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Amend Regulations to Conform to Changes in Federal Regulations
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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.

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

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

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

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

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

"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 (73 Stat. 689) (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 12VAC5-481-3690 10 CFR Part 20, Appendix B; 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 offsite.

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

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

"Analytical x-ray system" means a group of components utilizing x-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 12VAC5-481-3690 10 CFR Part 20, Appendix B.

"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.

"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.

"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.

"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.

"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.

"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. 12VAC5-481-2010 12VAC5-481-2018;

g. 12VAC5-481-2030;

h. 12VAC5-481-2040; or

2. Is identified as an authorized user on:

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

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

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

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

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

"Background 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.

"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 Pub. L. 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:

http://leg5.state.va.us/images/664255964679LEGAB_files/image001.gif

where:

s = Standard deviation of the observed values;

X̅ = 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 any clearing of land, excavation, or other substantial action that would adversely affect the environment of a land disposal facility. The term does not mean disposal site exploration, necessary roads for disposal site exploration, borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the disposal site or the protection of environmental values 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" is 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 = Σ (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 +7T of the dose profile along a line perpendicular to the tomographic plane divided by the product of the nominal tomographic section thickness and the number of tomograms produced in a single scan, that is:

http://leg5.state.va.us/images/664618692977LEGAB_files/image001.gif

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.

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

http://leg5.state.va.us/images/664618692977LEGAB_files/image002.gif

where:

μx = Linear attenuation coefficient of the material of interest;
μw = Linear attenuation coefficient of water;
http://leg5.state.va.us/images/647598334281LEGAB_files/image003.gif = of the material of interest;
http://leg5.state.va.us/images/647598334281LEGAB_files/image004.gif = 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.

"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 containing fissile material during transportation. Determination of the criticality safety index is described in Part XIII (12VAC5-481-2950 et seq.).

"CS" (See "Contrast scale").

"CT" (See "Computed tomography").

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

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

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

"CTN" (See "CT number").

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

http://leg5.state.va.us/images/647599454951LEGAB_files/image001.gif

where:     

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

http://leg5.state.va.us/images/664618692977LEGAB_files/image003.gif = Linear attenuation coefficient of the material of interest;

http://leg5.state.va.us/images/664618692977LEGAB_files/image004.gif = 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" means is a unit of quantity of activity. One curie (Ci) is that quantity of radioactive material that decays at the rate of 3.7E+10 disintegrations or transformations per second (dps or tps).

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

"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 commission or Agreement State 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 part 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 Pub. L. 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 (Pub. L. (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 (Pub. L. (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 12VAC5-481-3690 10 CFR Part 20, Appendix B.

"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 = Σ wTHT).

"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 EPA the U.S. Environmental Protection Agency as required by 40 CFR Part 263.

"Equipment" (See "X-ray "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 and/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 C 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 (Gy)" 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.

"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 kilabecquerel.

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

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

"Limits" (See "Dose limits").

"Line-voltage regulation" means the difference between the no-load and the load line potentials expressed as a 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 radioactive radionuclide that are not intended to be processed for the use of these radionuclides;

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

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

3. LSA-III

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

a. The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (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 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 nuclear medicine service" means the transportation and medical use of radioactive material.

"Mobile x-ray equipment" (See "X-ray "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:

http://leg5.state.va.us/images/664618692977LEGAB_files/image005.gif

where:

http://leg5.state.va.us/images/665129392481LEGAB_files/image001.gif = Linear attenuation coefficient of the material of interest.

http://leg5.state.va.us/images/665129392481LEGAB_files/image002.gif = 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 part 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.

"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 "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, or a radiation safety officer.

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

1. In a written directive; or

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

"Prescribed dose" means:

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

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

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

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

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

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

"Primary protective barrier" 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 purpose(s) for which the license was issued or amended. Storage during which no licensed material is accessed for use or disposal and activities incidental to decontamination or decommissioning are not principal activities.

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

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

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

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

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

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

"Protective 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.

"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.

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

"Special nuclear material" means:

1. Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material the 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:

http://leg5.state.va.us/images/664618692977LEGAB_files/image007.gif

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

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

"Spot-film device" means a device intended to transport and/or 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 "x-ray equipment").

"Stochastic effect" means a health effect that occurs randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects. For purposes of these regulations, "probabilistic effect" is an equivalent term.

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

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

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

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

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

"Supplied-air respirator," "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 4 E+04 becquerel per cm² (1.0 μCi/cm²) for beta and gamma and low toxicity alpha emitters, or 4 E+03 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 4 E+04 becquerel per cm² (1 μCi/cm²) for beta and gamma and low toxicity alpha emitters, or 4 E+03 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 8 E+05 becquerel per cm² (20 μCi/cm²) for beta and gamma and low toxicity alpha emitters, or 8 E+04 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 8 E+05 becquerel per cm² (20 μCi/cm²) for beta and gamma and low toxicity alpha emitters, or 8 E+04 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.

"Technologically Enhanced Naturally Occurring Radioactive Material" 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 or both, 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 location(s) 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.

"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 which 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 ft)).

"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 and/or and 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 A-1 of 12VAC5-481-3770 or may be determined by procedures described in Table A-1 of 12VAC5-481-3770.

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

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

"Underwater radiography" means radiographic operations performed when the radiographic exposure device or radiation machine and/or 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 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 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 and/or 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 1.3E+5 MeV of potential alpha particle energy. The short-lived radon daughters of radon-222 are polonium-218, lead-214, bismuth-214, and polonium-214; and those of radon-220 are polonium-216, lead-212, bismuth-212, and polonium-212.

"Working level month" 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 order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation, except as specified in subdivision 6 of this definition, containing the following information:

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

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

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

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

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

6. For all other brachytherapy,

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

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

"X-ray 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 and/or and terminates the radiation exposure. The x-ray exposure control may include such associated equipment as timers and back-up timers.

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

1. "Mobile x-ray equipment" means x-ray equipment mounted on a permanent base with wheels and/or 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 tube(s) tube or 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 and/or fluoroscopy. This includes, but is not limited to, any stretcher equipped with a radiolucent panel and any table equipped with a cassette tray (or bucky), cassette tunnel, 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.

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

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

12VAC5-481-250. Units of radioactivity.

The following regulation, Units of radioactivity (10 CFR 20.1005) is applicable and identical in the Commonwealth of Virginia. 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.

Article 2
Exemptions from the Regulatory Requirements

12VAC5-481-390. Source material.

The following regulations, Carriers (10 CFR 40.12 (a)) and Unimportant quantities of source material (10 CFR 40.13) are applicable in the Commonwealth of Virginia.

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 Part III (12VAC5-481-380 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 counterweights are not manufactured for a military purpose using Australian-obligated source material.

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 manufacturing processes other than the assembly of such lens into optical systems and devices without any alteration of the lens; 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 section 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 adoption of this subdivision. 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 adoption of this chapter.

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 (12VAC5-481-1170 et seq.) of this chapter.

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

A. Exempt concentrations. The following regulation, Exempt concentrations (10 CFR 30.14) is applicable in the Commonwealth of Virginia and include the regulation of natural occurring and accelerator produced radioactive materials (NARM).

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. The following regulation, Exempt quantities (10 CFR 30.18) is applicable in the Commonwealth of Virginia and include the regulation of NARM. The exemption stated in paragraph (b) of 10 CFR 30.18 does not apply for radium-226.

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. The following regulation, Certain items containing byproduct material (10 CFR 30.15) is applicable in the Commonwealth of Virginia and include the regulation of NARM. The following item is specifically included: 37 kBq (1μCi) of radium-226 per timepiece in timepieces acquired prior to September 1, 1980.

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. The following regulation, Self-luminous products containing tritium, krypton-85, or promethium-147 (10 CFR 30.19) is applicable in the Commonwealth of Virginia and includes the regulation of NARM. In addition, any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers, or owns articles containing less than 3.7 kBq (0.1 μCi) of radium-226 that were acquired prior to September 1, 1980.

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. The following regulation, Gas and aerosol detectors containing byproduct material (10CFR 30.20) is applicable in the Commonwealth of Virginia and include the regulation of NARM. 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 subsection E, should apply to the agency for a license in accordance with 12VAC5-481-480 C.

2. 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.

3. 4. Gas and aerosol detectors containing NARM previously manufactured and distributed in accordance with a specific license issued by a licensing state 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. The following regulation, Capsules containing carbon-14 urea for "in-vivo" diagnostic use for humans (10 CFR 30.21(a), (b) and (d)) is applicable in the Commonwealth of Virginia.

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. Special nuclear material. The following regulation, Carriers (10 CFR 70.12) is applicable in the Commonwealth of Virginia. 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 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.

Article 3
Licenses

12VAC5-481-410. Types of licenses.

The following regulations, Types of licenses (10 CFR 30.31, 10 CFR 40.20(a) and 10 CFR 70.18) are applicable in the Commonwealth of Virginia, and include the regulation of NARM. 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.

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

A. Small quantities of source material. The following regulation, Small quantities of source material (10 CFR 40.22) is applicable in the Commonwealth of Virginia.

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 byproduct radioactive material. The following regulation, General license to receive title to source or byproduct material (10 CFR 40.21) is applicable in the Commonwealth of Virginia. 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. The following regulation, General license for use of certain industrial products or devices (10 CFR 40.25) is applicable in the Commonwealth of Virginia.

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.

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 paragraph 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 Federal and State Materials and Environmental Management Programs, 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 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.

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

A. Certain devices and equipment. The following regulations, Certain devices and equipment (10 CFR 31.3) and Terms and Conditions (10 CFR 31.2) are applicable in the Commonwealth of Virginia.

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

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

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 byproduct radioactive material. The following regulations, General license to own byproduct material (10 CFR 31.9), Terms and Conditions (10 CFR 31.2) and General license to own special nuclear material (10 CFR 70.20) are applicable in the Commonwealth of Virginia and includes NARM.

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. The following regulations, Americium-241 in the form of calibration or reference sources (10 CFR 31.8), Terms and Conditions (10 CFR 31.2) and General license for calibration or reference sources (10 CFR 70.19) are applicable in the Commonwealth of Virginia and include NARM. 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, any or another agreement state or licensing state pursuant to licensing requirements equivalent to those contained in 10 CFR 32.57 or 10 CFR Part 70.39.

5. The general licenses provided in 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 185 kBq (5 μCi) 5 μCi (185 kBq) of americium-241, 185 kBq ( 5 μCi) of plutonium, or 185 kBq (5 μCi) of radium-226 in such sources;

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

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

CAUTION—RADIOACTIVE MATERIAL

THIS SOURCE CONTAINS (AMERICIUM-241).

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

DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

____________________Name of manufacturer or importer

(2) The receipt, possession, use, and transfer of this source, Model __________, Serial No. __________, are subject to a general license and the regulations of a licensing state. Do not remove this label.

CAUTION—RADIOACTIVE MATERIAL

THIS SOURCE CONTAINS RADIUM-226.

DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

____________________Name of manufacturer or importer

c. Shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license from the agency, the 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.

The following regulations, General license for use of byproduct material for certain in vitro clinical or laboratory testing (10 CFR 31.11) and Terms and Conditions (10 CFR 31.2) are applicable in the Commonwealth of Virginia and include NARM.

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. Ice detection devices. The following regulations, General license for use strontium-90 in ice detection devices (10 CFR 31.10) and Terms and Conditions (10 CFR 31.2) are applicable in the Commonwealth of Virginia. 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 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. The following regulations, General license for certain items and self-luminous products containing radium-226 (10 CFR 31.12) and Terms and Conditions (10 CFR 31.2) are applicable in the Commonwealth of Virginia.

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.

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 must 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); or

3. For sources or devices containing NARM radioactive material manufactured prior to November 30, 2007 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 must 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 must 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 must 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 must 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 must 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 must 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 half-life greater than 100 days, the time may be omitted.

(2) A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must 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.

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; and

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

5. 6.The applicant satisfies any applicable special requirements in 12VAC5-481-460, 12VAC5-481-470, 12VAC5-481-480, Part V (12VAC5-481-1170 et seq.), Part VII (12VAC5-481-1660 et seq.), Part XI (12VAC5-481-2330 et seq.), 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. Decommissioning funding plan.

a. A decommissioning funding plan shall include all the following information:

(1) A cost estimate for decommissioning that considers all of the following:

(a) Probable extent of contamination through the use or possession of radioactive material at the facility or site and the projected cost of removal of the contamination to a level specified by the agency. The evaluation shall encompass probable contaminating events associated with the licensee's or applicant's operation and shall be based on factors such as quantity, half-life, radiation hazard, toxicity and chemical and physical forms.

(b) The extent of possible offsite property damage caused by operation of the facility or site.

(c) The cost of removal and disposal of radiation sources that are or would be generated, stored, processed or otherwise present at the licensed facility or site.

(d) The costs involved in reclaiming the property on which the facility or site is located and all other properties contaminated by radioactive material authorized under the license.

(2) A description of the method of assuring funds for decommissioning according to subdivision 7 of this subsection.

(3) A description of the method for adjusting cost estimates and associated funding levels periodically over the life of the facility.

b. The decommissioning funding plan shall also contain the licensee's certification that financial assurance has been provided in the amount of the cost estimate for decommissioning and a signed original of the financial instrument obtained to satisfy the requirements of subdivision 7 of this subsection.

7. A licensee may use any of the following methods to provide financial assurance for decommissioning:

a. Prepayment. Prepayment is the deposit prior to operation into an account segregated from licensee assets and outside the licensee's administrative control of cash or liquid assets in an amount sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit or deposit of government securities. 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 must 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.

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 above3

 

 

See footnote 4 below

 

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…. ≥ 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 must ensure that the individuals specified in subdivision 1 c of this subsection are trustworthy and reliable.

b. 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.

c. 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.

d. 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. 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 but not limited to, 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 12VAC5-481-451, "Increased controls and fingerprinting," 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 submit to the U.S. Nuclear Regulatory Commission, Director, Division of Facilities and Security, 11545 Rockville Pike, ATTN: Criminal History Program/Mail Stop T-03B46M, Rockville, MD, 20852-2738, 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 writing the Office of Information Services, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by calling (630) 829-9565, or by email to forms.resource@nrc.gov. Guidance on submitting electronic fingerprints can be found at http://www.nrc.gov/site-help/e-submittals.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 Security Branch, Division of Facilities and Security at (301) 492-3531.) 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 Electronic Submittals page at http://www.nrc.gov/site-help/e-submittals.html and see the link for the Criminal History Program under Electronic Submission Systems.

(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 § 274 i. of the Atomic Energy Act (42 USC § 2021i);

(7) (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;

(8) (9) Emergency response personnel who are responding to an emergency;

(9) (10) Commercial vehicle drivers for road shipments of Category 2 quantities of radioactive material;

(10) (11) Package handlers at transportation facilities such as freight terminals and railroad yards;

(11) (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

(12) (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, but are not limited to:

(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 and implementing procedures.

(3) Before granting an individual access to the security plan or implementing procedures, licensees shall:

(a) Evaluate an individual's need to know the security plan or implementing procedures; 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 or implementing procedures.

(6) Licensees shall maintain a list of persons currently approved for access to the security plan or implementing procedures. When a licensee determines that a person no longer needs access to the security plan or implementing procedures 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 or implementing procedures.

(7) When not in use, the licensee shall store its security plan and implementing procedures 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 or implementing procedures 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 804-624-2400 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 804-624-2400 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 http://nrc-stp.ornl.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.

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.

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, but not be limited to, 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, but not be limited to, 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. 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.

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, D.C. 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; and

c. Each device bears a durable, legible, clearly visible label or labels approved by the agency, which contain in a clearly identified and separate statement:

(1) Instructions and precautions necessary to assure safe installation, operation, and servicing of the device; documents such as operating and service manuals may be identified in the label and used to provide this information;

(2) The requirement, or lack of requirement, for leak testing, or for testing any "on-off" mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and

(3) The information called for in one of the following statements, as appropriate, in the same or substantially similar form:

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

CAUTION—RADIOACTIVE MATERIAL

____________________Name of manufacturer or 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 must shall be maintained for a period of three years following the date of the recorded event.

D. Special requirements for the manufacture, initially transfer, assembly, or repair of luminous safety devices for use in aircraft. An application for a specific license to manufacture, assemble, or repair luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under 12VAC5-481-430 D will be approved if:

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

2. The applicant satisfies the requirements of 10 CFR 32.53, 32.54, 32.55, 32.56, 32.101 and 32.110, or their equivalent. 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 4 d 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; or

(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; and

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, 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 in 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 U.S. 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 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 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. 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 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 to (i) the NRC at Director, Office of Federal and State Materials and Environmental Management Programs, 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; and

2. The applicant satisfies the requirements of 10 CFR 32.57, 32.58, 32.59, 32.102 and 10 CFR 70.39 or their equivalent. 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 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, 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 must 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; and

2. The criteria of 10 CFR 32.61, 32.62, 32.103 and 32.110 are met. 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 which 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; or

(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.

8. Quality assurance; prohibition of transfer.

a. Each person licensed under this subsection shall visually inspect each device and shall reject any which 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, 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 subdivision 8 c (2) 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 satisfies the following labeling requirements:

(1) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label must 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 must 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 in 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.

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 or for the uses listed in 12VAC5-481-2010, 12VAC5-481-2020, 12VAC5-481-2040 and 12VAC5-481-2060 will be approved if:

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

2. The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

a. The radioactive material contained, its chemical and physical form, and amount;

b. Details of design and construction of the source or device;

c. Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents;

d. For devices containing radioactive material, the radiation profile of a prototype device;

e. Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests;

f. Procedures and standards for calibrating sources and devices;

g. Legend and methods for labeling sources and devices as to their radioactive content; and

h. Instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device provided, that instructions that are too lengthy for such label may be summarized on the label and printed in detail on a brochure that is referenced on the label;

3. The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, and date of assay, and a statement that the source or device is licensed by the agency for distribution to persons licensed pursuant to 12VAC5-481-1830, 12VAC5-481-2010, 12VAC5-481-2020 and 12VAC5-481-2040 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; and

5. In determining the acceptable interval for test of leakage of radioactive material, the agency will consider information that includes, but is not limited to:

a. Primary containment or source capsule;

b. Protection of primary containment;

c. Method of sealing containment;

d. Containment construction materials;

e. Form of contained radioactive material;

f. Maximum temperature withstood during prototype tests;

g. Maximum pressure withstood during prototype tests;

h. Maximum quantity of contained radioactive material;

i. Radiotoxicity of contained radioactive material; and

j. Operating experience with identical sources or devices or similarly designed and constructed sources or devices; 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(s) of the industrial product or device cannot be reasonably foreseen.

4. Each person licensed pursuant to subdivision 1 of this subsection shall:

a. Maintain the level of quality control required by the license in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device;

b. Label or mark each unit to:

(1) Identify the manufacturer or initial transferor of the product or device and the number of the license under which the product or device was manufactured or initially transferred, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and

(2) State that the receipt, possession, use, and transfer of the product or device are subject to a general license or the equivalent and the regulations of the 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 must shall be composed only of alpha-numeric characters.

Article 9
Reciprocity

12VAC5-481-590. Reciprocal recognition of licenses.

A. Licenses of byproduct 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 this state the Commonwealth for a period not in excess of 180 days in any calendar year 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 in writing at least three days prior to engaging in such activity. Such notification shall indicate the location, period, and type of proposed possession and use within the state, and shall be accompanied by a copy of the pertinent licensing document. If, for a specific case, the three-day period would impose an undue hardship on the out-of-state licensee, the licensee may, upon application to the agency, obtain permission to proceed sooner. The agency may waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general license provided in this subdivision;

c. The out-of-state licensee complies with all applicable regulations of the agency and with all the terms and conditions of the licensing document, except any such terms and conditions that may be inconsistent with applicable regulations of the agency;

d. The out-of-state licensee supplies such other information as the agency may request; and

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

(1) Specifically licensed by the agency, 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 A 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.

B. Licenses of NARM.

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 this state for a period not in excess of 180 days in any calendar year provided that:

a. The licensing document does not limit the activity authorized by such document to specified installations or locations;

b. The out-of-state licensee notifies the agency in writing at least three days prior to engaging in such activity. Such notification shall indicate the location, period, and type of proposed possession and use within the state, and shall be accompanied by a copy of the pertinent licensing document. If, for a specific case, the three-day period would impose an undue hardship on the out-of-state licensee, the licensee may, upon application to the agency, obtain permission to proceed sooner. The agency may waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general license provided in subdivision 1 of this subsection;

c. The out-of-state licensee complies with all applicable regulations of the agency and with all the terms and conditions of the licensing document, except any such terms and conditions which may be inconsistent with applicable regulations of the agency;

d. The out-of-state licensee supplies such other information as the agency may request; and

e. The out-of-state licensee shall not transfer or dispose of radioactive material possessed or used under the general license provided in subdivision 1 of this subsection except by transfer to a person:

(1) Specifically licensed by the agency, the NRC or another agreement state to receive such material, or

(2) Exempt from the requirements for a license for such material under 12VAC5-481-400.

2. Notwithstanding the provisions of subdivision 1 of this subsection, any person who holds a specific license issued by 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.

Article 2
Radiation Protection Programs

12VAC5-481-630. Radiation protection programs.

The following regulation, Radiation protection programs (10 CFR 20.1101) is applicable in the Commonwealth of Virginia.

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.

Article 3
Occupational Dose Limits

12VAC5-481-640. Occupational dose limits for adults.

The following regulation, Occupational dose limits for adults (10 CFR 20.1201) is applicable in the Commonwealth of Virginia.

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).

12VAC5-481-650. Compliance with requirements for summation of external and internal doses.

The following regulation, Compliance with requirements for summation of external and internal doses (10 CFR 20.1202) is applicable in the Commonwealth of Virginia.

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.

12VAC5-481-660. Determination of external dose from airborne radioactive material.

The following regulation, Determination of external dose from airborne radioactive material (10 CFR 20.1203) is applicable in the Commonwealth of Virginia.

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.

12VAC5-481-670. Determination of internal exposure.

The following regulation, Determination of internal exposure (10 CFR 20.1204) is applicable in the Commonwealth of Virginia.

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.

12VAC5-481-690. Planned special exposures.

The following regulation, Planned special exposures (10 CFR 20.1206) is applicable in the Commonwealth of Virginia.

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.

12VAC5-481-700. Occupational dose limits for minors.

The following regulation, Occupational dose limits for minors (10 CFR 20.1207) is applicable in the Commonwealth of Virginia. The annual occupational dose limits for minors are 10% of the annual dose limits specified for adult workers in 12VAC5-481-640.

12VAC5-481-710. Dose to an embryo/fetus.

The following regulation, Dose to an embryo/fetus (10 CFR 20.1208) is applicable in the Commonwealth of Virginia.

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.

Article 4
Radiation Dose Limits for Individual Members of the Public

12VAC5-481-720. Dose limits for individual members of the public.

The following regulation, Dose limits for individual members of the public (10 CFR20.1301) is applicable in the Commonwealth of Virginia.

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.

12VAC5-481-730. Compliance with dose limits for individual members of the public.

The following regulation, Compliance with dose limits for individual members of the public (10 CFR 20.1302) is applicable in the Commonwealth of Virginia. 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).

Article 6
Surveys and Monitoring

12VAC5-481-750. General.

The following regulation, (10 CFR 20.1501) is applicable in the Commonwealth of Virginia. 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.

12VAC5-481-760. Conditions requiring individual monitoring of external and internal occupational dose.

The following regulation, Conditions requiring individual monitoring of external and internal occupational dose (10 CFR 20.1502) is applicable in the Commonwealth of Virginia. 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).

Article 7
Control of Exposure from External Sources in Restricted Areas

12VAC5-481-780. Control of access to high radiation areas.

A. The following regulation, Control of access to high radiation areas (10 CFR 20.1601) is applicable in the Commonwealth of Virginia. 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.

B. 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.

Article 8
Respiratory Protection and Controls to Restrict Internal Exposure in Restricted Areas

12VAC5-481-810. Use of process or other engineering controls.

The following regulation, Use of process or other engineering controls (10 CFR 20.1701) is applicable in the Commonwealth of Virginia. 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.

12VAC5-481-820. Use of other controls.

The following regulation, Use of other controls (10 CFR 20.1702) is applicable in the Commonwealth of Virginia.

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.

12VAC5-481-830. Use of individual respiratory protection equipment.

The following regulations, Use of individual respiratory protection equipment (10 CFR 20.1703), Further restrictions on the use of respiratory protection equipment, (10 CFR 20.1704), and Applications for use of higher assigned protection factors (10 CFR 20.1705) are applicable in the Commonwealth of Virginia. 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.

Article 9
Security and Control of Licensed or Registered Sources of Radiation

12VAC5-481-840. Security and control of licensed or registered sources of radiation.

A. The following regulations, Security of stored materials (10 CFR 20.1801), and Control of material not in storage (10 CFR 20.1802) are applicable in the Commonwealth of Virginia. 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. Security requirements for portable gauges. Each portable gauge licensee shall use a minimum of two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee.

Article 10
Precautionary Procedures

12VAC5-481-850. Caution Radiation symbol; caution signs.

The following regulation, Caution signs (10 CFR 20.1901) is applicable in the Commonwealth of Virginia. 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.

radsym.gif

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.

12VAC5-481-860. Posting requirements.

The following regulation, Posting requirements (10 CFR 20.1902) is applicable in the Commonwealth of Virginia. 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 and the words "CAUTION, RADIOACTIVE MATERIALS" or "DANGER, RADIOACTIVE MATERIALS."

12VAC5-481-870. Exceptions to posting requirements.

The following regulation, Exceptions to posting requirements (10 CFR 20.1903) is applicable in the Commonwealth of Virginia. 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.

12VAC5-481-880. Labeling containers and radiation machines.

A. The following regulation, Labeling containers (10 CFR 20.1904) is applicable in the Commonwealth of Virginia. 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.

12VAC5-481-890. Exemptions to labeling requirements.

The following regulation, Exemptions to labeling requirements (10 CFR 20.1905) is applicable in the Commonwealth of Virginia. 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.

12VAC5-481-900. Procedures for receiving and opening packages.

The following regulation, Procedures for receiving and opening packages (10 CFR 20.1906) is applicable in the Commonwealth of Virginia.

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.

Article 11
Waste Disposal

12VAC5-481-910. General requirements.

The following regulation, General requirements (10 CFR 20.2001) is applicable in the Commonwealth of Virginia.

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.

12VAC5-481-930. Disposal by release into sanitary sewerage.

The following regulation, Disposal by release into sanitary sewerage (10 CFR 20.2003) is applicable in the Commonwealth of Virginia.

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 12VAC5-481-3690; and

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.

12VAC5-481-940. Treatment or disposal by incineration.

The following regulation, Treatment or disposal by incineration (10 CFR 20.2004) is applicable in the Commonwealth of Virginia. 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.

12VAC5-481-950. Disposal of specific wastes.

The following regulation, Disposal of specific wastes (10 CFR 20.2005) is applicable in the Commonwealth of Virginia. 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.

12VAC5-481-960. Transfer for disposal and manifests.

The following regulation, Transfer for disposal and manifests (10 CFR 20.2006) is applicable in the Commonwealth of Virginia. 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.

12VAC5-481-970. Compliance with environmental and health protection regulations.

The following regulation, Compliance with environmental and health protection regulations (10 CFR 20.2007) is applicable in the Commonwealth of Virginia. 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.

12VAC5-481-971. Disposal of certain byproduct radioactive material.

The following regulation, Disposal of certain byproduct material (10 CFR 20.2008) is applicable in the Commonwealth of Virginia. 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.).

Article 12
Records

12VAC5-481-980. General provisions.

The following regulation, General Provisions (10 CFR 20.2101) is applicable in the Commonwealth of Virginia. 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).

12VAC5-481-990. Records of radiation protection programs.

The following regulation, Records of radiation protection programs (10 CFR 20.2102) is applicable in the Commonwealth of Virginia. 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.

12VAC5-481-1000. Records of surveys.

The following regulation, Records of surveys (10 CFR 20.2103) is applicable in the Commonwealth of Virginia. 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.

12VAC5-481-1030. Records of planned special exposures.

The following regulation, Records of planned special exposures (10 CFR 20.2105) is applicable in the Commonwealth of Virginia. 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.

12VAC5-481-1040. Records of individual monitoring results.

The following regulation, Records of individual monitoring results (10 CFR 20.2106) is applicable in the Commonwealth of Virginia. 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.

Article 13
Reports

12VAC5-481-1090. Reports of stolen, lost, or missing licensed or registered sources of radiation.

A. Telephone reports. Each licensee or registrant shall report to the agency by telephone as follows:

1. Immediately after its occurrence becomes known to the licensee or registrant, stolen, lost, or missing licensed or registered radioactive material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in 12VAC5-481-3700 under such circumstances that it appears to the licensee or registrant that an exposure could result to individuals in unrestricted areas;

2. Within 30 days after its occurrence becomes known to the licensee or registrant, lost, stolen, or missing licensed or registered radioactive material in an aggregate quantity greater than 10 times the quantity specified in 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. Written reports. Each licensee or registrant required to make a report pursuant to subsection A of this section shall, within 30 days after making the telephone report, make a written report to the agency setting forth the following information:

1. A description of the licensed or registered source of radiation involved, including, for radioactive material, the kind, quantity, and chemical and physical form; and, for radiation machines, the manufacturer, model and serial number, type and maximum energy of radiation emitted;

2. A description of the circumstances under which the loss or theft occurred;

3. A statement of disposition, or probable disposition, of the licensed or registered source of radiation involved;

4. Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas;

5. Actions that have been taken, or will be taken, to recover the source of radiation; and

6. Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed or registered sources of radiation.

C. Subsequent to filing the written report, the licensee or registrant shall also report additional substantive information on the loss or theft within 30 days after the licensee or registrant learns of such information.

D. The licensee or registrant shall prepare any report filed with the agency pursuant to this section so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.

12VAC5-481-1100. Notification of incidents.

The following regulation, Notification of incidents (10 CFR 20.2202) is applicable in the Commonwealth of Virginia, and notifications are made by telephone to the agency during normal business hours at (804) 864-8150, and after business hours to the State Emergency Operations Center (804) 674-2400. 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.

12VAC5-481-1110. Reporting requirements.

The following regulations, Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the constraints or limits (10 CFR 20.2203 (a) and (b)) and Reporting requirements (10 CFR 30.50, 10 CFR 40.60, and 10 CFR 70.50(a)(b)(c)) are applicable in the Commonwealth of Virginia, and reports are submitted to the agency at the following address: 109 Governor Street, Room 730, Richmond, VA 23219. 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) 624-2400.

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) 624-2400 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.

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.

12VAC5-481-1161. Radiological criteria for license termination.

A. General provisions and applicability.

1. This part applies to the decommissioning of facilities licensed under this chapter.

2. This part does not apply to sites that:

a. Have been decommissioned before the effective date as stated in 12VAC5-481-160; or

b. Have previously submitted and received NRC's approval on a license termination plan or decommissioning plan.

3. After a site has been decommissioned and the license terminated according to this section, the agency shall require additional cleanup only if, based on new information, the agency determines that the criteria of this part were not met and residual radioactivity remaining at the site could result in a significant threat to public health and safety.

4. When calculating the Total Effective Dose Equivalent (TEDE) to the average member of the critical group, the licensee must 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 must 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 must 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 must 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 must 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 must 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.

2. 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 must 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 US 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 State 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.

12VAC5-481-1290. Labeling, storage, and transportation.

A. The licensee 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. The licensee 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, must 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. The licensee Licensees shall lock and physically secure the transport package containing radioactive material in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal.

E. The licensee's or registrant's name and city or town where the main business office is located shall be prominently displayed with a durable, clearly visible label(s) on both sides of all vehicles used to transport radioactive material or radiation machines for temporary job site use.

Article 4
Notifications

12VAC5-481-1530. Notifications.

A. In addition to the reporting requirements specified in 10 CFR 30.50 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.

Article 2
General Information

12VAC5-481-1670. General requirements.

The following regulations, Maintenance of records (10 CFR 35.5), Provisions for the protection of human research subjects (10 CFR 35.6), FDA, other Federal, and State requirements (10 CFR 35.7), and Implementation (10 CFR 35.10) are applicable in the Commonwealth of Virginia. 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.

12VAC5-481-1680. Licensing and exemptions.

The following regulations, License required (10 CFR 35.11(a) and (b)), Application for license, amendment, or renewal (10 CFR 35.12), Exemptions regarding Type A licenses of broad scope (10 CFR 35.15), License issuance (10 CFR 35.18), and Specific exemptions (10 CFR 35.19) are applicable in the Commonwealth of Virginia. 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, 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 12VAC5-481-2046, 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. The provisions of 12VAC5-481-500, regarding additions to or changes in any authorized user, authorized nuclear pharmacist, or authorized medical physicist.

3. The provisions of 12VAC5-481-500, regarding 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.

12VAC5-481-1690. Notifications.

The following regulation, Notifications (10 CFR 35.14) is applicable in the Commonwealth of Virginia. 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, or an authorized medical physicist, under 12VAC5-481-500:

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 A 2 a (2) (g) 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, 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.

Article 3
General Administrative Requirements

12VAC5-481-1700. Authority and responsibilities for the radiation protection programs and changes.

The following regulations, Authority and responsibilities for the radiation protection programs (10 CFR 35.24), and Radiation Protection program changes (10 CFR 35.26) are applicable in the Commonwealth of Virginia. A. In addition to the radiation protection program requirements of 12VAC5-481-630, the licensee's management or designee 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 F 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. This written document shall establish the authority, duties, and responsibilities of the RSO.  Licensees, through the RSO, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements. Licensees shall provide the RSO sufficient authority, organization 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.

C. For up to 60 days each year, licensees may permit an authorized user or an individual qualified to be a RSO, under 12VAC5-481-1750 and 12VAC5-481-1790, to function as a temporary radiation safety officer, 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. Licensees may simultaneously appoint more than one temporary RSO in accordance with subsection C of this section, if needed to ensure that the temporary RSO satisfies the requirements to be a RSO for each of the different types of uses of radioactive material permitted by the licensee.

E. Licensees that are 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 shall include an authorized user for 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 a RSO. The RSC may include other members the licensee considers appropriate.

F. 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, 12VAC5-481-500, 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.

12VAC5-481-1710. Supervision.

The following regulation, Supervision (10 CFR 35.27) is applicable in the Commonwealth of Virginia. 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.

12VAC5-481-1720. Written directives.

The following regulation, Written directives (10 CFR 35.40) is applicable in the Commonwealth of Virginia. 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; or

6. 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).

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.

12VAC5-481-1730. Procedures for administrations requiring a written directive.

The following regulation, Procedures for administrations requiring a written directive (10 CFR 35.41) is applicable in the Commonwealth of Virginia. 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. 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; and

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 12VAC5-481-2060.

12VAC5-481-1740. Suppliers for sealed sources or devices for medical use.

The following regulation, Suppliers for sealed sources or devices for medical use (10 CFR 35.49) is applicable in the Commonwealth of Virginia. 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.

12VAC5-481-1750. Training for Radiation Safety Officer radiation safety officer.

The following regulation, Training for Radiation Safety Officer (10 CFR 35.50) is applicable in the Commonwealth of Virginia. Except as provided in 12VAC5-481-1780, licensees shall require an individual fulfilling the responsibilities of the radiation safety officer (RSO) as provided in 12VAC5-481-1700 to be an individual who:

1. Is certified by a specialty board who has been recognized by the NRC; or

2. Has completed a structured educational program consisting of provisions, as follows:

a. 200 hours of classroom and laboratory training in the following areas:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of radioactivity;

(3) Radiation biology; and

(4) Radiation dosimetry; and

b. One year of full-time radiation safety experience under the supervision of the individual identified as the RSO on an agency, NRC, or another agreement state license or permit issued by a master material licensee that authorizes similar types of uses of radioactive material involving the following:

(1) Shipping, receiving, and performing related radiation surveys;

(2) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides;

(3) Securing and controlling radioactive material;

(4) Using administrative controls to avoid mistakes in the administration of radioactive material;

(5) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures;

(6) Using emergency procedures to control radioactive material; and

(7) Disposing of radioactive material; or

3. Meets the following qualifications:

a. Is a medical physicist who has been certified by a specialty board whose certification process has been recognized by the NRC under 12VAC5-481-1760 A 1 and has experience in radiation safety for similar types of use of radioactive material for which the licensee is seeking the approval of the individual as RSO and who meets the requirements in subdivisions 4 and 5 of this section; or

b. Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on the license and has experience with the radiation safety aspects of similar types of use of radioactive material for which the individual has RSO responsibilities; and meets subdivisions 4 and 5 of this section; and

4. Has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval. This training requirement may be satisfied by completing training that is supervised by a RSO, authorized medical physicist, authorized nuclear pharmacist, or authorized user, as appropriate, who is authorized for the types of use for which the licensee is seeking approval; and

5. Has obtained written attestation, signed by a preceptor RSO, that the individual has satisfactorily completed the requirements in subdivisions 1, 2, or 3; and 4 of this section, and has achieved a level of radiation safety knowledge sufficient to function independently as a RSO for a medical use licensee.

12VAC5-481-1760. Training for an authorized medical physicist.

The following regulation, Training for an authorized medical physicist (10 CFR 35.51) is applicable in the Commonwealth of Virginia. Except as provided in 12VAC5-481-1780, licensees shall require the authorized medical physicist (AMP) to be an individual who:

1. Is certified by a specialty board whose certification process has been recognized by the NRC, or

2. Meets the following requirements:

a. Holds a master's or doctor's degree in physics, biophysics, radiological physics, medical physics, health physics, other physical science, engineering, or applied mathematics from an accredited college or university or an equivalent training program approved by the agency, the NRC, or another agreement state and has completed one year of full-time training in medical physics and an additional year of full-time practical experience under the supervision of an individual who meets the requirements for an authorized medical physicist for the types of use for which the individual is seeking authorization. This training and work experience shall be conducted in clinical radiation facilities that provide high-energy, external beam therapy (photons and electrons with energies greater than or equal to one million electron volts) and brachytherapy services and shall include:

(1) Performing sealed source leak tests and inventories;

(2) Performing decay corrections;

(3) Performing full calibration and periodic spot checks of external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and

(4) Conducting radiation surveys around external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and

3. Has training for the types of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system. This training requirement may be satisfied by satisfactorily completing either a training program provided by the vendor or by training supervised by an authorized medical physicist authorized for the types of use for which the individual is seeking authorization; and

4. Has obtained written attestation that the individual has satisfactorily completed the requirements of subdivisions 1 or 2; and 3 of this section; and has achieved a level of competency sufficient to function independently as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation shall be signed by a preceptor authorized medical physicist who meets the requirements in 12VAC5-481-1760, 12VAC5-481-1780, or equivalent requirements for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status.

 

12VAC5-481-1770. Training for an authorized nuclear pharmacist.

The following regulation, Training for an authorized nuclear pharmacist (10 CFR 35.55) is applicable in the Commonwealth of Virginia. Except as provided in 12VAC5-481-1780, licensees shall require the authorized nuclear pharmacist (ANP) to be a pharmacist who:

1. Is certified by a specialty board whose certification process has been recognized by the NRC; or

2. Meets the following requirements:

a. Has completed 700 hours in a structured educational program consisting:

(1) 200 hours of classroom and laboratory training in the following areas:

(a) Radiation physics and instrumentation;

(b) Radiation protection;

(c) Mathematics pertaining to the use and measurement of radioactivity;

(d) Chemistry of byproduct material for medical use; and

(e) Radiation biology; and

(2) Supervised practical experience in a nuclear pharmacy involving:

(a) Shipping, receiving, and performing related radiation surveys;

(b) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha-emitting or beta-emitting radionuclides;

(c) Calculating, assaying, and safely preparing dosages for patients or human research subjects;

(d) Using administrative controls to avoid medical events in the administration of radioactive material; and

(e) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and

3. Has obtained written attestation, signed by a preceptor ANP, that the individual has satisfactorily completed the requirements in subdivision 1 or 2 of this section and has achieved a level of competency sufficient to function independently as an ANP.

12VAC5-481-1780. Training for experienced Radiation Safety Officer radiation safety officer, teletherapy or medical physicist, authorized nuclear pharmacist, and authorized user, and pharmacist.

The following regulation, Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and pharmacist (10 CFR 35.57) is applicable in the Commonwealth of Virginia. A. The following applies to individuals with experience as a radiation safety officer (RSO), teletherapy or medical physicist (AMP), or authorized nuclear pharmacist (ANP):

1. An individual identified as an RSO, AMP, or ANP on a specific license or a permit issued by the agency, the NRC, or another agreement state; broad scope licensee or master material license permit; or by a master material license permittee of broad scope that authorizes medical use or the practice of nuclear pharmacy before October 24, 2002, need not comply with the training requirements of 12VAC5-481-1750, 12VAC5-481-1760, or 12VAC5-481-1770, respectively.

2. An individual identified as an RSO, AMP, or ANP on a license or a permit issued by a the agency, NRC, or another agreement state broad scope licensee or master material license permit or by a master material license permittee of broad scope between October 24, 2002, and April 29, 2005, need not comply with the training requirements of 12VAC5-481-1750, 12VAC5-481-1760, or 12VAC5-481-1770, respectively.

3. An RSO, AMP, or ANP, who used only accelerator-produced radioactive materials or discrete sources of radium-226, or both, for medical uses 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, need not comply with the training requirements of 12VAC5-481-1750, 12VAC5-481-1760, or 12VAC5-481-1770, respectively, when performing the same uses. A nuclear pharmacist, who prepared only radioactive drugs containing accelerator-produced radioactive materials, or a medical physicist, who used only accelerator-produced radioactive materials, at the locations and time period identified in this subdivision, qualifies as an authorized nuclear pharmacist or an authorized medical physicist, respectively, for those materials and uses performed before these dates, for purposes of this part.

B. The following applies to experienced authorized users (AU):

1. Physicians, dentists, or podiatrists identified as AUs for the medical use of radioactive material on a license issued by the agency, the NRC, or another agreement state; a permit issued by an NRC master material licensee; a permit issued by an agency, NRC, or other agreement state broad scope licensee; or a permit issued by an NRC master material license broad scope permittee before October 24, 2002, who perform only those medical uses for which they were authorized on that date need not comply with the training requirements of Articles 5 (12VAC5-481-1900 et seq.) through 9 (12VAC5-481-2040 et seq.) of this part.

2. Physicians, dentists, or podiatrists identified as AUs for the medical use of radioactive material on a license issued by the agency, the NRC, or another agreement state; a permit issued by an NRC master material licensee; a permit issued by an agency, NRC, or other agreement state broad scope licensee; or a permit issued by an NRC master material license broad scope permittee who perform only those medical uses for which they were authorized between October 24, 2002, and April 29, 2005, need not comply with the training requirements of Articles 5 (12VAC5-481-1900 et seq.) through 9 (12VAC5-481-2040 et seq.) of this part.

3. Physicians, dentists, or podiatrists who used only accelerator-produced radioactive materials or discrete sources of radium-226, or both, for medical uses performed 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, need not comply with the training requirements of Articles 5 (12VAC5-481-1900 et seq.) through 9 (12VAC5-481-2040 et seq.) of this part when performing the same medical uses. A physician, dentist, or podiatrist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both for medical uses at the locations and time period identified in this subdivision, qualifies as an AU for those materials and uses performed before these dates for purposes of this chapter.

C. Individuals who need not comply with training requirements as described in this section may serve as preceptors for, and supervisors of, applicants seeking authorization on NRC licenses for the same uses for which these individuals are authorized.

12VAC5-481-1790. Recentness of training.

The following regulation, Recentness of training (10 CFR 35.59) is applicable in the Commonwealth of Virginia. The training and experience specified in this article and Articles 5 (12VAC5-481-1900 et seq.), 6 (12VAC5-481-1950 et seq.), 7 (12VAC5-481-2010 et seq.), 8 (12VAC5-481-2020 et seq.), and 9 (12VAC5-481-2040 et seq.) of this part shall have been obtained within the seven years preceding the date of the application or the individual shall have had related continuing education and experience since the required training and experience was completed.

Article 4
General Technical Requirements

12VAC5-481-1800. Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct radioactive material.

The following regulation, Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material (10 CFR 35.60) is applicable in the Commonwealth of Virginia. A. For direct measurements performed in accordance with 12VAC5-481-1820, licensees shall possess and use instrumentation to measure the activity of unsealed radioactive material before it is administered to each patient or human research subject.

B. Licensees shall test the instrumentation required by subsection A of this section in accordance with nationally recognized standards or the manufacturer's instructions.

12VAC5-481-1810. Calibration of survey instruments. (Repealed.)

The following regulation, Calibration of survey instruments (10 CFR 35.61) is applicable in the Commonwealth of Virginia.

12VAC5-481-1820. Determination of dosages of unsealed byproduct radioactive material for medical use.

The following regulation, Determination of dosages of unsealed byproduct material for medical use (10 CFR 35.63) is applicable in the Commonwealth of Virginia. A. Licensees shall determine and record the activity of each dosage before medical use.

B. For a unit dosage, this determination shall be made by:

1. Direct measurement of the radioactivity; or

2. A decay correction based on activity or activity concentration determined by:

a. A manufacturer or preparer licensed under 12VAC5-481-480 I or equivalent NRC or other agreement state requirements;

b. An agency, NRC, or another agreement state licensee for use in research in accordance with Radioactive Drug Research Committee-approved protocol or Investigational New Drug (IND) protocol accepted by FDA; or

c. A PET radioactive drug producer licensed under 12VAC5-481-440 H or equivalent NRC or other agreement state requirements.

C. For other than unit dosages, this determination shall be made by:

1. Direct measurement of radioactivity;

2. Combination of measurement of radioactivity and mathematical calculations; or

3. Combination of volumetric measurements and mathematical calculations, based on the measurement made by:

a. A manufacturer or preparer licensed under 12VAC5-481-480 I or equivalent NRC or other agreement state requirements; or

b. A PET radioactive drug producer licensed under 12VAC5-481-440 H or equivalent NRC or other agreement state requirements.

D. Unless otherwise directed by the authorized user, licensees may not use a dosage if the dosage does not fall within the prescribed dosage range or the dosage differs from the prescribed dosage by more than 20%.

12VAC5-481-1830. Authorization for calibration, transmission, and reference sources.

The following regulation, Authorization for calibration, transmission, and reference sources (10 CFR 35.65) is applicable in the Commonwealth of Virginia. Any person authorized by 12VAC5-481-1680 for medical use of radioactive material may receive, possess, and use any of the following radioactive material for check, calibration, transmission, and reference use:

1. Sealed sources, not exceeding 1.11 GBq (30 mCi) each, manufactured and distributed by a person licensed under 12VAC5-481-480 or equivalent NRC or other agreement state regulations.

2. Sealed sources, not exceeding 1.11 GBq (30 mCi) each, redistributed by a licensee authorized to redistribute the sealed sources manufactured and distributed by a person licensed under 12VAC5-481-480 or equivalent NRC or other agreement state regulations, providing the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer's approved instructions.

3. Any radioactive material with a half-life not longer than 120 days in individual amounts not to exceed 0.56 GBq (15 mCi).

4. Any radioactive material with a half-life longer than 120 days in individual amounts not to exceed the smaller of 7.4 MBq (200 µCi) or 1000 times the quantities in 12VAC5-481-3730.

5. Technetium-99m in amounts as needed.

12VAC5-481-1840. Requirements for possession of sealed sources and brachytherapy sources.

The following regulation, Requirements for possession of sealed sources and brachytherapy sources (10 CFR 35.67) is applicable in the Commonwealth of Virginia. A. Licensees in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer.

B. Licensees in possession of a sealed source shall:

1. Test the source for leakage before its first use unless the licensee has a certificate from the supplied indicating that the source was tested within six months before transfer to the licensee; and

2. Test the source for leakage at intervals not to exceed six months or at other intervals approved by the NRC or another agreement state in the Sealed Source and Device Registry.

C. To satisfy the leak test requirements of this section, licensees shall measure the sample so that the leak test can detect the presence of 0.005 µCi (185 Bq) of radioactive material in the sample.

D. If the leak test reveals the presence of 0.005 µCi (185 Bq) or more of removable contamination, the licensee shall:

1. Immediately withdraw the sealed source from use and store, dispose, or cause it to be repaired in accordance with the requirements in Parts III (12VAC5-481-600 et seq.) and IV (12VAC5-481-380 et seq.) of this chapter; and

2. File a report within five days of the leak test in accordance with 12VAC5-481-2080 C.

E. Licensees need not perform a leak test on the following sources:

1. Containing only radioactive material with a half-life of less than 30 days;

2. Containing only radioactive material as a gas;

3. Containing 100 µCi (3.7 MBq) or less of beta or gamma-emitting material;

4. Containing 10 µCi (0.37 MBq) or less of alpha-emitting material;

4. Seeds of iridium-192 encased in nylon ribbon; and

5. Sources stored and not being used. However, the licensee shall test each such source for leakage before any use or transfer unless it has been leak tested within six months before the date of use or transfer.

F. Licensees in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such sources in its possession. 

12VAC5-481-1850. Labeling of vials and syringes.

The following regulation, Labeling of vials and syringes (10 CFR 35.69) is applicable in the Commonwealth of Virginia. Each syringe and vial that contains unsealed radioactive material shall be labeled to identify the radioactive drug. Each syringe shield and vial shield shall also be labeled unless the label on the syringe or vial is visible when shielded.

12VAC5-481-1860. Surveys of ambient radiation exposure rate.

The following regulation, Surveys of ambient radiation exposure rate (10 CFR 35.70) is applicable in the Commonwealth of Virginia. A. In addition to the surveys required by Part IV (12VAC5-481-600 et seq.) of this chapter, licensees shall survey with a radiation detection survey instrument at the end of each day of use. Licensees shall survey all areas where unsealed radioactive material requiring a written directive was prepared for use or administered.

B. Licensees do not need to perform the surveys required by subsection A of this section in an area where patients or human research subjects are confined when they cannot be released under 12VAC5-481-1870.

12VAC5-481-1870. Release of individuals containing unsealed byproduct radioactive material or implants containing byproduct radioactive material.

The following regulation, Release of individuals containing unsealed byproduct material or implants containing byproduct material (10 CFR 35.75) is applicable in the Commonwealth of Virginia. A. Licensees may authorize the release from its control of any individual who has been administered unsealed radioactive material or implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 500 mrem (5 mSv).

B. Licensees shall provide the released individual, or the individual's parent or guardian, with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonable achievable if the total effective dose equivalent to any other individual is likely to exceed 100 mrem (1 mSv). If the total effective dose equivalent to a nursing infant or child could exceed 100 mrem (1 mSv), assuming there were no interruption of breast-feeding, the instructions shall also include:

1. Guidance on the interruption or discontinuation of breast-feeding; and

2. Information on the potential consequences, if any, on failure to follow guidance.

12VAC5-481-1880. Provision of mobile medical service.

The following regulation, Provision of mobile medical service (10 CFR 35.80) is applicable in the Commonwealth of Virginia. A. The mobile medical service shall be licensed if the service receives, uses, or possesses radioactive material. The client of the mobile medical service shall be licensed if the client receives or possesses radioactive material to be used by a mobile medical service.

B. Licensees providing mobile medical service shall:

1. Obtain a letter signed by the management of each client for whom services are rendered that permits the use of radioactive material at the client's address and clearly delineates the authority and responsibility of the licensee and the client;

2. Inform the client's management who is on site at each client's address of use at the time that radioactive material is being administered;

3. Check instruments used to measure the activity of unsealed radioactive material for proper function before medical use at each client's address or on each day of use, whichever is more frequent. At a minimum, the check for proper function required by this subdivision shall include a constancy check;

4. Check survey instruments for proper operation with a dedicated check source before use at each client's address; and

5. Before leaving a client's address, survey all areas of use for dose rate and removable contamination to ensure compliance with the requirements in Part IV (12VAC5-481-600 et seq.) of this chapter.

C. A mobile medical service may not have radioactive material delivered from the manufacturer or the distributor to the client unless the client has a license allowing possession of the radioactive material. Radioactive material delivered to the client shall be received and handled in conformance with the client's license.

12VAC5-481-1890. Decay-in-storage.

The following regulation, Decay-in-storage (10 CFR 35.92) is applicable in the Commonwealth of Virginia. Licensees may hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if it:

1. Monitors material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding; and

 2. Removes or obliterates all radiation labels, except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee.

Article 5
Unsealed Byproduct Material – Written Directive Not Required

12VAC5-481-1900. Use of unsealed byproduct radioactive material for uptake, dilution, and excretion studies for which a written directive is not required.

The following regulation, Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required (10 CFR 35.100) is applicable in the Commonwealth of Virginia. Except for quantities that require a written directive under 12VAC5-481-1720, licensees may use any unsealed radioactive material prepared for medical use for uptake, dilution, or excretion studies that is:

1. Obtained from a manufacturer or preparer licensed under 12VAC5-481-480 I or equivalent NRC or other agreement state regulations or a PET radioactive drug producer licensed under 12VAC5-481-440 H or equivalent NRC or other agreement state requirements;

2. Excluding PET radionuclides, prepared by an ANP; a physician who is an AU and who meets the requirements specified in 12VAC5-481-1940 or 12VAC5-481-1980 and 12VAC5-481-1940 3 a 1; or an individual under supervision, as specified in 12VAC5-481-1710,

3. Obtained from and prepared by an agency, NRC, or another agreement state licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigation New Drug (IND) protocol accepted by FDA; or

4. Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigation New Drug (IND) protocol accepted by FDA for use in research.

12VAC5-481-1910. Training for uptake, dilution, and excretion studies.

The following regulation, Training for uptake, dilution, and excretion studies (10 CFR 35.190) is applicable in the Commonwealth of Virginia. Except as provided in 12VAC5-481-1780, licensees shall require an authorized user of unsealed radioactive material for the uses authorized under 12VAC5-481-1900 to be a physician:

1. Who is certified by a medical specialty board whose certification process has been recognized by the NRC and who meets the requirements in subdivision 3 b of this section;

2. Who is an authorized user under 12VAC5-481-1940, 12VAC5-481-1980, or equivalent NRC or other agreement state requirements; or

3. Who has:

a. Completed 60 hours of training and experience, including a minimum of eight hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for uptake, dilution, and excretion studies. The training and experience shall include the following:

(1) Classroom and laboratory training in the following areas:

(a) Radiation physics and instrumentation;

(b) Radiation protection;

(c) Mathematics pertaining to the use and measurement of radioactivity;

(d) Chemistry of radioactive material for medical use; and

(e) Radiation biology; and

(2) Work experience under the supervision of an authorized user who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1940, 12VAC5-481-1980, or equivalent NRC or other agreement state requirements, involving:

(a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(b) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(c) Calculating, measuring, and safely preparing patient or human research subject dosages;

(d) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

(e) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

(f) Administering dosages of radioactive drugs to patients or human research subjects; and

b. Obtained written attestation, signed by a preceptor authorized user who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1940, or 12VAC5-481-1980, or equivalent NRC or other agreement state requirements, that the individual has satisfactorily completed the requirements in subdivisions 1 a or 3 a of this section and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 12VAC5-481-1900.

12VAC5-481-1920. Use of unsealed byproduct radioactive material for imaging and localization studies for which a written directive is not required.

The following regulation, Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required (10 CFR 35.200) is applicable in the Commonwealth of Virginia. Except for quantities that require a written directive under 12VAC5-481-1720, licensees may use any unsealed radioactive material prepared for medical use for imaging and localization studies that is:

1. Obtained from a manufacturer or preparer licensed under 12VAC5-481-480 I or equivalent NRC or other agreement state requirements or a PET radioactive drug producer licensed under 12VAC5-481-440 H or equivalent NRC or other agreement state requirements;

2. Excluding production of PET radionuclides, prepared by an ANP; a physician who is an authorized user (AU) and who meets the requirements specified in 12VAC5-481-1940, or 12VAC5-481-1980 and 12VAC5-481-1940 3 a (1) (g); or an individual under the supervision, as specified in 12VAC5-481-1710, of an ANP or a physician who is an AU;

3. Obtained from and prepared by an agency, NRC, or another agreement state licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an IND protocol accepted by FDA; or

4. Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an IND protocol accepted by FDA.

12VAC5-481-1930. Permissible molybdenum-99 concentration, strontium-82, and strontium-85 concentrations.

The following regulation, Permissible molybdenum-99 concentration (10 CFR 35.204) is applicable in the Commonwealth of Virginia. A. Licensees may not administer to humans a radiopharmaceutical that contains:

1. More than 0.15 μCi of molybdenum-99 per mCi of technetium-99m (0.15 kBq of molybdenum-99 per MBq of technetium-99m); or

2. More than 0.02 μCi of strontium-82 per mCi of rubidium-82 chloride (0.02 kBq of strontium-82 per MBq of rubidium-82 chloride injection) or more than 0.2 μCi of strontium-85 per mCi of rubidium-82 (0.2 kBq of strontium-85 per MBq of rubidium-82 chloride injection).

B. To demonstrate compliance with subsection A of this section, the licensee preparing the radioactive drug from the radionuclide generator shall:

1. Measure the concentration of radionuclide contaminant in the first eluate after receipt of a molybdenum-99/technetium-99m generator;

2. Measure the concentration of radionuclide contaminant in each eluate or extract, as appropriate for other generator systems, not to exceed before the first patient use of the day for a strontium/rubidium-82 generator. 

12VAC5-481-1940. Training for imaging and localization studies.

The following regulation, Training for imaging and localization studies (10 CFR 35.290) is applicable in the Commonwealth of Virginia. Except as provided in 12VAC5-481-1780, licensees shall require an authorized user (AU) of unsealed radioactive material for the uses authorized under 12VAC5-481-1920 to be a physician:

1. Who is certified by a medical specialty board whose certification process has been recognized by the NRC and who meets the requirements in subdivision 3 b of this section;

2. Who is an AU under 12VAC5-481-1980 and meets the requirements in subdivision 3 a (2) (g) of this section, or equivalent NRC or other agreement state requirements; or

3. Who has:

a. Completed 700 hours of training and experience, including a minimum of 80 hours of classroom and laboratory training in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for imaging and localization studies. The training and experience shall include at a minimum:

(1) Classroom and laboratory training in the following areas:

(a) Radiation physics and instrumentation;

(b) Radiation protection;

(c) Mathematics pertaining to the use and measurement of radioactivity;

(d) Chemistry of radioactive material for medical use; and

(e) Radiation biology; and

(2) Work experience, under the supervision of an authorized user who meets the requirements in this section, 12VAC5-481-1780, or 12VAC5-481-1980 and subdivision 3 a (2) (g) of this section, or equivalent NRC or other agreement state requirements, involving:

(a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(b) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(c) Calculating, measuring, and safely preparing patient or human research subject dosages;

(d) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

(e) Using procedures to safely contain spilled radioactive material and using proper decontamination procedures;

(f) Administering dosages of radioactive drugs to patients or human research subjects; and

(g) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclide purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and

b. Obtained written attestation, signed by a preceptor authorized user who meets the requirements in this section, 12VAC5-481-1780, or 12VAC5-481-1980 and subdivision 3 a (2) (g), or equivalent NRC or other agreement state requirements, that the individual has satisfactorily completed the requirements in subdivisions 1 a or 3 a of this section and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 12VAC5-481-1900 and 12VAC5-481-1920.

Article 6
Unsealed Byproduct Material - Written Directive Required

12VAC5-481-1950. Use of unsealed by product radioactive material for which a written directive is required.

The following regulation, Use of unsealed by product material for which a written directive is required (10 CFR 35.300) is applicable in the Commonwealth of Virginia. Licensees may use any unsealed radioactive material prepared for medical use and for which a written directive is required that is:

1. Obtained from a manufacturer or preparer licensed under 12VAC5-481-480 I or equivalent NRC or other agreement state requirements or a PET radioactive drug producer licensed under 12VAC5-481-440 H or equivalent NRC or another agreement state requirements;

2. Excluding production of PET radionuclides, prepared by an ANP; a physician who is an authorized user (AU) and who meets the requirements specified in 12VAC5-481-1940 or 12VAC5-481-1980; or an individual under the supervision, as specified in 12VAC5-481-1710, of an ANP or the physician who is an AU;

3. Obtained from and prepared by an agency, NRC, or another agreement state licensee for use in research in accordance with an investigational new drug (IND) protocol accepted by U.S. Food and Drug Administration (FDA); or

4. Prepared by the licensee for use in research in accordance with an IND protocol accepted by FDA.

12VAC5-481-1960. Safety instruction.

The following regulation, Safety instruction (10 CFR 35.310) is applicable in the Commonwealth of Virginia. In addition to the requirements of 12VAC5-481-2270, licensees shall provide radiation safety instruction initially and at least annually to personnel caring for patients or human research subjects who cannot be released under 12VAC5-481-1870.  To satisfy this requirement, the instruction shall be commensurate with the duties of the personnel and include:

1. Patient or human research subject control;

2. Visitor control, including:

a. Routine visitation to hospitalized individuals in accordance with 12VAC5-481-720 A 1; and

b. Visitation authorized in accordance with 12VAC5-481-720 C;

3. Contamination control;

4. Waste control; and

5. Notification of the RSO, or his designee, and an authorized user if the patient or human research subject has a medical emergency or dies.

12VAC5-481-1970. Safety precautions.

The following regulation, Safety precautions (10 CFR 35.315) is applicable in the Commonwealth of Virginia. A. For each patient or human research subject who cannot be released under 12VAC5-481-1870, licensees shall:

1. Quarter the patient or the human research subject either in:

a. A private room with a private sanitary facility; or

b. A room, with a private sanitary facility, with another individual who also has received therapy with unsealed byproduct material and who also cannot be released under 12VAC5-481-1870;

2. Visibly post the patient's or the human research subject's room with a "Radioactive Materials" sign;

3. Note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or human research subject's room; and

4. Either monitor material and items removed from the patient's or human research subject's room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding or handle the material and items as radioactive waste.

B. Licensees shall notify the RSO, or his designee, and an AU as soon as possible if the patient or human research subject has a medical emergency or dies.

12VAC5-481-1980. Training for use of unsealed byproduct radioactive material for which a written directive is required.

The following regulation, Training for use of unsealed byproduct material for which a written directive is required (10 CFR 35.390) is applicable in the Commonwealth of Virginia. Except as provided in 12VAC5-481-1780, licensees shall require an AU of unsealed radioactive material for the uses authorized under 12VAC5-481-1950 to be a physician:

1. Who is certified by a medical specialty board whose certification process has been recognized by the NRC; or

2. Who has:

a. Completed 700 hours of training and experience, including a minimum of 200 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material requiring a written directive. The training and experience shall include:

(1) Classroom and laboratory training in the following areas:

(a) Radiation physics and instrumentation;

(b) Radiation protection;

(c) Mathematics pertaining to the use and measurement of radioactivity;

(d) Chemistry of radioactive material for medical use; and

(e) Radiation biology; and

(2) Work experience under the supervision of an AU who meets the requirements in this section, 12VAC5-481-1780, or equivalent NRC or another agreement state requirements. A supervising AU, who meets the requirements of this subdivision 2 shall also have experience in administering dosages in the same dosage category or categories (i.e., subdivision 2 a (2) (g) of this section) as the individual requesting authorized user status. The work experience shall involve:

(a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(b) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;

(c) Calculating, measuring, and safely preparing patient or human research subject dosages;

(d) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

(e) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures;

(f) (Reserved.)

(g) Administering dosages of radioactive drugs to patients or human research subjects involving a minimum of three cases in each categories for which the individual is requesting authorized user status. These categories are oral administration of less than or equal to 33 mCi (1.22 GBq) of sodium iodide I-131, for which a written directive is required; oral administration of greater than 33 mCi (1.22 GBq) of sodium iodide I-131; parenteral administration of any beta emitter or a photon-emitting radionuclide with a photon energy less than 150 keV, for which a written directive is required; or parenteral administration of any other radionuclide, for which a written directive is required.

3. Who has obtained written attestation that the individual has satisfactorily completed the requirements in either subdivisions 1 and 2 a (2) (g) of this section or subdivision 2  of this section and has achieved a level of competency sufficient to function independently as an AU for the medical uses authorized under 12VAC5-481-1950. The written attestation shall be signed by a preceptor AU who meets the requirements in this section, 12VAC5-481-1780, or equivalent NRC or other agreement state requirements. The preceptor AU, who meets the requirements in subdivision 2 of this section shall have experience in administering dosages in the same dosage category or categories (i.e., subdivision 2 a (2) (g) of this section) as the individual requesting authorized user status.

12VAC5-481-1990. Training for the oral administration of sodium iodide (I-131) requiring a written directive in quantities less than or equal to 1.22 Gigabecquerels (33 millicuries) 33 mCi (1.22 GBq).

The following regulation, Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 Gigabecquerels (33 millicuries) (10 CFR 35.392) is applicable in the Commonwealth of Virginia. Except as provided in 12VAC5-481-1780, licensees shall require an authorized user (AU) for the oral administration of sodium iodide (I-131) requiring a written directive in quantities less than or equal to 33 mCi (1.22 GBq) to be a physician:

1. Who is certified by a medical specialty board whose certification process has been recognized by the NRC; or

2. Who is an AU under 12VAC5-481-1980 for uses listed in subdivision 2 a (2) (g) of 12VAC5-481-1980, 12VAC5-481-2000, or equivalent NRC or other agreement state requirements; or

3. Who has:

a. Completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide (I-131) for procedures requiring a written directive. The training shall include:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of radioactivity;

(4) Chemistry of byproduct material for medical use; and

(5) Radiation biology; and

b. Work experience under the supervision of an AU who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, 12VAC5-481-2000, or equivalent NRC or another agreement state requirements. A supervising AU who meets the requirements in subdivision 2 of 12VAC5-481-1980 shall also have experience in administering dosages as specified in subdivision 2 a (2) (g) of 12VAC5-481-1980. The work experience shall involve:

(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(2) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(3) Calculating, measuring, and safely preparing patient or human research subject dosages;

(4) Using administrative controls to prevent a medical event involving the use of byproduct material;

(5) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and

(6) Administering dosages to patients or human research subjects, that includes at least three cases involving the oral administration of less than or equal to 33 mCi (1.22 GBq) of sodium iodide (I-131); and

4. Obtained written attestation that the individual has satisfactorily completed the requirements in subdivisions 1 and 3 b of this section or subdivision3 of this section and has achieved a level of competency sufficient to function independently as an AU for medical uses authorized under 12VAC5-481-1950. The written attestation shall be signed by a preceptor AU who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, 12VAC5-481-2000, or equivalent NRC or other agreement state requirements. A preceptor AU who meets the requirement in subdivision 2 of 12VAC5-481-1980 shall also have experience in administering dosages as specified in subdivision  2 a (2) (g) of 12VAC5-481-1980.

12VAC5-481-2000. Training for the oral administration of sodium iodide (I-131) requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries) 33 mCi (1.22 GBq).

The following regulation, Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries) (10 CFR 35.394) is applicable in the Commonwealth of Virginia. Except as provided in 12VAC5-481-1780, licensees shall require an authorized user (AU) for the oral administration of sodium iodide (I-131) requiring a written directive in quantities greater than 33 mCi (1.22 GBq) to be a physician:

1. Who is certified by a medical specialty board whose certification has been recognized by the NRC;

2. Who is an AU under 12VAC5-481-1980 for uses listed in subdivision 2 a (2) (g) of 12VAC5-481-1980 or equivalent NRC or other agreement state requirements; or

3. Who has:

a. Completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide (I-131) for procedures requiring a written directive. The training shall include:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of radioactivity;

(4) Chemistry of radioactive material for medical use; and

(5) Radiation biology; and

b. Work experience, under the supervision of an AU who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, 12VAC5-481-1990, or equivalent NRC or other agreement state requirements. A supervising AU who meets the requirements in subdivision 2 of 12VAC5-481-1980 shall also have experience in administering dosages as specified in subdivision 2 a (2) (g) of 12VAC5-481-1980. The work experience shall involve:

(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(2) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(3) Calculating, measuring, and safely preparing patient or human research subject dosages;

(4) Using administrative controls to prevent a medical event involving the use of radioactive material;

(5) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

(6) Administering dosages to patients or human research subjects that includes at least three cases involving the oral administration of greater than 33 mCi (1.22 GBq) of sodium iodide (I-131); and

c. Obtained written attestation that the individual has satisfactorily completed the requirements in subdivisions 1 and 3 b of this section or subdivision 3 of this section and has achieved a level of competency sufficient to function independently as an AU for medical uses authorized under 12VAC5-481-1950. The written attestation shall be signed by a preceptor AU who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, 12VAC5-481-1990, or equivalent NRC or other agreement state requirements. A preceptor AU who meets the requirements in subdivision 2 of 12VAC5-481-1980 shall also have experience in administering dosages as specified in subdivision 2 a (2) (g) of 12VAC5-481-1980.

12VAC5-481-2001. Training for the parental parenteral administration of unsealed byproduct radioactive material requiring a written directive.

The following regulation, Training for the parenteral administration of unsealed byproduct material requiring a written directive (10 CFR 35.396) is applicable in the Commonwealth of Virginia. Except as provided in 12VAC5-481-1780, licensees shall require an authorized user (AU) for the parenteral administration requiring a written directive to be a physician:

1. Who is an AU under 12VAC5-481-1980 for uses listed in subdivision 2 a (2) (g) of 12VAC5-481-1980 or equivalent NRC or other agreement state requirements;

2. Who is an AU under 12VAC5-481-2010, 12VAC5-481-2040, or equivalent NRC or other agreement state requirements and who meets the requirements in subdivision 4 of this section; or

3. Who is certified by a medical specialty board whose certification process has been recognized by the NRC; or

4. Who has:

a. Completed 80 hours of classroom and laboratory training applicable to parenteral administrations for which a written directive is required of any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV or parenteral administration of any other radionuclide for which a written directive is required. The training shall include:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of radioactivity;

(4) Chemistry of radioactive material for medical use; and

(5) Radiation biology; and

b. Work experience under the supervision of an AU who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, or equivalent NRC or other agreement state requirements in the parenteral administration for which a written directive is required of any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV or parenteral administration of any other radionuclide for which a written directive is required. A supervising AU who meets the requirements in 12VAC5-481-1980 shall have experience in administering dosages as specified in subdivision 2 a (2) (g) of 12VAC5-481-1980. The work experience shall involve:

(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(2) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(3) Calculating, measuring, and safely preparing patient or human research subject dosages;

(4) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

(5) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

(6) Administering dosages to patients or human research subjects that include at least three cases involving the parenteral administration for which a written directive is required of any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV or at least three cases involving the parenteral administration of any other radionuclide for which a written directive is required; and

5. Obtained a written attestation that the individual has satisfactorily completed the requirements in subdivision 2 or 3; and 4b of this section or subdivision 4 of this section, and has achieved a level of competency sufficient to function independently as an AU for the parenteral administration of unsealed radioactive material requiring a written directive. The written attestation shall be signed by a preceptor AU who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, or equivalent NRC or other agreement state requirements. A preceptor AU who meets the requirements in 12VAC5-481-1980 shall have experience in administering dosages as specified in subdivision 2 a (2) (g) of 12VAC5-481-1980.

Article 7
Manual Brachytherapy

12VAC5-481-2010. Manual Brachytherapy Use of sources for manual brachytherapy.

The following regulations, Use of sources for manual brachytheray (10 CFR 35.400), Surveys after source implant and removal (10 CFR 35.404), Brachytherapy sources accountability (10 CFR 35.406), Safety instruction (10 CFR 35.410), Safety precautions (10 CFR 35.415), Calibration measurements of brachytherapy sources (10 CFR 35.432), Decay of strontium-90 sources for ophthalmic treatment (10 CFR 35.433), Therapy-related computer systems (10 CFR 35.457), Training for use of manual brachytherapy sources (10 CFR 35.490), and Training for ophthalmic use of strontium-90 (10 CFR 35.491) are applicable in the Commonwealth of Virginia. Licensees shall use only brachytherapy sources for therapeutic medical uses:

1. As approved in the Sealed Source and Device Registry; or

2. In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of 12VAC5-481-1740 are met.

12VAC5-481-2011. Surveys after source implant and removal.

A. Immediately after implanting sources in a patient or a human research subject, the licensee shall make a survey to locate and account for all sources that have not been implanted.

B. Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed.

C. A licensee shall retain a record of the surveys required by subsections A and B of this section in accordance with 12VAC5-481-2070 O.

12VAC5-481-2012. Brachytherapy sources accountability.

A. Licensees shall maintain accountability at all times for all brachytherapy sources in storage or use.

B. As soon as possible after removing sources from a patient or a human research subject, licensees shall return brachytherapy sources to a secure storage area.

12VAC5-481-2013. Safety instruction.

A. In addition to the requirements of 12VAC5-481-2270, licensees shall provide radiation safety instruction initially and at least annually, to personnel caring for patients or human research subjects who are receiving brachytherapy and cannot be released under 12VAC5-481-1870.

B. To satisfy this requirement, the instruction shall be commensurate with the duties of the personnel and include:

1. Size and appearance of the brachytherapy sources;

2. Safe handling and shielding instructions;

3. Patient or human research subject control;

4. Visitor control, including both:

a. Routine visitation of hospitalized individuals in accordance with 12VAC5-481-720 A 1; and

b. Visitation authorized in accordance with 12VAC5-481-720 C; and

5. Notification of the RSO, or his designee, and an AU if the patient or the human research subject has a medical emergency or dies. The licensee shall also notify the agency if it is possible that any individual could receive exposures in excess of regulatory limits as a result of the deceased's body.

12VAC5-481-2014. Safety precautions.

A. For each patient or human research subject who is receiving brachytherapy and cannot be released under 12VAC5-481-1870, licensees shall:

1. Not quarter the patient or human research subject in the same room as an individual who is not receiving brachytherapy;

2. Visibly post the patient's or human research subject's room with a "Radioactive Materials" sign; and

3. Note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or human research subject's room.

B. Licensees shall have applicable emergency response equipment available near each treatment room to respond to a source that becomes:

1. Dislodged from the patient; and

2. Lodged within the patient following removal of the source applicators.

C. Licensees shall notify the RSO, or his designee, and an AU as soon as possible if the patient or human research subject has a medical emergency or dies.

12VAC5-481-2015. Calibration measurements of brachytherapy sources.

A. Before the first medical use of a brachytherapy source, licensees shall have:

1. Determined the source output or activity using a dosimetry system that meets the requirements of 12VAC5-481-2044;

2. Determined source positioning accuracy with applicators; and

3. Used published protocols currently accepted by nationally recognized bodies to meet the requirements of subdivision 1 and 2 of this subsection.

B. Instead of a licensee making its own measurements as required in subsection A of this section, the licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine that are made in accordance with subsection A of this section.

C. A licensee shall mathematically correct the outputs or activities determined in subsection A of this section for physical decay at intervals consistent with 1.0% physical decay.

12VAC5-481-2016. Decay of strontium-90 sources for opthalmic treatments.

Only an authorized medical physicist shall calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay shall be based on the activity determined under 12VAC5-481-2015.

12VAC5-481-2017. Therapy-related computer systems.

Licensees shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing shall include, as applicable, verification of:

1. The source-specific input parameters required by the dose calculation algorithm;

2. The accuracy of dose, dwell time, and treatment time calculations at representative points;

3. The accuracy of isodose plots and graphic displays; and

4. The accuracy of the software used to determine sealed source positions from radiographic images.

12VAC5-481-2018. Training for use of manual brachytherapy sources.

Except as provided in 12VAC5-481-1780, licensees shall require an authorized user of a manual brachytherapy source for uses authorized under 12VAC5-481-2010 to be a physician:

1. Who is certified by a medical specialty board whose certification process has been recognized by the NRC; or

2. Who has:

a. Completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes:

(1) 200 hours of classroom and laboratory training in the following areas:

(a) Radiation physics and instrumentation;

(b) Radiation protection;

(c) Mathematics pertaining to the use and measurement of radioactivity; and

(d) Radiation biology; and

(2) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in this subsection, 12VAC5-481-1780, or equivalent NRC or another agreement state requirements at a medical institution, involving:

(a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(b) Checking survey meters for proper operation;

(c) Preparing, implanting, and removing brachytherapy sources;

(d) Maintaining running inventories of material on hand;

(e) Using administrative controls to prevent a medical event involving the use of radioactive material;

(f) Using emergency procedures to control radioactive material; and

b. Completed three years of supervised clinical experience in radiation oncology, under an AU who meets the requirements in this section, 12VAC5-481-1780, or equivalent NRC or another agreement state requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by subdivision 2 a (2) of this section.

3. Who has obtained written attestation, signed by a preceptor AU who meets the requirements in this section, 12VAC5-481-1780, or equivalent NRC or other agreement state requirements, that the individual has satisfactorily completed the requirements in this section and has achieved a level of competency sufficient to function independently as an AU of manual brachytherapy sources for the medical uses authorized in 12VAC5-481-2010.

12VAC5-481-2019. Training for opthalmic use of strontium-90.

Except as provided in 12VAC5-481-1780, licensees shall require the AU of strontium-90 for ophthalmic radiotherapy to be a physician:

1. Who is an authorized user (AU) under 12VAC5-481-2018 or equivalent NRC or other agreement state requirements; or

2. Who has:

a. Completed 24 hours of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy. The training shall include:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of radioactivity; and

(4) Radiation biology; and

b. Clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution, clinic, or private practice that includes the use of strontium-90 for the ophthalmic treatment of five individuals. This supervised clinical training shall involve:

(1) Examination of each individual to be treated;

(2) Calculation of the dose to be administered;

(3) Administration of the dose; and

(4) Follow up and review of each individual's case history; and

c. Obtained written attestation, signed by a preceptor AU who meets the requirements in 12VAC5-481-1780, 12VAC5-481-2018, this section, or equivalent NRC or other agreement state requirements, that the individual has satisfactorily completed the requirements in this subdivision 2 and has achieved a level of competency sufficient to function independently as an AU of strontium-90 for ophthalmic use.

Article 8
Sealed Sources for Diagnosis

12VAC5-481-2020. Use of sealed sources for diagnosis.

The following regulation, Use of sealed sources for diagnosis (10 CFR 35.500) is applicable in the Commonwealth of Virginia. Licensees shall use only sealed sources for diagnostic medical uses as approved in the Sealed Source and Device Registry.

12VAC5-481-2030. Training for use of sealed sources for diagnosis.

The following regulation, Training for use of sealed sources for diagnosis (10 CFR 35.590) is applicable in the Commonwealth of Virginia. Except as provided by 12VAC5-481-1780, licensees shall require the authorized user of a diagnostic sealed source for use in a device authorized under 12VAC5-481-2020 to be a physician, dentist, or podiatrist who:

1. Is certified by a specialty board that has been recognized by the NRC; or

2. Has completed eight hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device.  The training shall include:

a. Radiation physics and instrumentation;

b. Radiation protection;

c. Mathematics pertaining to the use and measurement of radioactivity; and

d. Radiation biology; and

3. Has completed training in the use of the device for the uses requested.

Article 9
Photon Emitting Remote Afterloader Units, Teletherapy Units, and Stereotactic Radiosurgery Units

12VAC5-481-2040. Photon Emitting Remote Afterloader Units, Teletherapy Units, and Stereotactic Radiosurgery Units Training requirements and use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.

The following regulations, Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit (10 CFR 35.600), Surveys of patients and human research subjects treated with a remote afterloader unit (10 CFR 35.604), Installation, maintenance, adjustment, and repair (10 CFR 35.605), Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units (10 CFR 35.610), Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units (10 CFR 35.615), Dosimetry equipment (10 CFR 35.630), Full calibration measurements on teletherapy units (10 CFR 35.632), Full calibration measurements on remote afterloader units, (10 CFR 35.633), Full calibration measurements on gamma stereotactic radiosurgery units (10 CFR 35.635), Periodic spot-checks for teletherapy units (10 CFR 35.642), Periodic spot-checks for remote afterloader units (10 CFR 35.643), Periodic spot-checks for gamma stereotactic radiosurgery units (10 CFR 35.645), Additional technical requirements for mobile remote afterloader units (10 CFR 35.647), Radiation surveys, (10 CFR 35.652), Five-year inspection for teletherapy and gamma stereotactic radiosurgery units (10 CFR 35.655), Therapy-related computer systems (10 CFR 35.657), and Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units (10 CFR 35.690) are applicable in the Commonwealth of Virginia. A. Except as provided in 12VAC5-481-1780, licensees shall require an authorized user (AU) of a sealed source in remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units to be a physician:

1. Who is certified by a medical specialty board whose certification process has been recognized by the NRC; or

2. Who has:

a. Completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes:

(1) 200 hours of classroom and laboratory training in the following areas: radiation physics and instrumentation; radiation protection; mathematics pertaining to the use and measurement of radioactivity; and radiation biology; and

(2) 500 hours of work experience, under the supervision of an AU who meets the requirements in this section, 12VAC5-481-1780, or equivalent NRC or another agreement state requirements at a medical institution, involving: reviewing full calibration measurements and periodic spot-checks; preparing treatment plans and calculating treatment doses and times; using administrative controls to prevent a medical event involving the use of radioactive material; implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console; checking and using survey meters; and selecting the proper dose and knowing how it is to be administered; and

b. Completed three years of supervised clinical experience in radiation therapy under an AU who meets the requirements in this section, 12VAC5-481-1780, or equivalent NRC or another agreement state requirements as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by this subdivision.

3. Who has obtained written attestation that the individual has satisfactorily completed the requirements in (i) subdivision 1 or 2 of this subsection and (ii) subdivisions 3 and 4 of this subsection and has achieved a level of competency sufficient to function independently as an AU of each type of therapeutic medical unit for which the individual is requesting AU status. The written attestation shall be signed by a preceptor AU who meets the requirements in this subsection, 12VAC5-481-1780, or equivalent NRC or another agreement state requirements for an AU for each type of therapeutic medical unit for which the individual is requesting AU status.

4. Who has received training in device operation, safety procedures, and clinical use for the types of use for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an AU or authorized medical physicist, as appropriate, who is authorized for the types of use for which the individual is seeking authorization.

B. Licensees shall use sealed sources in photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units for therapeutic medical uses:

1. As approved in the Sealed Source and Device Registry; or

2. In research in accordance with an active Investigational Device Exemption application accepted by the U.S. Food and Drug Administration provided the requirements of 12VAC5-481-1740 are met.

12VAC5-481-2041. Surveys required.

A. Radiation surveys.

1. In addition to the survey requirements in 12VAC5-481-750, licensees shall make surveys to ensure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source in the shielded position do not exceed the levels stated in the Sealed Source and Device Registry.

2. The licensee shall make the survey required by subdivision 1 of this subsection at installation of a new source and following repairs to the source shielding, the source driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source, or compromise the radiation safety of the unit or the source.

B. Patient surveys. Before releasing a patient or human research subject from licensee control, a licensee shall survey the patient or human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source has been removed from the patient or human research subject and returned to the safe shielded position.

12VAC5-481-2042. Installation, maintenance, adjustment, and repair.

A. Only a person specifically licensed by the agency, the NRC, or another agreement state shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source shielding, the source driving unit, or other electronic or mechanical components that could expose the source, reduce the shielding around the source, or compromise the radiation safety of the unit or the source.

B. Except for low dose-rate remove afterloader unit, only a person specifically licensed by the agency, the NRC, or another agreement state shall install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units.

C. For a low dose-rate remote afterloader unit, only a person specifically licensed by the agency, the NRC, or another agreement state or an authorized medical physicist shall install, replace, relocate, or remove a sealed source contained in the unit.

12VAC5-481-2043. Safety procedures and instructions, and precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

A. Safety procedures and instructions.

1. Licensees shall:

a. Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;

b. Permit only individuals approved by the AU, the AMP, or the RSO to be present in the treatment room during treatment with sources;

c. Prevent dual operation of more than one radiation producing device in a treatment room if applicable; and

d. Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source in the shielded position, or remove the patient or human research subject from the radiation field with controls from the outside the treatment room. These procedures shall include:

(1) Instructions for responding to equipment failure and the names of the individuals responsible for implementing corrective actions;

(2) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and

(3) The names and telephone numbers of the authorized user (AU), the authorized medical physicist (AMP), and the RSO to be contacted if the unit or the console operates abnormally.

2. A copy of the procedures required by subdivision 1 d of this subsection shall be physically located at the unit console.

3. Licensees shall post instructions at the unit console to inform the operator of:

a. The location of the procedures required by subdivision 1 d of this subsection; and

b. The names and telephone numbers of the AU, the AMP, and the RSO to be contacted if the unit or console operates abnormally.

4. Licensees shall provide instruction and document initially and at least annually to all individuals who operate the unit, as appropriate to the individual's assigned duties, in:

a. The procedures identified in subdivision 1 d of this subsection; and

b. The operating procedures for the unit.

5. Licensees shall ensure that operators, authorized users, and authorized medical physicists participate in drills of the emergency procedures initially and at least annually and document the exercise.

B. Safety procedures for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

1. Licensees shall control access to the treatment room by a door at each entrance.

2. Licensees shall equip each entrance to the treatment room with an electrical interlock system that will:

a. Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

b. Cause the source to be shielded when an entrance door is opened; and

c. Prevent the source from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source on-off console is reset at the console.

3. Licensees shall require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels.

4. Except for low-dose remote afterloader units, licensees shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation.

5. For licensed activities where sources are placed within the patient's or human research subject's body, licensees shall only conduct treatments that allow for expeditious removal of a decoupled or jammed source.

6. In addition to the requirements specified in subdivisions 1 through 5 of this subsection, licensees shall:

a. For medium dose-rate and pulsed dose-rate remote afterloader units, require:

(1) An AMP and either an AU or an physician under the supervision of an AU who has been trained to the operation and emergency response for the unit to be physically present during the initiation of all patient treatments involving the units; and

(2) An AMP and either an AU or an individual under the supervision of an AU who has been trained to remove the source applicators in the event of an emergency involving the unit to be immediately available during the continuation of all patient treatments involving the unit.

b. For high dose-rate remote afterloader units, require:

(1) An AU and an AMP to be physically present during the initiation of all patient treatments involving the unit; and

(2) An AMP and either an AU or a physician under the supervision of an AU who has been trained in the operation and emergency response for the unit to be physically present during continuation of all patient treatments involving the unit.

c. For gamma stereotactic radiosurgery units, require an AU and an AMP to be physically present throughout all patient treatments involving the unit.

d. Notify the RSO, or his designee, and the authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

7. Licensees shall have applicable emergency response equipment available near each treatment room to respond to a source that:

a. Remains in the unshielded position; or

b. Lodges within the patient following completion of the treatment.

12VAC5-481-2044. Dosimetry equipment.

A. Except for low dose-rate remote afterloader sources where the source output or activity is determined by the manufacturer, licensees shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions shall be met.

1. The system shall have been calibrated using a system or source traceable to the National Institute of Standards and Technology (NIST) and published protocols accepted by nationally recognized bodies or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration shall have been performed within the previous two years and after any servicing that may have affected system calibration; or

2. The system shall have been calibrated within the previous four years. 18 to 30 months after that calibration, the system shall have been intercompared with another dosimetry system that was calibrated within the past 24 months by NIST or by a calibration laboratory accredited by the AAPM. The results of the intercomparison shall indicate that the calibration factor of the licensee's system had not changed by more than 2.0%. The licensee may not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating sealed sources for therapeutic units, the licensee shall use a comparable unit with beam attenuators or collimators, as applicable, and sources of the same radionuclide as the source used at the licensee's facility.

B. Licensees shall have a dosimetry system available for use for spot-check output measurements, if applicable. To satisfy this requirement, the system may be compared with a system that has been calibrated in accordance with subsection A of this section. This comparison shall have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in subsection A of this section.

12VAC5-481-2045. Full calibration measurements.

A. Teletherapy units.

1. Licensees authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit:

a. Before the first medical use of the unit; and

b. Before medical use under the following conditions:

(1) Whenever spot-check measurements indicate that the output differs by more than 5.0% from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(2) Following replacement of the source or following reinstallation of the teletherapy unit in a new location; and

(3) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and

c. At intervals not exceeding one year.

2. To satisfy the requirement of subdivision 1 of this subsection, full calibration measurements shall include determination of:

a. The output within plus or minus 3.0% for the range of field sizes and for the distance or range of distances used for medical use;

b. The coincidence of the radiation field and the field indicated by the light beam localizing device;

c. The uniformity of the radiation field and its dependence on the orientation of the useful beam;

d. Timer accuracy and linearity over the range of use;

e. On-off error; and

f. The accuracy of all distance measuring and localization devices in medical use.

3. Licensees shall use the dosimetry system described in 12VAC5-481-2044 to measure the output for one set of exposure conditions. The remaining radiation measurements required in subdivision 2 a of this subsection may be made using a dosimetry system that indicates relative dose rates.

4. Licensees shall make full calibration measurements required by subdivision 1 of this subsection in accordance with published protocols accepted by nationally recognized bodies.

5. Licensees shall mathematically correct the outputs determined in subdivision 2 a of this subsection for physical decay for intervals not exceeding one month for cobalt-60, six months for cesium-137, or at intervals consistent with 1.0% decay for all other nuclides.

6. Full calibration measurements required by subdivision 1 of this subsection and physical decay corrections required by subdivision 5 of this subsection shall be performed by the authorized medical physicist (AMP).

B. Remote afterloader units.

1. Licensees authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit:

a. Before the first medical use of the unit;

b. Before medical use under the following conditions:

(1) Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and

(2) Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly;

c. At intervals not exceeding one quarter for high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units with sources whose half-life exceeds 75 days; and

d. At intervals not exceeding one year for low dose-rate remote afterloader units.

2. To satisfy the requirement of subdivision 1 of this subsection, full calibration measurements shall include, as applicable, determination of:

a. The output within plus or minus 5.0%;

b. Source positioning accuracy to within plus or minus 1 millimeter;

c. Source retraction with backup battery upon power failure;

d. Length of the source transfer tubes;

e. Timer accuracy and linearity over the typical range of use;

f. Length of the applicators; and

g. Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces.

3. Licensees shall use the dosimetry system described in 12VAC5-481-2044 to measure the output.

4. Licensees shall make full calibration measurements required by subdivision 1 of this subsection in accordance with published protocols accepted by nationally recognized bodies.

5. In addition to the requirements for full calibrations for low dose-rate remote afterloader units in subdivision 2 of this subsection, licensees shall perform an autoradiograph of the sources to verify inventory and source arrangement at intervals not exceeding one calendar quarter.

6. For low dose-rate remote afterloader units, licensees may use measurements provided by the source manufacturer that are made in accordance with subdivisions 1 through 5 of this subsection.

7. Licensees shall mathematically correct the outputs determined in subdivision 2 a of this subsection for physical decay at intervals consistent with 1.0% physical decay.

8. Full calibration measurements required by subdivision 1 of this subsection and physical decay corrections required by subdivision 7 of this subsection shall be performed by the AMP.

C. Gamma stereotactic radiosurgery units.

1. Licensees authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit:

a. Before the first medical use of the unit;

b. Before medical use under the following conditions:

(1) Whenever spot-check measurements indicate that the output differs by more than 5.0% from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(2) Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and

(3) Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and

c. At intervals not exceeding one year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet.

2. To satisfy the requirement of subdivision 1 of this subsection, full calibration measurements shall include determination of:

a. The output within plus or minus 3.0%;

b. Relative helmet factors;

c. Isocenter coincidence;

d. Timer accuracy and linearity over the range of use;

e. On-off error;

f. Trunnion centricity;

g. Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

h. Helmet microswitches;

i. Emergency timing circuits; and

j. Stereotactic frames and localizing devices (trunnions).

3. Licensees shall use the dosimetry system described in 12VAC5-481-2044 to measure the output for one set of exposure conditions. The remaining radiation measurements required in subdivision 2 a of this subsection may be made using a dosimetry system that indicates relative dose rates.

4. Licensees shall make full calibration measurements required by subdivision 1 of this subsection in accordance with published protocols accepted by nationally recognized bodies.

5. Licensees shall mathematically correct the outputs determined in subdivision 2 a of this subsection at intervals not exceeding one month for cobalt-60 and at intervals consistent with 1.0% physical decay for all other radionuclides.

6. Full calibration measurements required by subdivision 1 of this subsection and physical decay corrections required by subdivision 5 of this subsection shall be performed by the AMP.

12VAC5-481-2046. Periodic spot-checks.

A. Periodic spot-checks for teletherapy units.

1. Licensees authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of:

a. Timer accuracy and timer linearity over the range of use;

b. On-off error;

c. The coincidence of the radiation field and the field indicated by the light beam localizing device;

d. The accuracy of all distance measuring and localization devices used for medical use;

e. The output for one typical set of operating conditions measured with the dosimetry system described in 12VAC5-481-2044; and

f. The difference between the measurement made in subdivision 1 e of this subsection and the anticipated output, expressed as a percentage of the anticipated output (i.e. the value obtained at last full calibration corrected mathematically for physical decay).

2. Licensees shall perform measurements required by subdivision 1 of this subsection in accordance with written procedures established by the authorized medical physicist (AMP). That individual need not actually perform the spot-check measurements.

3. Licensees shall have the AMP review the results of each spot-check within 15 days. The shall notify the licensee as soon as possible in writing of the results of each spot-check.

4. Licensees authorized to use a teletherapy unit for medical use shall perform safety spot-checks of each teletherapy facility once in each calendar month and after each source installation to assure proper operation of:

a. Electrical interlocks at each teletherapy room entrance;

b. Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel, and operation of the beam on-off mechanism);

c. Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility;

d. Viewing and intercom systems;

e. Treatment room doors from inside and outside the treatment room; and

f. Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.

5. If the results of the checks required in subdivision 4 of this subsection indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

B. Periodic spot-checks for remote afterloader units.

1. Licensees authorized to use a remote afterloader unit for medical use shall perform spot-checks of each remote afterloader facility and on each unit:

a. Before the first use of a high dose-rate, medium dose-rate, or pulsed dose-rate remote afterloader unit on a given day;

b. Before each patient treatment with a low dose-rate remote afterloader unit; and

c. After each source installation.

2. Licensees shall perform the measurements required by subdivision 1 of this subsection in accordance with written procedures established by the AMP. That individual need not actually perform the spot-check measurements.

3. Licensees shall have the authorized medical physicist review the results of each spot-check within 15 days. The AMP shall notify the licensee as soon as possible in writing of the results of each spot-check.

4. To satisfy the requirements of subdivision 1 of this subsection, spot-checks shall, at a minimum, assure proper operation of:

a. Electrical interlocks at each remote afterloader unit room entrance;

b. Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

c. Viewing and intercom systems in each high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader facility;

d. Emergency response equipment;

e. Radiation monitors used to indicate the source position;

f. Timer accuracy;

g. Clock (date and time) in the unit's computer; and

h. Decayed sources activity in the unit's computer.

5. If the results of the checks required in subdivision 4 of this subsection indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

C. Periodic spot-checks for gamma stereotactic radiosurgery units.

1. Licensees authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit:

a. Monthly;

b. Before the first use of the unit on a given day; and

c. After each source installation.

2. Licensees shall:

a. Perform the measurements required by subdivision 1 of this subsection in accordance with written procedures established by the AMP. That individual need not actually perform the spot check measurements.

b. Have the AMP review the results of each spot-check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.

3. To satisfy the requirements of subdivision 1 a of this subsection, spot-checks shall, at a minimum:

a. Assure proper operation of:

(1) Treatment table retraction mechanisms, using backup battery power or hydraulic backups with the unit off;

(2) Helmet microswitches;

(3) Emergency timing circuits; and

(4) Stereotactic frames and localizing devices (trunnions).

b. Determine the following:

(1) The output for one typical set of operating conditions measured with the dosimetry system described in 12VAC5-481-2044;

(2) The difference between the measurement made in subdivision 3 b (1) of this subsection and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay);

(3) Source output against computer calculation;

(4) Timer accuracy and linearity over the range of use;

(5) On-off error; and

(6) Trunnion centricity.

4. To satisfy the requirements of subdivisions 1 b and 1 c of this subsection, spot-checks shall assure proper operation of:

a. Electrical interlocks at each gamma stereotactic radiosurgery room entrance;

b. Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility;

c. Viewing and intercom systems;

d. Timer termination;

e. Radiation monitors used to indicate room exposures; and

f. Emergency off buttons.

5. A licensee shall arrange for the repair of any system identified in subdivision 3 of this subsection that is not operating properly as soon as possible.

6. If the results of the checks required in subdivision 4 of this subsection indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

12VAC5-481-2047. Additional technical requirements for mobile remote afterloader units.

A. Licensees providing mobile remote afterloader service shall:

1. Check survey instruments before medical use at each address of use or on each day of use, whichever is more frequent; and

2. Account for all sources before departure from a client's address of use.

B. In addition to the periodic spot-checks required by 12VAC5-481-2046, licensees authorized to use a mobile remote afterloader for medical use shall perform checks on each remote afterloader unit before use at each address of use. At a minimum, checks shall be made to verify the operation of:

1. Electrical interlocks on treatment area access points;

2. Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

3. Viewing and intercom systems;

4. Applicators, source transfer tubes, and transfer tube-applicator interfaces;

5. Radiation monitors used to indicate room exposures;

6. Source positioning (accuracy); and

7. Radiation monitors used to indicate whether the source has returned to a safe shielded position.

C. In addition to the requirements for checks in subsection B of this section, licensees shall ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use.

D. If the results of the checks required in subsection B of this section indicate the malfunction of any system, licensees shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

12VAC5-481-2048. Five-year inspection for teletherapy and gamma stereotactic radiosurgery units.

A. Licensees shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during source replacement or at intervals not to exceed five years, whichever comes first, to assure proper functioning of the source exposure mechanism.

B. This inspection and servicing may only be performed by person specifically licensed to do so by the agency, the NRC, or another agreement state.

12VAC5-481-2049. Therapy-related computer systems.

Licensees shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies.  At a minimum, the acceptance testing shall include, as applicable, verification of:

1. The source-specific input parameters required by the dose calculation algorithm;

2. The accuracy of dose, dwell time, and treatment time calculations at representative points;

3. The accuracy of isodose plots and graphic displays;

4. The accuracy of the software used to determine sealed source positions from radiographic images; and

5. The accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

Article 11
Other Medical Uses of Byproduct Material or Radiation from Byproduct Material

12VAC5-481-2060. Other medical uses of byproduct radioactive material or radiation from byproduct radioactive materials.

The following regulation, Other medical uses of byproduct material or radiation from byproduct materials (10 CFR 35.1000) is applicable in the Commonwealth of Virginia. Licensees may use radioactive material or a radiation source approved for medical use that is not specifically addressed in Articles 3 (12VAC5-481-1700 et seq.) through 9 (12VAC5-481-2040 et seq.) of this part if:

1. The applicant or licensee has submitted the information required by 12VAC5-481-1680; and

2. The applicant or licensee has received written approval from the agency in a license or license amendment and uses the material in accordance with this chapter and specific conditions the agency considers necessary for the medical use of the material.

Article 12
Records

12VAC5-481-2070. Records.

The following regulations, Records of authority and responsibilities for radiation protection programs (10 CFR 35.2024), Records of radiation protection program changes (10 CFR 35.2026), Records of written directives (10 CFR 35.2040), Records for procedures for administrations requiring a written directive (10 CFR 35.2041), Records of calibrations of instruments used to measure the activity of unsealed byproduct materials (10 CFR 35.2060), Records of radiation survey instrument calibrations (10 CFR 35.2061), Records of dosages of unsealed byproduct material for medical use (10 CFR 35.2063), Records of leaks tests and inventory of sealed sources and brachytherapy sources (10 CFR 35.2067), Records of surveys for ambient radiation exposure rate (10 CFR 35.2070), Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material (10 CFR 35.2075), Records of mobile medical services (10 CFR 35.2080), Records of decay-in-storage (10 CFR 35.2092), Records of molybdenum-99 concentrations (10 CFR 35.2204), Records of safety instruction (10 CFR 35.2310), Records of surveys after source implant and removal (10 CFR 35.2404), Records of brachytherapy source accountability (10 CFR 35.2406), Records of calibration measurements of brachytherapy sources (10 CFR 35.2432), Records of decay of strontium-90 sources for ophthalmic treatments (10 CFR 35.2433), Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units (10 CFR 35.2605), Records of safety procedures (10 CFR 35.2610), Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units (10 CFR 35.2630), Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations (10 CFR 35.2632), Records of periodic spot-checks for teletherapy units (10 CFR 35.2642), Records of periodic spot-checks for remote afterloader units (10 CFR 35.2643), Records of periodic spot-checks for gamma stereotactic radiosurgery units (10 CFR 35.2645), Records of additional technical requirements for mobile remote afterloader units (10 CFR 35.2647), Records of surveys of therapeutic treatment units (10 CFR 35.2652), and Records of 5-year inspection for teletherapy and gamma stereotactic radiosurgery units (10 CFR 35.2655) are applicable in the Commonwealth of Virginia. A. Records of authority and responsibilities for radiation protection programs.

1. Licensees shall retain a record of actions taken by the licensee's management in accordance with 12VAC5-481-1700 for five years. The record shall include a summary of the actions taken and a signature of licensee management.

2. Licensees shall retain a copy of both authority, duties, and responsibilities of the RSO as required by 12VAC5-481-1700 and a signed copy of each RSO's agreement to be responsible for implementing the radiation safety program, as required by 12VAC5-481-1700, for the duration of the license. The records shall include the signature of the RSO and licensee management.

B. Records of radiation protection program changes. Licensees shall retain a record of each radiation protection program change made in accordance with 12VAC5-481-1700 F for five years. The record shall include a copy of the old and new procedures, the effective date of the change, and the signature of the licensee management that reviewed and approved the change.

C. Records of written directives. Licensees shall retain a copy of each written directive as required by 12VAC5-481-1720 for three years.

D. Records for procedures for administrations requiring written directive. Licensees shall retain a copy of the procedures required by 12VAC5-481-1730 for the duration of the license.

E. Records of dosages of unsealed radioactive material for medical use. Licensees shall maintain a record of dosage determinations required by 12VAC5-481-1820 for three years. The record shall contain the radiopharmaceutical; the patient's or human research subject's name or identification number if one has been assigned; the prescribed dosage, the determined dosage, or a notation that the total activity is less than 30 µCi (1.1 MBq); the date and time of dosage determination; and the name of the individual who determined the dosage.

F. Records of leak tests and inventory of sealed sources and brachytherapy sources.

1. Licensees shall retain records of leak tests required by 12VAC5-481-1840 for three years. The records shall include the model number, and the serial number, if one has been assigned, of each source tested; the identity of each source by radionuclide and its estimated activity; the results of the test; the date of the test; and the name of the individual who performed the test.

2. Licensees shall retain records of the semi-annual physical inventory of sealed sources and brachytherapy sources required by 12VAC5-481-1840 for three years. The inventory records shall contain the model number of each source, and serial number of each source if one has been assigned, the identity of each source by radionuclide and its nominal activity, the location of each source, and the name of the individual who performed the inventory.

G. Records of surveys for ambient radiation exposure rate. Licensees shall retain a record of each survey required by 12VAC5-481-1860 for three years. The record shall include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.

H. Records of the release of individuals containing unsealed radioactive material or implants containing radioactive material.

1. Licensees shall retain a record signed by the authorized user of the basis for authorizing the release of an individual in accordance with 12VAC5-481-1870 for three years after the date of release if the total effective dose equivalent is calculated by:

a. Using the retained activity rather than the activity administered;

b. Using an occupancy factor less than 0.25 at 1 meter;

c. Using the biological or effective half-life; or

d. Considering the shielding by tissue.

2. Licensees shall retain a record for three years after the date of release of the instruction required by 12VAC5-481-1870 that were provided to a breast-feeding female if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 500 mrem (5 mSv).

I. Records of mobile medical services.

1. Licensees shall retain a copy of each letter that permits the use of radioactive material at the client's address, as required by 12VAC5-481-1880. Each letter shall clearly delineate the authority and responsibility of the licensee and the client and shall be retained for three years after the last provision of service.

2. Licensees shall retain the record of each survey required by 12VAC5-481-1880 for three years. The record shall include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.

J. Records of decay-in-storage. Licensees shall maintain records of the disposal of licensed materials, as required by 12VAC5-481-1890 for three years. The record shall include the date of the disposal, the survey instrument used, the background radiation level, the radiation level measured at the surface of each waste container, and the name of the individual who performed the survey.

K. Records of molybdenum-99, strontium-82 and strontium-85 concentrations. Licensee shall maintain a record of molybdenum-99 concentration or strontium-82 and stontrium-85 concentration tests required by 12VAC5-481-1930 for three years. The record shall include:

1. For each measured elution of technetium-99m, the ratio of measures expressed as microcuries of molybdenum-99 per millicurie of technetium-99m or kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m, the time and date of the measurement, and the name of the individual who made the measurement; or

2. For each measured elution of rubidium-82, the ratio of the measures expressed as microcurie of strontium-82 per millicurie of rubidium-82 or kilobecquerel of strontium-82 per megabecquerel of rubidium-82, microcurie of strontium-85 per millicurie of rubidium-82 or kilobecquerel of strontium-85 per megabecquerel of rubidium-82, the time and date of the measurement, and the name of the individual who made the measurement.

L. Records of safety instruction. Licensees shall maintain a record of safety instructions and training required by 12VAC5-481-1960 and 12VAC5-481-1970 for three years. Each record shall include a list of topics covered, the date of the instruction or training, the names of the attendees, and the names of the individuals who provided the instruction.

M. Records of surveys after source implant and removal. Licensees shall maintain a record of the surveys required by 12VAC5-481-2011 and 12VAC5-481-2041 for three years. Each record shall include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey.

N. Records of brachytherapy source accountability.

1. Licensee shall maintain a record of brachytherapy source accountability required by 12VAC5-481-2012 for three years.

2. For temporary implants, the record shall include the number and activity of sources removed from storage, the time and date they were removed from storage, the name of the individual who removed them from storage, and the location of use and the number and activity of sources returned to storage, the time and date they were returned to storage, and the name of the individual who returned them to storage.

3. For permanent implants, the record shall include the number and activity of sources removed from storage, the date they were removed from storage, the name of the individual who removed them from storage, the number and activity of sources not implanted, the date they were returned to storage, the name of the individual who returned them to storage, and the number and activity of sources permanently implanted in the patient or human research subject.

O. Records of calibration measurements of brachytherapy sources. Licensees shall maintain a record of the calibrations of brachytherapy sources required by 12VAC5-481-2015 for three years after the last use of the source. The record shall include the date of the calibration; the manufacturer's name, model number and serial number for the source and the instruments used to calibrate the source; the source output or activity; the source positioning accuracy within the applicators; and the name of the individual, the source manufacturer, or the calibration laboratory that performed the calibration.

P. Records of decay of strontrium-90 sources for ophthalmic treatments. Licensees shall maintain a record of the activity of a strontium-90 source required by 12VAC5-481-2016 for the life of the source. The record shall include the date and initial activity of the source as determined under 12VAC5-481-2016, and for each decay calculation, the date and the source activity as determined under 12VAC5-481-2016 and the signature of the authorized medical physicist.

Q. Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. Licensees shall retain a record of the installation, adjustment, maintenance, and repair of remote afterloaders units, teletherapy units, and gamma stereotactic radiosurgery units as required by 12VAC5-481-2042 for three years. For each installation, adjustment, maintenance, and repair, the record shall include the date, description of the service, and names of the individuals who performed the work.

R. Records of safety procedures. Licensees shall retain a copy of the procedures required by 12VAC5-481-2043 until the licensee no longer possesses the remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.

S. Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. Licensees shall retain a record of the calibration, intercomparison, and comparisons of its dosimetry equipment done in accordance with 12VAC5-481-2044 for the duration of the license. For each calibration, intercomparison, or comparison, the record shall include the date; the manufacturer's name, model numbers, and serial numbers of the instruments that were calibrated, intercompared, or compared as required by 12VAC5-481-2044; the correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; and the names of the individuals who performed the calibration, intercomparison, or comparison.

T. Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations. Licensees shall maintain a record of the teletherapy unit, remote afterloader unit, and gamma stereotactic radiosurgery unit full calibrations required by 12VAC5-481-2045 for three years. The record shall include the date of calibration; the manufacturer's name, model number, and serial number of the teletherapy, remote afterloader, and gamma stereotactic radiosurgery unit, the source, and the instruments used to calibrate the unit; the results and an assessment of the full calibrations; the results of the autoradiograph required for low dose-rate remote afterloader units; and the signature of the authorized medical physicist who performed the full calibration.

U. Records of periodic spot-checks for teletherapy units, remote afterloader units, and gamma stereotactic radiosurgery units.

1. Licensees shall retain a record of each periodic spot-check for teletherapy units, remote afterloader units, and gamma stereotactic radiosurgery units required by 12VAC5-481-2046 for three years. The record shall include:

a. For each teletherapy unit; the date of the spot-check, the manufacturer's name, model number, and serial number, source, and instrument used to measure the output of the teletherapy unit; an assessment of timer linearity and constancy; the calculated on-off error; a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device; the determined accuracy of each distance measuring and localization device; the difference between the anticipated output and the measured output; notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light, and the viewing and intercom system and doors; the name of the individual who performed the periodic spot-check; and the signature of the authorized medical physicist who reviewed the record of the spot-check.

b. For each remote afterloader unit: the date of the spot-check, the manufacturer's name, model and serial number for the remote afterloader unit and source; an assessment of timer accuracy; notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems, and clock and decayed source activity in the unit's computer; the name of the individual who performed the periodic spot-check; and the signature of the authorized medical physicist who reviewed the record of the spot-check.

c. For each gamma stereotactic radiosurgery unit: the date of the spot-check, the manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit; an assessment of timer linearity and accuracy; the calculated on-off error; a determination of trunnion centricity; the difference between the anticipated output and the measured output; an assessment of source output against computer calculations; notations indicating the operability of radiation monitors; helmet microswitches, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems; timer termination, treatment table retraction mechanism, and stereotactic frames and localizing device (trunnions); the name of the individual who performed the periodic spot-check; and the signature of the authorized medical physicist who reviewed the record of the spot-check.

2. Licensees shall retain a copy of the procedures required by 12VAC5-481-2046 B until the licensee no longer possesses the teletherapy unit, remote afterloader unit, or gamma stereotactic radiosurgery unit.

V. Records of additional technical requirements for mobile remote afterloader units. Licensees shall retain a record of each check for mobile remote afterloader units required by 12VAC5-481-2047 for three years. The record shall include the date of the check, the manufacturer's name, model number, and serial number of the remote afterloader unit; notations accounting for all sources before the licensee departs from a facility; notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators, source transfer tubes, and transfer tube applicator interfaces; source positioning accuracy; and the signature of the individual who performed the check.

W. Records of surveys of therapeutic treatment units. Licensees shall maintain a record of radiation surveys of treatment units made in accordance with 12VAC5-481-2041 for the duration of use of the unit. The record shall include the date of the measurements, the manufacturer's name, model number, and serial number of the treatment unit; source and instrument used to measure radiation levels; each dose rate measured around the source while the unit is in the off position and the average of all measurements; and the signature of the individual who performed the test.

X. Records of five-year inspection for teletherapy and gamma stereotactic radiosurgery units. Licensees shall maintain a record of the five-year inspections for teletherapy and gamma stereotactic radiosurgery required by 12VAC5-481-2048 for the duration of use of the unit. The record shall include the inspector's radioactive materials license number, the date of inspection, the manufacturer's name, model number, and serial number of both the treatment unit and source, a list of components inspected and serviced, the type of service, and the signature of the inspector.

Article 13
Reports

12VAC5-481-2080. Reports.

The following regulations, Report and notification of a medical event (10 CFR 35.3045), Report and notification of a dose to an embryo/fetus or a nursing child (10 CFR 35.3047), and Report of a leaking source (10 CFR 35.3067), are applicable in the Commonwealth of Virginia. A. Report and notification of a medical event.

1. Licensees shall report any event, except for an event that results from patient intervention, in which the administration of radioactive material or radiation from radioactive material results in:

a. A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 5 rem (0.05 Sv) effective dose equivalent, 50 rem (0.5 Sv) to an organ or tissue, or 50 rem (0.5 Sv) shallow dose equivalent to the skin; and

(1) The total dose delivered differs from the prescribed dose by 20% or more;

(2) The total dosage delivered differs from the prescribed dosage by 20% or more or falls outside the prescribed dosage range; or

(3) The fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50% or more.

b. A dose that exceeds 5 rem (0.05 Sv) effective dose equivalent, 50 rem (0.5 Sv) to an organ or tissue, or 50 rem  (0.5 Sv) shallow dose equivalent to the skin from any of the following:

(1) An administration of a wrong radioactive drug containing radioactive material;

(2) An administration of a radioactive drug containing radioactive material by the wrong route of administration;

(3) An administration of a dose or dosage to the wrong individual or human research subject;

(4) An administration of a dose or dosage delivered by the wrong mode of treatment; or

(5) A leaking sealed source.

c. A dose to the skin or an organ or tissue other than the treatment site that exceeds by 50 rem (0.5 Sv) to an organ or tissue and 50% or more of the dose expected from the administration defined in the written directive (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site).

2. Licensees shall report any event resulting from intervention of a patient or human research subject in which the administration of radioactive material or radiation from radioactive material results in unintended permanent functional damage to an organ or a physiological system, as determined by a physician.

3. Licensees shall notify the agency by telephone no later than the next calendar day after discovery of the medical event.

4. By an appropriate method listed in 12VAC5-481-150, licensees shall submit a written report to the agency within 15 days after discovery of the medical event.

a. The written report shall include:

(1) The licensee's name;

(2) The name of the prescribing physician;

(3) A brief description of the event;

(4) Why the event occurred;

(5) The effect, if any, on the individuals who received the administration;

(6) What actions, if any, have been taken or are planned to prevent recurrence; and

(7) Certification that the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not.

b. The report may not contain the individual's name or any other information that could lead to identification of the individual.

5. Licensees shall provide notification of the event to the referring physician and also notify the individual who is the subject of the medical event no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he will inform the individual or that, based on medical judgment, telling the individual would be harmful. Licensees are not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours, licensees shall notify the individual as soon as possible thereafter. Licensees may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification. To meet the requirements of this subdivision, the notification of the individual who is the subject of the medical event may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, licensees shall inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. Licensees shall provide such a written description if requested.

6. Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals affected by the medical event, or to that individual's responsible relatives or guardians.

7. Licensees shall:

a. Annotate a copy of the report provided to the agency with the:

(1) Name of the individual who is the subject of the event; and

(2) Social security number or other identification number, if one has been assigned, of the individual who is the subject of the event; and

b. Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.

B. Report and notification of a dose to an embryo/fetus or a nursing child.

1. Licensees shall report any dose to an embryo/fetus that is greater than 500 mrem (5 mSv) dose equivalent that is a result of an administration of radioactive material or radiation from radioactive material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user.

2. Licensees shall report any dose to a nursing child that is a result of an administration of radioactive material to a breast-feeding individual that:

a. Is greater than 5 mSv (500 rem) total effective dose equivalent; or

b. Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.

3. Licensees shall notify the agency by telephone no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing child that requires a report in accordance with subdivision 1 or 2 in this subsection.

4. By an appropriate method listed in 12VAC5-481-150, licensees shall submit a written report to the agency within 15 days after discovery of a dose to the embryo/fetus or nursing child that requires a report in subdivision 1 or 2 of this subsection.

a. The written report shall include

(1) The licensee's name;

(2) The name of the prescribing physician;

(3) A brief description of the event;

(4) Why the event occurred;

(5) The effect, if any, on the embryo/fetus or the nursing child;

(6) What actions, if any, have been taken or are planned to prevent recurrence; and

(7) Certification that the licensee notified the pregnant individual or mother (or the mother's or child's responsible relative or guardian), and if not, why not.

b. The report shall not contain the individual's or child's name or any other information that could lead to identification of the individual or child.

5. Licensees shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as "mother," no later than 24 hours after discovery of an event that would require reporting under subdivisions 1 or 2 of this subsection, unless the referring physician personally informs the licensee either that the mother will be informed or that, based on medical judgment, telling the mother would be harmful. Licensees are not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within 24 hours, licensees shall make the appropriate notifications as soon as possible thereafter. Licensees may not delay any appropriate medical care for the embryo/fetus or for the nursing child, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this subdivision, the notification may be made to the mother's or child's responsible relative or guardian instead of the mother, when appropriate. If a verbal notification is made, licensees shall inform the mother, or the mother's or child's responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. Licensees shall provide such a written description if requested.

6. Licensees shall:

a. Annotate a copy of the report provided to the agency with the:

(1) Name of the pregnant individual or the nursing child who is the subject of the event; and

(2) Social security number or other identification number, if one has been assigned, of the pregnant individual or the nursing child who is the subject of the event; and

b. Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.

C. Report of a leaking source.

1. Licensees shall file a report within five days if a leak test required by 12VAC5-481-1840 reveals the presence of 0.005 µCi (185 Bq) or more of removable contamination.

2. The report shall be filed with the agency by an appropriate method listed in 12VAC5-481-150. The written report shall include

a. The model number and serial number, if assigned, of the leaking source;

b. The radionuclide and its estimated activity;

c. The results of the test;

d. The date of the test; and

e. The action taken.

12VAC5-481-2240. Ventilation systems.

A. Ventilation systems shall be provided to ensure that personnel entering any area where airborne radioactivity may be produced will not be exposed to airborne radioactive material in excess of those limits specified in 12VAC5-481-3690 Appendix B to 10 CFR Part 20.

B. A registrant, as required in 12VAC5-481-3690 Appendix B to 10 CFR Part 20 shall not vent, release, or otherwise discharge airborne radioactive material to an unrestricted area which exceeds the limits specified in 12VAC5-481-3690 Appendix B to 10 CFR Part 20, except as authorized pursuant to 12VAC5-481-730. For purposes of this subsection concentrations may be averaged over a period not greater than one year. Every effort should be made to maintain releases of radioactive material to unrestricted areas as far below these limits as is reasonably achievable.

12VAC5-481-2280. Notifications and reports to individuals.

A. Radiation exposure data for an individual and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual shall be reported to the individual as specified in this section. The information reported shall include data and results obtained pursuant to these regulations, orders, or license conditions, as shown in records maintained by the licensee or registrant pursuant to 12VAC5-481-1040. Each notification and report shall:

1. Be in writing;

2. Include appropriate identifying data such as the name of the licensee or registrant, the name of the individual, and the individual's identification number;

3. Include the individual's exposure information; and

4. Contain the following statement:

"This report is furnished to you under the provisions of Part X (12VAC5-481-2250 et seq.) of 12VAC5-481, Virginia Radiation Protection Regulations. You should preserve this report for further reference."

B. Each licensee shall make dose information available to workers as shown in records maintained by the licensee under the provisions of 12VAC5-481-1040. The licensee shall provide an annual report to each individual monitored under 12VAC5-481-760 of the dose received in that monitoring year if:

1. The individual's occupational does dose exceeds 1 mSv (100 mrem) 100 mrem (1 mSv) TEDE or 1 mSv (100 mrem) 100 mrem (1 mSv) to any individual organ or tissue; or

2. The individual requests his annual dose report.

C. Each licensee or registrant shall furnish a written report of the worker's exposure to sources of radiation at the request of a worker formerly engaged in activities controlled by the licensee or registrant. The report shall include the dose record for each year the worker was required to be monitored pursuant to 12VAC5-481-760. Such report shall be furnished within 30 days from the date of the request, or within 30 days after the dose of the individual has been determined by the licensee or registrant, whichever is later. The report shall cover the period of time that the worker's activities involved exposure to sources of radiation and shall include the dates and locations of work under the license or registration in which the worker participated during this period.

D. When a licensee or registrant is required pursuant to 12VAC5-481-1100, 12VAC5-481-1110, or 12VAC5-481-1120 to report to the agency any exposure of an individual to sources of radiation, the licensee or the registrant shall also provide the individual a written report on the exposure data included therein. Such reports shall be transmitted at a time not later than the transmittal to the agency.

E. At the request of a worker who is terminating employment with the licensee or registrant in work involving exposure to radiation or radioactive material, during the current year, each licensee or registrant shall provide at termination to each such worker, or to the worker's designee, a written report regarding the radiation dose received by that worker from operations of the licensee or registrant during the current year or fraction thereof. If the most recent individual monitoring results are not available at that time, a written estimate of the dose shall be provided together with a clear indication that this is an estimate.

Part XII
Licensing and Radiation Safety Requirements for Irradiators

Article 1
Purpose and Scope

12VAC5-481-2660. Purpose and scope.

The following regulation, Purpose and scope (10 CFR 36.1) is applicable in the Commonwealth of Virginia. A. This part contains requirements for the issuance of a license authorizing the use of sealed sources containing radioactive materials in irradiators used to irradiate objects or materials using gamma radiation. This part also contains radiation safety requirements for operating irradiators. The requirements of this part are in addition to other requirements of this chapter. In particular, the provisions of Parts 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 applications and licenses subject to this part. Nothing in this part relieves licensees from complying with other applicable federal, state, and local regulations governing the siting, zoning, land use, and building code requirements for industrial facilities.

B. This part applies to panoramic irradiators that have either dry or wet storage of the radioactive sealed sources and to underwater irradiators in which both the source and the product being irradiated are underwater. Irradiators whose dose rates exceed 500 rad (5 gray) per hour at 1 meter from the radioactive sealed sources in air or in water, as applicable for the irradiator type, are covered by this part.

C. This part does not apply to self-contained dry-source-storage irradiators (those in which both the source and the area subject to irradiation are contained within a device and are not accessible by personnel), medical radiology or teletherapy, radiography (the irradiation of materials for nondestructive testing purposes), gauging, or open-field (agricultural) irradiators.

Article 2
Specific Licensing Requirements

12VAC5-481-2670. Application for a specific license.

The following regulation, Application for a specific license (10 CFR 36.11) is applicable in the Commonwealth of Virginia. A person, as defined in 12VAC5-481-10, may file an application for a specific license authorizing the use of sealed sources in an irradiator.  Each application shall be sent to the agency along with the appropriate fee prescribed in 12VAC5-490.

12VAC5-481-2680. Specific licenses for irradiators.

The following regulation, Specific licenses for irradiators (10 CFR 36.13) is applicable in the Commonwealth of Virginia. A. The agency will approve an application for a specific license for the use of licensed material in an irradiator if the applicant meets the requirements contained in subsection B of this section and includes the information, as appropriate, from subsections C through I of this section.

B. The applicant shall satisfy the general requirements specified in 12VAC5-481-450 and the requirements contained in this part.

C. The application shall describe the training provided to the irradiator operators including:

1. Classroom training;

2. On-the-job training or simulator training;

3. Safety reviews;

4. Means employed by the applicant to test each operator's understanding of the agency regulations and licensing requirements and the irradiator operating and emergency procedures; and

5. Minimum training and experience of personnel who may provide training.

D. The application shall include the outline of the written operating and emergency procedures listed in the 12VAC5-481-2840 that describes the radiation safety aspects of the procedures.

E. The application shall describe the organizational structure for managing the irradiator, specifically the radiation safety responsibilities and authorities of the radiation safety officer and those management personnel who have important radiation safety responsibilities or authorities. In particular, the application shall specify who, within the management structure, has the authority to stop unsafe operations. The application shall also describe the training and experience required for the position of radiation safety officer.

F. The application shall include a description of the access control systems required by 12VAC5-481-2730, the radiation monitors required by 12VAC5-481-2760, the method of detecting leaking sources required by 12VAC5-481-2870 including the sensitivity of the method, and a diagram of the facility that shows the locations of all required interlocks and radiation monitors.

G. If the applicant intends to perform leak testing of dry-source-storage sealed sources, the applicant shall establish procedures for leak testing and submit a description of these procedures to the agency.  The description shall include:

1. Instruments to be used;

2. Methods of performing the analysis; and

3. Pertinent experience of the individual who analyzes the samples.

H. If licensee personnel are to load or unload sources, the applicant shall describe the qualifications and training of the personnel and the procedures to be used. If the applicant intends to contract for source loading or unloading at its facility, the loading or unloading shall be done by an organization specifically licensed by the agency, NRC, or another agreement state to load or unload irradiator sources.

I. The applicant shall describe the inspection and maintenance checks, including the frequency of the checks required by 12VAC5-481-2880.

12VAC5-481-2690. Start Commencement of construction.

The following regulation, Start of construction (10 CFR 36.15) is applicable in the Commonwealth of Virginia. Commencement of construction of a new irradiator may occur prior to the submission to the agency of both an application for a license for the irradiator and the fee required by 12VAC5-490. Any activities undertaken prior to the issuance of a license are entirely at the risk of the applicant and have no bearing on the issuance of a license. Commencement of construction, as defined in 12VAC5-481-10, may not include non-construction activities if the activity has a reasonable nexus to radiological safety and security.

12VAC5-481-2700. Applications for exemptions.

The following regulation, Applications for exemptions (10 CFR 36.17) is applicable in the Commonwealth of Virginia. A. The agency may, upon application of any interested person or upon its own initiative, grant any exemptions from the requirements in this part that it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.

B. Any application for a license or for amendment of a license authorizing use of a teletherapy-type unit for irradiation of materials or objects may include proposed alternatives for the requirements in this part. The agency will approve the proposed alternatives if the applicant provides adequate rationale for the proposed alternatives and demonstrates that it is likely to provide an adequate level of safety for workers and the public.

12VAC5-481-2710. Request for written statements.

The following regulation, Request for written statements (10 CFR 36.19) is applicable in the Commonwealth of Virginia. A. After the filing of an application, the agency may request further information necessary to enable the agency to determine whether the application shall be granted or denied.

B. Each license is issued with the condition that the licensee will, at any time before expiration of the license, upon the agency's request, submit written statements to enable the agency to determine whether the license shall be modified, suspended, or revoked.

Article 3
Design and Performance Requirements for Irradiators

12VAC5-481-2720. Performance criteria for sealed sources.

The following regulation, Performance criteria for sealed sources (10 CFR 36.21) is applicable in the Commonwealth of Virginia. A. Sealed sources installed after July 1, 1993, shall:

1. Have a certificate of registration issued by the NRC or another agreement state;

2. Be doubly encapsulated;

3. Use radioactive material that is as nondispersible as practical and that is as insoluble as practical if the source is used in a wet-source-storage or wet-source-change irradiator;

4. Be encapsulated in a material resistant to general corrosion and to localized corrosion, such as 316L stainless steel or other material with equivalent resistance if the sources are for use in irradiator pools; and

5. In prototype testing of the sealed source, have been leak tested and found leak-free after each of the tests described in subsections B through G of this section.

B. The test source shall be held at -40ºC for 20 minutes, 600ºC for one hour, then be subjected to a thermal shock test with a temperature drop from 600ºC to 20ºC within 15 seconds.

C. The test source shall be twice subjected for at least five minutes to an external pressure (absolute) of 2 million newtons per square meter.

D. A 2-kilogram steel weight (2.5. centimeters in diameter) shall be dropped from a height of 1 meter onto the test source.

E. The test source shall be subjected three times for 10 minutes each to vibrations sweeping from 25 hertz to 500 hertz with a peak amplitude of five times the acceleration of gravity. In addition, each test source shall be vibrated for 30 minutes at each resonant frequency found.

F. A 50-gram weight and a pin (0.3 centimeter pin diameter) shall be dropped from a height of 1 meter onto the test source.

G. If the length of the source is more than 15 times larger than the minimum cross-sectional dimension, the test source shall be subjected to a force of 2000 newtons at its center equidistant from two support cylinders, the distance between which is 10 times the minimum cross-sectional dimension of the source.

12VAC5-481-2730. Access control.

The following regulation, Access control (10 CFR 36.23) is applicable in the Commonwealth of Virginia. A. Each entrance to a radiation room at a panoramic irradiator shall have a door or other physical barrier to prevent inadvertent entry of personnel if the sources are not in the shielded position. Product conveyor systems may serve as barriers as long as they reliably and consistently function as a barrier. It shall not be possible to move the sources out of their shielded position if the door or barrier is open. Opening the door or barrier while the sources are exposed shall cause the sources to return promptly to their shielded position. The personnel entrance door or barrier shall have a lock that is operated by the same key used to move the sources. The doors and barriers shall not prevent any individual in the radiation room from leaving.

B. In addition, each entrance to a radiation room at a panoramic irradiator shall have an independent backup access control to detect personnel entry while the sources are exposed. Detection of entry while the sources are exposed shall cause the sources to return to their fully shielded position and shall also activate a visible and audible alarm to make the individual entering the room aware of the hazard. The alarm shall also alert at least one other individual who is onsite of the entry. That individual shall be trained on how to respond to the alarm and prepared to promptly render or summon assistance.

C. A radiation monitor shall be provided to detect the presence of high radiation levels in the radiation room of a panoramic irradiator before personnel entry. The monitor shall be integrated with personnel access door locks to prevent room access when radiation levels are high. Attempted personnel entry while the monitor measures high radiation levels, shall activate the alarm described in subsection B of this section. The monitor may be located in the entrance (normally referred to as the maze) but not in the direct radiation beam.

D. Before the sources move from their shielded position in a panoramic irradiator, the source control shall automatically activate conspicuous visible and audible alarms to alert personnel in the radiation room that the sources will be moved from their shielded position. The alarms shall give individuals enough time to leave the room before the sources leave the shielded position.

E. Each radiation room at a panoramic irradiator shall have a clearly visible and readily accessible control that would allow an individual in the room to make the sources return to their fully shielded position.

F. Each radiation room of a panoramic irradiator shall contain a control that prevents the sources from moving from the shielded position unless the control has been activated and the door or barrier to the radiation room has been closed within a preset time after activation of the control.

G. Each entrance to the radiation room of a panoramic irradiator and each entrance to the area within the personnel access barrier of an underwater irradiator shall be posted as required by 12VAC5-481-860. Radiation postings for panoramic irradiators shall comply with the posting requirements of 12VAC5-481-860, except that signs may be removed, covered, or otherwise made inoperative when the sources are fully shielded.

H. If the radiation room of a panoramic irradiator has roof plugs or other movable shielding, it shall not be possible to operate the irradiator unless the shielding is in its proper location. This requirement may be met by interlocks that prevent operation if shielding is not placed properly or by an operating procedure requiring inspection of shielding before operating.

I. Underwater irradiators shall have a personnel access barrier around the pool which shall be locked to prevent access when the irradiator is not attended. Only operators and facility management may have access to keys to the personnel access barrier. There shall be an intrusion alarm to detect unauthorized entry when the personnel access barrier is locked. Activation of the intrusion alarm shall alert an individual (not necessarily on site) who is prepared to respond or summon assistance.

12VAC5-481-2740. Shielding.

The following regulation, Shielding (10 CFR 36.25) is applicable in the Commonwealth of Virginia. A. The radiation dose rate in areas that are normally occupied during operation of a panoramic irradiator may not exceed 2 mrem (0.02 mSv) per hour at any location 30 centimeters or more from the wall of the room when the sources are exposed. The dose rate shall be averaged over an area not to exceed 100 square cm having no linear dimension greater than 20 centimeters. Areas where the radiation dose rate exceeds 2 mrem (0.02 mSv) per hour shall be locked, roped off, or posted.

B. The radiation dose at 30 centimeters over the edge of the pool of a pool irradiator may not exceed 2 mrem (0.02 mSv) per hour when the sources are in the fully shielded position.

C. The radiation dose rate at 1 meter from the shield of a dry-source-storage panoramic irradiator may not exceed 2 mrem (0.02 mSv) per hour and at 5 centimeters from the shield may not exceed 20 mrem (0.2 mSv) per hour.

12VAC5-481-2750. Fire protection.

The following regulation, Fire protection (10 CFR 36.27) is applicable in the Commonwealth of Virginia. A. The radiation room at panoramic irradiator must have heat and smoke detectors. The detectors must activate an audible alarm. The alarm must be capable of alerting a person who is prepared to summon assistance promptly. The sources must automatically become fully shielded if a fire is detected.

B. The radiation room at a panoramic irradiator must be equipped with a fire extinguishing system capable of extinguishing a fire without the entry of personnel into the room. The system for the radiation room must have a shut-off valve to control flooding into unrestricted areas.

12VAC5-481-2760. Radiation monitors.

The following regulation, Radiation monitors (10 CFR 36.29) is applicable in the Commonwealth of Virginia. A. Irradiators with automatic product conveyor systems must have a radiation monitor with an audible alarm located to detect loose radioactive sources that are carried toward the product exit. If the monitor detects a source, an alarm must sound and product conveyors must stop automatically. The alarm must be capable of alerting an individual in the facility who is prepared to summon assistance. Underwater irradiators in which the product moves within an enclosed stationary tube are exempt from this requirement.

B. Underwater irradiators that are not in a shielded radiation room must have a radiation monitor over the pool to detect abnormal radiation levels. The monitor must have an audible alarm and a visible indicator at entrances to the personnel access barrier around the pool. The alarm must be capable of alerting an individual who is prepared to respond promptly.

12VAC5-481-2770. Control of source movement.

The following regulation, Control of source movement (10 CFR 36.31) is applicable in the Commonwealth of Virginia. A. The mechanism that moves the sources of a panoramic irradiator must require a key to actuate. Actuation of the mechanism must cause an audible signal to indicate that the sources are leaving the shielded position. Only one key may be in use at any time, and only operators or facility management may possess it. The key must be attached to a portable radiation survey meter by a chain or cable. The lock for source control must be designed so that the key may not be removed if the sources are in an unshielded position. The door to the radiation room must require the same key.

B. The console of a panoramic irradiator must have source position indicator that indicates when the sources are in the fully shielded position, when they are in transit, and when the sources are exposed.

C. The control console of a panoramic irradiator must have a control that promptly returns the sources to the shielded position.

D. Each control for a panoramic irradiator must be clearly marked as to its function.

12VAC5-481-2780. Irradiator pools.

The following regulation, Irradiator pools (10 CFR 36.33) is applicable in the Commonwealth of Virginia. A. For licenses initially issued after July 1, 1993, irradiator pools must have a method to safely store the sources during repairs of the pool and either:

1. Have a watertight stainless steel liner or a liner metallurgically compatible with other components in the pools; or

2. Be constructed so that there is a low likelihood of substantial leakage and have a surface designed to facilitate decontamination.

B. For licenses initially issued after July 1, 1993, irradiator pools must have no outlets more than 0.5 meter below the normal low water level that could allow water to drain out of the pool. Pipes that have intakes more than 0.5 meter below the normal low water level and that could act as siphons must have siphon breakers to prevent siphoning of pool water.

C. A means must be provided to replenish water losses from the pool.

D. A visible indicator must be provided in a clearly visible location to indicate if the pool water level is below the normal low water level or above the normal high water level.

E. Irradiator pools must be equipped with a purification system designed to be capable of maintaining the water during normal operation at a conductivity of 20 microsiemens per centimeter or less and with a clarity so that the sources can be seen clearly.

F. A physical barrier, such as a railing or cover, must be used around or over irradiator pools during normal operation to prevent personnel from accidentally falling into the pool. The barrier may be removed during maintenance, inspection, and service operations.

G. If long-handled tools or poles are used in irradiator pools, the radiation dose rate on the handling areas of the tools may not exceed 2 mrem (0.02 mSv) per hour.

12VAC5-481-2790. Source rack protection.

The following regulation, Source rack protection (10 CFR 36.35) is applicable in the Commonwealth of Virginia. If the product to be irradiated moves on a product conveyor system, the source rack and the mechanism that moves the rack must be protected by a barrier or guides to prevent products and product carriers from hitting or touching the rack or mechanism.

12VAC5-481-2800. Power failures.

The following regulation, Power failures (10 CFR 36.37) is applicable in the Commonwealth of Virginia. A. If electrical power at a panoramic irradiator is lost for longer than 10 seconds, the sources must automatically return to the shielded position.

B. The lock on the door of the radiation room of a panoramic irradiator may not be deactivated by a power failure.

C. During a power failure, the area of any irradiator where sources are located may be entered only when using an operable and calibrated radiation survey meter.

12VAC5-481-2810. Design requirements.

The following regulation, Design requirements (10 CFR 36.39) is applicable in the Commonwealth of Virginia. A. For all irradiators, licensees shall evaluate the location and sensitivity of the monitor to detect sources carried by the product conveyor system as required by 12VAC5-481-2760 A. Licensees shall verify that the product conveyor is designed to stop before a source on the product conveyor would cause a radiation overexposure to any person.

B. For panoramic irradiators:

1. Licensees shall design shielding walls to meet generally accepted building code requirements for reinforced concrete and design the walls, wall penetrations, and entrance ways to meet the radiation shielding requirements of 12VAC5-481-2740. If the irradiator will use more than 5 million curies (2 x 1017 Bq) of activity, licensees shall evaluate the effects of heating of the shielding walls by the irradiator sources.

2. Licensees shall design the foundation, with consideration given to soil characteristics, to ensure it is adequate to support the weight of the facility shield walls.

3. Licensees shall verify from the design and logic diagram that the access control system will meet the requirements of 12VAC5-481-2730.

4. Licensees shall verify that the number, locations, and spacing of the smoke and heat detectors are appropriate to detect fires and that the detectors are protected from mechanical and radiation damage. Licensees shall verify that the design of the fire extinguishing system provides the necessary discharge patterns, densities, and flow characteristics for complete coverage of the radiation room and that the system is protected from mechanical and radiation damage.

5. Licensees shall verify that the source rack will automatically return to the fully shielded position if offsite power is lost for more than 10 seconds.

6. Licensees shall verify that electrical wiring and electrical equipment in the radiation room are selected to minimize failures due to prolonged exposure to radiation.

7. Licensees shall determine that source rack drops due to loss of power will not damage the source rack and that source rack drops due to failure of cables (or alternate means of support) will not cause loss of integrity of sealed sources.

8. Licensees shall review the design of the mechanism that moves the sources to assure that the likelihood of a struck source is low and that, if the rack sticks, a means exists to free it with minimal risk to personnel.

9. For panoramic irradiators to be built in seismic areas, licensees shall design the reinforced concrete radiation shields to retain their integrity in the event of an earthquake by designing to the seismic requirements of an appropriate source or local building codes, if current.

D. For pool irradiators:

1. Licensees shall design the pool to assure that it is leak resistant, that it is strong enough to bear the weight of the pool water and shipping casks, that a dropped cask would not fall on sealed sources, that all outlets or pipes meet the requirements of 12VAC5-481-2780 C, and that metal components are metallurgically compatible with other components in the pool.

2. Licensees shall verify that the design of the water purification system is adequate to meet the requirements of 12VAC5-481-2780 E. The system must be designed so that water leaking from the system does not drain to unrestricted areas without being monitored.

3. Licensees shall verify that there are no crevices on the source or between the source and the source holders that would promote corrosion on a critical area of the source.

4. If licensees use radiation monitors to detect contamination under 12VAC5-481-2870 B, they shall verify that the design of radiation monitoring systems to detect pool contamination includes sensitive detectors located close to where contamination is likely to concentrate.

12VAC5-481-2820. Construction monitoring and acceptance testing.

The following regulation, Construction monitoring and acceptance testing (10 CFR 36.41) is applicable in the Commonwealth of Virginia. A. For all irradiators, licensees shall verify the proper operation of the monitor to detect sources carried on the product conveyor system and the related alarms and interlocks required by 12VAC5-481-2760 A.

B. For all irradiators with product conveyor systems, the licensee shall observe and test the operation of the conveyor system to assure that the requirements in 12VAC5-481-2790 are met for protection of the source rack and the mechanism that moves the rack; testing must include tests of any limit switches and interlocks used to protect the source rack and mechanism that moves the rack from moving product carriers.

C. For panoramic irradiators:

1. Licensees shall monitor the construction of the shielding to verify that its construction meets design specifications and generally accepted building code requirements for reinforced concrete.

2. Licensees shall monitor the construction of the foundations to verify that their construction meets design specifications.

3. Licensees shall test the movement of the source racks for proper operation prior to source loading; testing must include source rack lowering due to simulated loss of power.

4. Licensees shall test the completed access control system to assure that it functions as designed and that all alarms, controls, and interlocks work properly.

5. Licensees shall test the ability of the heat and smoke detectors to detect a fire, to activate alarms, and to cause the source rack to automatically become fully shielded. Licensees shall test the operability of the fire extinguishing system.

6. Licensees shall demonstrate that the source racks can be returned to their fully shielded positions without offsite power.

7. For panoramic irradiators that use a computer system to control the access control system, licensees shall verify that the access control system will operate properly if offsite power is lost and shall verify that the computer has security features that prevent an irradiator operator from commanding the computer to override the access control system when it is required to be operable.

8. Licensees shall verify that the electrical wiring and electrical equipment that were installed meet the design specifications.

D. For pool irradiators:

1. Licensees shall verify that the pool meets design specifications and shall test the integrity of the pool. Licensees shall verify that outlets and pipes meet the requirements of 12VAC5-481-2780 B.

2. Licensees shall verify that the water purification system, the conductivity meter, and the water level indicators operate properly.

3. Licensees shall verify the proper operation of the radiation monitors and the related alarm if used to meet 12VAC5-481-2870 B.

E. For underwater irradiators, licensees shall verify the proper operation of the over-the-pool monitor, alarms, and interlocks required by 12VAC5-481-2760 B.

Article 4
Operation of Irradiators

12VAC5-481-2830. Training.

The following regulation, Training (10 CFR 36.51) is applicable in the Commonwealth of Virginia. A. Before an individual is permitted to operate an irradiator without a supervisor present, the individual must be instructed in:

1. The fundamentals of radiation protection applied to irradiators, including the differences between external radiation and radioactive contamination, units of radiation dose, agency dose limits, why large radiation doses must be avoided, how shielding and access controls prevent large doses, how an irradiator is designed to prevent contamination, the proper use of survey meters and personnel dosimeters, other radiation safety features of an irradiator, and the basic function of the irradiator;

2. The requirements of Part X (12VAC5-481-2250, et seq.) and Part XII (12VAC5-481-2660 et seq.) of this chapter that are relevant to the irradiator;

3. The operation of the irradiator;

4. Those operating and emergency procedures listed in 12VAC5-481-2840 that the individual is responsible for performing; and

5. Case histories of accidents or problems involving irradiators.

B. Before an individual is permitted to operate an irradiator without a supervisor present, the individual shall pass a written test on the instruction received consisting primarily of questions based on the licensee's operating and emergency procedures that the individual is responsible for performing and other operations necessary to safely operate the irradiator without supervision.

C. Before an individual is permitted to operate an irradiator without a supervisor present, the individual must have received on-the-job training or simulator training in the use of the irradiator as described in the license application. The individual shall also demonstrate the ability to perform those portions of the operating and emergency procedures that the individual is to perform.

D. Licensees shall conduct safety reviews for irradiator operators at least annually. Licensees shall give each operator a brief written test on the information. Each safety review must include, to the extent appropriate, each of the following:

1. Changes in operating and emergency procedures since the last review;

2. Changes in regulations and license conditions since the last review;

3. Reports on recent accidents, mistakes, or problems that have occurred at irradiators;

4. Relevant results of inspections of operator safety performance;

5. Relevant results of the facility's inspection and maintenance checks; and

6. A drill to practice an emergency or abnormal event procedure.

E. Licensees shall evaluate the safety performance of each irradiator operator at least annually to ensure that regulations, license conditions, and operating and emergency procedures are followed. Licensees shall discuss the results of the evaluation with the operator and shall instruct the operator on how to correct mistakes or deficiencies observed.

F. Individuals who will be permitted unescorted access to the radiation room of the irradiator or the area around the pool of an underwater irradiator, but who have not received the training required for operators or for the radiation safety officer, shall be instructed and tested in precautions they shall take to avoid radiation exposure, procedures or parts of procedures listed in 12VAC5-481-2840 that they are expected to perform or comply with, and their proper response to alarms required in this part. Tests may be oral.

G. Individuals who must be prepared to respond to alarms required by 12VAC5-481-2730 B and I, 12VAC5-481-2750 A, 12VAC5-481-2760, and 12VAC5-481-2870 B shall be trained and tested on how to respond. Each individual shall be retested at least once a year. Tests may be oral.

12VAC5-481-2840. Operating and emergency procedures.

The following regulation, Operating and emergency procedures (10 CFR 36.53) is applicable in the Commonwealth of Virginia. A. Licensees shall have and follow written operating procedures for:

1. Operation of the irradiator, including entering and leaving the radiation room;

2. Use of personnel dosimeters;

3. Surveying the shielding of panoramic irradiators;

4.  Monitoring pool water for contamination while the water is in the pool and before release of pool water to unrestricted areas;

5. Leak testing of sources;

6. Inspection and maintenance checks required by 12VAC5-481-2880;

7. Loading, unloading, and repositioning sources if the operations will be performed by the licensee; and

8. Inspection of movable shielding required by 12VAC5-481-2730, if applicable.

B. Licensees shall have and follow written emergency or abnormal event procedures appropriate for the irradiator type for:

1. Sources stuck in the unshielded position;

2. Personnel overexposures;

3. A radiation alarm from the product exit portal monitor or pool monitor;

4. Detection of leaking sources, pool contamination, or alarm caused by contamination of pool water;

5. A low or high water level indicator, an abnormal water loss, or leakage from the source storage pool;

6. A prolonged loss of electrical power;

7. A fire alarm or explosion in the radiation room;

8. An alarm indicating unauthorized entry into the radiation room, area around pool, or another alarmed area;

9. Natural phenomena, including an earthquake, a tornado, flooding, or other phenomena as appropriate for the geographical location of the facility; and

10. The jamming of automatic conveyor systems.

C. Licensees may revise operating and emergency procedures without agency approval only if all of the following conditions are met:

1. The revisions do not reduce the safety of the facility;

2. The revisions are consistent with the outline or summary of procedures submitted with the license application;

3. The revisions have been reviewed and approved by the radiation safety officer; and

4. The users or operators are instructed and tested on the revised procedures before they are put into use.

12VAC5-481-2850. Personnel monitoring.

The following regulation, Personnel monitoring (10 CFR 36.55) is applicable in the Commonwealth of Virginia. A. Irradiator operators shall wear a personnel dosimeter that is processed and evaluated by an accredited National Voluntary Laboratory Accreditation Program (NVLAP) processor while operating a panoramic irradiator or while in the area around the pool of an underwater irradiator. The personnel dosimeter processor must be accredited for the high energy photons in the normal and accident dose ranges (see 12VAC5-481-750). Each personnel dosimeter must be assigned to and worn by only one individual. Film badges must be processed at least monthly, and other personnel dosimeters must be processed at least quarterly.

B. Other individuals who enter the radiation room of a panoramic irradiator shall wear a dosimeter, which may be a pocket dosimeter. For groups of visitors, only two people who enter the radiation room are required to wear dosimeters. If pocket dosimeters are used to meet the requirements of this subsection, a check of their response to radiation must be done at least annually. Acceptable dosimeters must read within plus or minus 20% of the true radiation dose.

12VAC5-481-2860. Radiation surveys.

The following regulation, Radiation surveys (10 CFR 36.57) is applicable in the Commonwealth of Virginia. A. A radiation survey of the area outside the shielding of the radiation room of a panoramic irradiator must be conducted with the sources in the exposed position before the facility starts to operate. A radiation survey of the area above the pool of pool irradiators must be conducted after the sources are loaded but before the facility starts to operate. Additional radiation surveys of the shielding must be performed at intervals not to exceed three years and before resuming operation after addition of new sources or any modification to the radiation room shielding or structure that might increase dose rates.

B. If the radiation levels specified in 12VAC5-481-2740 are exceeded, the facility must be modified to comply with the requirements in 12VAC5-481-2740.

C. Portable radiation survey meters must be calibrated at least annually to an accuracy of plus or minus 20% for the gamma energy of the sources in use. The calibration must be done at two points on each scale or for digital instruments at one point per decade over the range that will be used. Portable radiation survey meters must be of a type that does not saturate and read zero at high radiation dose rates.

D. Water from the irradiator pool, other potentially contaminated liquids, and sediments from pool vacuuming must be monitored for radioactive contamination before release to unrestricted areas. Radioactive concentrations must not exceed those specified in Appendix B to 10 CFR Part 20, Table 2, Column 2 or Table 3.

E. Before releasing resins for unrestricted use, they must be monitored in an area with a background level less than 0.05 mrem (0.5 μSv) per hour. The resins may be released only if the survey does not detect radiation levels above background radiation levels. The survey meter used must be capable of detecting radiation levels of 0.05 mrem (0.5 μSv) per hour.

12VAC5-481-2870. Detection of leaking sources.

The following regulation, Detection of leaking sources (10 CFR 36.59) is applicable in the Commonwealth of Virginia. A. Each dry-source-storage sealed source must be tested for leakage at intervals not to exceed six months using a leak test kit or method approved by the agency, NRC, or another agreement state. In the absence of a certificate from a transferor that a test has been made within the six months before the transfer, the sealed source may not be used until tested. The test must be capable of detecting the presence of 0.005 μCi (200 Bq) of radioactive material and must be performed by a person approved by the agency, the NRC, or another agreement state to perform the test.

B. For pool irradiators, sources may not be put into the pool unless the licensee tests the sources for leaks or has a certificate from a transferor that a leak test has been done within the six months before the transfer. Water from the pool must be checked for contamination each day the irradiator operates. The check may be done either by using a radiation monitor on a pool water circulating system or by analysis of a sample of pool water. If a check for contamination is done by analysis of a sample of pool water, the results of the analysis must be available within 24 hours. If the licensee uses a radiation monitor on a pool water circulating system, the detection of above normal radiation levels must activate an alarm. The alarm set-point must be set as low as practical, but high enough to avoid false alarms. The licensee may reset the alarm set-point to a higher level if necessary to operate the pool water purification system to clean up contamination in the pool if specifically provided for in written emergency procedures.

C. If a leaking source is detected, the licensee shall arrange to remove the leaking source from service and have it decontaminated, repaired, or disposed of by an agency, the NRC, or another agreement state licensee that is authorized to perform these functions. The licensee shall promptly check its personnel, equipment, facilities, and irradiated product for radioactive contamination. No product may be shipped until the product has been checked and found free of contamination. If a product has been shipped that may have been inadvertently contaminated, the licensee shall arrange to locate and survey that product for contamination. If any personnel are found to be contaminated, decontamination must be performed promptly. If contaminated equipment, facilities, or products are found, the licensee shall arrange to have them decontaminated or disposed of by an agency, the NRC, or another agreement state licensee that is authorized to perform these functions. If a pool is contaminated, the licensee shall arrange to clean the pool until the contamination levels do not exceed the appropriate concentration in Table 2, Column 2 of Appendix B to 10 CFR Part 20. (See 12VAC5-481-1110 for reporting requirements.)

12VAC5-481-2880. Inspection and maintenance.

The following regulation, Inspection and maintenance (10 CFR 36.61) is applicable in the Commonwealth of Virginia. A. Licensees shall perform inspection and maintenance checks that include, as a minimum, each of the following at the frequency specified in the license or license application:

1. Operability of each aspect of the access control system required by 12VAC5-481-2730;

2. Functioning of the source position indicator required by 12VAC5-481-2770 B;

3. Operability of the radiation monitor for radioactive contamination in pool water required by 12VAC5-481-2870 B using a radiation check source, if applicable;

4. Operability of the over-pool radiation monitor at underwater irradiators as required by 12VAC5-481-2760 B;

5. Operability of the product exit monitor required by 12VAC5-481-2760 A;

6. Operability of the emergency source return control required by 12VAC5-481-2770 C;

7. Leak-tightness of systems through which pool water circulates (visual inspection);

8. Operability of the heat and smoke detectors and extinguisher system required by 12VAC5-481-2750 (but without turning extinguishers on);

9. Operability of the means of pool water replenishment required by 12VAC5-481-2780 C;

10. Operability of the indicators of high and low pool water levels required by 12VAC5-481-2780 D;

11. Operability of the intrusion alarm required by 12VAC5-481-2730 I, if applicable;

12. Functioning and wear of the system, mechanisms, and cables used to raise and lower sources;

13. Condition of the barrier to prevent products from hitting the sources or source mechanism as required by 12VAC5-481-2790;

14. Amount of water added to the pool to determine if the pool is leaking;

15. Electrical wiring on required safety systems for radiation damage; and

16. Pool water conductivity measurements and analysis as required by 12VAC5-481-2890 B.

B. Malfunctions and defects found during inspection and maintenance checks must be repaired without undue delay.

12VAC5-481-2890. Pool water purity.

The following regulation, Pool water purity (10 CFR 36.63) is applicable in the Commonwealth of Virginia. A. Pool water purification system must be run sufficiently to maintain the conductivity of the pool water below 20 microsiemens per centimeter under normal circumstances. If pool water conductivity rises above 20 microsiemens per centimeter, licensees shall take prompt actions to lower pool water conductivity and shall take corrective actions to prevent future recurrences.

B. Licensees shall measure the pool water conductivity frequently enough, but no less than weekly, to assure that the conductivity remains below 20 microsiemens per centimeter. Conductivity meters must be calibrated at least annually.

12VAC5-481-2900. Attendance during operation.

The following regulation, Attendance during operation (10 CFR 36.65) is applicable in the Commonwealth of Virginia. A. Both an irradiator operator and at least one other individual who is trained on how to respond and prepared to promptly render or summon assistance if the access control alarm sounds shall be present on site:

1. Whenever the irradiator is operated using an automatic product conveyor system; and

2. Whenever the product is moved into or out of the radiation room when the irradiator is operated in a batch mode.

B. At a panoramic irradiator at which static irradiations (no movement of the product) are occurring, a person who has received the training on how to respond to alarms described in 12VAC5-481-2830 G must be on site.

C. At an underwater irradiator, an irradiator operator must be present at the facility whenever the product is moved into or out of the pool. Individuals who move the product into or out of the pool of an underwater irradiator need not be qualified as irradiator operators; however, they must have received the training described in 12VAC5-481-2830 F and G. Static irradiations may be performed without a person present at the facility.

12VAC5-481-2910. Entering and leaving the radiation room.

The following regulation, Entering and leaving the radiation room (10 CFR 36.67) is applicable in the Commonwealth of Virginia. A. Upon first entering the radiation room of a panoramic irradiator after an irradiation, the irradiator operator shall use a survey meter to determine that the source has returned to the fully shielded position. The operator shall check the functioning of the survey meter with a radiation check source prior to entry.

B. Before exiting from and locking the door to the radiation room of a panoramic irradiator prior to a planned irradiation, the irradiator operator shall:

1. Visually inspect the entire radiation room to verify that no one else is in it; and

2. Activate a control in the radiation room that permits the sources to be moved from the shielded position only if the door to the radiation room is locked within a preset time after setting the control.

C. During a power failure, the area around the pool of an underwater irradiator may not be entered without using an operable and calibrated radiation survey meter unless the over-the-pool monitor required by 12VAC5-481-2760 B is operating with backup power.

12VAC5-481-2920. Irradiation of explosive or flammable materials.

The following regulation, Irradiation of explosive or flammable materials (10 CFR 36.69) is applicable in the Commonwealth of Virginia. A. Irradiation of explosive material is prohibited unless the licensee has received prior written authorization from the agency. Authorization will not be granted unless the licensee can demonstrate that denotation of the explosive would not rupture the sealed sources, injure personnel, damage safety systems, or cause radiation overexposures to personnel.

B. Irradiation of more than small quantities of flammable material (flash point below 140ºF) is prohibited in panoramic irradiators unless the licensee has received prior written authorization from the agency. Authorization will not be granted unless the licensee can demonstrate that a fire in the radiation room could be controlled without damage to sealed sources or safety systems and without radiation overexposures to personnel.

Article 5
Records

12VAC5-481-2930. Records and retention periods.

The following regulation, Records and retention periods (10 CFR 36.81) is applicable in the Commonwealth of Virginia. Licensees shall maintain the following records at the irradiator for the periods specified:

1. A copy of the license, license conditions, documents incorporated into a license by reference, and amendments thereto until superseded by new documents or until the agency terminates the license for documents not superseded.

2. Records of each individual's training, tests, and safety reviews provided to meet the requirements of 12VAC5-481-2830 until three years after the individual terminates work.

3. Records of the annual evaluations of the safety performance of irradiator operators required by 12VAC5-481-2830 E for three years after the evaluations.

4. A copy of the current operating and emergency procedures required by 12VAC5-481-2840 until superseded or the agency terminates the license. Records of the radiation safety officer's review and approval of changes in procedures as required by 12VAC5-481-2840 C retained for three years from the date of the change.

5. Evaluations of personnel dosimeters required by 12VAC5-481-2850 until the agency terminates the license.

6. Records of radiation surveys required by 12VAC5-481-2860 for three years from the date of the survey.

7. Records of radiation survey meter calibrations required by 12VAC5-481-2860 and pool water conductivity meter calibrations required by 12VAC5-481-2890 B until three years from the date of calibration.

8. Records of the results of leak tests required by 12VAC5-481-2870 A and the results of contamination checks required by 12VAC5-481-2870 B for three years from the date of each test.

9. Records of inspection and maintenance checks required by 12VAC5-481-2880 for three years.

10. Records of major malfunctions, significant defects, operating difficulties or irregularities, and major operating problems that involve required radiation safety equipment for three years after repairs are completed.

11. Records of receipt, transfer, and disposal, of all licensed sealed sources as required by 12VAC5-481-571 and 12VAC5-481-3100.

12. Records on the design checks required by 12VAC5-481-2810 and the construction control checks as required by 12VAC5-481-2820 until the license is terminated. The records must be signed and dated. The title or qualification of the person signing must be included.

13. Records related to decommissioning of the irradiator as required by 12VAC5-481-450 C.

12VAC5-481-2940. Reports.

The following regulation, Reports (10 CFR 36.83) is applicable in the Commonwealth of Virginia. A. In addition to the reporting requirements in this chapter, licensees shall report the following events:

1. Source stuck in an unshielded position;

2. Any fire or explosion in a radiation room;

3. Damage to the source racks;

4. Failure of the cable or drive mechanism used to move the source racks;

5. Inoperability of the access control system;

6. Detection of radiation source by the product exit monitor;

7. Detection of radioactive contamination attributable to licensed radioactive material;

8. Structural damage to the pool liner or walls;

9. Abnormal water loss or leakage from the source storage pool (greater than the design parameters); and

10. Pool water conductivity exceeding 100 microsiemens per centimeter.

B. The reports must include a telephone report within 24 hours as described in 12VAC5-481-1100 and a written report within 30 days as described in 12VAC5-481-1110.

12VAC5-481-3120. Advance notification of transport of nuclear waste.

A. Prior to the transport of any nuclear waste outside of the confines of the licensee's facility or other place of use or storage, or prior to the delivery of any nuclear waste to a carrier for transport, each licensee shall provide advance notification of such transport to the governor, or governor's designee and the agency.

B. Advance notification for transport of licensed material is required only when:

1. The nuclear waste licensed material is required to be in Type B packaging for transportation;

2. The nuclear waste licensed material is being transported through Virginia enroute to a disposal facility or to a collection point for transport to a disposal facility; and

3. The quantity of licensed material in a single package exceeds:

a. 3000 times the A1 value of the radionuclides as specified in 12VAC5-481-3770;

b. 3000 times the A2 value of the radionuclides as specified in 12VAC5-481-3770; or

c. 1000 terabecquerel (27,000 curies).

C. Each advance notification required by subsection A and B of this section shall contain the following information:

1. The name, address, and telephone number of the shipper, carrier, and receiver of the shipment;

2. A description of the nuclear waste contained in the shipment as required by 49 CFR 172.202 and 172.203(d);

3. The point of origin of the shipment and the seven-day period during which departure of the shipment is estimated to occur;

4. The seven-day period during which arrival of the shipment at state boundaries is estimated to occur;

5. The destination of the shipment, and the seven-day period during which arrival of the shipment is estimated to occur; and

6. A point of contact with a telephone number for current shipment information.

D. The notification required by subsection A and B of this section shall be made in writing to the office of the governor, or governor's designee, the office of each appropriate tribal official or tribal official's designee, and to the agency. A notification delivered by mail must be postmarked at least seven days before the beginning of the seven-day period during which departure of the shipment is estimated to occur. A notification delivered by messenger must reach the office of the governor, or governor's designee, the office of each appropriate tribal official or tribal official's designee, and the agency, at least four days before the beginning of the seven-day period during which departure of the shipment is estimated to occur. A copy of the notification shall be retained by the licensee for three years.

E. The licensee shall notify the governor, or governor's designee, the office of each appropriate tribal official or tribal official's designee, and the agency of any changes to schedule information provided pursuant to subsection A and B of this section. Such notification shall be by telephone to a responsible individual in the office of the governor, or governor's designee, the office of each appropriate tribal official or tribal official's designee, and the agency. The licensee shall maintain for three years a record of the name of the individual contacted.

F. Each licensee who cancels a nuclear waste shipment, for which advance notification has been sent, shall send a cancellation notice, identifying the advance notification that is being canceled, to the governor, or governor's designee, the office of each appropriate tribal official or tribal official's designee, and to the agency. A copy of the notice shall be retained by the licensee for three years.

Part XVII
Schedules

12VAC5-481-3680. Assigned protection factors for respiratorsa.

 

Operating mode

Assigned Protection Factors

I. Air Purifying Respirators (Particulateb only)c:

 

 

Filtering facepiece disposabled

Negative Pressure

(d)

Facepiece, halfe

Negative Pressure

10

Facepiece, full

Negative Pressure

100

Facepiece, half

Powered air-purifying respirators

50

Facepiece, full

Powered air-purifying respirators

1000

Helmet/hood

Powered air-purifying respirators

1000

Facepiece, loose-fitting

Powered air-purifying respirators

25

II. Atmosphere supplying respirators (particulate, gases and vaporsf):

 

 

1. Air-line respirator:

 

 

Facepiece, half

Demand

10

Facepiece, half

Continuous Flow

50

Facepiece, half

Pressure Demand

50

Facepiece, full

Demand

100

Facepiece, full

Continuous Flow

1000

Facepiece, full

Pressure Demand

1000

Helmet/hood

Continuous Flow

1000

Facepiece, loose-fitting

Continuous Flow

25

Suit

Continuous Flow

(g)

2. Self-contained breathing Apparatus (SCBA):

 

 

Facepiece, full

Demand

h100

Facepiece, full

Pressure Demand

i10,000

Facepiece, full

Demand, Recirculating

h100

Facepiece, full

Positive Pressure Recirculating

i10,000

III. Combination Respirators:

 

 

Any combination of air-purifying and atmosphere-supplying respirators

Assigned protection factor for type and mode of operation as listed above.

aThese assigned protection factors apply only in a respiratory protection program that meets the requirements of this section. They are applicable only to airborne radiological hazards and may not be appropriate to circumstances when chemical or other respiratory hazards exist instead of, or in addition to, radioactive hazards. Selection and use of respirators for such circumstances must also comply with Department of Labor regulations.

Radioactive contaminants for which the concentration values in Table 1, Column 3 of 12VAC5-481-3690 Table 1, Column 3 of 10 CFR Part 20, Appendix B are based on internal dose due to inhalation may, in addition, present external exposure hazards at higher concentrations. Under these circumstances, limitations on occupancy may have to be governed by external dose limits.

bAir purifying respirators with APF <100 must be equipped with particulate filters that are at least 95% efficient. Air purifying respirators with APF = 100 must be equipped with particulate filters that are at least 99% efficient. Air purifying respirators with APFs >100 must be equipped with particulate filters that are at least 99.97% efficient.

cThe licensee may apply to VDH for the use of an APF greater than 1 for absorbent cartridges as protection against airborne radioactive gases and vapors (e.g., radioiodine).

dLicensees may permit individuals to use this type of respirator who have not been medically screened or fit tested on the device provided that no credit be taken for their use in estimating intake or dose. It is also recognized that it is difficult to perform an effective positive or negative pressure pre-use user seal check on this type of device. All other respiratory protection program requirements listed in 12VAC5-481-820 apply. An assigned protection factor has not been assigned for these devices. However, an APF equal to 10 may be used if the licensee can demonstrate a fit factor of at least 100 by use of a validated or evaluated, qualitative or quantitative fit test.

eUnder-chin type only. No distinction is made in this section between elastomeric half-masks with replaceable cartridges and those designed with the filter medium as an integral part of the facepiece (e.g., disposable or reusable disposable). Both types are acceptable so long as the seal area of the latter contains some substantial type of seal-enhancing material such as rubber or plastic, the two or more suspension straps are adjustable, the filter medium is at least 95 percent efficient and all other requirements of this section are met.

fThe assigned protection factors for gases and vapors are not applicable to radioactive contaminants that present an absorption or submersion hazard. For tritium oxide vapor, approximately one-third of the intake occurs by absorption through the skin so that an overall protection factor of 3 is appropriate when atmosphere-supplying respirators are used to protect against tritium oxide. Exposure to radioactive noble gases is not considered a significant respiratory hazard, and protective actions for these contaminants should be based on external (submersion) dose considerations.

gNo NIOSH approval schedule is currently available for atmosphere supplying suits. This equipment may be used in an acceptable respiratory protection program as long as all the other minimum program requirements, with the exception of fit testing, are met (i.e., 12VAC5-481-820).

hThe licensee should implement institutional controls to assure that these devices are not used in areas immediately dangerous to life or health (IDLH).

iThis type of respirator may be used as an emergency device in unknown concentrations for protection against inhalation hazards. External radiation hazards and other limitations to permitted exposure such as skin absorption shall be taken into account in these circumstances. This device may not be used by any individual who experiences perceptible outward leakage of breathing gas while wearing the device.

12VAC5-481-3690. Annual Limits on Intake (ALI) and Derived Air Concentrations (DACs) of radionuclides for occupational exposure; effluent concentrations; concentration. (Repealed.)

The following regulation, Annual Limits on Intake (ALI)s and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage, 10 CFR Part 20 - Appendix B, is applicable in the Commonwealth of Virginia.

12VAC5-481-3750. Quantities for use with decommissioning.

 

Materials

Microcuries

 

 

Americium-241

.01

 

 

Antimony-122

100

 

 

Antimony-124

10

 

 

Antimony-125

10

 

 

Arsenic-73

100

 

 

Arsenic-74

10

 

 

Arsenic-76

10

 

 

Arsenic-77

100

 

 

Barium-131

10

 

 

Barium-133

10

 

 

Barium-140

10

 

 

Bismuth-210

1

 

 

Bromine-82

10

 

 

Cadmium-109

10

 

 

Cadmium-115m

10

 

 

Cadmium-115

100

 

 

Calcium-45

10

 

 

Calcium-47

10

 

 

Carbon-14

100

 

 

Cerium-141

100

 

 

Cerium-143

100

 

 

Cerium-144

1

 

 

Cesium-131

1,000

 

 

Cesium-134m

100

 

 

Cesium-134

1

 

 

Cesium-135

10

 

 

Cesium-136

10

 

 

Cesium-137

10

 

 

Chlorine-36

10

 

 

Chlorine-38

10

 

 

Chromium-51

1,000

 

 

Cobalt-55

100

 

 

Cobalt-56

10

 

 

Cobalt-57

100

 

 

Cobalt-58m

10

 

 

Cobalt-58

10

 

 

Cobalt-60

1

 

 

Copper-64

100

 

 

Dysprosium-165

10

 

 

Dysprosium-166

100

 

 

Erbium-169

100

 

 

Erbium-171

100

 

 

Europium-152 9.2h

100

 

 

Europium-152 13 yr

1

 

 

Europium-154

1

 

 

Europium-155

10

 

 

Fluorine-18

1,000

 

 

Gadolinium-153

10

 

 

Gadolinium-159

100

 

 

Gallium-72

10

 

 

Germanium-71

100

 

 

Gold-198

100

 

 

Gold-199

100

 

 

Hafnium-181

10

 

 

Holmium-166

100

 

 

Hydrogen-3

1,000

 

 

Indium-113m

100

 

 

Indium-114m

10

 

 

Indium-115m

100

 

 

Indium-115

10

 

 

Iodine-125

1

 

 

Iodine-126

1

 

 

Iodine-129

0.1

 

 

Iodine-131

1

 

 

Iodine-132

10

 

 

Iodine-133

1

 

 

Iodine-134

10

 

 

Iodine-135

10

 

 

Iridium-192

10

 

 

Iridium-194

100

 

 

Iron-55

100

 

 

Iron-59

10

 

 

Krypton-85

100

 

 

Krpton-87

10

 

 

Lanthanum-140

10

 

 

Lutetium-177

100

 

 

Manganese-52

10

 

 

Manganese-54

10

 

 

Manganese-56

10

 

 

Mercury-197m

100

 

 

Mercury-197

100

 

 

Mercury-203

10

 

 

Molbdenum-99

100

 

 

Neodymium-147

100

 

 

Neodymium-149

100

 

 

Nickel-59

100

 

 

Nickel-63

10

 

 

Nickel-65

100

 

 

Niobium-93m

10

 

 

Niobium-95

10

 

 

Niobium-97

10

 

 

Osmium-185

10

 

 

Osmium-191m

100

 

 

Osmium-191

100

 

 

Osmium-193

100

 

 

Palladium-103

100

 

 

Palladium-109

100

 

 

Phosphorus-32

10

 

 

Platinum-191

100

 

 

Platinum-193m

100

 

 

Platinum-193

100

 

 

Platinum-197m

100

 

 

Platinum-197

100

 

 

Plutonium-239

.01

 

 

Polonium-210

0.1

 

 

Potassium-42

10

 

 

Praseodymium-142

100

 

 

Praseodymium-143

100

 

 

Promethium-147

10

 

 

Promethium-149

10

 

 

Radium-226

.01

 

 

Rhenium-186

100

 

 

Rhenium-188

100

 

 

Rhodium-103m

100

 

 

Rhodium-105

100

 

 

Rubidium-86

10

 

 

Rubidium-87

10

 

 

Ruthenium-97

100

 

 

Ruthenium-103

10

 

 

Ruthenium-105

10

 

 

Ruthenium-106

1

 

 

Samarium-151

10

 

 

Samarium-153

100

 

 

Scandium-46

10

 

 

Scandium-47

100

 

 

Scandium-48

10

 

 

Seleium-75

10

 

 

Silicon-31

100

 

 

Silver-105

10

 

 

Silver-110m

1

 

 

Silver-111

100

 

 

Sodium-24

10

 

 

Strontium-85

10

 

 

Strontium-89

1

 

 

Strontium-90

0.1

 

 

Strontium-91

10

 

 

Strontium-92

10

 

 

Sulphur-35

100

 

 

Tantalum-182

10

 

 

Technetium-96

10

 

 

Technetium-97m

100

 

 

Technetium-97

100

 

 

Technetium-99m

100

 

 

Technetium-99

10

 

 

Tellurium-125m

10

 

 

Tellurium127m

10

 

 

Tellurium-127

100

 

 

Tellurium129m

10

 

 

Tellurium-129

100

 

 

Tellurium-131m

10

 

 

Tellurium-132

10

 

 

Terbium-160

10

 

 

Thallium-200

100

 

 

Thallium-201

100

 

 

Thallium-202

100

 

 

Thallium-204

10

 

 

Throium (natural)1

100

 

 

Thulium-170

10

 

 

Thulium-171

10

 

 

Tin-113

10

 

 

Tin-125

10

 

 

Tungsten-181

10

 

 

Tungsten-185

10

 

 

Tungsten-187

100

 

 

Uranium (natural)2

100

 

 

Uranium-233

.01

 

 

Uranium-234--Uranium-235

.01

 

 

Vandium-48

10

 

 

Xenon-131m

1,000

 

 

Xenon-133

100

 

 

Xenon-135

100

 

 

Ytterbium-175

100

 

 

Yttrium-90

10

 

 

Yttrium-91

10

 

 

Yttrium-92

100

 

 

Yttrium-93

100

 

 

Zinc-65

10

 

 

Zinc-69m

100

 

 

Zinc-69

1,000

 

 

Zirconium-93

10

 

 

Zirconium-95

10

 

 

Zirconium-97

10

 

 

Any alpha emitting radionuclide not listed above or mixtures of
alpha emitters of unknown composition

.01

 

 

Any radionuclide other than alpha emitting radio-nuclides,
not listed above or mixtures of beta emitters of unknown
composition

.1

 

 

1Based on alpha disintegration rate of Th-232, Th-230, and their daughter products.
2Based on alpha disintegration rate of U-238, U-234, and U-235. 

 

Note: For purposes of § 20.2003 12VAC5-481-930, where there is involved a combination of isotopes in known amounts, the limit for the combination should be derived as follows: Determine, for each isotope in the combination, the ratio between the quantity present in the combination and the limit otherwise established for the specific isotope when not in combination. The sum of such ratios for all the isotopes in the combination may not exceed "1" (i.e., "unity").

12VAC5-481-3770. Determination of A1 and A2.

The following regulation, Determination of A1 and A2 (10 CFR Part 71, Appendix A) is applicable in the Commonwealth of Virginia. A. Values of A1 and A2 for individual radionuclides, which are the bases for many activity limits elsewhere in these regulations, are given in Table 1 of this section. The curie (Ci) values specified are obtained by converting from the Terabecquerel (TBq) value. The terabecquerel values are the regulatory standard. The curie values are for information only and are not intended to be the regulatory standard. Where values of A1 and A2 are unlimited, it is for radiation control purposes only. For nuclear criticality safety, some materials are subject to controls placed on fissile material.

B. For individual radionuclides whose identities are known, but that are not listed in Table 1 or Table 2 of this section, the A1 and A2 values or exempt material activity concentration and exempt consignment activity values contained in Table 3 of this section may be used. Otherwise, the licensee shall obtain prior agency approval for radionuclides not listed in Table 1 or Table 2 of this section, before shipping the material. The licensee shall submit requests for prior approval to the agency.

C. In the calculations of A1 and A2 for a radionuclide not in Table 1 of this section, a single radioactive decay chain, in which radionuclides are present in their naturally occurring proportions, and in which no daughter radionuclide has a half-life either longer than 10 days, or longer than that of the parent radionuclide, shall be considered as a single radionuclide, and the activity to be taken into account, and the A1 or A2 value to be applied, shall be those corresponding to the parent radionuclide of that chain. In the case of radioactive decay chains in which any daughter radionuclide has a half-life either longer than 10 days or greater than that of the parent radionuclide, the parent and those daughter radionuclides shall be considered as mixtures of different radionuclides.

D. For mixtures of radionuclides whose identities and respective activities are known, the following conditions apply:

1. For special form radioactive material, the maximum quantity transported in a Type A package is as follows:

Value for normal form radioactive
material, transported in A Sub1 package

where B(i) is the activity of radionuclide (i), and A1(i) is the A1 value for radionuclide (i).

2. For normal form radioactive material, the maximum quantity transported in a Type A package is as follows:

∑B(i)/A2(i)≤1

where B(i) is the activity of radionuclide (i), and A2(i) is the A2 value for radionuclide (i) in special form.

3. Alternatively, the A1 value for mixtures of special form material may be determined as follows:

Formula for A Sub1 value for
mixtures of special form material

where f(i) is the fraction of activity for radionuclide (i) in the mixture, and A1(i) is the appropriate A1 value for radionuclide (i).

4. Alternatively, the A2 value for mixtures of normal form material may be determined as follows:

Formula for A Sub2 value for
mixtures of normal form material

where f(i) is the fraction of activity for radionuclide (i) in the mixture, and A2(i) is the appropriate A2 value for radionuclide (i).

5. The exempt activity concentration for mixtures of nuclides may be determined as follows:

Formula for exempt activity
concentration for mixture of nuclides

where f(i) is the fraction of activity concentration of radionuclide (i) in the mixture, and [A](i) is the activity concentration for exempt material containing radionuclide (i).

6. The activity limit for an exempt consignment for mixtures of radionuclides may be determined as follows:

Formula for the activity limit for an
exempt consignment for mixtures of radionuclides

where f(i) is the fraction of activity of radionuclide (i) in the mixture, and [A](i) is the activity limit for exempt consignments for radionuclide (i).

E. When the identity of each radionuclide is known, but the individual activities of some of the radionuclides are not known, the radionuclides may be grouped, and the lowest A1 or A2 value, as appropriate, for the radionuclides in each group may be used in applying the formulas in subsection D of this section. Groups may be based on the total alpha activity and the total beta/gamma activity when these are known, using the lowest A1 or A2 values for the alpha emitters and beta/gamma emitters.

F. Table 1. A1 and A2 Values for Radionuclides.

Symbol of radionuclide

Element and atomic number

A1 (TBq)

A1(Ci)b

A2 (TBq)

A2(Ci)b

Specific activity

(TBq/g)

(Ci/g)

Ac-225 (a)

Actinium (89)

8.0X10-1

2.2X10-1

6.0X10-3

1.6X10-1

2.1X103

5.8X104

Ac-227 (a)

 

9.0X10-1

2.4X10-1

9.0X10-5

2.4X10-3

2.7

7.2X101

Ac-228

 

6.0X10-1

1.6X101

5.0X10-1

1.4X101

8.4X104

2.2X106

Ag-105

Silver (47)

2.0

5.4X101

2.0

5.4X101

1.1X103

3.0X104

Ag-108m (a)

 

7.0X10-1

1.9X101

7.0X10-1

1.9X101

9.7X10-1

2.6X101

Ag-110m (a)

 

4.0X10-1

1.1X101

4.0X10-1

1.1X101

1.8X102

4.7X103

Ag-111

 

2.0

5.4X101

6.0X10-1

1.6X101

5.8X103

1.6X105

Al-26

Aluminum (13)

1.0X10-1

2.7

1.0X10-1

2.7

7.0X10-4

1.9X10-2

Am-241

Americium (95)

1.0X101

2.7X102

1.0X10-3

2.7X10-2

1.3X10-1

3.4

Am-242m (a)

 

1.0X101

2.7X102

1.0X10-3

2.7X10-2

3.6X10-1

1.0X101

Am-243 (a)

 

5.0

1.4X102

1.0X10-3

2.7X10-2

7.4X10-3

2.0X10-1

Ar-37

Argon (18)

4.0X101

1.1X103

4.0X101

1.1X103

3.7X103

9.9X104

Ar-39

 

4.0X101

1.1X103

2.0X101

5.4X102

1.3

3.4X101

Ar-41

 

3.0X10-1

8.1

3.0X10-1

8.1

1.5X106

4.2X107

As-72

Arsenic (33)

3.0X10-1

8.1

3.0X10-1

8.1

6.2X104

1.7X106

As-73

 

4.0X101