Chapter 481. Virginia Radiation Protection Regulations
Part I
General Provisions
12VAC5-481-10. Definitions.
The following words and terms as used in this chapter shall have the following meanings unless the context clearly indicates otherwise:
"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 F.
"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 F.
"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.
"Access control" means a system for allowing only approved individuals to have unescorted access to the security zone and for ensuring that all other individuals are subject to escorted access.
"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).
"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.
"Aggregated" means accessible by the breach of a single physical barrier that would allow access to radioactive material in any form, including any devices that contain the radioactive material, when the total activity equals or exceeds a Category 2 quantity of radioactive material as listed in 12VAC5-481-451.
"Agreement state" means any state with which the NRC or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954, as amended (42 USC § 2021(b)).
"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; 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" or "K" means kerma in air (see definition of "kerma").
"Air kerma rate" or "AKR" means the air kerma per unit time.
"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 off site.
"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-rays or gamma-rays to determine the elemental composition or to examine the microstructure of materials.
"Annual limit on intake" or "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 to 10 CFR Part 20.
"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.
"Approved individual" means an individual whom the licensee has determined to be trustworthy and reliable for unescorted access in accordance with 12VAC5-481-451 and has completed the training required in 12VAC5-481-451.
"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.
"Articulated joint" means a joint between two separate sections of a tabletop that provides the capacity for one of the sections to pivot on the line segment along which the sections join.
"As low as is reasonably achievable" or "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 employee or agent who assembles components into an x-ray system that is subsequently used to provide professional or commercial services.
"Assigned protection factor" or "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.
"Associate radiation safety officer" means an individual who (i) meets the requirements of 12VAC5-481-1750 and 12VAC5-481-1790 and (ii) is currently identified as an associate radiation safety officer for the types of use of byproduct material for which the individual has been assigned duties and tasks by the radiation safety officer on (a) a specific medical use license issued by the agency, NRC, or another agreement state or (b) a medical use permit issued by a NRC master material licensee.
"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:
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. 12VAC5-481-2018;
g. 12VAC5-481-2030;
h. 12VAC5-481-2040 A; 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" or "AEC" means a device that automatically controls one or more technique factors in order to obtain, at a preselected location, a required quantity of radiation (includes devices such as phototimers and ion chambers).
"Background investigation" means the investigation conducted by a licensee or applicant to support the determination of trustworthiness and reliability.
"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 or useful beam.
"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" or "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 using special nuclear material;
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 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 U.S. Environmental Protection Agency, the U.S. Secretary of Energy, the U.S. 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 fluoroscope" 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.
"Cassette holder" means a device, other than a spot-film device, that supports or fixes the position of an x-ray film (imaging) cassette during an x-ray exposure.
"Category 1 quantities of radioactive material" or "Category 1" means a quantity of radioactive material meeting or exceeding the Category 1 threshold in Table 1 of 12VAC5-481-451. This is determined by calculating the ratio of the total activity of each radionuclide to the Category 1 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds 1, the quantity would be considered a Category 1 quantity. Category 1 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.
"Category 2 quantities of radioactive material" or "Category 2" means a quantity of radioactive material meeting or exceeding the Category 2 threshold but less than the Category 1 threshold in Table 1 of 12VAC5-481-451. This is determined by calculating the ratio of the total activity of each radionuclide to the Category 2 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds 1, the quantity would be considered a Category 2 quantity. Category 2 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.
"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" or "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 P.L. 90-602, the Radiation Control for Health and Safety Act of 1968 of the Food and Drug Administration.
"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 NRC regulations.
"CFR" means Code of Federal Regulations.
"Chelating agent" means amine polycarboxylic acids, hydroxycarboxylic acids, gluconic acid, and polycarboxylic acids.
"Chemical description" means a description of the principal chemical characteristics of a low-level radioactive waste.
"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.
"cm" means centimeters.
"Coefficient of variation" or "C" means the ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:
where:
s = Standard deviation of the observed values;
X%u0305 = Mean value of observations in sample;
xi = ith 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 taking any action defined as "construction" or any other activity at the site of a facility subject to the regulations in this chapter that has a reasonable nexus to radiological health and safety.
"Committed dose equivalent" or "HT,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" or "HE,50" means the sum of the products of the weighting factors (wT) applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (HE,50 = S (wT HT,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 %2B7T 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.
"Computer-readable medium" means that the regulatory agency's computer can transfer the information from the medium into its memory.
"Consignee" means the designated receiver of the shipment of low-level radioactive waste.
"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" or "dose constraint" means a value above which specified licensee actions are required.
"Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to this chapter. The term "construction" does not include:
1. Changes for temporary use of the land for public recreational purposes;
2. Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;
3. Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;
4. Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to this chapter;
5. Excavation;
6. Erection of support buildings (e.g., construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;
7. Building of service facilities (e.g., paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);
8. Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or
9. Taking any other action that has no reasonable nexus to radiological health and safety.
"Contact therapy system" means a therapeutic radiation machine with a short target to skin distance (TSD), usually less than five centimeters.
"Contamination" means, as applicable to Part XIII (12VAC5-481-2950 et seq.) of this chapter, the presence of a radioactive substance on a surface in quantities in excess of 0.4 Bq/cm2 (1 x 10-5 µCi/cm2) for beta and gamma emitters and low toxicity alpha emitters, or 0.04 Bq/cm2 (1 x 10-6 µCi/cm2) for all other alpha emitters.
1. Fixed contamination means contamination that cannot be removed from a surface during normal conditions of transport.
2. Nonfixed contamination means contamination that can be removed from a surface during normal conditions of transport.
"Contrast scale" means the change in the linear attenuation coefficient per CTN relative to water, that is:
where:
µx = Linear attenuation coefficient of the material of interest;
µw = Linear attenuation coefficient of water; 
= of the material of interest; 
= of water.
"Control cable" or "drive" 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.
"Conventional simulator" means any x-ray system designed to reproduce the geometric conditions of the radiation therapy equipment.
"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.
"Cradle" means either:
1. A removable device that supports and may restrain a patient above an x-ray table; or
2. A device:
a. Whose patient support structure is interposed between the patient and the image receptor during normal use;
b. Which is equipped with means for patient restraint; and
c. Which is capable of rotation about its long (longitudinal) axis.
"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" or "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, overpacks or freight containers containing fissile material during transportation. Determination of the criticality safety index is described in 12VAC5-481-3040, 12VAC5-481-3051, and 10 CFR 71.59. The criticality safety index for an overpack, freight container, consignment, or conveyance containing fissile material packages is the arithmetic sum of the critically safety indices of all the fissile material packages contained within the overpack, freight container, consignment, or conveyance.
"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:
k = A constant, a normal value of 1,000 when the Hounsfield scale of CTN is used;
µx = Linear attenuation coefficient of the material of interest;
µw = Linear attenuation coefficient of water.
"Cumulative air kerma" means the total air kerma accrued from the beginning of an examination or procedure and includes all contribution from fluoroscopic and radiographic irradiation.
"Curie" is a unit of quantity of activity. One curie (Ci) is that quantity of radioactive material that decays at the rate of 3.7E%2B10 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.
"Declared pregnant woman" means a woman who has voluntarily informed 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.
"Decontamination facility" means a facility operating under a commission or Agreement state license whose principal purpose is decontamination of equipment or materials to accomplish recycle, reuse, or other waste management objectives, and, for purposes of this chapter, is not considered to be a consignee for LLW shipments.
"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" or "Hd," 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 P.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 §§ 104(b), (c) and (d) of the Energy Reorganization Act of 1974 (P.L. 93-438, October 11, 1974, 88 Stat. 1233 at 1237, 42 USC § 5814, effective January 19, 1975) and retransferred to the U.S. Secretary of Energy pursuant to § 301(a) of the Department of Energy Organization Act (P.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" or "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 Appendix B to 10 CFR Part 20.
"Derived air concentration-hour" or "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.) of this chapter, 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.
"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 and 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 container" means a container principally used to confine low-level radioactive waste during disposal operations at a land disposal facility (also see "high integrity container"). Note that for some shipments, the disposal container may be the transport package.
"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.
"Diversion" means the unauthorized movement of radioactive material subject to 12VAC5-481-451 to a location different from the material's authorized destination inside or outside of the site at which the material is used or stored.
"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" or "HT" 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" or "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" or "HE" means the sum of the products of the dose equivalent (HT) to each organ or tissue and the weighting factor (wT) applicable to each of the body organs or tissues that are irradiated (HE = S wTHT).
"Electronic brachytherapy" means a method of radiation therapy where an electrically generated source of ionizing radiation is placed in or near the tumor or target tissue to deliver therapeutic radiation dosage.
"Electronic brachytherapy device" means the system used to produce and deliver therapeutic radiation including the x-ray tube, the control mechanism, the cooling system, and the power source.
"Electronic brachytherapy source" means the x-ray tube component used in an electronic brachytherapy device.
"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" or "ECS" means a small sealed source, with an activity not exceeding 3.7 MBq (100 µCi), 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 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.
"EPA identification number" means the number received by a transporter following application to the Administrator of the U.S. Environmental Protection Agency as required by 40 CFR Part 263.
"Equipment" (See "x-ray equipment").
"Escorted access" means accompaniment while in a security zone by an approved individual who maintains continuous direct visual surveillance at all times over an individual who is not approved for unescorted access.
"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 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.
"Facility" means the location, building, vehicle, or complex under one administrative control, at which one or more radiation machines are installed, located or used.
"Fail-safe characteristics" means 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" or "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.
"Fingerprint orders" means the requirements of 12VAC5-481-451 B or orders issued by the U.S. Nuclear Regulatory Commission or the legally binding requirements issued by Agreement states that require fingerprints and criminal history records checks for individuals with unescorted access to Category 1 and Category 2 quantities of radioactive material or safeguards information-modified handling.
"Fissile material" means 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 set of fluoroscopic images or radiographic images recorded from the fluoroscopic image receptor. It includes the image receptors, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.
"Fluoroscopic irradiation time" means the cumulative duration during an examination or procedure of operator-applied continuous pressure to the device, enabling x-ray tube activation in any fluoroscopic mode of operation.
"Fluoroscopy" means a technique for generating x-ray images and presenting them simultaneously and continuously as visible images. This term has the same meaning as the term "radioscopy" in the standards of the International Electrotechnical Commission.
"Focal spot" or "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 NRC licensed facilities" means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where Atomic Energy Commission or 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 U.S. Environmental Protection Agency under the authority of the Atomic Energy Act of 1954, as amended, (42 USC § 2011 et seq.) 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 that, by design, is not limited to radiographic examination of specific anatomical regions.
"Generator" means a licensee who (i) is a waste generator as defined in this chapter, or (ii) is the licensee to whom waste can be attributed within the context of the Low-Level Radioactive Waste Policy Amendments Act of 1985 (42 USC § 2021) (e.g., waste generated as a result of decontamination or recycle activities).
"Gonad shield" means a protective barrier for the testes or ovaries.
"Gray" or "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" or "HVL" means the thickness of a specified material that attenuates the beam of radiation to an extent that the AKR is reduced by one-half of its original value. In this definition, the contribution of all scattered radiation, other than any which might be present initially in the beam concerned, is deemed to be excluded.
"Hand-held radiographic unit" means x-ray equipment that is designed to be hand-held during operation.
"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 B 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 U.S. 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 integrity container" or "HIC" means a container commonly designed to meet the structural stability requirements of 12VAC5-481-2572 and to meet U.S. Department of Transportation requirements for a Type A package.
"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.
"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, radiographic film, x-ray image intensifier tube, solid-state detector, or gaseous detector 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. In those cases where means are provided to preselect a portion of the image receptor, the term "image receptor" shall mean the preselected portion of the device.
"Image receptor support device" means, for mammographic systems, that part of the system designed to support the image receptor during mammographic examination and to provide a primary protective barrier.
"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.
"Indian tribe" means an Indian or Alaska Native tribe, band, nation, pueblo, village, or community that the U.S. Secretary of the Interior acknowledges to exist as an Indian tribe pursuant to the Federally Recognized Indian Tribe List Act of 1994 (25 USC § 479a).
"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 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").
"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.
"Intensity modulated radiation therapy" or "IMRT" means radiation therapy that uses nonuniform radiation beam intensities that have been determined by various computer-based optimization techniques.
"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 smallest sphere through which the beam axis passes when the equipment moves through a full range of rotations about its common center.
"kBq" means kilobecquerel.
"Kerma" or "K" means the quantity defined by the International Commission on Radiation Units and Measurements. The kerma is the quotient of dEtr by dm, where dEtr is the sum of the initial kinetic energies of all charged particles liberated by uncharged particles in a mass dm of materials; thus K=dEtr/dm, in units of J/kg, where the special name for the units of kerma is gray (Gy). When the materials is air, the quantity is referred to as "air kerma."
"Kilovolt" or "kV" 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 are 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.
"Last image hold radiograph" or "LIH" means an image obtained either by retaining one or more fluoroscopic images, which may be temporarily integrated, at the end of a fluoroscopic exposure or by initiating a separate and distinct radiographic exposure automatically and immediately in conjunction with termination of the fluoroscopic exposure.
"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 or the radiation therapy system 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, (10 mAs), 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; or
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" or "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 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.
"Light field" means the area illuminated by light, simulating the radiation field.
"Limits" (See "Dose limits").
"Line-voltage regulation" means the difference between the no-load and the load line potentials expressed as a percent of the load line potential as follows:
Percent line-voltage regulation = 100 (Vn-Vl)/Vl
where:
Vn = No-load line potential; and
Vl = Load line potential.
"Lixiscope" means a portable light-intensified imaging device using a sealed source.
"Local components" means 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.
"Local law-enforcement agency" or "LLEA" means a public or private organization that has been approved by a federal, state, or local government to carry firearms and make arrests, and is authorized and has the capability to provide an armed response in the jurisdiction where the licensed Category 1 or Category 2 quantity of radioactive material is used, stored, or transported.
"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 licensed material or provides personal supervision in the use of licensed material at a temporary jobsite and who is responsible to the licensee for assuring compliance with the requirements of this chapter and the conditions of the license.
"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 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 material" or "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. Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radionuclides that are intended to be processed for the use of these radionuclides;
b. Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;
c. Radioactive material other than fissile material, for which the A2 value is unlimited; or
d. 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. Other radioactive material in which the activity is distributed throughout and the estimated 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 (e.g., concrete, bitumen, or ceramic);
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, excluding any shielding material, 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.
"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" or "MV" 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.
"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 either:
1. An x-ray teletherapy radiation dose:
a. Involving the wrong patient;
b. Involving the wrong mode of treatment;
c. Involving the wrong treatment site;
d. Where the calculated total administered dose differs from the total prescribed dose by more than 10% when the treatment consists of three or fewer fractions;
e. Where the calculated weekly administered dose differs from the weekly prescribed dose by 30%; or
f. Where the calculated total administered dose differs from the total prescribed dose by more than 20%; or
2. An x-ray brachytherapy radiation dose:
a. Involving the wrong patient;
b. Involving the wrong treatment site; or
c. Where the calculated administered dose differs from the prescribed dose by more than 20%.
"mm" means millimeters.
"Mobile device" means a piece of equipment containing licensed radioactive materials that is either mounted on wheels or casters, or otherwise equipped for moving without a need for disassembly or dismounting, or designed to be hand carried. Mobile devices do not include stationary equipment installed in a fixed location.
"Mobile electronic brachytherapy service" means transportation of an electronic brachytherapy device to provide electronic brachytherapy at an address that is not the address of record.
"Mobile nuclear medicine service" means the transportation of byproduct material to and its medical use at the client's address.
"Mobile x-ray equipment" (See "x-ray equipment").
"Mode of operation" means, for fluoroscopy systems, a distinct method of fluoroscopy or radiography provided by the manufacturer and selected with a set of several technique factors or other control settings uniquely associated with the mode. The set of distinct technique factors and control settings for the mode may be selected by the operation of a single control. Examples of distinct modes of operation include normal fluoroscopy (analog or digital), high-level control fluoroscopy, cineradiography (analog and digital), digital subtraction angiography, electronic radiography using the fluoroscopic image receptor, and photospot recording. In a specific mode of operation, certain system variables affecting kerma, AKR, or image quality, such as image magnification, x-ray field size, pulse rate, pulse duration, number of pulses, source-image receptor distance (SID), or optical aperture, may be adjustable or may vary; their variation per se does not comprise a mode of operation different from the one that has been selected.
"Monitor unit" or "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.
"Movement control center" means an operation center that is remote from the transport activity and that maintains the position information on the movement of radioactive material, receives reports of attempted attacks or thefts, provides a means for reporting these and other problems to appropriate agencies and can request and coordinate appropriate aid.
"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.
"National Sealed Source and Device Registry" or "SSDR" means the national registry that contains the registration certificates, maintained by the NRC, that summarize the radiation safety information for sealed sources and devices, and describes the licensing and use conditions approved for the product.
"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 with 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" or "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.
"No-later-than arrival time" means the date and time that the shipping licensee and receiving licensee have established as the time at which an investigation will be initiated if the shipment has not arrived at the receiving facility. The no-later-than arrival times may not be more than six hours after the estimated arrival time for shipments of Category 2 quantities of radioactive material.
"Noise" means the standard deviation of the fluctuations in CTN expressed as a percentage of the attenuation coefficient of water. Its estimate (Sn) is calculated using the following expression:
where:
= Linear attenuation coefficient of the material of interest.
µw = Linear attenuation coefficient of water.
s = 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.
"Non-image-intensified fluoroscopy" means fluoroscopy using only a fluorescent screen.
"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.
"NRC Forms 540, 540A, 541, 541A, 542, and 542A" means official NRC forms referenced in this chapter. Licensees need not use originals of these NRC Forms as long as any substitute forms are equivalent to the original documentation in respect to content, clarity, size, and location of information. Upon agreement between the shipper and consignee, NRC Forms 541 (and 541A) and NRC Forms 542 (and 542A) may be completed, transmitted, and stored in electronic media. The electronic media must have the capability for producing legible, accurate, and complete records in the format of the uniform manifest.
"Nuclear Regulatory Commission" or "NRC" means the 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 chapter is used in the same way as in 49 CFR 173.403) required to be in 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, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with 12VAC5-481-1870, 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.
"Ophthalmic physicist" means an individual who (i) meets the requirements of 12VAC5-481-1790 and 12VAC5-481-2016 A 2 and (ii) is identified as an ophthalmic physicist on a specific medical use license issued by the agency, NRC, or another agreement state; permit issued by agency, NRC, or another agreement state broad scope licensee; medical use permit issued by a NRC master material licensee; or a permit issued by a NRC master material broad scope medical use permittee.
"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, department of the Commonwealth other than the Department of Health, political subdivision of the Commonwealth, any other state or political subdivision or department thereof, and any legal successor, representative, agent, or department of the foregoing, but not including federal government agencies.
"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.
"Physical description" means the items called for on NRC Form 541 to describe a low-level radioactive waste.
"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 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.
"Positron emission tomography radionuclide production facility" or "PET" means a facility operating a cyclotron or other particle accelerator for the purpose of producing radionuclides that decay by positron emission.
"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" or "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, a radiation safety officer, or an associate 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;
2. For teletherapy, the total dose and dose per fraction as documented in the written directive. The prescribed dose is an estimation from measured data from a specified therapeutic machine using assumptions that are clinically acceptable for that treatment technique and historically consistent with the clinical calculations previously used for patients treated with the same clinical technique; 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" means the material, excluding filters, placed in the useful beam to reduce the radiation exposure (beyond the patient and cassette holder) for protection barriers.
"Principal activities," as used in this chapter, means activities authorized by the license that are essential to achieving the purposes 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 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.
"Pulsed mode" means operation of the x-ray system such that the x-ray tube is pulsed by the x-ray control to produce one or more exposure intervals of duration less than one-half second.
"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.
"Qualified inspector" means an individual who is granted professional privileges based on education and experience to provide clinical services in diagnostic and therapeutic medical physics.
"Qualified medical physicist" means an individual qualified in accordance with 12VAC5-481-3390 D.
"Qualitative fit test" or "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" or "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" or "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).
"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 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" or "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 or 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.
"Radiation therapy system" means a device that delivers radiation to a specific area of the body where cancer cells or tumors are located.
"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 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.
"Radiographic personnel" means any radiographer, radiographer instructor, or radiographer trainee.
"Radiography" means:
1. For radioactive materials: See "Industrial radiography."
2. For x-ray: A technique for generating and recording an x-ray pattern for the purpose of providing the user with an image after termination of the exposure.
"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.
"Recording" means producing a retrievable 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 U.S. 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 rems is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 Sv).
"Reportable event" means the administration of either:
1. A diagnostic x-ray exposure where an actual or suspected acute or long-term functional damage to an organ or a physiological system has occurred. Exempt from this reporting requirement is any event when any functional damage to a patient organ or a physiological system that was an expected outcome when the causative procedures were prescribed;
2. A procedure where the patient or operator is injured as a result of a mechanical injury;
3. A teletherapy x-ray or electron dose where the calculated weekly administered dose differs from the weekly prescribed dose by 15% or more; or
4. A brachytherapy x-ray dose where the calculated administered dose differs from the prescribed dose by 10% or more.
"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 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 U.S. 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 U.S. 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.
"Residual waste" means low-level radioactive waste resulting from processing or decontamination activities that cannot be easily separated into distinct batches attributable to specific waste generators. This waste is attributable to the processor or decontamination facility, as applicable.
"Respiratory protective 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 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.
"Reviewing official" means the individual who shall make the trustworthiness and reliability determination of an individual to determine whether the individual may have, or continue to have, unescorted access to the Category 1 or Category 2 quantities of radioactive materials that are possessed by the licensee.
"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.
"Sabotage" means deliberate damage, with malevolent intent, to a Category 1 or Category 2 quantity of radioactive material, a device that contains a Category 1 or Category 2 quantity of radioactive material, or the components of the security system.
"Safe haven" means a readily recognizable and readily accessible site at which security is present or from which, in the event of an emergency, the transport crew can notify and wait for the local law-enforcement authorities.
"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 radioactive material that is encased in a capsule designed to prevent leakage or escape of any radioactive material.
"Secondary dose monitoring system" means a system which will terminate irradiation in the event of failure of the primary dose monitoring system.
"Security zone" means any temporary or permanent area determined and established by the licensee for the physical protection of Category 1 or Category 2 quantities of radioactive material.
"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" or "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" or "Hs," 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).
"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.
"Shipper" means the licensed entity (i.e., the waste generator, waste collector, or waste processor) who offers low-level radioactive waste for transportation, typically consigning this type of waste to a licensed waste collector, waste processor, or land disposal facility operator.
"Shipping paper" means NRC Form 540 and, if required, NRC Form 540A, which includes the information required by the U.S. Department of Transportation in 49 CFR Part 172.
"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" or "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" or "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 of radiation" means any radioactive material or any device or equipment emitting, or capable of producing, radiation.
"Source-skin distance" or "SSD" means the distance from the source to the center of the entrant x-ray field in the plane tangent to the patient's skin surface.
"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 requirements of 10 CFR 71.75. A special form encapsulation designed in accordance with the NRC requirements of 10 CFR 71.4 in effect on June 30, 1983 (see 10 CFR Part 71, revised as of January 1, 1983), and constructed before July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 CFR 71.4 in effect on March 31, 1996 (see 10 CFR Part 71, revised as of January 1, 1996), and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015, in accordance with the requirements of 10 CFR 71.75(d) in effect before September 10, 2015, may continue to be used. Any other special form encapsulation must meet requirements of this definition.
"Special nuclear material" means:
1. Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material the NRC, pursuant to the provisions of § 51 of the Atomic Energy Act of 1954, as amended, (42 USC § 2071) 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:
(175 grams contained U235/350) %2B (50 grams U – 233/200) %2B (50 grams Pu/200) = 1
"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 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.
"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 this chapter, "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," "airline respirator," or "SAR" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.
"Surface contaminated object" or "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 µCi/cm²) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerel per cm² (1 E-05 µCi/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 4x104 becquerel per cm² (1.0 µCi/cm²) for beta and gamma and low toxicity alpha emitters, or 4x103 becquerel per cm² (0.1 µCi/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 4x104 becquerel per cm² (1 µCi/cm²) for beta and gamma and low toxicity alpha emitters, or 4x103 Becquerel per cm² (0.1 µCi/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 µCi/cm²) for beta and gamma and low toxicity alpha emitters or 40 becquerel per cm² (1 E-03 µCi/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 8x105 becquerel per cm² (20 µCi/cm²) for beta and gamma and low toxicity alpha emitters, or 8x104 becquerel per cm² (2 µCi/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 8x105 becquerel per cm² (20 µCi/cm²) for beta and gamma and low toxicity alpha emitters, or 8x104 becquerel per cm² (2 µCi/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 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.
"Tabletop, stationary" means a tabletop that, when assembled for use, is incapable of movement with respect to its supporting structure within the plane of the tabletop.
"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.
"Target-skin distance" or "TSD" means the distance measured along the beam axis from the center of the front surface of the x-ray target or electron virtual source, or both, to the surface of the irradiated object or patient.
"Technologically enhanced naturally occurring radioactive material" or "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 NRC regulations.
"Technique factors" means the following conditions of operation:
1. For capacitor energy storage equipment, peak tube potential in kilovolts (kV) and quantity of charge in milliampere-seconds (mAs);
2. For field emission equipment rated for pulsed operation, peak tube potential in kilovolts (kV), and number of x-ray pulses;
3. For CT equipment designed for pulsed operation, peak tube potential in kilovolts (kV), scan time in seconds, and either tube current in milliamperes (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 milliampere-seconds (mAs);
4. For CT equipment not designed for pulsed operation, peak tube potential in kilovolts (kV), and either tube current in milliamperes (mA) and scan time in seconds, or the product of tube current and exposure time in milliampere-seconds (mAs) and the scan time when the scan time and exposure time are equivalent; and
5. For all other equipment, peak tube potential in kilovolts (kV), and either tube current in milliamperes (mA) and exposure time in seconds, or the product of tube current and exposure time in milliampere-seconds (mAs).
"Telemetric position monitoring system" means a data transfer system that captures information by either instrumentation or measuring devices, or both, about the location and status of a transport vehicle or package between the departure and destination locations.
"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 x-ray fluorescence use is performed and where licensed material may be stored other than those locations of use authorized on the license.
"Tenth-value layer" or "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.
"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. For the purpose of this chapter, devices used to administer electronic brachytherapy shall also be considered therapeutic radiation machines.
"These regulations" mean all parts of this chapter.
"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 that 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" or "TEDE" means the sum of the effective dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.
"Total organ dose equivalent" or "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 that meets all applicable requirements of the U.S. Department of Transportation.
"Transport index" or "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 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 by 100 (equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet)).
"Treatment site" means the correct anatomical description of the area intended to receive a radiation dose, as described in a written directive.
"Tribal official" means the highest ranking individual that represents tribal leadership, such as the chief, president, or tribal council leadership.
"Tritium neutron generator target source" means a tritium source used within a neutron generator tube to produce neutrons for use in well-logging applications.
"Trustworthiness and reliability" means characteristics of an individual considered dependable in judgment, character, and performance, such that unescorted access to Category 1 or Category 2 quantities of radioactive material by that individual does not constitute an unreasonable risk to the public health and safety or security. A determination of trustworthiness and reliability for this purpose is based upon the results from a background investigation.
"Tube" means an x-ray tube, unless otherwise specified.
"Tube housing assembly" means the tube housing with tube installed. It includes high-voltage 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 Table 1 of 12VAC5-481-3770 F or may be determined by procedures described in 12VAC5-481-3770 A through E.
"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 or related equipment are beneath the surface of the water.
"Unescorted access" means solitary access to an aggregated Category 1 or Category 2 quantity of radioactive material or the devices that contain the material.
"Uniform Low-Level Radioactive Waste Manifest" or "uniform manifest" means the combination of NRC Forms 540 and 541, and, if necessary, 542, and their respective continuation sheets as needed, or equivalent.
"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. Processing does not include sieving or encapsulating of ore or preparation of samples for laboratory analysis.
"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 (which may be chemically separated) 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 that passes through the tube housing port and the aperture of the beam-limiting device when the exposure switch or timer is activated.
"User seal check" or "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 simulator" means a computed tomography (CT) unit used in conjunction with relevant software that recreates the treatment machine and that allows import, manipulation, display, and storage of images from CT or other imaging modalities, or both.
"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 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 collector" means an entity, operating under a specific license, whose principal purpose is to collect and consolidate waste generated by others, and to transfer this waste, without processing or repackaging the collected waste, to another licensed waste collector, licensed waste processor, or licensed land disposal facility.
"Waste description" means the physical, chemical and radiological description of a low-level radioactive waste as called for on NRC Form 541.
"Waste generator" means an entity, operating under a license, that (i) possesses any material or component that contains radioactivity or is radioactively contaminated for which the licensee foresees no further use, and (ii) transfers this material or component to a licensed land disposal facility or to a licensed waste collector or processor for handling or treatment prior to disposal. A licensee performing processing or decontamination services may be a "waste generator" if the transfer of low-level radioactive waste from its facility is defined as "residual waste."
"Waste handling licensees" mean persons licensed to receive and store radioactive wastes prior to disposal or persons licensed to dispose of radioactive waste.
"Waste processor" means an entity, operating under a specific license, whose principal purpose is to process, repackage, or otherwise treat low-level radioactive material or waste generated by others prior to eventual transfer of waste to a licensed low-level radioactive waste land disposal facility.
"Waste type" means a waste within a disposal container having a unique physical description (i.e., a specific waste descriptor code or description; or a waste sorbed on or solidified in a specifically defined media).
"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" or "wT" 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 wT are:
Organ Dose Weighting Factors | |
Organ or Tissue | wT |
Gonads | 0.25 |
Breast | 0.15 |
Red bone marrow | 0.12 |
Lung | 0.12 |
Thyroid | 0.03 |
Bone surfaces | 0.03 |
Remainder | 0.30a/ |
Whole Body | 1.00b/ |
a/0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses. | |
b/For the purpose of weighting the external whole body dose for adding it to the internal dose, a single weighting factor, wT = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued. | |
"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" or "WL" means any combination of short-lived radon daughters in one liter of air that will result in the ultimate emission of 1.3x105 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" or "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 authorized user's written order for the administration of radioactive material, radiation from radioactive material, or radiation from a radiation producing machine to a specific patient or human research subject.
"X-ray control" means a device that controls input power to the x-ray high-voltage generator or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices, which control the technique factors of an x-ray exposure.
"X-ray exposure control" means a device, switch, button or other similar means by which an operator initiates 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 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 AKR is one-fourth of the maximum in the intersection.
"X-ray high-voltage generator" means a device that 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 tubes, 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 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, fluoroscopic image receptor, 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 this chapter. 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; Volume 25, Issue 2, eff. November 1, 2008; Volume 31, Issue 24, eff. August 27, 2015; Volume 32, Issue 13, eff. March 23, 2016; Volume 32, Issue 24, eff. August 25, 2016; Errata, 33:11 VA.R. 1299 January 23, 2017; amended, Virginia Register Volume 34, Issue 2, eff. October 18, 2017; Volume 34, Issue 14, eff. April 5, 2018; Volume 37, Issue 25, eff. January 14, 2022; Errata, 39:5 VA.R. 943 October 24, 2022.
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 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 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. 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.
12VAC5-481-40. Reserved. (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.
12VAC5-481-50. Reserved. (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.
12VAC5-481-60. Reserved. (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.
12VAC5-481-70. Reserved. (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.
12VAC5-481-80. Reserved. (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.
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 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 NRC when the state and the 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.
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.
12VAC5-481-120. [Reserved].
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-130. Impounding.
Sources of radiation shall be subject to impounding pursuant to § 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.
12VAC5-481-140. Prohibited uses.
A. A hand-held fluoroscopic screen shall not be used with X-ray equipment unless it has been listed in the Registry of Sealed Source and Devices or accepted for certification by the Food and Drug Administration, Center for Devices and Radiological Health.
B. Shoe-fitting fluoroscopic devices shall not be used.
C. No person shall intentionally apply or allow to be applied, either directly or indirectly, radiation to human beings except by, or under the supervision of, a practitioner of the healing arts licensed by this state, except in the case of healing arts screening programs approved in advance by the commissioner. Supervision, as used in this subsection, means the responsibility for and control of quality, radiation safety and technical aspects of the application of radiation to human beings for diagnostic or therapeutic purposes. This prohibition does not apply to persons who are occupationally exposed to radiation or as otherwise provided in these 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.
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, Radioactive Materials Program, 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.
12VAC5-481-160. Effective date.
The application of these regulations to possess by-product materials, source and special nuclear materials shall not become operative until 30 days after publication in the Virginia Register of a notice of an agreement executed by the Commonwealth of Virginia and the Federal Government under the provisions of Section 274b of the Atomic Energy Act of 1954, as amended (73 Statute 689). All other applications of the provisions of this chapter shall become effective September 20, 2006.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-170. Removal of notices posted by agency prohibited.
Any sign, notice, warning or label affixed by the agency to equipment or facilities of any registrant or licensee shall not be removed, defaced or concealed by any person other than the agency without written permission.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-180. Tests.
Each licensee and registrant shall perform upon instructions from the agency, or shall permit the agency to perform, such reasonable tests as the agency deems appropriate or necessary including, but not limited to, tests of:
1. Sources of radiation;
2. Facilities wherein sources of radiation are used or stored;
3. Radiation detection and monitoring instruments; and
4. Other equipment and devices used in connection with utilization or storage of licensed or registered 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.
12VAC5-481-190. Additional regulatory requirements.
The agency may, by rule, regulation, or order, impose upon any licensee or registrant such requirements in addition to those established in these regulations as it deems appropriate or necessary to minimize danger 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.
12VAC5-481-200. (Repealed.)
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.
12VAC5-481-210. Types of hearings.
Hearings before the board, the commissioner, or their designees shall include any of the following forms depending upon the nature of the controversy and the interests of the parties involved. All concerned parties will be provided with a reasonable notice of any intent to consider any public data, documents or information in making case decisions.
1. Informal conference. An informal conference is a conference with the commissioner or his designee with concerned parties, in person, with counsel or other representatives held in accordance with § 2.2-4019 of the Code of Virginia.
2. Hearing. A hearing is a formal, public proceeding before the commissioner or a designated hearing officer and held in conformance with § 2.2-4020 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.
12VAC5-481-220. Hearing as a matter of right.
Any licensee or registrant whose licensure, certification or registration has been, or may be affected by any decision of the board or its subordinates in the administration of this chapter shall have a right to both informal and adjudicatory hearings. The commissioner may require participation in an informal hearing before granting the request for a full adjudicatory hearing.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-230. Appeal.
A. Any appeal from a denial of a license or certification must be made in writing and received by the 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.
A. As used in this chapter, the unit of exposure is the coulomb per kilogram (C/kg) of air and the units of radiation dose are gray (Gy), rad, rem, and sievert. (See 12VAC5-481-10 for definitions.) One roentgen is equal to 2.58E-4 coulomb per kilogram of air.
1. Gray (Gy) is the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).
2. Rad is the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs per gram or 0.01 joule per kilogram (0.01 Gy).
3. Rem is the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 Sv).
4. Sievert is the SI unit of any of the quantities as dose equivalent. The dose equivalent is equal to the absorbed dose in gray multiplied by the quality factor (1 Sv = 100 rem).
B. As used in this chapter, the quality factors for converting absorbed dose to dose equivalent are shown in Quality Factors and Absorbed Dose Equivalencies table in this subsection.
|
| Quality Factors and Absorbed Dose Equivalencies | ||
| Type of Radiation | Quality factor (Q) | Absorbed dose equal to a unit dose equivalenta | |
| X, gamma, or beta | 1 | 1 | |
| Alpha particles, multiple-charged particles, fission fragments and heavy particles of unknown charge | 20 | 0.05 | |
| Neutrons of unknown energy | 10 | 0.1 | |
| High energy protons | 10 | 0.1 | |
|
| aAbsorbed dose in rad equal to 1 rem or the absorbed dose in gray equal to 1 sievert. | ||
C. If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in rems per hour or sieverts per hour, as provided in subsection B of this section, 1 rem (0.01 Sv) of neutron radiation of unknown energies may, for purposes of this chapter, be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy of the neutrons, the licensee may use the fluence rate per unit dose equivalent of the approximate Q value from the Mean Quality Factors, Q, and Fluence per Unit Dose Equivalent for Monoenergetic Neutrons table in this subsection to convert a measured tissue dose in rads to dose equivalent in rems.
|
| Mean Quality Factors, Q, and Fluence per Unit Dose Equivalent for Monoenergetic Neutrons | |||
|
|
| Neutron energy (MeV) | Quality factor (Q)a | Fluence per unit dose equivalent (neutrons cm-2 rem-1)b |
|
| (thermal) | 2.5 x 10-8 | 2 | 980 x 106 |
|
| 1 x 10-7 | 2 | 980 x 106 | |
|
| 1 x 10-6 | 2 | 810 x 106 | |
|
| 1 x 10-5 | 2 | 810 x 106 | |
|
| 1 x 10-4 | 2 | 840 x 106 | |
|
| 1 x 10-3 | 2 | 980 x 106 | |
|
| 1 x 10-2 | 2.5 | 1010 x 106 | |
|
| 1 x 10-1 | 7.5 | 170 x 106 | |
|
| 5 x 10-1 | 11 | 39 x 106 | |
|
| 1 | 11 | 27 x 106 | |
|
| 2.5 | 9 | 29 x 106 | |
|
| 5 | 8 | 23 x 106 | |
|
| 7 | 7 | 24 x 106 | |
|
| 10 | 6.5 | 24 x 106 | |
|
| 14 | 7.5 | 17 x 106 | |
|
| 20 | 8 | 16 x 106 | |
|
| 40 | 7 | 14 x 106 | |
|
| 60 | 5.5 | 16 x 106 | |
|
| 1 x 102 | 4 | 20 x 106 | |
|
| 2x102 | 3.5 | 19x106 | |
|
| 3x102 | 3.5 | 16x106 | |
|
| 4x102 | 3.5 | 14x106 | |
| aValue of quality factor (Q) at the point where the dose equivalent is maximum in a 30-cm diameter cylinder tissue-equivalent phantom. bMonoenergetic neutrons incident normally on a 30-cm diameter cylinder tissue-equivalent phantom. | ||||
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-250. Units of radioactivity.
For the purposes of this chapter, activity is expressed in the special unit of curies (Ci) or in the SI unit of becquerels (Bq), their multiples, or their disintegrations (transformations) per unit of time.
1. One becquerel equals 1 disintegration per second (s-1).
2. One curie equals 3.7 x 1010 disintegrations per second equals 3.7 x 1010 becquerels equals 2.22 x 1012 disintegrations per minute.
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; Volume 32, Issue 24, eff. August 25, 2016.
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 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 μSv (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.
12VAC5-481-280. Shielding plan review.
A. Prior to construction, the floor plans, shielding specifications and equipment arrangement of all new installations, or modifications of existing installations, utilizing ionizing radiation machines shall be available to the agency for review. The required information is found in 12VAC5-481-280 E.
B. The agency may require the applicant to utilize the services of a private inspector to determine the shielding requirements prior to the plan review.
C. The review of such plans shall not preclude the requirement of additional modifications should a subsequent analysis of operating conditions indicate the possibility of an individual receiving a dose in excess of the limits prescribed in 12VAC5-481-640 and 12VAC5-481-680 through 12VAC5-481-730.
D. After installation of a radiation machine, the registrant shall maintain for inspection by the agency:
1. The maximum rated technique factors of each machine;
2. A scale drawing of the room in which a stationary radiation machine system is located with such drawing indicating the use of areas adjacent to the room and an estimation of the extent of occupancy by an individual in such areas. In addition, the drawing shall include:
a. The results of a survey for radiation levels present at the operator's position and at pertinent points outside the room at specified test conditions; or
b. The type and thickness of materials, or lead equivalency, of each protective barrier.
E. In order for the private inspector to provide an evaluation, technical advice, and approval on shielding requirements for a radiation installation, the following information shall be required.
1. The plans showing, as a minimum, the following:
a. The normal location of the system's radiation port; the port's travel and traverse limits; general direction(s) of the useful beam; locations of any windows and doors or other openings; the location of the operator's booth; and the location of the control panel;
b. The structural composition and thickness or lead equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned;
c. The dimensions of the room(s) concerned;
d. The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that individuals may be present;
e. The make and model of the equipment, the maximum technique factors, and the energy waveform (single phase, three phase, etc.);
f. The type of examination(s) or treatment(s) that will be performed with the equipment.
2. Information on the anticipated workload of the system(s) in Ma-minutes per week.
3. A report showing all basic assumptions used in the development of the shielding specifications.
F. The following requirements shall be used in the design for an operator's booth:
1. Space requirements:
a. The operator shall be allotted not less than 0.70 square meter (7.5 square feet) of unobstructed floor space in the booth;
b. The operator's booth may be any geometric configuration with no dimension of less than 0.6 m (2 feet);
c. The space shall be allotted excluding any encumbrance by the X-ray control panel, such as overhang, cables, or other similar encroachments;
d. The booth shall be located or constructed such that unattenuated direct scatter radiation originating on the examination table or at the wall-mounted image receptor will not reach the operator's position in the booth.
2. Structural requirements:
a. The booth walls shall be permanently fixed barriers of at least 2 m (7 feet) high;
b. When a door or movable panel is used as an integral part of the booth structure, it must have an interlock which will prevent an exposure when the door or panel is not closed;
c. Shielding shall be provided to meet the requirements of Part IV (12VAC5-481-600 et seq.) of this chapter.
3. Radiation exposure control placement: The radiation exposure control for the system shall be fixed within the booth and:
a. Shall allow the operator to remain in the protected area and not be exposed to direct scatter, leakage or primary beam radiation;
b. Shall allow the operator to use the majority of the available viewing windows.
4. Viewing system requirements:
a. Each booth shall have at least one viewing device that will:
(1) Be so placed that the operator can view the patient during any exposure; and
(2) Be so placed that the operator can have full view of any occupant of the room and should be so placed that the operator can view any entry into the room. If any door that allows access to the room cannot be seen from the booth, then outside that door there shall be an "X-ray on" warning sign that will be lighted anytime the rotor of the X-ray tube is activated. Alternatively, an interlock shall be present such that exposures are prevented unless the door is closed.
b. When the viewing system is a window, the following requirements also apply:
(1) The window shall have a viewing area of at least 0.09 square meter (1 square foot); Regardless of size or shape, at least 0.09 square meter (1 square foot) of the window area must be centered no less than 0.6 meter (2 feet) from the open edge of the booth and no less than 1.5 meter (5.0 feet) from the floor;
(2) The window shall have at least the same lead equivalence as that required in the booth's wall in which it is mounted.
c. When the viewing system is by mirrors, the mirror(s) shall be so located as to accomplish the general requirements of subdivision 1 of this subsection.
d. When the viewing system is by electronic means:
(1) The camera shall be so located as to accomplish the general requirements of subdivision 1 of this subsection; and
(2) There shall be an alternate viewing system as a backup for the primary system.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-290. Registration of radiation machine facilities.
Each person having a radiation machine facility shall:
1. Apply for registration of such facility with the agency within 30 days following installation of equipment. Application for registration shall be completed on forms furnished by the agency and shall contain all the information required by the form and accompanying instructions. Registrations filed with the agency prior to September 20, 2006, shall remain in effect until a renewal notice is issued by the agency pursuant to 12VAC5-481-310.
2. Designate on the application form an individual to be responsible for radiation protection.
3. Submit to the agency as part of any application for registration or renewal of registration one copy of each radiation survey or calibration report for which records are required to be maintained pursuant to 12VAC5-481-1591 A 12 c. Records submitted once need not be submitted again for renewal of registration.
4. Have an initial inspection by a private or state inspector no later than 30 days after the registration of the equipment. Subsequent inspections shall be made periodically in accordance with other parts of these regulations or whenever the equipment is moved to a new location. The agency shall furnish a list of private inspectors.
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 31, Issue 24, eff. August 27, 2015.
12VAC5-481-300. Issuance of registration certificate.
A. Upon a determination that an applicant meets the requirements of this chapter and has paid the appropriate registration fee, the agency shall issue a registration certificate.
B. The agency may incorporate in the registration certificate at the time of issuance or thereafter by appropriate rule, regulation or order, such additional requirements and conditions with respect to the registrant's receipt, possession, use and transfer of radiation machines as he deems appropriate or necessary.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-310. Renewal of registration and approval not implied.
A. Application for renewal of registration shall be filed in accordance with 12VAC5-481-290.
B. In any case in which a registrant not less than 30 days prior to the expiration of his existing registration certificate has filed an application in proper form for renewal, such existing registration certificate shall not expire until the application status has been finally determined by the agency.
C. No person, in any advertisement, shall refer to the fact that he or his facility is registered with the agency pursuant to the provisions of 12VAC5-481-290, and no person shall state or imply that any activity under such registration has been approved 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.
12VAC5-481-320. Expiration of registration certificate.
Except as provided by 12VAC5-481-310 B, each registration certificate shall expire at the end of the specified day in the month and year stated therein or upon notice issued to the registrant 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.
12VAC5-481-330. Report of changes.
The registrant shall notify the agency in writing before making any change that would render the information contained in the application for registration and/or the notice of registration no longer accurate.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
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 inspections or calibrations according to the following criteria and must submit to the 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 agency shall disqualify any individual from this designation if the agency has determined that the individual has demonstrated unsatisfactory performance as a private inspector. The individual may request an informal hearing.
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 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 inspections without the supervision of a qualified private inspector. Before independently 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 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, 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 or therapeutic medical 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, 12VAC5-481-3420 Q, 12VAC5-481-3430 T, and 12VAC5-481-3430 U under the supervision of a radiation therapy physicist during the year of work experience.
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. 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. The private inspector must have 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 an inspection without the supervision of a qualified private inspector. Before independently 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 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 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 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 inspections of mammography facilities; and
c. The experience of conducting 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. 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. At all times after the first anniversary of the completion of the initial requirements of this section, the private inspector shall have 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 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 inspections without the supervision of a qualified private inspector. Before independently 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 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; Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-350. Assembler or transfer obligation.
A. Any person who sells, leases, transfers, lends, disposes, assembles, or installs radiation machines or upon significant service or modification thereof of any radiation machine (such as tube inserts, generators, or collimators) in this state shall notify the agency within 15 days of:
1. The name and address of persons who have received these machines;
2. The manufacturer, model, and serial number of each radiation machine transferred; however, in the case of diagnostic x-ray systems that contain certified components, a copy of the assembler's report (Form FDA 2579) prepared in compliance with the requirements of the Food and Drug Administration's Federal Diagnostic X-ray Standard (21 CFR 1020.30(d)) shall be submitted and shall suffice in lieu of any other report by the assembler; and
3. The date of transfer of each radiation machine.
B. No person shall make, sell, lease, transfer, lend, assemble, or install radiation machines or the supplies used in connection with such machines unless such supplies and equipment when properly placed in operation and used shall meet the requirements of these 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 31, Issue 24, eff. August 27, 2015.
12VAC5-481-360. Reciprocal recognition of out-of-state radiation machines.
A. Whenever any radiation machine is to be brought into the state, for any temporary use, the person proposing to bring such machine into the state shall give written notice to the agency at least two working days before such machine is to be used in the state. The notice shall include:
1. The type of radiation machine;
2. The nature, duration, and scope of use;
3. The exact location(s) where the radiation machine is to be used; and
4. States in which this machine is registered.
B. If, for a specific case, the two-working-day period would impose an undue hardship on the person, upon application to the agency, permission to proceed sooner may be granted.
C. The person referred to in subsection A of this section shall:
1. Comply with all applicable regulations of the agency;
2. Supply the agency with such other information as the agency may reasonably request; and
3. Not operate within the state on a temporary basis in excess of 180 calendar days per year.
4. Supply the agency a copy of a medical physicist or private inspector report not less than one year old indicating the equipment is certified by another 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.
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 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 inspection or calibration report for which records are required to be maintained pursuant to Part VI (12VAC5-481-1580 et seq.) of this chapter. If the inspection was performed by a state inspector and the inspection was not initiated by the agency pay the appropriate fee as established by the 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.
Article 1
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.), 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.), 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 VII (12VAC5-481-1660 et seq.) of this chapter, licensees engaged in 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.
Article 2
Exemptions from the Regulatory Requirements
A. Common and contract carriers, freight forwarders, warehousemen, and the U.S. Postal Service are exempt from this part and the requirements for a license set forth in this chapter to the extent that they transport or store radioactive material in the regular course of the carriage for another or storage incident thereto.
B. Any person is exempt from Part III (12VAC5-481-380 et seq.) of this chapter to the extent that such person receives, possesses, uses, owns, transfers, or delivers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than 0.05% of the mixture, compound, solution or alloy. The exemption contained in this chapter does not apply to Australian-obligated radioactive material, nor does it include byproduct materials as defined in 12VAC5-481-10.
C. Any person is exempt from Part III (12VAC5-481-380 et seq.) of this chapter to the extent that such person receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material; provided that, except as authorized in a specific license, such person shall not refine or process such ore.
D. Any person is exempt from Parts III (12VAC5-481-380 et seq.), IV (12VAC5-481-600 et seq.), and X (12VAC5-481-2250 et seq.) of this chapter to the extent such person receives, possesses, uses, or transfers:
1. Any quantities of thorium contained in (i) incandescent gas mantles, (ii) vacuum tubes; (iii) welding rods; (iv) electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams of thorium; (v) germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting provided that each lamp does not contain more than 2 grams of thorium; (vi) rare earth metals and compounds, mixtures, and products containing not more than 0.25% by weight thorium, uranium, or any combination of these; or (vii) personnel neutron dosimeters provided that each dosimeter does not contain more than 50 milligrams of thorium.
2. Source material contained in the following products:
a. Glaze ceramic tableware manufactured before August 27, 2013, provided that the glaze contains not more than 20% by weight source material;
b. Piezoelectric ceramic containing not more than 2.0% by weight source material;
c. Glassware containing not more than 2.0% by weight source material or for glassware manufactured before August 27, 2013, 10% by weight source material, but not including commercially manufactured glass brick, pane glass, ceramic tile, or other glass or ceramic used in construction; or
d. Glass enamel or glass enamel frit containing not more than 10% by weight source material imported or ordered for importation into the United States, or initially distributed by manufacturers in the United States, before July 25, 1983. (On July 25, 1983, the exemption of glass enamel or glass enamel frit was suspended. The exemption was eliminated on September 11, 1984.)
3. Photographic film, negatives, and prints containing uranium or thorium.
4. Any finished product or part fabricated of or containing tungsten-thorium or magnesium-thorium alloys, provided that the thorium content of the alloy does not exceed 4.0% by weight and that the exemption shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such product or part.
5. Uranium contained in counterweights installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of such counterweights provided that:
a. Each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "Depleted Uranium";
b. Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer, and the statement: "Unauthorized Alterations Prohibited" (The requirements of this subdivision need not be met by counterweights manufactured prior to December 31, 1969, provided that such counterweights were manufactured under a specific license issued by the Atomic Energy Commission and were impressed with the legend required by 10 CFR 40.13(c)(5)(ii) in effect on June 30, 1969); and
c. The exemption contained in this subsection shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such counterweights other than repair or restoration of any plating or other covering.
6. Natural or depleted uranium metal used as shielding constituting part of any shipping container, provided that:
a. The shipping container is conspicuously and legibly impressed with the legend: "CAUTION—RADIOACTIVE SHIELDING—URANIUM", and
b. The uranium metal is encased in mild steel or equally fire-resistant metal of minimum wall thickness of 1/8 inch (3.2 mm).
7. Thorium or uranium contained in or on finished optical lenses and mirrors, provided that each lens or mirror does not contain more than 10% by weight thorium or uranium or, for lenses manufactured before August 27, 2013, 30% by weight of thorium; and that the exemption contained in this paragraph does not authorize either:
a. The shaping, grinding, or polishing of such lens or mirror or manufacturing processes other than the assembly of such lens or mirror into optical systems and devices without any alteration of the lens or mirror; or
b. The receipt, possession, use, or transfer of uranium or thorium contained in contact lens, spectacles, or eyepieces in binoculars or other optical instruments.
8. Thorium contained in any finished aircraft engine part contained nickel-thoria alloy, provided that:
a. The thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide); and
b. The thorium content in the nickel-thoria alloy does not exceed 4.0% by weight.
9. The exemptions in this subsection do not authorize the manufacture of any products described.
10. No person may initially transfer for sale or distribution a product containing source material to persons exempt under this subsection or equivalent regulations of the NRC or another agreement state, unless authorized by the NRC with a license issued under 10 CFR 40.52 to initially transfer such products for sale or distribution.
a. Persons initially distributing source material in products covered by the exemptions in this section before August 27, 2013, without specific authorization may continue such distribution for one year beyond this date. Initial distribution may also be continued until the NRC takes final action on a pending application for license or license amendment to specifically authorize distribution submitted no later than one year beyond this date.
b. Persons authorized to manufacture, process, or produce these materials or products containing source material, and persons who import finished products or parts, for sale or distribution shall be authorized by an NRC license issued under 10 CFR 40.52 for distribution only and are exempt from the requirements of 12VAC5-481-450 and Parts 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; Volume 25, Issue 2, eff. November 1, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 33, Issue 11, eff. February 22, 2017.
12VAC5-481-400. Radioactive material other than source material.
A. Exempt concentrations.
1. Except as provided in subdivisions 3 and 4 of this subsection, any person is exempt from the requirements for a license set forth in this part to the extent that such person receives, possesses, uses, transfers, owns, or acquires products or materials containing radioactive material in concentrations not in excess of those listed in 12VAC5-481-3720.
2. This subsection shall not be deemed to authorize the import of radioactive material or products containing radioactive material.
3. A manufacturer, processor, or producer of a product or material is exempt from the requirements for a license set forth in this part to the extent that this person transfers radioactive material (i) contained in a product or material in concentrations not in excess of those specified in 12VAC5-481-3720 and (ii) introduced into the product or material by a licensee holding a specific license issued by the NRC expressly authorizing such introduction. This exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by or application to a human being.
4. No person may introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under this subsection or equivalent regulations by the NRC or another agreement state except in accordance with a license issued under 12VAC5-481-480.
B. Exempt quantities.
1. Except as provided in subdivisions 3, 4, and 5 of this subsection, any person is exempt from the requirements of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in individual quantities, each of which does not exceed the applicable quantity set forth in 12VAC5-481-3730.
2. Any person who possesses radioactive material received or acquired before September 25, 1971, under the general license provided in 12VAC5-481-430 is exempt from the requirements for a license set forth in this part and from the regulations contained therein to the extent that this person possesses, uses, transfers, or owns radioactive material.
3. This subsection does not authorize for purposes of commercial distribution the production, packaging, repackaging, or transfer of radioactive material or the incorporation of radioactive material into products intended for commercial distribution.
4. No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in 12VAC5-481-3730, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under this part or equivalent regulations of the NRC or another agreement state, except in accordance with a license issued under 12VAC5-481-480, which license states that the radioactive material may be transferred by the licensee to persons exempt under this part or the equivalent regulations of the NRC or another agreement state.
5. No person may, for purposes of producing an increased radiation level, combine quantities of radioactive material covered by this exemption so that the aggregate quantity exceeds the limits set forth in 12VAC5-481-3730, except for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise permitted by this part.
C. Exempt items.
1. Except for persons who apply radioactive material to or persons who incorporate radioactive material into the following products, or persons who initially transfer for sale or distribution the following products containing radioactive material, any person is exempt from this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires the following products:
a. Timepieces or hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified quantities:
(1) 25 mCi (925 MBq) of tritium per timepiece;
(2) 5 mCi (185 MBq) of tritium per hand;
(3) 15 mCi (555 MBq) of tritium per dial (bezels when used shall be considered as part of the dial);
(4) 100 μCi (3.7 MBq) of promethium 147 per watch or 200 μCi (7.4 MBq) of promethium 147 per any other timepiece;
(5) 20 μCi (0.74 MBq) of promethium 147 per watch hand or 40 μCi (1.48 MBq) of promethium 147 per other timepiece hand;
(6) 60 μCi (2.22 MBq) of promethium 147 per watch dial or 120 μCi (4.44 MBq) of promethium 147 per other timepiece dial (bezels when used shall be considered as part of the dial);
(7) The levels of radiation from hands and dials containing promethium 147 will not exceed, when measured through 50 milligrams per square centimeter of absorber:
(a) For wrist watches, 0.1 millirad per hour (1 microgray per hour) at 10 centimeters from any surface,
(b) For pocket watches, 0.1 millirad per hour (1 microgray per hour) at 1 centimeter from any surface, or
(c) For any other timepiece, 0.2 millirad per hour (1 microgray per hour) at 10 centimeters from any surface; or
(8) 1 μCi (37 kBq) of radium-226 per timepiece in intact timepieces manufactured prior to November 30, 2007.
b. Other products including:
(1) Static elimination devices that contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 μCi (18.5 MBq) of polonium-210 per device;
(2) Ion generating tubes designed for ionization of air that contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 μCi (18.5 MBq) of polonium-210 per device or of a total of not more than 50 mCi (1.85 GBq) of hydrogen-3 (tritium) per device; and
(3) Such devices authorized before October 23, 2012, for use under the general license then provided in 12VAC5-481-430 and equivalent regulations of the NRC or another agreement state and manufactured, tested, and labeled by the manufacturer in accordance with the specifications contained in a specific license issued by the agency, the NRC, or another agreement state.
c. Balances of precision containing not more than 1 mCi (37 MBq) of tritium per balance or not more than 0.5 mCi (18.5 MBq) of tritium per balance part manufactured before December 17, 2007.
d. (Reserved.)
e. Marine compasses containing not more than 750 mCi (27.8 GBq) of tritium gas and other marine navigational instruments containing not more than 250 mCi (9.25 GBq) of tritium gas manufactured before December 17, 2007.
f. (Reserved.)
g. Ionization chamber smoke detectors containing not more than 1 μCi (37 kBq) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.
h. Electron tubes (includes: spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pickup tubes, radiation detection tubes, and any other completely sealed tube that is designed to conduct or control electrical currents), provided that each tube does not contain more than one of the following specified quantities:
(1) 150 mCi (5.55 GBq) of tritium per microwave receiver protector tube or 10 mCi (370 MBq) of tritium per any other electron tube;
(2) 1 μCi (37 kBq) of cobalt-60;
(3) 5 μCi (185 kBq) of nickel-63;
(4) 30 μCi (1.11 MBq) of krypton-85;
(5) 5 μCi (185 kBq) of cesium-137; or
(6) 30 μCi (1.11 MBq) of promethium-147; and
(7) Provided further that the levels of radiation dose from each electron tube containing radioactive material do not exceed 1 millirad per hour (10 microgray per hour) at 1 centimeter (0.39 inches) from any surface when measured through 7 milligrams per square centimeter of absorber.
i. Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided that:
(1) Each source contains no more than one exempt quantity set forth in 12VAC5-481-3730, and
(2) Each instrument contains no more than 10 exempt quantities. For purposes of this subdivision, an instrument's source or sources may contain either one type or different types of radionuclides and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in 12VAC5-481-3730, provided that the sum of such fractions shall not exceed unity.
(3) For purposes of this subdivision, 0.05 μCi (1.85 kBq) of americium-241 is considered an exempt quantity under 12VAC5-481-3730.
j. (Reserved.)
2. Any person who desires to apply radioactive material to, or to incorporate radioactive material into, the products exempted in subdivision 1 of this subsection, or who desires to initially transfer for sale or distribution such products containing radioactive material, should apply for a specific license pursuant to 12VAC5-481-480 C, which license states that the product may be distributed by the licensee to persons exempt from the regulations pursuant to subdivision 1 of this subsection.
D. Self-luminous products containing radioactive material.
1. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147, or except as provided in subdivision 3 of this subsection, any person is exempt from the requirements for a license set forth in this part to the extent that such person receives, possesses, uses, transfers, own, or acquires tritium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, produced, or initially transferred in accordance with a specific license issued pursuant to 12VAC5-481-480 D, which license authorizes the initial transfer of the product to persons who are exempt from regulatory requirements.
2. Any person is exempt from this chapter to the extent that such person receives, possesses, uses, transfers, or owns articles containing less than 0.1 microcurie (3.7 kBq) of radium-226 acquired prior to September 1, 1980.
3. Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147 for use under subdivision 1 of this subsection should apply for a license and for a certificate of registration in accordance with 12VAC5-481-480 D.
4. The exemption in subdivision 1 of this subsection does not apply to tritium, krypton-85, or promethium-147 used in products primarily for frivolous purposes or in toys or adornments.
E. Gas and aerosol detectors containing radioactive material.
1. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution gas and aerosol detectors containing radioactive material, any person is exempt from this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in gas and aerosol detectors designed to protect health, safety, or property from fires and airborne hazards provided that the detectors containing radioactive material shall have been manufactured, processed, produced, or initially transferred in accordance with a specific license issued under 12VAC5-481-480 E, which license authorizes use under this subsection. This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007, in accordance with a specific license issued by the NRC or another agreement state under provisions comparable to 12VAC5-481-480 C authorizing distribution to persons exempt from regulatory requirements.
2. Any person who desires to manufacture, process, or produce gas and aerosol detectors containing radioactive material, or to initially transfer such products for use under subdivision 1 of this subsection, should apply to the agency for a license in accordance with 12VAC5-481-480 C and for a certificate of registration with the NRC in accordance with 10 CFR 32.210.
3. 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 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.
4. Gas and aerosol detectors containing NARM previously manufactured and distributed in accordance with a specific license issued by the NRC or another agreement state shall be considered exempt under subdivision 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.
F. Radioactive drug: Capsules containing carbon-14 urea for "in-vivo" diagnostic use for humans.
1. Except as provided in subdivision 2 of this subsection, any person is exempt from the requirements for a license set forth in this part, provided that such person receives, possess, uses, transfers, owns, or acquires capsules containing 1 μCi (37 kBq) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each for "in vivo" diagnostic use for humans.
2. Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to Part VII (12VAC5-481-1660 et seq.) of this chapter.
3. Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for a license under and a certification of registration in accordance with 12VAC5-481-480 I.
4. Nothing in this subsection relieves persons from complying with applicable U.S. Food and Drug Administration (FDA), other federal, and state requirements governing receipt, administration, and use of drugs.
G. Carriers. Common and contract carriers, freight forwarders, warehousemen, and the U.S. Postal Service are exempt from this part to the extent that they transport special nuclear material in the regular course of carriage for another or storage incident thereto. This exemption does not apply to the storage in transit or transport of material by persons covered by a general license issued under 12VAC5-481-430 E.
H. Certain industrial devices.
1. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing radioactive material designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing an ionized atmosphere, any person is exempt from the requirements for a license set forth in § 32.1-229 of the Code of Virginia and in Parts III (12VAC5-481-380 et seq.), IV (12VAC5-481-600 et seq.), V (12VAC5-481-1170 et seq.), VII (12VAC5-481-1660 et seq.), X (12VAC5-481-2250 et seq.), XII (12VAC5-481-2660 et seq.), and XIV (12VAC5-481-3140 et seq.) of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material, in these certain detecting, measuring, gauging, or controlling devices and certain devices for producing an ionized atmosphere, and manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the NRC under 10 CFR 32.30, which license authorizes the initial transfer of the device for use under this subsection. This exemption does not cover sources not incorporated into a device, such as calibration and reference sources.
2. Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing radioactive material for use under subdivision 1 of this subsection, should apply to the NRC for a license under 10 CFR 32.30 and for a certificate of registration in accordance with 10 CFR 32.210.
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; Volume 25, Issue 2, eff. November 1, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 33, Issue 11, eff. February 22, 2017.
Article 3
Licenses
12VAC5-481-410. Types of licenses.
Article 3
Licenses
A radioactive materials license will be one of the following:
1. A general license is provided by regulation, grants authority to a person for certain activities involving radioactive material, and is effective without the filing of an application with the agency or the issuance by the agency of licensing documents to the particular person; although, the filing of a certificate with the agency may be required by the particular general license. The general licensee is subject to all applicable parts of this chapter and any limitations of the general license.
2. A specific license requires the submission of an application to the agency and the issuance of a licensing document to a named person by the agency. A licensee is subject to all applicable parts of this chapter as well as any limitations specified in the licensing document.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-420. General licenses -- source material.
A. Small quantities of source material.
1. A general license is hereby issued authorizing commercial and industrial firms; research, educational, and medical institutions; and federal, state, and local government agencies to receive, possess, use, and transfer uranium and thorium, in their natural isotopic concentrations and in the form of depleted uranium, for research, development, educational, commercial, or operational purposes in the following forms and quantities:
a. No more than 1.5 kg (3.3 lb) of uranium and thorium in dispersible forms (e.g. gaseous, liquid, powder, etc.) at any one time. Any material processed by the general licensee that alters the chemical or physical form of the material containing source material shall be accounted for as a dispersible form. A person authorized to possess, use, and transfer source material under this subdivision may not receive more than a total of 7 kg (15.4 lb) of uranium and thorium in any one calendar year; and
b. No more than a total of 7 kg (15.4 lb) of uranium and thorium at any one time. A person authorized to possess, use, and transfer source material under this subdivision may not receive more than a total of 70 kg (154 lb) of uranium and thorium in any one calendar year. A person may not alter the chemical or physical form of the source material possessed under this subdivision unless it is accounted for under the limits of subdivision 1 a of this subsection; or
c. No more than 7 kg (15.4 lb) of uranium, removed during the treatment of drinking water, at any one time. A person may not remove more than 70 kg (154 lb) of uranium from drinking water during a calendar year under this paragraph; or
d. No more than 7 kg (15.4 lb) of uranium and thorium at laboratories for the purpose of determining the concentration of uranium and thorium contained within the material being analyzed at any one time. A person authorized to possess, use, and transfer source material under this paragraph may not receive more than a total of 70 kg (154 lb) of source material in any one calendar year.
2. Any person who receives, possesses, uses, or transfers source material in accordance with the general license in subdivision 1 of this subsection:
a. Is prohibited from administering source material, or the radiation therefrom, either externally or internally, to human beings except as may be authorized by the agency in a specific license.
b. Shall not abandon such source material. Source material may be disposed of as follows:
(1) A cumulative total of 0.5 kg (1.1 lb) of source material in a solid, nondispersible form may be transferred each calendar year, by a person authorized to receive, possess, use, and transfer source material under this general license to persons receiving the material for permanent disposal. The recipient of source material transferred under the provisions of this subdivision is exempt from the requirements to obtain a license under this part to the extent the source material is permanently disposed. This provision does not apply to any person who is in possession of source material under a specific license issued under this chapter; or
(2) In accordance with 12VAC5-481-910.
c. Is subject to the provisions in 12VAC5-481-100, 12VAC5-481-110, 12VAC5-481-380, 12VAC5-481-500, 12VAC5-481-570, 12VAC5-481-580, and 12VAC5-481-1110.
d. Shall not export such source material except in accordance with 10 CFR Part 110.
3. Any person who receives, possesses, uses, or transfers source material in accordance with subdivision 1 of this subsection shall conduct activities so as to minimize contamination of the facility and the environment. When activities involving such source material are permanently ceased at any site, if evidence of significant contamination is identified, the general licensee shall notify the agency about such contamination and may consult with the agency as to the appropriateness of sampling and restoration activities to ensure that any contamination or residual source material remaining at the site where source material was used under this general license is not likely to result in exposures that exceed the limits in 12VAC5-481-1161.
4. Any person who receives, possesses, uses, or transfers source material in accordance with the general license granted in subdivision 1 of this subsection is exempt from the provisions of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter to the extent that such receipt, possession, use, and transfer are within the terms of this general license, except that such person shall comply with the provisions of 12VAC5-481-910 and 12VAC5-481-1161 to the extent necessary to meet the provisions of subdivisions 2 (b) and 3 of this subsection. However, this exemption does not apply to any person who also holds a specific license issued under this chapter.
5. No person may initially transfer or distribute source material to persons generally licensed under subdivision 1 a or b of this subsection, or equivalent regulations of the NRC or another agreement state, unless authorized by a specific license issued in accordance with subdivision E of this subsection or equivalent provisions of the NRC or another agreement state. This prohibition does not apply to analytical laboratories returning processed samples to the client who initially provided the sample.
B. General license to receive title to source or radioactive material. A general license is hereby issued authorizing the receipt of title to source or radioactive material without regard to quantity. This general license does not authorize any person to receive, possess, deliver, use or transfer source or radioactive material.
C. Depleted uranium in industrial products and devices.
1. A general license is hereby issued to receive, acquire, possess, use or transfer, in accordance with the provisions of subdivisions 2, 3, 4, and 5 of this subsection, depleted uranium contained in industrial products or devices for the purpose of providing a concentrated mass in a small volume of the product or device.
2. The general license in subdivision 1 of this subsection applies only to industrial products or devices that have been manufactured or initially transferred in accordance with a specific license issued by the agency, the NRC, or another agreement state, which authorizes manufacture of the products or devices for distribution to persons generally licensed.
3. Persons who receive, acquire, possess, or use depleted uranium pursuant to the general license in subdivision 1 of this subsection shall file a registration form with the agency by an appropriate method. The form shall be submitted within 30 days after the first receipt or acquisition of such depleted uranium and the agency shall be notified, in writing, within 30 days, of any change afterwards. The registrant shall furnish the following information and such other information as may be required:
a. Name and address of the registrant;
b. A statement that the registrant has developed and will maintain procedures designed to establish physical control over the depleted uranium described in subdivision 1 of this subsection and designed to prevent transfer of such depleted uranium in any form, including metal scrap, to persons not authorized to receive the depleted uranium; and
c. Name, title, or both; address; and telephone number of the individual duly authorized to act for and on behalf of the registrant in supervising the procedures identified in this subdivision.
4. A person who receives, acquires, possesses, or uses depleted uranium pursuant to the general license established in subdivision 1 of this subsection:
a. Shall not introduce such depleted uranium, in any form, into a chemical, physical, or metallurgical treatment or process, except a treatment or process for repair or restoration of any plating or other covering of the depleted uranium.
b. Shall not abandon such depleted uranium.
c. Shall transfer or dispose of such depleted uranium only by transfer in accordance with 12VAC5-481-570. In the case where the transferee receives the depleted uranium pursuant to the general license established by subdivision 1 of this subsection, the transferor shall furnish the transferee a copy of this subsection and a copy of the appropriate agency form. In the case where the transferee receives the depleted uranium pursuant to a general license contained in a NRC or another agreement state's regulation equivalent to this subsection, the transferor shall furnish the transferee with a copy of this subsection and a copy of the appropriate agency form accompanied by a note explaining that use of the product or device is regulated by the NRC or agreement state under requirements substantially the same as those in this subsection.
d. Within 30 days of any transfer, shall report, in writing, to the agency the name and address of the person receiving the source material pursuant to such transfer.
5. Any person receiving, acquiring, possessing, using, or transferring depleted uranium pursuant to the general license established by subdivision 1 of this subsection is exempt from the requirements of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of 12VAC5-481 with respect to the depleted uranium covered by that general license.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-421. Requirements for license to initially transfer source material for use under the small quantities of source material general license.
A. An application for a specific license to initially transfer source material for use under 12VAC5-481-420 A or equivalent regulations of the NRC or another agreement state will be approved if:
1. The applicant satisfies the general requirements specified in 12VAC5-481-450; and
2. The applicant submits adequate information on, and the agency approves the methods to be used for quality control, labeling, and providing safety instructions to recipients.
B. Conditions of licenses to initially transfer source material for use under the small quantities of source material general license: quality control, labeling, safety instructions, and records and reports.
1. Each person licensed under subsection A of this section shall label the immediate container of each quantity of source material with the type of source material and quantity of material and the words, "radioactive material."
2. Each person licensed under subsection A of this section shall ensure that the quantities and concentrations of source material are as labeled and indicated in any transfer records.
3. Each person licensed under subsection A of this section shall provide the information specified in this subdivision to each person to whom source material is transferred for use under 12VAC5-481-420 A or equivalent provisions of the NRC or another agreement state. This information shall be transferred before the source material is transferred for the first time in each calendar year to the particular recipient. The required information includes:
a. A copy of 12VAC5-481-420 A and 12VAC5-481-570, or relevant equivalent regulations of the NRC or another agreement state.
b. Appropriate radiation safety precautions and instructions relating to handling, use, storage, and disposal of the material.
4. Each person licensed under subsection A of this section shall report transfers as follows:
a. File a report with the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555. The report shall include the following information:
(1) The name, address, and license number of the person who transferred the source material;
(2) For each general licensee under 10 CFR 40.22 or equivalent agreement state provisions to whom greater than 50 grams (0.11 lb) of source material has been transferred in a single calendar quarter, the name and address of the general licensee to whom source material is distributed; a responsible agent, by name, position, or both and phone number, of the general licensee to whom the material was sent and the type, physical form, and quantity of source material transferred; and
(3) The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients.
b. File a report with the agency and other agreement state agencies that identifies all persons operating under provisions equivalent to 12VAC5-481-420 A to whom greater than 50 grams (0.11 lb) of source material has been transferred within a single calendar quarter. The report shall include the following information specific to those transfers made to the agreement state to which the report is being made:
(1) The name, address, and license number of the person who transferred the source material;
(2) The name and address of the general licensee to whom source material was distributed; a responsible agent, by name, position, or both and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred; and
(3) The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients within the agreement state.
c. Submit each report by January 31 of each year covering all transfers for the previous calendar year. If no transfers were made to persons generally licensed under 12VAC5-481-420 A or equivalent NRC and other agreement state provisions during the current period, a report shall be submitted to the agency indicating so. If no transfers have been made to general licensees of the NRC or in a particular agreement state during the reporting period, this information shall be reported to the NRC or responsible agreement state agency upon request of the agency.
5. Each person licensed under subsection A of this section shall maintain all information that supports the reports required by this section concerning each transfer to a general licensee for a period of one year after the event is included in a report to the agency, the NRC, or another agreement state.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016; amended, Virginia Register Volume 33, Issue 11, eff. February 22, 2017; Volume 34, Issue 2, eff. October 18, 2017.
12VAC5-481-430. General licenses -- radioactive material other than source material.
A. Certain devices and equipment.
1. A general license is hereby issued to transfer, receive, acquire, own, possess, and use radioactive material incorporated in the following devices or equipment that have been manufactured, tested, and labeled by the manufacturer in accordance with a specific license issued to the manufacturer by the agency or equivalent requirements by the NRC or another agreement state for use pursuant to 12VAC5-481-480 B or C.
a. Devices designed for use as static eliminators that contain, as a sealed source or sources, radioactive material consisting of a total not more than 500 μCi (18.5 MBq) of polonium-210 per device.
b. Devices designed for ionization of air that contain, as a sealed source or sources, radioactive material consisting of a total not more than 500 μCi (18.5 MBq) of polonium-210 per device or a total of not more than 50 mCi (1.85 GBq) of hydrogen-3 per device.
2. The general licenses provided in this subsection are subject to the general provisions of this subsection, the provisions of this part, and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.
B. Certain detecting, measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere.
1. A general license is hereby issued to commercial and industrial firms and research, educational and medical institutions, individuals in the conduct of their business, and federal, state, or local government agencies to acquire, receive, possess, use, or transfer, in accordance with the provisions of subdivisions 2, 3, 4, 5, and 6 of this subsection, radioactive material, excluding special nuclear material, contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.
2. The general license in subdivision 1 of this subsection applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in:
a. A specific license issued by the agency; or
b. An equivalent specific license issued by the NRC or another agreement state.
3. The devices shall have been received from one of the specific licensees described in this subsection or through a transfer made under subdivision 4 of this subsection.
4. Any person who owns, acquires, receives, possesses, uses, or transfers radioactive material in a device pursuant to the general license in subdivision 1 of this subsection:
a. Shall assure that all labels affixed to the device at the time of receipt and bearing a statement that removal of the label is prohibited are maintained thereon and shall comply with all instructions and precautions provided by such labels.
b. Shall assure that the device is tested for leakage of radioactive material and proper operation of the on-off mechanism and indicator, if any, at no longer than six-month intervals or at such other intervals as are specified in the label; however:
(1) Devices containing only krypton need not be tested for leakage of radioactive material; and
(2) Devices containing only tritium or not more than 100 μCi (3.7 MBq) of other beta or gamma emitting material or 10 μCi (0.37 MBq) of alpha emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose.
c. Shall assure that the tests required by subdivision 4 of this subsection and other testing, installation, servicing, and removal from installation involving the radioactive materials, its shielding or containment, are performed:
(1) In accordance with the instructions provided by the labels; or
(2) By a person holding a specific license issued by the agency, the NRC, or another agreement state to perform such activities.
d. Shall maintain records showing compliance with the requirements of subdivision 4 of this subsection. The records shall show the results of tests. The records also shall show the dates of performance of, and the names of persons performing, testing, installing, servicing, and removing from the installation radioactive material and its shielding or containment. The licensee shall retain these records as follows:
(1) Each record of a test for leakage or radioactive material required by subdivision 4 of this subsection shall be retained for three years after the next required leak test is performed or until the sealed source is transferred or disposed of.
(2) Each record of a test of the on-off mechanism and indicator required by subdivision 4 of this subsection shall be retained for three years after the next required test of the on-off mechanism and indicator is performed or until the sealed source is transferred or disposed of.
(3) Each record that is required by subdivision 4 of this subsection shall be retained for three years from the date of the recorded event or until the device is transferred or disposed of.
e. Shall immediately suspend operation of the device if there is a failure of, damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of 0.005 μCi (185 Bq) or more removable radioactive material. The device may not be operated until it has been repaired by the manufacturer or other person holding a specific license to repair such devices that was issued by the agency, NRC, or another agreement state. The device and any radioactive material from the device may only be disposed of by transfer to a person authorized by a specific license to receive the radioactive material in the device or as otherwise approved by the agency. A report containing a brief description of the event and the remedial action taken; and, in the case of detection of 0.005 μCi (185 Bq) or more removable radioactive material or failure of or damage to a source likely to result in contamination of the premises or the environs, a plan for ensuring that the premises and environs are acceptable for unrestricted use, shall be furnished to the agency within 30 days. Under these circumstances, the criteria set out in 12VAC5-481-1161 may be applicable, as determined by the agency on a case-by-case basis.
f. Shall not abandon the device containing radioactive material.
g. Shall not export the device containing radioactive material except in accordance with applicable provisions of this chapter.
h. Shall transfer or dispose of the device containing radioactive material only by export as provided by subdivision 4 g of this subsection, by transfer to another general licensee as authorized in subdivision 4 i of this subsection, or to a person authorized to receive the device by a specific license issued by the agency, the NRC, or another agreement state that authorizes waste collection or as otherwise approved under the following provisions of this subdivision B 4 h:
(1) Within 30 days after the transfer of a device to a specific licensee or export, furnish a report to the agency with the following information:
(a) The identification of the device by manufacturer's or initial transferor's name, model number, and serial number;
(b) The name, address, and license number of the person receiving the device (license number not applicable if exported); and
(c) The date of the transfer; and
(2) Obtain written agency approval before transferring the device to any other specific licensee not specifically identified in this subdivision; however, a holder of a specific license may transfer a device for possession and use under its own specific license without prior approval if the holder:
(a) Verifies that the specific license authorizes the possession and use, or applies for and obtains an amendment to the license authorizing the possession and use;
(b) Removes, alters, covers, or clearly and unambiguously augments the existing label (otherwise required by subdivision 4 of this subsection) so that the device is labeled in compliance with 12VAC5-481-880; however, the manufacturer, model number, and serial number shall be retained;
(c) Obtains the manufacturer's or initial transferor's information concerning maintenance that would be applicable under the specific license (e.g., as leak testing procedures); and
(d) Reports the transfer under subdivision 4 of this subsection.
i. Shall transfer the device to another general licensee only if:
(1) The device remains in use at a particular location. In this case, the transferor shall give the transferee a copy of this subsection, a copy of this part and 12VAC5-481-1090 and 12VAC5-481-1100, and any safety documents identified in the label of the device. Within 30 days of the transfer, the transferor shall report to the agency:
(a) The manufacturer's or initial transferor's name;
(b) The model number and the serial number of the device transferred;
(c) The transferee's name and mailing address for the location of use; and
(d) The name, title, and phone number of the responsible individual identified by the transferee in accordance with subdivision 4 l of this subsection to have knowledge of and authority to take actions to ensure compliance with the appropriate regulations and requirements; or
(2) The device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee.
j. 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.
k. Shall respond to written requests from the agency to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the agency a written justification for the request.
l. Shall appoint an individual responsible for having knowledge of the appropriate regulations and requirements and the authority for taking required actions to comply with appropriate regulations and requirements. The general licensee, through this individual, shall ensure the day-to-day compliance with appropriate regulations and requirements. This appointment does not relieve the general licensee of any of its responsibility in this regard.
m. Shall annually register devices containing at least 10 mCi (370 MBq) of cesium-137, 0.1 mCi (3.7 MBq) of strontium-90, 1 mCi (37 MBq) of cobalt-60, 0.1 mCi (3.7 MBq) of radium-226, or 1 mCi (37 MBq) of americium-241 or any other transuranic (i.e., element with atomic number greater than uranium (92)), based on the activity indicated on the label. Each address for a location of use represents a separate general licensee and requires a separate registration and fee. The registration fee will be $50 per device.
(1) The registration information shall be submitted to the agency within 30 days of the requested date for registration or as otherwise indicated in the request, and at a minimum include the following information and any other information specifically requested by the agency:
(a) Name and mailing address of the general licensee.
(b) Information about each device, including the manufacturer or initial transferor, model number, serial number, the radioisotope and activity (as indicated on the label).
(c) Name, title, and telephone number of the responsible person designated as a representative of the general licensee under subdivision 4 l of this subsection.
(d) Address or location at which the device or devices are used or stored. For portable devices, the address of the primary place of storage.
(e) Certification by the responsible representative of the general licensee that the information concerning the device or devices has been verified through a physical inventory and checking of label information.
(f) Certification by the responsible representative of the general licensee that they are aware of the requirements of the general license.
(2) A general licensee holding devices meeting the criteria of subdivision 4 m of this subsection is subject to the bankruptcy notification requirement in 12VAC5-481-500 E.
n. Shall report changes to the mailing address for the location of use, including change in name of general licensee, to the agency within 30 days of the effective date of the change. For a portable device, a report of address change is only required for a change in the device's primary place of storage of the device.
o. May not hold devices that are not in use for longer than two years. If devices with shutters are not being used, the shutter shall be locked in the closed position. The testing required by subdivision 4 of this subsection need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person and have not been tested within the required test interval they shall be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use are excluded from the two-year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.
5. The general license in this subsection does not authorize the manufacture or import of devices containing radioactive material.
6. The general license provided in this subsection is subject to the provisions of this part and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.
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. 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.
1. A general license is hereby issued to own, receive, acquire, possess, and use tritium or promethium-147 contained in luminous safety devices for use in aircraft, provided each device contains not more than 10 Ci (370 GBq) of tritium or 300 mCi (11.1 GBq) of promethium-147 and that each device has been manufactured, assembled, or initially transferred in accordance with a license issued under the provisions of 12VAC5-481-480 D or manufactured or assembled in accordance with a specific license issued by the NRC or another agreement state that authorizes manufacture or assembly of the device for distribution to persons generally licensed the agency or NRC.
2. Persons who own, receive, acquire, possess or use luminous safety devices pursuant to the general license in this subdivision are exempt from the requirements of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter, except that they shall comply with the provisions of 12VAC5-481-1090 and 12VAC5-481-1100.
3. This general license does not authorize the manufacture, assembly, repair, or import of luminous safety devices containing tritium or promethium-147.
4. This general license does not authorize the export of luminous safety devices containing tritium or promethium-147.
5. This general license does not authorize the ownership, receipt, acquisition, possession, or use of promethium-147 contained in instrument dials.
6. The general license provided in this subsection is subject to the general provisions of this subsection, the provisions of this part, and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.
E. General license to own radioactive material.
1. A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provision of this subsection, a general license under this subsection is not authorized to manufacture, produce, transfer, receive, possess, use, import, or export radioactive material, except as authorized in a specific license.
2. A general license is hereby issued to receive title to and own special nuclear material without regard to quantity. Notwithstanding any other provision of this subsection, a general license under this subsection is not authorized to acquire, deliver, receive, possess, use, transfer, import, or export special nuclear material, except as authorized in a specific license.
3. The general license provided in this subsection is subject to the general provisions of this subsection, the provisions of this part, and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.
F. Calibration and reference sources.
1. A general license is hereby issued to own, receive, acquire, possess, use, and transfer americium-241 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 receipt, possession, use, and transfer of radioactive material.
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 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 or another agreement 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 subdivisions 1 through 3 of this 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 5 μCi (185 kBq) of americium-241, plutonium, or 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 NRC, or another agreement 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.
6. These general licenses do not authorize the manufacture of calibration or reference sources containing americium-241, plutonium, or radium-226.
7. This general license does not authorize the export of calibration or reference sources containing americium-241, plutonium, or radium-226.
8. The general license provided in this subsection is subject to the general provisions of this subsection and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.
G. General license for use of radioactive material for certain in vitro clinical or laboratory testing.
1. A general license is hereby issued to any physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital to receive, acquire, possess, transfer, or use for any of the following stated tests in accordance with the provisions of this subsection the following radioactive materials in prepackaged units for use in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals:
a. Iodine-125, in units not exceeding 10 μCi (370 kBq) each.
b. Iodine-131, in units not exceeding 10 μCi (370 kBq) each.
c. Carbon-14, in units not exceeding 10 μCi (370 kBq) each.
d. Hydrogen-3 (tritium), in units not exceeding 50 μCi (1.85 MBq) each.
e. Iron-59, in units not exceeding 20 μCi (740 kBq) each.
f. Selenium-75, in units not exceeding 10 μCi (370 kBq) each.
g. Mock Iodine-125 reference or calibration sources, in units not exceeding 0.05 μCi (1.85 kBq) of iodine-129 and 0.005 μCi (185 Bq) of americium-241 each.
h. Cobalt-57, in units not exceeding 10 μCi (0.37 MBq) each.
2. A person shall not receive, acquire, possess, use, or transfer radioactive material under the general license established by subdivision 1 of this subsection unless that person:
a. Has filed the In Vitro Testing GL form with the agency and has received from the agency a validated copy with a registration number assigned. The physician, veterinarian, clinical laboratory, or hospital shall furnish the name and address of the physician, veterinarian, clinical laboratory, or hospital; the location of use; and a statement that the physician, veterinarian, clinical laboratory, or hospital has appropriate radiation measuring instruments to carry out in-vitro clinical or laboratory tests with radioactive material as authorized by this subsection and that such tests will be performed only by personnel competent in the use of such instruments and in the handling of the radioactive material; or
b. Has a license that authorizes the medical use of radioactive material that was issued under Part VII (12VAC5-481-1660 et seq.) of 12VAC5-481.
3. A person who receives, acquires, possesses, or uses radioactive material pursuant to the general license established by subdivision 1 of this subsection shall comply with the following:
a. The general licensee shall not possess at any one time under the general license in subdivision 1 of this subsection at any one location of storage or use, a total amount of iodine-125, iodine-131, selenium-75, cobalt-57, or iron-59 in excess of 200 μCi (7.4 MBq).
b. The general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection.
c. The general licensee shall use the radioactive material only for the uses authorized by subdivision 1 of this subsection.
d. The general licensee shall not transfer the radioactive material except by transfer to a person authorized to receive it by a license pursuant to this chapter, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier.
e. The general licensee shall dispose of the Mock Iodine-125 reference or calibration sources described in this subsection as required by 12VAC5-481-910.
4. The general licensee shall not receive, acquire, possess, or use radioactive material pursuant to subdivision 1 of this subsection:
a. Except as prepackaged units which are labeled in accordance with the provisions of a specific license issued under the provisions of 12VAC5-481-480 G or in accordance with the provisions of a specific license issued by the NRC or another agreement state that authorizes the manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), selenium-75, iron-59, cobalt-57, or Mock Iodine-125 for distribution to persons generally licensed, and
b. Unless the following statement, or a substantially similar statement that contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure that accompanies the package:
"This radioactive material may be received, acquired, possessed, and used only by physicians or veterinarians in the practice of veterinary medicine, 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 U.S. Nuclear Regulatory Commission or of a state with which the Commission has entered into an agreement for the exercise of regulatory authority.
(Name of Manufacturer)"
5. The registrant possessing or using radioactive materials under the general license of subdivision 1 of this subsection shall report in writing to the agency, any changes in the information furnished to the agency in the Registration Certificate – In Vitro Testing With Radioactive Material Under General License within 30 days after the effective date of such change.
6. Any person using radioactive material pursuant to the general license of subdivision 1 of this subsection is exempt from the requirements of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter with respect to radioactive materials covered by that general license, except that such persons using the Mock Iodine-125 described in subdivision 1 of this subsection shall comply with the provisions of 12VAC5-481-910, 12VAC5-481-1090, and 12VAC5-481-1100.
7. The general license provided in this subsection is subject to the provisions of this part and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.
H. Strontium-90 in ice detection devices.
1. A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium-90 contained in ice detection devices, provided each device contains not more than 50 μCi (1.85 MBq) of strontium-90 and each device has been manufactured or initially transferred in accordance with the specifications contained in a license issued pursuant to 12VAC5-481-480 H or in accordance with the specifications contained in a specific license issued to the manufacturer by the NRC or another agreement state authorizing manufacture of the ice detection devices for distribution to persons generally licensed.
2. Persons who own, receive, acquire, possess, use, or transfer strontium-90 contained in ice detection devices pursuant to the general license in subdivision 1 of this subsection:
a. Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating, to the device, (i) discontinue use of the device until it has been inspected, tested for leakage, and repaired by a person holding a specific license pursuant to this part or Part IV (12VAC5-481-600 et seq.) of this chapter, or from the NRC or another agreement state to manufacture or service such devices; or (ii) dispose of the device pursuant to the provisions of 12VAC5-481-910.
b. Shall assure that all labels affixed to the device at the time of receipt, and that bear a statement that prohibits removal of the labels, are maintained thereon.
c. Are exempt from the requirements of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter except that such persons shall comply with the provisions of 12VAC5-481-910, 12VAC5-481-1090, and 12VAC5-481-1100.
3. The general license does not authorize the manufacture, assembly, disassembly, repair, or import of strontium-90 in ice detection devices.
4. The general license provided in this subsection is subject to the provisions of this part, and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.
I. Certain items and self-luminous products containing radium-226.
1. A general license is hereby issued to any person to acquire, receive, possess, use, or transfer in accordance with the provisions of the following subdivisions radium-226 contained in the following products manufactured prior to November 30, 2007.
a. Antiquities originally intended for use by the general public. For the purposes of this subsection, "antiquities" mean products originally intended for use by the general public and distributed in the late 19th and early 20th centuries, such as radium emanator jars, revigators, radium water jars, radon generators, refrigerator cards, radium bath salts, and healing pads.
b. Intact timepieces containing greater than 1 μCi (0.037 MBq), nonintact timepieces, and timepiece hands and dials no longer installed in timepieces.
c. Luminous items installed in air, marine, or land vehicles.
d. All other luminous products, provided that no more than 100 items are used or stored at the same location at any one time.
e. Small radium sources containing no more than 1 μCi (0.037 MBq) of radium-226. For the purposes of this subsection, "small radium sources" means discrete survey instrument check sources, sources contained in radiation measuring instruments, sources used in educational demonstrations (such as cloud chambers and spinthariscopes), electron tubes, lightning rods, ionization sources, static eliminators, or as designated by the NRC.
2. Persons who acquire, receive, possess, use, or transfer radioactive material under the general license issued in subdivision 1 of this subsection are exempt from the provisions of Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter, as well as 12VAC5-481-1090 and 12VAC5-481-1100, to the extent that the receipt, possession, use, or transfer of radioactive material is within the terms of the general license; provided, however, that this exemption shall not be deemed to apply to any such person specifically licensed.
3. Any person who acquires, receives, possesses, uses, or transfers radioactive material in accordance with the general license in subdivision 1 of this subsection:
a. Shall notify the agency should there be any indication of possible damage to the product so that it appears it could result in a loss of the radioactive material. A report containing a brief description of the event and the remedial action taken shall be furnished to the agency within 30 days.
b. Shall not abandon products containing radium-226. The product, and any radioactive material from the product, may only be disposed of according to 12VAC5-481-971 or by transfer to a person authorized by a specific license to receive the radium-226 in the product or as otherwise approved by the agency.
c. Shall not export products containing radium-226 except in accordance with this chapter.
d. Shall dispose of products containing radium-226 at a disposal facility authorized to dispose of radioactive material in accordance with any federal or state solid or hazardous waste law, including the Solid Waste Disposal Act (42 USC § 6901 et seq.), as authorized under the Energy Policy Act of 2005 (42 USC § 15801 et seq.), by transfer to a person authorized to receive radium-226 by a specific license issued under this part or equivalent regulations of the NRC or another agreement state, or as otherwise approved by the agency.
e. Shall respond to written requests from the agency to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the agency a written justification for the request.
4. The general license in subdivision 1 of this subsection does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium-226, except that timepieces may be disassembled and repaired.
5. The general license provided in this subsection is subject to the general provisions of this subsection, the provisions of this part, and Parts IV (12VAC5-481-600 et seq.) and X (12VAC5-481-2250 et seq.) of this chapter unless indicated otherwise in the specific provision of the general license.
J. General license to install and service generally licensed devices. Any person who holds a specific license issued by the NRC or another agreement state authorizing the holder to manufacture, install, or service a device described in this subsection, is hereby granted a general license to install and perform nonradiological service (i.e., leak testing, surveys, routine maintenance) of the devices, provided that:
1. The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by the NRC or another agreement state; and
2. Such person assures that any labels required to be affixed to the device under regulations of the NRC or another agreement state licensing the manufacture of the device bear a statement that removal of the label is prohibited.
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; Volume 32, Issue 24, eff. August 25, 2016.
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. Applications and documents submitted to the agency may be made available for public inspection 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 shall 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);
3. For sources or devices containing radioactive material manufactured prior to October 23, 2012, 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 shall 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 shall 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;
4. For sealed sources and devices allowed to be distributed without registration of safety information in accordance with 10 CFR 32.210(g)(1), the applicant may supply only the manufacturer, model number, and radionuclide and quantity; or
5. If it is not feasible to identify each sealed source and device individually, the applicant may propose constraints on the number and type of sealed sources and devices to be used and the conditions under which they will be used in lieu of identifying each sealed source and device.
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 shall 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 shall evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel and overall effectiveness of the response. Deficiencies found by the critiques shall be corrected.
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 shall include the radiation symbol as described in 12VAC5-481-850 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 shall include the radiation symbol as described in 12VAC5-481-850 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. The licensee shall report the results of any test that exceeds the permissible concentration listed in 12VAC5-481-1930 A at the time of the generator elution in accordance with 12VAC5-481-2080 D.
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; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.
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;
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;
5. Licensees shall, to the extent practical, conduct operations to minimize the introduction of residual radioactivity into the site, including the subsurface, in accordance with this chapter; and
6.The applicant satisfies any applicable special requirements in 12VAC5-481-460, 12VAC5-481-470, 12VAC5-481-480, or Part V (12VAC5-481-1170 et seq.), Part VII (12VAC5-481-1660 et seq.), Part XI (12VAC5-481-2330 et seq.), 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 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. Each decommissioning funding plan (DFP) shall be submitted for review and approval by the agency.
a. The DFP shall include a detailed cost estimate for decommissioning, in an amount reflecting:
(1) The cost of an independent contractor to perform all decommissioning activities;
(2) The cost of meeting the criteria for unrestricted use in 12VAC5-481-1161 B provided that if the applicant or licensee can demonstrate its ability to meet the provisions of 12VAC5-481-1161 C, the cost estimate may be based on meeting the criteria in 12VAC5-481-1161 C;
(3) The volume of onsite subsurface material containing residual radioactivity that will require remediation to meet the criteria for license termination; and
(4) An adequate contingency factor;
b. The DFP shall include identification of and justification for using the key assumptions contained in the decommissioning cost estimate (DCE);
c. The DFP shall include a description of the method of assuring funds for decommissioning from subdivision 7 of this subsection, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;
d. The DFP shall include a certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning;
e. The DFP shall include a signed original of the financial instrument obtained to satisfy the requirements of subdivision 7 of this subsection (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning); and
f. The DFP shall (i) be submitted with license renewal and at intervals not to exceed three years and (ii) contain adjustments as necessary to account for changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The DFP shall update the information submitted with the original or prior approved plan and shall specifically consider the effect of the following events on decommissioning costs:
(1) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;
(2) Waste inventory increasing above the amount previously estimated;
(3) Waste disposal costs increasing above the amount previously estimated;
(4) Facility modifications;
(5) Changes in authorized possession limits;
(6) Actual remediation costs that exceed the previous cost estimate;
(7) Onsite disposal; and
(8) Use of a settling pond.
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. Funds placed into a trust segregated from the licensee's assets and outside the licensee's administrative control, and in which the adequacy of the trust funds is to be assessed based on an assumed annual 1.0% real rate of return on investment.
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 shall 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.
11. A person applying for a specific license authorizing the possession and use of more than 100 mCi of source material in a readily dispersible form shall submit a decommissioning funding plan as described in subdivision 6 of this subsection.
12. A person applying for a specific license authorizing the possession and use of quantities of source material greater than 10 mCi but less than or equal to 100 mCi in a readily dispersible form shall either:
a. Submit a decommissioning funding plan as described in subdivision 6 of this subsection; or
b. Submit a certification that financial assurance for decommissioning has been provided in the amount of $225,000 using one of the methods described in subdivision 7 of this subsection.
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; Volume 25, Issue 2, eff. November 1, 2008; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-451. Physical protection of Category 1 and Category 2 quantities of radioactive material.
A. Any licensee who possesses or uses an aggregated quantity of Category 1 or Category 2 radioactive material equal to or in excess of those in subdivision 1 of this subsection shall establish a physical protection program that meets all requirements detailed in this section.
1. Radionuclides of concern.
Radionuclide | Category 1 (TBq)1,2 | Category 1 (Ci)1,2 | Category 2 (TBq)1,2 | Category 2 (Ci)1,2 |
Am-241 | 60 | 1,620 | 0.6 | 16.2 |
Am-241/Be | 60 | 1,620 | 0.6 | 16.2 |
Cf-252 | 20 | 540 | 0.2 | 5.4 |
Cm-244 | 50 | 1,350 | 0.5 | 13.5 |
Co-60 | 30 | 810 | 0.3 | 8.1 |
Cs-137 | 100 | 2,700 | 1 | 27 |
Gd-153 | 1,000 | 27,000 | 10 | 270 |
Ir-192 | 80 | 2,160 | 0.8 | 21.6 |
Pm-147 | 40,000 | 1,080,000 | 400 | 10,800 |
Pu-238 | 60 | 1,620 | 0.6 | 16.2 |
Pu-239/Be | 60 | 1,620 | 0.6 | 16.2 |
Ra-226 | 40 | 1,080 | 0.4 | 10.8 |
Se-75 | 200 | 5,400 | 2 | 54 |
Sr-90 (Y-90) | 1,000 | 27,000 | 10 | 270 |
Tm-170 | 20,000 | 540,000 | 200 | 5,400 |
Yb-169 | 300 | 8,100 | 3 | 81 |
Combinations of radioactive materials listed | See footnote 4 | |||
1The aggregate activity of multiple, collocated sources of the same radionuclides should be included when the total activity equals or exceeds the Category 1 or Category 2 threshold. 2The primary values used for compliance are TBq. The curie (Ci) values are rounded to two significant figures for informational purposes only. 3Radioactive materials are to be considered aggregated or collocated if breaching a common physical barrier (e.g., a locked door at the entrance to a storage room) would allow access to the radioactive material or devices containing the radioactive material. 4If several radionuclides are aggregated, the sum of the ratios of the activity of each source, i of radionuclide, n, A (i,n), to the Category 1 or Category 2 threshold for radionuclide n, Qn, listed for that radionuclide equals or exceeds one. [(aggregated source activity for radionuclide A) / (quantities of concern for radionuclide A)] + [(aggregated source activity for radionuclide B) / (quantities of concern for radionuclide B)] + etc…. greater to or equal than 1. | ||||
2. A licensee that possesses radioactive waste that contains Category 1 or Category 2 quantities of radioactive material is exempt from the requirements of this section.
3. A licensee that possesses radioactive waste that contains discrete sources, ion-exchange resins, or activated material that weighs less than 2,000 kg (4,409 lbs) is not exempt from the requirements of this section. The licensee shall implement the following requirements to secure the radioactive waste:
a. Use continuous physical barriers that allow access to the radioactive waste only through established access control points;
b. Use a locked door or gate with monitored alarm at the access control point;
c. Assess and respond to each actual or attempted unauthorized access to determine whether an actual or attempted theft, sabotage, or diversion occurred; and
d. Immediately notify the local law-enforcement agency (LLEA) and request an armed response from the LLEA upon determination that there was an actual or attempted theft, sabotage, or diversion of the radioactive waste.
B. Background investigations and access authorization program.
1. Personnel access authorization requirements for Category 1 or Category 2 quantities of radioactive material.
a. Each licensee that possesses an aggregated quantity of radioactive material that equals or exceeds the Category 2 threshold shall establish, implement, and maintain its access authorization program in accordance with the requirements in this subsection. An applicant for a new license and each licensee that would become newly subject to the requirements in this subsection upon an amendment request of its license shall implement the requirements of this subsection, as appropriate, before taking possession of an aggregated quantity of radioactive material that equals or exceeds the Category 2 threshold. Any licensee that has not previously implemented the increased control requirements of this section shall implement the provisions of this subsection before aggregating radioactive material to a quantity that equals or exceeds the Category 2 threshold.
b. The licensee's access authorization program shall ensure that the individuals specified in subdivision 1 c of this subsection are trustworthy and reliable.
c. Licensees shall subject the following individuals to an access authorization program:
(1) Any individual whose assigned duties require unescorted access to Category 1 or Category 2 quantities of radioactive material; and
(2) Reviewing officials.
d. Licensees shall approve for unescorted access to Category 1 or Category 2 quantities of radioactive material only those individuals whose assigned job duties require unescorted access to Category 1 or Category 2 quantities of radioactive material.
e. Licensees need not subject the categories of individuals listed in subdivision 5 a of this subsection to the investigation elements of the access authorization program.
2. Access authorization program requirements.
a. Granting unescorted access authorization.
(1) Licensees shall implement the requirements of this subsection for granting initial or reinstated unescorted access authorization.
(2) Individuals who have been determined to be trustworthy and reliable shall also complete the security training required by subdivision C 2 c of this section before being allowed unescorted access to Category 1 or Category 2 quantities of radioactive material.
b. Reviewing officials.
(1) Reviewing officials are the only individuals who may make trustworthiness and reliability determinations that allow individuals to have unescorted access to Category 1 or Category 2 quantities of radioactive materials possessed by the licensee.
(2) Each licensee shall name one or more individuals to be reviewing officials. After completing the background investigation on the reviewing official, the licensee shall provide under oath or affirmation a certification that the reviewing official is deemed trustworthy and reliable by the licensee. Provide oath or affirmation certifications to the agency via an appropriate means listed in 12VAC5-481-150. The fingerprints of the named reviewing official shall be taken by a law-enforcement agency, a federal or state agency that provides fingerprinting services to the public, or a commercial fingerprinting service authorized by a state to take fingerprints. The licensee shall recertify that the reviewing official is deemed trustworthy and reliable every 10 years in accordance with subdivision 3 c of this subsection.
(3) Reviewing officials shall be permitted to have unescorted access to Category 1 or Category 2 quantities of radioactive material.
(4) Reviewing officials cannot approve other individuals to act as reviewing officials.
(5) A reviewing official does not need to undergo a new background investigation before being named by the licensee as the reviewing official if:
(a) The individual has undergone a background investigation that included fingerprinting and an FBI criminal history records check and has been determined to be trustworthy and reliable by the licensee; or
(b) The individual is subject to a category listed in subdivision 5 a of this subsection.
c. Informed consent.
(1) Licensees may not initiate a background investigation without the informed and signed consent of the subject individual. This consent shall include authorization to share personal information with other individuals or organizations as necessary to complete the background investigation. Before a final adverse determination, the licensee shall provide the individual with an opportunity to correct any inaccurate or incomplete information that is developed during the background investigation. Licensees do not need to obtain signed consent from those individuals who meet the requirements of subdivision 3 b of this subsection. A signed consent shall be obtained prior to any reinvestigation.
(2) The subject individual may withdraw his consent at any time. Licensees shall inform the individual that:
(a) If an individual withdraws his consent, the licensee may not initiate elements of the background investigation that were not in progress at the time the individual withdrew his consent; and
(b) The withdrawal of consent for the background investigation is sufficient cause of denial or termination of unescorted access authorization.
d. Any individual who is applying for unescorted access authorization shall disclose the personal history information that is required by the licensee's access authorization program for the reviewing official to make a determination of the individual's trustworthiness and reliability. Refusal to provide, or the falsification of, any personal history information required by this subsection is sufficient cause for denial or termination of unescorted access.
e. Determination basis.
(1) The reviewing official shall determine whether to permit, deny, unfavorably terminate, maintain, or administratively withdraw an individual's unescorted access authorization based on an evaluation of all the information collected to meet the requirements of this subsection.
(2) The reviewing official may not permit any individual to have unescorted access until the reviewing official has evaluated all the information collected to meet the requirements of this subsection and determined that the individual is trustworthy and reliable. The reviewing official may deny unescorted access to any individual based on information obtained at any time during the background investigation.
(3) The licensee shall document the basis for concluding whether or not there is reasonable assurance that an individual is trustworthy and reliable.
(4) The reviewing official may terminate or administratively withdraw an individual's unescorted access authorization based on information obtained after the background investigation has been completed and the individual granted unescorted access information.
(5) Licensees shall maintain a list of persons currently approved for unescorted access authorization. When a licensee determines that a person no longer requires unescorted access or meets the access authorization requirement, the licensee shall remove the person from the approved list as soon as possible, but no later than seven working days, and take prompt measures to ensure that the individual is unable to have unescorted access to the material.
f. Licensees shall develop, implement, and maintain written procedures for implementing the access authorization program. The procedures shall include the provisions for the notification of individuals who are denied unescorted access. The procedures shall include provisions for the review, at the request of the affected individual, of a denial or termination of unescorted access authorization. The procedures shall contain a provision to ensure that the individual is informed of the grounds for the denial or termination of unescorted access authorization and allow the individual an opportunity to provide additional relevant information.
g. Right to correct and complete information.
(1) Prior to any final adverse determination, licensees shall provide each individual subject to this subsection with the right to complete, correct, and explain information obtained as a result of the licensee's background investigation. Confirmation of receipt by the individual of this notification shall be maintained by the licensee for a period of one year from the date of the notification.
(2) If, after reviewing his criminal history record, an individual believes that it is incorrect or incomplete in any respect and wishes to change, correct, update, or explain anything in the record, the individual may initiate challenge procedures. These procedures include direct application by the individual challenging the record to the law-enforcement agency that contributed the questioned information or a direct challenge as to the accuracy or completeness of any entry on the criminal history record to the Federal Bureau of Investigation, Criminal Justice Information Services (CJIS) Division, ATTN: SCU, Mod. D-2, 1000 Custer Hollow Road, Clarksburg, WV 26306 as set forth in 28 CFR 16.30 through 28 CFR 16.34. In the latter case, the Federal Bureau of Investigation (FBI) will forward the challenge to the agency that submitted the data and will request that the agency verify or correct the challenged entry. Upon receipt of an official communication directly from the agency that contributed the original information, the FBI Identification Division will make any change necessary in accordance with the information supplied by that agency. Licensees shall provide at least 10 days for an individual to initiate action to challenge the results of an FBI criminal history records check after the record being made available for his review. The licensee may make a final adverse determination based upon the criminal history records only after receipt of the FBI's confirmation or correction of the record.
h. Records.
(1) The licensee shall retain documentation regarding the trustworthiness and reliability of individual employees for three years from the date the individual no longer requires unescorted access to Category 1 or Category 2 quantities of radioactive material.
(2) The licensee shall retain a copy of the current access authorization program procedures as a record for three years after the procedure is no longer needed. If any portion of the procedure is superseded, the licensee shall retain the superseded material for three years after the record is superseded.
(3) The licensee shall retain the list of individuals approved for unescorted access authorization for three years after the list is superseded or replaced.
3. Background investigations.
a. Before allowing an individual unescorted access to Category 1 or Category 2 quantities of radioactive material or to the devices containing the material, licensees shall complete a background investigation of the individual seeking unescorted access authorization. The scope of the investigation shall encompass at least the seven years preceding the date of the background investigation or since the individual's 18th birthday, whichever is shorter. The background investigation shall include at a minimum:
(1) Fingerprinting and an FBI identification and criminal history records check in accordance with subdivision 4 of this subsection;
(2) Verification of true identity of the individual who is applying for unescorted access authorization. A licensee shall review official identification documents (e.g., driver's license; passport; government identification; certificate of birth issued by the state, province, or country of birth) and compare the documents to personal information data provided by the individual to identify any discrepancy in the information. Licensees shall document the type, expiration, and identification number of the identification document or maintain a photocopy of identifying documents on file in accordance with subdivision 6 of this subsection. Licensees shall certify in writing that the identification was properly reviewed and shall maintain the certification and all related documents for review upon inspection;
(3) Verification of employment history, including military history. Licensees shall verify the individual's employment with each previous employer for the most recent seven years before the date of application;
(4) Verification that the individual participated in the education process during the claimed period;
(5) Completion of reference checks to determine the character and reputation of the individual who has applied for unescorted access authorization. Unless other references are not available, reference checks may not be conducted with any person who is known to be a close member of the individual's family, including the individual's spouse, parents, siblings, or children, or any individual who resides in the individual's permanent household. Reference checks under this subsection shall be limited to whether the individual has been and continues to be trustworthy and reliable;
(6) To the extent possible, obtain independent information to corroborate the information provided by the individual (e.g., seek references not supplied by the individual); and
(7) If a previous employer, educational institution, or any other entity with which the individual claims to have been engaged fails to provide the information or indicates an inability or unwillingness to provide information within a timeframe deemed appropriate by the licensee but at least after 10 business days of the request or if the licensee is unable to reach the entity, the licensee shall document the refusal, unwillingness, or inability in the record of investigation and attempt to obtain the information from an alternate source.
b. Individuals who have been determined to be trustworthy and reliable for unescorted access to Category 1 or Category 2 quantities of radioactive material in accordance with fingerprint orders as effective on October 3, 2008, can continue to have unescorted access to Category 1 and Category 2 quantities of radioactive material without further investigation. These individuals shall be subject to the reinvestigation requirement of subdivision 3 c of this subsection.
c. Licensees shall conduct a reinvestigation every 10 years for any individual with unescorted access to Category 1 or Category 2 quantities of radioactive material. The reinvestigation shall consist of fingerprinting and an FBI identification and criminal history records check in accordance with subdivision 4 of this subsection. The reinvestigations shall be completed within 10 years of the date on which these elements were last completed.
4. Requirements for criminal history records checks of individuals granted unescorted access to Category 1 or Category 2 quantities of radioactive material.
a. General performance objective and requirements.
(1) Except for those individuals listed in subdivision 5 a of this subsection and those individuals grandfathered under subdivision 3 b of this subsection, each licensee subject to the provisions of this section shall fingerprint each individual who is to be permitted unescorted access to Category 1 or Category 2 quantities of radioactive material. The licensee shall submit all collected fingerprints to the NRC for transmission to the FBI. The licensee shall use the information received from the FBI as part of the required background investigation to determine whether to grant or deny further unescorted access to Category 1 or Category 2 quantities of radioactive materials for that individual.
(2) The licensee shall notify each affected individual that his fingerprints will be used to secure a review of his criminal history record and shall inform him of the procedures for revising the record or adding explanations to the record.
(3) Fingerprinting is not required if a licensee is reinstating an individual's unescorted access authorization to Category 1 or Category 2 quantities of radioactive material if:
(a) The individual returns to the same facility that granted unescorted access authorization within 365 days of the termination of his unescorted access authorization; and
(b) The previous access was terminated under favorable conditions.
(4) Fingerprints do not need to be taken if an individual who is an employee of a licensee, contractor, manufacturer, or supplier has been granted unescorted access to Category 1 or Category 2 quantities of radioactive material, access to safeguards information, or safeguards information-modified handling by another licensee based upon a background investigation conducted under this subsection, regulations or Fingerprint Orders from another agreement state, or 10 CFR Part 73. An existing criminal history records check file may be transferred to the licensee asked to grant unescorted access in accordance with the provisions of subdivision 6 c of this subsection.
(5) Licensees shall use the information obtained as part of a criminal history records check solely for the purpose of determining an individual's suitability for unescorted access authorization to Category 1 or Category 2 quantities of radioactive materials, access to safeguards information, or safeguards information-modified handling.
b. Prohibitions.
(1) Licensees may not base a final determination to deny an individual unescorted access authorization to Category 1 or Category 2 quantities of radioactive material solely on the basis of information received from the FBI involving:
(a) An arrest more than one year old for which there is no information of the disposition of the case; or
(b) An arrest that resulted in dismissal of the charge or an acquittal.
(2) Licensees may not use information received from a criminal history records check obtained under this subsection in a manner that would infringe upon the rights of any individual under the First Amendment to the Constitution of the United States, nor shall licensees use the information in any way that would discriminate among individuals on the basis of race, religion, national origin, gender, or age.
c. Procedures for processing of fingerprint checks.
(1) For the purpose of complying with this subsection, licensees shall use an appropriate method listed in 10 CFR 37.7 to submit to the U.S. Nuclear Regulatory Commission, Director, Division of Physical and Cyber Security Policy, 11545 Rockville Pike, ATTN: Criminal History Program/Mail Stop T-07D04M, Rockville, MD, 20852, one completed, legible standard fingerprint card (form FD-258, ORIMDNRCOOOZ), electronic fingerprint scan, or, where practicable, other fingerprint record for each individual requiring unescorted access to Category 1 or Category 2 quantities of radioactive material. Copies of these forms may be obtained by emailing MAILSVS.Resource@nrc.gov. Guidance on submitting electronic fingerprints can be found at https://www.nrc.gov/security/chp.html.
(2) Fees for processing of fingerprint cards are due upon application. Licensees shall submit payment with the application for the processing of fingerprints through corporate check, certified check, cashier's check, money order, or electronic payment, made payable to the "U.S. NRC." (For guidance on making electronic payments, contact the Division of Physical and Cyber Security Policy by emailing crimhist.resource@nrc.gov.) Combined payment for multiple applications is acceptable. The NRC publishes the amount of the fingerprint check application fee on the NRC public website. To find the current fee amount, go to the Licensee Criminal History Records Checks & Firearms Background Check information page at https://www.nrc.gov/security/chp.html and see the link for How do I determine how much to pay for the request?.
(3) The NRC will forward to the submitting licensee all data received from the FBI as a result of the licensee's application for a criminal history records check.
5. Relief.
a. Fingerprinting, identification and criminal history records checks, and other elements of the background investigation required by this subsection are not required for the following individuals prior to granting unescorted access to Category 1 or Category 2 quantities of radioactive material:
(1) An employee of the NRC or of the executive branch of the U.S. government who has undergone fingerprinting for a prior U.S. government criminal history records check;
(2) A member of Congress;
(3) An employee of a member of Congress or congressional committee who has undergone fingerprinting for a prior U.S. government criminal history records check;
(4) The governor of a state or his designated state employee representative;
(5) Federal, state, or local law-enforcement personnel;
(6) State radiation control program directors and state homeland security advisors or their designated employee representatives;
(7) State radiation program employees conducting security inspections on behalf of the NRC under an agreement executed under § 274i of the Atomic Energy Act (42 USC § 2021i);
(8) Representatives of the International Atomic Energy Agency (IAEA) engaged in activities associated with the U.S./IAEA Safeguards Agreement who have been certified by the NRC;
(9) Emergency response personnel who are responding to an emergency;
(10) Commercial vehicle drivers for road shipments of Category 1 and Category 2 quantities of radioactive material;
(11) Package handlers at transportation facilities such as freight terminals and railroad yards;
(12) Any individual who has an active federal security clearance and provides the appropriate documentation. Written confirmation from the agency or employer that granted the federal security clearance or reviewed the criminal history records check shall be provided to the licensee. The licensee shall retain this documentation for a period of three years from the date the individual no longer requires unescorted access to Category 1 or Category 2 quantities of radioactive material; and
(13) Any individual employed by a service provider licensee for whom the service provider licensee has conducted the background investigation for the individual and approved the individual for unescorted access to Category 1 or Category 2 quantities of radioactive material. Written verification from the service provider shall be provided to the licensee. The licensee shall retain the documentation for a period of three years from the date the individual no longer requires unescorted access to Category 1 or Category 2 quantities of radioactive material.
b. Fingerprinting and identification and criminal history records checks required by this subsection are not required for an individual who has had a favorably adjudicated U.S. Government criminal history records check within the last five years, under a comparable U.S. Government program involving fingerprinting and an FBI identification and criminal history records check, and the individual provides the appropriate documentation. Written confirmation from the agency or employer that reviewed the criminal history records check shall be provided to the licensee. The licensee shall retain this documentation for a period of three years from the date the individual no longer requires unescorted access to Category 1 or Category 2 quantities of radioactive material. These programs include:
(1) National Agency Check;
(2) Transportation Worker Identification Credentials (TWIC) under 49 CFR Part 1572;
(3) Bureau of Alcohol, Tobacco, Firearms, and Explosives background check and clearances under 27 CFR Part 555;
(4) Health and Human Services security risk assessments for possession and use of select agents and toxins under 42 CFR Part 73;
(5) Hazardous material security threat assessment for hazardous material endorsement to commercial driver's license under 49 CFR Part 1572; and
(6) Customs and Border Protection's Free and Secure Trade (FAST) Program.
6. Protection of information.
a. Each licensee that obtains background information on an individual under this subsection shall establish and maintain a system of files and written procedures for protection of the record and the personal information from unauthorized disclosure.
b. The licensee may not disclose the record or personal information collected and maintained to persons other than the subject individual, his representative, or to those who have a need to have access to the information in performing assigned duties in the process of granting or denying unescorted access to Category 1 or Category 2 quantities of radioactive material. No individual authorized to have access to the information may disseminate the information to any other individual who does not have a need to know.
c. The personal information obtained on an individual from a background investigation may be provided to another licensee:
(1) Upon the individual's written request to the licensee holding the data to disseminate the information contained in that individual's file; and
(2) The recipient licensee verifies information such as name, date of birth, social security number, gender, and other applicable physical characteristics.
d. The licensee shall make background investigation records obtained under this subsection available for examination by an authorized representative of the agency to determine compliance with the regulations and laws.
e. The licensee shall retain all fingerprint and criminal history records (including data indicating no record) received from the FBI, or a copy of these records if the individual's file has been transferred, on an individual for three years from the date the individual no longer requires unescorted access to Category 1 or Category 2 quantities of radioactive material.
7. Access authorization program review.
a. Each licensee shall be responsible for the continuing effectiveness of the access authorization program. Each licensee shall ensure that access authorization programs are reviewed to confirm compliance with the requirements of this subsection and that comprehensive actions are taken to correct any noncompliance that is identified. The review program shall evaluate all program performance objectives and requirements. The review shall be performed at least annually.
b. The results of the reviews, along with all recommendations, shall be documented. Each review report shall identify conditions that are adverse to the proper performance of the access authorization program; the cause of the conditions and, when appropriate, recommend corrective actions; and corrective actions taken. The licensee shall review the findings and take additional corrective actions necessary to preclude repetition of the condition, including reassessment of the deficient areas where indicated.
c. Review records shall be maintained for three years.
C. Physical protection requirements during use.
1. Security program.
a. Each licensee that possesses an aggregated Category 1 or Category 2 quantity of radioactive material shall establish, implement, and maintain a security program in accordance with the requirements of this subsection. An applicant for a new license and each licensee that would become newly subject to the requirements of this subsection upon an amendment request for modification of its license shall implement the requirements of this subsection, as appropriate, before taking possession of an aggregated Category 1 or Category 2 quantity of radioactive material. Any licensee that has not previously implemented the requirements of this subsection shall provide written notification to the agency at least 90 days before aggregating radioactive material to a quantity that equals or exceeds the Category 2 threshold.
b. Each licensee shall establish, implement, and maintain a security program that is designed to monitor and, without delay, detect, assess, and respond to an actual or attempted unauthorized access to Category 1 or Category 2 quantities of radioactive material.
c. Each licensee's security program shall include the program features, as appropriate, described in subdivisions 2 through 8 of this subsection.
2. General security program requirements.
a. Security plan.
(1) Each licensee identified in subdivision 1 a of this subsection shall develop a written security plan specific to its facilities and operations. The purpose of the security plan is to establish the licensee's overall security strategy to ensure the integrated and effective functioning of the security program required by this subsection. The security plan shall, at a minimum, (i) describe the measures and strategies used to implement the requirements of this subsection and (ii) identify the security resources, equipment, and technology used to satisfy the requirements of this subsection.
(2) The security plan shall be reviewed and approved by the individual with overall responsibility for the security program.
(3) A licensee shall revise its security plan as necessary to ensure the effective implementation of agency requirements. The licensee shall ensure that (i) the revision has been reviewed and approved by the individual with overall responsibility for the security program and (ii) the affected individuals are instructed on the revised plan before the changes are implemented.
(4) The licensee shall retain a copy of the current security plan as a record for three years after the security plan is no longer required. If any portion of the plan is superseded, the licensee shall retain the superseded material for three years after the record is superseded.
b. Implementing procedures.
(1) The licensee shall develop and maintain written procedures that document how the requirements of this subsection and the security plan will be met.
(2) The implementing procedures and revisions to these procedures shall be approved in writing by the individual with overall responsibility for the security program.
(3) The licensee shall retain a copy of the current procedure as a record for three years after the procedure is no longer needed. Superseded portions of the procedure shall be retained for three years after the record is superseded.
c. Training.
(1) Each licensee shall conduct training to ensure that those individuals implementing the security program possess and maintain the knowledge, skills, and abilities to carry out their assigned duties and responsibilities effectively. The training shall include at a minimum, instruction on:
(a) The licensee's security program and procedures to secure Category 1 or Category 2 quantities of radioactive material, and the purpose and function of the security measures employed;
(b) The responsibility to report promptly to the licensee any condition that causes or may cause a violation of agency requirements;
(c) The responsibility of the licensee to report promptly to the local law-enforcement agency and the agency any actual or attempted theft, sabotage, or diversion of Category 1 or Category 2 quantities of radioactive material; and
(d) The appropriate response to security alarms.
(2) In determining those individuals who shall be trained on the security program, the licensee shall consider each individual's assigned activities during authorized use and response to potential situations involving actual or attempted theft, diversion, or sabotage of Category 1 or Category 2 quantities of radioactive material. The extent of the training shall be commensurate with the individual's potential involvement in the security of Category 1 or Category 2 quantities of radioactive material.
(3) Refresher training shall be provided at a frequency not to exceed 12 months and when significant changes have been made to the security program. This training shall include (i) review of the training requirements of this subsection and changes made to the security program since the last training; (ii) reports on all relevant security issues, problems, and lessons learned; (iii) relevant results of agency inspections; and (iv) relevant results of the licensee's program review and testing and maintenance.
(4) The licensee shall maintain records of the initial and refresher training for three years from the date of the training. The training records shall include dates of the training, topics covered, a list of licensee personnel in attendance, and related information.
d. Protection of information.
(1) Licensees authorized to possess Category 1 or Category 2 quantities of radioactive material shall limit access to and prevent the unauthorized disclosure of their security plan, implementing procedures, and the list of individuals who have been approved for unescorted access.
(2) Efforts to limit access shall include the development, implementation, and maintenance of written policies and procedures for controlling access to and for proper handling and protection against unauthorized disclosure of the security plan, implementing procedures, and the list of individuals who have been approved for unescorted access.
(3) Before granting an individual access to the security plan, implementing procedures, or the list of individuals who have been approved for unescorted access, licensees shall:
(a) Evaluate an individual's need to know the security plan, implementing procedures, or the list of individuals who have been approved for unescorted access; and
(b) If the individual has not been authorized for unescorted access to Category 1 or Category 2 quantities of radioactive material, the licensee shall complete a background investigation to determine the individual's trustworthiness and reliability. A trustworthiness and reliability determination shall be conducted by the reviewing official and shall include the background investigation elements contained in subdivisions B 3 a (2) through (7) of this section.
(4) Licensees need not subject any individual to background investigation elements for protection of information if that individual is included in the categories of individuals listed in subdivisions B 5 a (1) through (12) of this section or is a security service provider employee, provided written verification that the employee has been determined to be trustworthy and reliable, by the required background investigation in subdivisions B 3 a (2) though (7) of this subsection, has been provided by the security service provider.
(5) The licensee shall document the basis for concluding that an individual is trustworthy and reliable and should be granted access to the security plan, implementing procedures, or the list of individuals who have been approved for unescorted access.
(6) Licensees shall maintain a list of persons currently approved for access to the security plan implementing procedures, or the list of individuals who have been approved for unescorted access. When a licensee determines that a person no longer needs access to the security plan, implementing procedures, or the list of individuals who have been approved for unescorted access or no longer meets the access authorization requirements for access to the information, the licensee shall remove the person from the approved list as soon as possible, but no later than seven working days after the determination, and take prompt measures to ensure that the individual is unable to obtain the security plan, implementing procedures, or the list of individuals who have been approved for unescorted access.
(7) When not in use, the licensee shall store its security plan, implementing procedures, and the list of individuals who have been approved for unescorted access in a manner to prevent unauthorized access. Information stored in nonremovable electronic form shall be password protected.
(8) The licensee shall retain as a record a copy of the information protection procedures and the list of individuals approved for access to the security plan, implementing procedures, or the list of individuals who have been approved for unescorted access for three years after the document has been superseded.
3. Local law-enforcement agency (LLEA) coordination.
a. A licensee subject to this subsection shall coordinate, to the extent practicable, with an LLEA for responding to threats to the licensee's facility, including any necessary armed response. The information provided to the LLEA shall include:
(1) A description of the facilities and the Category 1 and Category 2 quantities of radioactive materials along with a description of the licensee's security measures that have been implemented to comply with this subsection; and
(2) A notification that the licensee will request a timely armed response by the LLEA to any actual or attempted theft, sabotage, or diversion of Category 1 or Category 2 quantities of material.
b. The licensee shall notify the agency within three business days if:
(1) The LLEA has not responded to the request for coordination within 60 days of the coordination request; or
(2) The LLEA notifies the licensee that the LLEA does not plan to participate in coordination activities.
c. The license shall document its efforts to coordinate with the LLEA. The documentation shall be kept for three years.
d. The licensee shall coordinate with the LLEA at least every 12 months, or when changes to the facility design or operation adversely affect the potential vulnerability of the licensee's material to theft, sabotage, or diversion.
4. Security zones.
a. Licensees shall ensure that all aggregated Category 1 or Category 2 quantities of radioactive material are used or stored within licensee-established security zones. Security zones may be permanent or temporary.
b. Temporary security zones shall be established as necessary to meet the licensee's transitory or intermittent business activities, such as periods of maintenance, source delivery, and source replacement.
c. Security zones shall, at a minimum, allow unescorted access only to approved individuals by:
(1) Isolation of Category 1 and Category 2 quantities of radioactive materials by the use of continuous physical barriers that allow access to the security zone only through established access control points. A physical barrier is a natural or man-made structure or formation sufficient for the isolation of the Category 1 or Category 2 quantities of radioactive material within a security zone;
(2) Direct control of the security zone by approved individuals at all times; or
(3) A combination of continuous physical barriers and direct control.
d. For Category 1 quantities of radioactive material during periods of maintenance, source receipt, preparation for shipment, installation, or source removal or exchange, the licensee shall, at a minimum, provide sufficient individuals approved for unescorted access to maintain continuous surveillance of sources in temporary security zones and in any security zone in which physical barriers or intrusion detection systems have been disabled to allow such activities.
e. Individuals not approved for unescorted access to Category 1 or Category 2 quantities of radioactive material shall be escorted by an approved individual when in a security zone.
5. Monitoring, detection, and assessment.
a. Monitoring and detection.
(1) Licensees shall establish and maintain the capability to continuously monitor and detect without delay all unauthorized entries into its security zones. Licensees shall provide the means to maintain continuous monitoring and detection capability in the event of a loss of the primary power source, or provide for an alarm and response in the event of a loss of this capability to continuously monitor and detect unauthorized entries.
(2) Monitoring and detection shall be performed by:
(a) A monitored intrusion detection system that is linked to an onsite or offsite central monitoring facility;
(b) Electronic devices for intrusion detection alarms that will alert nearby facility personnel;
(c) A monitored video surveillance system;
(d) Direct visual surveillance by approved individuals located within the security zone; or
(e) Direct visual surveillance by a licensee designed individual located outside the security zone.
(3) A licensee subject to this subsection shall also have a means to detect unauthorized removal of the radioactive material from the security zone. This detection capability shall provide:
(a) For Category 1 quantities of radioactive material, immediate detection of any attempted unauthorized removal of the radioactive material from the security zone. Such immediate detection capability shall be provided by electronic sensors linked to an alarm, continuous monitored video surveillance, or direct visual surveillance; and
(b) For Category 2 quantities of radioactive material, weekly verification through physical checks, tamper indicating devices, use, or other means to ensure that the radioactive material is present.
b. Licensees shall immediately assess each actual or attempted unauthorized entry into the security zone to determine whether the unauthorized access was an actual or attempted theft, sabotage, or diversion.
c. For personnel and automated or electronic systems supporting the licensee's monitoring, detection, and assessments system, licensees shall:
(1) Maintain continuous capability for personnel communication and electronic data transmission and processing among site security systems; and
(2) Provide an alternate communication capability for personnel, and an alternative data transmission and processing capability, in the event of a loss of the primary means of communication or data transmission and processing. Alternative communications and data transmissions systems may not be subject to the same failure modes as the primary systems.
d. Licensees shall immediately respond to any actual or attempted unauthorized access to the security zones, or actual or attempted theft, sabotage, or diversion of Category 1 or Category 2 quantities of radioactive material at licensee facilities or temporary job sites. For any unauthorized access involving an actual or attempted theft, sabotage, or diversion of Category 1 or Category 2 quantities of radioactive material, the licensee's response shall include requesting, without delay, an armed response from the LLEA.
6. Maintenance and testing.
a. Each licensee subject to this subsection shall implement a maintenance and testing program to ensure that intrusion alarms, associated communication systems, and other physical components of the systems used to secure or detect unauthorized access to radioactive material are maintained in operable condition and are capable of performing their intended function when needed. The equipment relied on to meet the security requirements of this subsection shall be inspected and tested for operability and performance at the manufacturer's suggested frequency. If there is no frequency suggested by the manufacturer or the frequency specified is greater than three months, the testing shall be performed at least quarterly, not to exceed three months.
b. The licensee shall maintain records on the maintenance and testing activities for three years.
7. Requirements for mobile devices. Each licensee that possesses mobile devices containing Category 1 or Category 2 quantities of radioactive material shall:
a. Have two independent physical controls that form tangible barriers to secure the material from unauthorized removal when the device is not under direct control and constant surveillance by the licensee; and
b. For devices in or on a vehicle or trailer, unless the health and safety requirements for a site prohibit the disabling of the vehicle, the licensee shall utilize a method to disable the vehicle or trailer when not under direct control and constant surveillance by the licensee. Licensees shall not rely on the removal of an ignition key to meet this requirement.
8. Security program review.
a. Each licensee shall be responsible for the continuing effectiveness of the security program. Each licensee shall ensure that the security program is reviewed to confirm compliance with the requirements of this subsection and that comprehensive actions are taken to correct any noncompliance that is identified. The review shall include the radioactive material security program content and implementation. The review shall be conducted at least annually, not to exceed 12 months.
b. The results of the review, along with all recommendations, shall be documented. Each review report shall identify conditions that are adverse to the proper performance of the security program, the cause of the condition, corrective actions taken, and, when appropriate, recommend corrective actions. The licensee shall review the findings and take any additional corrective actions necessary to preclude repetition of the condition, including reassessment of the deficient areas where indicated.
c. The licensee shall maintain the review documentation for three years.
9. Reporting of events.
a. The licensee shall immediately notify the LLEA after determining that an unauthorized entry resulted in an actual or attempted theft, sabotage, or diversion of Category 1 or Category 2 quantity of radioactive material. As soon as possible after initiating a response, but not at the expense of causing delay or interfering with the LLEA response to the event, the licensee shall notify the agency by telephone at 804-864-8150 during normal business hours and 804-674-2400 after hours. In no case shall the notification to the agency be later than four hours after the discovery of any attempted or actual theft, sabotage, or diversion.
b. The licensee shall assess any suspicious activity related to possible theft, sabotage, or diversion of Category 1 or Category 2 quantities of radioactive material and notify the LLEA as appropriate. As soon as possible but not later than four hours after notifying the LLEA, the licensee shall notify the agency by telephone 804-864-8150 during normal business hours and 804-674-2400 after hours.
c. The initial telephonic notification shall be followed within a period of 30 days by a written report submitted to the agency. The report shall include sufficient information for agency analysis and evaluation, including identification of any necessary corrective actions to prevent future instances.
D. Physical protection in transit.
1. Additional requirements for transfer of Category 1 and Category 2 quantities of radioactive material. A licensee transferring a Category 1 or Category 2 quantity of radioactive material to a licensee of the agency, the NRC, or another agreement state shall meet the license verification provisions listed in this subdivision instead of those listed in 12VAC5-481-570.
a. Any licensee transferring Category 1 quantities of radioactive material to a licensee of the agency, the NRC, or another agreement state, prior to conducting such transfer, shall verify with the NRC's license verification system or the license issuing authority that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred and that the licensee is authorized to receive radioactive material at the location requested for delivery. If the verification is conducted by contacting the license-issuing authority, the transferor shall document the verification. For transfers within the same organization, the licensee does not need to verify the transfer.
b. Any licensee transferring Category 2 quantities of radioactive material to a licensee of the agency, the NRC, or another agreement state, prior to conducting such transfer, shall verify with the NRC's license verification system or the license-issuing authority that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred. If the verification is conducted by contacting the license-issuing authority, the transferor shall document the verification. For transfers within the same organization, the licensee does not need to verify the transfer.
c. In an emergency where the licensee cannot reach the license-issuing authority and the license verification system is nonfunctional, the licensee may accept a written certification by the transferee that it is authorized by license to receive the type, form, and quantity of radioactive material to be transferred. The certification shall include the license number, current revision number, issuing agency, expiration date, and for a Category 1 shipment, the authorized address. The licensee shall keep a copy of the certification. The certification shall be confirmed by use of the NRC's license verification system or by contacting the license-issuing authority by the end of the next business day.
d. The transferor shall keep a copy of the verification documentation as a record for three years.
2. Applicability of physical protection of Category 1 and Category 2 quantities of radioactive material during transit.
a. For shipments of category 1 quantities of radioactive material, each shipping licensee shall comply with the requirements for physical protection contained in subdivisions 3 a, 3 e, 4, 5 a (1), 5 b (1), 5 c, 6 a, 6 c, 6 e, 6 g, and 6 h of this subsection.
b. For shipments of Category 2 quantities of radioactive material, each shipping licensee shall comply with the requirements for physical protection contained in subdivisions 3 b through 3 e, 5 a (2), 5 a (3), 5 b (2), 5 c, 6 b, 6 d, 6 f, 6 g, and 6 h of this subsection.
c. The shipping licensee shall be responsible for meeting the requirements of this subsection unless the receiving licensee has agreed in writing to arrange for the in-transit physical protection required under this subsection.
3. Preplanning and coordination of shipment of Category 1 or Category 2 quantities of radioactive material.
a. Each licensee that plans to transport, or deliver to a carrier for transport, licensed material that is a Category 1 quantity of radioactive material outside the confines of the licensee's facility or other place of use or storage shall:
(1) Preplan and coordinate shipment arrival and departure times with the receiving licensee;
(2) Preplan and coordinate shipment information with the governor or the governor's designee of any state through which the shipment will pass to discuss the state's intention to provide law-enforcement escorts and identify safe havens; and
(3) Document the preplanning and coordination activities.
b. Each licensee that plans to transport, or deliver to a carrier for transport, licensed material that is a Category 2 quantity of radioactive material outside the confines of the licensee's facility or other place of use or storage shall coordinate the shipment no-later-than arrival time and the expected shipment arrival with the receiving licensee. The licensee shall document the coordination activities.
c. Each licensee that receives a shipment of a Category 2 quantity of radioactive material shall confirm receipt of the shipment with the originator. If the shipment has not arrived by the no-later-than arrival time, the receiving licensee shall notify the originator.
d. Each licensee that transports or plans to transport a shipment of a Category 2 quantity of radioactive material and determines that the shipment will arrive after the no-later-than arrival time provided pursuant to subdivision 3 b of this subsection, shall promptly notify the receiving licensee of the new no-later-than arrival time.
e. The licensee shall retain a copy of the documentation for preplanning and coordination and any revision thereof as a record for three years.
4. As specified in subdivision 3 of this subsection, each licensee shall provide advance notification to the agency and the governor of a state, or the governor's designee, of the shipment of licensed material in a Category 1 quantity, through or across the boundary of the state, before the transport or delivery to a carrier for transport of the licensed material outside the confines of the licensee's facility or other place of use or storage.
a. Procedures for submitting advance notification:
(1) The notification shall be made to the agency and to the office of each appropriate governor or governor's designee. The contact information, including telephone and mailing addresses, of governors and governor's designees is available on the NRC website at https://scp.nrc.gov/special/designee.pdf. The notification to the agency shall be in accordance with 12VAC5-481-150.
(2) A notification delivered by mail shall be postmarked at least seven days before transport of the shipment commences at the shipping facility.
(3) A notification delivered by any means other than mail shall reach the agency at least four days before the transport of the shipment commences and shall reach the office of the governor or the governor's designee at least four days before transport of a shipment within or through the state.
b. Each advance notification of shipment of Category 1 quantities of radioactive material shall contain the following information, if available at the time of the notification:
(1) The name, address, and telephone number of the shipper, carrier, and receiver of the Category 1 radioactive material;
(2) The license numbers of the shipper and receiver;
(3) A description of the radioactive material contained in the shipment, including the radionuclides and quantity;
(4) The point of origin of the shipment and the estimated time and date that shipment will commence;
(5) The estimated time and date that the shipment is expected to enter each state along the route;
(6) The estimated time and date of arrival for the shipment at the destination; and
(7) A point of contact, with a telephone number, for current shipment information.
c. Revision notice.
(1) The licensee shall provide any information not previously available at the time of the initial notification, as soon as the information becomes available but not later than commencement of the shipment, to the agency and the governor of the state or the governor's designee.
(2) A licensee shall promptly notify the agency and governor of the state or the governor's designee of any changes to the information provided in accordance with this subdivision 4.
d. Each licensee who cancels a shipment for which advance notification has been sent shall send a cancellation notice to the agency and the governor of each state or to the governor's designee previously notified. The licensee shall send the cancellation notice before the shipment would have commenced or as soon thereafter as possible. The licensee shall state in the notice that it is a cancellation and identify the advance notification that is being canceled.
e. The licensee shall retain a copy of the advance notification and any revision and cancellation notices as a record for three years.
f. State officials, state employees, and other individuals, whether or not licensees of the agency, NRC, or another agreement state, who receive schedule information of the kind specified in subdivision 4 b of this subsection shall protect that information against unauthorized disclosure as specified in subdivision C 2 d of this section.
5. Requirements for physical protection of Category 1 and Category 2 quantities of radioactive material during shipment.
a. Shipments by road.
(1) Each licensee who transports or delivers to a carrier for transport in a single shipment a Category 1 quantity of radioactive material shall:
(a) Ensure that movement control centers are established that maintain position information from a remote location. These control centers shall monitor shipments 24 hours a day, seven days a week and have the ability to communicate immediately, in an emergency, with the appropriate law-enforcement agencies;
(b) Ensure that redundant communications are established that allow the transport to contact the escort vehicle, when an escort vehicle is used, and movement control center at all times. Redundant communications may not be subject to the same interference factors as the primary communication;
(c) Ensure that shipments are continuously and actively monitored by a telemetric position monitoring system or an alternative tracking system reporting to a movement control center. A movement control center shall provide positive confirmation of the location, status, and control over the shipment. The movement control center shall be prepared to promptly implement preplanned procedures in response to deviations from the authorized route or a notification of actual, attempted, or suspicious activities related to the theft, loss, or diversion of a shipment. These procedures will include the identification of and contact information for the appropriate LLEA along the shipment route;
(d) Provide an individual to accompany the driver for those highway shipments with a driving time period greater than the maximum number of allowable hours of service in a 24-hour duty day as established by the U.S. Department of Transportation Federal Motor Carrier Safety Administration. The accompanying individual may be another driver; and
(e) Develop written normal and contingency procedures to address (i) notifications to the communication center and law-enforcement agencies; (ii) communication protocols that shall include a strategy for the use of authentication codes and duress codes and provisions for refueling and other stops, detours, and locations where communication is expected to be temporarily lost; (iii) loss of communication; and (iv) responses to an actual or attempted theft or diversion of a shipment.
(f) Each licensee who makes arrangements for the shipment of Category 1 quantities of radioactive material shall ensure that drivers, accompanying personnel, and movement control center personnel have access to the normal and contingency procedures.
(2) Each licensee that transports Category 2 quantities of radioactive material shall maintain constant control and surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance.
(3) Each licensee who delivers to a carrier for transport in a single shipment a Category 2 quantity of radioactive material shall:
(a) Use carriers that have established package tracking systems. An established package tracking system is a documented, proven, and reliable system routinely used to transport objects of value. In order for a package tracking system to maintain constant control and surveillance, the package tracking system shall allow the shipper or transporter to identify when and where the package was last and when it should arrive at the next point of control;
(b) Use carriers that maintain constant control and surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance; and
(c) Use carriers that have established tracking systems that require an authorized signature prior to releasing the package for delivery or return.
b. Shipments by rail.
(1) Each licensee who transports, or delivers to a carrier for transport, in a single shipment a Category 1 quantity of radioactive material shall:
(a) Ensure that rail shipments are monitored by a telemetric position monitoring system or an alternative tracking system reporting to the licensee, third-party, or railroad communications center. The communications center shall provide positive confirmation of the location of the shipment and its status. The communications center shall implement preplanned procedures in response to deviations from the authorized route or to a notification of actual, attempted, or suspicious activities related to the theft or diversion of a shipment. These procedures will include the identification of and contact information for the appropriate LLEA along the shipment route; and
(b) Ensure that periodic reports to the communications center are made at preset intervals.
(2) Each licensee who transports, or delivers to a carrier for transport, in a single shipment a Category 2 quantity of radioactive material shall:
(a) Use carriers that have established package tracking systems. An established package tracking system is a documented, proven, and reliable system routinely used to transport objects of value. In order for a package tracking system to maintain constant control and surveillance, the package tracking system shall allow the shipper or transporter to identify when and where the package was last and when it should arrive at the next point of control;
(b) Use carriers that maintain constant control and surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance; and
(c) Use carriers that have established tracking systems that require an authorized signature prior to releasing the package for delivery or return.
c. Each licensee who makes arrangements for the shipment of Category 1 quantities of radioactive material shall immediately conduct an investigation upon discovery that a Category 1 shipment is lost or missing. Each licensee who makes arrangements for the shipment of Category 2 quantities of radioactive material shall immediately conduct an investigation, in coordination with the receiving licensee, of any shipment that has not arrived by the designated no-later-than arrival time.
6. Reporting of events.
a. The shipping licensee shall notify the appropriate LLEA and the agency within one hour of its determination that a shipment of Category 1 quantities of radioactive material is lost or missing. The appropriate LLEA would be the law-enforcement agency in the area of the shipment's last confirmed location. During the investigation required by this subsection, the shipping licensee will provide agreed upon updates to the agency on the status of the investigation.
b. The shipping licensee shall notify the agency within four hours of its determination that a shipment of Category 2 quantities of radioactive material is lost or missing. If, after 24 hours of its determination that the shipment is lost or missing, the radioactive material has not been located and secure, the licensee shall immediately notify the agency.
c. The shipping licensee shall notify the designated LLEA along the shipment route as soon as possible upon discovery of any actual or attempted theft of diversion of a shipment or suspicious activities related to the theft or diversion of a shipment of a Category 1 quantity of radioactive material. As soon as possible after notifying the LLEA, the licensee shall notify the agency upon discovery of any actual or attempted theft or diversion of a shipment, or any suspicious activity related to the shipment, of Category 1 radioactive material.
d. The shipping licensee shall notify the agency as soon as possible upon discovery of any actual or attempted theft or diversion of a shipment, or any suspicious activity related to the shipment, of a Category 2 quantity of radioactive material.
e. The shipping licensee shall notify the agency and the LLEA as soon as possible upon recovery of any lost or missing Category 1 quantities of radioactive material.
f. The shipping licensee shall notify the agency as soon as possible upon recovery of any lost or missing Category 2 quantities of radioactive material.
g. The initial telephonic notification required by subdivisions 6 a through 6 d of this subsection shall be followed within a period of 30 days by a written report submitted to the agency. A written report is not required for notifications on suspicious activities required by subdivisions 6 c and 6 d of this subsection. The report shall include the following information:
(1) A description of the licensed material involved, including kind, quantity, and chemical and physical form;
(2) A description of the circumstances under which the loss or theft occurred;
(3) A statement of disposition, or probable disposition, of the licensed material involved;
(4) Actions that have been taken, or will be taken, to recover the material; and
(5) Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed material.
h. Subsequent to filing the written report, the licensee shall also report any additional substantive information on the loss or theft within 30 days after the licensee learns of such information.
E. Records.
1. Each record required by this section shall be legible throughout the retention period specified. The record may be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications shall include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
2. Licensees shall maintain the records that are required by this section for the period specified. If a retention period is not otherwise specified, these records shall be retained until the agency terminates the facility's license. All records related to this section may be destroyed upon agency termination of the facility license.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 24, Issue 25, eff. October 3, 2008; amended, Virginia Register Volume 25, Issue 21, eff. August 6, 2009; Volume 32, Issue 12, eff. March 9, 2016; Volume 32, Issue 24, eff. August 25, 2016; Volume 34, Issue 2, eff. October 18, 2017; Volume 37, Issue 25, eff. January 14, 2022; Volume 39, Issue 24, eff. August 16, 2023.
12VAC5-481-460. (Repealed.)
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.
12VAC5-481-470. 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 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 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 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 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 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 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 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 Part III (12VAC5-481-380 et seq.), Part V (12VAC5-481-1170 et seq.) or Part VII (12VAC5-481-1660 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. Reserved.
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 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, DC 20555-0001.)
C. Licensing the manufacture or initial transfer of devices to persons generally licensed under 12VAC5-481-430 B.
1. An application for a specific license to manufacture or initially transfer devices containing radioactive material, excluding special nuclear material, to persons generally licensed under 12VAC5-481-430 B or equivalent regulations of the NRC, or another Agreement 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 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 dose to the appropriate organ as specified in 12VAC5-481-3580, Column IV;
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 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 initial transferor;
d. Each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number, the isotope and quantity, and the words, "Caution Radioactive Material," the radiation symbol described in 12VAC5-481-850, and the name of the manufacturer or initial distributor;
e. Each device meeting the criteria of 12VAC5-481-430 B 4 m bears a permanent (e.g., embossed, etched, stamped, or engraved) label affixed to the source housing if separate, or the device if the source housing is not separable, that includes the words, "Caution Radioactive Material," and, if practicable, the radiation symbol described in 12VAC5-481-850; and
f. The device has been registered in the Sealed Source and Device Registry.
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 B, or under equivalent regulations of the NRC, or another Agreement 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 12VAC5-481-640.
4. Each person licensed under this subsection to distribute devices to generally licensed persons shall:
a. Furnish a copy of the general license contained in 12VAC5-481-430 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 B;
b. Furnish a copy of the general license contained in the NRC's, or another Agreement state's, regulation equivalent to 12VAC5-481-430 B, or alternatively, furnish a copy of the general license contained in 12VAC5-481-430 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 NRC, or another Agreement state. If a copy of the general license in 12VAC5-481-430 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 NRC, or another Agreement state, under requirements substantially the same as those in 12VAC5-481-430 B;
c. Report to the agency all transfers of such devices to persons for use under the general license in 12VAC5-481-430 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 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 NRC all transfers of such devices to persons for use under the NRC's general license 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 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 NRC general licensees during the reporting period, this information shall be reported to the 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 B, or equivalent regulations of the NRC or another Agreement 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 shall be maintained for a period of three years following the date of the recorded event.
D. Special requirements for the manufacture, initial 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 D will be approved if:
1. The applicant satisfies the general requirements specified in 12VAC5-481-450.
2. The applicant submits sufficient information regarding each device pertinent to evaluation of the potential radiation exposure, including:
a. Chemical and physical form and maximum quantity of tritium or promethium-147 in each device;
b. Details of construction and design;
c. Details of the method of binding or containing the tritium or promethium-147;
d. Procedures for and results of prototype testing to demonstrate that the tritium or promethium-147 will not be released to the environment under the most severe conditions likely to be encountered in normal use;
e. Quality assurance procedures to be followed that are sufficient to ensure compliance with subdivision 8 of this subsection; and
f. Any additional information, including experimental studies and tests, required by the NRC to facilitate a determination of the safety of the device.
3. Each device will contain no more than 10 curies of tritium or 300 millicuries of promethium-147. The levels of radiation from each device containing promethium-147 will not exceed 0.5 millirad per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber.
4. The agency determines that:
a. The method of incorporation and binding of the tritium or promethium-147 in the device is such that the tritium or promethium-147 will not be released under the most severe conditions likely to be encountered in normal use and handling of the device;
b. The tritium or promethium-147 is incorporated or enclosed so as to preclude direct physical contact with it by any person;
c. The device is so designed that it cannot easily be disassembled; and
d. Prototypes of the device have been subjected to and have satisfactorily passed the tests required by subdivision 5 of this subsection.
5. The applicant shall subject at least five prototypes of the device to tests as follows:
a. The devices are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of tritium or promethium-147, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering.
b. The devices are inspected for evidence of physical damage and for loss of tritium or promethium-147 after each stage of testing using methods of inspection adequate for determining compliance with the criteria in subdivision 5 c of this subsection.
c. Device designs are rejected for which the following has been detected for any unit:
(1) A leak resulting in a loss of 0.1% or more of the original amount of tritium or promethium-147 from the device;
(2) Surface contamination of tritium or promethium-147 on the device of more than 2,200 disintegrations per minute per 100 square centimeters of surface area; or
(3) Any other evidence of physical damage.
6. The device has been registered in the Sealed Source and Device Registry.
7. Labeling.
a. A person licensed to manufacture, assemble, or initially transfer devices containing tritium or promethium-147 for distribution to persons generally licensed under 12VAC5-481-430 D, except as provided in subdivision 7 b of this subsection, shall affix to each device a label containing the radiation symbol prescribed by 12VAC5-481-850, such other information as may be required by the agency including disposal instructions when appropriate, and the following or a substantially similar statement that contains the information in the following statement:
The receipt, possession, use, and transfer of this device, Model* ___________, Serial No.*_______, containing ____________ (Identity and quantity of radioactive material) are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or of a state with which the NRC has entered into an agreement for the exercise of regulatory authority. Do not remove this label.
CAUTION--RADIOACTIVE MATERIAL
____________________________________________
(Name of manufacturer, assembler, or initial transferor.)*
*The model, serial number, and name of manufacturer, assembler, or initial transferor may be omitted from this label provided they are elsewhere specified in labeling affixed to the device.
b. If the agency determines that it is not feasible to affix a label to the device containing all the information called for in subdivision 7 a of this subsection, it may waive those requirements and require the following:
(1) A label is affixed to the device identifying:
(i) The manufacturer, assembler, or initial transferor; and
(ii) The type of radioactive material; and
(2) A leaflet bearing the following information be enclosed in or accompany the container in which the device is shipped:
(i) The name of the manufacturer, assembler, or initial transferor;
(ii) The type and quantity of radioactive material;
(iii) The model number;
(iv) A statement that the receipt, possession, use, and transfer of the device are subject to a general license or the equivalent and the regulations of the NRC or of an Agreement state; and
(v) Such other information as may be required by the agency, including disposal instructions when appropriate.
8. Quality assurance; prohibition of transfer.
a. Each person licensed under this subsection shall visually inspect each device and shall reject any that has an observable physical defect that could adversely affect containment of the tritium or promethium-147.
b. Each person licensed under this subsection shall:
(1) Maintain quality assurance systems in the manufacture of the luminous safety device in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed devices are capable of performing their intended functions; and
(2) Subject inspection lots to acceptance sampling procedures, by procedures specified in subdivision 8 c of this subsection and in the license issued under this subsection, to provide at least 95% confidence that the lot tolerance percent defective of 5.0% will not be exceeded.
c. The licensee shall subject each inspection lot to the following:
(1) Tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of tritium or promethium-147, such as absolute pressure and water immersion.
(2) Inspection for evidence of physical damage, containment failure, or for loss of tritium or promethium-147 after each stage of testing using methods of inspection adequate for applying the following criteria for defective:
(i) A leak resulting in a loss of 0.1% or more of the original amount of tritium or promethium-147 from the device;
(ii) Levels of radiation in excess of 0.5 millirad (5 microgray) per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber if the device contains promethium-147; and
(iii) Any other criteria specified in the license issued under this subsection.
d. No person licensed under this subsection shall transfer to persons generally licensed under 12VAC5-481-430 D or under an equivalent general license of the NRC or other Agreement state:
(1) Any luminous safety device tested and found defective under any condition of a license issued under subdivisions 1 through 6 or this subdivision 8 of this subsection, unless the defective luminous safety device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or
(2) Any luminous safety device contained within any lot that has been sampled and rejected as a result of the procedures in subdivision 8 b (2) of this subsection, unless:
(i) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under this subsection; and
(ii) Each individual sub-lot is sampled, tested, and accepted in accordance with subdivisions 8 b (2) and d (2) (i) of this subsection and any other criteria that may be required as a condition of the license issued under this subsection.
9. Transfer reports.
a. Each person licensed under this subsection shall file an annual report with the agency, which shall state the total quantity of tritium or promethium-147 transferred to persons generally licensed under 12VAC5-481-430 D. The report shall identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. Each report shall cover the year ending June 30 and shall be filed within 30 days thereafter. If no transfers have been made to persons generally licensed under 12VAC5-481-430 D during the reporting period, the report shall indicate so.
b. Each person licensed under this subsection shall report annually all transfers of devices to persons for use under a general license in the NRC or another Agreement state's regulations that are equivalent to 12VAC5-481-430 D to (i) the NRC at Director, Office of Nuclear Material Safety and Safeguards, ATTN: Document Control Desk/GLTS, by an appropriate method listed in 10 CFR 30.6(a) and (ii) the responsible Agreement state agency. The report shall state the total quantity of tritium or promethium-147 transferred, identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. If no transfers have been made to the NRC or particular Agreement state during the reporting period, this information shall be reported to the NRC and responsible Agreement state agency.
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 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 F will be approved if:
1. The applicant satisfies the general requirement of 12VAC5-481-450.
2. The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including:
a. Chemical and physical form and maximum quantity of americium 241 or radium-226 in the source;
b. Details of construction and design;
c. Details of the method of incorporation and binding of the americium-241 or radium-226 in the source;
d. Procedures for and results of prototype testing of sources, which are designed to contain more than 0.005 microcurie (0.185 kilobecquerel) of americium-241 or radium-226, to demonstrate that the americium-241 or radium-226 contained in each source will not be released or be removed from the source under normal conditions of use;
e. Details of quality control procedures to be followed in manufacture of the source;
f. Description of labeling to be affixed to the source or the storage container for the source; and
g. Any additional information, including experimental studies and tests, required by the NRC to facilitate a determination of the safety of the source.
3. Each source will contain no more than 5 microcuries of americium-241 or radium-226.
4. The agency determines, with respect to any type of source containing more than 0.005 microcurie (0.185 kilobecquerel) of americium-241 or radium-226, that:
a. The method of incorporation and binding of the americium-241 or radium-226 in the source is such that the americium-241 will not be released or be removed from the source under normal conditions of use and handling of the source; and
b. The source has been subjected to and has satisfactorily passed appropriate tests required by subdivision 5 of this subsection.
5. The applicant shall subject at least five prototypes of each source that is designed to contain more than 0.005 microcurie (0.185 kilobecquerel) of americium-241 or radium-226 to tests as follows:
a. The initial quantity of radioactive material deposited on each source is measured by direct counting of the source.
b. The sources are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment or binding of americium-241 or radium-226, such as physical handling, moisture, and water immersion.
c. The sources are inspected for evidence of physical damage and for loss of americium-241 or radium-226 after each stage of testing using methods of inspection adequate for determining compliance with the criteria in subdivision 5 d of this subsection.
d. Source designs are rejected for which the following has been detected for any unit (i) removal of more than 0.005 microcurie (0.185 kilobecquerel) of americium-241 or radium-226 from the source or (ii) any other evidence of physical damage.
6. Labeling of devices. Each person licensed under this subsection shall affix to each source or storage container for the source a label that shall contain sufficient information relative to safe use and storage of the source and shall include the following statement or a substantially similar statement which contains the information in the following statement:
"The receipt, possession, use, and transfer of this source, Model, Serial No., are subject to a general license and the regulations of the U.S. Nuclear Regulatory Commission (NRC) or of a state with which the NRC has entered into an agreement for the exercise of regulatory authority. Do not remove this label.
CAUTION - RADIOACTIVE MATERIAL - THIS SOURCE CONTAINS AMERICIUM-241 (or RADIUM-226). DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
_________________________________
(Name of manufacturer or initial transferor)"
7. Leak testing of each source. Each person licensed under this subsection shall perform a dry wipe test upon each source containing more than 0.1 microcurie (3.7 kilobecquerel) of americium-241 or radium-226 before transferring the source to a general licensee under 12VAC5-481-430 F or under equivalent regulations of the NRC or another Agreement state. This test shall be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the filter paper shall be measured using methods capable of detecting 0.005 microcurie (0.185 kilobecquerel) of americium-241 or radium-226. If a source has been shown to be leaking or losing more than 0.005 microcurie (0.185 kilobecquerel) of americium-241 or radium-226 by the methods described in this section, the source shall be rejected and shall not be transferred to a general licensee under 12VAC5-481-430 F, or equivalent regulations of the NRC or another Agreement state.
F. Reserved.
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 370 kBq (10 μCi) each.
b. Cobalt-57 in units not exceeding 370 kBq (10 μCi) each.
c. Hydrogen-3 (tritium) in units not exceeding 1.85 MBq (50 μCi) each.
d. Iodine-125 in units not exceeding 370 kBq (10 μCi) each.
e. Mock iodine-125 in units not exceeding 1.85 kBq (0.05 μCi) of iodine-129 and 185 Bq (0.005 μCi) of americium-241 each.
f. Iodine-131 in units not exceeding 370 kBq (10 μCi) each.
g. Iron-59 in units not exceeding 740 kBq (20 μCi) each.
h. Selenium-75 in units not exceeding 370 kBq (10 μCi) each.
3. Each prepackaged unit bears a durable, clearly visible label:
a. Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 370 kBq (10 μCi) of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 1.85 MBq (50 μCi) of hydrogen-3 (tritium); 740 kBq (20 μCi) of iron-59; or mock iodine-125 in units not exceeding 1.85 kBq (0.05 μCi) of iodine-129 and 185 Bq (0.005 μCi) 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 shall also contain directions to the licensee regarding the waste disposal requirements set out in 12VAC5-481-910.
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;
2. The applicant submits sufficient information regarding each type of device pertinent to evaluation of the potential radiation exposure, including:
a. Chemical and physical form and maximum quantity of strontium-90 in the device;
b. Details of construction and design of the source of radiation and its shielding;
c. Radiation profile of a prototype device;
d. Procedures for and results of prototype testing of devices to demonstrate that the strontium-90 contained in each device will not be released or be removed from the device under the most severe conditions likely to be encountered in normal handling and use;
e. Details of quality control procedures to be followed in manufacture of the device;
f. Description of labeling to be affixed to the device;
g. Instructions for handling and installation of the device;
h. Any additional information, including experimental studies and tests, required by the agency to facilitate a determination of the safety of the device;
3. Each device will contain no more than 50 microcuries of strontium-90 in an insoluble form;
4. Each device will bear durable, legible labeling that includes the radiation caution symbol prescribed by 12VAC5-481-850, a statement that the device contains strontium-90 and the quantity thereof, instructions for disposal and statements that the device may be possessed pursuant to a general license, that the manufacturer or civil authorities should be notified if the device is found, that removal of the labeling is prohibited, and that disassembly and repair of the device may be performed only by a person holding a specific license to manufacture or service such devices;
5. The agency determines that:
a. The method of incorporation and binding of the strontium-90 in the device is such that the strontium-90 will not be released from the device under the most severe conditions that are likely to be encountered in normal use and handling of the device;
b. The strontium-90 is incorporated or enclosed so as to preclude direct physical contact by any individual with it and is shielded so that no individual will receive a radiation exposure to a major portion of his body in excess of 0.5 rem in a year under ordinary circumstances of use;
c. The device is so designed that it cannot be easily disassembled;
d. Prototypes of the device have been subjected to and have satisfactorily passed the tests required by subdivision 6 of this subsection;
e. Quality control procedures have been established to satisfy the requirements of subdivision 8 of this subsection;
6. The applicant shall subject at least five prototypes of the device to tests as follows:
a. The devices are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of strontium-90, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering.
b. The devices are inspected for evidence of physical damage and for loss of strontium-90 after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in subdivision 6 c of this subsection.
c. Device designs are rejected for which the following has been detected for any unit:
(1) A leak resulting in a loss of 0.1% or more of the original amount of strontium-90 from the device;
(2) Surface contamination of strontium-90 on the device of more than 2,200 disintegrations per minute per 100 square centimeters of surface area; or
(3) Any other evidence of physical damage;
7. The device has been registered in the Sealed Source and Device Registry; and
8. Quality assurance; prohibition of transfer.
a. Each person licensed under this subsection shall visually inspect each device and shall reject any that has an observable physical defect that could affect containment of the strontium-90.
b. Each person licensed under this subsection shall test each device for possible loss of strontium-90 or for contamination by wiping with filter paper an area of at least 100 square centimeters on the outside surface of the device, or by wiping the entire surface area if it is less than 100 square centimeters. The detection on the filter paper of more than 2,200 disintegrations per minute of radioactive material per 100 square centimeters of surface wiped shall be cause for rejection of the tested device.
c. Each person licensed under this subsection shall:
(1) Maintain quality assurance systems in the manufacture of the ice detection device containing strontium-90 in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed devices are capable of performing their intended functions; and
(2) Subject inspection lots to acceptance sampling procedures by procedures specified in subdivision 8 d of this subsection and in the license issued under this subsection, to provide at least 95% confidence that the lot tolerance percent defective of 5.0% will not be exceeded.
d. Each person licensed under this subsection shall subject each inspection lot to:
(1) Tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could possibly affect the effective containment of strontium-90, such as absolute pressure and water immersion.
(2) Inspection for evidence of physical damage, containment failure, or for loss of strontium-90 after each stage of testing using methods of inspection adequate to determine compliance with the following criteria for defective (i) a leak resulting in a loss of 0.1% or more of the original amount of strontium-90 from the device and (ii) any other criteria specified in the license issued under this subsection.
e. No person licensed under this subsection shall transfer to persons generally licensed under 12VAC5-481-430 H, or under an equivalent general license of the NRC or another Agreement state:
(1) Any ice detection device containing strontium-90 tested and found defective under the criteria specified in a license issued under this subsection unless the defective ice detection device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or
(2) Any ice detection device containing strontium-90 contained within any lot that has been sampled and rejected as a result of the procedures in subdivision 8 c (2) of this subsection, unless:
(i) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under this subsection; and
(ii) Each individual sub-lot is sampled, tested, and accepted in accordance with subdivisions 8 c (2) and 8 e (2) (i) of this subsection and any other criteria as may be required as a condition of the license issued under this subsection.
I. Manufacture, preparation, or transfer for commercial distribution of drugs containing radioactive material for medical use under Part VII (12VAC5-481-1660 et seq.) of this chapter.
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.) of this chapter 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 with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 CFR 207.20(a);
(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 commits to 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 shall include the radiation symbol as described in 12VAC5-481-850 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 shall include the radiation symbol as described in 12VAC5-481-850 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 who 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 as specified in 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. A licensee shall satisfy the labeling requirements in subsection I 1 d of this section.
6. Nothing in this subsection relieves the licensee from complying with applicable FDA, other federal, and state requirements governing radioactive drugs.
7. 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.
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 the medical use of radioactive material or use as a calibration, transmission or reference source 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 for the medical use of radioactive material or under equivalent licenses of the NRC, or another Agreement 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, the applicant shall include 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;
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; and
6. The device has been registered in the Sealed Source and Device Registry.
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 C or equivalent regulations of the NRC or 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 or uses 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 NRC or 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 C and a copy of agency form "Certificate - Use of Depleted Uranium under a General License" to each person to whom depleted uranium in a product or device for use pursuant to the general license contained in 12VAC5-481-420 C is transferred; or
(2) Furnish a copy of the general license contained in the NRC's or another Agreement state's regulation equivalent to 12VAC5-481-420 B and a copy of the NRC's or another Agreement state's certificate, or alternatively, furnish a copy of the general license contained in 12VAC5-481-420 C and a copy of agency form "Certificate - Use of Depleted Uranium under a General License" to each person to whom depleted uranium in a product or device for use pursuant to the general license of the NRC or another Agreement state is transferred, with a note explaining that use of the product or device is regulated by the NRC or another Agreement state under requirements substantially the same as those in 12VAC5-481-420 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 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 C during the reporting period, the report shall so indicate;
f. Do the following:
(1) Report to the NRC all transfers of industrial products or devices to persons for use under the NRC general license in 10 CFR 40.25;
(2) 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 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 NRC licensees during the reporting period, this information shall be reported to the NRC; and
(5) If no transfers have been made to general licensees within 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 C or equivalent regulations of the NRC or 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. 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 shall 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; Volume 25, Issue 2, eff. November 1, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 33, Issue 11, eff. February 22, 2017; Volume 37, Issue 25, eff. January 14, 2022.
12VAC5-481-490. Issuance of specific licenses.
A. Upon a determination that an application meets the requirements of the Act and the regulations of the agency, the agency will issue a specific license authorizing the proposed activity in such form and containing such conditions and limitations as it deems appropriate or necessary.
B. The agency may incorporate in any license at the time of issuance, or thereafter by appropriate rule, regulation, or order, such additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of radioactive material subject to this part as it deems appropriate or necessary in order to:
1. Minimize danger to public health and safety or property;
2. Require such reports and the keeping of such records, and to provide for such inspections of activities under the license as may be appropriate or necessary; and
3. Prevent loss or theft of material subject to 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.
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.
A request for license transfer shall include (i) the identity, technical, and financial qualifications of the proposed transferee and (ii) financial assurance for decommissioning information required under 12VAC5-481-450 C.
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(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; Volume 32, Issue 24, eff. August 25, 2016.
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, a specific license shall expire at the end of the specified day in the month and year stated 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. 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.
12VAC5-481-520. Renewal of licenses.
A. Applications for renewal of specific licenses shall be filed in accordance with 12VAC5-481-440.
B. In any case in which a licensee, not less than 30 days prior to expiration of his existing license, has filed an application in proper form for renewal or for a new license authorizing the same activities, such existing license shall not expire until final action 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.
12VAC5-481-530. Amendment of licenses at request of licensee.
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.), 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.
Article 5
Licenses Held at the Time of the Effective Date of These Regulations
Any person who, on 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 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 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 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.
Article 6
Transfer of Material
A. No licensee shall transfer radioactive material except as authorized pursuant to this section.
B. Except as otherwise provided in 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 NRC, or another agreement state, or to any person otherwise authorized to receive such material by the federal government or any agency thereof, the agency, or another agreement state; or
5. As otherwise authorized by the agency in writing.
C. Before transferring radioactive material to a specific licensee of the agency, the NRC, or another agreement state, or to a general licensee who is required to register with the agency, the NRC, or another agreement 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 NRC, or another agreement 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 NRC, or another agreement 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.
Article 7
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 8
Modification and Revocation of Licenses
12VAC5-481-580. Modification and revocation of licenses.
Article 8
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. 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 9
Reciprocity
12VAC5-481-590. Reciprocal recognition of licenses.
Licenses of radioactive, 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 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 the Commonwealth for a period not in excess of 180 days during the one-year reciprocal approval period, 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 using Applications for Reciprocal Recognition of Out-of-State Radioactive Materials License and Reciprocity Notification forms 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;
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, 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 A; and
f. The out-of-state licensee submits the payment required by 12VAC5-490-40 to the agency.
2. Notwithstanding the provisions of subdivision 1 of this section, any person who holds a specific license issued by the NRC or 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 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 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 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; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.
Part IV
Standards for Protection Against Radiation
Article 1
General Provisions
12VAC5-481-600. Purpose.
Article 1
General Provisions
A. Part IV (12VAC5-481-600 et seq.) of this chapter establishes standards for protection against ionizing radiation resulting from activities conducted pursuant to licenses or registrations issued by the agency. These regulations are issued pursuant to the Act, as amended.
B. The requirements of Part IV (12VAC5-481-600 et seq.) of this chapter are designed to control the receipt, possession, use, transfer, and disposal of sources of radiation by any licensee or registrant so the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in Part IV (12VAC5-481-600 et seq.) of this chapter. However, nothing in Part IV (12VAC5-481-600 et seq.) of this chapter shall be construed as limiting actions that may be necessary to protect health and safety in an emergency.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-610. Scope.
Except as specifically provided in other parts of these regulations, Part IV (12VAC5-481-600 et seq.) of this chapter applies to persons licensed or registered by the agency to receive, possess, use, transfer, or dispose of sources of radiation. The limits in Part IV (12VAC5-481-600 et seq.) of this chapter do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, or to voluntary participation in medical research programs.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-620. Implementation.
A. Any existing license or registration condition that is more restrictive than Part IV (12VAC5-481-600 et seq.) of this chapter remains in force until there is an amendment or renewal of the license or registration.
B. If a license or registration condition exempts a licensee or registrant from a provision of Part IV (12VAC5-481-600 et seq.) of this chapter in effect on or before September 20, 2006, it also exempts the licensee or registrant from the corresponding provision of Part IV (12VAC5-481-600 et seq.) of this chapter.
C. If a license or registration condition cites provisions of Part IV (12VAC5-481-600 et seq.) of this chapter in effect prior to September 20, 2006, which do not correspond to any provisions of Part IV (12VAC5-481-600 et seq.) of this chapter, the license or registration condition remains in force until there is an amendment or renewal of the license or registration that modifies or removes this condition.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
Article 2
Radiation Protection Programs
12VAC5-481-630. Radiation protection programs.
Article 2
Radiation Protection Programs
A. Each licensee shall develop, document, and implement a radiation protection program commensurate with the scope and extent of licensed activities and sufficient to ensure compliance with the provisions of this chapter.
B. The licensee shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA).
C. The licensee shall periodically (not to exceed 12 months) review the radiation protection program content and implementation.
D. To implement the ALARA requirements of subsection B of this section, and notwithstanding the requirements of 12VAC5-481-720, a constraint on air emissions of radioactive material to the environment, excluding Radon-222 and its daughters, shall be established by licensees such that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of 10 mrem (0.1 mSv) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the exceedance as provided in 12VAC5-481-1110 and promptly take appropriate corrective action to ensure against recurrence.
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; Volume 32, Issue 24, eff. August 25, 2016.
Article 3
Occupational Dose Limits
12VAC5-481-640. Occupational dose limits for adults.
Article 3
Occupational Dose Limits
A. The licensee shall control the occupational dose to individual adults, except for planned special exposures under 12VAC5-481-690, to the following dose limits.
1. An annual limit, which is the more limiting of:
a. The total effective dose equivalent being equal to 5 rem (0.05 Sv); or
b. The sum of the deep-dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 50 rem (0.5 Sv).
2. The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, which are:
a. A lens dose equivalent of 15 rem (0.15 Sv), and
b. A shallow-dose equivalent of 50 rem (0.5 Sv) to the skin of the whole body or to the skin of any extremity.
B. Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current year and during the individual's lifetime in accordance with 12VAC5-481-690 A 5.
C. When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent shall be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the agency. The assigned deep-dose equivalent shall be for the part of the body receiving the highest exposure. The assigned shallow-dose equivalent shall be the dose averaged over the contiguous 10 square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits if the individual monitoring device was not in the region of highest potential exposure or the results of individual monitoring are unavailable.
D. Derived air concentration (DAC) and annual limit on intake (ALI) values are presented in Appendix B to 10 CFR Part 20 and may be used to determine the individual's dose (see 12VAC5-481-1040) and to demonstrate compliance with the occupational dose limits.
E. In addition to the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to 10 milligrams in a week in consideration of chemical toxicity (see Appendix B to 10 CFR Part 20).
F. The licensee shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person (see 12VAC5-481-1020).
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-650. Compliance with requirements for summation of external and internal doses.
A. If the licensee is required to monitor under subdivisions 1 and 2 of 12VAC5-481-760, the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only under subdivision 1 of 12VAC5-481-760 or only under subdivision 2 of 12VAC5-481-760, then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses by meeting one of the conditions specified in subsections B, C, and D of this section. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.
B. Intake by inhalation. If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep-dose equivalent divided by the total effective dose equivalent limit and one of the following does not exceed unity:
1. The sum of the fractions of the inhalation ALI for each radionuclide,
2. The total number of derived air concentration-hours (DAC-hours) for all radionuclides divided by 2,000, or
3. The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For the purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors and the committed dose equivalent per unit intake is greater than 10% of the maximum weighted value of the committed dose equivalent per unit intake of any organ or tissue.
C. Intake by oral ingestion. If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than 10% of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits.
D. Intake through wounds or absorption through skin. The licensee shall evaluate and to the extent practical account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be evaluated.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-660. Determination of external dose from airborne radioactive material.
A. Licensees shall, when determining the dose from airborne radioactive material, include the contribution to the deep-dose equivalent, lens dose equivalent, and shallow-dose equivalent from external exposure to the radioactive cloud (see Appendix B to 10 CFR Part 20).
B. Airborne radioactive measurements and DAC values shall not be used as the primary means to assess the deep dose equivalent when the airborne radioactive materials includes radionuclides other than noble gases or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual shall be based upon measurements using instruments or individual monitoring devices.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-670. Determination of internal exposure.
A. For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required under 12VAC5-481-760, take suitable and timely measurements of either:
1. Concentrations of radioactive materials in air in work areas;
2. Quantities of radionuclides in the body;
3. Quantities of radionuclides excreted from the body; or
4. Combinations of these measurements.
B. Unless respiratory protective equipment is used as provided in 12VAC5-481-830 or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.
C. When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior or the material in an individual is known, the licensee may:
1. Use that information to calculate the committed effective dose equivalent, and if used, the licensee shall document that information in the individual's record;
2. Upon prior approval from the agency, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material (e.g., aerosol size distribution or density); and
3. Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide (see Appendix B to 10 CFR Part 20) to the committed effective dose equivalent.
D. If the licensee chooses to assess intakes of Class Y material using the measurements given in subdivision A 2 or A 3 of this section, the licensee may delay the recording and reporting of the assessments for periods up to seven months, unless otherwise required by 12VAC5-481-1100 or 12VAC5-481-1110, in order to permit the licensee to make additional measurements basic to the assessments.
E. If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either:
1. The sum of the ratios of the concentration to the appropriate DAC value (e.g., D, W, or Y) from Appendix B to 10 CFR Part 20 for each radionuclide in the mixture; or
2. The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.
F. If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall be the most restrictive DAC of any radionuclide in the mixture.
G. When a mixture of radionuclides in air exists, licensees may disregard certain radionuclides in the mixture if:
1. The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in 12VAC5-481-640 and in complying with the monitoring requirements in 12VAC5-481-760 A 2,
2. The concentration of any radionuclide disregarded is less than 10% of its DAC, and
3. The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed 30%.
H. When determining the committed effective dose equivalent, the following information may be considered:
1. In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one ALI or an exposure of 2,000 DAC-hours results in a committed effective dose equivalent of 5 rem (0.05 Sv) for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent.
2. When the ALI and the associated DAC is determined by the nonstochastic organ dose limit of 50 rem (0.5 Sv), the intake of radionuclides that would result in a committed effective dose equivalent of 5 rem (0.05 Sv) (the stochastic ALI) is listed in parentheses of Appendix B to 10 CFR Part 20. In this case, the licensee may, as a simplifying assumption, use the stochastic ALIs to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALIs, the licensee shall also demonstrate that the limit in 12VAC5-481-640 A 1 (b) is 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; Volume 32, Issue 24, eff. August 25, 2016.
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 12VAC5-481-760, the licensee or registrant shall determine the occupational radiation dose received during the current year.
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 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, 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 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 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 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 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 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.
A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in 12VAC5-481-640 provided that each of the following conditions is satisfied:
1. The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the dose estimated to result from the planned special exposure are unavailable or impractical.
2. The licensee, and employer if the employer is not the licensee, specifically authorizes the planned special exposure in writing before the exposure occurs.
3. Before a planned special exposure, the licensee ensures that each individual involved is:
a. Informed of the purpose of the planned operation;
b. Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and
c. Instructed in the measure to be taken to keep the dose ALARA considering other risks that may be present.
4. Prior to permitting an individual to participate in a planned special exposure, the licensee ascertains prior doses as required by 12VAC5-481-1020 during the lifetime of the individual for each individual involved.
5. Subject to 12VAC5-481-640 A 2, the licensee does not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:
a. The numerical values of any of the dose limits in 12VAC5-481-640 A 1 in any year; and
b. Five times the annual dose limits in 12VAC5-481-640 A 1 during the individual's lifetime.
6. The licensee maintains records of the conduct of a planned special exposure in accordance with 12VAC5-481-1030 and submits a written report in accordance with 12VAC5-481-1120.
7. The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual in writing of the dose within 30 days from the date of the planned special exposure. The dose from planned special exposures is not be considered in controlling future occupational dose limits of the individual under 12VAC5-481-640 A 1 but is to be included in evaluations required by subdivisions 4 and 5 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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-700. Occupational dose limits for minors.
The annual occupational dose limits for minors are 10% of the annual dose limits specified for adult workers in 12VAC5-481-640.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-710. Dose to an embryo/fetus.
A. The licensee shall ensure that the dose equivalent to the embryo/fetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 500 millirem (5 mSv).
B. The licensee shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limits in subsection A of this section.
C. The dose equivalent to the embryo/fetus is the sum of:
1. The deep dose equivalent to the declared pregnant woman; and
2. The dose equivalent to the embryo/fetus resulting from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman.
D. If the dose equivalent to the embryo/fetus is found to have exceeded 500 millirem (5 mSv), or is within 50 millirem (0.5 mSv) of this dose, by the time the woman declares the pregnancy to the licensee, the licensee shall be deemed to be in compliance with subsection A of this section if the additional dose equivalent to the embryo/fetus does not exceed 50 millirem (0.5 mSv) during the remainder of the pregnancy.
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; Volume 32, Issue 24, eff. August 25, 2016.
Article 4
Radiation Dose Limits for Individual Members of the Public
12VAC5-481-720. Dose limits for individual members of the public.
Article 4
Radiation Dose Limits for Individual Members of the Public
A. Each licensee shall conduct operations so that:
1. The total effective dose equivalent to individual members of the public from the licensed operation does not exceed 100 millirem (1 mSv) in a year exclusive of the dose contribution from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released under 12VAC5-481-1870, from voluntary participation in medical research programs, and from the licensee's disposal of radioactive material into sanitary sewerage in accordance with 12VAC5-481-930; and
2. The dose in any unrestricted area from external sources exclusive of the dose contribution from individuals administered radioactive material and released in accordance with 12VAC5-481-1870 does not exceed 2 millirem (0.02 millisievert) in any one hour.
B. If the licensee permits members of the public to have access to controlled areas, the limits for members of the public continue to apply to those individuals.
C. Notwithstanding subdivision A 1 of this section, a licensee may permit visitors to an individual who cannot be released under 12VAC5-481-1870 to receive a radiation dose greater than 100 millirem (1 mSv) if:
1. The radiation dose received does not exceed 500 millirem (5 mSv); and
2. The authorized user as defined in 12VAC5-481-10 has determined before the visit that it is appropriate.
D. A licensee or licensee applicant may apply for prior agency authorization to operate up to an annual dose limit for an individual member of the public of 500 millirem (5 mSv). The licensee or license applicant shall include the following information in this application:
1. Demonstration of the need for and the expected duration of operations in excess of the limit in subsection A of this section;
2. The licensee's program to assess and control dose within the 500 millirem (5 mSv) annual limit; and
3. The procedures to be followed to maintain the dose as low as is reasonably achievable.
E. In addition to these requirements, a licensee subject to the provisions of the U.S. Environmental Protection Agency's generally applicable environmental radiation standards in 40 CFR Part 190 shall comply with those standards.
F. The agency may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-730. Compliance with dose limits for individual members of the public.
A. The licensee shall make or cause to be made, as appropriate, surveys of radiation levels in unrestricted and controlled areas and radioactive materials in effluents released to unrestricted and controlled areas to demonstrate compliance with the dose limits for individual members of the public in 12VAC5-481-720.
B. A licensee shall show compliance with the annual dose limits in 12VAC5-481-720 by:
1. Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed operation does not exceed the annual dose limit; or
2. Demonstrating that:
a. The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in Table 2 of Appendix B to 10 CFR Part 20; and
b. If an individual were continuously present in an unrestricted area, the dose from external sources would not exceed 2 millirem (0.02 mSv) in an hour and 50 millirem (0.5 mSv) in a year.
C. Upon approval from the agency, the licensee may adjust the effluent concentration values in Table 2 of Appendix B to 10 CFR Part 20, for members of the public, to take into account the actual physical and chemical characteristics of the effluents (e.g., aerosol size distribution, solubility, density, radioactive decay equilibrium, and chemical form).
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; Volume 32, Issue 24, eff. August 25, 2016.
Article 5
Testing for Leakage or Contamination of Sealed Sources
12VAC5-481-740. Testing for leakage or contamination of sealed sources.
Article 5
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 J 4 and 5, the 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 J 4 and 5, the 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 μCi) 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 μCi) of radon-222 in a 24-hour period when the collection efficiency for radon-222 and its daughters has been determined with respect to collection method, volume and time;
7. Tests for contamination from radium daughters 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 μCi) 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 μCi) or less of beta or photon-emitting material or 370 kBq (10 μCi) or less of alpha-emitting material;
4. Sealed sources containing only hydrogen-3;
5. Seeds of iridium-192 encased in nylon ribbon; and
6. Sealed sources 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, the 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 μCi) or more of removable contamination on any test sample;
2. Leakage of 37 Bq (0.001 μCi) of radon-222 per 24 hours for brachytherapy sources manufactured to contain radium;
3. The presence of removable contamination resulting from the decay of 185 Bq (0.005 μCi) or more of radium.
F. 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.
Article 6
Surveys and Monitoring
A. Licensees shall make or cause to be made surveys of areas, including the subsurface, that:
1. Are necessary for the licensee to comply with this chapter; and
2. Are reasonable under the circumstances to evaluate:
a. The magnitude and extent of radiation levels;
b. The concentrations or quantities of radioactive material; and
c. The potential radiological hazards of the radiation levels and residual radioactivity detected.
B. Notwithstanding 12VAC5-481-1000 A, records from surveys describing the location and amount of subsurface residual radioactivity identified at the site shall be kept with records important for decommissioning, and such records shall be retained in accordance with 12VAC5-481-450 C 8.
C. Licensees shall ensure that the survey instruments used to show compliance with this chapter are calibrated before first use, annually (not to exceed 12 months), except when a more frequent interval is specified in another applicable part of this chapter or a license condition, and following a repair that affects the calibration. These calibrations shall include:
1. Use of a radiation source on all scales;
2. At energies appropriate for the use;
3. 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 2 and 1000 mrem (0.02 and 10 millisieverts) per hour;
4. For dose rate instruments, so that an accuracy within plus or minus 20% of the true radiation dose can be demonstrated at each point checked; and
5. Conspicuously note on the instrument the date of calibration.
D. Licensees may not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is more than 20%.
E. All personnel dosimeters, except for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to the extremities, that require processing to determine the radiation dose and that are used by the licensee to comply with 12VAC5-481-640, with other applicable provisions of this chapter, or with conditions specified in a license shall be processed and evaluated by a dosimetry processor with the following:
1. Holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; and
2. Approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximates the type of radiation or radiation for which the individual wearing the dosimeter is monitored.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-760. Conditions requiring individual monitoring of external and internal occupational dose.
Each licensee shall monitor exposures from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of this part. At a minimum:
1. Each licensee shall monitor occupational exposure to radiation from licensed and unlicensed radiation sources under the control of the licensee and shall supply and require the use of individual monitoring devices by:
a. Adults likely to receive, in one year from sources external to the body, a dose in excess of 10% of the limits in 12VAC5-481-640 A;
b. Minors likely to receive, in one year from radiation sources external to the body, a deep dose equivalent in excess of 100 millirem (1 mSv), a lens dose equivalent in excess of 150 millirem (1.5 mSv), or a shallow dose equivalent to the skin or to the extremities in excess of 500 millirem (5 mSv);
c. Declared pregnant women likely to receive, during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 100 millirem (1 mSv); and
d. Individuals entering a high or very high radiation area.
2. Each licensee shall monitor (see 12VAC5-481-670) the occupational intake of radioactive material by and assess the committed effective dose equivalent to:
a. Adults likely to receive, in one year, an intake in excess of 10% of the applicable ALIs in Table 1, Columns 1 and 2, of Appendix B to 10 CFR Part 20;
b. Minors likely to receive, in one year, a committed effective dose equivalent in excess of 100 millirem (1 mSv); and
c. Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of 100 millirem (1 mSv).
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-770. Location of individual monitoring devices.
Each licensee or registrant shall ensure that individuals who are required to monitor occupational doses in accordance with 12VAC5-481-760 wear individual monitoring devices as follows:
1. An individual monitoring device used for monitoring the dose to the whole body shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck (collar);
2. An individual monitoring device used for monitoring the dose to an embryo/fetus of a declared pregnant woman, pursuant to 12VAC5-481-710, shall be located at the waist under any protective apron being worn by the woman;
3. An individual monitoring device used for monitoring the eye dose equivalent, to demonstrate compliance with 12VAC5-481-640, shall be located at the neck (collar), outside any protective apron being worn by the monitored individual, or at an unshielded location closer to the eye;
4. An individual monitoring device used for monitoring the dose to the extremities, to demonstrate compliance with 12VAC5-481-640, shall be worn on the extremity likely to receive the highest exposure. Each individual monitoring device shall be oriented to measure the highest dose to the extremity being monitored.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
Article 7
Control of Exposure from External Sources in Restricted Areas
12VAC5-481-780. Control of access to high radiation areas.
Article 7
Control of Exposure from External Sources in Restricted Areas
A. The licensee shall ensure that each entrance or access point to a high radiation area has one or more of the following features:
1. A control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep dose equivalent of 100 millirem (1 mSv) in 1 hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates;
2. A control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of entry; or
3. Entryways that are locked, except during periods when access to the areas is required, with positive control over each individual entry.
B. In place of the controls required by subsection A of this section for a high radiation area, the licensee may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.
C. A licensee may apply to the agency for approval of alternative methods for controlling access to high radiation areas.
D. The licensee shall establish the controls required by subsections A and C of this section in a way that does not prevent individuals from leaving a high radiation area.
E. Control is not required for each entrance or access point to a room or other area that is a high radiation area solely because of the presence of radioactive materials prepared for transport and packaged and labeled in accordance with regulations of the U.S. Department of Transportation provided that:
1. The packages do not remain in the area longer than three days; and
2. The dose rate at one meter from the external surface of any package does not exceed 10 millirem (0.1 mSv) per hour.
F. Control of entrance or access to rooms or other areas in hospitals is not required solely because of the presence of patients containing radioactive material, provided that there are personnel in attendance who will take the necessary precautions to prevent the exposure of individuals to radiation or radioactive material in excess of the limits established in this part and to operate within the ALARA provisions of the licensee's radiation protection program.
G. 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, 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; Volume 32, Issue 24, eff. August 25, 2016.
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 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, 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. (Repealed.)
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.
Article 8
Respiratory Protection and Controls to Restrict Internal Exposure in Restricted Areas
The licensee shall use, to the extent practical, process or other engineering controls (e.g., containment, decontamination, or ventilation) to control the concentration of radioactive material in air.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-820. Use of other controls.
A. When it is not practical to apply process or other engineering controls to control the concentrations of radioactive material in the air to values below those that define an airborne radioactivity area, the licensee shall, consistent with maintaining the total effective dose equivalent ALARA, increase monitoring and limit intakes by one or more of the following means:
1. Control of access;
2. Limitation of exposure times;
3. Use of respiratory protection equipment; or
4. Other controls.
B. If the licensee performs an ALARA analysis to determine whether or not respirators should be used, the licensee may consider safety factors other than radiological factors. The licensee should also consider the impact of respirator use on the industrial health and safety of workers.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-830. Use of individual respiratory protection equipment.
A. If the licensee assigns or permits the use of respiratory protection equipment to limit the intake of radioactive material:
1. The licensee shall use only respiratory protection equipment that is tested and certified by the National Institute for Occupational Safety and Health (NIOSH) except as otherwise noted in this part.
2. If the licensee wishes to use equipment that has not been tested or certified by NIOSH, or for which there is no schedule for testing or certification, the licensee shall submit an application to the agency for authorized use of this equipment except as provided in this part. The application shall include evidence that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use. This shall be demonstrated either by licensee testing or on the basis of reliable test information.
3. The licensee shall implement and maintain a respiratory protection program that includes:
a. Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate doses;
b. Surveys and bioassays, as necessary, to evaluate actual intakes;
c. Testing of respirators for operability (i.e., user seal check for face sealing devices and functional check for others) immediately prior to each use;
d. Written procedures regarding:
(1) Monitoring, including air sampling and bioassays;
(2) Supervision and training of respirator users;
(3) Fit testing;
(4) Respirator selection;
(5) Breathing air quality;
(6) Inventory and control;
(7) Storage, issuance, maintenance, repair, testing, and quality assurance of respiratory protection equipment;
(8) Recordkeeping; and
(9) Limitations on periods of respirator use and relief from respirator use;
e. Determination by a physician that the individual user is medically fit to use respiratory protection equipment at the following stages:
(1) Before the initial fitting of a face sealing respirator;
(2) Before the first field use of non-face sealing respirators, and
(3) Either every 12 months thereafter, or periodically at a frequency determined by a physician; and
f. Fit testing, with fit factor greater than 10 times the assigned protection factor (APF) for negative pressure devices, and a fit factor greater than 500 for any positive pressure, continuous flow, and pressure-demand devices, before the first field use of tight fitting, face-sealing respirators and periodically thereafter at a frequency not to exceed one year. Fit testing shall be performed with the facepiece operating in the negative pressure mode.
4. The licensee shall advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require such relief.
5. The licensee shall also consider limitations appropriate to the type and mode of use. When selecting respiratory devices the licensee shall provide for vision correction, adequate communication, low temperature work environments, and the concurrent use of other safety or radiological protection equipment. The licensee shall use equipment in such a way as not to interfere with the proper operation of the respirator.
6. Standby rescue persons are required whenever one-piece atmosphere-supplying suits, or any combination of supplied air respiratory protection device and personnel protective equipment, are used from which an unaided individual would have difficulty extricating himself. The standby persons shall be equipped with respiratory protection devices or other apparatus appropriate for the potential hazards. The standby rescue persons shall observe or otherwise maintain continuous communication with the workers (e.g., visual, voice, signal line, telephone, radio, or other suitable means), and be immediately available to assist them in case of a failure of the air supply or for any other reason that requires relief from distress. A sufficient number of standby rescue persons shall be immediately available to assist all users of this type of equipment and to provide effective emergency rescue if needed.
7. Atmosphere-supplying respirators shall be supplied with respirable air of grade D quality or better as defined by the Compressed Gas Association in publication G-7.1, "Commodity Specification for Air," 1997, and included in the regulations of the Occupational Safety and Health Administration (29 CFR 1910.134(i)(1)(ii)(A) through (E). Grade D quality air criteria include:
a. Oxygen content (v/v) of 19.5-23.5%;
b. Hydrocarbon (condensed) content of 5 milligrams per cubic meter of air or less;
c. Carbon monoxide (CO) content of 10 ppm or less;
d. Carbon dioxide content of 1,000 ppm or less; and
e. Lack of noticeable odor.
8. The licensee shall ensure that no objects, materials or substances, such as facial hair, or any conditions that interfere with the face (facepiece seal or valve function) and that are under the control of the respirator wearer, are present between the skin of the wearer's face and the sealing surface of a tight-fitting respirator facepiece.
9. In estimating the dose to individuals from intake of airborne radioactive materials, the concentration of radioactive material in the air that is inhaled when respirators are worn is initially assumed to be the ambient concentration in air without respiratory protection, divided by the assigned protection factor. If the dose is later found to be greater than the estimated dose, the corrected value shall be used. If the dose is later found to be less than the estimated dose, the corrected value may be used.
B. The agency may impose restrictions in addition to the provisions of this section, 12VAC5-481-820, and 12VAC5-481-3680 in order to:
1. Ensure that the respiratory protection program of the licensee is adequate to limit doses to individuals from intakes of airborne radioactive materials consistent with maintaining total effective dose equivalent ALARA; and
2. Limit the extent to which a licensee may use respiratory protection equipment instead of process or other engineering controls.
C. The licensee shall obtain authorization from the agency before using assigned protection factors in excess of those specified in 12VAC5-481-3680. The agency may authorize a licensee to use higher assigned protection factors on receipt of an application that:
1. Describes the situation for which a need exists for higher protection factors; and
2. Demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use.
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; Volume 32, Issue 24, eff. August 25, 2016.
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.
Article 9
Security and Control of Licensed or Registered Sources of Radiation
A. The licensee shall:
1. Secure radioactive material from unauthorized removal or access when stored in controlled or unrestricted areas.
2. Control and maintain constant surveillance and use devices or administrative procedures to prevent unauthorized use of radioactive material that is in a controlled or unrestricted area and that is not in storage.
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. 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; Volume 32, Issue 24, eff. August 25, 2016.
Article 10
Precautionary Procedures
12VAC5-481-850. Radiation symbol; caution signs.
Article 10
Precautionary Procedures
A. Unless otherwise authorized by the agency, the symbol prescribed by this section shall use the colors magenta, purple, or black on a yellow background. The symbol prescribed by this section is the three-bladed design:
1. The cross-hatched area is to be magenta, purple, or black, and
2. The background is to be yellow.
B. Exception to color requirements for standard radiation symbol. Notwithstanding the requirements of subsection A of this section, licensees are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures with conspicuously etched or stamped radiation caution symbols and without a color requirement.
C. Additional information on signs and labels. In addition to the contents of signs and labels prescribed in this section, the licensee may provide on or near the required signs and labels, additional information, as appropriate, to make individuals aware of potential radiation exposures and to minimize the exposures.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-860. Posting requirements.
A. Licensees shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol as described in 12VAC5-481-850 and the words "CAUTION, RADIATION AREA."
B. Licensees shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol as described in 12VAC5-481-850 and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA."
C. Licensees shall post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol as described in 12VAC5-481-850 and the words "GRAVE DANGER, VERY HIGH RADIATION AREA."
D. Licensees shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol as described in 12VAC5-481-850 and the words, "CAUTION, AIRBORNE RADIOACTIVITY AREA," or "DANGER, AIRBORNE RADIOACTIVITY AREA."
E. The licensee shall post each area or room in which there is used or stored an amount of licensed material exceeding 10 times the quantity of such material specified in 12VAC5-481-3700 with a conspicuous sign or signs bearing the radiation symbol as described in 12VAC5-481-850 and the words "CAUTION, RADIOACTIVE MATERIALS" or "DANGER, RADIOACTIVE MATERIALS."
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-870. Exceptions to posting requirements.
A. Licensees are not required to post caution signs in areas or rooms containing radioactive materials for periods of less than eight hours, if the following conditions are met:
1. The materials are constantly attended during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to radiation or radioactive materials in excess of the limits established in this part; and
2. The area or room is subject to the licensee's control.
B. Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs pursuant to 12VAC5-481-860, provided that the patient could be released from licensee control pursuant to 12VAC5-481-1870.
C. A room or area is not required to be posted with a caution sign because of the presence of a sealed source, provided that the radiation level at 30 centimeters from the surface of the sealed source container or housing does not exceed 5 millirem (0.05 mSv) per hour.
D. Rooms in hospitals or clinics that are used for teletherapy are exempt from the requirement to post caution signs under 12VAC5-481-860 if
1. Access to the room is controlled pursuant to 12VAC5-481-2043; and
2. Personnel in attendance take necessary precautions to prevent the inadvertent exposure of workers, other patients, and members of the public to radiation in excess of the limits established in 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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-880. Labeling containers and radiation machines.
A. Licensees shall ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol as described in 12VAC5-481-850 and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL." The label shall also provide sufficient information, such as the radionuclides present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment, to permit individuals handling or using the containers or working in the vicinity of the containers to take precautions to avoid or minimize exposures.
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.
C. Licensees shall, prior to removal or disposal of empty uncontaminated containers to unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-890. Exemptions to labeling requirements.
Licensees are not required to label:
1. Containers holding licensed material in quantities less than the quantities listed in 12VAC5-481-3700;
2. Containers holding licensed material in concentrations less than those specified in Appendix B to 10 CFR Part 20;
3. Containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by this part;
4. Containers when they are in transport and packaged and labeled in accordance with regulations of the U.S. Department of Transportation;
5. Containers that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, if the contents are identified to these individuals by readily available written record (e.g., containers in locations such as water filled canals, storage vaults, or hot cells). The record shall be retained as long as the containers are in use for the purpose indicated on the record; or
6. Installed manufacturing or process equipment, such as reactor components, piping, and tanks.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-900. Procedures for receiving and opening packages.
A. Licensees who expect to receive a package containing quantities of radioactive material in excess of a Type A quantity, as defined in 12VAC5-481-10 and 12VAC5-481-3770, shall make arrangements to receive:
1. The package when the carrier offers it for delivery; or
2. Notification of the arrival of the package at the carrier's terminal and to take possession of the package expeditiously.
B. Licensees shall monitor the following:
1.The external surfaces of a labeled package for radioactive contamination unless the package contains only radioactive material in the form of a gas or in special form as defined in 12VAC5-481-10;
2. The external surfaces of a labeled package for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the Type A quantity, as defined in 12VAC5-481-10 and 12VAC5-481-3770; and
3. All packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as packages that are crushed, wet, or damaged.
C. Licensees shall perform the monitoring required by subsection B of this section as soon as practical after receipt of the package, but not later than three hours after the package is received at the licensee's facility if it is received during the licensee's normal working hours, if there is evidence of degradation of package integrity (e.g., packages that are crushed, wet, or damaged), or if it is received after working hours, not later than three hours from the beginning of the next working day.
D. Licensees shall immediately notify the final delivery carrier and the agency by telephone, when:
1. Removable contamination exceeds the limits of subdivision 9 of 12VAC5-481-3080; or
2. External radiation levels exceed the limits of subdivision 10 of 12VAC5-481-3080.
E. Licensees shall:
1. Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and
2. Ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened.
F. Licensees transferring special form sources in licensee-owned or licensee-operated vehicles to and from a work site are exempt from the contamination monitoring requirements of subsection B of this section, but are not exempt from the survey requirements in subsection B of this section for measuring radiation levels that are required to ensure that the source is still properly lodged in its shield.
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; Volume 32, Issue 24, eff. August 25, 2016.
Article 11
Waste Disposal
12VAC5-481-910. General requirements.
Article 11
Waste Disposal
A. Licensees shall dispose of licensed material only in the following ways:
1. By transfer to an authorized recipient as provided in 12VAC5-481-570;
2. By decay in storage;
3. By release in effluents within the limits of 12VAC5-481-720; or
4. As authorized under 12VAC5-481-920, 12VAC5-481-930, 12VAC5-481-940, 12VAC5-481-950, or 12VAC5-481-971.
B. A person shall be specifically licensed to receive waste containing licensed material from other persons for the following actions:
1. Treatment prior to disposal;
2. Treatment or disposal by incineration;
3. Decay in storage;
4. Disposal at a land disposal facility licensed under Part XI (12VAC5-481-2330 et seq.) of this chapter; or
5. Disposal at a geologic repository under 10 CFR Part 60 or 10 CFR Part 63.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-920. Method for obtaining approval of proposed disposal procedures.
A licensee or registrant or applicant for a license or registration may apply to the agency for approval of proposed procedures, not otherwise authorized in these regulations, to dispose of licensed or registered material generated in the licensee's or registrant's operations. Each application shall include:
1. A description of the waste containing licensed or registered material to be disposed of, including the physical and chemical properties that have an impact on risk evaluation, and the proposed manner and conditions of waste disposal;
2. An analysis and evaluation of pertinent information on the nature of the environment;
3. The nature and location of other potentially affected facilities; and
4. Analyses and procedures to ensure that doses are maintained ALARA and within the dose limits in Part IV (12VAC5-481-600 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.
12VAC5-481-930. Disposal by release into sanitary sewerage.
A. Licensees may discharge licensed material into sanitary sewerage if each of the following conditions is satisfied:
1. The licensed or other radioactive material is readily soluble or is readily dispersible biological material in water;
2. The quantity of licensed or other radioactive material that the licensee releases into the sewer in one month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in Table 3 of Appendix B to 10 CFR Part 20;
3. If more than one radionuclide is released, the following conditions shall also be satisfied:
a. The licensee shall determine the fraction of the limit in Table 3 of Appendix B to 10 CFR Part 20 represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in Table 3 of Appendix B to 10 CFR Part 20; and
b. The sum of the fractions for each radionuclide required by subdivision 3 a of this subsection does not exceed unity; and
4. The total quantity of licensed and other radioactive material that the licensee releases into the sanitary sewerage system in one year does not exceed 5 curies (185 GBq) of hydrogen-3, 1 curie (37 GBq) of carbon-14, and 1 curie (37 GBq) of all other radioactive materials combined.
B. Excreta from individuals undergoing medical diagnosis or therapy with radioactive material are not subject to the limitations contained 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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-940. Treatment or disposal by incineration.
Licensees may treat or dispose of licensed material by incineration only if the material is in a form or concentration specified in 12VAC5-481-950, or as specifically approved by the agency pursuant to 12VAC5-481-920.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-950. Disposal of specific wastes.
A. Licensees may dispose of the following licensed material as if it were not radioactive:
1. 0.05 μCi (1.85 kBq) or less of hydrogen-3 or carbon-14 per gram of medium used for liquid scintillation counting; and
2. 0.05 μCi (1.85 kBq) or less of hydrogen-3 or carbon-14 per gram of animal tissue, averaged over the weight of the entire animal.
B. Licensees may not dispose of tissue under subdivision A 2 of this section in a manner that would permit its use either as food for humans or as animal feed.
C. Licensees shall maintain records in accordance with 12VAC5-481-1060.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-960. Transfer for disposal and manifests.
A. The requirements of this section and 12VAC5-481-3710 are designed to accomplish the following:
1. Control transfers of low level radioactive waste by any waste generator, waste collector, or waste processor licensee that ships low level waste either directly or indirectly through a waste collector or waste processor to a licensed low level waste land disposal facility (as defined in 12VAC5-481-10);
2. Establish a manifest tracking system; and
3. Supplement existing requirements concerning transfers and recordkeeping for those wastes.
B. Licensees shipping radioactive waste intended for ultimate disposal at a licensed land disposal facility shall document the information required and transfer this recorded information to the intended consignee in accordance with 12VAC5-481-3710.
C. Each shipment manifest shall include a certification by the waste generator as specified in 12VAC5-481-3710 G.
D. Each person involved in the transfer for disposal and disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in 12VAC5-481-3710 H.
E. Licensees shipping radioactive material as defined in subdivisions 3 and 4 under the definition of "byproduct material" in 12VAC5-481-10 intended for ultimate disposal at a land disposal facility licensed under Part XI (12VAC5-481-2330 et seq.) of this chapter, 10 CFR Part 61, or equivalent agreement state regulations shall document the information required on a manifest and transfer this recorded manifest information to the intended consignee in accordance with 12VAC5-481-3710.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-970. Compliance with environmental and health protection regulations.
Nothing in this part relieves the licensee from complying with other applicable federal, state, and local regulations governing any other toxic or hazardous properties of materials that may be disposed of under 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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-971. Disposal of certain radioactive material.
A. Licensed material meeting the definition in subdivisions 3 and 4 of the definition of "byproduct material" in 12VAC5-481-10 may be disposed of in accordance with Part XI (12VAC5-481-2330 et seq.) of this chapter, even though it is not defined as low level radioactive waste. Therefore, any licensed byproduct material being disposed of at a facility or transferred for ultimate disposal at a facility licensed under Part XI (12VAC5-481-2330 et seq.) of this chapter, 10 CFR Part 61, or equivalent agreement state regulations shall meet the requirements of 12VAC5-481-960.
B. A licensee may dispose of byproduct material, as defined in subsection A of this section, at a disposal facility authorized to dispose of such material in accordance with any federal or state solid or hazardous waste law, including the Solid Waste Disposal Act (42 USC § 6901 et seq.).
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008; amended, Virginia Register Volume 32, Issue 24, eff. August 25, 2016.
Article 12
Records
12VAC5-481-980. General provisions.
Article 12
Records
A. Licensees shall (i) use the units curie, rad, rem, and roentgen, including multiples and subdivisions, and may include the International System of Units (SI) units (Becquerel, gray, sievert, and coulomb per kilogram) and (ii) clearly indicate the units of all quantities on records required by this part.
B. Notwithstanding the requirements of subsection A of this section, when recording information on shipment manifests as required in 12VAC5-481-960 B, information shall be recorded in SI units or in SI units and units as specified in subsection A of this section.
C. The licensee shall make a clear distinction among the quantities entered on the records required by this part (e.g., total effective dose equivalent, shallow dose equivalent, lens dose equivalent, deep dose equivalent, and committed dose equivalent).
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-990. Records of radiation protection programs.
A. Licensees shall maintain records of the radiation protection program, including:
1. The provisions of the program; and
2. Audits and other reviews of program content and implementation.
B. Licensees shall retain the records required by subdivision A 1 of this section until the agency terminates each pertinent license requiring the record. Licensees shall retain the records required by subdivision A 2 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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-1000. Records of surveys.
A. Licensees shall maintain records showing the results of surveys and calibrations required by 12VAC5-481-750 and 12VAC5-481-900 B. Licensees shall retain these records for three years after the record is made.
B. Licensees shall retain each of the following records until the agency terminates each pertinent license condition requiring the record:
1. Records of the results of surveys to determine the dose from external sources and used in the absence of or in combination with individual monitoring data in the assessment of individual dose equivalents;
2. Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose;
3. Records showing the results of air sampling, surveys, and bioassays required pursuant to 12VAC5-481-830 A 3; and
4. Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment.
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; Volume 32, Issue 24, eff. August 25, 2016.
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 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.
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 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 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.
12VAC5-481-1030. Records of planned special exposures.
A. For each use of the provisions of 12VAC5-481-690 for planned special exposures, licensees shall maintain records that describe the following:
1. The exceptional circumstances requiring the use of a planned special exposure;
2. The name of the management official who authorized the planned special exposure and a copy of the signed authorization;
3. What actions were necessary;
4. Why the actions were necessary;
5. How doses were maintained ALARA; and
6. What individual and collective doses results were expected and the doses actually received in the planned special exposure.
B. Licensees shall retain the records until the agency terminates each pertinent license requiring these records.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-1040. Records of individual monitoring results.
A. Licensees shall maintain records of doses received by all individuals for whom monitoring is required pursuant to 12VAC5-481-760 and records of doses received during planned special exposures, accidents, and emergency conditions. These records shall include, when applicable:
1. The deep dose equivalent to the whole body, lens deep dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities;
2. The estimated intake of radionuclides (see 12VAC5-481-650);
3. The committed effective dose equivalent assigned to the intake of radionuclides;
4. The specific information used to assess the committed effective dose equivalent pursuant to 12VAC5-481-670 A and C and when required by 12VAC5-481-760;
5. The total effective dose equivalent when required by 12VAC5-481-650; and
6. The total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose.
B. Licensees shall make entries of the records specified in subsection A of this section at least annually.
C. Licensees shall maintain the records specified in subsection A of this section in clear and legible records containing all the information required by 12VAC5-481-2280.
D. The records required under this section should be protected from public disclosure because of the personal privacy nature of the records. These records are protected by privacy laws, including when the records are transferred to the agency.
E. Licensees shall maintain the records of dose to an embryo/fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy, including the estimated date of conception, shall also be kept on file, but may be maintained separately from the dose records.
F. Licensees shall retain the required form or record until the agency terminates each pertinent license requiring this 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; Volume 32, Issue 24, eff. August 25, 2016.
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 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.
12VAC5-481-1060. Records of waste disposal.
A. Each licensee or registrant shall maintain records of the disposal of licensed or registered materials made pursuant to 12VAC5-481-920 through 12VAC5-481-950, Part XI (12VAC5-481-2330 et seq.) of this chapter, and disposal by burial in soil, including burials authorized before, September 1, 1980, of the rule that removed the authorization.
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.
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 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.
12VAC5-481-1080. Form of records.
Each record required by Part IV (12VAC5-481-600 et seq.) of this chapter shall be legible throughout the specified retention period. The record shall be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period or the record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
Article 13
Reports
12VAC5-481-1090. Reports of stolen, lost, or missing licensed or registered sources of radiation.
Article 13
Reports
A. Each licensee or registrant shall report to the agency by telephone as follows:
1. Immediately after its occurrence becomes known to the licensee, 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 12VAC5-481-3700;
2. Within 30 days after its occurrence becomes known to the licensee, lost, stolen, or missing licensed or registered radioactive material in an aggregate quantity greater than 10 times the quantity specified in 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.
B. 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.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-1100. Notification of incidents.
A. Notwithstanding any other requirements for notification, licensees shall immediately report each event involving radioactive material possessed by the licensee that may have caused or threatens to cause any of the following conditions:
1. An individual to receive:
a. A total effective dose equivalent of 25 rem (0.25 Sv) or more;
b. A lens dose equivalent of 75 rem (0.75 Sv) or more; or
c. A shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 250 rad (2.5 Gy) or more; and
2. The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake five times the occupational annual limits on intake. The provision of this subdivision does not apply to locations where personnel are not normally stationed during routine operations, such as hot cells or process enclosures.
B. Licensees shall, within 24 hours of discovery of the event, report any event involving loss of control of a licensed material possessed by the licensee that may have caused, or threatened to cause, any of the following conditions:
1. An individual to receive, in a period of 24 hours:
a. A total effective dose equivalent exceeding 5 rem (0.05 Sv);
b. A lens dose equivalent exceeding 15 rem (0.15 Sv); or
c. A shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 50 rem (0.5 Sv); and
2. The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake in excess of one occupational annual limits on intake. The provisions of this subdivision do not apply to locations where personnel are not normally stationed during routine operations, such as hot cells or process enclosures.
C. Licensees shall prepare any report filed with the agency pursuant to this section so that names of individuals who received exposure to radiation or radioactive material are stated in a separate and detachable part of the report.
D. Reports made by licensees in response to the requirements of this section shall be made, via telephone, to the agency at (804) 864-8150 during normal business hours and to the State Emergency Operations Center at (804) 674-2400 after normal business hours.
E. The provisions of this section do not include doses that result from planned special exposures, provided that such doses are within the limits for planned special exposures, and are reported under 12VAC5-481-1120.
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; Volume 32, Issue 24, eff. August 25, 2016; Errata, 39:5 VA.R. 943 October 24, 2022.
12VAC5-481-1110. Reporting requirements.
A. Licensees shall notify the agency as soon as possible but not later than four hours after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits or releases of licensed material that could exceed regulatory limits (events may include fires, explosions, toxic gas releases, etc.). Licensees shall:
1. If required by this subsection and subsection B, notify the agency of any event, via telephone, during normal business hours to (804) 864-8150 or after hours to the State Emergency Operations Center at (804) 674-2400.
2. Submit a written report, either by mail or by hand delivery to the agency at 109 Governor Street, 7th Floor, Richmond, VA 23219.
B. Licensees shall notify the agency within 24 hours after the discovery of any of the following events involving licensed material:
1. An unplanned contamination event that:
a. Requires access to the contaminated area by workers or the public to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area;
b. Involves a quantity of material greater than five times the lowest annual limit on intake specified in Appendix B to 10 CFR Part 20; and
c. Has access to the area restricted for a reason other than to allow isotopes with a half-life of less than 24 hours to decay prior to decontamination.
2. An event in which equipment is disabled or fails to function as designed when:
a. The equipment is required by regulation or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident;
b. The equipment is required to be available and operable when it is disabled or fails to function; and
c. No redundant equipment is available and operable to perform the required safety function.
3. An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body.
4. An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:
a. The quantity of material involved is greater than five times the lowest annual limit on intake specified in Appendix B to 10 CFR Part 20; and
b. The damage affects the integrity of the licensed material or its container.
C. Notifications of any event made by licensees in response to the requirements of subsections A and B of this section shall be made to the agency, via telephone, during normal business hours to (804) 864-8150 or after hours to the State Emergency Operations Center at (804) 674-2400 and provide the following:
1. To the extent that the information is available at the time of the notification, provide a name and call back telephone number;
2. A description of the event, including date and time; if known, the sequence of occurrences leading to the event including degradation or failure of structures, systems, equipment, components; and activities of personnel relied on to prevent potential accidents;
3. The exact location of the event and whether the remaining structures, systems, equipment, components, and activities of personnel relied on to mitigate the consequences are available and reliable to perform their function;
4. Radiological or chemical hazards involved including the isotopes, quantities, and chemical and physical form of the licensed material;
5. Actual or potential health and safety consequences to the workers, the public, and the environment, including relevant chemical and any radiation data for actual personnel exposures to radiation or radioactive materials or hazardous chemicals produced from licensed material;
6. External conditions affecting the event;
7. Status of the event including actions taken by the licensee in response to the event and the current and planned site status;
8. Notification, related to the event, that were made or are planned to be made to any other local, state, or federal agencies; and
9. Status of any press releases related to the event that were made or are planned.
10. Each licensee that makes a report required by subsection A or B of this section shall submit a written follow-up report within 30 days of the initial report. Written reports prepared pursuant to other regulations may be submitted to fulfill this requirement if the report contains all necessary information and the appropriate distribution is made. These written reports must be sent to the agency at 109 Governor Street, 7th Floor, Richmond, VA 23219, and must include the following:
a. All information required from the telephone notification included in this subsection;
b. The probable cause of the event, including all factors that contributed to the event and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned;
c. Corrective actions taken or planned to prevent occurrence of similar or identical events in the future and the results of any evaluations or assessments; and
d. For licenses subject to 10 CFR Part 70 Subpart H, whether the event was identified and evaluated in the integrated safety analysis.
D. In addition to the notifications required by 12VAC5-481-1100 or subsections A and B of this section, each licensee shall submit a written report within 30 days after learning of any of the following occurrences, either by mail or by hand delivery, to the agency at 109 Governor Street, 7th Floor, Richmond, VA 23219:
1. Any incident for which notification is required by 12VAC5-481-1100 or subsections A and B of this section;
2. Doses in excess of any of the following:
a. The occupational dose limits for adults in 12VAC5-481-640;
b. The occupational dose limits for a minor in 12VAC5-481-700;
c. The limits for an embryo/fetus of a declared pregnant woman in 12VAC5-481-710;
d. The limits for an individual member of the public in 12VAC5-481-720;
e. Any applicable limits in the license; or
f. The ALARA constraints for air emissions established under 12VAC5-481-630 D;
3. Levels of radiation or concentrations of radioactive material in:
a. A restricted area in excess of any applicable limit in the license; or
b. An unrestricted area in excess of 10 times any applicable limit set forth in this part or in the license, whether or not involving exposure of any individual in excess of the limits in 12VAC5-481-720; or
4. For licensee subject to the provisions of the U.S. Environmental Protection Agency's generally applicable environmental radiation standards in 40 CFR Part 190, levels of radiation or releases of radioactive materials in excess of those standards, or of license conditions related to those standards.
E. Each report, required by subsection A of this section shall:
1. Describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:
a. A description of the event, including the probable cause, the exact location, the isotopes and quantities, chemical and physical form of the licensed material involved, date and time of the event, and if applicable, the manufacturer and model number of any equipment that failed or malfunctioned;
b. Estimates of each individual's dose;
c. The levels of radiation and concentrations of radioactive material involved;
d. The cause of the elevated exposures, dose rates, or concentrations; and
e. Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints, generally applicable environmental standards, and associated license conditions and the results of all evaluations or assessments.
2. Include for each individual the name, social security number, and date of birth. With respect to the limit for the embryo/fetus, the identifiers should be those of the declared pregnant woman. The report shall be prepared so that this information is stated in a separate and detachable part of the report and shall be clearly labeled for protection under privacy laws.
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; Volume 32, Issue 24, eff. August 25, 2016; Volume 34, Issue 2, eff. October 18, 2017; Errata, 39:5 VA.R. 943 October 24, 2022.
12VAC5-481-1120. Reports of planned special exposures.
The licensee or registrant shall submit a written report to the agency within 30 days following any planned special exposure conducted in accordance with 12VAC5-481-690, informing the agency that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by 12VAC5-481-1030.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
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:
| Radionuclide | Activitya GBq | Ci |
| Cesium-137 | 37 | 1 |
| Cobalt-60 | 37 | 1 |
| Gold-98 | 3,700 | 100 |
| Iodine-131 | 37 | 1 |
| Iridium-192 | 270 | 10 |
| Krypton-85 | 37,000 | 1,000 |
| Promethium-147 | 370 | 10 |
| Technecium-99m | 37,000 | 1,000 |
| aThe agency may require as a license condition, or by rule, regulation, or an order pursuant to 12VAC5-481-190, reports from licensees or registrants who are licensed or registered to use radionuclides not on this list, in quantities sufficient to cause comparable radiation levels. | ||
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 the agency's record of individual monitoring results form or equivalent or electronic media containing all the information required by 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.
12VAC5-481-1140. Notifications and reports to individuals.
A. Requirements for notification and reports to individuals of exposure to radiation or radioactive material are specified in 12VAC5-481-2280.
B. When a licensee or registrant is required pursuant to 12VAC5-481-1110 to report to the agency any exposure of an individual to radiation or radioactive material, the licensee or registrant shall also notify the individual. Such notice shall be transmitted at a time not later than the transmittal to the agency, and shall comply with the provisions of 12VAC5-481-2280 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.
12VAC5-481-1150. Reports of leaking or contaminated sealed sources.
The licensee or registrant shall file a report within five days with the agency if the test for leakage or contamination required pursuant to 12VAC5-481-740 indicates a sealed source is leaking or contaminated. The report shall include the equipment involved, the test results and the corrective action taken.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
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. (Repealed.)
Article 14
Additional Requirements
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 shall 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 shall 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 shall 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 shall 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 shall 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 shall 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. Has provided sufficient financial assurance in the form of a trust fund 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.
3. 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 shall:
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 U.S. 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 Virginia Register of Regulations 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; amended, Virginia Register Volume 32, Issue 24, eff. August 25, 2016.
Part V
Radiation Safety Requirements for Industrial Radiographic Operations
Article 1
General Requirements
12VAC5-481-1170. Purpose.
Article 1
General Requirements
This part prescribes requirements for the issuance of licenses or registrations for the industrial use of sources of radiation and radiation safety requirements for persons using these sources of radiation in industrial radiography.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-1180. Scope.
The provisions and requirements of this part are in addition to, and not in substitution for, other requirements of these regulations. In particular, the general requirements and provisions of Parts I (12VAC5-481-10 et seq.); II (12VAC5-481-260 et seq.); III (12VAC5-481-380 et seq.); IV (12VAC5-481-600 et seq.); X (12VAC5-481-2250 et seq.) and XIII (12VAC5-481-2950 et seq.), of this chapter apply to applicants, licensees and registrants subject to this part. Parts III (12VAC5-481-380 et seq.) and XIII (12VAC5-481-2950 et seq.) of this chapter apply to licensing and transportation of radioactive material and Part II (12VAC5-481-260 et seq.) of this chapter applies to the registration of radiation machines. Except for sections that are applicable only to sealed radioactive sources, radiation machines and sealed radioactive sources are both covered by this part. This regulation does not apply to medical uses of sources of radiation that are addressed in Parts VII (12VAC5-481-1660 et seq.) and XV (12VAC5-481-3380 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.
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, 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, 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 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;
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.
12VAC5-481-1210. Performance requirements for industrial radiography equipment.
A. Equipment used in industrial radiographic operations must meet the following minimum criteria:
Each radiographic exposure device, source assembly or sealed source, and all associated equipment must meet the requirements specified in American National Standard Institute, N432‑1980 "Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography," (published as NBS Handbook 136, issued January 1981). This publication may be purchased from the American National Standards Institute, Inc., 25 West 43rd Street, New York, NY 10036; telephone (212) 642‑4900.
B. In addition to the requirements specified in this section the following requirements apply to radiographic exposure devices, source changers, source assemblies and sealed sources:
1. The licensee shall ensure that each radiographic exposure device has attached to it a durable, legible, clearly visible label bearing the:
a. Chemical symbol and mass number of the radionuclide in the device;
b. Activity and the date on which this activity was last measured;
c. Model or product code and serial number of the sealed source;
d. Name of the manufacturer of the sealed source; and
e. Licensee's name, address, and telephone number.
2. Radiographic exposure devices intended for use as Type B packages must meet the applicable transportation requirements of Part XIII (12VAC5-481-2950 et seq.) of this chapter.
3. Modification of radiographic exposure devices, source changers, and source assemblies and associated equipment is prohibited, unless approved by the agency or other approval body.
C. In addition to the requirements specified in subsections A and B of this section, the following requirements apply to radiographic exposure devices, source assemblies, and associated equipment that allow the source to be moved out of the device for radiographic operations or to source changers:
1. The coupling between the source assembly and the control cable must be designed in such a manner that the source assembly will not become disconnected if cranked outside the guide tube. The coupling must be such that it cannot be unintentionally disconnected under normal and reasonably foreseeable abnormal conditions.
2. The device must automatically secure the source assembly when it is cranked back into the fully shielded position within the device. This securing system may only be released by means of a deliberate operation on the exposure device.
3. The outlet fittings, lock box, and drive cable fittings on each radiographic exposure device must be equipped with safety plugs or covers that must be installed during storage and transportation to protect the source assembly from water, mud, sand or other foreign matter.
4. Each sealed source or source assembly must have attached to it or engraved on it, a durable, legible, visible label with the words:
"DANGER—RADIOACTIVE."
The label may not interfere with the safe operation of the exposure device or associated equipment.
5. The guide tube must be able to withstand a crushing test that closely approximates the crushing forces that are likely to be encountered during use, and be able to withstand a kinking resistance test that closely approximates the kinking forces that are likely to be encountered during use.
6. Guide tubes must be used when moving the source out of the device.
7. An exposure head or similar device designed to prevent the source assembly from passing out of the end of the guide tube must be attached to the outermost end of the guide tube during industrial radiography operations.
8. The guide tube exposure head connection must be able to withstand the tensile test for control units specified in ANSI N432‑1980.
9. Source changers must provide a system for ensuring that the source will not be accidentally withdrawn from the changer when connecting or disconnecting the drive cable to or from a source assembly.
D. All radiographic exposure devices and associated equipment in use after January 10, 1996, must comply with the requirements of this section.
E. As an exception to subsection A of this section, equipment used in industrial radiographic operations need not comply with 8.9.2(c) of the Endurance Test in American National Standards Institute N432‑1980, if the prototype equipment has been tested using a torque value representative of the torque that an individual using the radiography equipment can reasonably exert on the lever or crankshaft of the drive mechanism.
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 33, Issue 11, eff. February 22, 2017.
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 2 mSv (200 mrem) per hour at any exterior surface, and 0.1 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 mSv (2 mrem) per hour through 0.01 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 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 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 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 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 Bq (0.005 μCi) of radioactive material on the test sample and must be performed by a person specifically authorized by the agency, the 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 Bq (0.005 μCi) 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 Bq (0.005 μCi) of radioactive material on the test sample and must be performed by a person specifically authorized by the agency, the 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.
12VAC5-481-1260. Quarterly inventory.
A. Each licensee or registrant shall conduct a quarterly physical inventory to account for all sources of radiation, and for devices containing depleted uranium received and possessed under the license.
B. The licensee or registrant shall maintain records of the quarterly inventory in accordance with 12VAC5-481-1430.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-1270. Inspection and maintenance of radiation machines, radiographic exposure devices, transport and storage containers, associated equipment, source ....
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.
12VAC5-481-1280. Permanent radiographic installations.
A. Each entrance that is used for personnel access to the high radiation area in a permanent radiographic installation must have either:
1. An entrance control of the type described in 12VAC5-481-780 that causes the radiation level upon entry into the area to be reduced; or
2. Both conspicuous visible and audible warning signals to warn of the presence of radiation. The visible signal must be actuated by radiation whenever the source is exposed or the machine is energized. The audible signal must be actuated when an attempt is made to enter the installation while the source is exposed or the machine is energized.
B. The alarm system must be tested for proper operation with a radiation source each day before the installation is used for radiographic operations. The test must include a check of both the visible and audible signals. Entrance control devices that reduce the radiation level upon entry as designated in subdivision A 1 of this section must be tested monthly. If an entrance control device or an alarm is operating improperly, it must be immediately labeled as defective and repaired within seven calendar days. The facility may continue to be used during this seven-day period, provided the licensee or registrant implements the continuous surveillance requirements of 12VAC5-481-1370 and uses an alarming ratemeter. Test records for entrance controls and audible and visual alarms must be maintained in accordance with 12VAC5-481-1460.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-1290. Labeling, storage, and transportation.
A. Licensees may not use a source changer or a container to store radioactive material unless the source changer or the storage container has securely attached to it a durable, legible, and clearly visible label bearing the standard trefoil radiation caution symbol conventional colors, i.e., magenta, purple, or black on a yellow background, having a minimum diameter of 25 mm, and the wording:
CAUTION *
RADIOACTIVE MATERIAL
NOTIFY CIVIL AUTHORITIES (or "NAME OF COMPANY")
* ——or "DANGER"
B. Licensees may not transport radioactive material unless the material is packaged, and the package is labeled, marked, and accompanied with appropriate shipping papers in accordance with regulations set out in Part XIII (12VAC5-481-2950 et seq.) of this chapter.
C. Radiographic exposure devices, source changers, storage containers, and radiation machines, shall be physically secured to prevent tampering or removal by unauthorized personnel. The licensee shall store radioactive material in a manner that will minimize danger from explosion or fire.
D. Licensees shall lock and physically secure the transport package containing radioactive material in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal.
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 32, Issue 24, eff. August 25, 2016.
Article 2
Radiation Safety Requirements
12VAC5-481-1300. Conducting industrial radiographic operations.
Article 2
Radiation Safety Requirements
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 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.
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 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 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).
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 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 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 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, writtenand 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.
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.
12VAC5-481-1330. Operating and emergency procedures.
A. Operating and emergency procedures must include, as a minimum, instructions in the following:
1. Appropriate handling and use of sources of radiation so that no person is likely to be exposed to radiation doses in excess of the limits established in Part IV (12VAC5-481-600 et seq.) of this chapter;
2. Methods and occasions for conducting radiation surveys;
3. Methods for posting and controlling access to radiographic areas;
4. Methods and occasions for locking and securing sources of radiation;
5. Personnel monitoring and the use of personnel monitoring equipment;
6. Transporting equipment to field locations, including packing of radiographic exposure devices and storage containers in the vehicles, placarding of vehicles when required, and control of the equipment during transportation as described in Part XIII (12VAC5-481-2950 et seq.) of this chapter;
7. The inspection, maintenance, and operability checks of radiographic exposure devices, radiation machines, survey instruments, alarming ratemeters, transport containers, and storage containers;
8. Steps that must be taken immediately by radiography personnel in the event a pocket dosimeter is found to be off-scale or an alarming ratemeter alarms unexpectedly;
9. The procedure(s) for identifying and reporting defects and noncompliance, as required by 12VAC5-481-1530;
10. The procedure for notifying proper persons in the event of an accident or incident;
11. Minimizing exposure of persons in the event of an accident or incident, including a source disconnect, a transport accident, or loss of a source of radiation;
12. Source recovery procedure if licensee will perform source recoveries; and
13. Maintenance of records.
B. The licensee or registrant shall maintain copies of current operating and emergency procedures in accordance with 12VAC5-481-1480 and 12VAC5-481-1520.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-1340. Supervision of radiographer's assistants.
The radiographer's assistant shall be under the personal supervision of a radiographer when using sources of radiation or conducting radiation surveys required by subdivision 2 of 12VAC5-481-1360 to determine that the sealed source has returned to the shielded position or the radiation machine is off after an exposure. The personal supervision must include:
1. The radiographer's physical presence at the site where the sources of radiation are being used;
2. The availability of the radiographer to give immediate assistance if required; and
3. The radiographer's direct observation of the assistant's performance of the operations referred to 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.
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 direct reading dosimeter, an operating alarming ratemeter, and a personnel dosimeter. At permanent radiographic installations where other appropriate alarming or warning devices are in routine use, or during radiographic operations using radiation machines, the wearing of an alarming ratemeter is not required.
1. Pocket dosimeters must have a range from 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 personnel dosimeter must be assigned to and worn by only one individual.
3. Film badges must be exchanged monthly, and all other dosimeters that require replacement must be exchanged at periods not to exceed three months. All personnel dosimeters must be evaluated at periods not to exceed three months or promptly after replacement, whichever is more frequent.
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 2 mSv (200 mrem), the individual's personnel dosimeter must be sent for processing within 24 hours. For personnel dosimeters that do not require processing, evaluation of the dosimeter must be started 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 the personnel dosimeter is lost or damaged, the worker shall cease work immediately until a replacement personnel dosimeter meeting the requirements of subsection A of this section is provided and the exposure is calculated for the time period from issuance to loss or damage of the personnel dosimeter. The results of the calculated exposure and the time period for which the personnel dosimeter was lost or damaged must be included in the records maintained in accordance with 12VAC5-481-1490.
F. Dosimetry results 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 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; Volume 37, Issue 25, eff. January 14, 2022.
12VAC5-481-1360. Radiation surveys.
The licensee or registrant shall:
1. Conduct all surveys with a calibrated and operable radiation survey instrument that meets the requirements of 12VAC5-481-1240;
2. Conduct a survey of the radiographic exposure device and the guide tube after each exposure when approaching the device or the guide tube. The survey must determine that the sealed source has returned to its shielded position before exchanging films, repositioning the exposure head, or dismantling equipment. Radiation machines shall be surveyed after each exposure to determine that the machine is off;
3. Conduct a survey of the radiographic exposure device whenever the source is exchanged and whenever a radiographic exposure device is placed in a storage area, as defined in 12VAC5-481-10, to ensure that the sealed source is in its shielded position; and
4. Maintain records in accordance with 12VAC5-481-1500.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-1370. Surveillance.
During each radiographic operation, the radiographer shall ensure continuous direct visual surveillance of the operation to protect against unauthorized entry into a radiation area or a high radiation area, as defined in Part I (12VAC5-481-10 et seq.) of this chapter, except at permanent radiographic installations where all entryways are locked and the requirements of 12VAC5-481-1280 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.
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 12VAC5-481-870 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.
Article 3
Recordkeeping Requirements
12VAC5-481-1390. Records for industrial radiography.
Article 3
Recordkeeping Requirements
Each licensee or registrant shall maintain a copy of its license or registration, documents incorporated by reference, and amendments to each of these items until superseded by new documents approved by the agency, or 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.
12VAC5-481-1400. Records of receipt and transfer of sources of radiation.
A. Each licensee or registrant shall maintain records showing the receipts and transfers of sealed sources, devices using DU for shielding, and radiation machines, and retain each record for three years after it is made.
B. These records must include the date, the name of the individual making the record, radionuclide, number of becquerels (curies) or mass (for DU), and manufacturer, model, and serial number of each source of radiation and/or device, as appropriate.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-1410. Records of radiation survey instruments.
Each licensee or registrant shall maintain records of the calibrations of its radiation survey instruments that are required under 12VAC5-481-1240 and retain each record for three years after it 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.
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 (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.
12VAC5-481-1430. Records of quarterly inventory.
A. Each licensee or registrant shall maintain records of the quarterly inventory of sources of radiation, including devices containing depleted uranium as required by 12VAC5-481-1260, and retain each record for three years.
B. The record must include the date of the inventory, name of the individual conducting the inventory, radionuclide, number of becquerels (curies) or mass (for DU) in each device, location of sources of radiation and/or devices, and manufacturer, model, and serial number of each source of radiation and/or device, as appropriate.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
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 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.
12VAC5-481-1450. Records of inspection and maintenance of radiation machines, radiographic exposure devices, transport and storage containers, associated equipment,....
A. Each licensee or registrant shall maintain records specified in 12VAC5-481-1270 of equipment problems found in daily checks and quarterly inspections of radiation machines, radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments, and retain each record for three years after it is made.
B. The record must include the date of check or inspection, name of inspector, equipment involved, any problems found, and what repair and/or maintenance, if any, was performed.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-1460. Records of alarm system and entrance control checks at permanent radiographic installations.
Each licensee or registrant shall maintain records of alarm system and entrance control tests required by 12VAC5-481-1280 and retain each record for three years after it 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.
12VAC5-481-1470. Records of training and certification.
Each licensee or registrant shall maintain the following records for three years:
1. Records of training of each radiographer and each radiographer's assistant. The record must include radiographer certification documents and verification of certification status, copies of written tests, dates of oral and practical examinations, the names of individuals conducting and receiving the oral and practical examinations, and a list of items tested and the results of the oral and practical examinations; and
2. Records of annual refresher safety training and semi-annual inspections of job performance for each radiographer and each radiographer's assistant. The records must list the topics discussed during the refresher safety training, the dates the annual refresher safety training was conducted, and names of the instructors and attendees. For inspections of job performance, the records must also include a list showing the items checked and any noncompliance observed by the radiation safety officer or designee.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-1480. Copies of operating and emergency procedures.
Each licensee or registrant shall maintain a copy of current operating and emergency procedures until the agency terminates the license or registration. Superseded material must be retained for three years after the change 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.
12VAC5-481-1490. Records of personnel monitoring.
Each licensee or registrant shall maintain the following exposure records specified in 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. Personnel dosimeter results 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 personnel dosimeters 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; Volume 37, Issue 25, eff. January 14, 2022.
12VAC5-481-1500. Records of radiation surveys.
Each licensee shall maintain a record of each exposure device survey conducted before the device is placed in storage as specified in subdivision 3 of 12VAC5-481-1360. Each record must be maintained for three years after it 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.
12VAC5-481-1510. Form of records.
Each record required by this part must be legible throughout the specified retention period. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of reproducing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, must include all pertinent information, such as stamps, initials, and signatures. The licensee or registrant shall maintain adequate safeguards against tampering with and loss of records.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
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 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 4
Notifications
12VAC5-481-1530. Notifications.
Article 4
Notifications
A. In addition to the reporting requirements specified in 12VAC5-481-1110 and in Part IV (12VAC5-481-600 et seq.) of this chapter, each licensee or registrant shall provide a written report to the agency within 30 days of the occurrence of any of the following incidents involving radiographic equipment:
1. Unintentional disconnection of the source assembly from the control cable;
2. Inability to retract the source assembly to its fully shielded position and secure it in this position;
3. Failure of any component, which is critical to safe operation of the device, to properly perform its intended function; or
4. An indicator on a radiation machine fails to show that radiation is being produced, an exposure switch fails to terminate production of radiation when turned to the off position, or a safety interlock fails to terminate X-ray production.
B. The licensee or registrant shall include the following information in each report submitted under subsection A of this section, and in each report of overexposure submitted under 12VAC5-481-1110 that involves failure of safety components of radiography equipment:
1. Description of the equipment problem;
2. Cause of each incident, if known;
3. Name of the manufacturer and model number of equipment involved in the incident;
4. Place, date, and time of the incident;
5. Actions taken to establish normal operations;
6. Corrective actions taken or planned to prevent recurrence; and
7. Names and qualifications of personnel involved in the incident.
C. Any licensee or registrant conducting radiographic operations or storing sources of radiation at any location not listed on the license or registration for a period in excess of 180 days in a calendar year shall notify the agency prior to exceeding the 180 days.
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 32, Issue 24, eff. August 25, 2016.
Article 5
Jobsite Requirements
12VAC5-481-1540. (Repealed.)
Article 5
Jobsite Requirements
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. (Repealed.)
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.
12VAC5-481-1560. 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 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 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.
Part VI
Use of Diagnostic X-Rays in the Healing Arts
12VAC5-481-1580. (Repealed.)
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-1581. Purpose and scope.
This part establishes requirements, for which a registrant is responsible, for use of diagnostic x-ray equipment and imaging systems by or under the supervision of an individual authorized by and licensed in accordance with Virginia law to engage in the healing arts or veterinary medicine. The provisions of this part are in addition to and not in substitution for other applicable provisions of this chapter.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-1590. (Repealed.)
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-1591. General and administrative requirements.
A. Radiation safety requirements. The registrant shall be responsible for directing the operation of the x-ray system under his administrative control. The registrant or the registrant's agent shall assure that the requirements of this chapter are met in the operation of the x-ray system or systems.
1. An x-ray system that does not meet the provisions of this chapter shall not be operated for diagnostic purposes.
2. Individuals who will be operating the x-ray systems shall meet the qualifications of this part to conduct the practice of radiologic technology.
3. A chart shall be provided in the vicinity of the diagnostic x-ray system's control panel that specifies, for all examinations performed with that system, the following information:
a. Patient's body part and anatomical size, or body part thickness, or age (for pediatrics), versus technique factors to be utilized;
b. Type and size of the image receptor to be used;
c. Type and size of the image receptor combination to be used, if any;
d. Source to image receptor distance to be used (except for dental intraoral radiography);
e. Type and location of placement of patient shielding (e.g., gonad, etc.) to be used; and
f. For mammography, indication of kVp/target/filter combination.
4. The registrant of a facility shall create and make available to x-ray operators written safety procedures, including patient holding and any restrictions of the operating technique required for the safe operation of the particular x-ray system. The operator shall be able to demonstrate familiarity with these procedures.
5. Except for patients who cannot be moved out of the room, only the staff, ancillary personnel, or other persons required for the medical procedure or training shall be in the room during the radiographic exposure. Other than the patient being examined:
a. All individuals shall be positioned such that no part of the body will be struck by the useful beam unless protected by not less than 0.5 mm lead equivalent material;
b. The x-ray operator, other staff, ancillary personnel, and other persons required for the medical procedure shall be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 mm lead equivalent material. However, when distances provide sufficient protection from scatter radiation, or for low dose rate devices such as bone densitometry equipment, no protective devices may be necessary; and
c. Human patients who cannot be removed from the room shall be protected from the direct scatter radiation by whole body protective barriers of not less than 0.25 mm lead equivalent material or shall be so positioned that the nearest portion of the body is at least two meters from both the tube head and the nearest edge of the image receptor.
6. Gonad shielding of not less than 0.5 mm lead equivalent material shall be used for human patients, who have not passed the reproductive age, during radiographic procedures in which the gonads are in the useful beam, except for cases in which this would interfere with the diagnostic procedure.
7. Individuals shall not be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure for the following purposes:
a. Exposure of an individual for training, demonstration, or other non-healing arts purposes; and
b. Exposure of an individual for the purpose of healing arts screening except as authorized by subdivision 11 of this subsection.
8. When a patient or image receptor must be provided with auxiliary support during a radiation exposure:
a. Mechanical holding devices shall be used when the technique permits. The written safety procedures, as required by subdivision 4 of this subsection, shall list individual projections where holding devices cannot be utilized;
b. Written safety procedures, as required by subdivision 4 of this subsection, shall indicate the requirements for selecting a holder and the procedure the holder shall follow;
c. The human holder shall be instructed in personal radiation safety and protected as required by subdivision 5 of this subsection. Caregivers who stay in the room to assist with imaging of patients shall be positioned and instructed to keep the protective apron between themselves and the patient;
d. No individual shall be used routinely to hold image receptors or patients;
e. In those cases where the patient must hold the image receptor, except during intraoral examinations, any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than 0.5 mm lead equivalent material; and
f. Each facility shall have leaded aprons and gloves available in sufficient numbers to provide protection for all personnel who are involved with x-ray operations and who are otherwise not shielded.
9. Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized.
a. The fastest imaging system consistent with the diagnostic objective of the examinations shall be used. Film cassettes without intensifying screens shall not be used for any routine diagnostic radiological imaging, with the exception of veterinary radiography and standard film packets for intraoral use in dental radiography.
b. The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality.
c. Portable or mobile radiographic (exclude fluoroscopic) x-ray equipment shall be used only for examinations where it is impractical to transfer the patient to a stationary x-ray installation.
d. X-ray systems subject to 12VAC5-481-1621 shall not be utilized in procedures where the source to patient distance is less than 30 cm, except for veterinary systems.
e. If grids are used between the patient and the image receptor to decrease scatter to the film and improve contrast, the grid shall:
(1) Be positioned properly, that is, tube side facing the right direction, and grid centered to the central ray; and
(2) If the grid is of the focused type, be of the proper focal distance for the SIDs being used.
10. All individuals who are associated with the operation of an x-ray system are subject to the requirements of 12VAC5-481-640, 12VAC5-481-700, and 12VAC5-481-710.
11. Any person proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the agency. If any information submitted to the agency becomes invalid or outdated, the agency shall be immediately notified. Persons requesting that the agency approve a healing arts screening program shall submit the following information and evaluation:
a. Name and address of the applicant and, where applicable, the names and addresses of agents within this state;
b. Diseases or conditions for which the x-ray examinations are to be used in diagnoses;
c. A description of the x-ray examinations proposed in the screening program, that is, type and number of views;
d. Description of the population to be examined in the screening program, that is, age range, sex, physical condition, and other appropriate information;
e. An evaluation of any known alternate methods not involving ionizing radiation that could achieve the goals of the screening program and why these methods are not used instead of the x-ray examinations;
f. An evaluation by a qualified medical physicist of the x-ray system or systems to be used in the screening program. The evaluation shall include the following:
(1) Documentation that such systems satisfy all requirements of this chapter; and
(2) Measurement of patient exposures from the x-ray examinations to be performed;
g. A description of the diagnostic x-ray quality control program;
h. A copy of the technique chart for the x-ray examination procedures to be used;
i. The qualifications of each individual who will be operating the x-ray system or systems;
j. The qualifications of the individual who will be supervising the operators of the x-ray system or systems. The extent of supervision and the method of work performance evaluation shall be specified;
k. The name and address of the practitioner licensed in the state who will interpret the radiograph;
l. Procedures to be used in advising the individuals screened and their practitioners of the healing arts or health care providers of the results of the screening procedure and any further medical needs indicated;
m. Procedures for the retention or disposition of the radiographs and other records pertaining to the x-ray examinations;
n. Frequency of screening of individuals; and
o. The duration of the screening program.
12. The registrant shall maintain the following information and maintenance record for each x-ray system for inspection by the agency:
a. Model and serial numbers of all major components, and user's manuals for those components;
b. Tube rating charts and cooling curves;
c. Records of surveys, calibrations, maintenance, and modifications performed on the x-ray system or systems; and
d. A copy of all correspondence with the agency regarding that x-ray system.
13. Except for veterinary facilities, each facility shall maintain an x-ray utilization log containing the patient's name, the type of examination, and the date the examination was performed.
14. The registrant shall maintain a list of x-ray operators for each facility. Operators must be licensed by the Department of Health Professions where x-rays are used within the scope of practice or be certified by the American Registry of Radiological Technologists (ARRT), or be an individual enrolled, or was enrolled within the past three months, in an accredited program for radiologic technology and under the supervision of a licensed or certified radiological technologist, or if a dental assistant, comply with the Board of Dentistry's radiation certification requirements in 18VAC60-20-195.
B. X-ray film processing facilities and practices.
1. Each installation using a radiographic x-ray system and analog image receptors (e.g., radiographic film) shall have available suitable equipment for handling and processing radiographic film in accordance with the following provisions:
a. Manually developed film.
(1) Processing tanks shall be constructed of mechanically rigid, corrosion resistant material; and
(2) The temperature of solutions in the tanks shall be maintained within the range of 60°F to 80°F (16°C to 27°C). Film shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer or, in the absence of such recommendations, with the following time-temperature chart:
|
| Time-Temperature Chart | ||
|
| Thermometer Reading (Degrees) | Minimum Developing Time (Minutes) | |
|
| °C | °F |
|
|
| 26.7 | 80 | 2 |
|
| 26.1 | 79 | 2 |
|
| 25.6 | 78 | 2-1/2 |
|
| 25.0 | 77 | 2-1/2 |
|
| 24.4 | 76 | 3 |
|
| 23.9 | 75 | 3 |
|
| 23.3 | 74 | 3-1/2 |
|
| 22.8 | 73 | 3-1/2 |
|
| 22.2 | 72 | 4 |
|
| 21.7 | 71 | 4 |
|
| 21.1 | 70 | 4-1/2 |
|
| 20.6 | 69 | 4-1/2 |
|
| 20.0 | 68 | 5 |
|
| 19.4 | 67 | 5-1/2 |
|
| 18.9 | 66 | 5-1/2 |
|
| 18.3 | 65 | 6 |
|
| 17.8 | 64 | 6-1/2 |
|
| 17.2 | 63 | 7 |
|
| 16.7 | 62 | 8 |
|
| 16.1 | 61 | 8-1/2 |
|
| 15.6 | 60 | 9-1/2 |
(3) Devices shall be utilized that will indicate the actual temperature of the developer and signal the passage of a preset time appropriate to the developing time required.
b. Automatic processors and other closed processing systems. Films shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer. In the absence of such recommendations, the film shall be developed using the following chart:
|
| Developer Temperature | Minimum Immersion Time* | |
|
| °C | °F | Seconds |
|
| 35.5 | 96 | 19 |
|
| 35 | 95 | 20 |
|
| 34.5 | 94 | 21 |
|
| 34 | 93 | 22 |
|
| 33.5 | 92 | 23 |
|
| 33 | 91 | 24 |
|
| 32 | 90 | 25 |
|
| 31.5 | 89 | 26 |
|
| 31 | 88 | 27 |
|
| 30.5 | 87 | 28 |
|
| 30 | 86 | 29 |
|
| 29.5 | 85 | 30 |
|
| *Immersion time only, no crossover time included. | ||
Processing deviations from the requirements of this subdivision shall be documented by the registrant in such manner that the requirements are shown to be met or exceeded (e.g., extended processing and special rapid chemistry).
2. Other requirements.
a. Pass boxes, if provided, shall be so constructed as to exclude light from the darkroom when cassettes are placed in or removed from the boxes and shall incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film.
b. The darkroom shall be light tight and use proper safelighting such that any film type in use exposed in a cassette to x-ray radiation sufficient to produce an optical density from one to two when processed shall not suffer an increase in density greater than 0.1 (0.05 for mammography) when exposed in the darkroom for two minutes with all safelights on. If used, daylight film handling boxes shall preclude fogging of the film.
c. Darkrooms typically used by more than one individual shall be provided a method to prevent accidental entry while undeveloped films are being handled or processed.
d. Film shall be stored in a cool, dry place and shall be protected from exposure to stray radiation. Film in open packages shall be stored in a light tight container.
e. Film cassettes and intensifying screens shall be inspected periodically and shall be cleaned and replaced as necessary to best assure radiographs of good diagnostic quality.
f. Outdated x-ray film shall not be used for diagnostic radiographs, unless the film has been stored in accordance with the manufacturer's recommendations and a sample of the film passes a sensitometric test for normal ranges of base plus fog and speed.
g. Film developing solutions shall be prepared in accordance with the directions given by the manufacturer and shall be maintained in strength by replenishment or renewal so that full development is accomplished within the time specified by the manufacturer.
h. Living and deceased patients' diagnostic images shall be maintained for a minimum of five years. Diagnostic images for minors shall be maintained for a minimum of five years beyond their 18th birthday.
C. The registrant shall submit to the agency a copy of all surveys, calibrations, and inspections performed by a private inspector within 30 days of completion of the survey, calibration, or inspection.
D. The private inspector shall provide the inspection report to the registrant within 14 days of the completion of the inspection. A summary or recommendation shall be included with this report. The inspector shall notify the registrant of any noncompliances that need corrective action.
E. Violations identified as "serious" must be corrected within 30 days. Certification of the unit will not be issued until the violation is corrected. Violations identified as "non-serious" shall be corrected before the next inspection cycle. Uncorrected "non-serious" violations will become "serious" and require immediate correction.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-1600. (Repealed.)
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-1601. General requirements for all diagnostic x-ray systems.
In addition to other requirements of this part, all diagnostic x-ray systems shall meet the following requirements:
1. Warning label. The control panel containing the main power switch shall bear the warning statement, legible and accessible to view:
"WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions, and maintenance schedules are observed."
2. Leakage radiation from the diagnostic source assembly. The leakage radiation from the diagnostic source assembly measured at a distance of one meter in any direction from the source shall not exceed 0.88 milligray (mGy) air kerma (100 milliroentgen (mR) exposure) in one hour when the x-ray tube is operated at its leakage technique factors. If the maximum rated peak tube potential of the tube housing assembly is greater than the maximum rated peak tube potential for the diagnostic source assembly, positive means shall be provided to limit the maximum x-ray tube potential to that of the diagnostic source assembly. Compliance shall be determined by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm.
3. Radiation from components other than the diagnostic source assembly. The radiation emitted by a component other than the diagnostic source assembly shall not exceed an air kerma of 18 microgray (two milliroentgens exposure) in one hour at five cm from any accessible surface of the component when it is operated in an assembled x-ray system under any conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm.
4. Beam quality half-value layer (HVL).
a. The HVL of the useful beam for a given x-ray tube potential shall not be less than the values shown in Table 1 (i) under the heading "Specified Dental Systems" for any dental x-ray system designed for use with intraoral image receptors and manufactured after December 1, 1980; (ii) under the heading "I-Other X-Ray Systems" for any dental x-ray system designed for use with intraoral image receptors and manufactured before or on December 1, 1980, and all other x-ray systems subject to this section and manufactured before June 10, 2006; and (iii) under the heading "II-Other X-Ray Systems" for all x-ray systems, except dental x-ray systems designed for use with intraoral image receptors, subject to this section and manufactured on or after June 10, 2006. If it is necessary to determine such half-value layer at an x-ray tube potential that is not listed in Table 1, linear interpolation or extrapolation may be made. Positive means shall be provided to ensure that at least the minimum filtration needed to achieve beam quality requirements is in the useful beam during each exposure. In the case of a system, which is to be operated with more than one thickness of filtration, this requirement can be met by a filter interlocked with the kilovoltage selector that will prevent x-ray emissions if the minimum required filtration is not in place.
|
| TABLE 1 | ||||
|
| X-Ray Tube Voltage (kilovolt peak) | ||||
|
| Design Operating Range | Measured Operating Potential | Minimum HVL (mm in Aluminum) | ||
|
| Specified Dental Systems1 | I-Other X-Ray Systems2 | II-Other X-Ray Systems3 | ||
|
| Below 51 | 30 | 1.5 | 0.3 | 0.3 |
|
|
| 40 | 1.5 | 0.4 | 0.4 |
|
|
| 50 | 1.5 | 0.5 | 0.5 |
|
| 51 to 70 | 51 | 1.5 | 1.2 | 1.3 |
|
|
| 60 | 1.5 | 1.3 | 1.5 |
|
|
| 70 | 1.5 | 1.5 | 1.8 |
|
| Above 70 | 71 | 2.1 | 2.1 | 2.5 |
|
|
| 80 | 2.3 | 2.3 | 2.9 |
|
|
| 90 | 2.5 | 2.5 | 3.2 |
|
|
| 100 | 2.7 | 2.7 | 3.6 |
|
|
| 110 | 3.0 | 3.0 | 3.9 |
|
|
| 120 | 3.2 | 3.2 | 4.3 |
|
|
| 130 | 3.5 | 3.5 | 4.7 |
|
|
| 140 | 3.8 | 3.8 | 5.0 |
|
|
| 150 | 4.1 | 4.1 | 5.4 |
|
| 1 Dental x-ray systems designed for use with intraoral image receptors and manufactured after December 1, 1980. 2 Dental x-ray systems designed for use with intraoral image receptors and manufactured before or on December 1, 1980, and all other x-ray systems subject to this section and manufactured before June 10, 2006. 3 All x-ray systems, except dental x-ray systems designed for use with intraoral image receptors, subject to this section and manufactured on or after June 10, 2006. | ||||
b. Optional filtration. Fluoroscopic systems manufactured on or after June 10, 2006, incorporating an x-ray tube or tubes with a continuous output of one kilowatt or more and an anode heat storage capacity of one million heat units or more shall provide the option of adding x-ray filtration to the diagnostic source assembly in addition to the amount needed to meet the half-value layer provisions in Table 1. The selection of this additional x-ray filtration shall be either at the option of the user or automatic as part of the selected mode of operation. A means of indicating which combination of additional filtration is in the x-ray beam shall be provided.
c. Measuring compliance. For capacitor energy storage equipment, compliance shall be determined with the maximum selectable quantity of charge per exposure.
5. Aluminum equivalent of material between patient and image receptor. Except when used in a CT x-ray system, the aluminum equivalent of each of the items listed in Table 2, which are used between the patient and the image receptor, shall not exceed the indicated limits. Compliance shall be determined by x-ray measurements made at a potential of 100 kilovolts peak and with an x-ray beam that has an HVL specified in Table 1 for the potential. This requirement applies to front panel or panels of cassette holders and film changers provided by the manufacturer for patient support or for prevention of foreign object intrusions. It does not apply to screens and their associated mechanical support panels or grids.
|
| TABLE 2 | |
|
| Item | Maximum Aluminum Equivalent (mm) |
|
| Front panel(s) of cassette holders (total of all) | 1.2 |
|
| Film panel(s) of film changer (total of all) | 1.2 |
|
| Cradle | 2.3 |
|
| Tabletop, stationary, without articulated joints | 1.2 |
|
| Tabletop, movable, without articulated joints (including stationary subtop) | 1.7 |
|
| Tabletop, with radiolucent panel having one articulated joint | 1.7 |
|
| Tabletop, with radiolucent panel having two or more articulated joints | 2.3 |
|
| Tabletop, cantilevered | 2.3 |
|
| Tabletop, radiation therapy simulator | 5.0 |
6. Battery charge indicator. On battery-powered generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.
7. Modification of certified diagnostic x-ray components and systems.
a. Diagnostic x-ray components and systems certified in accordance with 21 CFR Part 1020 shall not be modified such that the component or system fails to comply with any applicable provision of this part.
b. The owner of a diagnostic x-ray system who uses the system in a professional or commercial capacity may modify the system provided the modification does not result in the failure of the system or a component to comply with the applicable requirements of this part. The owner who causes such modification need not submit the reports required by this part, provided the owner records the date and the details of the modification in the system records and maintains this information, and provided the modification of the x-ray system does not result in a failure to comply with this part.
8. Multiple tubes. Where two or more radiographic tubes are controlled by one exposure switch, the tube or tubes that have been selected shall be clearly indicated prior to initiation of the exposure. This indication shall be both on the x-ray control panel and at or near the tube housing assembly which has been selected.
9. Mechanical support of tube head. The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the x-ray system.
10. Technique indicators.
a. For x-ray equipment capable of displaying technique factors, the technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exposure controls are used, the technique factors that are set prior to the exposure shall be indicated.
b. The requirement of subdivision 10 a of this subsection may be met by permanent markings on equipment having fixed technique factors. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist.
11. Maintaining compliance. Diagnostic x-ray systems and their associated components used on humans and certified pursuant to the Federal X-Ray Equipment Performance Standard (21 CFR Part 1020) shall be maintained in compliance with applicable requirements of that standard.
12. Locks. All position locking, holding, and centering devices on x-ray system components and systems shall function as intended.
13. Mechanical timers. The use of mechanical timers is prohibited.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-1610. (Repealed.)
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-1611. Fluoroscopic equipment.
A. The provisions of this section apply to equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, except computed tomography x-ray systems manufactured on or after November 29, 1984.
B. Primary protective barrier.
1. Limitation of useful beam. The fluoroscopic imaging assembly shall be provided with a primary protective barrier that intercepts the entire cross section of the useful beam at any SID. The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in position to intercept the entire useful beam. The AKR due to transmission through the barrier with the attenuation block in the useful beam combined with radiation from the fluoroscopic imaging receptor shall not exceed 3.34x10-3% of the entrance AKR, at a distance of 10 cm from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor. Radiation therapy simulation systems shall be exempt from this requirement provided the systems are intended only for remote control operation.
2. Measuring compliance. The AKR shall be measured in accordance with subsection E of this section. The AKR due to transmission through the primary barrier combined with radiation from the fluoroscopic image receptor shall be determined by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm. If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 cm above the tabletop. If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 cm. Movable grids and compression devices shall be removed from the useful beam during the measurement. For all measurements, the attenuation block shall be positioned in the useful beam 10 cm from the point of measurement of entrance AKR and between this point and the input surface of the fluoroscopic imaging assembly.
C. Field limitation.
1. Angulation. For fluoroscopic equipment manufactured after February 25, 1978, when the angle between the image receptor and the beam axis of the x-ray beam is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor. Compliance with subdivisions 4 and 5 of this subsection shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.
2. Further means for limitation. Means shall be provided to permit further limitation of the x-ray field to sizes smaller than the limits of subdivisions 4 and 5 of this subsection. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID or capability of a visible area of greater than 300 square cm, shall be provided with means for stepless adjustment of the x-ray field. Equipment with a fixed SID and the capability of a visible area of no greater than 300 square cm shall be provided with either stepless adjustment of the x-ray field or with a means to further limit the x-ray field size at the plane of the image receptor to 125 square cm or less. Stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size containable in a square of five cm by five cm. This paragraph does not apply to non-image-intensified fluoroscopy.
3. Non-image-intensified fluoroscopy. The x-ray field produced by non-image-intensified fluoroscopic equipment shall not extend beyond the entire visible area of the image receptor. Means shall be provided for stepless adjustment of field size. The minimum field size, at the greatest SID, shall be containable in a square of five cm by five cm.
4. Fluoroscopy and radiography using the fluoroscopic imaging assembly with inherently circular image receptors.
a. For fluoroscopic equipment manufactured before June 10, 2006, other than radiation therapy simulation systems, the following applies:
(1) Neither the length nor width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3.0% of the SID. The sum of the excess length and the excess width shall be no greater than 4.0% of the SID.
(2) For rectangular x-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the x-ray field that pass through the center of the visible area of the image receptor.
b. For fluoroscopic equipment manufactured on or after June 10, 2006, other than radiation simulation systems, the maximum area of the x-ray field in the plane of the image receptor shall conform with one of the following requirements:
(1) When any linear dimension of the visible area of the image receptor measured through the center of the visible area is less than or equal to 34 cm in any direction, at least 80% of the area of the x-ray field overlaps the visible area of the image receptor; or
(2) When any linear dimension of the visible area of the image receptor measured through the center of the visible area is greater than 34 cm in any direction, the x-ray field measured along the direction of greatest misalignment with the visible area of the image receptor does not extend beyond the edge of the visible area of the image receptor by more than two cm.
5. Fluoroscopy and radiography using fluoroscopic imaging assembly with inherently rectangular image receptors. For x-ray systems manufactured on or after June 10, 2006, the following applies:
a. Neither the length nor width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3.0% of the SID. The sum of the excess length and the excess width shall be no greater than 4.0% of the SID.
b. The error in alignment shall be determined along the length and width dimensions of the x-ray field that pass through the center of the visible area of the image receptor.
If the fluoroscopic x-ray field size is adjusted automatically as the SID or image receptor size is changed, a capability may be provided for overriding the automatic adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position shall indicate whenever the automatic field adjustment is overridden. Each such system failure override switch shall be clearly labeled as follows:
"For X-Ray Field Limitation System Failure"
D. Activation of tube. X-ray production in the fluoroscopic mode shall be controlled by a device that requires continuous pressure by the operator for the entire time of any exposure. When recording serial radiographic images from the fluoroscopic image receptor, the operator shall be able to terminate the x-ray exposure or exposures at any time, but means may be provided to permit completion of any single exposure of the series in process.
E. Air kerma rates. For fluoroscopic equipment, the following requirements apply:
1. Fluoroscopic equipment manufactured before May 19, 1995.
a. Equipment provided with automatic exposure rate control (AERC) shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (10 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection, except as specified in subdivision 1 e of this subsection.
b. Equipment provided without AERC shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 44 mGy per minute (5 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection, except as specified in subdivision 1 e of this subsection.
c. Equipment provided with both an AERC mode and a manual mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (10 R/min exposure rate) in either mode at the measurement point specified in subdivision 3 of this subsection, except as specified in subdivision 1 e of this subsection.
d. Equipment may be modified in accordance with this part to comply with subdivision 2 of this subsection. When the equipment is modified, it shall bear a label indicating the date of the modification and the statement:
"Modified to comply with 21 CFR 1020.32(h)(2)"
e. Exceptions:
(1) During recording of fluoroscopic images; or
(2) When a mode of operation has an optional high-level control, in which case that mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of any of the rates specified in subdivisions 1 a, b, and c of this subsection at the measurement point specified in subdivision 3 of this subsection, unless the high-level control is activated. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed.
2. Fluoroscopic equipment manufactured on or after May 19, 1995.
a. Equipment shall be equipped with AERC if operable at any combination of tube potential and current that results in an AKR greater than 44 mGy per minute (5 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection. Provision or manual selection of technique factors may be provided.
b. Equipment shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (10 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection, except as specified in subdivision 2 c of this subsection.
c. Exceptions:
(1) For equipment manufactured prior to June 10, 2006, during the recording of images from the fluoroscopic image receptor using photographic film or a video camera when the x-ray source is operated in a pulsed mode.
(2) For equipment manufactured on or after June 10, 2006, during the recording of images from the fluoroscopic image receptor for the purpose of providing the user with a recorded image or images after termination of the exposure. Such recording does not include images resulting from a last-image-hold feature that are not recorded.
(3) When a mode of operation has an optional high-level control and the control is activated, in which case the equipment shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 176 mGy per minute (20 R/min exposure rate) at the measurement point specified in subdivision 3 of this subsection. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is employed.
3. Measuring compliance. Compliance with this subsection shall be determined as follows:
a. If the source is below the x-ray table, the AKR shall be measured at one cm above the tabletop or cradle.
b. If the source is above the x-ray table, the AKR shall be measured at 30 cm above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.
c. In a C-arm type of fluoroscope, the AKR shall be measured at 30 cm from the input surface of the fluoroscopic imaging assembly, with the source positioned at any available SID, provided that the end of the beam-limiting device or spacer is no closer than 30 cm from the input surface of the fluoroscopic imaging assembly.
d. In a C-arm type of fluoroscope having an SID less than 45 cm, the AKR shall be measured at the minimum SSD.
e. In a lateral type of fluoroscope, the air kerma rate shall be measured at a point 15 cm from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 cm to the centerline of the x-ray table.
4. Exemptions. Fluoroscopic radiation therapy simulation systems are exempt from the requirements set forth in this subsection when used for therapy simulation purposes.
F. (Reserved.)
G. Indication of potential and current. During fluoroscopy and cinefluorography, x-ray tube potential and current shall be continuously indicated. Deviation of x-ray tube potential and current from the indicated value shall not exceed the maximum deviation as stated by the manufacturer.
H. Source-skin distance.
1. Means shall be provided to limit the source-skin distance to not less than 38 cm on stationary fluoroscopes and to not less than 30 cm on mobile and portable fluoroscopes. In addition, for fluoroscopes intended for specific surgical application that would be prohibited at the source-skin distances specified in this subsection, provisions may be made for operating at shorter source-skin distances but in no case less than 20 cm.
2. For stationary, mobile, or portable C-arm fluoroscopic systems manufactured on or after June 10, 2006, having a maximum source-image receptor distance of less than 45 cm, means shall be provided to limit the source-skin distance to not less than 19 cm. Such systems shall be labeled for extremity use only. In addition, for those systems intended for specific surgical application that would be prohibited at the source-skin distance specified in this subsection, provisions may be made for operation at shorter source-skin distances but in no case less than 10 cm.
I. Fluoroscopic irradiation time, display, and signal.
1. Fluoroscopic equipment manufactured before June 10, 2006.
a. Equipment shall be provided with means to preset the cumulative irradiation time of the fluoroscopic tube. The maximum cumulative time of the timing device shall not exceed five minutes without resetting. A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative irradiation time. Such signal shall continue to sound while x-rays are produced until the timing device is reset. Fluoroscopic equipment may be modified in accordance with 21 CFR 1020.30(q) to comply with the requirements of this subdivision. When the equipment is modified, it shall bear a label indicating the statement:
"Modified to comply with 21 CFR 1020.32(h)(2)"
b. As an alternative to the requirements of this subsection, radiation therapy simulation systems may be provided with a means to indicate the total cumulative exposure time during which x-rays were produced, and which is capable of being reset between x-ray examinations.
2. For x-ray controls manufactured on or after June 10, 2006, there shall be provided for each fluoroscopic tube:
a. A display of the fluoroscopic irradiation time at the fluoroscopist's working position. This display shall function independently of the audible signal described in this subsection. The following requirements apply:
(1) When the x-ray tube is activated, the fluoroscopic irradiation time in minutes and tenths of minutes shall be continuously displayed and updated at least once every six seconds.
(2) The fluoroscopic irradiation time shall also be displayed within six seconds of termination of an exposure and remain displayed until reset.
(3) Means shall be provided to reset the display to zero prior to the beginning of a new examination or procedure.
b. A signal audible to the fluoroscopist shall sound for each passage of five minutes of fluoroscopic irradiation time during an examination or procedure. The signal shall sound until manually reset or, if automatically reset, for at least two seconds.
J. Mobile and portable fluoroscopes. In addition to the other requirements of this subsection, mobile and portable fluoroscopes shall provide an image receptor incorporating more than a simple fluorescent screen.
K. Display of last-image-hold (LIH). Fluoroscopic equipment manufactured on or after June 10, 2006, shall be equipped with means to display LIH image following termination of the fluoroscopic exposure.
1. For an LIH image obtained by retaining pretermination fluoroscopic images, if the number of images and method of combining images are selectable by the user, the selection shall be indicated prior to initiation of the fluoroscopic exposure.
2. For an LIH image obtained by initiating a separate radiographic-like exposure at the termination of fluoroscopic imaging, the technique factors for the LIH image shall be selectable prior to the fluoroscopic exposure, and the combination selected shall be indicated prior to initiation of the fluoroscopic exposure.
3. Means shall be provided to clearly indicate to the user whether a displayed image is the LIH radiograph or fluoroscopy. Display of the LIH radiograph shall be replaced by the fluoroscopic image concurrently with re-initiation of fluoroscopic exposure, unless separate displays are provided for the LIH radiograph and fluoroscopic images.
L. Displays of values of AKR and cumulative air kerma. Fluoroscopic equipment manufactured on or after June 10, 2006, shall display at the fluoroscopist's working position the AKR and cumulative air kerma. The following requirements apply for each x-ray tube used during an examination or procedure:
1. When the x-ray tube is activated and the number of images produced per unit time is greater than six images per second, the AKR in mGy/min shall be continuously displayed and updated at least once every second.
2. The cumulative air kerma in units of mGy shall be displayed either within five seconds of termination of an exposure or displayed continuously and updated at least once every five seconds.
3. The display of the AKR shall be clearly distinguishable from the display of the cumulative air kerma.
4. The AKR and cumulative air kerma shall represent the value for conditions of free-in-air irradiation at one of the following reference locations specified according to the type of fluoroscope.
a. For fluoroscopes with x-ray source below the x-ray table, x-ray source above the table, or of lateral type, the reference location shall be the respective locations specified in subdivision E 3 a or E 3 e of this section.
b. For C-arm fluoroscopes, the reference location shall be 15 cm from the isocenter toward the x-ray source along the beam axis. Alternatively, the reference location shall be at a point specified by the manufacturer to represent the location of the intersection of the x-ray beam with the patient's skin.
5. Means shall be provided to reset to zero the display of cumulative air kerma prior to the commencement of a new examination or procedure.
6. The displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ±35% over the range of six mGy/min and 100 mGy to the maximum indication of AKR and cumulative air kerma, respectively. Compliance shall be determined with an irradiation time greater than three seconds.
M. Control of scattered radiation.
1. Fluoroscopic table designs when combined with procedures utilized shall be such that no unprotected part of any staff or ancillary individual's body shall be exposed to unattenuated scattered radiation that originates from under the table. The attenuation required shall be not less than 0.25 mm lead equivalent.
2. Equipment configuration when combined with procedures shall be such that no portion of any staff or ancillary individual's body, except the extremities, shall be exposed to the unattenuated scattered radiation emanating from above the tabletop unless that individual:
a. Is at least 120 centimeters from the center of the useful beam; or
b. The radiation has passed through not less than 0.25 mm lead equivalent material including, but not limited to, drapes, Bucky-slot cover panel, or self-supporting curtains, in addition to any lead equivalency provided by the protective apron referred to in 12VAC5-481-1591 A 5.
3. The agency may grant exemptions to subdivision 2 of this subsection where a sterile field will not permit the use of the normal protective barriers. Where the use of prefitted sterilized covers for the barriers is practical, the agency shall not permit such exemption.
N. Operator qualifications. The facility shall ensure that only a licensed practitioner of the healing arts or a radiologic technologist or equivalent be allowed to operate fluoroscopic x-ray systems.
O. Equipment operation.
1. All imaging formed by the use of fluoroscopic x-ray systems shall be viewed, directly or indirectly, and interpreted by a licensed practitioner of the healing arts.
2. The operation of fluoroscopic x-ray systems by radiologic technologists or equivalent shall be performed under the direct supervision of a licensed practitioner of the healing arts.
3. Radiologic technology students shall not be allowed to operate fluoroscopic x-ray systems unless directly supervised by a licensed practitioner of the healing arts or radiologic technologist as specified in subsection N of this section.
4. Overhead fluoroscopy shall not be used as a positioning tool for general purpose radiographic examinations.
5. Facilities shall maintain a record of the cumulative fluoroscopic exposure time used and the number of fluorographic images recorded for each examination. This record shall include patient identification, type and date of examination, the fluoroscopic system used, and operator's name.
P. Surveys. Radiation safety and equipment performance surveys shall be performed annually on all fluoroscopic x-ray systems by or under the direct supervision of a private or state inspector who is physically present at the facility during the inspection in order to assure compliance with these regulations.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-1620. (Repealed.)
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-1621. Radiographic equipment.
A. Control and indication of technique factors.
1. Visual indication. The technique factors to be used during an exposure shall be indicated before the exposure begins, except when automatic exposure controls are used, in which case the technique factors that are set prior to the exposure shall be indicated. On equipment having fixed technique factors, this requirement may be met by permanent markings. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist.
2. Timers. Means shall be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor.
a. Except during serial radiography, the operator shall be able to terminate the exposure at any time during an exposure of greater than one-half second. Except during panoramic dental radiography, termination of exposure shall cause automatic resetting of the timer to its initial setting or to zero. It shall not be possible to make an exposure when the timer is set to a zero or off position if either position is provided.
b. During serial radiography, the operator shall be able to terminate the x-ray exposure at any time, but means may be provided to permit completion of any single exposure of the series in process.
3. Automatic exposure controls. When an automatic exposure control is provided:
a. Indication shall be made on the control panel when this mode of operation is selected;
b. When the x-ray tube potential is equal to or greater than 51 kilovolts peak (kVp), the minimum exposure time for field emission equipment rated for pulse operation shall be equal to or less than a time interval equivalent to two pulses and the minimum exposure time for all other equipment shall be equal to or less than 1/60 second or a time interval required to deliver five milliampere-seconds (mAs), whichever is greater;
c. Either the product of peak x-ray tube potential, current, and exposure time shall be limited to not more than 60 kilowatt-seconds (kWs) per exposure or the product of x-ray tube current and exposure time shall be limited to not more than 600 mAs per exposure, except when the x-ray tube potential is less than 51 kVp, in which case the product of x-ray tube current and exposure time shall be limited to not more than 2,000 mAs per exposure; and
d. A visible signal shall indicate when an exposure has been terminated at the limits described in subdivision 3 c of this subsection, and manual resetting shall be required before further automatically timed exposures can be made.
4. Accuracy. Deviation of technique factors from indicated values shall not exceed the limits given by the manufacturer. In the absence of manufacturer's limits, the deviation shall not exceed 10% of the indicated value for kVp and time.
B. Reproducibility. The following requirements shall apply when the equipment is operated on an adequate power supply as specified by the manufacturer:
1. Coefficient of variation. For any specific combination of selected technique factors, the estimated coefficient of variation of the air kerma shall be no greater than 0.10.
2. Measuring compliance. Determination of compliance shall be based on four consecutive measurements taken within a time period of one hour. Equipment manufactured after September 5, 1978, shall be subject to the additional requirement that all variable controls for technique factors shall be adjusted to alternate settings and reset to the test setting after each measurement. The percent line-voltage regulation shall be within ±1 of the mean value for all measurements. For equipment having automatic exposure controls, compliance shall be determined with a sufficient thickness of attenuating material in the useful beam such that the technique factors can be adjusted to provide individual exposures of a minimum of 12 pulses on field emission equipment rated for pulsed operation or no less than one-tenth second per exposure on all other equipment.
C. Linearity. The following requirements apply when the equipment is operated on a power supply as specified by the manufacturer in accordance with 21 CFR Part 1020 for any fixed x-ray tube potential within the range of 40% to 100% of the maximum rated.
1. Equipment having independent selection of x-ray tube current (mA). The average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two consecutive tube current settings shall not differ by more than 0.10 times their sum. This is:
|X1 – X2| ≤ 0.10(X1 + X2)
where X1 and X2 are the average mGy/mAs values obtained at each of two consecutive mAs selector settings or at two settings differing by no more than a factor of 2 where the mAs selector provides continuous selection.
2. Equipment having selection of x-ray tube current-exposure time product (mAs). For equipment manufactured after May 3, 1994, the average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two consecutive mAs selector settings shall not differ by more than 0.10 times their sum. This is:
|X1 – X2| ≤ 0.10(X1 + X2)
where X1 and X2 are the average mGy/mAs values obtained at each of two consecutive mAs selector settings or at two settings differing by no more than a factor of 2 where the mAs selector provides continuous selection.
3. Measuring compliance. Determination of compliance shall be based on four exposures, made within one hour, at each of the two settings. These two settings may include any two focal spot sizes except where one is equal to or less than 0.45 mm and the other is greater than 0.45 mm. For purposes of this requirement, focal spot size is the focal spot size specified by the x-ray tube manufacturer. The percent line-voltage regulation shall be determined for each measurement. All values for percent line-voltage regulation at any one combination of technique factors shall be within ±1 of the mean value for all measurements at these technique factors.
D. Field limitation and alignment for mobile, portable, and stationary general purpose x-ray systems. Except when spot-film devices are in service, mobile, portable, and stationary general purpose radiographic x-ray systems shall meet the following requirements:
1. Variable x-ray field limitation. A means for stepless adjustment of the size of the x-ray field shall be provided. Each dimension of the minimum field size at an SID of 100 cm shall be equal to or less than five cm.
2. Visual definition.
a. Means for visually defining the perimeter of the x-ray field shall be provided. The total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or width of the visually defined field shall not exceed 2.0% of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the x-ray beam.
b. When a light localizer is used to define the x-ray field, it shall provide an average illuminance of not less than 10 foot-candles at 100 cm or at the maximum SID, whichever is less. The average illuminance shall be based on measurements made in the approximate center of each quadrant of the light field. Radiation therapy simulation systems are exempt from this requirement.
c. The edge of the light field at 100 cm or at the maximum SID, whichever is less, shall have a contrast ratio, corrected for ambient lighting, of not less than four in the case of beam-limiting devices designed for use on stationary equipment, and a contrast ratio of not less than three in the case of beam-limiting devices designed for use on mobile and portable equipment. The contrast ratio is defined as I1/I2, where I1 is the illuminance three mm from the edge of the light field toward the center of the field, and I2 is the illuminance three mm from the edge of the light field away from the center of the field. Compliance shall be determined with a measuring aperture of one mm.
E. Field indication and alignment on stationary general purpose x-ray equipment. Except when spot-film devices are in service, stationary general purpose x-ray systems shall meet the following requirements in addition to those prescribed in subsection D of this section:
1. Means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, to align the center of the x-ray field with respect to the center of the image receptor to within 2.0% of the SID and to indicate the SID to within 2.0%;
2. The beam-limiting device shall numerically indicate the field size in the plane of the image receptor to which it is adjusted;
3. Indication of field size dimensions and SIDs shall be specified in centimeters or inches and shall be such that aperture adjustments result in x-ray field dimensions in the plane of the image receptor that correspond to those indicated by the beam-limiting device to within 2.0% of the SID when the beam axis is indicated to be perpendicular to the plane of the image receptor; and
4. Compliance measurements will be made at discrete SIDs and image receptor dimensions in common clinical use (such as SIDs of 100, 150, and 200 cm or 36, 40, 48, and 72 inches and nominal image receptor dimensions of 13, 18, 24, 30, 35, 40, and 43 cm or 5, 7, 8, 9, 10, 11, 12, 14, and 17 inches) or at any other specific dimensions at which the beam-limiting device or its associated diagnostic x-ray system is uniquely designed to operate.
F. Field limitation on radiographic x-ray equipment other than general purpose radiographic systems.
1. Equipment for use with intraoral image receptors. Radiographic equipment designed for use with an intraoral image receptor shall be provided with means to limit the x-ray beam such that:
a. If the minimum - source-skin distance (SSD) is 18 cm or more, the x-ray field at the minimum SSD shall be containable in a circle having a diameter of no more than seven cm; and
b. If the minimum SSD is less than 18 cm, the x-ray field at the minimum SSD shall be containable in a circle having a diameter of no more than six cm.
For dental intraoral uses, an open ended shielded positioning device shall be used.
2. X-ray systems designed for one image receptor size. Radiographic equipment designed for only one image receptor size at a fixed SID shall be provided with means to limit the field at the plane of the image receptor to dimensions no greater than those of the image receptor and to align the center of the x-ray field with the center of image receptor to within 2.0% of the SID, or shall be provided with means to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond the edge of the image receptor.
3. Systems designed for mammography.
a. Radiographic systems designed only for mammography and general purpose radiography systems, when special attachments for mammography are in service, manufactured on or after November 1, 1977, and before September 30, 1999, shall be provided with means to limit the useful beam such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor at any designated SID except the edge of the image receptor designed to be adjacent to the chest wall where the x-ray field may not extend beyond this edge by more than 2.0% of the SID. This requirement can be met with a system that performs as prescribed in subdivisions 4 a, b, and c of this subsection. When the beam-limiting device and image receptor support device are designed to be used to immobilize the breast during a mammographic procedure and the SID may vary, the SID indication specified in subdivisions 4 b and c of this subsection shall be the maximum SID for which the beam-limiting device or aperture is designed.
b. Mammographic beam-limiting devices manufactured on or after September 30, 1999, shall be provided with a means to limit the useful beam such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor by more than 2.0% of the SID. This requirement can be met with a system that performs as prescribed in subdivisions 4 a, b, and c of this subsection. For systems that allow changes in SID, the SID indication specified in subdivisions 4 b and c of this subsection shall be the maximum SID for which the beam-limiting device or aperture is designed.
c. Each image receptor support device manufactured on or after November 1, 1977, intended for installation on a system designed for mammography shall have clear and permanent markings to indicate the maximum image receptor size for which it is designed.
4. Other x-ray systems. Radiographic systems not specifically covered in subsections D, E, and H of this section, which are also designed for use with extraoral image receptors and when used with an extraoral image receptor, shall be provided with means to limit the x-ray field in the plane of the image receptor so that such field does not exceed each dimension of the image receptor by more than 2.0% of the SID when the axis of the x-ray beam is perpendicular to the plane of the image receptor. In addition, means shall be provided to align the center of the x-ray field with the center of the image receptor to within 2.0% of the SID, or means shall be provided to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor. These requirements may be met with:
a. A system that performs in accordance with subsections D and E of this section; or when alignment means are also provided, may be met with either;
b. An assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Each such device shall have clear and permanent markings to indicate the image receptor size and SID for which it is designed; or
c. A beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use.
G. Positive beam limitation (PBL). The requirements of this subsection shall apply to radiographic systems that contain PBL.
1. Field size. When a PBL system is provided, it shall prevent x-ray production when:
a. Either the length or width of the x-ray field in the plane of the image receptor differs from the corresponding image receptor dimension by more than 3.0% of the SID; or
b. The sum of the length and width differences stated in subdivision 1 a of this subsection without regard to sign exceeds 4.0% of the SID.
c. The beam-limiting device is at an SID for which PBL is not designed for sizing.
2. Conditions for PBL. When provided, the PBL system shall function as described in subdivision 1 of this subsection whenever all the following conditions are met:
a. The image receptor is inserted into a permanently mounted cassette holder;
b. The image receptor length and width are less than 50 cm;
c. The x-ray beam axis is within ±3 degrees of vertical and the SID is 90 cm to 130 cm inclusive; or the x-ray beam axis is within ±3 degrees of horizontal and the SID is 90 cm to 205 cm inclusive;
d. The x-ray beam axis is perpendicular to the plane of the image receptor to within ±3 degrees; and
e. Neither tomographic nor stereoscopic radiography is being performed.
3. Measuring compliance. Compliance with the requirements of subdivision 1 of this subsection shall be determined when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor and the provisions of subdivision 2 of this subsection are met. Compliance shall be determined no sooner than five seconds after insertion of the image receptor.
4. Operator initiated undersizing. The PBL system shall be capable of operating such that, at the discretion of the operator, the size of the field may be made smaller than the size of the image receptor through stepless adjustment of the field size. Each dimension of the minimum field size at an SID of 100 cm shall be equal to or less than five cm. Return to PBL function as described in subdivision 1 of this subsection shall occur automatically upon any change of image receptor size or SID.
5. Override of PBL. A capability may be provided for overriding PBL in case of system failure and for servicing the system. This override may be for all SIDs and image receptor sizes. A key shall be required for any override capability that is accessible to the operator. It shall not be possible to remove the key while PBL is overridden. Each such key switch or key shall be clearly and durably labeled as follows:
"For X-Ray Field Limitation System Failure"
The override capability is considered accessible to the operator if it is referenced in the operator's manual or in other material intended for the operator or if its location is such that the operator would consider it part of the operational controls.
H. Field limitation and alignment for spot-film devices. The following requirements shall apply to spot-film devices, except when the spot-film device is provided for use with a radiation therapy simulation system:
1. Means shall be provided between the source and the patient for adjustment of the x-ray field size in the plane of the image receptor to the size of that portion of the image receptor that has been selected on the spot-film selector. Such adjustment shall be accomplished automatically when the x-ray field size in the plane of the image receptor is greater than the selected portion of the image receptor. If the x-ray field size is less than the size of the selected portion of the image receptor, the field size shall not open automatically to the size of the selected portion of the image receptor unless the operator has selected that mode of operation.
2. Neither the length nor width of the x-ray field in the plane of the image receptor shall differ from the corresponding dimensions of the selected portion of the image receptor by more than 3.0% of the SID when adjusted for full coverage of the selected portion of the image receptor. The sum, without regard to sign, of the length and width differences shall not exceed 4.0% of the SID. On spot film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.
3. The center of the x-ray field in the plane of the image receptor shall be aligned with the center of the selected portion of the image receptor to within 2.0% of the SID.
4. Means shall be provided to reduce the x-ray field size in the plane of the image receptor to a size smaller than the selected portion of the image receptor such that:
a. For spot-film devices used on fixed-SID fluoroscopic systems that are not required to and do not provide stepless adjustment of the x-ray field, the minimum field size, at the greatest SID, does not exceed 125 square cm; or
b. For spot-film devices used on fluoroscopic systems that have a variable SID or stepless adjustment of the field size, the minimum field size, at the greatest SID, shall be containable in a square of five cm by five cm.
5. A capability may be provided for overriding the automatic x-ray field size adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position shall indicate whenever the automatic x-ray field size adjustment override is engaged. Each such system failure override switch shall be clearly labeled as follows:
"For X-ray Field Limitation System Failure"
I. Source-skin distance.
1. X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit the source-skin distance to not less than:
a. 18 cm if operable above 50 kVp; or
b. 10 cm if not operable above 50 kVp.
2. Mobile and portable x-ray systems other than dental shall be provided with means to limit the source-skin distance to not less than 30 cm.
J. Beam-on indicators. The x-ray control shall provide visual indication whenever x-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.
K. (Reserved.)
L. Radiation from capacitor energy storage equipment. Radiation emitted from the x-ray tube shall not exceed:
1. An air kerma of 0.26 microGy (0.03 mR exposure) in one minute at five cm from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open, the system fully charged, and the exposure switch, timer, or any discharge mechanism not activated. Compliance shall be determined by measurements averaged over an area of 100 square cm, with no linear dimensions greater than 20 cm: and
2. An air kerma of 0.88 mGy (100 mR exposure) in one hour at 100 cm from the x-ray source, with beam-limiting device fully open, when the system is discharged through the x-ray tube either manually or automatically by use of a discharge switch or deactivation of the input power. Compliance shall be determined by measurements of the maximum air kerma per discharge multiplied by the total number of discharges in one hour (duty cycle). The measurements shall be averaged over an area of 100 square cm with no linear dimension greater than 20 cm.
M. Primary protective barrier for mammography x-ray systems.
1. For x-ray systems manufactured after September 5, 1978, and before September 30, 1999, which are designed only for mammography, the transmission of the primary beam through any image receptor support provided with the system shall be limited such that the air kerma five cm from any accessible surface beyond the plane of the image receptor supporting device does not exceed 0.88 microGy (0.1 mR exposure) for each activation of the tube.
2. For mammographic x-ray systems manufactured on or after September 30, 1999:
a. At any SID where exposures can be made, the image receptor support device shall provide a primary protective barrier that intercepts the cross section of the useful beam along every direction except at the chest wall edge.
b. The x-ray system shall not permit exposure unless the appropriate barrier is in place to intercept the useful beam as required in subdivision 2 a of this subdivision.
c. The transmission of the useful beam through the primary protective barrier shall be limited such that the air kerma five cm from any accessible surface beyond the plane of the primary protective barrier does not exceed 0.88 microGy (0.1 mR exposure) for each activation of the tube.
3. Compliance with the requirements of subdivisions 1 and 2 c of this subsection for transmission shall be determined with the x-ray system operated at the minimum SID for which it is designed, at maximum rated peak tube potential, at the maximum rated product of x-ray tube current and exposure time (mAs) for the maximum rated peak tube potential, and by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm. The sensitive volume of the radiation measuring instrument shall not be positioned beyond the edge of the primary protective barrier along the chest wall side.
N. (Reserved.)
O. Beam limitation, except mammographic systems. The useful beam shall be limited to the area of clinical interest. This shall be deemed to have been met if a positive beam-limiting device meeting manufacturer's specifications and the requirements of subsection G of this section have been properly used or if evidence of collimation is shown on at least three sides or three corners of the film, for example, projections from the shutters of the collimator, cone cutting at the corners, or borders at the film's edge.
P. Radiation exposure control.
1. Exposure initiation. Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action. In addition, it shall not be possible to initiate an exposure when the timer is set to a "zero" or "off" position if either position is provided.
2. Exposure indication. Means shall be provided for visual indication observable at or from the operator's protected position whenever x-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.
3. Operator protection, except veterinary systems.
a. Stationary systems. Stationary x-ray systems shall be required to have the x-ray control permanently mounted in a protected area so that the operator may remain in that protected area during the entire exposure. For dental intraoral systems installed prior to September 20, 2006, if the x-ray control is not permanently mounted behind a protected barrier, then dosimetry is required by all operators of the system.
b. Mobile and portable systems. Mobile and portable x-ray systems that are:
(1) Used continuously for greater than one week in the same location, that is, a room or suite, shall meet the requirements of subdivision 3 a of this subsection;
(2) Used for less than one week at the same location shall be provided with either a protective barrier at least two meters (6.5 feet) high for operator protection during exposures, or means shall be provided to allow the operator to be at least 2.7 meters (nine feet) from the tube housing assembly during the exposure.
4. Operator protection for veterinary systems. All stationary, mobile or portable x-ray systems used for veterinary work shall be provided with either a two meter (6.5 feet) high protective barrier for operator protection during exposures, or shall be provided with means to allow the operator to be at least 2.7 meters (nine feet) from the tube housing assembly during exposures.
Q. Tube stands for portable x-ray systems. A tube stand or other mechanical support shall be used for portable x-ray systems, so that the x-ray tube housing assembly need not be hand-held during exposures.
R. Surveys. Radiation safety and equipment performance surveys shall be performed annually on all x-ray machines covered by this section in order to assure compliance with the regulations, except that bone densitometers, hand-held units, and x-ray machines other than head CT or cone beam units used in the practice of podiatry, dentistry, or veterinary medicine shall be surveyed every three years. The surveys shall be performed by or under the direct supervision of a private or state inspector who is physically present at the facility during the inspection.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-1630. (Repealed.)
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-1631. Intraoral dental radiographic equipment.
In addition to the applicable provisions of 12VAC5-481-1591, 12VAC5-481-1601, and 12VAC5-481-1621, the requirements of this section apply to x-ray equipment and associated facilities used for dental intraoral radiography. Requirements for extraoral dental radiographic systems are in 12VAC5-481-1621.
1. Radiation exposure control. Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action.
2. Exposure control location and operator protection.
a. Stationary x-ray systems shall be required to have the x-ray exposure control permanently mounted in a protected area, so that the operator is required to remain in that protected area during the entire exposure; and
b. Mobile and portable x-ray systems that are:
(1) Used for greater than one week in the same location that is, a room or suite, shall meet the requirements of subdivision 2 a of this section.
(2) Used for less than one week in the same location shall be provided with either a protective barrier at least two meters (6.5 feet) high for operator protection, or means to allow the operator to be at least 2.7 meters (nine feet) from the tube housing assembly while making exposures.
3. kVp limitations. Dental x-ray machines with a nominal fixed kVp of less than 50 kVp shall not be used to make diagnostic dental radiographs of humans.
4. Administrative controls.
a. Patient and film holding devices shall be used when the techniques permit.
b. The tube housing and the PID for a permanently mounted intraoral dental system shall not be hand-held during an exposure.
c. Dental fluoroscopy without image intensification shall not be used.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-1640. (Repealed.)
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-1641. Computed tomography equipment.
A. (Reserved.)
B. Requirements for equipment.
1. Termination of exposure.
a. Means shall be provided to terminate the x-ray exposure automatically by either de-energizing the x-ray source or shuttering the x-ray beam in the event of equipment failure affecting data collection. Such termination shall occur within an interval that limits the total scan time to no more than 110% of its preset value through the use of either a backup timer or devices that monitor equipment function.
b. A visible signal shall indicate when the x-ray exposure has been terminated through the means required by subdivision 1 a of this subsection.
c. The operator shall be able to terminate the x-ray exposure at any time during a scan, or series of scans under CT x-ray system control, of greater than one-half second duration.
2. Tomographic plane indication and alignment.
a. For any single tomogram system, means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane.
b. For any multiple tomogram system, means shall be provided to permit visual determination of the location of a reference plane. This reference plane can be offset from the location of the tomographic planes.
c. If a device using a light source is used to satisfy the requirements of subdivision 2 a or b of this subsection, the light source shall provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to 500 lux.
3. Beam-on and shutter status indicators and control switches.
a. The CT x-ray control and gantry shall provide visual indication whenever x-rays are produced and, if applicable, whether the shutter is open or closed.
b. Each emergency button or switch shall be clearly labeled as to its function.
4. Indication of CT conditions of operation. The CT x-ray system shall be designed such that the CT conditions of operation to be used during a scan or a scan sequence shall be indicated prior to the initiation of a scan or a scan sequence. On equipment having all or some of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions of operation shall be visible from any position from which scan initiation is possible.
5. Extraneous radiation. When data are not being collected for image production, the radiation adjacent to the tube port shall not exceed that permitted by subdivision 3 of 12VAC5-481-1601.
6. Maximum surface CTDI identification. The angular position where the maximum surface CTDI occurs shall be identified to allow for reproducible positioning of a CT dosimetry phantom.
7. Additional requirements applicable to CT x-ray systems containing a gantry manufactured after September 3, 1985.
a. The total error in the indicated location of the tomographic plane or reference plane shall not exceed five mm.
b. If the x-ray production period is less than one-half second, the indication of x-ray production shall be actuated for at least one-half second. Indicators at or near the gantry shall be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible.
c. The deviation of indicated scan increment versus actual increment shall not exceed one millimeter with any mass from 0 to 100 kg resting on the support device. The patient support device shall be incremented from a typical starting position to the maximum incremented distance or 30 cm, whichever is less, and then returned to the starting position. Measurement of actual versus indicated scan increment may be taken anywhere along this travel.
d. Premature termination of the x-ray exposure by the operator shall necessitate resetting of the CT conditions of operation prior to the initiation of another scan.
C. Facility design requirements.
1. Aural communication. Provision shall be made for two-way aural communication between the patient and the operator at the control panel.
2. Viewing systems.
a. Windows, mirrors, closed-circuit television, or an equivalent shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel.
b. When the primary viewing system is by electronic means, an alternate viewing system (which may be electronic) shall be available for use in the event of failure of the primary viewing system.
D. Surveys, calibrations, spot checks, and operating procedures.
1. Surveys.
a. All CT x-ray systems installed after September 19, 2006, and those systems not previously surveyed shall have a survey made by, or under the direction of, a qualified medical physicist. In addition, such surveys shall be done after any change in the facility or equipment that might cause a significant increase in radiation hazard.
b. The registrant shall obtain a written report of the survey from the qualified medical physicist, and a copy of the report shall be made available to the agency upon request.
2. Radiation calibrations.
a. The calibration of the radiation output of the CT x-ray system shall be performed by, or under the direction of, a qualified medical physicist who is physically present at the facility during such calibration.
b. The calibration of a CT x-ray system shall be performed (i) after initial installation and before use on human patients, (ii) annually or at intervals specified by a qualified medical physicist, and (iii) after any change or replacement of components that in the opinion of the qualified medical physicist could cause a change in the radiation output.
c. The calibration of the radiation output of a CT x-ray system shall be performed with a calibrated dosimetry system. The calibration of such system shall be traceable to a national standard. The dosimetry system shall have been calibrated within the preceding two years.
d. CT dosimetry phantom shall be used in determining the radiation output of a CT x-ray system. Such phantom shall meet the following specifications and conditions of use:
(1) CT dosimetry phantom shall be right circular cylinders of polymethyl methacrylate of density 1.19 plus or minus 0.01 grams per cubic cm. The phantom shall be at least 14 cm in length and shall have diameters of 32.0 cm for testing CT x-ray systems designed to image any section of the body and 16.0 cm for systems designed to image the head or for whole body scanners operated in the head scanning mode;
(2) CT dosimetry phantom shall provide means for the placement of a dosimeter along the axis of rotation and along a line parallel to the axis of rotation 1.0 cm from the outer surface and within the phantom. Means for the placement of dosimeters or alignment devices at other locations may be provided;
(3) Any effects on the doses measured due to the removal of phantom material to accommodate dosimeters shall be accounted for through appropriate corrections to the reported data or included in the statement of maximum deviation for the values obtained using the phantom; and
(4) All dose measurements shall be performed with the CT dosimetry phantom placed on the patient couch or support device without additional attenuation materials present.
e. The calibration shall be required for each type of head, body, or whole-body scan performed at the facility.
f. Calibration shall meet the following requirements:
(1) The dose profile along the center axis of the CT dosimetry phantom for the minimum, maximum, and midrange values of the nominal tomographic section thickness used by the registrant shall be measurable. Where less than three nominal tomographic thicknesses can be selected, the dose profile determination shall be performed for each available nominal tomographic section thickness;
(2) The CTDI along the two axes specified in subdivision 2 d (2) of this subsection shall be measured. For the purpose of determining the CTDI, the manufacturer's statement as to the nominal tomographic section thickness for that particular system may be utilized. The CT dosimetry phantom shall be oriented so that the measurement point 1.0 cm from the outer surface and within the phantom is in the same angular position within the gantry as the point of maximum surface CTDI identified. The CT conditions of operation shall correspond to typical values used by the registrant; and
(3) The spot checks specified in subdivision 3 of this subsection shall be made.
g. Calibration procedures shall be in writing. Records of calibrations performed shall be maintained for inspection by the agency.
3. Spot checks.
a. The spot-check procedures shall be in writing and shall have been developed by a qualified medical physicist.
b. The spot-check procedures shall incorporate the use of a CT dosimetry phantom that has a capability of (i) providing an indication of contrast scale, noise, nominal tomographic section thickness, and the resolution capability of the system for low and high contrast objects; and (ii) measuring the mean CTN for water or other reference material.
c. All spot checks shall be included in the calibration required by subdivision 2 of this subsection and at time intervals and under system conditions specified by a qualified medical physicist.
d. Spot checks shall include acquisition of images obtained with the CT dosimetry phantom or phantoms using the same processing mode and CT conditions of operation as are used to perform calibrations required by subdivision 2 of this subsection.
e. The results of each spot check shall be maintained for two years.
4. Operating procedures.
a. The CT x-ray system shall not be operated except by an individual who has been specifically trained in its operation.
b. Information shall be available at the control panel regarding the operation and calibration of the system. Such information shall include the following:
(1) Dates of the latest calibration and spot checks and the location within the facility where the results of those tests may be obtained;
(2) Instructions on the use of the CT dosimetry phantoms including a schedule of spot checks appropriate for the system, allowable variations for the indicated parameters, and the results of at least the most recent spot checks conducted on the system;
(3) The distance in millimeters between the tomographic plane and the reference plane if a reference plane is utilized; and
(4) A current technique chart available at the control panel that specifies for each routine examination the CT conditions of operation and the number of scans per examination.
c. If the calibration or spot check of the CT x-ray system identifies that a system operating parameter has exceeded a tolerance established by the qualified medical physicist, use of the CT x-ray system on patients shall be limited to those uses permitted by established written instructions of the qualified medical physicist.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-1650. (Repealed.)
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; repealed, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-1651. Mammography requirements.
A. Only x-ray systems, pursuant to the Mammography Quality Standards Reauthorization Act of 1998 (Pub.L. 105-248) and 21 CFR Part 900, shall be used for screening and diagnostic mammography.
B. A facility performing mammography shall have a valid certificate issued by the U.S. Department of Health and Human Services, pursuant to the Mammography Quality Standards Reauthorization Act of 1998 and 21 CFR Part 900.
C. A facility performing mammography shall ensure that the additional mammography activities of processing the x-ray film, interpreting the image, and maintaining viewing conditions, wherever performed, meet all quality standards pursuant to the Mammography Quality Standards Reauthorization Act of 1998 and 21 CFR Part 900.
D. The operator of the mammography machine shall be certified by the American Registry of Radiologic Technologists (ARRT) and shall have had specialized training in mammography meeting the requirements set forth by the U.S. Food and Drug Administration under the Mammography Quality Standards Reauthorization Act of 1998.
E. When film developing is not available or the patient chooses not to wait, the patient shall be notified within two business days if another mammogram is necessary. This requirement does not imply or require that a diagnostic opinion be made at the time of the mammogram. The interpreting physician may require that the mammogram be retaken if, in the opinion of the physician, the study is of inadequate quality.
F. Agency inspectors may conduct unannounced inspections during normal business hours.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-1653. Hand-held radiographic units.
In addition to the applicable provisions found elsewhere in this chapter, the following provisions apply to a hand-held radiographic unit.
1. A hand-held radiograph unit shall be:
a. Certified by the manufacturer pursuant to 21 CFR Part 803, Medical Device Reporting of the Federal Food and Drug Administration Modernization Act of 1997; 21 USC Chapter 9, Subchapter V, Part C – Electronic Product Radiation Control (EPRC) (§ 360hh et seq.) of the Federal Food, Drug and Cosmetic Act; and 21 CFR 1020.30, Diagnostic x-ray systems and their major components.
b. Registered with the agency in accordance with applicable parts of this chapter.
c. Maintained and operated in accordance with the manufacturer's specifications.
2. For all uses:
a. Operators of a hand-held radiographic unit shall be specifically trained to operate such equipment.
b. When operating a hand-held radiographic unit, operators shall wear dosimetry unless otherwise authorized by the agency.
c. A hand-held radiographic unit shall have the backscatter radiation shield in place to protect the operator during operation.
d. The operator shall ensure there are no bystanders within a radius of at least six feet from the patient being examined with a hand-held radiograph unit.
e. A hand-held radiographic unit shall not be used in hallways or waiting rooms.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-1655. Bone densitometry.
A. A bone densitometry system shall be:
1. Certified by the manufacturer pursuant to 21 CFR Part 803, Medical Device Reporting of the Federal Food and Drug Administration Modernization Act of 1997; 21 USC Chapter 9, Subchapter V, Part C – Electronic Product Radiation Control (EPRC) (§ 360hh et seq.) of the Federal Food, Drug and Cosmetic Act; and 21 CFR 1020.30, Diagnostic x-ray systems and their major components.
2. Registered with the agency in accordance with applicable parts of this chapter.
3. Maintained and operated in accordance with the manufacturer's specifications.
B. Equipment requirements. A system with stepless collimators shall be provided with means to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond 2.0% of the SID.
C. Operators of a bone densitometry system shall meet one of the following:
1. Be certified by the American Registry of Radiologic Technologists (ARRT);
2. Be licensed by the Virginia Department of Health Professions, Board of Medicine as a radiologic technologist or a limited radiologic technologist for bone density operation;
3. Be licensed by the Virginia Department of Health Professions, Board of Medicine as a practitioner of the healing arts; or
4. Be in an accredited program for radiologic technology and under the supervision of an individual who meets one of the criteria listed in subdivision 1, 2, or 3 of this subsection.
D. During the operation of any bone densitometry system:
1. The operator, ancillary personnel, and members of the general public shall be positioned at least one meter from the patient and bone densitometry system during the examination.
2. The operator shall advise the patient that the bone densitometry examination is a type of x-ray procedure.
E. The registrant shall keep maintenance records for bone densitometry systems as prescribed by subdivision A 3 of this section. These records shall be maintained for inspection by the agency.
F. Bone densitometry on human patients shall be conducted only:
1. Under a prescription of an individual licensed by the Virginia Department of Health Professions, Board of Medicine as a practitioner of the healing arts; or
2. Under a screening program approved by the agency.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-1657. Quality assurance program.
All registrants of diagnostic x-ray imaging equipment may be required by the agency to establish and maintain a quality assurance program consisting of quality control assessments.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
Part VII
Use of Radionuclides in the Healing Arts
Article 1
Purpose and Scope
12VAC5-481-1660. Purpose and scope.
Article 1
Purpose and Scope
Part VII (12VAC5-481-1660 et seq.) of this chapter establishes requirements and provisions for the production, preparation, compounding and use of radionuclides in the healing arts and for issuance of licenses authorizing the medical use of this material. These requirements and provisions provide for the protection of the public health and safety. The requirements and provisions of Part VII (12VAC5-481-1660 et seq.) of this chapter are in addition to, and not in substitution for, others in these regulations. The requirements and provisions of these regulations apply to applicants and licensees subject to Part VII (12VAC5-481-1660 et seq.) of this chapter unless specifically exempted.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
Article 2
General Information
12VAC5-481-1670. General requirements.
Article 2
General Information
A. Licensees may conduct research involving human research subjects only if it uses the radioactive materials specified on its license for the uses authorized on its license.
B. If the research is conducted, funded, supported, or regulated by another agency that has implemented a policy for protection of human subjects, the licensee shall, before conducting research:
1. Obtain review and approval of the research from an authorized review board; and
2. Obtain informed consent, in writing, from the human research subject.
C. If the research will not be conducted, funded, supported, or regulated by another agency that has implemented an appropriate protection policy, licensees shall, before conducting research, apply for and receive a specific license amendment to its medical use license. The amendment request shall include a written commitment that licensees will, before conducting research:
1. Obtain review and approval of the research from an authorized review board; and
2. Obtain informed consent, in writing, from the human research subject.
D. Nothing in this section relieves licensees from complying with other requirements of this part.
E. Nothing in this part relieves licensees from complying with applicable FDA, federal, and other state requirements governing radioactive drugs or devices.
F. When a requirement in this part differs from the requirement in an existing license condition, the requirement in this part shall govern.
G. Licensees shall continue to comply with any license condition that requires it to implement procedures required by 12VAC5-481-2043 and 12VAC5-481-2046 until there is a license amendment or renewal that modifies the license condition.
H. Each record required by this part shall be legible throughout the specified retention period. The record may be the original, a reproduced copy, or a microform if the copy or microform is authenticated by authorized personnel and the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications shall include all pertinent information such as stamps, initials, and signatures. Licensees shall maintain adequate safeguards against tampering with and loss of records.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-1680. Licensing and exemptions.
A. A person may manufacture, produce, acquire, receive, possess, prepare, use, or transfer radioactive material for medical use only in accordance with a specific license issued by the agency, the NRC, or another agreement state, or as allowed in subsection B of this section.
B. A specific license is not needed for an individual who:
1. Receives, possesses, uses, or transfers radioactive material in accordance with this part under the supervision of an authorized user as provided in 12VAC5-481-1710, unless prohibited by license condition; or
2. Prepares unsealed radioactive material for medical use in accordance with this part under the supervision of an authorized nuclear pharmacist or authorized user as provided in 12VAC5-481-1710, unless prohibited by license condition.
C. An application shall be signed by the applicant's or licensee's management.
D. An application for a license for medical use of radioactive material as described in 12VAC5-481-1900, 12VAC5-481-1920, 12VAC5-481-1950, 12VAC5-481-2010, 12VAC5-481-2020, 12VAC5-481-2040 B, and 12VAC5-481-2060 shall be made by:
1. Filing a completed and signed application for medical use; and
2. Submitting procedures required by 12VAC5-481-2043 and 12VAC5-481-2046, as applicable.
E. A request for a license amendment or renewal shall be made by:
1. Submission of a license amendment may be completed by submitting in letter format including all necessary documentation;
2. Submission for a license renewal shall be completed by submitting a completed and signed renewal application for medical use; and
3. Submitting procedures required by 12VAC5-481-2043 and 12VAC5-481-2046, as applicable.
F. In addition to the requirements in subsections D and E of this section, submittal of a license application or amendment for medical use of radioactive material as described in 12VAC5-481-2060 shall also include information regarding any radiation safety aspects of the medical use of the material that is not otherwise addressed in this part, including but not limited to, the following specific information:
1. Radiation safety precautions and instructions;
2. Training and experience of proposed users;
3. Methodology for measurement or dosages or doses to be administered to patients or human research subjects;
4. Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety; and
5. Any other information requested by the agency in its review of the application.
G. An applicant that satisfies the requirements specified in 12VAC5-481-470 may apply for a specific license of broad scope. Licensees possessing a Type A specific license of broad scope for medical use, issued under 12VAC5-481-470, are exempt from:
1. The provisions of subsection E of this section regarding the need to file an amendment to the license for medical use of radioactive material, as described in 12VAC5-481-2060;
2. Additions to or changes in any authorized user, authorized nuclear pharmacist, or authorized medical physicist;
3. Additions to or changes in the areas of use at the addresses identified in the application or on the license;
4. The provisions of 12VAC5-481-1690 A;
5. The provisions of 12VAC5-481-1690 for an authorized user, an authorized nuclear pharmacist, or an authorized medical physicist;
6. The provisions of 12VAC5-481-1690 B 5;
7. The provisions of 12VAC5-481-1740.
H. The agency shall issue a license for medical use of radioactive material if:
1. The applicant has filed the appropriate application form in accordance with the instructions in this subsection and subsections D, F, G, and I of this section;
2. The applicant has paid any applicable fee as provided in 12VAC5-490;
3. The agency finds the applicant equipped and committed to observe the safety standards established by the agency in this part for the protection of the public health and safety; and
4. The applicant meets the requirements of 12VAC5-481-450.
I. The agency shall issue a license for mobile medical service if the applicant:
1. Meets the requirements of subsection H of this section and 12VAC5-481-1880; and
2. Assures that individuals or human research subjects to whom unsealed radioactive material or radiation from implants containing radioactive material will be administered may be released following treatment in accordance with 12VAC5-481-1870.
J. The agency may, upon application of any interested person or upon its own initiative, grant exemptions from the regulations in this part that it determines are authorized by law and will not endanger life, property, or the common defense and security and are otherwise in the public interest.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-1690. Notifications.
A. Licensees shall provide the agency the following information for each individual no later than 30 days after the date that the licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, an ophthalmic physicist, or an authorized medical physicist:
1. A copy of (i) the board certification, (ii) the written attestation signed by a preceptor, and (iii) the NRC or another Agreement state license;
2. The permit issued by a NRC master material licensee;
3. The permit issued by a broad scope licensee;
4. The permit issued by a NRC master material broad scope permittee; or
5. Documentation that only accelerator-produced radioactive materials, discrete sources of radium-226, or both, were used for medical use or 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.
6. For individuals permitted to work within the 30-day time frame, the licensee shall also provide, as appropriate, verification of completion of:
a. Any additional case experience required in 12VAC5-481-1980 2 b (7) for an authorized user under 12VAC5-481-1950;
b. Any additional training required in 12VAC5-481-2040 A 4 for an authorized user under 12VAC5-481-2040 A; or
c. Any additional training required in 12VAC5-481-1760 A 3 for an authorized medical physicist.
B. A licensee shall notify the agency no later than 30 days after:
1. An authorized user, an authorized nuclear pharmacist, a radiation safety officer, an associate radiation safety officer, an ophthalmic physicist, or an authorized medical physicist permanently discontinues performance of duties under the license or has a name change;
2. The licensee permits an authorized user or an individual qualified to be a radiation safety officer, under 12VAC5-481-1750 and 12VAC5-481-1790, to function as a temporary radiation safety officer and to perform the functions of a radiation safety officer in accordance with 12VAC5-481-1700 C;
3. The licensee's mailing address changes;
4. The licensee's name changes, but the name change does not constitute a transfer of control of the license as described in 12VAC5-481-500 B; or
5. The licensee has added to or changed the areas of use identified in the application or on the license where radioactive material is used in accordance with either 12VAC5-481-1900 or 12VAC5-481-1920 if the change does not include addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from the PET radionuclide/PET radioactive drug production area.
C. The licensee shall send the documents required in this section to the appropriate address identified in 12VAC5-481-150.
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; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.
Article 3
General Administrative Requirements
12VAC5-481-1700. Authority and responsibilities for the radiation protection programs and changes.
A. In addition to the radiation protection program requirements of 12VAC5-481-630, a licensee's management shall approve, in writing:
1. Requests for a license application, renewal, or amendment before submittal to the agency;
2. Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist, or an authorized medical physicist; and
3. Radiation protection program changes that do not require a license amendment and are permitted under subsection I of this section.
B. The licensee's management shall appoint a radiation safety officer (RSO) who agrees, in writing, to be responsible for implementing the radiation protection program.
The licensee, through the RSO, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements. A licensee's management may appoint, in writing, one or more associate RSOs to support the RSO. The RSO, with written agreement of the licensee's management, must assign the specific duties and tasks to each associate RSO. These duties and tasks are restricted to the types of use for which the associate RSO is listed on a license. The RSO may delegate duties and tasks to the associate RSO but shall not delegate the authority or responsibilities for implementing the radiation protection program.
C. For up to 60 days each year, licensees may permit an individual qualified to be an RSO, under 12VAC5-481-1750 and 12VAC5-481-1790, to function as a temporary RSO and to perform the functions of an RSO, as provided in subsection G if the licensee takes the actions required in subsections B, E, G, and H of this section and notifies the agency in accordance with 12VAC5-481-1690 B.
D. A licensee may simultaneously appoint more than one temporary RSO in accordance with subsection C of this section, if needed to ensure that the licensee has a temporary RSO that satisfies the requirements to be an RSO for each of the different types of uses of radioactive material permitted by the license.
E. A licensee shall establish the authority, duties, and responsibilities of the RSO in writing.
F. A licensee that is authorized for two or more different types of uses of radioactive material under Articles 6, 7, and 9 of this part, or two or more types of units under 12VAC5-481-2040 B, shall establish a Radiation Safety Committee (RSC) to oversee all uses of radioactive material permitted by the license. The RSC must include an authorized user of each type of use permitted by the license, the RSO, a representative of the nursing service, and a representative of management who is neither an authorized user nor an RSO. The RSC may include other members the licensee considers appropriate.
G. A licensee shall provide the RSO sufficient authority, organizational freedom, time, resources, and management prerogative to:
1. Identify radiation safety problems;
2. Initiate, recommend, or provide corrective actions;
3. Stop unsafe operations; and
4. Verify implementation of corrective actions.
H. A licensee shall retain a record of actions taken under subsections A, B, and E of this section in accordance with 12VAC5-481-2070.
I. A licensee may revise its radiation protection program without agency approval if:
1. The revision does not require a license amendment under 12VAC5-481-450 or 12VAC5-481-1680;
2. The revision is in compliance with this chapter and the license;
3. The revision has been reviewed and approved by the RSO and licensee management; and
4. The affected individuals are instructed on the revised program before the changes are implemented.
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; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022; Volume 39, Issue 24, eff. August 16, 2023.
12VAC5-481-1710. Supervision.
A. Licensees that permit the receipt, possession, use, or transfer of radioactive material by an individual under the supervision of an authorized user, as allowed by 12VAC5-481-1680 B 1, shall:
1. In addition to the requirements in 12VAC5-481-2270, instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, regulations, and license conditions with respect to the use of radioactive material; and
2. Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures established by the licensee, written directive procedures, regulations, and license conditions with respect to the medical use of radioactive material.
B. Licensees that permit the preparation of radioactive material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by 12VAC5-481-1680 B 2, shall:
1. In addition to the requirements in 12VAC5-481-2270, instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual's involvement with radioactive material; and
2. Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical use, written radiation protection procedures established by the licensee, this chapter, and the license conditions.
C. Licensees that permit supervised activities under subsections A and B of this section are responsible for the acts and omissions of the supervised individual.
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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-1720. Written directives.
A. A written directive shall be dated and signed by an authorized user before the administration of I-131 sodium iodide greater than 30 microcuries (µCi) (1.11 megabecquerels (MBq)), any therapeutic dose of unsealed radioactive material, or any therapeutic dose of radiation from radioactive material.
If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive is acceptable. The information contained in the oral directive shall be documented as soon as possible in writing in the patient's record. A written directive shall be prepared within 48 hours of the oral directive.
B. The written directive shall contain the patient or human research subject's name and the following information:
1. For any administration of quantities greater than 30 µCi (1.11 MBq) of sodium iodide (I-131): the dosage;
2. For an administration of a therapeutic dosage of unsealed radioactive material other than sodium iodide (I-131): the radioactive drug, dosage, and route of administration;
3. For gamma stereotactic radiosurgery: the total dose, treatment site, and values for the target coordinate settings per treatment for each anatomically distinct treatment site;
4. For teletherapy: the total dose, dose per fraction, number of fractions, and treatment site;
5. For high dose-rate remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions, and total dose;
6. For permanent implant brachytherapy:
a. Before implantation: treatment site, the radionuclide, and the total source strength; and
b. After implantation but before the patient leaves the post-treatment recovery area: treatment site, number of sources implanted, total source strength implanted, and the date; or
7. For all other brachytherapy, including low, medium and pulsed dose rate remote afterloaders:
a. Before implantation: treatment site, the radionuclide, and dose; and
b. After implantation but before completion of the procedure: the radionuclide, treatment site, number of sources, and total source strength and exposure time (or the total dose) and date.
C. A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user before the administration of the dosage of radioactive drug containing radioactive material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose.
If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive is acceptable. The oral revision shall be documented as soon as possible in the patient's record. A revised written directive shall be signed by the authorized user within 48 hours of the oral revision.
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; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.
12VAC5-481-1730. Procedures for administrations requiring a written directive.
For any administration requiring a written directive, licensees shall develop, implement, and maintain written directive procedures to provide high confidence that the patient's or human research subject's identity is verified before each administration and each administration is in accordance with the written directive. A licensee shall retain a copy of the procedures required by this section in accordance with 12VAC5-481-2070. At a minimum, the procedures required by this section shall address the following items that are applicable to the licensee's use of radioactive material:
1. Verifying the identity of the patient or human research subject;
2. Verifying that the specific details of the administration are in accordance with the treatment plan, if applicable, and the written directive;
3. Checking both manual and computer-generated dose calculations;
4. Verifying that all computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by 12VAC5-481-2040 B and C and 12VAC5-481-2060;
5. Determining if a medical event, as defined in 12VAC5-481-2080, has occurred; and
6. Determining, for permanent implant brachytherapy, within 60 calendar days from the date the implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-implantation portion of the written directive unless a written justification of patient unavailability is documented.
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; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.
12VAC5-481-1740. Suppliers for sealed sources or devices for medical use.
For medical use, licensees may only use the following:
1. Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a license issued under this part or equivalent requirements of the NRC or another agreement state;
2. Sealed sources or devices non-commercially transferred from another medical use licensee;
3. Teletherapy sources manufactured and distributed in accordance with a license issued under Part III (12VAC5-481-380 et seq.) of this chapter or equivalent requirements of the NRC or 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; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-1750. Training for radiation safety officer and associate radiation safety officer.
Except as provided in 12VAC5-481-1780, licensees shall require an individual fulfilling the responsibilities of the radiation safety officer (RSO) or an individual assigned duties and tasks as an associate radiation safety officer as provided in 12VAC5-481-1700 to be an individual who:
1. Is certified by a specialty board who has been recognized by the agency, the NRC, or an agreement state and who meets the requirements of subdivision 5 of this section. The names of