Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2340  institutions of 
higher education  
Request duplicate certificate t o 
operate due to school name or 
address change  $100  
Request duplicate agent permit, to 
replace lost/stolen/misplaced permit  $100  
Application fee for each additional 
branch  $300  
Application fee for each additional 
site $100  
Application fee for each additional 
program or modification to an 
existing program  $100  
E. A school that submits a payment that is returned for any 
reason must resubmit the required payment, any applicable 
late fee, and the assessed returned check fee of $35 via a 
money order or certified bank check only.  
VA.R. Doc. No. R16 -4393; Filed March 29, 2016, 12:00 p.m.  
  ––––––––––––––––––    
TITLE 12. HEALTH  
STATE BOARD  OF HEALTH  
Fast-Track Regulation  
Title of Regulation:  12VAC5 -481. Virginia Radiation 
Protection Regulations  (amending 12VAC5 -481-10, 
12VAC5 -481-3390  through 12VAC5 -481-3450; adding 
12VAC5 -481-3451, 12VAC5 -481-3452, 12VAC5 -481-
3453).  
Statutory Authority:  §§ 32.1 -12 and 32.1 -229 of  the Code of 
Virginia.  
Public Hearing Information:  No public hearings are 
scheduled.  
Public Comment Deadline:  May 18, 2016.  
Effective Date:  June 5, 2016.  
Agency Contact:  Steve Harrison, Director, Office of 
Radiological Health, Department of Health, 109 G overnor 
Street, Richmond, VA 23219, telephone (804) 864 -8151, 
FAX (804) 864 -8155, or email 
steve.harrison@vdh.virginia.gov.  
Basis:  Section 32.1 -229 of the Code of Virginia authorizes 
the State Board of Health to require the licensure and 
inspection of radi oactive materials facilities and mandates 
inspections of mammography facilities. Section 32.1 -229.1 of 
the Code of Virginia requires the State Board of Health to 
promulgate regulations for the registration, inspection, and 
certification of x -ray machines.  Purpose:  The Virginia Department of Health (VDH), Office 
of Radiological Health (ORH) proposes to amend 12VAC5 -
481, Virginia Radiation Protection Regulations, to reflect 
changes in and new x -ray modalities pertaining to the medical 
field, amend existing and add ne w definitions, and update the 
regulations to meet the current Virginia Register Form, Style, 
and Procedure Manual.  
Rationale for Using Fast -Track Rulemaking Process:  
Practitioners have requested that regulations providing for the 
use of therapeutic radiati on machines be instituted in the 
Commonwealth in order to remain up to date with regard to 
current practices. The regulated community has requested that 
regulations be put into place for the proper operation of 
therapeutic and electronic brachytherapy equi pment. This 
initiative was discussed and endorsed at the November 2014 
Radiation Advisory Board meeting. Accordingly, ORH does 
not view this initiative as being controversial in nature.  
Substance:  The Conference of Radiation Control Program 
Directors (CRCP D) develops Suggested State Regulations 
(SSRs) upon which an individual state may base its 
regulations. The x -ray regulations were based upon the SSRs 
when adopted in 2006; this amendment will ensure that 
Virginia's regulations are brought up to date by in corporating 
the most recent CRCPD SSRs in totality. This action adds or 
amends provisions concerning radiation therapy machines, 
including electronic brachytherapy, as follows:  
1. Adds new terms and definitions in 12VAC5 -481-10, 
including conventional simu lator, electronic 
brachytherapy, electronic brachytherapy device, 
electronic brachytherapy source, intensity modulated 
radiation therapy (IMRT), mobile electronic 
brachytherapy service, qualified inspector, qualified 
medical physicist, radiation therapy sy stem, target -skin 
distance (TSD), and virtual simulator.  
2. Amends definitions in 12VAC5 -481-10, including 
beam -limiting device, leakage radiation, light field, 
prescribed dose, and therapeutic radiation machine.  
3. Amends the following sections in Part XV , 
Therapeutic Radiation Machines: 12VAC5 -481-3390, 
General administrative requirements for facilities using 
therapeutic radiation machines; 12VAC5 -481-3400, 
General technical requirements for facilities using 
therapeutic radiation machines; 12VAC5 -481-3410 , 
Quality management program; 12VAC5 -481-3420, 
Therapeutic radiation machines of less than 500 kV; 
12VAC5 -481-3430, Therapeutic radiation machines - 
photon therapy systems (500 kV and above) and electron 
therapy systems (500 kV and above), and electron 
therapy systems (500kv and above); and 12VAC5 -481-
3450, Shielding and safety  design requirements.  
4. Adds the following new sections to Part XV, 
Therapeutic Radiation Machines: 12VAC5 -481-3451, 
Quality assurance for radiation therapy simulation 
systems; 12VA C5-481-3452, Electronic brachytherapy; Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2341 and 12VAC5 -481-3453, Other use of electronically -
produced radiation to deliver therapeutic radiation 
dosage.  
Issues:  The advantage of this action is that health care 
providers regulated by VDH will operate under clear  worker 
and machine performance standards. Another advantage for 
health care professionals and patients is that regulations 
governing the application of radiation will meet nationally 
recognized performance standards, which will promote 
quality of care. Th ere are no disadvantages to the public in 
promulgating the proposed regulation.  
The advantage of the proposed regulation to the agency is that 
the proper regulation of therapeutic radiation producing 
machines will now be addressed. There are no disadvanta ges 
to the agency in promulgating the proposed regulation. There 
are no disadvantages to the public or the Commonwealth as a 
result of this initiative.  
Department of Planning and Budget's Economic Impact 
Analysis:  
Summary of the Proposed Amendments to Regu lation: The 
State Health Commissioner proposes to amend the Virginia 
Radiation Protection Regulations to 1) add new definitions, 
amend existing definitions and update other sections of this 
regulation so that it accurately reflects current practice for 
therapeutic radiation machines and 2) update the regulation so 
that it conforms to the current Virginia Register Form, Style 
and Procedure Manual.  
Result of Analysis. Benefits likely outweigh costs for all 
proposed regulatory changes.  
Estimated Economic Impa ct. The Commissioner proposes to 
add eleven new definitions and amend a further five to 
account for new therapeutic radiation machine techniques and 
procedures. For instance, the Commissioner proposes to add a 
definition for "radiation therapy systems" and  amend the 
definition of "therapeutic radiation machine." The 
Commissioner also proposes to add language to the 
regulatory text to clarify current procedures and requirements 
for the regulated community. Some of these changes will, for 
instance, replace ge neral language that requires facilities that 
own machines covered by this regulation to have a quality 
management program with specific language that lays out 
exactly what is currently required of such a program.  
All of these amendments, as well as the ame ndments that 
bring regulatory language into conformity with the state's 
regulatory style manual, are clarifying rather than substantive. 
No affected entity is likely to incur costs on account of any of 
these changes. To the extent that this regulation was out of 
date and out of sync with current radiation machine practices 
and terminology, these changes will benefit readers who will 
likely find the regulation easier to understand and comply 
with.  
Businesses and Entities Affected. Virginia Department of 
Health staff reports that this x -ray program currently registers approximately 21,464 x -ray machines. Of these 21,464, 
approximately 90 are therapeutic radiation machines. Staff 
further reports that approximately 1,500 registrants meet the 
criteria for small business.  
Localities Particularly Affected. No locality will be 
particularly affected by this regulatory change.  
Projected Impact on Employment. These regulatory changes 
are unlikely to have any effect on employment in the 
Commonwealth.  
Effects on the Us e and Value of Private Property. These 
proposed regulatory changes are unlikely to affect the use or 
value of private property in the Commonwealth.  
Real Estate Development Costs. These proposed regulatory 
changes are unlikely to affect real estate developm ent costs in 
the Commonwealth.  
Small Businesses:  
Definition. Pursuant to § 2.2 -4007.04 of the Code of Virginia, 
small business is defined as "a business entity, including its 
affiliates, that (i) is independently owned and operated and 
(ii) employs fewer than 500 full -time employees or has gross 
annual sales of less than $6 million."  
Costs and Other Effects. Small businesses are unlikely to 
incur any costs on account of these proposed regulatory 
changes.  
Alternative Method that Minimizes Adverse Impact.  Small 
businesses are unlikely to incur any costs on account of these 
proposed regulatory changes.  
Adverse Impacts:  
Businesses. Businesses are unlikely to incur any costs on 
account of these proposed regulatory changes.  
Localities. Localities in the Commonw ealth are unlikely to 
see any adverse impacts on account of this proposed 
regulatory change.  
Other Entities. No entities are likely to incur any costs on 
account of these regulatory changes.  
Agency's Response to Economic Impact Analysis:  The 
Virginia Depar tment of Health concurs with the economic 
impact analysis submitted by the Department of Planning and 
Budget.  
Summary:  
To reflect changes in and new x -ray modalities for the 
medical field, including therapeutic and electonic 
brachytherapy equipment, this a ction (i) amends and adds 
defined terms and (ii) updates the regulatory text to clarify 
current procedures and requirements.  
Part I  
General Provisions  
12VAC5 -481-10. Definitions.  
The following words and terms as used in this chapter shall 
have the follo wing meanings unless the context clearly 
indicates otherwise:  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2342  "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 radioac tive 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 irradiat ed 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 o f 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 accelera tor" 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 ensur ing 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 equip ment 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 con trol 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 cov ers, 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 quanti ty 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).  
"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 m aterials composed wholly 
or partly of licensed material exist in concentrations:  
1. In excess of the derived air concentrations (DACs) 
specified in 12VAC5 -481-3690; or  
2. To such a degree that an individual present in the area 
without respiratory protect ive 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, ar e 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.  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2343 "Annual limit on intake" or "ALI" m eans 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 comm itted 
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.  
"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 
inspectio ns, 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 1 2VAC5 -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.  
"Assigned protection factor" or "APF" means the expected 
workplace lev el 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 concentratio n 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 s ocioeconomic 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.  
"Associated equipment" means equipment that is used in 
conjunction with a radiograph ic 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 atm osphere, 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 oth er 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 i ssued 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" m eans 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 
practic e 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.  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2344  "Authorized user" means a practitioner of the healing arts 
who:  
1. Meets the requirements in 12VAC5 -481-1790 and any 
of the following:  
a. 12VAC5 -481-1910;  
b. 12VAC5 -481-1940;  
c. 12VAC5 -481-1980;  
d. 12VAC5 -481-1990;  
e. 12VAC5 -481-2000;  
f. 12VAC5 -481-2010;  
g. 12VAC5 -481-2030;  
h. 12VAC5 -481-2040; or  
2. Is identified as an authorized user on:  
a. A specific license issued by the NRC or another 
agreement state that authorizes medical use;  
b. A permit issued by an NRC master material licensee 
that authorizes medical use;  
c. A permit issued by an NRC or another agreement state 
broad scope medical use licensee that authorizes medical 
use; or  
d. A permit issued by an NRC master material license 
broad scope medical use permittee that authorizes 
medical use.  
"Automatic exposure control" or "AEC" means a device that 
automatically con trols one or more technique factors in order 
to obtain, at a preselected location(s)  location , a required 
quantity of radiation (includes devices such as phototimers 
and ion chambers).  
"Background investigation" means the investigation 
conducted by a lice nsee 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 a s 
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 an d 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 thr ough the 
centers of the x -ray fields.  
"Beam -limiting device" means a device that provides a 
means to restrict the dimensions of the x -ray field or useful 
beam .  "Beam monitoring system" means a system designed and 
installed in the radiation head to detect  and measure the 
radiation present in the useful beam.  
"Beam scattering foil" means a thin piece of material 
(usually metallic) placed in the beam to scatter a beam of 
electrons in order to provide a more uniform electron 
distribution in the useful beam.  
"Becquerel" or "Bq" means the SI unit of activity. One 
becquerel is equal to one disintegration or transformation per 
second (dps or tps).  
"Beneficial attribute" means, as used in Part XVI (12VAC5 -
481-3460 et seq.) of this chapter, the radioactivity of t he 
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 b ending 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 materi als 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 del iver 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 betwee n 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 
speci al 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, o r 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  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2345 (2) Is produced, extracted, or converted after extraction, 
before, on, or after Au gust 8, 2005, for use for a 
commercial, medical, or research activity; and  
4. Any discrete source of naturally occurring radioactive 
material, other than source material, that:  
a. The NRC, in consultation with the Administrator of 
the Environmental Protect ion Agency, the Secretary of 
Energy, the Secretary of Homeland Security, and the 
head of any other appropriate federal agency, determines 
would pose a threat similar to the threat posed by a 
discrete source of radium -226 to the public health and 
safety or the common defense and security; and  
b. Before, on, or after August 8, 2005, is extracted or 
converted after extraction for use in a commercial, 
medical, or research activity.  
"C-arm 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 i ndividual 
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 cab inet 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 consi dered 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 thres hold 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 wo uld 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 "Catego ry 
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 co ntained 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 hold er" 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 radioactiv e material.  
"Certified cabinet x -ray system" means an x -ray system that 
has been certified in accordance with 21 CFR 1010.2 as being 
manufactured and assembled pursuant to the provisions of 21 
CFR 1020.40.  
"Certified components" means components of x -ray systems 
that are subject to regulations promulgated under Pub. L. 90 -
602, the Radiation Control for Health and Safety Act of 1968 
of the Food and Drug Administration.  
"Certifying entity" means an independent certifying 
organization meeting the agency's re quirements 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.  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2346  "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 p ulmonary 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" mea ns centimeters.  
"Coefficient of variation" or "C" means the ratio of the 
standard deviation to the mean value of a population of 
observations. It is estimated using the following equation:  
 
where:  
s = Standard deviation of the observed values;  
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, ne cessary 
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 v alues.  "Committed dose equivalent" or "H T,50" means the dose 
equivalent to organs or tissues of reference (T) that will be 
received from an intake of radioactive material by an 
individual during the 50 -year period following the intake.  
"Committed effecti ve dose equivalent" or "H E,50" is the sum 
of the products of the weighting factors (w T) applicable to 
each of the body organs or tissues that are irradiated and the 
committed dose equivalent to each of these organs or tissues 
(HE,50 = Σ (w T HT,50)).  
"Comp uted 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 tomographi c plane divided by the product of the nominal 
tomographic section thickness and the number of tomograms 
produced in a single scan, that is:  
 
where:  
z = Position along a line perpendicular to the 
tomographic plane;  
D(z) = Dose at position z;  
T = Nominal t omographic 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 packag e 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 r adionuclide 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.  
Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2347 "Constraint" or "dose constraint" means a value above which 
specified licensee actions are required.  
"Contact therapy system" means a therapeutic radiation 
machine with a short target to skin distance (TSD), usually 
less than five centimeters.  
"Contrast scale" means the change in the linear attenuation 
coefficient per CTN relative to water, that is:  
 
where:  
μx = Linear  attenuation  coefficient  of the material  of 
interest;  
μw = Linear  attenuation  coefficient  of water;  
 = of the material  of interest;  
 = of water.  
"Control cable" or "drive" means the cable that is connected 
to the source assembly and used to drive the source to and 
from the exposure location.  
"Control drive mechanism" means a device that enables the 
source assembly to be moved into and out of the exposure 
device.  
 
"Control panel" means that part of the x -ray control upon 
which are mounted the switches, knobs, pushbuttons, and 
other hardware necessary for manually setting the technique 
factors.  
"Contr ol tube" means a protective sheath for guiding the 
control cable. The control tube connects the control drive 
mechanism to the radiographic exposure device.  
"Controlled area" means an area, outside of a restricted area 
but inside the site boundary, access  to which can be limited 
by the licensee for any reason.  
"Conventional simulator" means any x -ray system designed 
to reproduce the geometric conditions of the radiation therapy 
equipment.  
"Conveyance" means:  
1. For transport by public highway or rail any t ransport 
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 t he 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 receiv e 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 "Co mputed tomography").  
"CT conditions of operation" means all selectable 
parameters governing the operation of a CT x -ray system 
including, but not limited to, nominal tomographic section 
thickness, filtration, and the technique factors as defined in 
these regulations.  
"CTDI" (See "Computed tomography dose index").  
"CT gantry" means the tube housing assemblies, beam -
limiting devices, detectors, and the supporting structures and 
frames which hold these components.  
"CTN" (See "CT number").  
"CT number" means the number used to represent the x -ray 
attenuation associated with each elemental area of the CT 
image.  
 
where:  
k = A constant, a normal value of 1,000 when the 
Hounsfield scale of CTN is used;  
μx = Linear attenuation coefficient of the  material of 
interest;  
μw = Linear attenuation coefficient of water.  
"Cumulative air kerma" means the total air kerma accrued 
from the beginning of an examination or procedure and 
includes all contribution from fluoroscopic and radiographic 
irradiation.  
"Curie" means a unit of quantity of activity. One curie (Ci) 
is that quantity of radioactive material that decays at the rate 
Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2348  of 3.7E+10 disintegrations or transformations per second (dps 
or tps).  
"Custodial agency" means an agency of the government 
designa ted 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 unti l 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 unrestr icted use and 
termination of the license or release of the property under 
restricted conditions and termination of the license.  
"Decontamination facility" means a facility operating under 
a Commission or Agreement State license whose principal 
purpose is d econtamination of equipment or materials to 
accomplish recycle, reuse, or other waste management 
objectives, and, for purposes of this part, 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 "H d," which applies to external 
whole body exposure, means the do se 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.  
"Departme nt of Energy" means the Department of Energy 
established by Pub. L. 95 -91, August 4, 1977, 91 Stat. 565, 
42 USC §  7101 et seq., to the extent that the Department 
exercises functions formerly vested in the Atomic Energy 
Commission, its Chairman, members, of ficers, 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. 93 -438, October 11, 
1974, 88 Stat. 1233 at 12 37, 42  USC §  5814, effective 
January 19, 1975) and retransferred to the Secretary of 
Energy pursuant to § 301(a) of the Department of Energy 
Organization Act (Pub. L. 95 -91, August 4, 1977, 91 Stat. 
565 at 577 -578, 42 USC § 7151, effective October 1, 1977) .  
"Depleted uranium" means the source material uranium in 
which the isotope uranium -235 is less than 0.711 weight 
percentage of the total uranium present. Depleted uranium 
does not include special nuclear material.  
"Derived air concentration" or "DAC" me ans 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 i s 
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.  
"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 equiva lent of 0.05 Sv (5 rem).  
"Detector" (See "Radiation detector").  
"Deuterium" means, for the purposes of Part XIII (12VAC5 -
481-2950 et seq.) deuterium and any deuterium compounds, 
including heavy water, in which the ratio of deuterium atoms 
to hydrogen ato ms 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 cli nical 
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 syste m" 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 concent ration 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 r esistance, 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).  
"Disposa l" 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.  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2349 "Disposal site" means that portion of a land disposal facility 
that is used for disposal of waste. It cons ists 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 sta tistical 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 th e time of intake the 
period of exposure to retained material will not exceed 50 
years.  
"Dose equivalent" or "H T" means the product of the 
absorbed dose in tissue, quality factor, and all other necessary 
modifying factors at the location of interest. The units of dose 
equivalent are the sievert (Sv) and rem.  
"Dose limits" means the permissible upper bounds of 
radia tion 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 calculat ed.  
"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 mo nitoring 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 equi valent" or "H E" means the sum of the 
products of the dose equivalent (H T) to each organ or tissue and the weighting factor (w T) applicable to each of the body 
organs or tissues that are irradiated (H E = Σ w THT).  
"Electronic brachytherapy" means a method o f radiation 
therapy where an electrically generated source of ionizing 
radiation is placed in or near the tumor or target tissue to 
deliver therapeutic radiation dosage.  
"Electronic brachytherapy device" means the system used to 
produce and deliver therap eutic radiation including the x -ray 
tube, the control mechanism, the cooling system, and the 
power source.  
"Electronic brachytherapy source" means the x -ray tube 
component used in an electronic brachytherapy device.  
"Elemental area" means the smallest area  within a tomogram 
for which the x -ray attenuation properties of a body are 
depicted. (See also "Picture element").  
"Embryo/fetus" means the developing human organism from 
conception until the time of birth.  
"Energy compensation source" or "ECS" means a small 
sealed source, with an activity not exceeding 3.7 MBq (100 
μCi), used within a logging tool, or other tool components, to 
provide a reference standard to maintain the tool's calibration 
when in use.  
"Engineered barrier" means a manmade structure or d evice 
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 ident ification number" means the number received by 
a transporter following application to the Administrator of 
EPA as required by 40 CFR Part 263.  
"Equipment" (See "X -ray equipment").  
"Escorted access" means accompaniment while in a security 
zone by an approved individual who maintains continuous 
direct visual surveillance at all times over an individual who 
is not approved for unescorted access.  
"Exclusive use" means the sole use by a single consignor of 
a conveyance for which all initial, intermediate,  and final 
loading and unloading are carried out in accordance with the 
direction of the consignor or consignee. The consignor and 
the carrier must ensure that any loading or unloading is 
performed by personnel having radiological training and 
resources ap propriate 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.  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2350  "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 radi ation 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  or used.  
"Fail -safe characteris tics" 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 st ored 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 
therapeut ic 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 compo sed 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 requirement s 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 materia l" 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 urani um 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 requ ire 
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 imag es 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 th e 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.  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2351 "Gantry" means that part of a radiation therapy system 
supporting and allowing movements of the radiation head 
about a center of rotation.  
"Generally applicable environmental radiation standards" 
means standards issued by the Environmental Protection 
Agency under the authority of the Atomic Energy Act of 
1954, as amended, that impose limits on radiation exposures 
or levels, or concentrations or quantities of radioactive 
material, in the general environment outside the boundaries of 
locations under the con trol 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 a ctivity, 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 ( 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)" means the SI unit of absorbed dose. One gray is 
equal to an absorbed dose of one joule per kilogr am (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 neces sary 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 t his 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 operat ion. 
"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 a nd 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 wast e" means those wastes designated as 
hazardous by the Environmental Protection Agency 
regulations in 40 CFR Part 261.  
"Healing arts" means the art or science or group of arts or 
sciences dealing with the prevention and cure or alleviation of 
ailments, dise ases 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 co ntainer 
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 l evels 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 pene trates.  
"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 bein gs.  
"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 housin g, 
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 dete ctor 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 Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2352  transformations. In those cases where means are provided to 
preselect a portion of the image receptor, the term "i mage 
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 protec tive 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 
radia tion from the waste.  
"Independent certifying organization" means an independent 
organization that meets the agency's criteria for documenting 
applicant's training in topics set forth in 12VAC5 -481-1320 
or equivalent agreement state or 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 do simeters (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 ionizi ng 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 a rchives, (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 
measurement s) means the ability to show that an instrument 
has been calibrated at specified time intervals using a national 
standard or a transfer standard. If a transfer standard is used, 
the calibration must be at a laboratory accredited by a program that requires continuing participation in 
measurement quality assurance with the National Institute of 
Standards and Technology or other equivalent national or 
international program.  
"Intensity modulated radiation therapy" or "IMRT" means 
radiation therapy that uses no nuniform radiation beam 
intensities that have been determined by various computer -
based optimization techniques.  
"Interlock" means a device arranged or connected such that 
the occurrence of an event or condition is required before a 
second event or conditi on 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 irradi ation 
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 th e 
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 ra dioactive 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, b ut 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 an d 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 kilabecquerels.  
"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 t he 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 Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2353 special name for the units of kerma is gray (Gy). When the 
materials is air, the quantit y 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 fo r 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 termin ation of the fluoroscopic exposure.  
"Lay -barge radiography" means industrial radiography 
performed on any water vessel used for laying pipe.  
"Lead equivalent" means the thickness of the material in 
question affording the same attenuation, under specified 
conditions, as lead.  
"Leakage radiation" means radiation emanating from the 
diagnostic source assembly or the radiation therapy system  
except  for:  
1. The useful beam; and  
2. Radiation produced when the exposure switch or timer is 
not activated.  
"Leakage technique factors" means the technique factors 
associated with the diagnostic source assembly that are used 
in measuring leakage radiation. They are defined as follows:  
1. For diagnostic source assemblies intended for capacitor 
energy storage equipment, the maximum -rated peak tube 
potential and the maximum -rated number of exposures in 
an hour for operation at the maximum -rated peak tube 
poten tial 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 continu ous 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 iss ued 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 the 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  
illuminated by light, simulating the radiation field .  
"Limits" (See "Dose limits").  
"Line -voltage regulation" means t he 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 (V n-Vl)/V l  
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 P art 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 assu ring compliance with the 
requirements of this chapter and the conditions of the license.  
"Logging tool" means a device used subsurface to perform 
well-logging.  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2354  "Loose -fitting facepiece" means a respiratory inlet covering 
that is designed to form a partia l 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 plan ned 
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 surr ounding 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, an d 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 A 2 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 spe cific activity does not 
exceed 1.0 E -04 A 2/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 radi oactive 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 A 2; 
and  
c. The estimated average spe cific activity of the solid 
does not exceed 2.0 E -03 A 2/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 chem ical 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 radioactiv e 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" mea ns 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;  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2355 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 dos e 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 f or disassembly or dismounting, or designed to be 
hand carried. Mobile devices do not include stationary 
equipment installed in a fixed location.  
"Mobile electronic brachytherapy service" means 
transportation of an electronic brachytherapy device to 
provide  electronic brachytherapy at an address that is not the 
address of record.  
"Mobile nuclear medicine service" means the transportation 
and medical use of radioactive material.  
"Mobile x -ray equipment" (See "X -ray equipment").  
"Mode of operation" means, fo r 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 subtra ction 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" o r "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 ex posures 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 ev aluate 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 r eports 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 mater ial.  
"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 l icensing 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 
containi ng 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 l and 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 Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2356  negative during inh alation 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 (S n) is calculated using the following 
expression:  
 
where:  
 = Linear attenuation coefficient of the material of 
interest.  
μw = Linear attenuation coefficient of water.  
s = Standard deviation of the CTN of picture elements in 
a specified area of the CT image.  
"Nominal tomographic section thickness" means the full 
width at half -maximum of the sensitivity profile taken at the 
center of the cross -sectio nal 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 th reshold 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, 5 41A, 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, accurat e, 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 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 radioac tive 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 w ater.  
"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 accidental ly 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 
Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2357 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 rad ioactive 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 re quirements 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 
auxiliar y 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 o f 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 p otentially 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 sto red 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 t he 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 installatio n" 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, dep artment 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 att enuation 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 dispen se 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" (S ee "Source assembly").  
"Pill" (See "Sealed source").  
"Planned special exposure" means an infrequent exposure to 
radiation, separate from and in addition to the annual 
occupational dose limits.  
"Portable x -ray equipment" (See "X -ray equipment").  
"Position indicating device" means a device on dental x -ray 
equipment used to indicate the beam position and to establish Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2358  a definite source -surface (skin) distance. It may or may not 
incorporate or serve as a beam -limiting device.  
"Positive beam limitatio n" 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 faci lity 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 dem onstration 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 th e 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 experien ce 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 wri tten 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, t he 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 . The prescribed dose is 
an estimation from measured data from a specified 
therapeutic machine using as sumptions that are clinically 
acceptable for that treatment technique and historically 
consistent with the clinical calculations previously used for 
patients treated with the same clinical technique ; or  
3. For brachytherapy, either the total source streng th 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 usefu l 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)  purposes  for which the license was 
issued or amended. Storage during which no licensed material 
is accessed for use or disposal and activities incidental to 
decontamination or decommissioning are not principal 
activities.  
"Private inspector" means an individual who meets the 
requirements set forth in 12VAC5 -481-340 and who has 
demonstrated to the satisfaction of the agency that such 
individual possesses the knowledge, training and experience 
to measure ionizing radiation, to evaluate safety techniques, 
and to advise regarding radiation protection needs.  
"Product" means, as used in Part XVI (12VAC5 -481-3460 et 
seq.) of this chapter, something produced, made, 
manufactured, refined, or benefited.  
"Product conveyor system" means a system for moving the 
product to be irr adiated 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.  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2359 "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 readi ly and, when ignited, burns so 
vigorously and persistently as to create a serious 
transportation, handling, or disposal hazard. Included are 
spontaneously combustible and water -reactive materials.  
"Qualified inspector" means an individual who is granted 
professional privileges based on education and experience to 
provide clinical services in diagnostic and therapeutic medical 
physics.  
"Qualified medical physicist" means an individual qualified 
in accordance with 12VAC5 -481-3390 D.  
"Qualitative fit test" or  "QLFT" means a pass/fail fit test to 
assess the adequacy of respirator fit that relies on the 
individual's response to the test agent.  
"Quality factor" or "Q" means the modifying factor, that is 
referenced in 12VAC5 -481-240, that is used to derive dose 
equivalent from absorbed dose.  
"Quantitative fit test" or "QNFT" means an assessment of 
the adequacy of respirator fit by numerically measuring the 
amount of leakage into the respirator.  
"Quarter" means a period of time equal to one -fourth of the 
year obser ved 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 uni t 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 parti cles 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 ultraviole t 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 a ny 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 ind ividual 
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 irr adiation 
field.  
"Radiation therapy system" means a device that delivers 
radiation to a specific area of the body where cancer cells or 
tumors are located.  
"Radioactive material" means any solid, liquid, or gas which 
emits radiation spontaneously.  
"Radioa ctive 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 att endance 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 t he 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 .  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2360  "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 assistan t" 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 a ny 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.  
"Radiographi c 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 t he 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 exp osure.  
"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 TENO RM 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 ex posure, 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 dos e 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 Internati onal 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 regist ered 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. Depa rtment 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 
facto r (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 req uirement 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 in jury;  
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 
demons trative 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 bei ngs.  
"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 radioactiv e 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 Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2361 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 r emediation 
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 licens ee'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 
radioa ctive 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 agains t 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 ind ividual 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 radiog raphic 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 th e 
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 s ewerage" 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 t ime 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 directio n 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 pr event 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 
accele ration 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 "H s," which applies to the 
external exposure of the skin or an extremity, means the dose 
equivalent at a t issue 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 radio graphy" means industrial radiography 
conducted in a room shielded so that radiation levels at every Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2362  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" mean s 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 t hose 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 so urce 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 in clude 
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, determines to be special 
nuclear material, but does not include source material; or  
2. Any material artifici ally 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; Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2363 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 quantitie s in combination would 
not exceed the limitation and are within the formula:  
 
"Specific activity" of a radionuclide means the radioactivity 
of a radionuclide per unit mass of that nuclide. The specific 
activity of a material in which the radionuclide is essentially 
uniformly distributed is the radioactivity per unit mass of the 
material.  
"Spot film" means a radiograph that is made during a 
fluoroscopic examination to permanently record conditions 
that exist during that fluoroscopic procedure.  
"Spot -film device" means a device intended to transport 
and/or  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 pur pose of making a radiograph.  
"Stability" means structural stability.  
"State inspector" means an employee of the Virginia 
Department of Health designated to perform those duties or 
functions assigned the Radiological Health Program.  
"Stationary beam radiation therapy" means radiation therapy 
without displacement of one or more mechanical axes relative 
to the patient during irradiation.  
"Stationary x -ray equipment" (See "X -ray equipment").  
"Stochastic effect" means a health effect th at 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  this chapter , "probabilistic 
effect" is an equivalent term.  
"Storage" means a condition in which a device or source is 
not being used for an extended period of time, and has been 
made inoperable.  
"Storage area" means any location, facilit y, 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.  
"Subsur face 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 "S AR" 
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 radio active 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 contami nation 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) fo r 
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 an d 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 f ixed 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 μC i/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) 
Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2364  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, custodi al 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 r adioactive 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 radioacti ve 
material present.  
"Tabletop, stationary" means a tabletop that, when 
assembled for use, is incapable of movement with respect to 
its supporting structure within the plane of the tabletop.  
"Target" means that part of an x -ray tube or accelerator onto 
which a beam of accelerated particles is directed to produce 
ionizing radiation or other particles.  
"Target -skin distance" or "TSD" means the distance 
measured along the beam axis from the center of the front 
surface of the x -ray target or electron virtual source, or both, 
to the surface of the irradiated object or patient.  
"Technologically Enhanced Naturally Occurring 
Radioactive Material" or "TENORM" means, as used in Part 
XVI (12VAC5 -481-3460 et seq.) of this chapter, naturally 
occurring radionuclides who se 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 pulse d 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 p osition monitoring system" means a data 
transfer system that captures information by either 
instrumentation, measuring devices about the location or 
both, and status of a transport vehicle or package between the 
departure and destination locations.  
"Teleth erapy 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 locatio n 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)  locations  
of use authorized on the license.  
"Tenth -value layer" o r "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 sam e point.  
"Test" means the process of verifying compliance with an 
applicable regulation.    
"Therapeutic radiation machine" means x -ray or electron -
producing equipment designed and used for external beam 
radiation therapy. For the purpose of this chapter,  devices 
used to administer electronic brachytherapy shall also be 
considered therapeutic radiation machines.   
"These regulations" mean all parts of this chapter.  
"Tight -fitting facepiece" means a respiratory inlet covering 
that forms a complete seal with  the face.  
"Tomogram" means the depiction of the x -ray attenuation 
properties of a section through the body.  
"Tomographic plane" means that geometric plane that is 
identified as corresponding to the output tomogram.  
"Tomographic section" means the volume  of an object 
whose x -ray attenuation properties are imaged in a tomogram.  
"Total effective dose equivalent" or "TEDE" means the sum 
of the effective dose equivalent for external exposures and the 
committed effective dose equivalent for internal exposures .  
"Total organ dose equivalent" or "TODE" means the sum of 
the deep dose equivalent and the committed dose equivalent 
to the organ receiving the highest dose as described in 
12VAC5 -481-1040.  
"Traceable to a National Standard" (See "Instrument 
traceabilit y" or "Source traceability").  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2365 "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 betwe en 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 safet y and security when sealed sources are 
transported and which 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 packa ge 
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 sur face of the package by 100 (equivalent to 
the maximum radiation level in millirem per hour at one 
meter (3.3 ft) feet)).  
"Treatment site" means the correct anatomical description of 
the area intended to receive a radiation dose, as described in a 
written directive.  
"Tritium neutron generator target source" means a tritium 
source used within a neutron generator tube to produce 
neutrons for use in well -logging applications.  
"Trustworthiness and reliability" means characteristics of an 
individual considered d ependable 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 determi nation 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 h igh-voltage and/or  or filament 
transformers and other appropriate elements when such are 
contained within the tube housing.  
"Tube rating chart" means the set of curves which specify 
the rated limits of operation of the tube in terms of the 
technique facto rs.  
"Type A quantity" means a quantity of radioactive material, 
the aggregate radioactivity of which does not exceed A 1 for 
special form radioactive material or A 2 for normal form 
radioactive material, where A 1 and A 2 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 irradiato r 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 radiogra phic 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 th e 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.  
"Unrestricted area" means an area, access to which is neither 
limited nor controlled by the licensee or registrant. For 
purposes of these regulations, "un controlled 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 b y 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 o f 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 a rea" means an area, accessible to 
individuals, in which radiation levels from radiation sources Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2366  external to the body could result in an individual receiving an 
absorbed dose in excess of five Gy (500 rad) in one hour at 
one meter from a source of radiation  or one meter from any 
surface that the radiation penetrates.  
"Virtual simulator" means a computed tomography (CT) 
unit used in conjunction with relevant software that recreates 
the treatment machine and that allows import, manipulation, 
display, and stor age of images from CT or other imaging 
modalities, or both.  
"Virtual source" means a point from which radiation appears 
to originate.  
"Visible area" means that portion of the input surface of the 
image receptor over which incident x -ray photons are 
produc ing 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 radioa ctive 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 "w T" for an organ or tissue (T ) means 
the proportion of the risk of stochastic effects resulting from 
irradiation of that organ or tissue to the total risk of stochastic 
effects when the whole body is irradiated uniformly. For 
calculating the effective dose equivalent, the values of w T are:  
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, w T = 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 abo ut 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.  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2367 "Worker" means an individual engaged in work under a 
license or re gistration 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 e mission 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 le vel 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 
administrat ion; 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 af terloading 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 init iates and/or  or 
terminates the radiation exposure. The x -ray exposure control 
may include such associated equipment as timers and back -up 
timers.  
"X-ray equipment" means an x -ray system, subsystem, or 
component thereof. Types of x -ray equipment are as fol lows:  1. "Mobile x -ray equipment" means x -ray equipment 
mounted on a permanent base with wheels and/or casters 
for moving while completely assembled.  
2. "Portable x -ray equipment" means x -ray equipment 
designed to be hand -carried.  
3. "Stationary x -ray e quipment" 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 devic e 
may also include means for transforming alternating current 
to direct current, filament transformers for the x -ray tube(s)  
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  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 cha nge 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 i s omitted or 
duplicated in consecutive years.  
12VAC5 -481-3390. General administrative requirements 
for facilities using therapeutic radiation machines.  
A. Administrative controls. The registrant shall be 
responsible for directing the operation of the the rapeutic 
radiation machines that have been registered with the agency 
and reporting misadministrations within 10 days . The 
registrant or the registrant's agent shall ensure that the 
requirements of Part XV (12VAC5 -481-3380 et seq.) of this 
chapter are met in the operation of the therapeutic radiation 
machine(s)  machines .  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2368  B. A therapeutic radiation machine that does not meet the 
provisions of these regulations  this chapter  shall not be used 
for irradiation of patients.  
C. Training for external beam radiati on therapy authorized 
users. The registrant for any therapeutic radiation machine 
subject to 12VAC5 -481-3420 or 12VAC5 -481-3430 shall 
require the authorized user to be a physician who:  
1. Is certified in:  
a. Radiology  Radiation oncology  or therapeutic ra diology 
by the American Board of Radiology or radiology 
(combined diagnostic and therapeutic radiology program) 
by the American Board of Radiology prior to 1976 ;  
b. Radiation oncology by the American Osteopathic 
Board of Radiology;  
c. Radiology, with spec ialization in radiotherapy, as a 
British "Fellow of the Faculty of Radiology" or "Fellow 
of the Royal College of Radiology"; or  
d. Therapeutic radiology by the Canadian Royal College 
of Physicians and Surgeons;  
or  
2. Is in the active practice of therape utic radiology, and has 
completed 200 hours of instruction in basic radiation 
techniques applicable to the use of an external beam 
radiation therapy unit, 500 hours of supervised work 
experience, and a minimum of three years of supervised 
clinical experien ce.  
a. To satisfy the requirement for instruction, the 
classroom and laboratory training shall include:  
(1) Radiation physics and instrumentation;  
(2) Radiation protection;  
(3) Mathematics pertaining to the use and measurement 
of ionization radiation; and  
(4) Radiation biology.  
b. To satisfy the requirement for supervised work 
experience, training shall be under the supervision of an 
authorized user and shall include:  
(1) Review of the full calibration measurements and 
periodic quality assurance checks;  
(2) Evaluation of prepared treatment plans and 
calculation of treatment times and patient treatment 
settings;  
(3) Using administrative controls to prevent miss-
adminis trations  misadministrations ;  
(4) Implementing emergency procedures to be followed 
in the event of the abnormal operation of an external 
beam radiation therapy unit or console; and  
(5) Checking and using radiation survey meters.  
c. To satisfy the require ment for a period of supervised 
clinical experience, training shall include one year in a 
formal training program approved by the Residency Review Committee for Radiology of the Accreditation 
Council for Graduate Medical Education or the 
Committee on Postd octoral Training of the American 
Osteopathic Association and an additional two years of 
clinical experience in therapeutic radiology under the 
supervision of an authorized user. The supervised clinical 
experience shall include:  
(1) Examining individuals a nd reviewing their case 
histories to determine their suitability for external beam 
radiation therapy treatment, and any limitations or 
contraindications;  
(2) Selecting proper dose and how it is to be 
administered;  
(3) Calculating the external beam radiat ion therapy doses 
and collaborating with the authorized user in the review 
of patients' progress and consideration of the need to 
modify originally prescribed doses and/or  or treatment 
plans as warranted by patients' reaction to radiation; and  
(4) Post -administration follow -up and review of case 
histories.  
3. Notwithstanding the requirements of subdivisions 1 and 
2 of this subsection, the registrant for any therapeutic 
radiation machine subject to 12VAC5 -481-3420 may also 
submit the training of the prospe ctive authorized user 
physician for agency review on a case -by-case basis.  
4. A physician shall not act as an authorized user for any 
therapeutic radiation machine until such time as said 
physician's training has been reviewed and approved by the 
agency.  
D. Training for radiation therapy  qualified medical  
physicist. The registrant for any therapeutic radiation machine 
subject to 12VAC5 -481-3420 and 12VAC5 -481-3430 shall 
require the radiation therapy  qualified medical  physicist to : 1. 
Be be registered with  the agency, under the provisions of Part 
II (12VAC5 -481-260 et seq.) of this chapter, as a provider of 
radiation services in the area of calibration and surveys of 
external beam radiation therapy units ; and 2. Shall meet the 
requirements of 12VAC5 -481-340 B 2 to:  
1. Be certified by the American Board of Radiology in:   
a. Therapeutic radiological physics;  
b. Roentgen -ray and gamma -ray physics;  
c. X-ray and radium physics; or  
d. Radiological physics;  
2. Be certified by the American Board of Medical Physics 
in Radiation Oncology Physics;  
3. Be certified by the Canadian College of Medical 
Physics; or  
4. Hold a master's or doctor's degree in physics, medical 
physics, other physical science, engineering, or applied 
mathematics from an accredited college or unive rsity and 
have completed one year of full -time training in medical 
physics and an additional year of full -time work experience Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2369 under the supervision of a qualified medical physicist at a 
medical institution. This training and work experience shall 
be condu cted in clinical radiation facilities that provide 
high-energy external beam radiation therapy (photons and 
electrons with energies greater than or equal to one 
MV/one MeV). To meet this requirement, the individual 
shall have performed the tasks listed in 12VAC5 -481-3400 
A, 12VAC5 -481-3420 P, 12VAC5 -481-3420 Q, 12VAC5 -
481-3430 T, and 12VAC5 -481-3430 U under the 
supervision of a qualified medical physicist during the year 
of work experience . 
E. Qualifications of operators.  
1. Individuals who will be operati ng a therapeutic radiation 
machine for medical use shall be American Registry of 
Radiologic Technologists (ARRT) Registered Radiation 
Therapy Technologists. Individuals who are not ARRT 
Registered Radiation Therapy Technologists shall submit 
evidence that they have satisfactorily completed a radiation 
therapy technologist training program that complies with 
the requirements of the Joint Review Committee on 
Education in Radiologic Technology.  
2. The names and training of all personnel currently 
operating a therapeutic radiation machine shall be kept on 
file at the facility. Information on former operators shall be 
retained for a period of at least two years beyond the last 
date they were authorized to operate a therapeutic radiation 
machine at that facility.   
F. Written safety procedures and rules shall be developed by 
a radiation therapy  qualified medical  physicist and shall be 
available in the control area of a therapeutic radiation 
machine, including any restrictions required for the safe 
operation of the particular therapeutic radiation machine. The 
operator shall be able to demonstrate familiarity with these 
rules.  
G. Individuals shall not be exposed to the useful beam 
except for medical therapy purposes and unless such exposure 
has been ordered in writi ng by a licensed practitioner of the 
healing arts who is specifically identified on the Certificate of 
Registration  therapeutic radiation machine authorized user . 
This provision specifically prohibits deliberate exposure of an 
individual for training, demo nstration or other nonhealing -
arts non-healing -arts purposes.  
H. Visiting authorized user. Notwithstanding the provisions 
of subsection G of this section, a registrant may permit any 
physician to act as a visiting authorized user under the term of 
the registrant's Certificate of Registration for up to 60 days 
per cal endar year under the following conditions:  
1. The visiting authorized user has the prior written 
permission of the registrant's management and, if the use 
occurs on behalf of an institution, the institution's radiation 
safety committee , where applicable ; and  2. The visiting authorized user meets the requirements 
established for an authorized user(s)  user in subdivisions 1 
and 2  C 1 and C 2  of this subsection  section ; and  
3. The registrant maintains copies of all records specified 
by this subsection for f ive years from the date of the last 
visit shall maintain copies of the written permission 
required in subdivision 1 of this subsection and 
documentation that the visiting authorized user met the 
requirements of subdivision 2 of this subsection for five 
years from the date of the last visit .  
I. All individuals associated with the operation of a 
therapeutic radiation machine shall be instructed in and shall 
comply with the provisions of the registrant's quality 
management program. In addition to the requirem ents of Part 
XV of this chapter, these individuals are also subject to the 
requirements of 12VAC5 -481-640, 12VAC5 -481-680, and 
12VAC5 -481-760.  
J. Information and maintenance record and associated 
information. The registrant shall maintain the following 
information in a separate file or package for each therapeutic 
radiation machine, for inspection by the agency:  
1. Report of acceptance testing;  
2. Records of all surveys, calibrations, and periodic quality 
assurance checks of the therapeutic radiation mac hine 
required by Part XV of this chapter, as well as the name(s) 
of person(s) who performed such activities;  
3. Records of maintenance and/or  or modifications 
performed on the therapeutic radiation machine after 
September 20, 2006, as well as the name(s)  names  of 
person(s)  persons  who performed such services;  
4. Signature of person authorizing the return of therapeutic 
radiation machine to clinical use after service, repair, or 
upgrade.  
K. Records retention. All records required by Part XV of 
this chapte r shall be retained until disposal is authorized by 
the agency unless another retention period is specifically 
authorized in Part XV of this chapter. All required records 
shall be retained in an active file from at least the time of 
generation until the ne xt agency inspection. Any required 
record generated prior to the last agency inspection may be 
microfilmed or otherwise archived as long as a complete copy 
of said record can be retrieved until such time as the agency 
authorizes final disposal.  
12VAC5 -481-3400. General technical requirements for 
facilities using therapeutic radiation machines.  
A. Surveys  Protection surveys .  
1. The registrant shall ensure that radiation protection  
surveys of all new facilities , and existing facilities not 
previously surve yed are performed with an operable 
radiation measurement survey instrument calibrated in 
accordance with 12VAC5 -481-3440. The radiation 
protection  survey shall be performed by, or under the 
direction of, a radiation therapy  qualified medical  physicist Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2370  or a private inspector  qualified inspector  and shall verify 
that, with the therapeutic radiation machine in a "BEAM -
ON" condition, with the largest clinically available 
treatment field , and with a scattering phantom in the useful 
beam of radiation:  
a. Radiati on levels in restricted areas are not likely to 
cause personnel exposures in excess of the limits 
specified in 12VAC5 -481-640; and  
b. Radiation levels in unrestricted areas do not exceed the 
limits specified in 12VAC5 -481-720.  
2. In addition to the requi rements of 12VAC5 -481-3400 A 
1 subdivision 1 of this subsection , a radiation protection  
survey shall also be performed prior to any subsequent 
medical use and:  
a. After making any change in the treatment room 
shielding;  
b. After making any change in the location of the 
therapeutic radiation machine within the treatment room;  
c. After relocating the therapeutic radiation machine; or  
d. Before using the therapeutic radiation machine in a 
manner that could result in increased radiation levels in 
areas outs ide the external beam radiation therapy 
treatment room.  
3. The survey record shall indicate all instances where the 
facility, in the opinion of the radiation therapy  qualified 
medical  physicist or a private inspector  qualified inspector , 
is in violation o f applicable regulations. The survey record 
shall also include : the date of the measurements ;, the 
reason the survey is required ;, the manufacturer's name ;, 
the model number and serial number of the therapeutic 
radiation machine ;, the instrument(s)  instrum ents used to 
measure radiation levels ;, a plan of the areas surrounding 
the treatment room that were surveyed ;, the measured dose 
rate at several points in each area expressed in 
microsieverts or millirems per hour ;, the calculated 
maximum level of radiati on over a period of one week for 
each restricted and unrestricted area ;, and the signature of 
the individual responsible for conducting the survey;  
4. If the results of the surveys required by subdivision 1 or 
2 of this subsection indicate any radiation l evels in excess 
of the respective limit specified in subdivision 1 of this 
subsection, the registrant shall lock the control in the 
"OFF" position and not use the unit:  
a. Except as may be necessary to repair, replace, or test 
the therapeutic radiation ma chine, the therapeutic 
radiation machine shielding, or the treatment room 
shielding; or  
b. Until the registrant has received a specific exemption 
from the agency.  
B. Modification of radiation therapy unit or room before 
beginning a treatment program. If the survey required by 
subsection A of this section indicates that an individual in an unrestricted area may be exposed to levels of radiation greater 
than those permitted by 12VAC5 -481-720, before beginning 
the treatment program the registrant shall:  
1. Either equip the unit with beam direction interlocks or 
add additional radiation shielding to ensure compliance 
with 12VAC5 -481-720;  
2. Perform the survey required by subsection A of this 
section again; and  
3. Include in the report required by subsection D of this 
section the results of the initial survey, a description of the 
modification made to comply with subdivision 1 of this 
subsection, and the results of the second survey; or  
4. Request and receive a registration amendment under 
12VAC5 -481-720 that authorizes radiation levels in 
unrestricted areas greater than those permitted by 
12VAC5 -481-720.  
C. Dosimetry equipment.  
1. The registrant shall have a calibrated dosimetry system 
available for use. The s ystem shall have been calibrated by 
the National Institute for Standards and Technology 
(NIST) or by an American Association of Physicists in 
Medicine (AAPM) Accredited Dosimetry Calibration 
Laboratory (ADCL). The calibration shall have been 
performed with in the previous 24 months and after any 
servicing that may have affected system calibration. An 
independent survey shall be conducted by a qualified 
inspector or qualified medical physicist other than the 
person performing the original survey prior to the 
equipment being used except as described in subsection A 
of this section:   
a. For beams with energies greater than one MV (1 
MeV), the dosimetry system shall have been calibrated 
for Cobalt -60;  
b. For beams with energies equal to or less than one MV 
(1 Me V), the dosimetry system shall have been calibrated 
at an energy (energy range) appropriate for the radiation 
being measured;  
2. The registrant shall have available for use a dosimetry 
system for quality assurance check measurements. To meet 
this requirem ent, the system may be compared with a 
system that has been calibrated in accordance with 
subdivision C 1 of this section  subsection . This comparison 
shall have been performed within the previous 12 months 
and after each servicing that may have affected sy stem 
calibration. The quality assurance check system may be the 
same system used to meet the requirement in subdivision C 
1 of this section  subsection ;  
3. The registrant shall maintain a record of each dosimetry 
system calibration, intercomparison, and co mparison for 
the duration of the license and/or  or registration. For each 
calibration, intercomparison, or comparison, the record 
shall include: the date; the model numbers and serial 
numbers of the instruments that were calibrated, inter -Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2371 compared, or comp ared as required by subdivisions C 1 
and 2 of this section  subsection ; the correction factors that 
were determined; the names of the individuals who 
performed the calibration, intercomparison, or comparison; 
and evidence that the intercomparison was performed by, 
or under the direct supervision and in the physical presence 
of, a radiation therapy  qualified medical  physicist.  
D. Reports of external beam radiation therapy surveys and 
measurements. The registrant for any therapeutic radiation 
machine subject to 12VAC5 -481-3420 or 12VAC5 -481-3430 
shall furnish a copy of the rec ords required in subsections A 
and B of this section to the agency within 30 days following 
completion of the action that initiated the record requirement.  
12VAC5 -481-3410. Quality management program.  
The facility shall implement a quality management pro gram. 
The facility shall include in the quality management program 
written notification to the agency within 72 hours of 
discovery of a reportable event or a misadministration  Each 
registrant or applicant subject to 12VAC5 -481-3420 and 
12VAC5 -481-3430 shal l develop, implement, and maintain a 
quality management program to provide high confidence that 
radiation will be administered as directed by the authorized 
user.  
A. Scope and applicability. The quality management 
program shall address, at a minimum, the following specific 
objectives:  
1. Written directives.  
a. A written directive shall be dated and signed by an 
authorized user prior to the administration of radiation. If 
because of the patient's condition a delay caused by 
providing a written revision to a n existing written 
directive would jeopardize the patient's health, an oral 
revision to an existing written directive will be 
acceptable, provided that the oral revision is documented 
as soon as possible in writing in the patient's record and a 
revised wri tten directive is signed by an authorized user 
within 48 hours of the oral revision.  
b. The written directive shall contain the patient's or 
human research subject's name, type and energy of the 
beam, total dose, dose per fraction, treatment site, and 
number of fractions.  
c. A written revision to an existing written directive may 
be made provided that the revision is dated and signed by 
an authorized user prior to the administration of the 
therapeutic radiation machine dose or the next fractional 
dose.  
d. The registrant shall retain a copy of the written 
directive for three years.  
2. Procedures for administrations. The registrant shall 
develop, implement, and maintain written procedures to 
provide high confidence that:  
a. Prior to the administration of eac h course of radiation 
treatment, the patient's or human research subject's identity is verified by more than one method as the 
individual named in the written directive;  
b. Each administration is in accordance with the written 
directive;  
c. Therapeutic rad iation machine final plans of treatment 
and related calculations are in accordance with the 
respective written directives by:  
(1) Checking both manual and computer -generated dose 
calculations to verify they are correct and in accordance 
with the written di rective; and  
(2) Verifying that any computer -generated calculations 
are correctly transferred into the consoles of authorized 
therapeutic medical units;  
d. Any unintended deviation from the written directive is 
identified and evaluated, and appropriate act ion is taken; 
and 
e. The registrant retains a copy of the procedures for 
administrations for the duration of the registration.  
B. Reports and notifications of misadministrations.  
1. A registrant shall report any event resulting from the 
treatment of a patient or human research subject in which 
the administration of therapeutic radiation machine 
radiation results, or will result in, unintended permanent 
functional damage to an organ  or a physiological system as 
determined by a physician.  
2. Other than events that result from the treatment of a 
patient or human research subject, a registrant shall report 
any event in which the administration of a therapeutic 
radiation machine therapy dose:  
a. Involves the wrong patient, wrong treatment modality, 
or wrong treatment site;  
b. The calculated weekly administered dose differs from 
the weekly prescribed dose by more than 30%; or  
c. The calculated total administered dose differs from the 
total prescribed dose by more than 20% of the total 
prescribed dose.  
3. The registrant shall notify the agency by telephone no 
later than the next calendar day after the discovery of a 
misadministration.  
4. The registrant shall submit a written report to the agency 
within 15 days after the discovery of a misadministration. 
The written report shall include:  
a. The registrant's name;  
b. The name of the prescribing physician;  
c. A brief description of the event;  
d. Why the event occurred;  
e. The effect, if any, o n the individual who received the 
misadministration;  
f. Actions, if any, that have been taken or are planned to 
prevent recurrence; and  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2372  g. Certification that the registrant notified the individual, 
or the individual's responsible relative or guardian, and if 
not, why not.  
5. The report shall not contain the individual's name or any 
other information that could lead to the identification of the 
individual.  
6. The registrant shall provide notification of the event to 
the referring physician and also notify th e individual who 
is the subject of the misadministration no later than 24 
hours after its discovery, unless the referring physician 
personally informs the registrant either that he will inform 
the individual or that, based on medical judgment, telling 
the individual would be harmful. The registrant is 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, the 
registrant shall notify the individual as soon as possible 
thereafter. The registrant may not delay any appropriate 
medical care for the individual, including any necessary 
remedial care as a result of the misadministration, because 
of any delay in notification. To meet the requireme nts of 
this subdivision, the notification of the individual who is 
the subject of the misadministration may be made instead 
to that individual's responsible relative or guardian. If a 
verbal notification is made, the registrant shall inform the 
individual,  or appropriate responsible relative or guardian, 
that a written description of the event can be obtained from 
the registrant upon request. The registrant shall provide 
such a written description if requested.  
7. Aside from the notification requirement, no thing in this 
section affects any rights or duties of registrants and 
physicians in relation to each other, to individuals affected 
by the misadministration, or to that individual's responsible 
relatives or guardians.  
8. The registrant shall retain a recor d of a 
misadministration in accordance with subsection C of this 
section. A copy of the required record shall be provided to 
the referring physician if other than the registrant within 15 
days after discovery of the misadministration.  
C. Records of misadmi nistrations. A registrant shall retain a 
record of misadministrations reported in accordance with 
subsection B of this section for three years. The record shall 
contain the following:  
1. The registrant's name and the names of the individuals 
involved;  
2. The social security number or other identification 
number, if one has been assigned, of the individual who is 
the subject of the misadministration;  
3. A brief description of the event; why it occurred; and the 
effect, if any, on the individual;  
4. The a ctions, if any, taken or planned to prevent 
recurrence; and  5. Whether the registrant notified the individual, or the 
individual's responsible relative or guardian and, if not, 
whether such failure to notify was based on guidance from 
the referring physici an. 
12VAC5 -481-3420. Therapeutic radiation machines of less 
than 500 kV.  
A. Leakage radiation. When the X-ray x-ray tube is operated 
at its maximum rated tube current for the maximum kV, the 
leakage air kerma rate shall not exceed the value specified at 
the distance specified for that classification of therapeutic 
radiation machine:  
1. 5-50 kV Systems  systems . The leak age air kerma rate 
measured at any position five centimeters from the tube 
housing assembly shall not exceed one mGy (100 mrad) in 
any one hour.  
2. > Greater than  50 and < less than  500 kV Systems  
systems . The leakage air kerma rate measured at a distance 
of one meter from the target in any direction shall not 
exceed one cGy (1 rad) in any one hour. This air kerma 
rate measurement may be averaged over areas no larger 
than 100 square centimeters. In additio n, the air kerma rate 
at a distance of five centimeters from the surface of the 
tube housing assembly shall not exceed 30 cGy (30 rad) 
per hour.  
3. For each therapeutic radiation machine, the registrant 
shall determine, or obtain from the manufacturer, the  
leakage radiation existing at the positions specified in 
subdivisions A 1 and 2 of this section  subsection  for the 
specified operating conditions. Records on leakage 
radiation measurements shall be maintained at the 
installation for inspection by the agen cy.  
B. Permanent beam limiting devices. Permanent diaphragms 
or cones used for limiting the useful beam shall provide at 
least the same degree of attenuation as required for the tube 
housing assembly.  
C. Adjustable or removable beam limiting devices.  
1. All adjustable or removable beam limiting devices, 
diaphragms, cones or blocks shall not transmit more than 
5.0% of the useful beam for the most penetrating beam 
used;  
2. When adjustable beam limiting devices are used, the 
position and shape of the radia tion field shall be indicated 
by a light beam.  
D. Filter system. The filter system shall be so designed that:  
1. Filters cannot be accidentally displaced at any possible 
tube orientation;  
2. For equipment installed after September 20, 2006, an 
interlock  system prevents irradiation if the proper filter is 
not in place;  
3. The air kerma rate escaping from the filter slot shall not 
exceed one cGy (1 rad) per hour at one meter under any 
operating conditions; and  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2373 4. Each filter shall be marked as to its mat erial of 
construction and its thickness.  
E. Tube immobilization.  
1. The X-ray x-ray tube shall be so mounted that it cannot 
accidentally turn or slide with respect to the housing 
aperture; and  
2. The tube housing assembly shall be capable of being 
immob ilized for stationary portal treatments.  
F. Source marking. The tube housing assembly shall be so 
marked that it is possible to determine the location of the 
source to within five millimeters, and such marking shall be 
readily accessible for use during ca libration procedures.  
G. Beam block. Contact therapy tube housing assemblies 
shall have a removable shield of material, equivalent in 
attenuation to 0.5 millimeters of lead at 100 kV, which can be 
positioned over the entire useful beam exit port during 
periods when the beam is not in use.  
H. Timer. A suitable irradiation control device shall be 
provided to terminate the irradiation after a pre -set time 
interval.  
1. A timer with a display shall be provided at the treatment 
control panel. The timer shall h ave a pre -set time selector 
and an elapsed time or time remaining indicator;  
2. The timer shall be a cumulative timer that activates with 
an indication of "BEAM -ON" and retains its reading after 
irradiation is interrupted or terminated. After irradiation is 
terminated and before irradiation can be reinitiated, it shall 
be necessary to reset the elapsed time indicator;  
3. The timer shall terminate irradiation when a preselected 
time has elapsed, if any dose monitoring system present 
has not previously term inated irradiation;  
4. The timer shall permit accurate pre -setting and 
determination of exposure times as short as one second;  
5. The timer shall not permit an exposure if set at zero;  
6. The timer shall not activate until the shutter is opened 
when irr adiation is controlled by a shutter mechanism 
unless calibration includes a timer error correction to 
compensate for mechanical lag; and  
7. Time r The timer  shall be accurate to within 1.0% of the 
selected value or one second, whichever is greater.  
I. Con trol panel functions. The control panel, in addition to 
the displays required by other provisions in this section, shall 
have:  
1. An indication of whether electrical power is available at 
the control panel and if activation of the X-ray x-ray tube 
is poss ible;  
2. An indication of whether X-rays x-rays are being 
produced;  
3. A means for indicating X-ray x-ray tube potential and 
current;  
4. The means for terminating an exposure at any time;  5. A locking device which will prevent unauthorized use of 
the therapeutic radiation machine; and  
6. For therapeutic radiation machines manufactured after 
September 20, 2006, a positive display of specific filter(s)  
filters  in the beam.  
J. Multiple tubes . When a control panel may energize more 
than one X-ray x-ray tube:  
1. It shall be possible to activate only one X-ray x-ray tube 
at any time;  
2. There shall be an indication at the control panel 
identifying which X-ray x-ray tube is activated; and  
3. T here shall be an indication at the tube housing 
assembly when that tube is energized.  
K. Target -to-skin distance (TSD). There shall be a means of 
determining the central axis TSD to within one centimeter 
and of reproducing this measurement to within two 
millimeters thereafter.  
L. Shutters. Unless it is possible to bring the X-ray x-ray 
output to the prescribed exposure parameters within five 
seconds after the X-ray x-ray "ON" switch is energized, the 
beam shall be attenuated by a shutter having a lead 
equivalency not less than that of the tube housing assembly. 
In addition, after the unit is at operating parameters, the 
shutter shall be controlled by the operator from the control 
panel. An indication of shutter position shall appear at the 
control panel.  
M. Low filtration X-ray x-ray tubes. Each therapeutic 
radiation machine equipped with a beryllium or other low -
filtration window shall be clearly labeled as such upon the 
tube housing assembly and shall be provided with a 
permanent warning device on the co ntrol panel that is 
activated when no additional filtration is present, to indicate 
that the dose rate is very high.  
N. Facility design requirements for therapeutic radiation 
machines capable of operating in the range 50 kV to 500 kV. 
In addition to adequ ate shielding to meet requirements of 
12VAC5 -481-3450, the treatment room shall meet the 
following design requirements:  
1. Aural communication. Provision shall be made for 
continuous two -way aural communication between the 
patient and the operator at the control panel;  
2. Viewing systems. Provision shall be made to permit 
continuous observation of the patient during irradiation and 
the viewing system shall be so located that the operator can 
observe the patient from the control panel. The therapeutic 
radiation machine shall not be used for patient irradiation 
unless at least one viewing system is operational.  
O. Additional requirements. Treatment rooms that contain a 
therapeutic radiation machine capable of operating above 150 
kV shall meet the following additional requirements:  
1. All protective barriers shall be fixed except for entrance 
doors or beam interceptors;  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2374  2. The control panel shall be located outside the treatment 
room or in a totally enclosed booth, which has a ceiling, 
inside the room;  
3. Interlocks shall be provided such that all entrance doors, 
including doors to any interior booths, shall be closed 
before treatment can be initiated or continued. If the 
radiation beam is interrupted by any door opening, it shall 
not be possible to restore  the machine to operation without 
closing the door and reinitiating irradiation by manual 
action at the control panel; and  
4. When any door referred to in subdivision 3 of this 
subsection is opened while the X-ray x-ray tube is 
activated, the air kerma ra te at a distance of one meter from 
the source shall be reduced to less than one mGy (100 
mrad) per hour.  
P. Full calibration measurements.  
1. Full calibration of a therapeutic radiation machine 
subject to this section shall be performed by, or under the 
direct supervision of, a radiation therapy  qualified medical  
physicist:  
a. Before the first medical use following installation or 
reinstallation of the therapeutic radiation machine;  
b. At intervals not exceeding one year; and  
c. Before medical use unde r the following conditions:  
(1) Whenever quality assurance check measurements 
indicate that the radiation output differs by more than 
5.0% from the value obtained at the last full calibration 
and the difference cannot be reconciled; and  
(2) Following any  component replacement, major repair, 
or modification of components that could significantly 
affect the characteristics of the radiation beam.  
d. Notwithstanding the requirements of subdivision 1 c of 
this subsection:  
(1) Full calibration of therapeutic radiation machines 
with multienergy capabilities is required only for those 
modes and/or  or energies that are not within their 
acceptable range; and  
(2) If the repair, replacement or modification does not 
affect all energies, full calibration shall be per formed on 
the affected energy that is in most frequent clinical use at 
the facility. The remaining energies may be validated 
with quality assurance check procedures against the 
criteria in subdivision 1 c (1) of this subsection.  
2. To satisfy the requirement of subdivision 1 of this 
subsection, full calibration shall include all measurements 
recommended for annual calibration by NCRP  the National 
Council on Radiation Protection and Measurements 
(NCRP)  Report 69, "Dosimetry of X -ray and Gamma Ray 
Beams for Radiation Therapy in the Energy Range 10 keV 
to 50 MeV" (1981).  
3. The registrant shall maintain a record of each calibration 
for the duration of the registration. The record shall include: the date of the calibration; the manufa cturer's 
name, model number, and serial number for both the 
therapeutic radiation machine and the X-ray x-ray tube; the 
model numbers and serial numbers of the instruments used 
to calibrate the therapeutic radiation machine; and the 
signature of the radiation therapy  qualified medical  
physicist responsible for performing the calibration.  
Q. Periodic quality assurance checks.  
1. Periodic quality assurance checks shall be performed on 
therapeutic radiation machines subject to this section, 
which are c apable of operation at greater than or equal to 
50 kV .;  
2. To satisfy the requirement of subdivision 1 of this 
subsection, quality assurance checks shall meet the 
following requirements:  
a. The registrant shall perform quality assurance checks 
in accorda nce with written procedures established by the 
radiation therapy  qualified medical  physicist .; and  
b. The quality assurance check procedures shall specify 
the frequency at which tests or measurements are to be 
performed. The quality assurance check proced ures shall 
specify that the quality assurance check shall be 
performed during the calibration specified in subdivision 
P 1 of this section. The acceptable tolerance for each 
parameter measured in the quality assurance check, when 
compared to the value for that parameter determined in 
the calibration specified in subdivision P 1 of this 
section, shall be stated .;  
3. The cause for a parameter exceeding a tolerance set by 
the radiation therapy  qualified medical  physicist shall be 
investigated and corrected be fore the system is used for 
patient irradiation;  
4. Whenever a quality assurance check indicates a 
significant change in the operating characteristics of a 
system, as specified in the radiation therapy  qualified 
medical  physicist's quality assurance check  procedures, the 
system shall be recalibrated as required in subdivision P 1 
of this section;  
5. The registrant shall use the dosimetry system described 
in 12VAC5 -481-3400 C 2 to make the quality assurance 
check required in subdivision 2 of this subsectio n;  
6. The registrant shall have the radiation therapy  qualified 
medical  physicist review and sign the results of each 
radiation output quality assurance check within one month  
30 days  of the date that the check was performed;  
7. The registrant shall ensu re that safety quality assurance 
checks of therapeutic radiation machines subject to this 
section are performed at intervals not to exceed one month  
30 days ;  
8. Notwithstanding the requirements of subdivisions 4 and 
7 of this subsection, the registrant sh all ensure that no 
therapeutic radiation machine is used to administer 
radiation to humans unless the quality assurance checks Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2375 required by subdivisions 6 4 and 7 of this subsection have 
been performed within the 30 -day period immediately 
prior to said admi nistration;  
9. To satisfy the requirement of subdivision 7 of this 
subsection, safety quality assurance checks shall ensure 
proper operation of:  
a. Electrical interlocks at each external beam radiation 
therapy room entrance;  
b. The "BEAM -ON" and termina tion switches;  
c. Beam condition indicator lights on the access door(s)  
door, control console, and in the radiation therapy room;  
d. Viewing systems; and 
e. If applicable, electrically operated treatment room 
doors from inside and outside the treatment r oom; and 
10. The registrant shall maintain a record of each quality 
assurance check required by subdivisions 1 and 7 of this 
subsection for three years. The record shall include : the 
date of the quality assurance check; the manufacturer's 
name, the model n umber, and serial number of the 
therapeutic radiation machine; the manufacturer's name ;, 
the model number , and serial number for the instrument(s)  
instruments  used to measure the radiation output of the 
therapeutic radiation machine; and the signature of t he 
individual who performed the periodic quality assurance 
check.  
R. Operating procedures.  
1. The therapeutic radiation machine shall not be used for 
irradiation of patients unless the requirements of 
subsections P and Q of this section have been met;  
2. Therapeutic radiation machines shall not be left 
unattended unless secured pursuant to subdivision I 5 of 
this section;  
3. When a patient must be held in position for radiation 
therapy, mechanical supporting or restraining devices shall 
be used;  
4. The  tube housing assembly shall not be held by an 
individual during operation unless the assembly is 
designed to require such holding and the peak tube 
potential of the system does not exceed 50 kV. In such 
cases, the holder shall wear protective gloves and an apron 
of not less than 0.5 millimeters lead equivalency at 100 
kV;  
5. A copy of the current operating and emergency 
procedures shall be maintained at the therapeutic radiation 
machine control console; and  
6. No individual other than the patient shall b e in the 
treatment room during exposures from therapeutic 
radiation machines operating above 150 kV. At energies 
less than or equal to 150 kV, any individual, other than the 
patient, in the treatment room shall be protected by a 
barrier sufficient to meet the requirements of 12VAC5 -
481-640.  S. Possession of survey instrument(s)  instruments . Each 
facility location authorized to use a therapeutic radiation 
machine in accordance with this section shall possess 
appropriately calibrated portable monitoring equi pment. As a 
minimum, such equipment shall include a portable radiation 
measurement survey instrument capable of measuring dose 
rates over the range 10 mSv µSv (1 mrem) per hour to 10 
mSv (1000 mrem) per hour. The survey instrument(s)  
instruments  shall be o perable and calibrated in accordance 
with 12VAC5 -481-3440.  
T. Electronic brachytherapy devices are subject to the 
requirements of 12VAC5 -481-3452 and are exempt from the 
requirements of this section.  
12VAC5 -481-3430. Therapeutic radiation machines - 
photon therapy systems (500 kV and above) and electron 
therapy systems (500 kV and above).  
A. Possession of survey instrument(s)  instruments . Each 
facility location authorized to use a therapeutic radiatio n 
machine in accordance with this section shall possess  have 
access to  appropriately calibrated portable monitoring 
equipment. As a minimum, such equipment shall include a 
portable radiation measurement survey instrument capable of 
measuring dose rates ove r the range 10 mSv µSv (1 mrem) 
per hour to 10 mSv (1000 mrem) per hour. The survey 
instrument(s)  instruments  shall be operable and calibrated in 
accordance with 12VAC5 -481-3440.  
B. Leakage radiation outside the maximum useful beam in 
photon and electron modes.  
1. The absorbed dose due to leakage radiation (excluding 
neutrons) at any point outside the maximum sized useful 
beam, but within a circular plane of radius two meters 
which is perpendicular to and centered on the central axis 
of the useful beam at  the nominal treatment distance (i.e. , 
patient plane), shall not exceed a maximum of 0.2% and an 
average of 0.1% of the absorbed dose on the central axis of 
the beam at the nominal treatment distance. Measurements 
shall be averaged over an area not exceedi ng 100 square 
centimeters at a minimum of 16 points uniformly 
distributed in the plane;  
2. Except for the area defined in subdivision 1 of this 
subsection, the absorbed dose due to leakage radiation 
(excluding neutrons) at one meter from the electron path  
between the electron source and the target or electron 
window shall not exceed 0.5% of the absorbed dose on the 
central axis of the beam at the nominal treatment distance. 
Measurements shall be averaged over an area not 
exceeding 100 square centimeters;  
3. For equipment manufactured after September 20, 2006, 
the neutron absorbed dose outside the useful beam shall be 
in compliance with International Electrotechnical 
Commission (IEC) Document 601 -2-1 (most current 
revision); and  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2376  4. For each therapeutic rad iation machine, the registrant 
shall determine, or obtain from the manufacturer, the 
leakage radiation existing at the positions specified in 
subdivisions 1 through , 2, and  3 of this subsection for the 
specified operating conditions. Records on leakage 
radiation measurements shall be maintained at the 
installation for inspection by the agency.  
C. Leakage radiation through beam limiting devices.  
1. Photon radiation. All adj ustable or interchangeable beam 
limiting devices shall attenuate the useful beam such that at 
the nominal treatment distance, the maximum absorbed 
dose anywhere in the area shielded by the beam limiting 
device(s)  devices  shall not exceed 2.0% of the maximu m 
absorbed dose on the central axis of the useful beam 
measured in a 10 centimeter by 10 centimeter radiation 
field, or for multileaf collimators, shall not exceed 
manufacturer's specifications  100 square centimeter 
radiation field, or maximum available fi eld size if less than 
100 square centimeters ;  
2. Electron radiation. All adjustable or interchangeable 
electron applicators shall attenuate the radiation, including 
but not limited to photon radiation generated by electrons 
incident on the beam limiting d evice and electron 
applicator and other parts of the radiation head, such that 
the absorbed dose in a plane perpendicular to the central 
axis of the useful beam at the nominal treatment distance 
shall not exceed:  
a. A maximum of 2.0% and average of 0.5% o f the 
absorbed dose on the central axis of the useful beam at 
the nominal treatment distance. This limit shall apply 
beyond a line seven centimeters outside the periphery of 
the useful beam; and  
b. A maximum of 10% of the absorbed dose on the 
central axis  of the useful beam at the nominal treatment 
distance. This limit shall apply beyond a line two 
centimeters outside the periphery of the useful beam.  
3. Measurement of leakage radiation.  
a. Photon radiation. Measurements of leakage radiation 
through the beam limiting devices shall be made with the 
beam limiting devices closed and any residual aperture 
blocked by at least two-tenth value  two tenth -value  layers 
of suitable absorbing material. In the case of overlapping 
beam limiting devices, the leakage rad iation through each 
set shall be measured independently at the depth of 
maximum dose. Measurements shall be made using a 
radiation detector of area not exceeding 10 square 
centimeters;  
b. Electron radiation. Measurements of leakage radiation 
through the e lectron applicators shall be made with the 
electron beam directed into the air and using a radiation 
detector of area up to but not exceeding one square 
centimeter suitably protected against radiation which has 
been scattered from material beyond the radia tion detector. Measurements shall be made using one 
centimeter of water equivalent build up material.  
D. Filters and wedges.  
1. Each wedge filter that is removable from the system 
shall be clearly marked with an identification number. For 
removable wedge  filters, the nominal wedge angle shall 
appear on the wedge or wedge tray (if permanently 
mounted to the tray). If the wedge or wedge tray is 
significantly damaged, the wedge transmission factor shall 
be redetermined ;.  
2. If the absorbed dose rate informa tion required by 
subsection I of this section relates exclusively to operation 
with a field flattening filter or beam scattering foil in place, 
such foil or filter shall be removable only by the use of 
tools ;.  
3. For equipment manufactured after September  20, 2006, 
that utilizes wedge filters, interchangeable field flattening 
filters, or interchangeable beam scattering foils:  
a. Irradiation shall not be possible until a selection of a 
filter or a positive selection to use "no filter" has been 
made at the treatment control panel, either manually or 
automatically;  
b. An interlock system shall be provided to prevent 
irradiation if the filter selected is not in the correct 
position;  
c. A display shall be provided at the treatment control 
panel showing the we dge filter(s)  filters , interchangeable 
field flattening filter(s)  filters , and/or  or interchangeable 
beam scattering foil(s)  foils in use; and  
d. An interlock shall be provided to prevent irradiation if 
any filter and/or  or beam scattering foil selection 
operation carried out in the treatment room does not 
agree with the filter and/or  or beam scattering foil 
selection operation carried out at the treatment control 
panel.  
E. Stray radiation in the useful beam. For equipment 
manufactured after September 20,  2006, the registrant shall 
determine during acceptance testing, or obtain from the 
manufacturer, data sufficient to ensure that X-ray x-ray stray 
radiation in the useful electron beam, absorbed dose at the 
surface during X-ray x-ray irradiation , and stray  neutron 
radiation in the useful X-ray x-ray beam are in compliance 
with International Electrotechnical Commission (IEC) 
Document 601 -2-1 (most current revision).  
F. Beam monitors. All therapeutic radiation machines 
subject to this section shall be provid ed with redundant beam 
monitoring systems. The sensors for these systems shall be 
fixed in the useful beam during treatment to indicate the dose 
monitor unit rate.  
1. Equipment manufactured after September 20, 2006, 
shall be provided with at least two ind ependently powered 
integrating dose meters. Alternatively, common elements Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2377 may be used if the production of radiation is terminated 
upon failure of any common element.  
2. Equipment manufactured on or before September 20, 
2006, shall be provided with at least one radiation detector. 
This detector shall be incorporated into a useful beam 
monitoring system ;.  
3. The detector and the system into which that detector is 
incorporated shall meet the following requirements:  
a. Each detector shall be removable on ly with tools and, 
if movable, shall be interlocked to prevent incorrect 
positioning ;.  
b. Each detector shall form part of a beam monitoring 
system from whose readings in dose monitor units the 
absorbed dose at a reference point can be calculated ;. 
c. Eac h beam monitoring system shall be capable of 
independently monitoring, interrupting, and terminating 
irradiation ; and .  
d. For equipment manufactured after September 20, 
2006, the design of the beam monitoring systems shall 
ensure that the:  
(1) Malfunctio ning of one system shall not affect the 
correct functioning of the other system(s)  systems ; and  
(2) Failure of either system shall terminate irradiation or 
prevent the initiation of radiation.  
e. Each beam monitoring system shall have a legible 
display a t the treatment control panel. For equipment 
manufactured after September 20, 2006, each display 
shall:  
(1) Maintain a reading until intentionally reset;  
(2) Have only one scale and no electrical or mechanical 
scale multiplying factors;  
(3) Utilize a de sign such that increasing dose is displayed 
by increasing numbers; and  
(4) In the event of power failure, the beam monitoring 
information required in subdivision 3 e (3) of this 
subsection displayed at the control panel at the time of 
failure shall be ret rievable in at least one system for a 20 -
minute period of time.  
G. Beam symmetry.  
1. Bent -beam linear accelerators  A bent -beam linear 
accelerator with beam flattening filter  subject to this 
section shall be provided with an auxiliary device(s)  device  
to monitor beam symmetry;  
2. The device(s)  device  referenced in subdivision 1 of this 
subsection shall be able to detect field asymmetry greater 
than 10%; and  
3. The device(s)  device  referenced in subdivision 1 of this 
subsection shall be configured to terminate irradiation if 
the specifications in subdivision 2 of this subsection cannot 
be maintained.  
H. Selection and display of dose monitor units.  1. Irradiation shall not be possi ble until a new selection of 
a number of dose monitor units has been made at the 
treatment control panel;  
2. The preselected number of dose monitor units shall be 
displayed at the treatment control panel until reset 
manually for the next irradiation;  
3. After termination of irradiation, it shall be necessary to 
reset the dosimeter display before subsequent treatment 
can be initiated; and  
4. For equipment manufactured after September 20, 2006, 
after termination of irradiation, it shall be necessary for th e 
operator to reset the preselected dose monitor units before 
irradiation can be initiated.  
I. Air kerma rate or absorbed dose rate. For equipment 
manufactured after September 20, 2006, a system shall be 
provided from whose readings the air kerma rate or absorbed 
dose rate at a reference point can be calculated. (The radiation 
detectors specified in subsection F of this section may form 
part of this system.) In addition:  
1. The dose monitor unit rate shall be displayed at the 
treatment control panel;  
2. If the equipment can deliver under any conditions an air 
kerma rate or absorbed dose rate at the nominal treatment 
distance more than twice the maximum value specified by 
the manufacturer, a device shall be provided that 
terminates irradiation when the air  kerma rate or absorbed 
dose rate exceeds a value twice the specified maximum. 
The dose rate at which the irradiation will be terminated 
shall be a record maintained by the registrant;  
3. If the equipment can deliver under any fault condition(s)  
condition s an air kerma rate or absorbed dose rate at the 
nominal treatment distance more than 10 times the 
maximum value specified by the manufacturer, a device 
shall be provided to prevent the air kerma rate or absorbed 
dose rate anywhere in the radiation field f rom exceeding 
twice the specified maximum value and to terminate 
irradiation if the excess absorbed dose at the nominal 
treatment distance exceeds 4 Gy (400 rad); and  
4. For each therapeutic radiation machine, the registrant 
shall determine, or obtain fro m the manufacturer, the 
maximum value(s)  values  specified in subdivisions 2 and 3 
of this subsection for the specified operating conditions. 
Records of these maximum value(s)  values  shall be 
maintained at the installation for inspection by the agency.  
J. Termination of irradiation by the beam monitoring system 
or systems during stationary beam radiation therapy.  
1. Each primary system shall terminate irradiation when 
the preselected number of dose monitor units has been 
detected by the system;  
2. If the original design of the equipment included a 
secondary dose monitoring system, that system shall be 
capable of terminating irradiation when not more than 15% 
or 40 dose monitor units above the preselected number of Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2378  dose monitor units set at the co ntrol panel has been 
detected by the secondary dose monitoring system; and  
3. For equipment manufactured after September 20, 2006, 
an indicator on the control panel shall show which 
monitoring system has terminated irradiation.  
K. Termination of irradiat ion. It shall be possible to 
terminate irradiation and equipment movement or go from an 
interruption condition to termination condition at any time 
from the operator's position at the treatment control panel.  
L. Interruption of irradiation. If a therapeut ic radiation 
machine has an interrupt mode, it shall be possible to 
interrupt irradiation and equipment movements at any time 
from the treatment control panel. Following an interruption it 
shall be possible to restart irradiation by operator action 
without  any reselection of operating conditions. If any change 
is made of a preselected value during an interruption, 
irradiation and equipment movements shall be automatically 
terminated.  
M. Timer. A suitable irradiation control device shall be 
provided to term inate the irradiation after a pre -set time 
interval.  
1. A timer shall be provided which has a display at the 
treatment control panel. The timer shall have a pre -set time 
selector and an elapsed time indicator;  
2. The timer shall be a cumulative timer tha t activates with 
an indication of "BEAM -ON" and retains its reading after 
irradiation is interrupted or terminated. After irradiation is 
terminated and before irradiation can be reinitiated, it shall 
be necessary to reset the elapsed time indicator;  
3. Th e timer shall terminate irradiation when a preselected 
time has elapsed , if the dose monitoring systems have not 
previously terminated irradiation.  
N. Selection of radiation type. Equipment capable of both 
X-ray x-ray therapy and electron therapy shall me et the 
following additional requirements:  
1. Irradiation shall not be possible until a selection of 
radiation type (X-rays (x-rays or electrons) has been made 
at the treatment control panel;  
2. The radiation type selected shall be displayed at the 
treatm ent control panel before and during irradiation;  
3. An interlock system shall be provided to ensure that the 
equipment can principally emit only the radiation type that 
has been selected;  
4. An interlock system shall be provided to prevent 
irradiation wi th X-rays x-rays, except to obtain an image, 
when electron applicators are fitted;  
5. An interlock system shall be provided to prevent 
irradiation with electrons when accessories specific for X-
ray x-ray therapy are fitted; and  
6. An interlock system sha ll be provided to prevent 
irradiation if any selected operations carried out in the treatment room do not agree with the selected operations 
carried out at the treatment control panel.  
O. Selection of energy. Equipment capable of generating 
radiation beam s of different energies shall meet the following 
requirements:  
1. Irradiation shall not be possible until a selection of 
energy has been made at the treatment control panel;  
2. The nominal energy value selected shall be displayed at 
the treatment control  panel until reset manually for the next 
irradiation. After termination of irradiation, it shall be 
necessary to reset the nominal energy value selected before 
subsequent treatment can be initiated;  
3. Irradiation shall not be possible until the appropria te 
flattening filter or scattering foil for the selected energy is 
in its proper location; and  
4. For equipment manufactured after September 20, 2006, 
the selection of energy shall be in compliance with 
International Electrotechnical Commission (IEC) 
Docu ment 601 -2-1.  
P. Selection of stationary beam radiation therapy or moving 
beam radiation therapy. Therapeutic radiation machines 
capable of both stationary beam radiation therapy and moving 
beam radiation therapy shall meet the following requirements:  
1. Irradiation shall not be possible until a selection of 
stationary beam radiation therapy or moving beam 
radiation therapy has been made at the treatment control 
panel;  
2. The mode of operation shall be displayed at the 
treatment control panel;  
3. An int erlock system shall be provided to ensure that the 
equipment can operate only in the mode that has been 
selected;  
4. An interlock system shall be provided to prevent 
irradiation if any selected parameter in the treatment room 
does not agree with the selec ted parameter at the treatment 
control panel;  
5. Moving beam radiation therapy shall be controlled to 
obtain the selected relationships between incremental dose 
monitor units and incremental movement. For equipment 
manufactured after September 20, 2006:  
a. An interlock system shall be provided to terminate 
irradiation if the number of dose monitor units delivered 
in any 10 degrees of rotation or one cm centimeter  of 
linear motion differs by more than 20% from the selected 
value;  
b. Where angle terminates the irradiation in moving 
beam radiation therapy, the dose monitor units delivered 
shall differ by less than 5.0% from the dose monitor unit 
value selected;  
c. An interlock shall be provided to prevent motion of 
more than five de grees or one cm centimeter  beyond the 
selected limits during moving beam radiation therapy;  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2379 d. An interlock shall be provided to require that a 
selection of direction be made at the treatment control 
panel in all units that are capable of both clockwise a nd 
counter -clockwise moving beam radiation therapy .;  
e. Moving beam radiation therapy shall be controlled 
with both primary position sensors and secondary 
position sensors to obtain the selected relationships 
between incremental dose monitor units and inc remental 
movement .;  
6. Where the beam monitor system terminates the 
irradiation in moving beam radiation therapy, the 
termination of irradiation shall be as required by 12VAC5 -
481-3430 J  subsection J of this section ; and  
7. For equipment manufactured aft er September 20, 2006, 
an interlock system shall be provided to terminate 
irradiation if movement:  
a. Occurs during stationary beam radiation therapy; or  
b. Does not start or stops during moving beam radiation 
therapy unless such stoppage is a pre -planne d function.  
Q. Facility design requirements for therapeutic radiation 
machines operating above 500 kV. In addition to shielding 
adequate to meet requirements of 12VAC5 -481-3450, the 
following design requirements are made:  
1. Protective barriers. All prot ective barriers shall be fixed, 
except for access doors to the treatment room or movable 
beam interceptors;  
2. Control panel. In addition to other requirements 
specified in Part XV (12VAC5 -481-3380 et seq.) of this 
chapter, the control panel shall also:  
a. Be located outside the treatment room;  
b. Provide an indication of whether electrical power is 
available at the control panel and if activation of the 
radiation is possible;  
c. Provide an indication of whether radiation is being 
produced; and  
d. Incl ude an access control (locking) device that will 
prevent unauthorized use of the therapeutic radiation 
machine;  
3. Viewing systems. Windows, mirrors, closed -circuit 
television or an equivalent viewing system shall be 
provided to permit continuous observat ion of the patient 
following positioning and during irradiation and shall be so 
located that the operator may observe the patient from the 
treatment control panel. The therapeutic radiation machine 
shall not be used for patient irradiation unless at least one 
viewing system is operational;  
4. Aural communications. Provision shall be made for 
continuous two-way aural communication between the 
patient and the operator at the control panel. The 
therapeutic radiation machine shall not be used for 
irradiation o f patients unless continuous two-way aural 
communication is possible;  5. Room entrances. Treatment room entrances shall be 
provided with warning lights in a readily observable 
position near the outside of all access doors, which will 
indicate when the use ful beam is "ON" and when it is 
"OFF";  
6. Entrance interlocks. Interlocks shall be provided such 
that all access controls are activated before treatment can 
be initiated or continued. If the radiation beam is 
interrupted by any access control, it shall no t be possible to 
restore the machine to operation without resetting the 
access control and reinitiating irradiation by manual action 
at the control panel;  
7. Beam interceptor interlocks. If the shielding material in 
any protective barrier requires the pre sence of a beam 
interceptor to ensure compliance with 12VAC5 -481-720, 
interlocks shall be provided to prevent the production of 
radiation, unless the beam interceptor is in place, whenever 
the useful beam is directed at the designated barrier(s)  
barrier ;  
8. Emergency cutoff switches. At least one emergency 
power cutoff switch shall be located in the radiation 
therapy room and shall terminate all equipment electrical 
power including radiation and mechanical motion. This 
switch is in addition to the terminat ion switch required by 
subsection K of this section. All emergency power cutoff 
switches shall include a manual reset so that the 
therapeutic radiation machine cannot be restarted from the 
unit's control console without resetting the emergency 
cutoff switc h;  
9. Safety interlocks. All safety interlocks shall be designed 
so that any defect or component failure in the safety 
interlock system prevents or terminates operation of the 
therapeutic radiation machine; and  
10. Surveys for residual radiation. Surveys  for residual 
activity shall be conducted on all therapeutic radiation 
machines capable of generating photon and electron 
energies above 10 MV prior to machining, removing from 
treatment room , or working on therapeutic radiation 
machine components which ma y have become activated 
due to photo -neutron production.  
R. Radiation therapy  Qualified medical  physicist support.  
1. The services of a radiation therapy  qualified medical  
physicist shall be required in facilities having therapeutic 
radiation machines wi th energies of 500 kV and above. 
The radiation therapy  qualified medical  physicist shall be 
responsible for:  
a. Full calibration(s)  calibrations  required by subsection 
T of this section and protection  surveys required by 
12VAC5 -481-3400 A;  
b. Supervision  and review of dosimetry;  
c. Beam data acquisition and transfer for computerized 
dosimetry, and supervision of its use;  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2380  d. Quality assurance, including quality assurance check 
review required by subdivision U 5 of this section .;  
e. Consultation with the authorized user in treatment 
planning, as needed; and  
f. Performance of calculations or assessments regarding 
misadministrations.  
2. If the radiation therapy  qualified medical  physicist is not 
a full -time employee of the registra nt, the operating 
procedures required by subsection S of this section shall 
also specifically address how the radiation therapy  
qualified medical  physicist is to be contacted for problems 
or emergencies, as well as the specific actions, if any, to be 
taken  until the radiation therapy  qualified medical  physicist 
can be contacted.  
S. Operating procedures.  
1. No individual, other than the patient, shall be in the 
treatment room during treatment or during any irradiation 
for testing or calibration purposes;  
2. Therapeutic radiation machines shall not be made 
available for medical use unless the requirements of 
12VAC5 -481-3400 A, and subsections T and U of this 
section have been met;  
3. Therapeutic radiation machines, when not in operation, 
shall be secured t o prevent unauthorized use;  
4. When adjustable beam limiting devices are used, the 
position and shape of the radiation field shall be indicated 
by a light field.  
5. If a patient must be held in position during treatment, 
mechanical supporting or restrain ing devices shall be used; 
and  
6. A copy of the current operating and emergency 
procedures shall be maintained at the therapeutic radiation 
machine control console.  
T. Acceptance testing, commissioning , and full calibration 
measurements.  
1. Acceptance t esting, commissioning and full calibration 
of a therapeutic radiation machine subject to this section 
shall be performed by, or under the direct supervision of, a 
radiation therapy  qualified medical  physicist.  
2. Acceptance testing and commissioning shall  be 
performed in accordance with the American Association of 
Physicists in Medicine (AAPM)  AAPM Code of Practice 
for Radiotherapy Accelerators: Report of  AAPM Report 
Number 47," prepared by  Radiation Therapy Task Group 
45" and the manufacturer's contractua l specifications. 
Acceptance testing and commissioning  shall be conducted 
before the first medical use following installation or 
reinstallation of the therapeutic radiation machine.  
3. Full calibration shall include measurement of all 
parameters required by Table II of "Comprehensive QA for 
Radiation Oncology: Report of AAPM Radiation Therapy : 
AAPM Report No. 46," prepared by  Committee Task Group 40 " and shall be performed in accordance with 
"AAPM Code of Practice for Radiotherapy Accelerators: 
Report of A APM  AAPM Report No. 47" prepared by  
Radiation Therapy Task Group 45 ". Although it shall not 
be necessary to complete all elements of a full calibration 
at the same time, all parameters (for all energies) shall be 
completed at intervals not exceeding 12 cal endar months, 
unless a more frequent interval is required in Table II.  
4. The radiation therapy  qualified medical  physicist shall 
perform all elements of a full calibration necessary to 
determine that all parameters are within acceptable limits:  
a. Whene ver quality assurance check measurements 
indicate that the radiation output differs by more than 
5.0% from the value obtained at the last full calibration 
and the difference cannot be reconciled. Therapeutic 
radiation machines with multienergy and/or  or 
multimode capabilities shall only require measurements 
for those modes and/or  or energies that are not within 
their acceptable range; and  
b. Following any component replacement, major repair, 
or modification of components that could significantly 
affect the  characteristics of the radiation beam. If the 
repair, replacement or modification does not affect all 
modes and/or  or energies, measurements shall be 
performed on the effected mode or energy that is in most 
frequent clinical use at the facility. The remai ning 
energies or modes may be validated with quality 
assurance check procedures against the criteria in 
subdivision 4 a of this subsection.  
5. The registrant shall maintain a record of each calibration 
in an auditable form for the duration of the registra tion. 
The record shall include : the date of the calibration; the 
manufacturer's name, model number , and serial number for 
the therapeutic radiation machine; the model numbers and 
serial numbers of the instruments used to calibrate the 
therapeutic radiation  machine; and the signature of the 
radiation therapy  qualified medical  physicist responsible 
for performing the calibration.  
U. Periodic quality assurance checks.  
1. Periodic quality assurance checks shall be performed on 
all therapeutic radiation machin es subject to this section at 
intervals not to exceed those specified in "Comprehensive 
QA for Radiation Oncology: Report of  AAPM Report No. 
46," prepared by  AAPM Radiation Therapy Committee 
Task Group 40 ";  
2. To satisfy the requirement of subdivision 1 o f this 
subsection, quality assurance checks shall include 
determination of central axis radiation output and a 
representative sampling of periodic quality assurance 
checks contained in "Comprehensive QA for Radiation 
Oncology: Report of  AAPM Report No. 46"  prepared by  
AAPM Radiation Therapy Committee Task Group 40 ". 
Representative sampling shall include all referenced Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2381 periodic quality assurance checks in an interval not to 
exceed 12 consecutive calendar months;  
3. The registrant shall use a dosimetry syste m that has been 
inter-compared within the previous 12 months with the 
dosimetry system described in 12VAC5 -481-3400 C 1 to 
make the periodic quality assurance checks required in 
subdivision 2 of this subsection;  
4. The registrant shall perform periodic qu ality assurance 
checks required by subdivision 1 of this subsection in 
accordance with procedures established by the radiation 
therapy  qualified medical  physicist;  
5. The registrant shall review the results of each periodic 
radiation output check accordin g to the following 
procedures:  
a. The authorized user and radiation therapy  qualified 
medical  physicist shall be immediately notified if any 
parameter is not within its acceptable tolerance. The 
therapeutic radiation machine shall not be made available 
for subsequent medical use until the radiation therapy  
qualified medical  physicist has determined that all 
parameters are within their acceptable tolerances;  
b. If all quality assurance check parameters appear to be 
within their acceptable ranges, the quali ty assurance 
check shall be reviewed and signed by either the 
authorized user or radiation therapy  qualified medical  
physicist within three treatment days; and  
c. The radiation therapy  qualified medical  physicist shall 
review and sign the results of each radiation output 
quality assurance check at intervals not to exceed one 
month  30 days .  
6. Therapeutic radiation machines subject to this section 
shall have applicable  safety quality assurance checks listed 
in "Comprehensive QA for Radiation Oncology: Report of  
AAPM Report No. 46," prepared by  AAPM Radiation 
Therapy Committee Task Group 40 " performed at intervals 
not to exceed one week;  
7. To satisfy the requirement of subdivision 6 of this 
subsection, safety quality assurance checks shall ensure 
proper operation of:  
a. Electrical interlocks at each external beam radiation 
therapy room entrance;  
b. Proper operation of the "BEAM -ON," int errupt , and 
termination switches;  
c. Beam condition indicator lights on the access doors, 
control console, and in the radiation therapy room;  
d. Viewing systems;  
e. Electrically operated treatment room door(s)  doors  
from inside and outside the treatment  room;  
f. At least one emergency power cutoff switch. If more 
than one emergency power cutoff switch is installed and 
not all switches are tested at once, each switch shall be 
tested on a rotating basis. Safety quality assurance checks of the emergency po wer cutoff switches may be 
conducted at the end of the treatment day in order to 
minimize possible stability problems with the therapeutic 
radiation machine.  
8. The registrant shall promptly repair any system 
identified in subdivision 7 of this subsection  that is not 
operating properly; and  
9. The registrant shall maintain a record of each quality 
assurance check required by subdivisions 1 and 7 of this 
subsection for three years. The record shall include: the 
date of the quality assurance check; the manu facturer's 
name, model number, and serial number of the therapeutic 
radiation machine; the manufacturer's name, model number 
and serial number for the instrument(s)  instruments  used to 
measure the radiation output of the therapeutic radiation 
machine; and the signature of the individual who 
performed the periodic quality assurance check.  
V. Quality assurance checks for intensity modulated 
radiation therapy (IMRT) shall:  
1. Include commissioning and testing of the treatment 
planning and delivery systems, ro utine quality assurance of 
the delivery system, and patient -specific validation of 
treatment plans;  
2. Be performed in accordance with "Guidance document 
on delivery, treatment planning, and clinical 
implementation of IMRT: Report of the IMRT 
subcommittee of the AAPM radiation therapy committee: 
AAPM Report No. 82"; and  
3. Be performed in accordance with the manufacturer's 
contractual specifications.  
12VAC5 -481-3450. Shielding and safety design 
requirements.  
A. Each therapeutic radiation machine subject to  12VAC5 -
481-3420 or 12VAC5 -481-3430 shall be provided with such 
primary and/or  or secondary barriers as are necessary to 
ensure compliance with 12VAC5 -481-640 and 12VAC5 -481-
720.  
B. Facility design information for all new installations of a 
therapeutic ra diation machine or installations of a therapeutic 
radiation machine of higher energy into a room not previously 
approved for that energy shall be submitted for agency 
approval prior to actual installation of the therapeutic 
radiation machine. At a minimum,  facility design information 
shall include:  
1. All therapeutic radiation machines.  
a. Basic facility information including name, telephone 
number, and agency registration number of the individual 
responsible for preparation of the shielding plan; name 
and telephone number of the facility supervisor; and the 
street address, including room number, of the therapeutic 
radiation machine facility. The plan shall also indicate 
whether this is a new structure or a modification to an 
existing structure.  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2382  b. The prima ry areas where all wall, floor, and ceiling 
areas are struck by the useful beam.  
c. The secondary barriers where all wall, floor, and 
ceiling areas do not have primary barriers.  
2. Therapeutic radiation machines less than or equal to 150 
kV (photons only).  In addition to the requirements listed in 
subdivision 1 of this subsection, therapeutic radiation 
machine facilities that produce only photons with a 
maximum energy less than or equal to 150 kV shall submit 
shielding plans that contain, at a minimum, the following 
additional information:  
a. Equipment specifications, including the manufacturer 
and model number of the therapeutic radiation machine, 
as well as the maximum technique factors;  
b. Maximum design workload for the facility including 
total weekly ra diation output, expressed in gray (rad) or 
air kerma at one meter; total beam -on time per day or per 
week; average treatment time per patient; and the 
anticipated number of patients to be treated per day or 
per week;  
c. A facility blueprint or drawing indi cating scale (0.25 
inch equals 1 foot is typical); direction of north; normal 
location of the therapeutic radiation machine's radiation 
port; the port's travel and traverse limits; general 
direction of the useful beam; locations of any windows 
and doors; a nd location of the therapeutic radiation 
machine control panel. If the control panel is located 
inside the therapeutic radiation machine treatment room, 
the location of the operator's booth shall be noted on the 
plan and the operator's station at the contr ol panel shall 
be behind a protective barrier sufficient to ensure 
compliance with 12VAC5 -481-640; 
d. The structural composition and thickness or lead or 
concrete equivalent of all walls, doors, partitions, floor, 
and ceiling of the room concerned;  
e. The type of occupancy of all adjacent areas inclusive 
of space above and below the room concerned. If there is 
an exterior wall, the distance to the closest areas where it 
is likely that individuals may be present shall be 
included; and  
f. At least one example  calculation that shows the 
methodology used to determine the amount of shielding 
required for each physical condition (e.g., primary, 
secondary, and leakage barriers; restricted and 
unrestricted areas; and entry doors) and shielding 
material in the facili ty: 
(1) If commercial software is used to generate shielding 
requirements, the software used and the version and 
revision date shall be identified.  
(2) If the software used to generate shielding 
requirements is not in the open literature, quality control 
sample calculations to verify the result obtained with the 
software shall be submitted.  3. Therapeutic radiation machines over 150 kV. In addition 
to the requirements listed in subdivision 1 of this 
subsection, therapeutic radiation machine facilities that 
produce photons with a maximum energy in excess of 150 
kV or electrons, or both, shall submit shielding plans that 
contain, at a minimum, the following additional 
information:  
a. Equipment specifications including the manufacturer 
and model number of the t herapeutic radiation machine, 
gray (rad) at the isocenter, and the energy and type of 
radiation produced (e.g., photon, electron). The target to 
isocenter distance shall be specified;  
b. Maximum design workload for the facility including 
total weekly radia tion output, expressed in gray (rad) at 
one meter; total beam -on time per day or per week; the 
average treatment time per patient; and the anticipated 
number of patients to be treated per day or per week;  
c. Facility blueprint or drawing, including both fl oor plan 
and elevation views, indicating relative orientation of the 
therapeutic radiation machine; scale (0.25 inch equals 1 
foot is typical); type, thickness, and minimum density of 
shielding material; direction of north, locations and size 
of all penetr ations through each shielding barrier (ceiling, 
walls, and floor); and details of the door and maze;  
d. The structural composition and thickness or concrete 
equivalent of walls, doors, partitions, floor, and ceiling of 
the room concerned;  
e. The type of oc cupancy of all adjacent areas inclusive 
of space above and below the room concerned. If there is 
an exterior wall, the distance to the closest areas where it 
is likely that individuals may be present shall be 
included;  
f. Description of all assumptions tha t were used in 
shielding calculations including, but not limited to, 
design energy (e.g., room may be designed for 6 MV unit 
although only a 4 MV unit is currently proposed), 
workload, presence of integral beam -stop in unit, 
occupancy and use of adjacent a reas, fraction of time that 
useful beam will intercept each permanent barrier (walls, 
floor, and ceiling), and "allowed" radiation exposure in 
both restricted and unrestricted areas; and  
g. At least one example calculation that shows the 
methodology used t o determine the amount of shielding 
required for each physical condition (e.g., primary, 
secondary, and leakage barriers; restricted and 
unrestricted areas; small angle scatter; entry doors; and 
maze), and shielding material in the facility.  
(1) If commerc ial software is used to generate shielding 
requirements, the software used and the version and 
revision date shall be identified; and  
(2) If the software used to generate shielding 
requirements is not in the open literature, quality control Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2383 sample calculat ions to verify the result obtained with the 
software shall be submitted.  
4. Neutron shielding. In addition to the requirements listed 
in subdivision 3 of this subsection, therapeutic radiation 
machine facilities that are capable of operating above 10 
MV sh all submit shielding plans that contain, at a 
minimum, the following additional information:  
a. The structural composition, thickness, minimum 
density, and location of all neutron shielding material;  
b. Description of all assumptions that were used in 
neutron shielding calculations including, but not limited 
to, neutron spectra as a function of energy, neutron 
fluence rate, absorbed dose and dose equivalent (due to 
neutrons) in both restricted and unrestricted areas;  
c. At least one example calculation that  shows the 
methodology used to determine the amount of neutron 
shielding required for each physical condition (e.g., 
restricted and unrestricted areas, entry doors, and maze), 
and neutron shielding material utilized in the facility.  
(1) If commercial softw are is used to generate shielding 
requirements, the software used and the version and 
revision date shall be identified; and  
(2) If the software used to generate shielding 
requirements is not in the open literature, control sample 
calculations to verify th e result obtained with the 
software shall be submitted.  
d. The methods and instrumentation that will be used to 
verify the adequacy of all neutron shielding installed in 
the facility.  
12VAC5 -481-3451. Quality assurance for radiation 
therapy simulation syst ems.  
Quality assurance for a conventional or virtual simulator 
shall include acceptance testing and periodic verification of 
system performance and shall be performed in accordance 
with (i) "Comprehensive QA for Radiation Oncology: AAPM 
Report No. 46, Repo rt of AAPM Radiation Therapy 
Committee Task Group No.40" for a conventional simulator 
or (ii) "Quality assurance for computed tomography 
simulators and the computed tomography -simulation process: 
AAPM Report No. 83, Report of the AAPM Radiation 
Therapy Com mittee Task Group No. 66" for a virtual 
simulator.  
12VAC5 -481-3452. Electronic brachytherapy.  
A. Applicability. Electronic brachytherapy devices shall be 
subject to the requirements of this section and shall be exempt 
for the requirements of 12VAC5 -481-3420. 
1. An electronic brachytherapy device that does not meet 
the requirements of this section shall not be used for 
irradiation of patients; and  
2. An electronic brachytherapy device shall only be 
utilized for human use applications specifically approved 
by the U.S. Food and Drug Administration (FDA) unless participating in a research study approved by the 
registrant's institutional review board (IRB).  
B. Possession of survey instruments. Each facility location 
authorized to use an electronic brachytherapy d evice in 
accordance with this section shall have access to 
appropriately calibrated portable monitoring equipment. At a 
minimum, such equipment shall include a portable radiation 
measurement survey instrument capable of measuring dose 
rates over the range 10 µSv (1 mrem) per hour to 10 mSv 
(1000 mrem) per hour. The survey instruments shall be 
operable and calibrated in accordance with 12VAC5 -481-
3440 for the applicable electronic brachytherapy source 
energy.  
C. Facility design requirements for electronic brachytherapy 
devices. In addition to shielding adequate to meet 
requirements of 12VAC5 -481-3450, the treatment room shall 
meet the following design requirements:  
1. If applicable, provision shall be made to prevent 
simultaneous operation of more than one therapeutic 
radiation machine in a treatment room.  
2. Access to the treatment room shall be controlled by a 
door at each entrance.  
3. Each treatment room shall have provisions to permit 
continuous aural communication and visual observation of 
the patient f rom the treatment control panel during 
irradiation. The electronic brachytherapy device shall not 
be used for patient irradiation unless the patient can be 
observed.  
4. For electronic brachytherapy devices capable of 
operating below 50 kV, radiation shield ing for the staff in 
the treatment room shall be available, either as a portable 
shield or as localized shielded material around the 
treatment site.  
5. For electronic brachytherapy devices capable of 
operating at greater than 150 kV:  
a. The control panel s hall be located outside the treatment 
room; and  
b. Electrical interlocks shall be provided for all doors to 
the treatment room that will:  
(a) Prevent the operator from initiating the treatment 
cycle unless each treatment room entrance door is closed;  
(b) C ause 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 control is reset at 
the console.  
D. Electrical safety for electronic brachytherapy devices.  
1. The high voltage transformer shall be electrically 
isolated to prevent electrical and magnetic interference 
with the surrounding environment and ancillary equipment.  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2384  2. The high voltage transformer shall be isolated from 
personnel (e.g., an operator) and the environment by a 
protective housing that can only be accessed through a 
cover requiring a tool for access or with electrical 
interlocks to prevent operation while open.  
3. The high voltage transf ormer shall have appropriate 
safety labels warning personnel of potential electrical 
shock or heat related injuries.  
4. Equipment manufactured after March 2009 shall be in 
compliance with the most current revision of the following 
International Electrotech nical Commission (IEC) 
Documents:  
a. IEC 60601 -1:1998+A1+A2:1995;  
b. IEC 60601 -1-2:2001;  
c. IEC 60601 -2-8:1999; and  
d. IEC 60601 -2-17:2004.  
E. Control panel functions. The control panel, in addition to 
the displays required by other provisions in this sect ion, shall:  
1. Provide an indication of whether electrical power is 
available at the control panel and if activation of the 
electronic brachytherapy source is possible;  
2. Provide an indication of whether x -rays are being 
produced;  
3. Provide a means for i ndicating electronic brachytherapy 
source potential and current;  
4. Provide the means for terminating an exposure at any 
time; and  
5. Include an access control (locking) device that will 
prevent unauthorized use of the electronic brachytherapy 
device.  
F. Timer. A suitable irradiation control device (timer) shall 
be provided to terminate the irradiation after a pre -set time 
interval or integrated charge on a dosimeter -based monitor.  
1. A timer shall be provided at the treatment control panel. 
The timer shall  indicate planned setting and the time 
elapsed or remaining;  
2. The timer shall not permit an exposure if set at zero;  
3. The timer shall be a cumulative device that activates 
with an indication of "BEAM -ON" and retains its reading 
after irradiation is int errupted or terminated. After 
irradiation is terminated and before irradiation can be 
reinitiated, it shall be necessary to reset the elapsed time 
indicator;  
4. The timer shall terminate irradiation when a preselected 
time has elapsed if any dose monitorin g system has not 
previously terminated irradiation.  
5. The timer shall permit setting of exposure times as short 
as 0.1 second; and  
6. The timer shall be accurate to within 1.0% of the 
selected value or 0.1 second, whichever is greater.  G. Qualified medica l physicist support.  
1. The services of a qualified medical physicist shall be 
required in facilities having electronic brachytherapy 
devices. The qualified medical physicist shall be 
responsible for:  
a. Evaluation of the output from the electronic 
brachyt herapy source;  
b. Generation of the necessary dosimetric information;  
c. Supervision and review of treatment calculations prior 
to initial treatment of any treatment site;  
d. Establishing the periodic and day -of-use quality 
assurance checks and reviewing the data from those 
checks as required in subsection K of this section;  
e. Consultation with the authorized user in treatment 
planning, as needed; and  
f. Performing calculations or assessments regarding 
patient treatments that may constitute a 
misadministr ation.  
2. If the qualified medical physicist is not a full -time 
employee of the registrant, the operating procedures 
required by subsection H of this section shall also 
specifically address how the qualified medical physicist is 
to be contacted for problem s or emergencies, as well as the 
specific actions, if any, to be taken until the qualified 
medical physicist can be contacted.  
H. Operating procedures.  
1. Only individuals approved by the authorized user, 
radiation safety officer, or qualified medical phys icist shall 
be present in the treatment room during treatment;  
2. Electronic brachytherapy devices shall not be made 
available for medical use unless the requirements of 
12VAC5 -481-3400 A and subsections I and J of this 
section have been met;  
3. The electr onic brachytherapy device shall be inoperable, 
either by hardware or password, when unattended by 
qualified staff or service personnel;  
4. During operation, the electronic brachytherapy device 
operator shall monitor the position of all persons in the 
treatment room and all persons entering the treatment room 
to prevent entering persons from unshielded exposure from 
the treatment beam;  
5. If a patient must be held in position during treatment, 
mechanical supporting or restraining devices shall be used;  
6. Written procedures shall be developed, implemented, 
and maintained for responding to an abnormal situation. 
These procedures shall include:  
a. Instructions for responding to equipment failures and 
the names of the individuals responsible for 
implementin g corrective actions; and  
b. The names and telephone numbers of the authorized 
users, the qualified medical physicist, and the radiation Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2385 safety officer to be contacted if the device or console 
operates abnormally;  
7. A copy of the current operating and eme rgency 
procedures shall be physically located at the electronic 
brachytherapy device control console. If the control 
console is integral to the electronic brachytherapy device, 
the required procedures shall be kept where the operator is 
located during elec tronic brachytherapy device operation;  
8. Instructions shall be posted at the electronic 
brachytherapy device control console to inform the 
operator of the names and telephone numbers of the 
authorized users, the qualified medical physicist, and the 
radia tion safety officer to be contacted if the device or 
console operates abnormally; and  
9. The radiation safety officer, or his designee, and an 
authorized user shall be notified as soon as possible if the 
patient has a medical emergency, suffers injury, or dies. 
The radiation safety officer or the qualified medical 
physicist shall inform the manufacturer of the event.  
I. Safety precautions for electronic brachytherapy devices.  
1. A qualified medical physicist shall determine which 
persons in the treatment room require monitoring when the 
beam is energized;  
2. An authorized user and a qualified medical physicist 
shall be physically present during the initiation of all 
patient treatments involving the electronic brachytherapy 
device;  
3. A qualified medical ph ysicist and either an authorized 
user or a nonauthorized user (physician or electronic 
brachytherapy device operator) under the supervision of an 
authorized user, who has been trained in the operation and 
emergency response for the electronic brachytherapy  
device, shall be physically present during continuation of 
all patient treatments involving the electronic 
brachytherapy device;  
4. When shielding is required by subdivision C 4 of this 
section, the electronic brachytherapy device operator shall 
use a sur vey meter to verify proper placement of the 
shielding immediately upon initiation of treatment. 
Alternatively, a qualified medical physicist shall designate 
shield locations sufficient to meet the requirements of 
12VAC5 -481-640 for any individual, other th an the 
patient, in the treatment room; and  
5. All personnel in the treatment room shall remain behind 
shielding during treatment. A qualified medical physicist 
shall approve any deviation from this requirement and shall 
designate alternative radiation safe ty protocols, compatible 
with patient safety, to provide an equivalent degree of 
protection.  
J. Electronic brachytherapy source calibration 
measurements.  
1. Calibration of the electronic brachytherapy source 
output for an electronic brachytherapy device su bject to this section shall be performed by or under the direct 
supervision of a qualified medical physicist;  
2. Calibration of the electronic brachytherapy source 
output shall be made for each electronic brachytherapy 
source after any repair affecting the  x-ray beam generation, 
or when indicated by the electronic brachytherapy source 
quality assurance checks;  
3. Calibration of the electronic brachytherapy source 
output shall utilize a dosimetry system described in 
12VAC5 -481-3400 C;  
4. Calibration of the e lectronic brachytherapy source 
output shall include, as applicable, determination of:  
a. The output within 2.0% of the expected value, if 
applicable, or determination of the output if there is no 
expected value;  
b. Timer accuracy and linearity over the ty pical range of 
use; 
c. Proper operation of back -up exposure control devices;  
d. Evaluation that the relative dose distribution about the 
source is within 5.0% of that expected; and  
e. Source positioning accuracy to within one millimeter 
within the applicat or;  
5. Calibration of the x -ray source output required by 
subdivisions 1 through 4 of this subsection shall be in 
accordance with current published recommendations from 
a recognized national professional association with 
expertise in electronic brachyther apy, when available. In 
the absence of a calibration protocol published by a 
national professional association, the manufacturer's 
calibration protocol shall be followed; and  
6. The registrant shall maintain a record of each calibration 
in an auditable for m for the duration of the registration. 
The record shall include the date of the calibration; the 
manufacturer's name, model number, and serial number for 
the electronic brachytherapy device and a unique identifier 
for its electronic brachytherapy source; the model numbers 
and serial numbers of the instrument used to calibrate the 
electronic brachytherapy device; and the name and 
signature of the qualified medical physicist responsible for 
performing the calibration.  
K. Periodic and day -of-use quality assur ance checks for 
electronic brachytherapy devices.  
1. Quality assurance checks shall be performed on each 
electronic brachytherapy device:  
a. At the beginning of each day of use;  
b. Each time the device is moved to a new room or each 
day of use at each oper ating location for a self -contained 
electronic brachytherapy unit transported in a van or 
trailer; and  
c. After each x -ray tube installation.  Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2386  2. The registrant shall perform periodic quality assurance 
checks required by subdivision 1 of this subsection in 
accordance with procedures established by the qualified 
medical physicist.  
3. To satisfy the requirements of subdivision 1 of this 
subsection, radiation output quality assurance checks shall 
include at a minimum:  
a. Verification that output of the electron ic brachytherapy 
source falls within 3.0% of expected values, as 
appropriate for the device, as determined by:  
(1) Output as a function of time, or  
(2) Output as a function of setting on a monitor chamber.  
b. Verification of the consistency of the dose dis tribution 
to within 3.0% of that found during calibration required 
by subsection J of this section; and  
c. Validation of the operation of positioning methods to 
ensure that the treatment dose exposes the intended 
location within one millimeter.  
4. The registrant shall use a dosimetry system that has been 
intercompared within the previous 12 months with the 
dosimetry system described in 12VAC5 -481-3400 C 1 to 
make the quality assurance checks required in subdivision 
3 of this subsection.  
5. The registran t shall review the results of each radiation 
output quality assurance check according to the following 
procedures:  
a. An authorized user and qualified medical physicist 
shall be immediately notified if any parameter is not 
within its acceptable tolerance. The electronic 
brachytherapy device shall not be made available for 
subsequent medical use until the qualified medical 
physicist has determined that all parameters are within 
the acceptable tolerances;  
b. If all radiation output quality assurance check 
parameters appear to be within the acceptable range, the 
quality assurance check shall be reviewed and signed by 
either the authorized user or qualified medical physicist 
within two days; and  
c. The qualified medical physicist shall review and sign 
the result s of each radiation output quality assurance 
check at intervals not to exceed 30 days.  
6. To satisfy the requirements of subdivision 1 of this 
subsection, safety device quality assurance checks shall, at 
a minimum, assure:  
a. Proper operation of radiation exposure indicator lights 
on the electronic brachytherapy device and on the control 
console;  
b. Proper operation of viewing and intercom systems in 
each electronic brachytherapy facility, if applicable;  
c. Proper operation of radiation monitors, if applica ble; d. The integrity of all cables, catheters, or parts of the 
device that carry high voltages; and  
e. Connecting guide tubes, transfer tubes, transfer -tube-
applicator interfaces, and treatment spacers are free from 
any defects that interfere with proper operation.  
7. If the results of the safety device quality assurance 
checks required in subdivision 6 of this subsection indicate 
the malfunction of any system, a registrant shall secure the 
control console in the "OFF" position and not use the 
electronic b rachytherapy device except as may be 
necessary to repair, replace, or check the malfunctioning 
system.  
8. The registrant shall maintain a record of each quality 
assurance check required by subdivisions 3 and 7 of this 
subsection in an auditable form for th ree years.  
a. The record shall include the date of the quality 
assurance check; the manufacturer's name, model 
number, and serial number for the electronic 
brachytherapy device; the name and signature of the 
individual who performed the periodic quality as surance 
check; and the name and signature of the qualified 
medical physicist who reviewed the quality assurance 
check; and  
b. For radiation output quality assurance checks required 
by subdivision 3 of this subsection, the record shall also 
include the uniq ue identifier for the electronic 
brachytherapy source and the manufacturer's name, 
model number, and serial number for the instrument used 
to measure the radiation output of the electronic 
brachytherapy device.  
L. Therapy -related computer systems. The regi strant shall 
perform acceptance testing on the treatment planning system 
of electronic brachytherapy -related computer systems in 
accordance with current published recommendations from a 
recognized national professional association with expertise in 
electro nic brachytherapy, when available. In the absence of 
an acceptance testing protocol published by a national 
professional association, the manufacturer's acceptance 
testing protocol shall be followed.  
1. Acceptance testing shall be performed by or under the  
direct supervision of a qualified medical physicist. At a 
minimum, the acceptance testing shall include, as 
applicable, verification of:  
a. The source -specific input parameters required by the 
dose calculation algorithm;  
b. The accuracy of dose, dwell tim e, and treatment time 
calculations at representative points;  
c. The accuracy of isodose plots and graphic displays;  
d. The accuracy of the software used to determine 
radiation source positions from radiographic images; and  
e. If the treatment -planning syst em is different from the 
treatment -delivery system, the accuracy of electronic Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2387 transfer of the treatment delivery parameters to the 
treatment delivery unit from the treatment planning 
system.  
2. The position indicators in the applicator shall be 
compared t o the actual position of the source or planned 
dwell positions, as appropriate, at the time of 
commissioning.  
3. Prior to each patient treatment regimen, the parameters 
for the treatment shall be evaluated and approved by the 
authorized user and the qualif ied medical physicist for 
correctness through means independent of that used for the 
determination of the parameters.  
M. Training.  
1. A registrant shall provide instruction, initially and at 
least annually, to all individuals who operate the electronic 
brachytherapy device, as appropriate to the individual's 
assigned duties, in the operating procedures identified in 
subsection H of this section. If the interval between 
patients exceeds one year, retraining of the individuals 
shall be provided.  
2. In additio n to the requirements of 12VAC5 -481-3390 C 
for therapeutic radiation machine authorized users and 
12VAC5 -481-3390 D for qualified medical physicists, the 
therapeutic radiation machine authorized users and 
qualified medical physicists shall also receive dev ice-
specific instruction initially from the manufacturer and 
annually from either the manufacturer or other qualified 
trainer. The training shall be of a duration recommended 
by a recognized national professional association with 
expertise in electronic br achytherapy, when available. In 
the absence of any training protocol recommended by a 
national professional association, the manufacturer's 
training protocol shall be followed. The training shall 
include, but not be limited to:  
a. Device -specific radiation  safety requirements;  
b. Device operation;  
c. Clinical use for the types of use approved by the U.S. 
Food and Drug Administration;  
d. Emergency procedures, including an emergency drill; 
and 
e. The registrant's quality assurance program.  
3. A registrant sha ll retain a record of individuals receiving 
instruction required by subdivisions 1 and 2 of this 
subsection for three years. The record shall include a list of 
the topics covered, the date of the instruction, the names of 
the attendees, and the names of th e individuals who 
provided the instruction.  
N. Mobile electronic brachytherapy service. A registrant 
providing mobile electronic brachytherapy service shall, at a 
minimum:  1. Check all survey instruments before medical use at each 
address of use or on each  day of use, whichever is more 
restrictive.  
2. Account for the electronic brachytherapy source in the 
electronic brachytherapy device before departure from the 
client's address.  
3. Perform at each location on each day of use all of the 
required quality ass urance checks specified in subsection K 
of this section to assure proper operation of the device.  
12VAC5 -481-3453. Other use of electronically produced 
radiation to deliver therapeutic radiation dosage.  
A person shall not utilize any device that is designe d to 
electronically generate a source of ionizing radiation to 
deliver therapeutic radiation dosage and that is not 
appropriately regulated under any existing category of 
therapeutic radiation machine until:  
1. The applicant or registrant has, at a minimum , provided 
the agency with:  
a. A detailed description of the device and its intended 
application;  
b. Facility design requirements, including shielding and 
access control;  
c. Documentation of appropriate training for authorized 
user physicians and qualified  medical physicists;  
d. Methodology for measurement of dosages to be 
administered to patients or human research subjects;  
e. Documentation regarding calibration, maintenance, 
and repair of the device, as well as instruments and 
equipment necessary for radi ation safety;  
f. Radiation safety precautions and instructions; and  
g. Other information requested by the agency in its 
review of the application; and  
2. The applicant or registrant has received written approval 
from the agency to utilize the device in acc ordance with 
the regulations and specific conditions the agency 
considers necessary for the medical use of the device.  
DOCUMENTS INCORPORATED BY REFERENCE 
(12VAC5 -481) 
Dosimetry of X -ray and Gamma -Ray Beams for Radiation 
Therapy in the Energy Range 10 keV to 50 MeV: NCRP 
Report 69, 1981, National Council on Radiation Protection 
and Measurements, 7910 Woodmont Avenue, Washington, 
DC 20 014 
Comprehensive QA for Radiation Oncology: AAPM Report 
No. 46, 1994, American Association of Physicists in 
Medicine, Committee Ta sk Group 40, Radiation Therapy 
Committee, published by the American Institute of Physics, 
One Physics Ellipse, College Park, MD 20740 -3846   
AAPM Code of Practice for Radiotherapy Accelerators: 
AAPM Report Number 47, 1994, American Association of 
Physicists in Medicine Radiation Therapy Task Group 45, Regulations  
Volume 32, Issue 17  Virginia Register of Regulations  April 18, 2016  
2388  published by the American Institute of Physics, One Physics 
Ellipse, College Park, MD  20740 -3846   
Guidance document on delivery, treatment planning, and 
clinical implementation of IMRT: Report of the IMRT 
subcommittee of the AAPM radiation therapy committee: 
AAPM Report No. 82, Medical Physics, Vol. 30, No. 8, 
August 2003, American Association of Physicists in 
Medicine  
Quality assurance for computed tomography simulators and 
the computed tomography -simulation process: Report of the 
AAPM Radiation The rapy Committee Task Group No. 66: 
AAPM Report No. 83, Medical Physics, Vol. 30, No. 10, 
October 2003, American Association of Physicists in 
Medicine  
VA.R. Doc. No. R16 -4305; Filed March 25, 2016, 1:12 p.m.  
DEPARTMENT  OF MEDICAL ASSISTANCE 
SERVICES  
Withdra wal of Proposed Regulation  
Title s of Regulation s: 12VAC30 -50. Amount, Duration, 
and Scope of Medical and Remedial Care Services  
(amending 12VAC30 -50-160, 12VAC30 -50-210).  
12VAC30 -80. Methods and Standards f or Establishing 
Payment Rates; O ther Types of Care  (amending 
12VAC30 -80-40).  
The Department of Medical Assistance Services has 
WITHDRAWN the proposed regulatory action for 12VAC30 -50, 
Amount, Duration, and Scope of Medical and Remedial Care 
Services; and 12VAC30 -80, Methods and Standar ds for 
Establishing Payment Rates; Other Types of Care, which was 
published in 16:26 VA.R. 3459 -3465 September 11, 2000 . The 
agency has determined that this action is no longer relevan t or 
necessary.  
Agency Contact:  William Lessard, Director, Division of Program 
Reimbursement, Department of Medical Assistance Services, 
600 East Broad Street, Suite 1300, Richmond, VA 23219, 
telephone (804) 225 -4593, or email 
william.lessard@dmas.virginia .gov.  
VA.R. Doc. No. R00 -1; Filed March 18, 2016, 11:41 a.m.  
  ––––––––––––––––––    
TITLE 15. JUDICIAL  
VIRGINIA STATE BAR  
Final Regulation  
REGISTRAR'S NOTICE:  The Virginia State Bar is claiming 
an exemption from the Administrative Process Act in 
accordance with §  2.2-4002 A 2 of the Code of Virginia, 
which exempts agencies of the Supreme Court.  Title of Regulation:  15VAC5 -40. Bylaws of the Virginia 
State Bar an d Council  (repealing 15VAC5 -40-10 through 
15VAC5 -40-430).  
Statutory Authority:  § 54.1 -3910 of the Code of Virginia.  
Effective Date:  March 25, 2016.  
Agency Contact:  Stepha nie Blanton, Executive Assistant, 
Virginia State Bar, 1111 East Main Street, Suite 700, 
Richmond, VA 23219, telephone (804) 775 -0576, or email 
blanton@vsb.org.  
Summary:  
Due to a determination that the Bylaws of the Virginia 
State Bar and Council are not regulations as defined by 
§ 2.2-4101 of the Code of Virginia, 15VAC5 -40 is 
repealed.  
VA.R. Doc. No. R16 -4610; Filed March 18, 2016, 3:05 p.m.  
Final Regulation  
REGISTRAR'S NOTICE:  The Virginia State Bar is claiming 
an exemption from the Administrative Pro cess Act in 
accordance with §  2.2-4002 A 2 of the Code of Virginia, 
which exempts agencies of the Supreme Court.  
Title of Regulation:  15VAC5 -80. Regulations under the 
Virginia Consumer Real Estate Settlement Protection Act  
(amending 15VAC5 -80-10 through 15VAC5 -80-50).  
Statutory Authority:  § 55-525.30 of the Code of Virginia.  
Effective Date:  March 25, 2016.  
Agency Contact:  Stephanie Blanton, Executive Assistant, 
Virginia State Bar, 1111 East Main Street, Suite 700, 
Richmond, VA 23219, telephone (804) 775 -0576, or email 
blanton@vsb.org.  
Summary:  
The amendments conform the regulation to changes 
enacted by Chapter 794 of the 2 010 Acts of Assembly, 
which repealed Title 6.1 of the Code of Virginia and 
transferred the provisions regarding real estate settlements 
and settlement agents to new Chapters 27.2 (§ 55 -525.8 et 
seq.) and 27.3 (§ 55 -525.16 et seq.) of Title 55 of the Code 
of Virginia as part of the recodification of Title 6.1. The 
amendments update citations to the Code of Virginia and 
terminology.  
CHAPTER 80  
REGULATIONS UNDER THE VIRGINIA CONSUMER  
ATTORNEY  REAL ESTATE SETTLEMENT 
PROTECTION ACT  AGENTS REGULATIONS  
15VAC5 -80-10. Authority; applicability; scope.  
These regulations are  This chapter is  issued by the Virginia 
State Bar pursuant to and under the authority of the Virginia 
Consumer Real Estate Settlement Protection Act (§ 6.1 -2.19 
et seq.  Chapter 27.3 (§ 55 -525.16 et  seq.) of Title 55  of the 
Code of Virginia) as enacted by the 1997 session of the 
General Assembly of  Virginia. The Act  Chapter 27.3  does not 
apply to licensed attorneys who provide escrow, closing , or