 et seq.) for industrial radiography, Part VI (12VAC5-481-1580 et seq.) for X-rays in the healing arts, and Part IX (12VAC5-481-2140 et seq.) for particle accelerators, and Part XII (12VAC5-481-2660 et seq.) for irradiators.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-800. Control of access to very high radiation areas—irradiators. (Repealed.)

A. This section applies to licensees or registrants with sources of radiation in nonself-shielded irradiators. This section does not apply to sources of radiation that are used in teletherapy, in industrial radiography, or in 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. Each area in which there may exist radiation levels in excess of five Gy (500 rad) in one hour at one meter from a source of radiation that is used to irradiate materials shall meet 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; and

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 one 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 one mSv (0.1 rem) in one hour.

2. Additional control devices shall be provided so that, upon failure of the entry control devices to function as required by subdivision 1 of this subsection:

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 one mSv (0.1 rem) in one hour; and

b. Conspicuous visible and audible alarm signals are generated to make an individual attempting to enter the area aware of the hazard and at least one other authorized individual, who is physically present, familiar with the activity, and prepared to render or summon assistance, aware of the failure of the entry control devices.

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 one mSv (0.1 rem) in one hour; and

b. Conspicuous visible and audible alarm signals are generated to make potentially affected individuals aware of the hazard and the licensee or registrant or at least one other individual, who is familiar with the activity and prepared to render or summon assistance, aware of the failure or removal of the physical barrier.

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 subdivisions 3 and 4 of this subsection.

6. Each area shall be equipped 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, that must be installed in the area and that can prevent the source of radiation from being put into operation.

7. Each area shall be controlled by use of such administrative procedures and such devices as are necessary to ensure that the area is cleared of personnel prior to each use of the source of radiation.

8. Each area shall be checked by a radiation measurement to ensure that prior to 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 one mSv (0.1 rem) in one hour.

9. The entry control devices required in subdivision 1 of this subsection shall be tested for proper functioning. See 12VAC5-481-1070 for recordkeeping requirements.

a. Testing shall be conducted prior to initial operation with the source of radiation on any day, unless operations were continued uninterrupted from the previous day;

b. Testing shall be conducted prior to resumption of operation of the source of radiation after any unintentional interruption; and

c. The licensee or registrant shall submit 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 safe condition or to effect repairs on controls, unless control devices are functioning properly.

11. 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, shall be controlled by such devices and administrative procedures as are 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 loose radioactive material that is carried toward such an exit and automatically to prevent loose radioactive material from being carried out of the area.

C. Licensees, registrants, or applicants for licenses or registrations for sources of radiation within the purview of subsection B of this section that will be used in a variety of positions or in locations, such as open fields or forests, that make it impracticable to comply with certain requirements of subsection B of this section, such as those for the automatic control of radiation levels, may apply to the agency for approval of alternative safety measures. Alternative safety measures shall provide personnel protection at least equivalent to those specified in subsection B of this section. At least one of the alternative measures shall include an entry-preventing interlock control based on a measurement of the radiation that ensures the absence of high radiation levels before an individual can gain access to the area where such sources of radiation are used.

D. The entry control devices required by subsections B and C of this section shall be established in such a way that no individual will be prevented from leaving the area.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 8
Respiratory Protection and Controls to Restrict Internal Exposure in Restricted Areas

12VAC5-481-810. Use of process or other engineering controls.

The following regulations regulation, Use of process or other engineering controls (10 CFR 20.1701, 64 FR 54556, October 7, 1999) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1701) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-820. Use of other controls.

The following regulations regulation, Use of other controls (10 CFR 20.1702, 64 FR 54556, October 7, 1999) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1702) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-830. Use of individual respiratory protection equipment.

The following regulations, Use of individual respiratory protection equipment (10 CFR 20.1703, 67 FR 77652, December 19, 2002) (10 CFR 20.1703), Further restrictions on the use of respiratory protection equipment, (10 CFR 20.173, 64 FR 54556, October 7, 1999) (10 CFR 20.1704), and Applications for use of higher assigned protection factors (10 CFR 20.173, 64 FR 54556, October 7, 1999) and Definitions (10 CFR 20.1003, 67 FR 62872, October 9, 2002) (10 CFR 20.1705) are applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 9
Security and Control of Licensed or Registered Sources of Radiation

12VAC5-481-840. Security and control of licensed or registered sources of radiation.

A. The following regulations, Security of stored materials (10 CFR 20.1801, 56 FR 23401, May 21, 1991) (10 CFR 20.1801), and Control of material not in storage (10 CFR 20.1802, 56 FR 23401, May 21, 1991) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) (10 CFR 20.1802) are applicable in the Commonwealth of Virginia.

B. The registrant shall secure registered radiation machines from unauthorized removal.

C. The registrant shall use devices or administrative procedures to prevent unauthorized use of registered radiation machines.

D. Security requirements for portable gauges. Each portable gauge licensee shall use a minimum of two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 10
Precautionary Procedures

12VAC5-481-850. Caution signs.

The following regulations regulation, Caution signs (10 CFR 20.1901, 56 FR 23401, May 21, 1991) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1901) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-860. Posting requirements.

The following regulations regulation, Posting requirements (10 CFR 20.1902, 63 FR 39482, July 23, 1998) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1902) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-870. Exceptions to posting requirements.

The following regulations regulation, Exceptions to posting requirements (10 CFR 20.1903, 63 FR 39482, July 23, 1998) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1903) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-880. Labeling containers and radiation machines.

A. The following regulations regulation, Labeling containers (10 CFR 20.1904, 56 FR 23401, May 21, 1991) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1904) is applicable in the Commonwealth of Virginia.

B. Each registrant shall ensure that each radiation machine is labeled in a conspicuous manner that cautions individuals that radiation is produced when it is energized.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-890. Exemptions to labeling requirements.

The following regulations regulation, Exemptions to labeling requirements (10 CFR 20.1905, 60 FR 20185, April 25, 1995) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1905) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-900. Procedures for receiving and opening packages.

The following regulations regulation, Procedures for receiving and opening packages (10 CFR 20.1906, 63 FR 39482, July 23, 1998) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.1906) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 11
Waste Disposal

12VAC5-481-910. General requirements.

The following regulations regulation, General requirements (10 CFR 20.2001, 66 FR 55789, November 2, 2001) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.2001) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-930. Disposal by release into sanitary sewerage.

The following regulations regulation, Disposal by release into sanitary sewerage (10 CFR 20.2003, 60 FR 20185, April 25, 1995) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.2003) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-940. Treatment or disposal by incineration.

The following regulations regulation, Treatment or disposal by incineration (10 CFR 20.2004, 57 FR 57656, December 7, 1992) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.2004) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-950. Disposal of specific wastes.

The following regulations regulation, Disposal of specific wastes (10 CFR 20.2005, 56 FR 23403, May 21, 1991) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.2005) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-960. Transfer for disposal and manifests.

The following regulations regulation, Transfer for disposal and manifests (10 CFR 20.2006, 63 FR 50128, September 21, 1998) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.2006) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-970. Compliance with environmental and health protection regulations.

The following regulations regulation, Compliance with environmental and health protection regulations (10 CFR 20.2007, 56 FR 23403, May 21, 1991) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.2007) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-971. Disposal of certain byproduct material.

The following regulation, Disposal of certain byproduct material (10 CFR 20.2008) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 12
Records

12VAC5-481-980. General provisions.

The following regulations regulation, General Provisions (10 CFR 20.2101, 63 FR 39483, July 23, 1998) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.2101) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-990. Records of radiation protection programs.

The following regulations regulation, Records of radiation protection programs (10 CFR 20.2102, 56 FR 23403, May 21, 1991) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.2102) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1000. Records of surveys.

A. The following regulations regulation, Records of surveys (10 CFR 20.2103, 66 FR 64737, December 14, 2001) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.2103) is applicable in the Commonwealth of Virginia.

B. Upon termination of the license or registration, the licensee or registrant shall permanently store records on agency form Y or equivalent, or shall make provision with the agency for transfer to the agency.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1010. Records of tests for leakage or contamination of sealed sources.

Records of tests for leakage or contamination of sealed sources (required by 12VAC5-481-740) shall be kept in units of becquerel or microcurie and maintained for inspection by the agency for five years after the records are made.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1020. Records of prior occupational dose.

A. The licensee or registrant shall retain the records of prior occupational dose and exposure history as specified in 12VAC5-481-680 on an occupational radiation exposure form provided by the agency form Y or equivalent until the agency terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing an occupational radiation exposure form provided by the agency form Y or equivalent for three years after the record is made.

B. Upon termination of the license or registration, the licensee or registrant shall permanently store records on agency form Y or equivalent, or shall make provision with the agency for transfer to the agency.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1030. Records of planned special exposures.

The following regulations regulation, Records of planned special exposures (10 CFR 20.2105, 56 FR 23403, May 21, 1991) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.2105) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1040. Records of individual monitoring results.

The following regulations regulation, Records of individual monitoring results (10 CFR 20.2107, 63 FR 39483, July 23, 1998) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.2106) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1050. Records of dose to individual members of the public.

A. Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public. See per 12VAC5-481-720.

B. The licensee or registrant shall retain the records required by subsection A of this section until the agency terminates each pertinent license or registration requiring the record.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1070. Records of testing entry control devices for very high radiation areas.

A. Each licensee or registrant shall maintain records of tests made pursuant to 12VAC5-481-800 B 9 on entry control devices for very high radiation areas. These records must include the date, time, and results of each such test of function.

B. The licensee or registrant shall retain the records required by subsection A of this section for three years after the record is made.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 13
Reports

12VAC5-481-1090. Reports of stolen, lost, or missing licensed or registered sources of radiation.

A. Telephone reports. Each licensee or registrant shall report to the agency, and Virginia State Police by telephone as follows:

1. Immediately after its occurrence becomes known to the licensee or registrant, stolen, lost, or missing licensed or registered radioactive material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in Appendix C in 10 CFR Part 20 12VAC5-481-3700 under such circumstances that it appears to the licensee or registrant that an exposure could result to individuals in unrestricted areas;

2. Within 30 days after its occurrence becomes known to the licensee or registrant, lost, stolen, or missing licensed or registered radioactive material in an aggregate quantity greater than 10 times the quantity specified in Appendix C in 10 CFR Part 20 12VAC5-481-3700 that is still missing; or

3. Immediately after its occurrence becomes known to the registrant, a stolen, lost, or missing radiation machine. Appendix C refers to Appendix C to 10 CFR Part 20 Standards for Radiation Protections (10 CFR Part 20, 60 FR 20186, April 25, 1995) and is applicable in the Commonwealth of Virginia.

B. Written reports. Each licensee or registrant required to make a report pursuant to subsection A of this section shall, within 30 days after making the telephone report, make a written report to the agency setting forth the following information:

1. A description of the licensed or registered source of radiation involved, including, for radioactive material, the kind, quantity, and chemical and physical form; and, for radiation machines, the manufacturer, model and serial number, type and maximum energy of radiation emitted;

2. A description of the circumstances under which the loss or theft occurred;

3. A statement of disposition, or probable disposition, of the licensed or registered source of radiation involved;

4. Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas;

5. Actions that have been taken, or will be taken, to recover the source of radiation; and

6. Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed or registered sources of radiation.

C. Subsequent to filing the written report, the licensee or registrant shall also report additional substantive information on the loss or theft within 30 days after the licensee or registrant learns of such information.

D. The licensee or registrant shall prepare any report filed with the agency pursuant to this section so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.

E. The agency will forward information regarding a stolen, lost, or missing radiation material or device to the Virginia State Police and the Virginia Department of Emergency Services.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1100. Notification of incidents.

The following regulations regulation, Notification of incidents (10 CFR 20.2107, 63 FR 39483, July 23, 1998) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) are (10 CFR 20.2202) is applicable in the Commonwealth of Virginia, and notifications are made by telephone to the agency during normal business hours at (804) 864-8150, and after business hours to the State Emergency Operations Center (804) 674-2400.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1110. Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the limits Reporting requirements.

The following regulations, Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the constraints or limits (10 CFR 20.2203, 61 FR 65127, December 10, 1996) and Definitions (10 CFR 20.1003, 66 FR 55789, November 2, 2001) (10 CFR 20.2203 (a) and (b)) and Reporting requirements (10 CFR 30.50, 10 CFR 40.60, and 10 CFR 70.50(a)(b)(c)) are applicable in the Commonwealth of Virginia, and reports are submitted to the agency at the following address: 109 Governor Street, Room 730, Richmond, VA 23219.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1130. Reports of individual monitoring.

A. This section applies to each person licensed or registered by the agency to:

1. Possess or use sources of radiation for purposes of industrial radiography pursuant to Parts III (12VAC5-481-380 et seq.) and V (12VAC5-481-1170 et seq.) of this chapter; or

2. Receive radioactive waste from other persons for disposal pursuant to Part XI (12VAC5-481-2330 et seq.) of this chapter; or

3. Possess or use at any time, for processing or manufacturing for distribution pursuant to Part III (12VAC5-481-380 et seq.) or VII (12VAC5-481-1660 et seq.) of this chapter, radioactive material in quantities exceeding any one of the following quantities:

B. Each licensee or registrant in a category listed in subsection A of this section shall submit an annual report of the results of individual monitoring carried out by the licensee or registrant for each individual for whom monitoring was required by 12VAC5-481-760 during that year. The licensee or registrant may include additional data for individuals for whom monitoring was provided but not required. The licensee or registrant shall use agency form Z the agency's record of individual monitoring results form or equivalent or electronic media containing all the information required by agency form Z the agency's record of individual monitoring results form.

C. The licensee or registrant shall file the report required by subsection B of this section, covering the preceding year, on or before April 30 of each year. The licensee or registrant shall submit the report to the agency.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1151. Reports of transactions involving nationally tracked sources.

A. Each licensee who manufactures a nationally tracked source shall complete and submit a National Source Tracking Transaction Report. The report must include the following information:

1. The name, address, and license number of the reporting licensee;

2. The name of the individual preparing the report;

3. The manufacturer, model, and serial number of the source;

4. The radioactive material in the source;

5. The initial source strength in becquerels (curies) at the time of manufacture; and

6. The manufacture date of the source.

B. Each licensee that transfers a nationally tracked source to another person shall complete and submit a National Source Tracking Transaction Report. The report must include the following information:

1. The name, address, and license number of the reporting licensee;

2. The name of the individual preparing the report;

3. The name and license number of the recipient facility and the shipping address;

4. The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source;

5. The radioactive material in the source;

6. The initial or current source strength in becquerels (curies);

7. The date for which the source strength is reported;

8. The shipping date;

9. The estimated arrival date; and

10. For nationally tracked sources transferred as waste under a Uniform Low-Level Radioactive Waste Manifest, the waste manifest number and the container identification of the container with the nationally tracked source.

C. Each licensee that receives a nationally tracked source shall complete and submit a National Source Tracking Transaction Report. The report must include the following information:

1. The name, address, and license number of the reporting licensee;

2. The name of the individual preparing the report;

3. The name, address, and license number of the person that provided the source;

4. The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source;

5. The radioactive material in the source;

6. The initial or current source strength in becquerels (curies);

7. The date for which the source strength is reported;

8. The date of receipt; and

9. For material received under a Uniform Low-Level Radioactive Waste Manifest, the waste manifest number and the container identification with the nationally tracked source.

D. Each licensee that disassembles a nationally tracked source shall complete and submit a National Source Tracking Transaction Report. The report must include the following information:

1. The name, address, and license number of the reporting licensee;

2. The name of the individual preparing the report;

3. The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source;

4. The radioactive material in the source;

5. The initial or current source strength in becquerels (curies);

6. The date for which the source strength is reported; and

7. The disassemble date of the source.

E. Each licensee who disposes of a nationally tracked source shall complete and submit a National Source Tracking Transaction Report. The report must include the following information:

1. The name, address, and license number of the reporting licensee;

2. The name of the individual preparing the report;

3. The waste manifest number;

4. The container identification with the nationally tracked source;

5. The date of disposal; and

6. The method of disposal.

F. The reports discussed in subsections A through E of this section must be submitted by the close of the next business day after the transaction. A single report may be submitted for multiple sources and transactions. The reports must be submitted to the National Source Tracking System by using:

1. The online National Source Tracking System;

2. Electronically using a computer-readable format;

3. By facsimile;

4. By mail to the address on the National Source Tracking Transaction Report Form (NRC Form 748); or

5. By telephone with followup by facsimile or mail.

G. Each licensee shall correct any error in previously filed reports or file a new report for any missed transaction within five business days of the discovery of the error or missed transaction. Such errors may be detected by a variety of methods such as administrative reviews or by physical inventories required by regulation. In addition, each licensee shall reconcile the inventory of nationally tracked sources possessed by the licensee against that licensee's data in the National Source Tracking System. The reconciliation must be conducted during the month of January in each year. The reconciliation process must include resolving any discrepancies between the National Source Tracking System and the actual inventory by filing the reports identified by subsections A through E of this section. By January 31 of each year, each licensee must submit to the National Source Tracking System confirmation that the data in the National Source Tracking System is correct.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 14
Additional Requirements

12VAC5-481-1160. Vacating premises. (Repealed.)

Each specific licensee or registrant shall, no less than 30 days before vacating or relinquishing possession or control of premises that may have been contaminated with radioactive material as a result of his activities, notify the agency in writing of intent to vacate. When deemed necessary by the agency, the licensee shall decontaminate the premises in such a manner as the agency may specify.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1161. Radiological criteria for license termination.

A. General provisions and applicability.

1. This part applies to the decommissioning of facilities licensed under this chapter.

2. This part does not apply to sites that:

a. Have been decommissioned before the effective date as stated in 12VAC5-481-160; or

b. Have previously submitted and received NRC's approval on a license termination plan or decommissioning plan.

3. After a site has been decommissioned and the license terminated according to this section, the agency shall require additional cleanup only if, based on new information, the agency determines that the criteria of this part were not met and residual radioactivity remaining at the site could result in a significant threat to public health and safety.

4. When calculating the Total Effective Dose Equivalent (TEDE) to the average member of the critical group, the licensee must determine the peak annual TEDE expected within the first 1,000 years after decommissioning.

B. Radiological criteria for unrestricted use. A site is considered acceptable for unrestricted use if the residual radioactivity that is distinguishable from background radiation results in a TEDE to an average member of the critical group that does not exceed 0.25 mSv (25 mrem) per year, including that from groundwater sources of drinking water; and the residual radioactivity has been reduced to levels that are ALARA. Determination of levels that are ALARA must take into account consideration of any detriments, such as deaths from transportation accidents, expected to potentially result from decontamination and waste disposal.

C. Criteria for termination under restricted conditions. A site is considered acceptable for license termination under restricted conditions, if the licensee:

1. Can demonstrate that further reductions in residual radioactivity necessary to comply with subsection B of this section would result in net public or environmental harm or are not being made because the residual levels associated with restricted conditions are ALARA. Determination of the levels that are ALARA must take into account consideration of any detriments, such as traffic accidents, expected to potentially result from decontamination and waste disposal;

2. Has made provisions for legally enforceable institutional controls that provide reasonable assurance that the TEDE from residual radioactivity, distinguishable from background radiation, will not exceed 0.25 mSv (25 mrem) per year to the average member of the critical group;

3. Has provided sufficient financial assurance to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site. Acceptable financial assurance mechanisms are:

a. Funds placed into an account segregated from the licensee's assets and outside the licensee's administrative control as described under 12VAC5-481-450 C 7 a;

b. Surety method, insurance, or other guarantee method as described under part 12VAC5-481-450 C 7 b;

c. A statement of intent, in the case of federal, state, or local government licensees, as described in 12VAC5-481-450 C 7 d; or

d. When a governmental entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by the governmental entity;

4. Has submitted a decommissioning plan or a license termination plan to the agency indicating the licensee's intent to decommission according to 12VAC5-481-510 and specifying that the licensee intends to decommission by restricting use of the site. The licensee must document in the license termination plan or decommissioning plan how the advice of individuals and institutions in the community has been sought according to subdivisions 5 and 6 of this subsection and incorporated, as appropriate, following analysis of that advice;

5. If proposing to decommission by restricting use of the site, seeks advice from individuals and institutions in the community who may be affected by the decommissioning regarding whether:

a. Institutional controls proposed by the licensee:

(1) Will provide reasonable assurance that the TEDE from residual radioactivity distinguishable from background radiation to the average member of the critical group will not exceed 0.25 mSv (25 mrem) TEDE per year;

(2) Will be enforceable; and

(3) Will not impose undue burdens on the local community or other affected parties; and

b. The licensee has provided sufficient financial assurance to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site;

6. While seeking advice under subdivision 5 of this subsection, provides for:

a. Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;

b. An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and

c. A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues; and

7. Reduces residual radioactivity at the site so that if the institutional controls were no longer in effect, there is reasonable assurance that the TEDE from residual radioactivity distinguishable from background radiation to the average member of the critical group is ALARA and would not exceed:

a. 1 mSv (100 mrem) per year; or

b. 5 mSv (500 mrem) per year, if the licensee:

(1) Demonstrates that further reductions in residual radioactivity necessary to comply with subdivision C 7 a of this section are not technically achievable, would be prohibitively expensive, or would result in net public or environmental harm;

(2) Makes provisions for durable institutional controls; and

(3) Provides sufficient financial assurance, according to subdivision C 3 of this section, to enable a responsible governmental entity or independent third party, including a governmental custodian of a site, to carry out periodic rechecks of the site no less frequently than every five years to ensure that the institutional controls remain in place as necessary to meet the criteria of subdivision C 2 of this section, and to assume and carry out responsibilities for any necessary control and maintenance of those controls.

D. Alternative criteria for license termination.

1. The agency may terminate a license using alternative criteria greater than the dose criterion of subsection B and subdivision C 5 a (1) of this section, if the licensee:

a. Provides assurance that public health and safety would continue to be protected and that it is unlikely that the dose from all manmade sources combined, other than medical, would be more than the 1 mSv (100 mrem) per year limit under 12VAC5-481-720, by submitting an analysis of possible sources of exposure;

b. Employs, to the extent practical, restrictions on site use according to subsection C of this section, in minimizing exposures at the site;

c. Reduces doses to ALARA levels, taking into consideration any detriments, such as traffic accidents, expected to potentially result from decontamination and waste disposal; and

d. Submits a decommissioning plan or license termination plan to the agency indicating the licensee's intent to decommission according to 12VAC5-481-510, and specifying that the licensee proposes to decommission by use of alternate criteria. The licensee must document in the decommissioning plan or license termination plan how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and addressed, as appropriate, following analysis of that advice. In seeking such advice, the licensee must provide for:

(1) Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;

(2) An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and

(3) A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues.

2. The use of alternate criteria to terminate a license requires the approval of the agency after consideration of staff recommendations of the agency that address any comments provided by federal, state and local governments and any public comments submitted pursuant under subsection E of this section.

E. Public notification and public participation. Upon receipt of a license termination plan or decommissioning plan from a licensee or a proposal by a licensee for release of a site according to subsection C or D of this section, or whenever the agency deems such notice to be in the public interest, the agency must:

1. Notify and solicit comments from:

a. Local and state governments in the vicinity of the site and any Indian Nation or other indigenous people that have treaty or statutory rights that could be affected by the decommissioning; and

b. The US Environmental Protection Agency and Virginia Department of Environmental Quality for cases when the licensee proposes to release a site according to subsection D of this section; and

2. Publish a notice in the State Register and in a forum, such as local newspapers, letters to state and local organizations, or other appropriate forum, that is readily accessible to individuals in the vicinity of the site and solicit comments from affected parties.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1190. Exemptions.

A. Uses of certified and certifiable cabinet X-ray systems are exempt from the requirements of this part except for 12VAC5-481-1200 and the following:

1. For certified and certifiable cabinet X-ray systems, including those designed to allow admittance of individuals:

a. No registrant shall permit any individual to operate a cabinet X-ray system until the individual has received a copy of and instruction in the operating procedures for the unit. Records that demonstrate compliance with this subdivision shall be maintained for agency inspection until disposal is authorized by the agency.

b. Tests for proper operation of interlocks must be conducted and recorded at intervals not to exceed six months. Records of these tests shall be maintained for agency inspection until disposal is authorized by the agency.

c. The registrant shall perform an evaluation of the radiation dose limits to determine compliance with 12VAC5-481-720 and 21 CFR 1020.40, Cabinet X-ray Systems (39 FR 12986, April 10, 1974), at intervals not to exceed one year. Records of these evaluations shall be maintained for agency inspection for two years after the evaluation.

2. Certified cabinet X-ray systems shall be maintained in compliance with 21 CFR 1020.40, Cabinet X-ray Systems (39 FR 12986, April 10, 1974), and no modification shall be made to the system unless prior agency approval has been granted.

B. Industrial uses of hand-held light intensified imaging devices are exempt from the requirements of exceed two millirem 0.2 mSv (2 mrem) per hour. Devices that exceed this limit shall meet the applicable requirements of this part and the licensing or registration requirements of Part II (12VAC5-481-260 et seq.) or Part III (12VAC5-481-380 et seq.) of this chapter, as applicable.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1200. Licensing and registration requirements for industrial radiography operations.

A. The agency will approve an application for a specific license for the use of licensed material or a registration for use of radiation machines if the applicant meets the following requirements:

1. The applicant satisfies the general requirements specified in Part II (12VAC5-481-260 et seq.) for radiation machine facilities or Part III (12VAC5-481-380 et seq.) for radioactive material, as applicable, and any special requirements contained in this part;

2. The applicant submits an adequate program for training radiographers and radiographer's assistants that meets the requirements of 12VAC5-481-1320:;

a. After two years after September 20, 2006, the applicant need not describe the initial training and examination program for radiographers in the subjects outlined in 12VAC5-481-1320 G.

b. From September 20, 2006, to two years after September 20, 2006, the applicant may affirm that all individuals acting as industrial radiographers will be certified in radiation safety by a certifying entity before commencing duty as radiographers. This affirmation substitutes for a description of its initial training and examination program for radiographers in the subjects outlined in 12VAC5-481-1320 G.

3. The applicant submits procedures for verifying and documenting the certification status of radiographers and for ensuring that the certification of individuals acting as radiographers remains valid;

4. The applicant submits written operating and emergency procedures as described in 12VAC5-481-1330;

5. The applicant submits a description of a program for inspections of the job performance of each radiographer and radiographer's assistant at intervals not to exceed six months as described in 12VAC5-481-1320 E;

6. The applicant submits a description of the applicant's overall organizational structure as it applies to the radiation safety responsibilities in industrial radiography, including specified delegation of authority and responsibility;

7. The applicant submits the qualifications of the individual(s) designated as the radiation safety officer as described in 12VAC5-481-1310 A 1;

8. If an applicant intends to perform leak testing of sealed sources or exposure devices containing depleted uranium (DU) shielding, the applicant must describe the procedures for performing the test. The description must include the:

a. Methods of collecting the samples;

b. Qualifications of the individual who analyzes the samples;

c. Instruments to be used; and

d. Methods of analyzing the samples.;

9. If the applicant intends to perform calibrations of survey instruments and alarming ratemeters, the applicant must describe methods to be used and the experience of the person(s) who will perform the calibrations. All calibrations must be performed according to the procedures described and at the intervals prescribed in 12VAC5-481-1240 and 12VAC5-481-1350 G 4;

10. The applicant identifies and describes the location(s) of all field stations and permanent radiographic installations;

11. The applicant identifies the location(s) where all records required by this and other parts of these regulations will be maintained;

12. If a license application includes underwater radiography, a description of:

a. Radiation safety procedures and radiographer responsibilities unique to the performance of underwater radiography;

b. Radiographic equipment and radiation safety equipment unique to underwater radiography; and

c. Methods for gas-tight encapsulation of equipment; and

13. If an application includes offshore platform and/or lay-barge radiography, a description of:

a. Transport procedures for radioactive material to be used in industrial radiographic operations;

b. Storage facilities for radioactive material; and

c. Methods for restricting access to radiation areas.

B. A license or registration will be issued if the requirements of subsection A of this section, as applicable, are met.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1220. Limits on external radiation levels from storage containers and source changers.

The maximum exposure rate limits for storage containers and source changers are two millisieverts 2 mSv (200 mrem) per hour at any exterior surface, and 0.1 millisieverts mSv (10 mrem) per hour at one meter from any exterior surface with the sealed source in the shielded position.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1230. Locking of sources of radiation, storage containers and source changers.

A. Each radiographic exposure device must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. The exposure device and/or its container must be kept locked, and if a keyed-lock, with the key removed at all times, when not under the direct surveillance of a radiographer or a radiographer's assistant except at permanent radiographic installations as stated in 12VAC5-481-1370. In addition, during radiographic operations the sealed source assembly must be secured in the shielded position each time the source is returned to that position.

B. Each sealed source storage container and source changer must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. Storage containers and source changers must be kept locked, and if a keyed-lock, with the key removed at all times, when containing sealed sources except when under the direct surveillance of a radiographer or a radiographer's assistant.

C. The control panel of each radiation machine shall be equipped with a lock that will prevent the unauthorized use of an X-ray system or the accidental production of radiation. The radiation machine shall be kept locked and the key removed at all times except when under the direct visual surveillance of a radiographer or a radiographer's assistant.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1240. Radiation survey instruments.

A. The licensee or registrant shall keep sufficient calibrated and operable radiation survey instruments at each location where sources of radiation are present to make the radiation surveys required by this part and by Part IV (12VAC5-481-600 et seq.) of this chapter. Instrumentation required by this section must be capable of measuring a range from 0.02 millisieverts mSv (2 mrem) per hour through 0.01 sievert Sv (1 rem) per hour.

B. The licensee or registrant shall have each radiation survey instrument required under subsection A of this section calibrated:

1. At energies appropriate for use and at intervals not to exceed six months or after instrument servicing, except for battery changes;

2. For linear scale instruments, at two points located approximately one-third and two-thirds of full-scale on each scale; for logarithmic scale instruments, at mid-range of each decade, and at two points of at least one decade; and for digital instruments, at three points between 0.02 and 10 millisieverts mSv (2 and 1000 mrem) per hour; and

3. So that an accuracy within plus or minus 20% of the true radiation dose rate can be demonstrated at each point checked.

C. The licensee or registrant shall maintain records of the results of the instrument calibrations in accordance with 12VAC5-481-1410.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1250. Leak testing and replacement of sealed sources.

A. The replacement of any sealed source fastened to or contained in a radiographic exposure device and leak testing of any sealed source must be performed by persons authorized to do so by the agency, the Nuclear Regulatory Commission NRC, or another agreement state.

B. The opening, repair, or modification of any sealed source must be performed by persons specifically authorized to do so by the agency, the Nuclear Regulatory Commission NRC, or another agreement state.

C. Testing and recordkeeping requirements.

1. Each licensee who uses a sealed source shall have the source tested for leakage at intervals not to exceed six months. The leak testing of the source must be performed using a method approved by the agency, the Nuclear Regulatory Commission NRC, or by another agreement state. The wipe sample should be taken from the nearest accessible point to the sealed source where contamination might accumulate. The wipe sample must be analyzed for radioactive contamination. The analysis must be capable of detecting the presence of 185 becquerel (0.005 Ci) Bq (0.005 ?Ci) of radioactive material on the test sample and must be performed by a person specifically authorized by the agency, the Nuclear Regulatory Commission NRC, or another agreement state to perform the analysis.

2. The licensee shall maintain records of the leak tests in accordance with 12VAC5-481-1420.

3. Unless a sealed source is accompanied by a certificate from the transferor that shows that it has been leak tested within six months before the transfer, it may not be used by the licensee until tested for leakage. Sealed sources that are in storage and not in use do not require leak testing, but must be tested before use or transfer to another person if the interval of storage exceeds six months.

D. Any test conducted pursuant to subsections B and C of this section that reveals the presence of 185 becquerel (0.005 Ci) Bq (0.005 ?Ci) or more of removable radioactive material must be considered evidence that the sealed source is leaking. The licensee shall immediately withdraw the equipment involved from use and shall have it decontaminated and repaired or disposed of in accordance with agency regulations. A report must be filed with the agency within five days of any test with results that exceed the threshold in this paragraph, describing the equipment involved, the test results, and the corrective action taken.

E. Each exposure device using depleted uranium (DU) shielding and an "S" tube configuration must be tested for DU contamination at intervals not to exceed 12 months. The analysis must be capable of detecting the presence of 185 becquerel (0.005 Ci) Bq (0.005 ?Ci) of radioactive material on the test sample and must be performed by a person specifically authorized by the agency, the Nuclear Regulatory Commission NRC, or another agreement state to perform the analysis. Should such testing reveal the presence of DU contamination, the exposure device must be removed from use until an evaluation of the wear of the S-tube has been made. Should the evaluation reveal that the S-tube is worn through, the device may not be used again. DU shielded devices do not have to be tested for DU contamination while not in use and in storage. Before using or transferring such a device, however, the device must be tested for DU contamination, if the interval of storage exceeds 12 months. A record of the DU leak test must be made in accordance with 12VAC5-481-1420.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1270. Inspection and maintenance of radiation machines, radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments.

A. The licensee or registrant shall perform visual and operability checks on survey meters, radiation machines, radiographic exposure devices, transport and storage containers, associated equipment and source changers before each day's use, or work shift, to ensure that:

1. The equipment is in good working condition;

2. The sources are adequately shielded; and

3. Required labeling is present.

B. Survey instrument operability must be performed using check sources or other appropriate means.

C. If equipment problems are found, the equipment must be removed from service until repaired.

D. Each licensee or registrant shall have written procedures for and perform inspection and routine maintenance of radiation machines, radiographic exposure devices, source changers, associated equipment, transport and storage containers, and survey instruments at intervals not to exceed three months or before the first use thereafter to ensure the proper functioning of components important to safety. If equipment problems are found, the equipment must be removed from service until repaired. Replacement components shall meet design requirements.

E. The licensee's inspection and maintenance program must include procedures to assure that Type B packages are shipped and maintained in accordance with the certificate of compliance or other approval.

F. Records of equipment problems and of any maintenance performed under this section must be made in accordance with 12VAC5-481-1450.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 2
Radiation Safety Requirements

12VAC5-481-1300. Conducting industrial radiographic operations.

A. Whenever radiography is performed at a location other than a permanent radiographic installation, the radiographer must be accompanied by at least one other qualified radiographer or an individual who has at a minimum met the requirements of 12VAC5-481-1320 C. The additional qualified individual shall observe the operations and be capable of providing immediate assistance to prevent unauthorized entry. Radiography may not be performed if only one qualified individual is present.

B. All radiographic operations must be conducted in a permanent radiographic installation unless otherwise specifically authorized by the agency.

C. Except when physically impossible, collimators shall be used in industrial radiographic operations that use radiographic exposure devices that allow the source to be moved out of the device.

D. A licensee or registrant may conduct lay-barge, offshore platform, or underwater radiography only if procedures have been approved by the agency, the Nuclear Regulatory Commission NRC, or by another agreement state.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1310. Radiation safety officer.

A. The radiation safety officer shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's or registrant's program.

B. The minimum qualifications, training, and experience for radiation safety officers for industrial radiography are as follows:

1. Completion of the training and testing requirements of 12VAC5-481-1320 A;

2. 2000 hours of hands-on experience as a qualified radiographer in industrial radiographic operations; and

3. Formal training in the establishment and maintenance of a radiation protection program.

C. The agency will consider alternatives when the radiation safety officer has appropriate training and experience in the field of ionizing radiation, and in addition, has adequate formal training with respect to the establishment and maintenance of a radiation safety protection program.

D. The specific duties and authorities of the radiation safety officer include:

1. Establishing and overseeing all operating, emergency, and ALARA procedures as required by Part IV (12VAC5-481-600 et seq.) of this chapter and reviewing them regularly to ensure that they conform to agency regulations and to the license or registration conditions;

2. Overseeing and approving the training program for radiographic personnel to ensure that appropriate and effective radiation protection practices are taught;

3. Ensuring that required radiation surveys and leak tests are performed and documented in accordance with the regulations, including any corrective measures when levels of radiation exceed established limits;

4. Ensuring that personnel monitoring devices are calibrated, if applicable, and used properly; that records are kept of the monitoring results; and that timely notifications are made as required by Part IV of this chapter; and

5. Ensuring that operations are conducted safely and for implementing corrective actions including terminating operations.

E. Licensees and registrants will have two years from September 20, 2006, to meet the requirements of subsections B and C of this section.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1320. Training.

A. The licensee or registrant may not permit any individual to act as a radiographer until the individual: 1. Has has received at least 40 hours of training in the subjects outlined in subsection G of this section in addition to on the job training consisting of hands-on experience under the supervision of a radiographer and is certified through a radiographer certification program by a certifying entity in accordance with the criteria specified in Appendix M of this part meeting the requirements of 10 CFR Part 34, Appendix A. The on-the-job training shall include a minimum of two months (320 hours) of active participation in the performance of industrial radiography utilizing radioactive material and/or one month (160 hours) of active participation in the performance of industrial radiography utilizing radiation machines. Individuals performing industrial radiography utilizing radioactive materials and radiation machines must complete both segments of the on-the-job training (3 months or 480 hours); or.

2. The licensee or registrant may, until two years after the effective date of these regulations September 20, 2006, allow an individual who has not met the requirements of subdivision 1 of this subsection, to act as a radiographer after the individual has received at least 40 hours of training in the subjects outlined in subsection G of this section and demonstrated an understanding of these subjects by successful completion of a written examination that was previously submitted to and approved by the agency, the Nuclear Regulatory Commission, or another agreement state, in addition to on-the-job training consisting of hands-on experience under the supervision of a radiographer. The on-the-job training shall include a minimum of two months (320 hours) of active participation in the performance of industrial radiography utilizing radioactive material and/or one month (160 hours) of active participation in the performance of industrial radiography utilizing radiation machines. Individuals performing industrial radiography utilizing radioactive materials and radiation machines must complete both segments of the on-the-job training (3 months or 480 hours).

B. In addition, the licensee or registrant may not permit any individual to act as a radiographer until the individual:

1. Has received copies of and instruction in the requirements described in the regulations contained in this part, 12VAC5-481-30 and applicable sections of Parts IV (12VAC5-481-600 et seq.), X (12VAC5-481-2250 et seq.), and XIII (12VAC5-481-2950 et seq.) of this chapter, in the license or registration under which the radiographer will perform industrial radiography, and the licensee's or registrant's operating and emergency procedures;

2. Has demonstrated an understanding of items in subdivision 1 of this subsection by successful completion of a written or oral examination;

3. Has received training in the use of the registrant's radiation machines, or the licensee's radiographic exposure devices, sealed sources, in the daily inspection of devices and associated equipment, and in the use of radiation survey instruments; and

4. Has demonstrated understanding of the use of the equipment described in subdivision 3 of this subsection by successful completion of a practical examination.

C. The licensee or registrant may not permit any individual to act as a radiographer's assistant until the individual:

1. Has received copies of and instruction in the requirements described in the regulations contained in this part, 12VAC5-481-30 and applicable sections of Parts IV (12VAC5-481-600 et seq.), X (12VAC5-481-2250 et seq.), and XIII (12VAC5-481-2950 et seq.) of this chapter, in the license or registration under which the radiographer's assistant will perform industrial radiography, and the licensee's or registrant's operating and emergency procedures;

2. Has demonstrated an understanding of items in subdivision 1 of this subsection by successful completion of a written or oral examination;

3. Under the personal supervision of a radiographer, has received training in the use of the registrant's radiation machines, or the licensee's radiographic exposure devices and sealed sources, in the daily inspection of devices and associated equipment, and in the use of radiation survey instruments; and

4. Has demonstrated understanding of the use of the equipment described in subdivision 3 of this subsection by successful completion of a practical examination.

D. The licensee or registrant shall provide annual refresher safety training for each radiographer and radiographer's assistant at intervals not to exceed 12 months.

E. Except as provided in subdivision 4 of this subsection, the radiation safety officer RSO or designee shall conduct an inspection program of the job performance of each radiographer and radiographer's assistant to ensure that the agency's regulations, license or registration requirements, and operating and emergency procedures are followed. The inspection program must:

1. Include observation of the performance of each radiographer and radiographer's assistant during an actual industrial radiographic operation, at intervals not to exceed six months;

2. Provide that, if a radiographer or a radiographer's assistant has not participated in an industrial radiographic operation for more than six months since the last inspection, the radiographer must demonstrate knowledge of the training requirements of subdivision B 3 of this section and the radiographer's assistant must demonstrate knowledge of the training requirements of subdivision C 3 of this section by a practical examination before these individuals can next participate in a radiographic operation;

3. The agency may consider alternatives in those situations where the individual serves as both radiographer and radiation safety officer; and

4. In those operations where a single individual serves as both radiographer and radiation safety officer, and performs all radiography operations, an inspection program is not required;

F. The licensee or registrant shall maintain records of the above training to include certification documents, written, oral and practical examinations, refresher safety training and inspections of job performance in accordance with 12VAC5-481-1470.

G. The licensee or registrant shall include the following subjects required in subsection A of this section:

1. Fundamentals of radiation safety including:

a. Characteristics of gamma and x-radiation;

b. Units of radiation dose and quantity of radioactivity;

c. Hazards of exposure to radiation;

d. Levels of radiation from sources of radiation; and

e. Methods of controlling radiation dose (time, distance, and shielding);

2. Radiation detection instruments including:

a. Use, operation, calibration, and limitations of radiation survey instruments;

b. Survey techniques; and

c. Use of personnel monitoring equipment;

3. Equipment to be used including:

a. Operation and control of radiographic exposure equipment, remote handling equipment, and storage containers, including pictures or models of source assemblies (pigtails);

b. Operation and control of radiation machines;

c. Storage, control, and disposal of sources of radiation; and

d. Inspection and maintenance of equipment.

4. The requirements of pertinent state and federal regulations; and

5. Case histories of accidents in radiography.

H. Licensees and registrants will have one year from September 20, 2006, to comply with the additional training requirements specified in subdivisions B 1 and C 1 of this section.

I. An independent certifying organizations shall:

1. Be an organization such as a society or association, whose members participate in, or have an interest in, the field of industrial radiography;

2. Make its membership available to the general public nationwide. Membership shall not be restricted because of race, color, religion, sex, age, national origin or disability;

3. Have a certification program open to nonmembers, as well as members;

4. Be an incorporated, nationally recognized organization that is involved in setting national standards of practice within its fields of expertise;

5. Have an adequate staff, a viable system for financing its operations, and a policy and decision making review board;

6. Have a set of written organizational by laws and policies that provide adequate assurance of lack of conflict of interest and a system for monitoring and enforcing those by laws and policies;

7. Have a committee, whose members can carry out their responsibilities impartially, to review and approve the certification guidelines and procedures, and to advise the organization's staff in implementing the certification program;

8. Have a committee, whose members can carry out their responsibilities impartially, to review complaints against certified individuals and to determine appropriate sanctions;

9. Have written procedures describing all aspects of its certification program, maintain records of the current status of each individual's certification and the administration of its certification program;

10. Have procedures to ensure that certified individuals are provided due process with respect to the administration of its certification program, including the process of becoming certified and any sanctions imposed against certified individuals;

11. Have procedures for proctoring examinations, including qualifications for proctors. These procedures must ensure that the individuals proctoring each examination are not employed by the same company or corporation (or a wholly-owned subsidiary of such company or corporation) as any of the examinees;

12. Exchange information about certified individuals with the Nuclear Regulatory Commission and other independent certifying organizations and/or agreement states and allow periodic review of its certification program and related records; and

13. Provide a description to the Nuclear Regulatory Commission of its procedures for choosing examination sites and for providing an appropriate examination environment.

J. Requirements for Certification Programs.

1. All certification programs must:

a. Require applicants for certification to (i) receive training in the topics set forth in 12VAC5-481-1320 or equivalent state or Nuclear Regulatory Commission regulations, and (ii) satisfactorily complete a written examination covering these topics;

b. Require applicants for certification to provide documentation that demonstrates the applicant has:

(1) Received training in the topics set forth in this section or equivalent state or Nuclear Regulatory Commission regulations;

(2) Satisfactorily completed a minimum period of on-the-job-training as specified in this section; and

(3) Received verification by a state licensee or registrant or a Nuclear Regulatory Commission licensee that the applicant has demonstrated the capability of independently working as a radiographer.

c. Include procedures to ensure that all examination questions are protected from disclosure;

d. Include procedures for denying an application and revoking, suspending, or reinstating a certification;

e. Provide a certification period of not less than three years nor more than five years;

f. Include procedures for renewing certifications and, if the procedures allow renewals without examination, require evidence of recent full-time employment and annual refresher training; and

g. Provide a timely response to inquiries, by telephone or letter, from members of the public, about an individual's certification status.

K. Requirements for written examinations. All examinations must:

1. Be designed to test an individual's knowledge and understanding of the topics listed in this section or equivalent state or Nuclear Regulatory Commission requirements;

2. Be written in a multiple choice format; and

3. Have test items drawn from a question bank containing psychometrically valid questions based on the material in this section.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1350. Personnel monitoring.

A. The licensee or registrant may not permit any individual to act as a radiographer or a radiographer's assistant unless, at all times during radiographic operations, each individual wears, on the trunk of the body, a combination of direct reading dosimeter, an alarming ratemeter, and either a film badge, an optically stimulated luminescence (OSL) dosimeter or a TLD thermoluminescent dosimeter (TLD). At permanent radiographic installations where other appropriate alarming or warning devices are in routine use, or during radiographic operations using radiation machines, the use of an alarming ratemeter is not required.

1. Pocket dosimeters must have a range from zero to two millisieverts 0 to 2 mSv (200 mrem) and must be recharged at the start of each shift. Electronic personal dosimeters may only be used in place of ion-chamber pocket dosimeters.

2. Each film badge and, OSL or TLD must be assigned to and worn by only one individual.

3. Film badges and TLD's must be exchanged at periods not to exceed one month monthly. OSLs or TLDs must be exchanged at periods not to exceed three months.

4. After replacement, each film badge, OSL or TLD must be returned to the supplier for processing within 14 calendar days of the end of the monitoring period, or as soon as practicable. In circumstances that make it impossible to return each film badge, OSL or TLD in 14 calendar days, such circumstances must be documented and available for review by the agency.

B. Direct reading dosimeters, such as pocket dosimeters or electronic personal dosimeters, must be read and the exposures recorded at the beginning and end of each shift, and records must be maintained in accordance with 12VAC5-481-1490.

C. Pocket dosimeters, or electronic personal dosimeters, must be checked at periods not to exceed 12 months for correct response to radiation, and records must be maintained in accordance with 12VAC5-481-1490. Acceptable dosimeters must read within plus or minus 20% of the true radiation exposure.

D. If an individual's pocket dosimeter is found to be off-scale, or the electronic personal dosimeter reads greater than two millisieverts 2 mSv (200 mrem), the individual's film badge, OSL or TLD must be sent for processing within 24 hours. In addition, the individual may not resume work associated with the use of sources of radiation until a determination of the individual's radiation exposure has been made. This determination must be made by the radiation safety officer or the radiation safety officer's designee. The results of this determination must be included in the records maintained in accordance with 12VAC5-481-1490.

E. If a film badge, OSL or TLD is lost or damaged, the worker shall cease work immediately until a replacement film badge, OSL or TLD is provided and the exposure is calculated for the time period from issuance to loss or damage of the film badge, OSL or TLD. The results of the calculated exposure and the time period for which the film badge, OSL or TLD was lost or damaged must be included in the records maintained in accordance with 12VAC5-481-1490.

F. Reports received from the film badge, OSL or TLD processor must be retained in accordance with 12VAC5-481-1490.

G. Each alarming ratemeter must:

1. Be checked to ensure that the alarm functions properly before using at the start of each shift;

2. Be set to give an alarm signal at a preset dose rate of five millisieverts (500 mrem per hour) 5 mSv (500 mrem) per hour with an accuracy of plus or minus 20% of the true radiation dose rate;

3. Require special means to change the preset alarm function; and

4. Be calibrated at periods not to exceed 12 months for correct response to radiation. The licensee shall maintain records of alarming ratemeter calibrations in accordance with 12VAC5-481-1490.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1380. Posting.

All areas in which industrial radiography is being performed must be conspicuously posted as required by 12VAC5-481-860. The exceptions listed in 12VAC5-481-880 12VAC5-481-870 do not apply to industrial radiographic operations.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1420. Records of leak testing of sealed sources and devices containing DU.

Each licensee shall maintain records of leak test results for sealed sources and for devices containing DU. The results must be stated in units of becquerels (Ci) (microcuries). The licensee shall retain each record for three years after it is made or until the source in storage is removed.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1440. Utilization logs.

A. Each licensee or registrant shall maintain utilization logs showing for each source of radiation the following information:

1. A description, including the make, model, and serial number of the radiation machine or the radiographic exposure device, transport, or storage container in which the sealed source is located;

2. The identity or and signature of the radiographer to whom assigned;

3. The location and dates of use, including the dates removed and returned to storage; and

4. For permanent radiographic installations, the dates each radiation machine is energized.

B. The licensee or registrant shall retain the logs required by subsection A of this section for three years.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1490. Records of personnel monitoring.

Each licensee or registrant shall maintain the following exposure records specified in 12VAC5-481-1270 12VAC5-481-1350:

1. Direct reading dosimeter readings and yearly operability checks required by 12VAC5-481-1350 B and 12VAC5-481-1350 C for three years after the record is made;

2. Records of alarming ratemeter calibrations for three years after the record is made;

3. Reports received from the film badge, OSL or TLD processor until the agency terminates the license or registration; and

4. Records of estimates of exposures as a result of off-scale personal direct reading dosimeters, or lost or damaged film badges, OSL or TLD's, until the agency terminates the license or registration.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1520. Location of documents and records.

A. Each licensee or registrant shall maintain copies of records required by this part and other applicable parts of these regulations at the location specified in 12VAC5-481-1200 A 11.

B. Each licensee or registrant shall also maintain current copies of the following documents and records sufficient to demonstrate compliance at each applicable field station and each temporary jobsite;

1. The license or registration authorizing the use of sources of radiation;

2. A copy of Parts I (12VAC5-481-10 et seq.); IV (12VAC5-481-600 et seq.); V (12VAC5-481-1170 et seq.); and X (12VAC5-481-2250 et seq.) of this chapter;

3. Utilization logs for each source of radiation dispatched from that location as required by 12VAC5-481-1440.

4. Records of equipment problems identified in daily checks of equipment as required by 12VAC5-481-1450 A;

5. Records of alarm system and entrance control checks required by 12VAC5-481-1460, if applicable;

6. Records of dosimeter readings as required by 12VAC5-481-1490;

7. Operating and emergency procedures as required by 12VAC5-481-1480;

8. Evidence of the latest calibration of the radiation survey instruments in use at the site, as required by 12VAC5-481-1410;

9. Evidence of the latest calibrations of alarming ratemeters and operability checks of dosimeters as required by 12VAC5-481-1490;

10. Survey records as required by 12VAC5-481-1500 and 12VAC5-481-1000 as applicable, for the period of operation at the site;

11. The shipping papers for the transportation of radioactive materials required by Part XIII (12VAC5-481-2950 et seq.) of this chapter; and

12. When operating under reciprocity pursuant to Part III (12VAC5-481-380 et seq.) of this chapter, a copy of the applicable state license or registration, or Nuclear Regulatory Commission NRC license authorizing the use of sources of radiation.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 5
Radiographer Certification Jobsite Requirements

12VAC5-481-1540. Application and examinations. (Repealed.)

A. Application.

1. An application for taking the examination shall be on forms prescribed and furnished by the agency.

2. A nonrefundable fee of $150 shall be submitted with the application to cover certification administrative costs, such as the examination, training documentation review, and issuance of certification.

3. The application and the nonrefundable fee shall be submitted to the agency on or before the dates specified by the agency.

4. An individual whose certification ID card has been suspended or revoked shall obtain written approval from the agency to apply to retake the examination.

B. Examination. The examination shall be given for the purpose of determining the qualifications of applicants.

1. A written examination shall be held at times and places determined by the agency. The scope of the examination and the methods of procedure, including determination of the passing score, shall be prescribed by the agency. The examination will assess the applicant's knowledge to safely use sources of radiation and related equipment and the applicant's knowledge of Parts IV (12VAC5-481-600 et seq.), V (12VAC5-481-1170 et seq.), and XIII (12VAC5-481-2950 et seq.) of this chapter.

2. The examination will be administered by the agency or persons authorized by the agency.

3. A candidate failing an examination may apply for reexamination in accordance with subsection A of this section and will be reexamined. A candidate shall not retake the same version of the examination.

4. The examination will be held at dates, times and locations designated by the agency.

5. The examination will be in English.

6. To take the examination, an individual shall have a picture identification card, such as a driver's license, at the time of the examination.

7. Calculators will be permitted during the examination. However, calculators or computers with preprogrammed data or formulas, including exposure calculators, will not be permitted during the examination.

8. The examination will be a "closed book" examination.

9. Any individual observed by an agency proctor to be compromising the integrity of the examination shall be required to surrender the examination, the answer sheet, and any work paper. Such individual will not be allowed to complete the examination, will forfeit the examination fee, and will leave the examination site to avoid disturbing other examinees. Such individual must wait 90 days and must resubmit a new application and an additional $50 fee before taking a new examination.

10. Examination material shall be returned to the agency at the end of the examination. No photographic or other copying of examination questions or materials shall be permitted. Disclosure by any individual of the contents of any examination prior to its administration is prohibited.

11. The names and scores of individuals taking the examination shall be a public record.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1550. Certification identification (ID) card. (Repealed.)

A. A certification ID card shall be issued to each person who successfully completes the requirements of 12VAC5-481-1320 A 1 and the examination prescribed in 12VAC5-481-1540 B.

1. Each person's certification ID card shall contain their photograph. The agency will take the photograph at the time the examination is administered.

2. The certification ID card remains the property of the agency and may be revoked or suspended.

3. Any individual who wishes to replace their certification ID card shall submit to the agency a written request for a replacement certification ID card, stating the reason a replacement certification ID card is needed. A nonrefundable fee of $50 shall be paid to the agency for each replacement of a certification ID card. The prescribed fee shall be submitted with the written request for a replacement certification ID card. The individual shall maintain a copy of the request in their possession while performing industrial radiographic operations until a replacement certification ID card is received from the agency.

B. Each certification ID card is valid for a period of five years, unless revoked or suspended in accordance with subsection D of this section. Each certification ID card expires at the end of the day, in the month and year stated on the certification ID card.

C. Renewal of certification ID card.

1. Applications for examination to renew a certification ID card shall be filed in accordance with 12VAC5-481-1540 A.

2. The examination for renewal of a certification ID card shall be administered in accordance with 12VAC5-481-1540 B.

3. A renewal certification ID card shall be issued in accordance with 12VAC5-481-1550 A.

D. Revocation or suspension of a certification ID card.

1. Any radiographer who violates these regulations, equivalent state or Nuclear Regulatory Commission regulations, or any applicable statutory requirements may be required to show cause at a formal hearing why their certification ID card should not be revoked or suspended in accordance with subdivision D 2 of this section.

2. When an agency order has been issued for an industrial radiographer to cease and desist from the use of sources of radiation or the agency revokes or suspends their certification ID card, the industrial radiographer shall surrender the certification ID card to the agency until the order is changed or the suspension expires.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1560. Reciprocity.

A. All reciprocal recognition of licenses and registrations by the agency will be granted in accordance with Part III (12VAC5-481-380 et seq.) of this chapter.

B. Reciprocal recognition by the agency of an individual radiographer certification will be granted provided that:

1. The individual holds a valid certification in the appropriate category issued by a certifying entity, as defined in 12VAC5-481-10;

2. The requirements and procedures of the certifying entity issuing the certification affords the same or comparable certification standards as those afforded by 12VAC5-481-1320 A;

3. The applicant presents the certification to the agency prior to entry into the state; and

4. No escalated enforcement action is pending with the Nuclear Regulatory Commission NRC or in any other agreement state.

C. Certified individuals who are granted reciprocity by the agency shall maintain the certification upon which the reciprocal recognition was granted, or prior to the expiration of such certification, shall meet the requirements of 12VAC5-481-1320 A.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1570. Specific requirements for radiographic personnel performing industrial radiography.

A. At a job site, the following shall be supplied by the licensee or registrant:

1. At least one operable, calibrated survey instrument for each exposure device or radiation machine in use;

2. A current whole body personnel monitor (TLD, OSL or film badge) for each person performing radiographic operations;

3. An operable, calibrated pocket dosimeter with a range of zero to 200 milliroentgens 0 to 2 mSv (200 mrem) for each person performing radiographic operations;

4. An operable, calibrated, alarming ratemeter for each person performing radiographic operations using a radiographic exposure device; and

5. The appropriate barrier ropes and signs.

B. Each radiographer at a job site shall have on their person a valid certification ID card issued by a certifying entity.

C. Industrial radiographic operations shall not be performed if any of the items in subsections A and B of this section are not available at the job site or are inoperable.

D. During an inspection, the agency may terminate an operation if any of the items in subsections A and B of this section are not available or operable, or if the required number of radiographic personnel are not present. Operations shall not be resumed until all required conditions are met.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 2
General Information

12VAC5-481-1670. General requirements.

The following regulations, Definitions (10 CFR 35.2, 70 FR 16361, March 30, 2005), Maintenance of records (10 CFR 35.5, 68 FR 35534, June 16, 2003) (10 CFR 35.5), Provisions for the protection of human research subjects (10 CFR 35.6, 67 FR 62872, October 9, 2002) (10 CFR 35.6), FDA, other Federal, and State requirements (10 CFR 35.7, 67 FR 20370, April 24, 2002) (10 CFR 35.7), and Implementation (10 CFR 35.10, 70 FR 16361, March 30, 2005) (10 CFR 35.10) are applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1680. Licensing and Exemptions exemptions.

The following regulations, License required (10 CFR 35.11, 67 FR 20370, April 24, 2002) (10 CFR 35.11(a) and (b)), Application for license, amendment, or renewal (10 CFR 35.12, 67 FR 62872, October 9, 2002) License amendments (10 CFR 35.13, 70 FR 16361, March 30, 2005) (10 CFR 35.12), Exemptions regarding Type A licenses of broad scope (10 CFR 35.15, 67 FR 20370, April 24, 2002) (10 CFR 35.15), License issuance (10 CFR 35.18, 67 FR 20370, April 24, 2002) (10 CFR 35.18), and Specific exemptions (10 CFR 35.19, 67 FR 20370, April 24, 2002) (10 CFR 35.19) are applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1690. Notifications.

The following regulation, Notifications (10 CFR 35.14, 70 FR 16361, March 20, 2005) (10 CFR 35.14) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 3
General Administrative Requirements

12VAC5-481-1700. Authority and responsibilities for the radiation protection programs and changes.

The following regulations, Authority and responsibilities for the radiation protection programs (10 CFR 35.24, 67 FR 20370, April 24, 2002) (10 CFR 35.24), and Radiation Protection program changes (10 CFR 35.26, 67 FR 20370, April 24, 2002) (10 CFR 35.26) are applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1710. Supervision.

The following regulation, Supervision (10 CFR 35.27, 67 FR 20370, April 24, 2002) (10 CFR 35.27) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1720. Written directives.

The following regulation, Written directives (10 CFR 35.40, 68 FR 75389, December 31, 2003) (10 CFR 35.40) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1730. Procedures for administrations requiring a written directive.

The following regulation, Procedures for administrations requiring a written directive (10 CFR 35.41, 67 FR 20370, April 24, 2002) (10 CFR 35.41) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1740. Suppliers for sealed sources or devices for medical use.

The following regulation, Suppliers for sealed sources or devices for medical use (10 CFR 35.49, 67 FR 20370, April 24, 2002) (10 CFR 35.49) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1750. Training for Radiation Safety Officer.

The following regulation, Training for Radiation Safety Officer (10 CFR 35.50, 71 FR 1926, January 12, 2006) (10 CFR 35.50) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1760. Training for an authorized medical physicist.

The following regulation, Training for an authorized medical physicist (10 CFR 35.51, 70 FR 16362, March 30, 2005) (10 CFR 35.51) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1770. Training for an authorized nuclear pharmacist.

The following regulation, Training for an authorized nuclear pharmacist (10 CFR 35.55, 70 FR 16362, March 30, 2005) (10 CFR 35.55) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1780. Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and pharmacist.

The following regulation, Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and pharmacist (10 CFR 35.57, 70 FR 16363, March 30, 2005) (10 CFR 35.57) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1790. Recentness of training.

The following regulation, Recentness of training (10 CFR 35.59, 67 FR 20370, April 24, 2002) (10 CFR 35.59) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 4
General Technical Requirements

12VAC5-481-1800. Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material.

The following regulation, Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material (10 CFR 35.60, 67 FR 20370, April 24, 2002) (10 CFR 35.60) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1810. Calibration of survey instruments.

The following regulation, Calibration of survey instruments (10 CFR 35.61, 67 FR 20370, April 24, 2002) (10 CFR 35.61) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1820. Determination of dosages of unsealed byproduct material for medical use.

The following regulation, Determination of dosages of unsealed byproduct material for medical use (10 CFR 35.63, 67 FR 20370, April 24, 2002) (10 CFR 35.63) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1830. Authorization for calibration, transmission, and reference sources.

The following regulation, Authorization for calibration, transmission, and reference sources (10 CFR 35.65, 67 FR 20370, April 24, 2002) (10 CFR 35.65) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1840. Requirements for possession of sealed sources and brachytherapy sources.

The following regulation, Requirements for possession of sealed sources and brachytherapy sources (10 CFR 35.67, 67 FR 20370, April 24, 2002) (10 CFR 35.67) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1850. Labeling of vials and syringes.

The following regulation, Labeling of vials and syringes (10 CFR 35.69, 67 FR 20370, April 24, 2002) (10 CFR 35.69) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1860. Surveys of ambient radiation exposure rate.

The following regulation, Surveys of ambient radiation exposure rate (10 CFR 35.70, 67 FR 20370, April 24, 2002) (10 CFR 35.70) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1870. Release of individuals containing unsealed byproduct material or implants containing byproduct material.

The following regulation, Release of individuals containing unsealed byproduct material or implants containing byproduct material (10 CFR 35.75, 70 FR 16363, March 30, 2005) (10 CFR 35.75) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1880. Provision of mobile medical service.

The following regulation, Provision of mobile medical service (10 CFR 35.80, 67 FR 20370, April 24, 2002) (10 CFR 35.80) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1890. Decay-in-storage.

The following regulation, Decay-in-storage (10 CFR 35.92, 67 FR 20370, April 24, 2002) (10 CFR 35.92) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 5
Unsealed Byproduct Material – Written Directive Not Required

12VAC5-481-1900. Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required.

The following regulation, Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required (10 CFR 35.100, 70 FR 16363, March 30, 2005) (10 CFR 35.100) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1910. Training for uptake, dilution, and excretion studies.

The following regulation, Training for uptake, dilution, and excretion studies (10 CFR 35.190, 70 FR 16363, March 30, 2005) (10 CFR 35.190) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1920. Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.

The following regulation, Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required (10 CFR 35.200, 70 FR 16363, March 30, 2005) (10 CFR 35.200) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1930. Permissible molybdenum-99 concentration.

The following regulation, Permissible molybdenum-99 concentration (10 CFR 35.204, 68 FRC 35534, June 16, 2003) (10 CFR 35.204) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1940. Training for imaging and localization studies.

The following regulation, Training for imaging and localization studies (10 CFR 35.290, 70 FR 16364, March 30, 2005) (10 CFR 35.290) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 6
Unsealed Byproduct Material - Written Directive Required

12VAC5-481-1950. Use of unsealed by product material for which a written directive is required.

The following regulation, Use of unsealed by product material for which a written directive is required (10 CFR 35.300, 69 FR 55738, September 16, 2004) (10 CFR 35.300) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1960. Safety instruction.

The following regulation, Safety instruction (10 CFR 35.300, 68 FR 19324, April 21, 2003) (10 CFR 35.310) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1970. Safety precautions.

The following regulation, Safety precautions (10 CFR 35.315, 68 FR 19325, April 21, 2003) (10 CFR 35.315) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1980. Training for use of unsealed byproduct material for which a written directive is required.

The following regulation, Training for use of unsealed byproduct material for which a written directive is required (10 CFR 35.390, 70 FR 16364, March 30, 2005) (10 CFR 35.390) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-1990. Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 Gigabecquerels (33 millicuries).

The following regulation, Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 Gigabecquerels (33 millicuries) (10 CFR 35.392, 70 FR 16364, March 30, 2005) (10 CFR 35.392) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2000. Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries).

The following regulation, Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries) (10 CFR 35.394, 70 FR 16365, March 30, 2005) and Training for the parenteral administration of unsealed byproduct material requiring a written directive (10 CFR 35.396, 70 FR 16365, March 30, 2005) are (10 CFR 35.394) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2001. Training for the parental administration of unsealed byproduct material requiring a written directive.

The following regulation, Training for the parenteral administration of unsealed byproduct material requiring a written directive (10 CFR 35.396) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 7
Manual Brachytherapy

12VAC5-481-2010. Manual Brachytherapy.

The following regulations, Use of sources for manual brachytheray (10 CFR 35.400, 67 FR 20370, April 24, 2002) (10 CFR 35.400), Surveys after source implant and removal (10 CFR 35.404, 67 FR 20370, April 24, 2002) (10 CFR 35.404), Brachytherapy sources accountability (10 CFR 35.406, 67 FR 20370, April 24, 2002) (10 CFR 35.406), Safety instruction (10 CFR 35.410, 67 FR 20370, April 24, 2002) (10 CFR 35.410), Safety precautions (10 CFR 35.415, 68 FR 19325, April 21, 2003) (10 CFR 35.415), Calibration measurements of brachytherapy sources (10 CFR 35.432, 67 FR 20370, April 24, 2002) (10 CFR 35.432), Decay of strontium-90 sources for ophthalmic treatment (10 CFR 35.433, 67 FR 20370, April 24, 2002) (10 CFR 35.433), Therapy-related computer systems (10 CFR 35.457, 67 FR 20370, April 24, 2002) (10 CFR 35.457), Training for use of manual brachytherapy sources (10 CFR 35.490, 70 FR 16366, March 30, 2005)(10 CFR 35.490), and Training for ophthalmic use of strontium-90 (10 CFR 35.491, 70 FR 16366, March 30, 2005) (10 CFR 35.491) are applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 8
Sealed Sources for Diagnosis

12VAC5-481-2020. Use of sealed sources for diagnosis.

The following regulation, Use of sealed sources for diagnosis (10 CFR 35.500, 67 FR 20370, April 24, 2002) (10 CFR 35.500) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2030. Training for use of sealed sources for diagnosis.

The following regulation, Training for use of sealed sources for diagnosis (10 CFR 35.590, 70 FR 16366, March 30, 2005) (10 CFR 35.590) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 9
Photon Emitting Remote Afterloader Units, Teletherapy Units, and Stereotactic Radiosurgery Units

12VAC5-481-2040. Photon Emitting Remote Afterloader Units, Teletherapy Units, and Stereotactic Radiosurgery Units.

The following regulations, Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit (10 CFR 35.600, 67 FR 20370, April 24, 2002) (10 CFR 35.600), Surveys of patients and human research subjects treated with a remote afterloader unit (10 CFR 35.604, 67 FR 20370, April 24, 2002) (10 CFR 35.604), Installation, maintenance, adjustment, and repair (10 CFR 35.605, 67 FR 20370, April 24, 2002) (10 CFR 35.605), Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units (10 CFR 35.610, 67 FR 20370, April 24, 2002) (10 CFR 35.610), Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units (10 CFR 35.615), Dosimetry equipment (10 CFR 35.630), Full calibration measurements on teletherapy units (10 CFR 35.632, 67 FR 20370, April 24, 2002) (10 CFR 35.632), Full calibration measurements on remote afterloader units (10 CFR 35.633, 67 FR 20370, April 24, 2002), Dosimetry equipment (10 CFR 35.630, 68 FR 19326, April 21, 2003 (10 CFR 35.633), Full calibration measurements on gamma stereotactic radiosurgery units (10 CFR 35.635, 67 FR 20370, April 24, 2002) (10 CFR 35.635), Periodic spot-checks for teletherapy units (10 CFR 35.642, 67 FR 20370, April 24, 2002) (10 CFR 35.642), Periodic spot-checks for remote afterloader units (10 CFR 35.643, 67 FR 20370, April 24, 2002) (10 CFR 35.643), Periodic spot-checks for gamma stereotactic radiosurgery units (10 CFR 35.645, 67 FR 20370, April 24, 2002) (10 CFR 35.645), Additional technical requirements for mobile remote afterloader units (10 CFR 35.647, 67 FR 20370, April 24, 2002) (10 CFR 35.647), Radiation surveys, (10 CFR 35.652, 67 FR 20370, April 24, 2002) (10 CFR 35.652), Five-year inspection for teletherapy and gamma stereotactic radiosurgery units (10 CFR 35.655, 67 FR 20370, April 24, 2002) (10 CFR 35.655), Therapy-related computer systems (10 CFR 35.657, 67 FR 20370, April 24, 2002) (10 CFR 35.657), and Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units (10 CFR 35.690, 70 FR 16366, March 30, 2005) (10 CFR 35.690) are applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 10
Training and Experience Requirements

12VAC5-481-2050. Training and experience requirements. (Repealed.)

The following regulations, Radiation Safety Officer (10 CFR 35.900, 67 FR 20370, April 24, 2002), Training for uptake, dilution, and excretion studies (10 CFR 35.910, 67 FR 20370, April 24, 2002), Training for imaging and localization studies (10 CFR 35.920, 67 FR 20370, April 24, 2002), Training for therapeutic use of unsealed byproduct material (10 CFR 35.930, 67 FR 20370, April 24, 2002), Training for treatment of hyperthyroidism (10 CFR 35.932, 67 FR 20370, April 24, 2002), Training for treatment of thyroid carcinoma (10 CFR 35.934, 67 FR 20370, April 24, 2002), Training for use of brachytherapy sources (10 CFR 35.940, 67 FR 20370, April 24, 2002), Training for ophthalmic use of strontium-90 (10 CFR 35.941, 67 FR 20370, April 24, 2002), Training for use of sealed sources for diagnosis (10 CFR 35.950, 67 FR 20370, April 24, 2002), Training for use of therapeutic medical devices (10 CFR 35.960, 67 FR 20370, April 24, 2002), Training for authorized medical physicist (10 CFR 35.961, 70 FR 16367, March 30, 2005), Training for an authorized nuclear pharmacist (10 CFR 35.980, 67 FR 20370, April 24, 2002), and Training for experienced nuclear pharmacists (10 CFR 35.981, 67 FR 20370, April 24, 2002), are applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 11
Other Medical Uses of Byproduct Material or Radiation from Byproduct Material

12VAC5-481-2060. Other medical uses of byproduct material or radiation from byproduct materials.

The following regulation, Other medical uses of byproduct material or radiation from byproduct materials (10 CFR 35.1000, 67 FR 20370, April 24, 2002) (10 CFR 35.1000) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 12
Records

12VAC5-481-2070. Records.

The following regulations, Records of authority and responsibilities for radiation protection programs (10 CFR 35.2024, 67 FR 20370, April 24, 2002) (10 CFR 35.2024), Records of radiation protection program changes (10 CFR 35.2026, 67 FR 20370, April 24, 2002) (10 CFR 35.2026), Records of written directives (10 CFR 35.2040, 67 FR 20370, April 24, 2002)(10 CFR 35.2040), Records for procedures for administrations requiring a written directive (10 CFR 35.2041, 67 FR 20370, April 24, 2002) (10 CFR 35.2041), Records of calibrations of instruments used to measure the activity of unsealed byproduct materials (10 CFR 35.2060, 67 FR 20370, April 24, 2002) (10 CFR 35.2060), Records of radiation survey instrument calibrations (10 CFR 35.2061, 67 FR 20370, April 24, 2002) (10 CFR 35.2061), Records of dosages of unsealed byproduct material for medical use (10 CFR 35.2063, 67 FR 20370, April 24, 2002) (10 CFR 35.2063), Records of leaks tests and inventory of sealed sources and brachytherapy sources (10 CFR 35.2067, 67 FR 20370, April 24, 2002) (10 CFR 35.2067), Records of surveys for ambient radiation exposure rate (10 CFR 35.2070, 67 FR 20370, April 24, 2002) (10 CFR 35.2070), Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material (10 CFR 35.2075, 67 FR 20370, April 24, 2002) (10 CFR 35.2075), Records of mobile medical services (10 CFR 35.2080, 67 FR 20370, April 24, 2002) (10 CFR 35.2080), Records of decay-in-storage (10 CFR 35.2092, 67 FR 20370, April 24, 2002) (10 CFR 35.2092), Records of molybdenum-99 concentrations (10 CFR 35.2204, 67 FR 20370, April 24, 2002) (10 CFR 35.2204), Records of safety instruction (10 CFR 35.2310, 67 FR 20370, April 24, 2002) (10 CFR 35.2310), Records of surveys after source implant and removal (10 CFR 35.2404, 67 FR 20370, April 24, 2002 as amended January 1, 2003) (10 CFR 35.2404), Records of brachytherapy source accountability (10 CFR 35.2406, 67 FR 20370, April 24, 2002) (10 CFR 35.2406), Records of calibration measurements of brachytherapy sources (10 CFR 35.2432, 68 FR 19326, April 21, 2003) (10 CFR 35.2432), Records of decay of strontium-90 sources for ophthalmic treatments (10 CFR 35.2433, 67 FR 20370, April 24, 2002) (10 CFR 35.2433), Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units (10 CFR 35.2605, 67 FR 20370, April 24, 2002) (10 CFR 35.2605), Records of safety procedures (10 CFR 35.2610, 67 FR 20370, April 24, 2002) (10 CFR 35.2610), Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units (10 CFR 35.2630, 67 FR 20370, April 24, 2002) (10 CFR 35.2630), Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations (10 CFR 35.2632, 67 FR 20370, April 24, 2002) (10 CFR 35.2632), Records of periodic spot-checks for teletherapy units (10 CFR 35.2642, 67 FR 20370, April 24, 2002) (10 CFR 35.2642), Records of periodic spot-checks for remote afterloader units (10 CFR 35.2643, 67 FR 20370, April 24, 2002) (10 CFR 35.2643), Records of periodic spot-checks for gamma stereotactic radiosurgery units (10 CFR 35.2645, 67 FR 20370, April 24, 2002) (10 CFR 35.2645), Records of additional technical requirements for mobile remote afterloader units (10 CFR 35.2647, 67 FR 20370, April 24, 2002) (10 CFR 35.2647), Records of surveys of therapeutic treatment units (10 CFR 35.2652, 67 FR 20370, April 24, 2002) (10 CFR 35.2652), and Records of 5-year inspection for teletherapy and gamma stereotactic radiosurgery units (10 CFR 35.2655, 67 FR 20370, April 24, 2002) (10 CFR 35.2655) are applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 13
Reports

12VAC5-481-2080. Reports.

The following regulations, Report and notification of a medical event (10 CFR 35.3045, 68 FR 58805, October 10, 2003) (10 CFR 35.3045), Report and notification of a dose to an embryo/fetus or a nursing child (10 CFR 35.3047, 68 FR 58805, October 10, 2003) (10 CFR 35.3047), and Report of a leaking source (10 CFR 35.3067, 68 FR 58805, October 10, 2003) (10 CFR 35.3067), are applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2100. Equipment requirements.

A. Safety device. A device that prevents the entry of any portion of an individual's body into the primary X-ray beam path or that causes the beam to be shut off upon entry into its path shall be provided on all open-beam configurations. A registrant (or licensee) may apply to the agency for an exemption from the requirement of a safety device. Such application shall include:

1. A description of the various safety devices that have been evaluated;

2. The reason each of these devices cannot be used; and

3. A description of the alternative methods that will be employed to minimize the possibility of an accidental exposure, including procedures to assure that operators and others in the area will be informed of the absence of safety devices.

B. Warning devices.

1. Open-beam configurations shall be provided with a readily discernible indication of:

a. X-ray tube "on-off" status located near the radiation source housing, if the primary beam is controlled in this manner; and/or

b. Shutter "open-closed" status located near each port on the radiation source housing, if the primary beam is controlled in this manner.

2. An easily visible warning light labeled with the words "X-RAY ON", ON,"or words having a similar intent, shall be located:

a. Near any switch that energizes an X-ray tube and shall be illuminated only when the tube is energized; or

b. In the case of a radioactive source, near any switch that opens a housing shutter and shall be illuminated only when the shutter is open.

3. Warning devices shall be labeled so that their purpose is easily identified. On equipment installed after September 20, 2006, warning devices shall have fail-safe characteristics.

C. Ports. Unused ports on radiation source housings shall be secured in the closed position in a manner that will prevent casual opening.

D. Labeling. All analytical X-ray equipment shall be labeled with a readily discernible sign or signs bearing the radiation symbol and the words:

1. "CAUTION—HIGH INTENSITY X-RAY BEAM", BEAM," or words having a similar intent, on the X-ray source housing; and

2. "CAUTION RADIATION—THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED", ENERGIZED," or words having a similar intent, near any switch that energizes an X-ray tube if the radiation source is an X-ray tube; or

3. "CAUTION—RADIOACTIVE MATERIAL", or words having a similar intent, on the source housing in accordance with 12VAC5-481-660 if the radiation source is a radionuclide.

E. Shutters. On open-beam configurations installed after September 20, 2006, each port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a coupling has been connected to the port.

F. Radiation source housing. Each radiation source housing shall be subject to the following requirements:

1. Each X-ray tube housing shall be equipped with an interlock that shuts off the tube if it is removed from the radiation source housing or if the housing is disassembled.

2. Each radioactive source housing or port cover or each X-ray tube housing shall be so constructed that, with all shutters closed, the radiation measured at a distance of five centimeters from its surface is not capable of producing a dose in excess of 2.5 millirems (0.025 mSv) in one hour. For systems utilizing X-ray tubes, this limit shall be met at any specified tube rating.

G. Generator cabinet. Each X-ray generator shall be supplied with a protective cabinet that limits leakage radiation measured at a distance of five centimeters from its surface such that it is not capable of producing a dose in excess of 0.25 millirem (2.5 ?Sv) in one hour.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2230. Radiation monitoring requirements.

A. There shall be available at each particle accelerator facility appropriate portable monitoring equipment that is operable and has been appropriately calibrated for the radiations being produced at the facility. Such equipment shall be tested for proper operation daily and calibrated at intervals not to exceed one year and after each servicing and repair.

B. A radiation protection survey shall be performed and documented by a private inspector, acceptable to the agency, when changes have been made in shielding, operation, equipment, or occupancy of adjacent areas.

C. Radiation levels in all high radiation areas shall be continuously monitored. The monitoring devices shall be electrically independent of the accelerator control and safety interlock systems and capable of providing a readout at the control panel.

D. All area monitors shall be calibrated at intervals not to exceed one year and after each servicing and repair.

E. Whenever applicable, periodic surveys shall be made to determine the amount of airborne particulate radioactivity present.

F. Whenever applicable, periodic smear surveys shall be made to determine the degree of contamination.

G. All surveys shall be made in accordance with the written procedures established by a private inspector, acceptable to the agency, or the radiation safety officer.

H. Records of all radiation protection surveys, calibrations, and instrumentation tests shall be maintained at the accelerator facility for inspection by the agency.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2240. Ventilation systems.

A. Ventilation systems shall be provided to ensure that personnel entering any area where airborne radioactivity may be produced will not be exposed to airborne radioactive material in excess of those limits specified in Table 1 of Appendix B to Part 20—Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage (10 CFR 20 Appendix B, 58 FR 67659, December 22, 1993) 12VAC5-481-3690.

B. A registrant, as required in Table 1 of Appendix B to Part 20—Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage (10 CFR 20 Appendix B, 58 FR 67659, December 22, 1993) 12VAC5-481-3690 shall not vent, release, or otherwise discharge airborne radioactive material to an unrestricted area which exceeds the limits specified in Table 2 of Appendix B to Part 20—Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage (10 CFR 20 Appendix B, 58 FR 67659, December 22, 1993) 12VAC5-481-3690, except as authorized pursuant to 12VAC5-481-730. For purposes of this subsection concentrations may be averaged over a period not greater than one year. Every effort should be made to maintain releases of radioactive material to unrestricted areas as far below these limits as is reasonably achievable.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2260. Posting of notices to workers.

A. Each licensee or registrant shall post current copies of the following documents:

1. The regulations in this part and in Part IV (12VAC5-481-600 et seq.) of this chapter;

2. The license, certificate of registration, conditions or documents incorporated into the license by reference and amendments thereto;

3. The operating procedures applicable to activities under the license or registration; and

4. Any notice of violation involving radiological working conditions, proposed imposition of civil penalty, or order issued pursuant to Part I (12VAC5-481-10 et seq.) of this chapter, and any response from the licensee or registrant.; and

5. Agency form "Notice to Employees" as required by these regulations.

B. If posting of a document specified in subdivisions A 1 through 3 of this subsection section is not practicable, the licensee or registrant may post a notice that describes the document and states where it may be examined.

C. Agency form X "Notice to Employees" shall be posted by each licensee or registrant as required by these regulations.

D. C. Agency documents posted pursuant to subdivision A 4 of this section shall be posted within five two working days after receipt of the documents from the agency; the licensee's or registrant's response, if any, shall be posted within five working days after dispatch from the licensee or registrant. Such documents shall remain posted for a minimum of five working days or until action correcting the violation has been completed, whichever is later.

E. D. Documents, notices, or forms posted pursuant to this section shall appear in a sufficient number of places to permit individuals engaged in work under the license or registration to observe them on the way to or from any particular work location to which the document applies, shall be conspicuous, and shall be replaced if defaced or altered.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2270. Instructions to workers.

A. All individuals likely to receive in a year an occupational dose in excess of 1 mSv (100 mrem):

1. Shall be kept informed of the storage, transfer, or use of sources of radiation in the licensee's or registrant's workplace;

2. Shall be instructed in the health protection problems associated with exposure to radiation or radioactive material to the individual and potential offspring, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;

3. Shall be instructed in, and instructed to observe, to the extent within the worker's control, the applicable provisions of these regulations and licenses for the protection of personnel from exposures to radiation or radioactive material;

4. Shall be instructed of their responsibility to report promptly to the licensee or registrant any condition that may constitute, lead to, or cause a violation of the Act, these regulations, or license condition, or any unnecessary exposure to radiation or radioactive material;

5. Shall be instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation or radioactive material; and

6. Shall be advised as to the radiation exposure reports that workers shall be furnished pursuant to 12VAC5-481-2280.

B. The extent of these instructions shall be commensurate with potential radiological health protection problems present in the workplace.

C. The instructions listed in subsection A of this section shall be given at least annually to said individuals.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2280. Notifications and reports to individuals.

A. Radiation exposure data for an individual and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual shall be reported to the individual as specified in this section. The information reported shall include data and results obtained pursuant to these regulations, orders, or license conditions, as shown in records maintained by the licensee or registrant pursuant to 12VAC5-481-1040. Each notification and report shall:

1. Be in writing;

2. Include appropriate identifying data such as the name of the licensee or registrant, the name of the individual, and the individual's identification number, preferably social security number;

3. Include the individual's exposure information; and

4. Contain the following statement:

"This report is furnished to you under the provisions of Part X (12VAC5-481-2250 et seq.) of 12VAC5-481, Virginia Radiation Protection Regulations. You should preserve this report for further reference."

B. Each licensee or registrant shall furnish to each worker annually a written report of the worker's dose shall make dose information available to workers as shown in records maintained by the licensee or registrant pursuant to under the provisions of 12VAC5-481-1040. The licensee shall provide an annual report to each individual monitored under 12VAC5-481-760 of the dose received in that monitoring year if:

1. The individual's occupational does exceeds 1 mSv (100 mrem) TEDE or 1 mSv (100 mrem) to any individual organ or tissue; or

2. The individual requests his annual dose report.

C. Each licensee or registrant shall furnish a written report of the worker's exposure to sources of radiation at the request of a worker formerly engaged in activities controlled by the licensee or registrant. The report shall include the dose record for each year the worker was required to be monitored pursuant to 12VAC5-481-760. Such report shall be furnished within 30 days from the date of the request, or within 30 days after the dose of the individual has been determined by the licensee or registrant, whichever is later. The report shall cover the period of time that the worker's activities involved exposure to sources of radiation and shall include the dates and locations of work under the license or registration in which the worker participated during this period.

D. When a licensee or registrant is required pursuant to 12VAC5-481-1100, 12VAC5-481-1110, or 12VAC5-481-1120 to report to the agency any exposure of an individual to sources of radiation, the licensee or the registrant shall also provide the individual a written report on the exposure data included therein. Such reports shall be transmitted at a time not later than the transmittal to the agency.

E. At the request of a worker who is terminating employment with the licensee or registrant in work involving exposure to radiation or radioactive material, during the current year, each licensee or registrant shall provide at termination to each such worker, or to the worker's designee, a written report regarding the radiation dose received by that worker from operations of the licensee or registrant during the current year or fraction thereof. If the most recent individual monitoring results are not available at that time, a written estimate of the dose shall be provided together with a clear indication that this is an estimate.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Part XI
Licensing Requirements for Land Disposal of Radioactive Waste

Article 1
Purpose and Scope

12VAC5-481-2330. Purpose and scope.

A. The regulations in this part establish procedures, criteria, and terms and conditions upon which the agency issues licenses for the land disposal of wastes received from other persons. (Applicability of the requirements in this part to agency licenses for waste disposal facilities in effect on September 20, 2006, will be determined on a case-by-case basis and implemented through terms and conditions of the license or by orders issued by the agency.) The requirements of this part are in addition to, and not in substitution for, other applicable requirements of these regulations.

B. The regulations in this part do not apply to disposal of byproduct material as defined in the definition of "byproduct material" in these regulations in quantities greater than 10,000 kilograms containing more than five millicuries 185 MBq (5 mCi) of radium-226 or disposal of radioactive material as provided for in Part IV (12VAC5-481-600 et seq.) of this chapter.

C. This part establishes procedural requirements and performance objectives applicable to any method of land disposal. It establishes specific technical requirements for near-surface disposal of radioactive waste that involves disposal in the uppermost portion of the earth.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2420. Conditions of licenses.

A. A license issued under this part, or any right thereunder, may be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the license to any person, only if the agency finds, after securing full information, that the transfer is in accordance with the provisions of the Act and gives its consent in writing in the form of a license amendment.

B. The licensee shall submit written statements under oath upon request of the agency, at any time before termination of the license, to enable the agency to determine whether the license should be modified, suspended, or revoked.

C. The license will be terminated only on the full implementation of the final closure plan as approved by the agency, including post-closure observation and maintenance.

D. The licensee shall be subject to the provisions of the Act now or hereafter in effect, and to all rules, regulations, and orders of the agency. The terms and conditions of the license are subject to amendment, revision, or modification, by reason of amendments to, or by reason of rules, regulations, and orders issued in accordance with the terms of the Act.

E. Each person licensed by the agency pursuant to the regulations in this part shall confine possession and use of materials to the locations and purposes authorized in the license.

F. The licensee shall not dispose of waste until the agency has inspected the land disposal facility and has found it to be in conformance with the description, design, and construction described in the application for a license.

G. The agency may incorporate in any license at the time of issuance, or thereafter, by appropriate rule, regulation or order, additional requirements and conditions with respect to the licensee's receipt, possession, and disposal of waste as it deems appropriate or necessary in order to:

1. Protect health or to minimize danger to life or property;

2. Require reports and the keeping of records, and to provide for inspections of activities under the license that may be necessary or appropriate to effectuate the purposes of the Act and regulations thereunder.

H. The authority to dispose of wastes expires on the date stated in the license. Any expiration date on a license applies only to the above ground activities and to the authority to dispose of waste. Failure to renew the license shall not relieve the licensee of responsibility for implementing site closure, post-closure observation, and transfer of the license to the site owner.

I. Each licensee shall notify the agency in writing immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 (Bankruptcy) of the United States Code by or against:

1. The licensee;

2. An entity (as that term is defined in 11 USC §101(14)) 11 USC §101(15)) controlling the licensee or listing the license or licensee as property of the estate; or

3. An affiliate (as that term is defined in 11 USC §101(2)) of the licensee.

J. The notification specified in this section shall indicate the bankruptcy court in which the petition for bankruptcy was filed and the date of the filing of the petition.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2430. Application for renewal or closure.

A. An application for renewal or an application for closure under 12VAC5-481-2440 must be filed at least 90 days prior to license expiration.

B. Applications for renewal of a license must be filed in accordance with 12VAC5-481-2350 through 12VAC5-481-2400. Applications for closure must be filed in accordance with 12VAC5-481-2440. Information contained in previous applications, statements, or reports filed with the agency under the license may be incorporated by reference if the references are clear and specific.

C. In any case in which a licensee has filed an application in proper form for renewal of a license, the license does not expire until the agency has taken final action on the application for renewal.

D. In determining whether a license will be renewed, the agency will apply the criteria set forth in 12VAC5-481-2410.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2470. Termination of license.

A. Following any period of institutional control needed to meet the requirements found necessary under 12VAC5-481-2410, the licensee may apply for an amendment to terminate the license.

B. This application will be reviewed in accordance with the provisions of 12VAC5-481-440 12VAC5-481-450.

C. A license shall be terminated only when the agency finds:

1. That the institutional control requirements found necessary under 1subdivision 8 of 2VAC5-481-2410 12VAC5-481-2410 8 have been met;

2. That any additional requirements resulting from new information developed during the institutional control period have been met; and

3. That permanent monuments or markers warning against intrusion have been installed.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2490. Protection of the general population from releases of radioactivity.

Concentrations of radioactive material that may be released to the general environment in ground water, surface water, air, soil, plants, or animals shall not result in an annual dose exceeding an equivalent of 25 millirems (0.25 mSv) 0.25 mSv (25 mrem) to the whole body, 75 millirems (0.75 mSv) 0.75 mSv (75 mrem) to the thyroid, and 25 millirems (0.25 mSv) 0.25 mSv (25 mrem) to any other organ of any member of the public. Reasonable effort should be made to maintain releases of radioactivity in effluents to the general environment as low as is reasonably achievable ALARA.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2510. Protection of individuals during operations.

Operations at the land disposal facility shall be conducted in compliance with the standards for radiation protection set out in Part IV (12VAC5-481-600 et seq.) of this chapter, except for releases of radioactivity in effluents from the land disposal facility, that shall be governed by 12VAC5-481-2490. Every reasonable effort should be made to maintain radiation exposures as low as is reasonably achievable ALARA.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 4
Technical Requirements for Land Disposal Facilities

12VAC5-481-2530. Disposal site suitability requirements for land disposal.

A. Disposal site suitability for near-surface disposal. The primary emphasis in disposal site suitability is given to isolation of wastes and to disposal site features that ensure that the long-term performance objectives are met.

1. The disposal site shall be capable of being characterized, modeled, analyzed and monitored.

2. Within the region where the facility is to be located, a disposal site should be selected so that projected population growth and future developments are not likely to affect the ability of the disposal facility to meet the performance objectives of this part.

3. Areas shall be avoided having known natural resources which, if exploited, would result in failure to meet the performance objectives of this part.

4. The disposal site shall be generally well drained and free of areas of flooding or frequent ponding. Waste disposal shall not take place in a 100-year flood plain, coastal high-hazard area or wetland, as defined in federal Executive Order 11988, "Floodplain Management Guidelines." Guidelines."

5. Upstream drainage areas shall be minimized to decrease the amount of runoff which could erode or inundate waste disposal units.

6. The disposal site shall provide sufficient depth to the water table that ground water intrusion, perennial or otherwise, into the waste will not occur. The agency will consider an exception to this requirement to allow disposal below the water table if it can be conclusively shown that disposal site characteristics will result in molecular diffusion being the predominant means of radionuclide movement and the rate of movement will result in the performance objectives being met. In no case will waste disposal be permitted in the zone of fluctuation of the water table.

7. The hydrogeologic unit used for disposal shall not discharge ground water to the surface within the disposal site.

8. Areas shall be avoided where tectonic processes such as faulting, folding, seismic activity, or vulcanism may occur with such frequency and extent to significantly affect the ability of the disposal site to meet the performance objectives of this part or may preclude defensible modeling and prediction of long-term impacts.

9. Areas shall be avoided where surface geologic processes such as mass wasting, erosion, slumping, landsliding, or weathering occur with such frequency and extent to significantly affect the ability of the disposal site to meet the performance objectives of this part, or may preclude defensible modeling and prediction of long-term impacts.

10. The disposal site must not be located where nearby facilities or activities could adversely impact the ability of the site to meet the performance objectives of this part or significantly mask the environmental monitoring program.

B. Reserved.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2540. Disposal site design for land disposal.

A. Disposal site design for near-surface disposal.

1. Site design features shall be directed toward long-term isolation and avoidance of the need for continuing active maintenance after site closure.

2. The disposal site design and operation shall be compatible with the disposal site closure and stabilization plan and lead to disposal site closure that provides reasonable assurance that the performance objectives will be met.

3. The disposal site shall be designed to complement and improve, where appropriate, the ability of the disposal site's natural characteristics to assure that the performance objectives will be met.

4. Covers shall be designed to minimize to the extent practicable water infiltration, to direct percolating or surface water away from the disposed waste, and to resist degradation by surface geologic processes and biotic activity.

5. Surface features shall direct surface water drainage away from disposal units at velocities and gradients that will not result in erosion that will require ongoing active maintenance in the future.

6. The disposal site shall be designed to minimize to the extent practicable the contact of water with waste during storage, the contact of standing water with waste during disposal, and the contact of percolating or standing water with wastes after disposal.

B. Reserved.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2550. Land disposal facility operation and disposal site closure.

A. Near-surface disposal facility operation and disposal site closure.

1. Wastes designated as Class A pursuant to these regulations shall be segregated from other wastes by placing in disposal units which are sufficiently separated from disposal units for the other waste classes so that any interaction between Class A wastes and other wastes will not result in the failure to meet the performance objectives of this part. This segregation is not necessary for Class A wastes if they meet the stability requirements of these regulations.

2. Wastes designated as Class C pursuant to these regulations shall be disposed of so that the top of the waste is a minimum of five 5 meters below the top surface of the cover or must be disposed of with intruder barriers that are designed to protect against an inadvertent intrusion for at least 500 years.

3. Except as provided in subdivision 12 of this subsection, only waste classified as Class A, B, or C shall be acceptable for near-surface disposal. All waste shall be disposed of in accordance with requirements of 4 through 11 of this subsection.

4. Wastes shall be emplaced in a manner that maintains the package integrity during emplacement, minimizes the void spaces between packages, and permits the void spaces to be filled.

5. Void spaces between waste packages shall be filled with earth or other material to reduce future subsidence within the fill.

6. Waste shall be placed and covered in a manner that limits the radiation dose rate at the surface of the cover to levels that at a minimum will permit the licensee to comply with all provisions of 12VAC5-481-640 at the time the license is transferred pursuant to 12VAC5-481-2460.

7. The boundaries and locations of each disposal unit shall be accurately located and mapped by means of a land survey. Near-surface disposal units shall be marked in such a way that the boundaries of each unit can be easily defined. Three permanent survey marker control points, referenced to United States Geological Survey (USGS) or National Geodetic Survey (NGS) survey control stations, shall be established on the site to facilitate surveys. The USGS or NGS control stations shall provide horizontal and vertical controls as checked against USGS or NGS record files.

8. A buffer zone of land shall be maintained between any buried waste and the disposal site boundary and beneath the disposed waste. The buffer zone shall be of adequate dimensions to carry out environmental monitoring activities specified in 12VAC5-481-2560 C and take mitigative measures if needed.

9. Closure and stabilization measures as set forth in the approved site closure plan shall be carried out as each disposal unit is filled and covered.

10. Active waste disposal operations shall not have an adverse effect on completed closure and stabilization measures.

11. Only wastes containing or contaminated with radioactive material shall be disposed of at the disposal site.

12. Proposals for disposal of waste that is not generally acceptable for near-surface disposal because the waste form and disposal methods must be different and, in general, more stringent than those specified for Class C waste, may be submitted to the agency for approval.

B. Reserved.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2571. Waste classification.

A. Considerations. Determination of the classification of radioactive waste involves two considerations. First, consideration must be given to the concentration of long-lived radionuclides (and their shorter-lived precursors) whose potential hazard will persist long after such precautions as institutional controls, improved waste form, and deeper disposal have ceased to be effective. These precautions delay the time when long-lived radionuclides could cause exposures. In addition, the magnitude of the potential dose is limited by the concentration and availability of the radionuclide at the time of exposure. Second, consideration must be given to the concentration of shorter-lived radionuclides for which requirements on institutional controls, waste form, and disposal methods are effective.

B. Classes of waste.

1. Class A waste is waste that is usually segregated from other waste classes at the disposal site. The physical form and characteristics of Class A waste must meet the minimum requirements set forth in 12VAC5-481-2572 A. If Class A waste also meets the stability requirements set forth in 12VAC5-481-2572 B, it is not necessary to segregate the waste for disposal.

2. Class B waste is waste that must meet more rigorous requirements on waste form to ensure stability after disposal. The physical form and characteristics of Class B waste must meet both the minimum and stability requirements set forth in 12VAC5-481-2572.

3. Class C waste is waste that not only must meet more rigorous requirements on waste form to ensure stability but also requires additional measures at the disposal facility to protect against inadvertent intrusion. The physical form and characteristics of Class C waste must meet both the minimum and stability requirements set forth 12VAC5-481-2572.

4. Waste that is not generally acceptable for near-surface disposal is waste for which form and disposal methods must be different, and in general more stringent, than those specified for Class C waste. In the absence of specific requirements in this part, such waste must be disposed of in a geologic repository as defined in 10 CFR Part 60 or 63 unless proposals for disposal of such waste in a disposal site licensed pursuant to this part are approved by the agency.

C. Classification determined by long-lived radionuclides. If radioactive waste contains only radionuclides listed in Table 2, classification shall be determined as follows:

1. If the concentration does not exceed 0.1 times the value in Table 2, the waste is Class A.

2. If the concentration exceeds 0.1 times the value in Table 2 but does not exceed the value in Table 3, the waste is Class C.

3. If the concentration exceeds the value in Table 2, the waste is not generally acceptable for near-surface disposal.

4. For wastes containing mixtures of radionuclides listed in Table 2, the total concentration shall be determined by the sum of fractions rule described in subsection G of this section.

D. Classification determined by short-lived radionuclides. If radioactive waste does not contain any of the radionuclides listed in Table 2, classification shall be determined based on the concentrations shown in Table 3. However, as specified in subsection F of this section, if radioactive waste does not contain any nuclides listed in either Table 2 or 3, it is Class A.

1. If the concentration does not exceed the value in Column 1, the waste is Class A.

2. If the concentration exceeds the value in Column 1, but does not exceed the value in Column 2, the waste is Class B.

3. If the concentration exceeds the value in Column 2, but does not exceed the value in Column 3, the waste is Class C.

4. If the concentration exceeds the value in Column 3, the waste is not generally acceptable for near-surface disposal.

5. For wastes containing mixtures of the nuclides listed in Table 3, the total concentration shall be determined by the sum of fractions rule described in subsection G of this section.

E. Classification determined by both long- and short-lived radionuclides. If radioactive waste contains a mixture of radionuclides, some of which are listed in Table 2, and some of which are listed in Table 3, classification shall be determined as follows:

1. If the concentration of a nuclide listed in Table 2 does not exceed 0.1 times the value listed in Table 2, the class shall be that determined by the concentration of nuclides listed in Table 3.

2. If the concentration of a nuclide listed in Table 2 exceeds 0.1 times the value listed in Table 2 but does not exceed the value in Table 2, the waste shall be Class C, provided the concentration of nuclides listed in Table 3 does not exceed the value shown in Column 3 of Table 3.

F. Classification of wastes with radionuclides other than those listed in Tables 2 and 3. If radioactive waste does not contain any nuclides listed in either Table 2 or 3, it is Class A.

G. The sum of the fractions rule for mixtures of radionuclides. For determining classification for waste that contains a mixture of radionuclides, it is necessary to determine the sum of fractions by dividing each nuclide's concentration by the appropriate limit and adding the resulting values. The appropriate limits must all be taken from the same column of the same table. The sum of the fractions for the column must be less than 1.0 if the waste class is to be determined by that column. Example: A waste contains Sr-90 in a concentration of 50 Ci/m³ and Cs-137 in a concentration of 22 Ci/m³. Since the concentrations both exceed the values in Column 1, Table 2, they must be compared to Column 2 values. For Sr-90 fraction 50/150=0.33; for Cs-137 fraction, 22/44=0.5; the sum of the fractions=0.83. Since the sum is less than 1.0, the waste is Class B.

H. Determination of concentrations in wastes. The concentration of a radionuclide may be determined by indirect methods such as use of scaling factors that relate the inferred concentration of one radionuclide to another that is measured, or radionuclide material accountability, if there is reasonable assurance that the indirect methods can be correlated with actual measurements. The concentration of a radionuclide may be averaged over the volume of the waste, or weight of the waste if the units are expressed as nanocuries per gram.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2572. Waste characteristics.

A. The following requirements are minimum requirements for all classes of waste and are intended to facilitate handling at the disposal site and provide protection of health and safety of personnel at the disposal site.

1. Waste must not be packaged for disposal in cardboard or fiberboard boxes.

2. Liquid waste must be solidified or packaged in sufficient absorbent material to absorb twice the volume of the liquid.

3. Solid waste containing liquid shall contain as little freestanding and noncorrosive liquid as is reasonably achievable, but in no case shall the liquid exceed 1.0% of the volume.

4. Waste must not be readily capable of detonation or of explosive decomposition or reaction at normal pressures and temperatures, or of explosive reaction with water.

5. Waste must not contain, or be capable of generating, quantities of toxic gases, vapors, or fumes harmful to persons transporting, handling, or disposing of the waste. This does not apply to radioactive gaseous waste packaged in accordance with subdivision 7 of this subsection.

6. Waste must not be pyrophoric. Pyrophoric materials contained in waste shall be treated, prepared, and packaged to be nonflammable.

7. Waste in a gaseous form must be packaged at a pressure that does not exceed 1.5 atmospheres at 20°C. Total activity must not exceed 100 curies per container.

8. Waste containing hazardous, biological, pathogenic, or infectious material must be treated to reduce to the maximum extent practicable the potential hazard from the nonradiological materials.

B. The requirements in this section are intended to provide stability of the waste. Stability is intended to ensure that the waste does not structurally degrade and affect overall stability of the site through slumping, collapse, or other failure of the disposal unit and thereby lead to water infiltration. Stability is also a factor in limiting exposure to an inadvertent intruder, since it provides a recognizable and nondispersible waste.

1. Waste must have structural stability. A structurally stable waste form will generally maintain its physical dimensions and its form, under the expected disposal conditions such as weight of overburden and compaction equipment, the presence of moisture, and microbial activity, and internal factors such as radiation effects and chemical changes. Structural stability can be provided by the waste form itself, processing the waste to a stable form, or placing the waste in a disposal container or structure that provides stability after disposal.

2. Notwithstanding the provisions in subdivision A 2 and A 3 of this section, liquid wastes, or wastes containing liquid, must be converted into a form that contains as little freestanding and noncorrosive liquid as is reasonably achievable, but in no case shall the liquid exceed 1.0% of the volume of the waste when the waste is in a disposal container designed to ensure stability, or 0.5% of the volume of the waste for waste processed to a stable form.

3. Void spaces within the waste and between the waste and its package must be reduced to the extent practicable.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2573. Labeling.

Each package of waste must be clearly labeled to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with 12VAC5-481-2571.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Part XII
Licensing and Radiation Safety Requirements for Irradiators

Article 1
Purpose and Scope

12VAC5-481-2660. Purpose and scope.

The regulations following regulation, Purpose and scope (10 CFR 36.1, as amended January 1, 2003) and Definitions (10 CFR 36.2, as amended January 1, 2003) are (10 CFR 36.1) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 2
Specific Licensing Requirements

12VAC5-481-2670. Application for a specific license.

The following regulation, Application for a specific license (10 CFR 36.11, 58 FR 7728, February 9, 1993) (10 CFR 36.11) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2680. Specific licenses for irradiators.

The following regulation, Specific licenses for irradiators (10 CFR 36.13, 58 FR 7728, February 9, 1993) (10 CFR 36.13) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2690. Start of construction.

The following regulation, Start of construction (10 CFR 36.15, 58 FR 7728, February 9, 1993) (10 CFR 36.15) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2700. Applications for exemptions.

The following regulation, Applications for exemptions (10 CFR 36.17, 58 FR 7728, February 9, 1993) (10 CFR 36.17) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2710. Request for written statements.

The following regulation, Request for written statements (10 CFR 36.19, 58 FR 7728, February 9, 1993) (10 CFR 36.19) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 3
Design and Performance Requirements for Irradiators

12VAC5-481-2720. Performance criteria for sealed sources.

The following regulation, Performance criteria for sealed sources (10 CFR 36.21, 58 FR 7728, February 9, 1993) (10 CFR 36.21) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2730. Access control.

The following regulation, Access control (10 CFR 36.23, 58 FR 7728, February 9, 1993) (10 CFR 36.23) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2740. Shielding.

The following regulation, Shielding (10 CFR 36.25, 58 FR 7728, February 9, 1993) (10 CFR 36.25) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2750. Fire protection.

The following regulation, Fire protection (10 CFR 36.27, 58 FR 7728, February 9, 1993) (10 CFR 36.27) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2760. Radiation monitors.

The following regulation, Radiation monitors (10 CFR 36.29, 58 FR 7728, February 9, 1993) (10 CFR 36.29) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2770. Control of source movement.

The following regulation, Control of source movement (10 CFR 36.31, 58 FR 7728, February 9, 1993) (10 CFR 36.31) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2780. Irradiator pools.

The following regulation, Irradiator pools (10 CFR 36.33, 58 FR 7728, February 9, 1993) (10 CFR 36.33) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2790. Source rack protection.

The following regulation, Source rack protection (10 CFR 36.35, 58 FR 7728, February 9, 1993) (10 CFR 36.35) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2800. Power failures.

The following regulation, Power failures (10 CFR 36.37, 58 FR 7728, February 9, 1993) (10 CFR 36.37) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2810. Design requirements.

The following regulation, Design requirements (10 CFR 36.39, 58 FR 7728, February 9, 1993) (10 CFR 36.39) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2820. Construction monitoring and acceptance testing.

The following regulation, Construction monitoring and acceptance testing (10 CFR 36.41, 58 FR 7728, February 9, 1993) (10 CFR 36.41) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 4
Operation of Irradiators

12VAC5-481-2830. Training.

The following regulation, Training (10 CFR 36.51, 58 FR 7728, February 9, 1993) (10 CFR 36.51) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2840. Operating and emergency procedures.

The following regulation, Operating and emergency procedures (10 CFR 36.53, 58 FR 7728, February 9, 1993) (10 CFR 36.53) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2850. Personnel monitoring.

The following regulation, Personnel monitoring (10 CFR 36.55, 58 FR 7728, February 9, 1993) (10 CFR 36.55) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2860. Radiation surveys.

The following regulation, Radiation surveys (10 CFR 36.57, 58 FR 7728, February 9, 1993) (10 CFR 36.57) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2870. Detection of leaking sources.

The following regulation, Detection of leaking sources (10 CFR 36.59, 58 FR 67660, December 22, 1993) (10 CFR 36.58) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2880. Inspection and maintenance.

The following regulation, Inspection and maintenance (10 CFR 36.61, 58 FR 7728, February 9, 1993) (10 CFR 36.61) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2890. Pool water purity.

The following regulation, Pool water purity (10 CFR 36.63, 58 FR 7728, February 9, 1993) (10 CFR 36.63) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2900. Attendance during operation.

The following regulation, Attendance during operation (10 CFR 36.65, 58 FR 7728, February 9, 1993) (10 CFR 36.65) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2910. Entering and leaving the radiation room.

The following regulation, Entering and leaving the radiation room (10 CFR 36.67, 58 FR 7728, February 9, 1993) (10 CFR 36.67) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2920. Irradiation of explosive or flammable materials.

The following regulation, Irradiation of explosive or flammable materials (10 CFR 36.41, 58 FR 7728, February 9, 1993) (10 CFR 36.69) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 5
Records

12VAC5-481-2930. Records and retention periods.

The following regulation, Records and retention periods (10 CFR 36.81, 65 FR 63752, October 24, 2000) (10 CFR 36.81) is applicable in the Commonwealth of Virginia.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2940. Reports.

The following regulation, Reports (10 CFR 36.83, 58 FR 7728, February 9, 1993) (10 CFR 36.83) is applicable in the Commonwealth of Virginia

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Part XIII
Transportation of Radioactive Material

Article 1
Purpose and Scope

12VAC5-481-2950. Purpose and scope.

The regulations in this part establish requirements for packaging, preparation for shipment, and transportation of radioactive material and apply to any person who transports radioactive material or delivers radioactive material to a carrier for transport.

The regulations in this part apply to any licensee authorized by specific or general license issued by the agency to receive, possess, use, or transfer licensed material, if the licensee delivers that material to a carrier for transport, transports the material outside the site of usage as specified in the agency license, or transports that material on public highways. No provision of this part authorizes possession of licensed material.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2970. Exemptions.

A. Common and contract carriers, freight forwarders, and warehouse workers that are subject to the requirements of the United States Department of Transportation (DOT) in 49 CFR Part 170 through 49 Part CFR 189 or the United States Postal Service in the Postal Service Domestic Mail Manual (DMM), Section C-023.9.0, and the United States Postal Service, are exempt from the requirements of this part to the extent that they transport or store radioactive material in the regular course of their carriage for others or storage incident thereto. Common and contract carriers that are not subject to the requirements of the United States Department of Transportation DOT or United States Postal Service are subject to 12VAC5-481-2960 and other applicable requirements of these regulations.

B. Any licensee is exempt from the requirements of this part to the extent that the licensee delivers to a carrier for transport a package containing radioactive material having a specific activity not greater than 70 becquerel per gram (0.002 ?Ci/g). A licensee is exempt from all the requirements of this part with respect to shipment or carriage of the following low-level materials:

1. NARM and ores containing naturally occurring radionuclides that are not intended to be processed for use of these radionuclides, provided the activity concentration of the material does not exceed 10 times the values specified in Table A-2 of 12VAC5-481-3770.

2. Materials for which the activity concentration is not greater than the activity concentration values specified in Table A-2 of 12VAC5-481-3770, or for which the consignment activity is not greater than the limit for an exempt consignment found in Table A-2 of 12VAC5-481-3770.

C. Fissile material meeting one of the following requirements are exempt from classification as fissile material and from the fissile material package standards of 10 CFR 71.55 and 71.59, but are subject to all other requirements of 10 CFR 71, except as noted.

1. Individual package containing two grams or less fissile material.

2. Individual or bulk packaging containing 15 grams or less of fissile material provided the package has at least 200 grams of solid nonfissile material for every gram of fissile material. Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be present in the package but must not be included in determining the required mass for solid nonfissile material.

3. Low concentrations of solid fissile material commingled with solid nonfissile material, provided that there is at least 2,000 grams of solid nonfissile material for every gram of fissile material, and there is no more than 180 grams of fissile material distributed within 360 kg of contiguous nonfissile material. Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be present in the package but must not be included in determining the required mass of solid nonfissile material.

4. Uranium enriched in uranium-235 to a maximum of 1.0% by weight, and with total plutonium and uranium-233 content of up to 1.0% of the mass of uranium-235, provided that the mass of any beryllium, graphite, and hydrogenous material enriched in deuterium constitutes less than 5.0% of the uranium mass.

5. Liquid solutions of uranyl nitrate enriched in uranium-235 to a maximum of 2.0% by mass, with a total plutonium and uranium-233 content not exceeding 0.002% of the mass of uranium, and with a minimum nitrogen to uranium atomic ratio (N/U) of 2. The material must be contained in at least a DOT Type A package.

6. Packages containing, individually, a total plutonium mass of not more than 1,000 grams, of which not more than 20% by mass may consist of plutonium-239, plutonium-241, or any combination of these radionuclides.

D. Any physician licensed by the Commonwealth of Virginia to dispense drugs in the practice of medicine is exempt from this section with respect to transport by the physician of radioactive material for use in the practice of medicine provided the physician is an authorized user under Part VII (12VAC5-481-1660 et seq.).

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-2980. Transportation of licensed material.

A. Each licensee who transports licensed material outside the site of usage, as specified in the agency license, or where transport is on public highways, or who delivers licensed material to a carrier for transport, shall:

1. Comply with the applicable requirements, appropriate to the mode of transport, of the regulations of the United States Department of Transportation DOT; particularly the regulations of the United States Department of Transportation DOT in the following areas:

a. Packaging – 49 CFR Part 173: Subparts A and B and I.

b. Marking and labeling – 49 CFR Part 172: Subpart D, 172.400 through 172.407, and 172.436 through 172.440, and Subpart E 172.441.

c. Placarding – 49 CFR Part 172: Subpart F, especially §§172.500 through 172.519, 172.556, and Appendices B and C.

d. Accident reporting – 49 CFR Part 171: §§171.15 and 171.16.

e. Shipping papers and emergency information – 49 CFR Part 172: Subpart C and Subpart G.

f. Hazardous material employee training – 49 CFR Part 172: Subpart H.

g. Hazardous material shipper/carrier registration – 49 CFR Part 107: Subpart G.

h. Security plans – 49 CFR Part 172: Subpart I.

2. The licensee shall also comply with applicable United States Department of Transportation DOT regulations pertaining to the following modes of transportation:

a. Rail – 49 CFR Part 174: Subparts A through D and K.

b. Air – 49 CFR Part 175.

c. Vessel – 49 CFR Part 176: Subparts A through F and M.

d. Public Highway – 49 CFR Part 177 and Parts 390 through 397.

3. Assure that any special instructions needed to safely open the package are sent to or have been made available to the consignee in accordance with 12VAC5-481-900.

B. If, for any reason, the regulations of the United States Department of Transportation DOT are not applicable to a shipment of licensed material, the licensee shall conform to the standards and requirements of 49 CFR Parts 170 through 49 CFR 189 49 CFR Parts 107, 171 through 180, and 390 through 397, appropriate to the mode of transport to the same extent as if the shipment was subject to the regulations.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3000. General license: Nuclear Regulatory Commission–approved NRC-approved packages.

A. A general license is hereby issued to any licensee to transport, or to deliver to a carrier for transport, licensed material in a package for which a license, certificate of compliance (CoC), or other approval has been issued by the Nuclear Regulatory Commission NRC.

B. This general license applies only to a licensee who:

1. Has a copy of the specific license, certificate of compliance CoC, or other approval by the Nuclear Regulatory Commission NRC of the package and has the drawings and other documents referenced in the approval relating to the use and maintenance of the packaging and to the actions to be taken prior to shipment;

2. Complies with the terms and conditions of the license, certificate, or other approval by the Nuclear Regulatory Commission NRC, as applicable, and the applicable requirements of this Part XIII (12VAC5-481-2950 et seq.) of this chapter;

3. Prior to the licensee's first use of the package, has registered with the Nuclear Regulatory Commission submits in writing to the NRC the licensee's name and license number and the package identification number specified in the package approval using the appropriate method listed in 10 CFR 71.1(a); and

4. Has a quality assurance program required by that complies with 12VAC5-481-3130.

C. The general license in subsection A of this section applies only when the package approval authorizes use of the package under this general license.

D. For a Type B or fissile material package, the design of which was approved by the Nuclear Regulatory Commission NRC before April 1, 1996, the general license is subject to the additional restrictions of 12VAC5-481-3010.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3010. General license: previously Previously approved packages.

A. A Type B package previously approved by the Nuclear Regulatory Commission, but not designated as B(U) or B(M) in the identification number of the Nuclear Regulatory Commission certificate of compliance, may be used under the general license of 12VAC5-481-3000 with the following additional conditions:

1. Fabrication of the packaging was satisfactorily completed before August 31, 1986, as demonstrated by application of its model number in accordance with Nuclear Regulatory Commission regulations at 10 CFR 71.85(c);

2. A package used for a shipment to a location outside the United States is subject to multilateral approval, as defined in United States Department of Transportation regulations at 49 CFR 173.403; and

3. A serial number that uniquely identifies each packaging that conforms to the approved design is assigned to, and legibly and durably marked on, the outside of each packaging.

B. A Type B(U) package, a Type B(M) package, a low specific activity (LSA) material package or a fissile material package, previously approved by the Nuclear Regulatory Commission NRC but without the designation "-85" in the identification number of the Nuclear Regulatory Commission certificate of compliance NRC CoC, may be used under the general license of 12VAC5-481-3000 with the following additional conditions:

1. Fabrication of the package is satisfactorily completed by April 1, 1999, as demonstrated by application of its model number in accordance with Nuclear Regulatory Commission regulations at 10 CFR 71.85(c);

2. A package used for a shipment to a location outside the United States is subject to multilateral approval except approved under special arrangement in accordance with United States Department of Transportation regulations at 49 CFR 173.403; and

3. A serial number that uniquely identifies each packaging that conforms to the approved design is assigned to and legibly and durably marked on the outside of each packaging.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3020. General License: United States Department of Transportation specification container.

A. A general license is issued to any licensee to transport, or to deliver to a carrier for transport, licensed material in a specification container for fissile material or for a Type B quantity of radioactive material as specified in 49 CFR Parts 173 and 178.

B. This general license applies only to a licensee who:

1. Has a copy of the specification;

2. Complies with the terms and conditions of the specification and the applicable requirements of this part; and

3. Has a quality assurance program required by that complies with 12VAC5-481-3130.

C. The general license in subsection A of this section is subject to the limitation that the specification container may not be used for a shipment to a location outside the United States except by multilateral approval as defined in 49 CFR 173.403.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3030. General License: use of foreign approved package.

A. A general license is issued to any licensee to transport, or to deliver to a carrier for transport, licensed material in a package the design of which has been approved in a foreign national competent authority certificate that has been revalidated by the United States Department of Transportation DOT as meeting the applicable requirements of 49 CFR 171.12.

B. This general license applies only to international shipments.

C. This general license applies only to a licensee who:

1. Has a copy of the applicable certificate, the revalidation, and the drawings and other documents referenced in the certificate relating to the use and maintenance of the packaging and to the actions to be taken prior to shipment;

2. Complies with the terms and conditions of the certificate and revalidation, and with the applicable requirements of this part; and

3. The licensee has a quality assurance program approved by the Nuclear Regulatory Commission that complies with 12VAC5-481-3130.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3040. General License: license: fissile material, limited quantity per package.

A. A general license is hereby issued to any licensee to transport fissile material, or to deliver fissile material to a carrier for transport, if the material is shipped in accordance with this section. The fissile material need not be contained in a package that meets the standards of 10 CFR Part 71, Subparts E and F; however, the material must be contained in a Type A package. The Type A package must also meet the DOT requirements of 49 CFR 173.417(a).

B. This The general license applies only when a package contains no more than a Type A quantity of radioactive material, including only one of the following: to a licensee who has a quality assurance program that complies with 12VAC5-481-3130.

1. Up to 40 grams of uranium-235;

2. Up to 30 grams of uranium-233;

3. Up to 25 grams of the fissile radionuclides of plutonium, except that for encapsulated plutonium-beryllium neutron sources in special form, an A1 quantity of plutonium may be present; or

4. A combination of fissile radionuclides in which the sum of the ratios of the amount of each radionuclide to the corresponding maximum amounts in subdivisions 1, 2, and 3 of this subsection do not exceed unity.

C. Except as specified in subdivision 2 of this subsection, this general license applies only when all of the following requirements are met:

1. A package containing more than 15 grams of fissile radionuclides is labeled with a transport index not less than the number given by the following equation:

Minimum Transport Index = (0.40x + 0.67y + z) (1–15/(x+y+z))

where the package contains x grams of uranium-235, y grams of uranium-233, and z grams of the fissile radionuclides of plutonium;

2. For a package in which the only fissile material is in the form of encapsulated plutonium-beryllium neutron sources in special form, the transport index based on criticality considerations may be taken as 0.026 times the number of grams of the fissile radionuclides of plutonium in excess of 15 grams.

3. In all cases, the transport index must be rounded up to one decimal place and shall not exceed 10.0.

4. The licensee has a quality assurance program as required by 12VAC5-481-3130.

C. The general license applies only when a package's contents:

1. Contain no more than a Type A quantity of radioactive material; and

2. Contain less than 500 total grams of beryllium, graphite, or hydrogenous material enriched in deuterium.

D. The general license applies only to packages containing fissile material that are labeled with a CSI that:

1. Has been determined in accordance with subsection E of this section;

2. Has a value less than or equal to 10; and

3. For a shipment of multiple packages containing fissile material, the sum of the CSIs must be less than or equal to 50 (for shipment on a nonexclusive use conveyance) and less than or equal to 100 (for shipment on an exclusive use conveyance).

E. The value for the CSI must be greater than or equal to the number calculated by the following equation:

1. The calculated CSI must be rounded up to the first decimal place;

2. The values of X, Y, and Z used in the CSI equation must be taken from Tables 5 or 6, as appropriate;

3. If Table 5 is used to obtain the value of X, then the values for the terms in the equation for uranium-233 and plutonium must be assumed to be zero; and

4. Table 4 values for X, Y, and Z must be used to determine the CSI if:

a. Uranium-233 is present in the package;

b. The mass of plutonium exceeds one percent of the mass of uranium-235;

c. The uranium is of unknown uranium-235 enrichment or greater than 24 weight percent enrichment; or

d. Substances having a moderating effectiveness (i.e., an average hydrogen density greater than H₂O) (e.g., certain hydrocarbon oils or plastics) are present in any form, except as polyethylene used for packing or wrapping.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3050. General License: fissile material, limited moderator per package. (Repealed.)

A. A general license is hereby issued to any licensee to transport fissile material, or to deliver fissile material to a carrier for transport, if the material is shipped in accordance with this section.

B. This general license applies only when all of the following requirements are met:

1. The package contains no more than a Type A quantity of radioactive material;

2. Neither beryllium nor hydrogenous material enriched in deuterium are present;

3. The total mass of graphite present does not exceed 7.7 times the total mass of uranium-235 plus plutonium;

4. Substances having a higher hydrogen density than water, for example certain hydrocarbon oils, are not present, except that polyethylene may be used for packing or wrapping;

5. Uranium-233 is not present, and the amount of plutonium does not exceed 1.0% of the amount of uranium-235;

6. The amount of uranium-235 is limited as follows:

a. If the fissile radionuclides are not uniformly distributed, the maximum amount of uranium-235 per package may not exceed the value given in Table I; or

b. If the fissile radionuclides are distributed uniformly, for example, cannot form a lattice arrangement within the packaging, the maximum amount of uranium-235 per package may not exceed the value given in Table II; and

7. The transport index of each package based on criticality considerations is taken as 10 times the number of grams of uranium-235 in the package divided by the maximum allowable number of grams per package in accordance with Table I or Table II as applicable.

C. The licensee has a quality assurance program as required by 12VAC5-481-3130.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3051. General license: plutonium-berylium special form material.

A. A general license is issued to any licensee to transport fissile material in the form of plutonium-beryllium (Pu-Be) special form sealed sources, or to deliver Pu-Be sealed sources to a carrier for transport, if the material is shipped in accordance with this section. This material need not be contained in a package that meets the standards of Subparts E and F of 10 CFR Part 71; however, the material must be contained in a Type A package. The Type A package must also meet the DOT requirements of 49 CFR 173.417(a).

B. The general license applies only to a licensee who has a quality assurance program that complies with 12VAC5-481-3130.

C. The general license applies only when a package's contents:

1. Contain no more than a Type A quantity of radioactive material; and

2. Contain less than 1,000 grams of plutonium, provided that: plutonium-239, plutonium-241, or any combination of these radionuclides, constitutes less than 240 grams of the total quantity of plutonium in the package.

D. The general license applies only to packages labeled with a CSI that:

1. Has been determined in accordance with subsection E of this section;

2. Has a value less than or equal to 100; and

3. For a shipment of multiple packages containing Pu-Be sealed sources, the sum of the CSIs must be less than or equal to 50 (for shipment on a nonexclusive use conveyance) and less than or equal to 100 (for shipment on an exclusive use conveyance).

E. The value for the CSI must be greater than or equal to the number calculated by the following equation:

The calculated CSI must be rounded up to the first decimal place.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3070. Preliminary determinations.

Prior to the first use of any packaging for the shipment of radioactive material:

1. The licensee shall ascertain that there are no cracks, pinholes, uncontrolled voids, or other defects which could significantly reduce the effectiveness of the packaging;

2. Where the maximum normal operating pressure will exceed 35 kilopascal (5 lb/in²) (5 lbf/in²) gauge, the licensee shall test the containment system at an internal pressure at least 50% higher than the maximum normal operating pressure to verify the capability of that system to maintain its structural integrity at that pressure;

3. The licensee shall determine that the packaging has been fabricated in accordance with the design approved by the Nuclear Regulatory Commission NRC; and

4. The licensee shall conspicuously and durably mark the packaging with its model number, serial number, gross weight, and a package identification number as assigned by the Nuclear Regulatory Commission NRC.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3080. Routine determinations.

Prior to each shipment of licensed material, the licensee shall determine that:

1. The package is proper for the contents to be shipped;

2. The package is in unimpaired physical condition except for superficial defects such as marks or dents;

3. Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects;

4. Any system for containing liquid is adequately sealed and has adequate space or other specified provision for expansion of the liquid;

5. Any pressure relief device is operable and set in accordance with written procedures;

6. The package has been loaded and closed in accordance with written procedures;

7. For fissile material, any moderator or neutron absorber, if required, is present and in proper condition;

7. 8. Any structural part of the package that could be used to lift or tie down the package during transport is rendered inoperable for that purpose unless it satisfies design requirements specified in 10 CFR 71.45;

8. 9. The level of nonfixed radioactive contamination on the external surfaces of each package offered for shipment is as low as reasonably achievable ALARA and within the limits specified in 49 CFR 173.443;

a. The level of nonfixed radioactive contamination may be determined by wiping an area of 300 square centimeters of the surface concerned with an absorbent material, using moderate pressure, and measuring the activity on the wiping material. Sufficient measurements must be taken in the most appropriate locations to yield a representative assessment of the removable contamination levels. Except as provided in subdivision 8 b of this section, the amount of radioactivity measured on any single wiping material, when averaged over the surface wiped, must not exceed the limits given in Table III at any time during transport. Other methods of assessment of equal or greater efficiency may be used. When other methods are used, the detection efficiency of the method used must be taken into account and in no case may the removable contamination on the external surfaces of the package exceed 10 times the limits listed in Table III.

b. In the case of packages transported as exclusive use shipments by rail or highway only, the non-fixed radioactive contamination at any time during transport must not exceed 10 times the levels prescribed in subdivision 8 a of this section. The levels at the beginning of transport must not exceed the levels in subdivision 8 a;

9. 10. External radiation levels around the package and around the vehicle, if applicable, will not exceed two millisievert per hour (200 mrem/hr) at any point on the external surface of the package at any time during transportation. The transport index shall not exceed 10.0 the limits specified in 10 CFR 71.47 at any time during transportation; and

10. For a package transported in exclusive use by rail, highway or water, radiation levels external to the package may exceed the limits specified in subdivision 9 of this section, but shall not exceed any of the following:

a. 2 millisievert per hour (200 mrem/hr) on the accessible external surface of the package unless the following conditions are met, in which case the limit is 10 millisievert per hour (1000 mrem/hr);

(1) The shipment is made in a closed transport vehicle;

(2) Provisions are made to secure the package so that its position within the vehicle remains fixed during transportation; and

(3) There are no loading or unloading operations between the beginning and end of the transportation.

b. Two millisievert per hour (200 mrem/hr) at any point on the outer surface of the vehicle, including the top and underside of the vehicle, or, in the case of a flat-bed style vehicle, with a personnel barrier, at any point on the vertical planes projected from the outer edges of the vehicle, on the upper surface of the load (or enclosure, if used), and on the lower external surface of the vehicle;

c. 0.1 millisievert per hour (10 mrem/hr) at any point two meters from the vertical planes represented by the outer lateral surfaces of the vehicle, or, in the case of a flat-bed style vehicle, at any point two meters from the vertical planes projected from the outer edges of the vehicle; and

d. 0.02 millisievert per hour (2 mrem/hr) in any normally occupied positions of the vehicle, except that this provision does not apply to private motor carriers when persons occupying these positions are provided with special health supervision, personnel radiation exposure monitoring devices, and training in accordance with 12VAC5-481-2270; and

11. A package must be prepared for transport so that in still air at 38°C (100°F) and in the shade, no accessible surface of a package would have a temperature exceeding 50°C (122°F) in a nonexclusive use shipment or 85°C (185°F) in an exclusive use shipment. Accessible package surface temperatures shall not exceed these limits at any time during transportation.

12. A package may not incorporate a feature intended to allow continuous venting during transport.

11. Accessible package surface temperatures will not exceed the limits specified in 10 CFR 71.43(g) at any time during transportation.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3090. Air transport of plutonium.

Notwithstanding the provisions of any general licenses and notwithstanding any exemptions stated directly in this part or included indirectly by citation of the United States Department of Transportation DOT regulations, as may be applicable, the licensee shall assure that plutonium in any form is not transported by air, or delivered to a carrier for air transport, unless:

1. The plutonium is contained in a medical device designed for individual human application;

2. The plutonium is contained in a material in which the specific activity is not greater than 70 becquerel per gram (0.002 %v(508)%E2%vCi/g/gm) of material less than or equal to the activity concentration values for plutonium specified in Table A-2 of 12VAC5-481-3770 and in which the radioactivity is essentially uniformly distributed;

3. The plutonium is shipped in a single package containing no more than an A₂ quantity of plutonium in any isotope or form and is shipped in accordance with 12VAC5-481-2980;

4. The plutonium is shipped in a package specifically authorized, in the certificate of compliance CoC, issued by the Nuclear Regulatory Commission NRC, for the shipment of plutonium by air and the licensee requires, through special arrangement with the carrier, compliance with 49 CFR 175.704, the United States Department of Transportation DOT regulations applicable to the air transport of plutonium.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3091. Opening instructions.

Before delivery of a package to a carrier for transport, the licensee shall ensure that any special instructions needed to safely open the package have been sent to, or otherwise made available to, the consignee for the consignee's use in accordance with 12VAC5-481-900.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3110. Reports.

The licensee shall report to the agency within 30 days:

1. Any instance in which there is significant reduction in the effectiveness of any packaging during use;

2. Details of any defects with safety significance in the packaging after first use, with the means employed to repair the defects and prevent their recurrence; or

3. Instances in which the conditions of approval in the certificate of compliance CoC were not observed in making a shipment.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3120. Advance notification of transport of nuclear waste.

A. Prior to the transport of any nuclear waste outside of the confines of the licensee's facility or other place of use or storage, or prior to the delivery of any nuclear waste to a carrier for transport, each licensee shall provide advance notification of such transport to the governor, or governor's designee, of each state within or through which the waste will be transported and the agency.

B. Advance notification is required only when:

1. The nuclear waste is required to be in Type B packaging for transportation;

2. The nuclear waste is being transported into, within, or through a state Virginia enroute to a disposal facility or to a collection point for transport to a disposal facility; and

3. The quantity of licensed material in a single package exceeds:

a. 3000 times the A1 A₁ value of the radionuclides as specified in Table A-1 of Appendix A to Part 71–Determination of A₁and A₂ (10 CFR 71, 69 FR 3800, January 26, 2004) for special form radioactive material 12VAC5-481-3770;

b. 3000 times the A2 A₂ value of the radionuclides as specified in Table A-1 of Appendix A to Part 71–Determination of A₁ and A₂ (10 CFR 71, 69 FR 3800, January 26, 2004) for normal form radioactive material 12VAC5-481-3770; or

c. 1000 terabecquerel (27,000 Ci) (27,000 curies).

C. Each advance notification required by subsection A of this section shall contain the following information:

1. The name, address, and telephone number of the shipper, carrier, and receiver of the shipment;

2. A description of the nuclear waste contained in the shipment as required by 49 CFR 172.202 and 172.203(d);

3. The point of origin of the shipment and the seven-day period during which departure of the shipment is estimated to occur;

4. The seven-day period during which arrival of the shipment at state boundaries is estimated to occur;

5. The destination of the shipment, and the seven-day period during which arrival of the shipment is estimated to occur; and

6. A point of contact with a telephone number for current shipment information.

D. The notification required by subsection A of this section shall be made in writing to the office of each appropriate the governor, or governor's designee, and to the agency. A notification delivered by mail must be postmarked at least seven days before the beginning of the seven-day period during which departure of the shipment is estimated to occur. A notification delivered by messenger must reach the office of the governor, or governor's designee and the agency, at least four days before the beginning of the seven-day period during which departure of the shipment is estimated to occur. A copy of the notification shall be retained by the licensee for three years.

E. The licensee shall notify each appropriate the governor, or governor's designee, and the agency of any changes to schedule information provided pursuant to subsection A of this section. Such notification shall be by telephone to a responsible individual in the office of the governor, or governor's designee, of the appropriate state or states and the agency. The licensee shall maintain for three years a record of the name of the individual contacted.

F. Each licensee who cancels a nuclear waste shipment, for which advance notification has been sent, shall send a cancellation notice, identifying the advance notification that is being canceled, to the governor, or governor's designee, of each appropriate state and to the agency. A copy of the notice shall be retained by the licensee for three years.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Article 5
Quality Assurance

12VAC5-481-3130. Quality assurance requirements.

A. Unless otherwise authorized by the agency, each licensee shall establish, maintain, and execute a quality assurance program to verify by procedures such as checking, auditing, and inspection that deficiencies, deviations, and defective material and equipment relating to the shipment of packages containing radioactive material are promptly identified and corrected.

B. The licensee shall identify the material and components to be covered by the quality assurance program.

C. Each licensee shall document the quality assurance program by written procedures or instructions and shall carry out the program in accordance with those procedures throughout the period during which packaging is used.

D. Prior to the use of any package for the shipment of radioactive material, each licensee shall obtain approval by the agency of its quality assurance program.

E. The licensee shall maintain sufficient written records to demonstrate compliance with the quality assurance program. Records of quality assurance pertaining to the use of a package for shipment of radioactive material shall be maintained for a period of three years after shipment.

A. Quality assurance requirements apply to the design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, and modification of components of packaging that are important to safety. Quality assurance comprises all those planned and systematic actions necessary to provide adequate confidence that a system or component will perform satisfactorily in service. Quality assurance includes quality control, which comprises those quality assurance actions related to control of the physical characteristics and quality of the material or component to predetermined requirements. The licensee, certificate holder, and applicant for a CoC are responsible for the quality assurance requirements as they apply to design, fabrication, testing, and modification of packaging. Each licensee is responsible for the quality assurance provision that applies to its use of packaging for the shipment of licensed material subject to this chapter.­

B. Each licensee, certificate holder and applicant for a CoC shall establish, maintain, and execute a quality assurance program satisfying each of that applicable criteria of this section, 10 CFR Part 71, Subpart H and satisfying any specific provisions that are applicable to the licensee's activities including procurement of packaging. The licensee, certificate holder, and applicant for CoC shall execute the applicable criteria in a graded approach to an extent that is commensurate with the quality assurance requirement's importance to safety.

C. Before the use of any package for the shipment of licensed material subject to this rule, each licensee shall obtain NRC approval of its quality assurance program.

D. A program for transport container inspection and maintenance limited to radiographic exposure devices, source changers, or packages transporting these devices and meeting the requirements of 12VAC5-481-1270, is deemed to satisfy the requirements of 12VAC5-481-3000 and subsection B of this section.

E. The licensee, certificate holder, and applicant for a CoC shall be responsible for the establishment and execution of the quality assurance program. The licensee, certificate holder, and applicant for a CoC may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or any part of the quality assurance program, but shall retain responsibility for the program. The licensee shall clearly establish and delineate, in writing, the authority and duties of persons and organizations performing activities affecting the safety-related functions of structures, systems, and components. These activities include performing the functions associated with attaining quality objectives and the quality assurance functions. While the term licensee is used in these criteria, the requirements are applicable to whatever design, fabrication, assembly, and testing of the package is accomplished with respect to a package before the time a package is issued.

F. The quality assurance functions are:

1. Assuring that an appropriate quality assurance program is established and effectively executed; and

2. Verifying, by procedures such as checking, auditing, and inspection, that activities affecting the safety-related functions have been performed correctly.

G. The persons and organizations performing quality assurance functions must have sufficient authority and organizational freedom to:

1. Identify quality problems;

2. Initiate, recommend, or provide solutions; and

3. Verify implementation of solutions.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Part XIV
Radiation Safety Requirements for Wireline Service Operations and Subsurface Tracer Studies

Article 1
Purpose and Scope

12VAC5-481-3140. Purpose.

The regulations in this part establish radiation safety requirements for using sources of radiation for wireline service operations including mineral-logging, radioactive markers, and subsurface tracer studies. The requirements of this part are in addition to, and not in substitution for, the requirements of Parts I (12VAC5-481-10 et seq.), II (12VAC5-481-260 et seq.), III (12VAC5-481-380 et seq.), IX (12VAC5-481-2140 et seq.), IV (12VAC5-481-600 et seq.), and X (12VAC5-481-2250 et seq.) of this chapter.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3151. Licensing.

A. The agency will approve an application for a specific license for the use of licensed material in well logging if the applicant meets the following requirements:

1. The applicant satisfies the general requirements specified in 12VAC5-481-440 and 12VAC5-481-450.

2. The applicant shall develop a program for training logging supervisors and logging assistants and submit to the agency a description of this program that specifies:

a. Initial training;

b. On-the-job training;

c. Annual safety reviews provided by the licensee;

d. Means the applicant will use to demonstrate the logging supervisor's knowledge and understanding of and ability to comply with the agency's regulations and licensing requirements and the applicant's operating and emergency procedures; and

e. Means the applicant will use to demonstrate the logging assistant's knowledge and understanding of and ability to comply with the applicant's operating and emergency procedures.

3. The applicant shall submit to the agency written operating and emergency procedures as described in 12VAC5-481-3280 or an outline or summary of the procedures that includes the important radiation safety aspects of the procedures.

4. The applicant shall establish and submit to the agency its program for annual inspections of the job performance of each logging supervisor to ensure that the agency's regulations, license requirements, and the applicant's operating and emergency procedures are followed. Inspection records shall be retained for three years after each annual internal inspection.

5. The applicant shall submit a description of its overall organizational structure as it applies to the radiation safety responsibilities in well logging, including specified delegations of authority and responsibility.

6. If an applicant wants to perform leak testing of sealed sources, the applicant shall identify the manufacturers and the model numbers of the leak test kits to be used. If the applicant wants to analyze its own wipe samples, the applicant shall establish procedures to be followed and submit a description of these procedures to the agency. The description must include the following:

a. Instruments to be used;

b. Methods of performing the analysis; and

c. Pertinent experience of the person who will analyze the wipe samples.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3160. Prohibition Agreement with well owner.

No licensee shall perform wireline service operations with a sealed source(s) unless, prior to commencement of the operation, the licensee has a written agreement with the well-operator  well operator, well-owner well owner, drilling contractor, or land owner that:

1. In the event a sealed source is lodged downhole, a reasonable effort at recovery will be made; and

2. No person may attempt to recover a sealed source in a manner which, in the licensee's opinion, could result in its rupture; and

2. 3. In the event a decision is made to abandon the sealed source downhole, the requirements of 12VAC5-481-3370 C shall be met.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3200. Radiation survey instruments.

A. The licensee or registrant shall maintain sufficient calibrated and operable radiation survey instruments at each field station to make physical radiation surveys as required by this part and by 12VAC5-481-640 Part IV (12VAC5-481-600 et seq.). Instrumentation shall be capable of measuring 0.1 milliroentgen (25.8 nanocoulombs/kg) 0.001 mSv (0.1 mrem) per hour through at least 50 milliroentgens (12.9 microcoulombs/kg) 0.5 mSv (50 mrem) per hour. Survey instruments acquired before September 20, 2006, and capable of measuring 0.1 milliroentgen (25.8 nanocoulombs/kg) per hour through at least 20 milliroentgens (5.16 microcoulombs/kg) per hour also satisfies this requirement five years after September 20, 2006.

B. Each radiation survey instrument shall be calibrated:

1. At intervals not to exceed six months and after each instrument servicing;

2. For linear scale instruments, at two points located approximately 25% and 75% of full-scale on each scale; for logarithmic scale instruments, at midrange of each decade, and at two points of at least one decade; and for digital instruments, at appropriate points; and

3. So that accuracy within 20% of the true radiation level can be demonstrated on each scale.

C. Calibration records shall be maintained for a period of two three years for inspection by the agency.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3210. Leak testing of sealed sources.

A. Requirements. Each licensee using sealed sources of radioactive material shall have the sources tested for leakage. Records of leak test results shall be kept in units of microcuries (Bq) becquerels (microcuries) and maintained for inspection by the agency for six months three years after the next required leak test is performed or until transfer or disposal of the sealed source.

B. Method of Testing. Tests for leakage shall be performed only by persons specifically authorized to perform such tests by the agency, the United States Nuclear Regulatory Commission (NRC) NRC, an or another agreement state, or a licensing state. The test sample shall be taken from the surface of the source, source holder, or from the surface of the device in which the source is stored or mounted and on which one might expect contamination to accumulate. The test sample shall be analyzed for radioactive contamination, and the analysis shall be capable of detecting the presence of 0.005 microcurie (185 Bq) 185 Bq (0.0005 ?Ci) of radioactive material on the test sample.

C. Interval of Testing. Each sealed source of radioactive material (except an energy compensated source (ECS)) shall be tested at intervals not to exceed six months. Each ECS that is not exempt in subsection E of this section must be tested at intervals not to exceed three years. In the absence of a certificate from a transferor indicating that a test has been made prior to the transfer, the sealed source shall not be put into use until tested. If, for any reason, it is suspected that a sealed source may be leaking, it shall be removed from service immediately and tested for leakage as soon as practical.

D. Leaking or Contaminated Sources. If the test reveals the presence of 0.005 microcurie (185 Bq) 185 Bq (0.005 ?Ci) or more of leakage or contamination, the licensee shall immediately withdraw the source from use and shall cause it to be decontaminated, repaired, or disposed of in accordance with these regulations. The licensee shall check the equipment associated with the leaking source for radioactive contamination and, if contaminated, have it decontaminated or disposed of in accordance with these regulations. A report describing the equipment involved, the test results, and the corrective action taken shall be filed with the agency within five days of receiving the test results.

E. Exemptions. The following sources are exempted from the periodic leak test requirements of subsections A through D of this sectioon:

1. Hydrogen-3 sources;

2. Sources of radioactive material with a half-life of 30 days or less;

3. Sealed sources of radioactive material in gaseous form;

4. Sources of beta- or gamma-emitting radioactive material with an activity of 100 microcuries (3.7 MBq) 3.7 MBq (100 ?Ci) or less; and

5. Sources of alpha-emitting radioactive material with an activity of 10 microcuries (0.370 MBq) 0.37 MBq (10 ?Ci) or less.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3220. Quarterly Physical inventory.

Each licensee or registrant shall conduct a quarterly semi-annual physical inventory to account for all sources of radiation. Records of inventories shall be maintained for two three years from the date of the inventory for inspection by the agency and shall include the quantities and kinds of sources of radiation, the location where sources of radiation are assigned, the date of the inventory, and the name of the individual conducting the inventory.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3230. Utilization records.

Each licensee or registrant shall maintain current records, which shall be kept available for inspection by the agency for two three years from the date of the recorded event, showing the following information for each source of radiation:

1. Make, model number, and a serial number or a description of each source of radiation used;

2. The identity of the well-logging supervisor or field unit to whom assigned responsible for the source and the logging assistant present;

3. Locations where used and dates of use; and

4. In the case of tracer materials and radioactive markers, the utilization record shall indicate the radionuclide and activity used in a particular well.

Statutory Authority

§32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

12VAC5-481-3240. Design, performance, and certification criteria for sealed sources used in downhole operations.

A. Each sealed source, except those containing radioactive material in gaseous form, and ECSs used in downhole operations and manufactured after one year after September 20, 2006, shall be certified by the manufacturer, or other testing organization acceptable to the agency, to meet the following minimum criteria:

1. Be of doubly encapsulated construction;

2. Contain radioactive material whose chemical and physical forms are as insoluble and nondispersible as practical; and

3. Has been individually pressure tested to at least 24,656 pounds per square inch absolute (170 MN/m²) without failure. Certified by one of the following methods:

a. For a sealed source manufactured on or before July 14,1989, a licensee may use the sealed source, for use in well-logging applications if it meets the requirements of USASI N5.10-1968, "Classification of Sealed Radioactive Sources," or the requirements in subdivision 3 b or c of this subsection;

b. For a sealed source manufactured after July 1989, a licensee may use the sealed source, for use in well-logging applications if it meets the oil well-logging requirements of ANSI/HPS N43.6-1997, "Sealed Radioactive Sources-Classification"; or

c. For a sealed source manufactured after July 14, 1989, a licensee may use the sealed source, for use in well-logging applications, if the sealed source's prototype has been tested and found to maintain its integrity after each of the following tests:

(1) Temperature. The test source must be held at -40°C for 20 minutes, 600°C for 1 hour, and then be subject to a thermal shock test with a temperature drop from 600°C to 20°C within 15 seconds.

(2) Impact test. A 5 kg steel hammer, 2.5 cm in diameter, must be dropped from a height of 1 m onto the test source.

(3) Vibrations test. The test source must be subject to a vibration from 25 Hz to 500 Hz at 5 g amplitude for 30 minutes.

(4) Puncture test. A 1 gram hammer and pin, 0.3 cm pin diameter, must be dropped from a height of 1 m onto the test source.

(5) Pressure test. The test source must be subject to an external pressure of 1.695 x 10⁷ pascals (24,600 pounds per square inch absolute).

B. For sealed sources, except those containing radioactive material in gaseous form, acquired after one year after September 20, 2006, in the absence of a certificate from a transferor certifying that an individual sealed source meets the requirements of 12VAC5-481-3240, the sealed source shall not be put into use until such determinations and testing have been performed.

C. Each sealed source, except those containing radioactive material in gaseous form, used in downhole operations after two years after September 20, 2006, shall be certified by the manufacturer, or other testing organization acceptable to the agency, as meeting the sealed source performance requirements for oil well-logging as contained in the American National Standard N43.6, "Classification of Sealed Radioactive Sources," (formerly N542, ANSI/NBS 126) in effect on September 20, 2006.

D. B. Certification documents shall be maintained for inspection by the agency for a period of two years after source disposal. If the source is abandoned downhole, the certification documents shall be maintained until the agency authorizes disposition.

C. Energy Compensated Source (ECS). Licensee use of an ECS, which may contain no greater than 3.7 MBq (100 ?Ci), is exempt from this part, except the following: