The following definitions apply for Radioactive Material
Licenses issued pursuant to this division and divisions 105, 113, 115, 117, and
121 of this chapter:
NOTE: Unless otherwise specified in this rule, the
licenses described in this rule are limited by conditions of the radioactive
materials license issued pursuant to OAR
333-102-0200,
and other applicable rules in this chapter.
(1) "Analytical Leak
Test" means a
facility-specific license issued pursuant to OAR
333-103-0010(2)(a),
authorizing possession of environmental samples,
sealed source leak-test,
contamination wipe and samples for radioanalytical measurements. This license
does not authorize collection of samples, or decommissioning or decontamination
activities.
(2) "Assets" means
anything of material value or usefulness. In the context of a materials
license, assets include all existing capital, effects, possessions, and
belongings and all probable future economic benefits obtained or controlled by
a particular entity.
(3) "Basic
License" means a
facility-specific license issued pursuant to OAR
333-103-0010(2)(b) authorizing the receipt, possession, use, transfer, and
disposal of sources of
radiation or radioactive materials incident to gauge
service, teletherapy service, medical afterloader service, and other
licensed
service activities; pre-packaged waste pickup (not packaging), storage of
materials prior to license termination, instrument quality control servicing or
calibration (excluding activities authorized by 333-103-0010(2)(m)), or other
minor activities not otherwise specified in these rules, such as authorization
for "systems," as defined in these rules, pursuant to that definition.
(4) "Beneficiating" means
subjecting a product to any process that can increase or concentrate any
component (including the radioactive materials) to benefit the product.
(5) "
Brachytherapy" means a
Healing Arts
facility-specific license issued pursuant to OAR
333-103-0010(2)(c) authorizing the use of
brachytherapy sources for in vivo
application of radiation in accordance with 333-116-0420.
Brachytherapy
includes radioactive material sealed sources in seeds, needles, plaques, or
other localized medical devices, but excludes remote afterloaders.
(6) "
Broad Scope A" means a
facility-specific
license issued pursuant to OAR
333-103-0010(2)(d), authorizing activities in
333-102-0900(1)(a), under the
authority of a
Radiation Safety Committee.
(7) "
Broad Scope B" means a
facility-specific license issued pursuant to OAR
333-103-0010(2)(e) authorizing
activities described in 333-102-0900(1)(b), under the
authority of a
Radiation
Safety Officer.
(8) "
Broad Scope
C" means a
facility-specific license issued pursuant to OAR
333-103-0010(2)(f)
authorizing activities described in 333-102-0900(1)(c), under the
authority of
an authorized user.
(9)
"Commencement of construction" means taking any action defined as
"construction" or any other activity at the site of a facility subject to the
regulations in this division that has a reasonable nexus to radiological health
and safety.
(10) "
Construction"
means the installation of foundations, or in-place assembly, erection,
fabrication, or testing for any structure, system, or component of a
facility
or activity subject to the regulations in this
division that are related to
radiological safety or security. The term "construction" does not include:
(a) Changes for temporary use of the land for
public recreational purposes;
(b)
Site exploration, including necessary borings to determine foundation
conditions or other preconstruction monitoring to establish background
information related to the suitability of the site, the environmental impacts
of construction or operation, or the protection of environmental values;
(c) Preparation of the site for
construction of the facility, including clearing of the site, grading,
installation of drainage, erosion and other environmental mitigation measures,
and construction of temporary roads and borrow areas;
(d) Erection of fences and other access
control measures that are not related to the safe use of, or security of,
radiological materials subject to this division;
(e) Excavation;
(f) Erection of support buildings (for
example, construction equipment storage sheds, warehouse and shop facilities,
utilities, concrete mixing plants, docking and unloading facilities, and office
buildings) for use in connection with the construction of the facility;
(g) Building of service facilities
(for example, paved roads, parking lots, railroad spurs, exterior utility and
lighting systems, potable water systems, sanitary sewerage treatment
facilities, and transmission lines);
(h) Procurement or fabrication of components
or portions of the proposed facility occurring at other than the final,
in-place location at the facility; or
(i) Taking any other action that has no
reasonable nexus to radiological health and safety.
(11) "Current assets" means cash or other
assets or resources commonly identified as those which are reasonably expected
to be realized in cash or sold or consumed during the normal operating cycle of
the business.
(12)
"
Decontamination and Decommissioning" means:
(a) A
facility specific license issued
pursuant to OAR
333-103-0010(2)(w) authorizing activities that result in
returning a site to its original pre-
license condition prior to termination of
licensed activities; and
(b)
Activities performed pursuant to OAR
333-102-0335 on any portion of a site
prior to
license termination.
(13) "Diagnosis" means examination,
determination, identification, study, or analysis of a medical condition.
(14) "
Distribution" means a
facility-specific license issued pursuant to OAR
333-103-0010(2)(g),
authorizing transfer or
distribution (sale) of general or specific
license
radioactive material to persons granted a
general license or issued a specific
license, or, in the case of NARM, to persons exempt from the rules in this
chapter.
(15) "Exempt Source"
means radioactive material, exempt from the rules in this chapter.
(16) "
Facility" means location of licensed
activities under the direct control of licensee management. If a "
facility," as
used in this
division, includes multiple separate addresses, the Authority may
determine how the scope of licensed activities, pursuant to OAR
333-102-0190,
333-102-0300,
333-102-0305,
333-102-0315,
333-102-0320, or
333-102-0325, is
authorized.
(17) "
Fixed Gauge"
means a source-specific license for measuring, gauging, or controlling devices
pursuant to OAR
333-103-0010(2)(h). The
fixed gauge license also includes X-ray
& Hybrid Gauges pursuant to
division 115 of this chapter that contain
either an X-ray source or a radioactive sealed source.
(18) "General License" means a granted
license, as opposed to an issued license, effective under these rules, to
acquire, own, possess, use, or transfer radioactive material or a device that
contains radioactive material.
(19) "
General License Depleted Uranium" means
the general license granted subject to receipt of the registration application
pursuant to OAR
333-101-0007, and fee, pursuant to 333-103-0015, for
depleted
uranium used for shielding or counter weights and issued pursuant to
333-102-0106.
(20) "
General
License Device" means the
general license for in vitro materials granted
subject to receipt of the registration application pursuant to OAR
333-101-0007, and fee, pursuant to 333-103-0015, for measuring, gauging.
(21) "
General License In Vitro
Laboratory" means the general license granted by OAR
333-102-0130, subject to
receipt of the
registration application pursuant to 333-101-0007, and fee,
pursuant to 333-103-0015, for in vitro materials granted a
general license by
333-102-0130.
(22) "
General
License Source Material" means the
general license granted for use and
possession of source material pursuant to OAR
333-102-0101.
(23) "
General License for Certain Devices and
Equipment" means the
general license granted for use and possession of devices
consisting of not more than 500 microcuries of polonium-210 or not more than 50
millicuries of tritium (H-3) per device, pursuant to
10
CFR
31.3.
(24) "General License for Luminous Devices
for Aircraft" means the general license granted for use and possession of
devices containing not more than ten curies of tritium or not more than 300
millicuries of promethium-147.
(25) "
General License for Ownership of
Radioactive Material and Limits of Possession" means the
general license
granted to own material that is not necessarily possessed; conversely, material
that is possessed is, by grant of
general license, not necessarily owned,
pursuant to the
general license in OAR
333-102-0120.
(26) "
General License for
Calibration and
Reference Sources" means the general license granted to possess not more than
five microcuries (185 kBq) of americium-241, plutonium-238, plutonium-239, or
radium-226, pursuant to the general license in OAR
333-102-0125.
(27) "
General License for Ice Detection
Devices" means the
general license granted to possess not more than 50
microcuries (1.85 MBq) of strontium-90, pursuant to the
general license in OAR
333-102-0135.
(28) "Generators and
Kits" means "Imaging and Localization."
(29) "Healing Arts Specific License" means a
specific license authorizing activities in division 116 of this chapter.
(30) "
High Doserate Remote
Afterloader" means a source-specific
license issued pursuant to OAR
333-103-0010(2)(i) authorizing the use of sources in accordance with
333-116-0475, which may be either mobile or stationary, and which deliver a
doserate in excess of two
Gray (200 rad) per hour at the point or surface where
the
dose is prescribed. A device may be designated as being high, medium, or
pulsed
dose remote afterloader or mobile high, medium, or pulsed doserate
remote afterloader.
(31) "Hybrid
Gauge" means a fixed gauging device that contains both a sealed source and an
X-ray source, pursuant to division 115 of this chapter.
(32) "In Vitro
Laboratory" means a Healing
Arts facility-specific license, under management of a physician or Healing Arts
specialist, issued pursuant to OAR
333-103-0010(2)(k) authorizing the use of
prepackaged radioactive materials in quantities greater than those authorized
by the
General License granted by 333-102-0130(2).
(33) Imaging and Localization means a
Healing
Arts facility-specific license issued pursuant to OAR
333-103-0010(2)(j)
authorizing the use of generators and kits for nuclear medicine
imaging and
localization in accordance with 333-116-0320 or positron emission tomography
studies in accordance with 333-116-0800 through 333-116-0880.
(34) "
Industrial Radiography" means a
facility-specific license issued pursuant to OAR
333-103-0010(2)(l) authorizing
activities in
division 105 of this chapter.
(35) "Instrument
Calibration" means a
source-specific radioactive materials license issued pursuant to OAR
333-103-0010(2)(m) for sources of
radiation used to calibrate instruments.
(36) "
Investigational New Drug"
means a
Healing Arts facility-specific license issued pursuant to OAR
333-103-0010(2)(n) authorizing the use of any investigational product or device
approved by the US Food and Drug Administration (FDA) for human use
research,
diagnosis, or therapy, in accordance with the rules in this chapter.
(37) "
Irradiator-Other" means an irradiator
with greater than 10,000 curies (370 TBq)
licensed pursuant to OAR
333-103-0010(2)(w) and
333-103-0010(7), designed to produce extremely high
dose
rates as authorized by
division 121 of this chapter.
(38) "Irradiator Self-shielded or Other -
Less than 10,000 Curies" means a source-specific
license issued pursuant to OAR
333-103-0010(2)(o) authorizing self-shielded irradiators, including blood
irradiators, panoramic irradiators, and converted
teletherapy units, with less
than 10,000 Ci (370 TBq)
activity.
(39) "Liabilities" means probable future
sacrifices of economic benefits arising from present obligations to transfer
assets or provide services to other entities in the future as a result of past
transactions or events.
(40) "Lot
Tolerance Percent Defective" means, expressed in percent defective, the poorest
quality in an individual inspection lot that can be accepted.
(41) "
Low Doserate Remote Afterloader Device"
means a
Healing Arts source-specific license issued pursuant to OAR
333-103-0010(2)(b) authorizing devices 333-116-0475, which remotely deliver a
doserate of less than two
Gray (200 rad) per hour at the point or surface where
the
dose is prescribed.
(42)
"
Manufacturing or Compounding" means a
facility-specific radioactive materials
license issued pursuant to OAR
333-103-0010(2)(p) authorizing manufacture,
fabrication, assembly,
construction, combining, processing, concentrating,
beneficiating, or processing items or products using or containing radioactive
materials into a finished product containing
radioactive material in accordance
with applicable requirements in
division 102 of this chapter.
(43) "Manufacturing or Compounding and
Distribution" means activities performed as defined in sections (14) and (42)
of this rule and require separate specific licenses for each activity.
(44) "
Mobile Nuclear Medicine
Service" means a
facility-specific Healing Arts license issued pursuant to OAR
333-116-0120 authorizing the medical use of
radioactive material at specified
temporary locations.
(45)
"
Nationally Tracked Source" means a
sealed source containing a quantity equal
to or greater than Category 1 or 2 levels of any
radioactive material listed in
10
CFR 20 Appendix E.
(46)
"Naturally occurring radioactive material (NORM)" means radioactive material in
the uranium or thorium decay series existing in nature in concentrations less
than 0.05 percent source material.
(47) "Net working capital" means current
assets minus current liabilities.
(48) "Net worth" means total assets minus
total liabilities and is equivalent to owner's equity.
(49) "
Neutron Howitzer" means a device that
contains a
sealed source containing Special Nuclear Material (see definition in
OAR
333-100-0005) that generates neutrons that are used for analytical,
teaching, or
research purposes.
(50) "Neutron Production" denotes a process
in which neutrons are produced, either by natural or artificial means.
(51) "
NORM (no processing)" means
a
facility-specific license pursuant to OAR
333-103-0010(2)(r) authorizing
possession, use, and transfer of NORM in accordance with
division 117 of this
chapter.
NOTE: NORM licenses authorize licensable
quantities of radioactive material in the uranium or thorium decay series.
Licensable quantities of NORM are derived from disposal limits in OAR chapter
345, division 50. Any material that contains NORM requires a specific license
unless exempted in OAR chapter 345, division 50. Zircon sand is used as the
NORM model for licensing purposes. Quantities of zircon sand in excess of
20,000 pounds in a year constitute a licensable quantity of NORM. NORM
materials that are not zircon are based on the zircon model.
(52) "
Nuclear Laundry" means a laundry
facility designed specifically to clean or launder clothing contaminated with
licensed radioactive materials. Nuclear Laundry facilities must have process
and waste management control procedures to prevent reconcentrating of licensed
materials in sewers, drains,
premises, and the environment. Nuclear Laundry
activities are authorized pursuant to OAR
333-103-0010(2)(w), "
Radioactive
Material Not Otherwise Specified
Facility," see 333-102-0203(61).
(53) "
Nuclear Pharmacy" means a
facility-specific license issued pursuant to OAR
333-103-0010(2)(s) for
activities authorized by 333-102-0285 and the Oregon Board of Pharmacy rules,
to compound Radiopharmaceutical and distribute (sell or transfer) to persons
specifically
licensed to receive such compounds or products.
NOTE: Nuclear Pharmacies, pursuant to policy
provisions of chapter 345 division 50 may collect syringes containing residual
licensed material from spent patient doses, since the syringe is considered to
be a transport device under the administrative control of the pharmacy rather
than the licensed material transferred as the dose. Residual licensed material
may be considered either to be exempt pursuant to Table 1 of division 50 or
under the authority of a division license if the receding licensee stores
syringes for decay. In either case, the division license specifies which
disposal method is being used by the pharmacy and licensee to avoid
compatibility conflicts with division 50 requirements.
(54) "
Other Measuring Device" means a
source-specific
license issued pursuant to OAR
333-103-0010(2)(t), authorizing
analytical instruments, gas chromatograph electron capture detectors, and other
non-portable analytical instruments, including those devices that contain
multiple sources but are configured and used as a "
system," in accordance with
the definition in this rule.
NOTE:
General license gas chromatograph detectors
that formerly were granted a general license by OAR 333-102-0115, but which
required a registration fee pursuant 333-103-0015(2)(b), now are subject to the
specific license in 333-103-0010(2)(t).
(55) "Pool-type Irradiator" means an
irradiator with greater than 10,000 curies (370 TBq) in which water provides
the radiation shielding, authorized in accordance with division 121 of this
chapter.
(56) "
Portable Gauge"
means a source-specific
license issued pursuant to OAR
333-103-0010(2)(u) for
sources used in devices that can be transported and used at temporary job
sites.
NOTE: Any device that meets the definition of
"portable gauge" and is transported or used at temporary job sites within the
state of Oregon, requires an application for and issuance of an Oregon specific
license subject to OAR 333-103-0010(2)(u).
(57) "
Positron Emission Tomography" (PET)
means a
licensed healing arts activity authorized by OAR
333-116-0800 and
included in the
facility specific license issued pursuant to
333-103-0010(2)(j). PET nuclides, which are NARM, are subject to all Oregon
rules.
(58) "Possession or Storage
of Industrial Wastes Containing Radioactive Material" means activities subject
to division 110 of this chapter for the production or storage of wastes that
are exempt from division 50 of chapter 345 facility siting requirements, and
were generated under a current NRC, Agreement State, or Licensing State
specific radioactive materials license.
(59) "Possession or Storage of Uranium
Tailings" means activities incident to uranium processing or milling operations
resulting in the production of tailings.
(60) "Principal Activities" means activities
authorized by the license that are essential to achieving the purpose(s) for
which the license was issued or amended. Storage during which no licensed
material is accessed for use or disposal and activities incidental to
decontamination or decommissioning are not principal activities.
(61) "Processing" means chemically or
physically changing a licensed material from one physical form to another form
or specie (for example, breaking an ore down into its components resulting in
"tailings"; milling a raw licensed material and combining to form another
product or material. See "Beneficiating"; "Manufacturing or Compounding").
(62) "
Radiation Source" means
source of
radiation (see definition of "Source of
radiation" in OAR
333-100-0005).
(63) "
Radioactive
Material Not Otherwise Specified
Facility" means a license issued pursuant to
OAR
333-103-0010(2)(w) authorizing activities that includes, but are not
limited to, complex licensable activities such as
facility decontamination and
decommissioning, nuclear laundry activities, uranium mill tailings storage,
storage of industrial wastes containing radioactive materials, large irradiator
management, and other complex activities not otherwise specified in these
rules.
(64) "Radioactive Materials
License" means the document, pursuant to OAR
333-102-0300, issued after an
application, pursuant to 333-102-0190, has been accepted as adequate, that
specifies radioactive materials, use authorizations, safety procedures, and use
locations.
(65)
"
Radiopharmaceutical Therapy" means a
Healing Arts facility-specific license
issued pursuant to OAR
333-103-0010(2)(v) authorizing the use of
Radiopharmaceutical for
therapy in accordance with 333-116-0360.
(66) "Remote Afterloader" means a medical
device that moves a sealed source to an interstitial (in vivo) location without
exposing the practitioner to the radiation dose. Remote afterloader sources may
be manipulated using computer software and engineering techniques.
(67) "
Research & Development" means a
facility-specific license issued pursuant to OAR
333-103-0010(2)(x) authorizing
research and development activities, as defined in 333-100-0005, but does not
authorize additional specific sources of radiation, which must be licensed
separately pursuant to 333-103-0010 and 333-103-0015.
(68) "
Responsible Representative" means
(a) The person designated as having
responsibility for general license device or general license material;
(b) The person management has
selected to certify general license inventory; and
(c) The individual responsible to the
Authority and to management to ensure that all regulatory elements are
adequate.
(69) "
Sealed
Source/Device Evaluation" means the review of a
licensee's prototype source or
device prior to registration by the Nuclear Regulatory
Commission in the Sealed
Source and Device Catalog.
NOTE: The Authority no longer has authority to
review sources or devices. All source or device reviews must be forwarded to
the NRC for review. Authority to conduct device or source evaluations was
rescinded by the NRC in 1998.
(70) "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.
(71) "Sealed Sources for
Diagnosis" means a
Healing Arts source-specific license issued pursuant to OAR
333-103-0010(2)(y)
authorizing the use of sealed sources for
diagnosis in accordance with
333-116-0400.
(72) "
Special
Nuclear Material" means:
(a) Plutonium,
uranium 233, uranium enriched in the isotope 233 or in the isotope 235, and any
other material which the NRC, pursuant to the provisions of section 51 of the
act, determines to be special nuclear material, but does not include source
material; or
(b) Any material
artificially enriched by any of the foregoing but does not include source
material.
(73)
"Specific
License Radioactive Material" means radioactive material that
requires authorization in a specific
license document pursuant to OAR
333-102-0075(2) where materials must be annotated on the specific
license, and
validated with a specific
license fee pursuant to 333-103-0010(2)(a) through
333-103-0010(2)(hh) (see "Radioactive Materials
License").
(74) "System," as used in this division,
means multiple separate (individual) sources of radiation (sealed radioactive
sources), which together, rather than independently, achieve a desired
functionality. Such "system" is subject to one specific license fee or general
license registration fee, as the case may be.
(75) "Tangible Net Worth" means the tangible
assets that remain after deducting liabilities; such assets may not include
intangibles such as goodwill and rights to patents or royalties.
(76) "
Teletherapy" means a
Healing Arts
source-specific license issued pursuant to OAR
333-103-0010(2)(cc) authorizing
teletherapy procedures in accordance with OAR
333-116-0480. This
license also
includes other high
dose rate external beam therapy devices such as the "gamma
knife."
(77) "
Temporary Job Site"
means any location, where specific
license material is used that is either:
(a) Not the specific location of the licensee
if an in-state licensee; or
(b)
Any location in the state if an out-of-state specific
licensee pursuant to a
specific radioactive materials
license.
NOTE: Persons authorized for temporary jobsites in
Oregon must have a specific license for such activities.
(78) "Therapy" means a process
that is meant to be restorative, promotes healing, or is beneficial to a
patient in a healing arts context.
(79) "
Unique" means a specific
license issued
pursuant to OAR
333-103-0010(2)(dd) to agencies in the Oregon Health
Authority.
(80) "
Uptake and Dilution" means a
Healing Arts facility-specific license issued pursuant to OAR
333-103-0010(2)(ee) authorizing activities in 333-116-0300 for uptake,
dilution, and excretion studies.
(81) "Use and Possession of
Source Material "
means a
facility-specific radioactive materials license issued pursuant to OAR
333-103-0010(2)(z) to possess, use, process, or transfer
source material, as
defined in OAR
333-100-0005, in quantities greater than
general license
quantities or in concentrations greater than 0.05 percent source material.
NOTE: This definition was amended to avoid
confusion between the definition of "source material" in division 100 of this
chapter and the specific license (billable object) in division 103 of this
chapter.
(82) "
Use of
Xenon Gas" means a
Healing Arts facility-specific license issued pursuant to
OAR
333-103-0010(2)(ff) authorizing the use of Xe-133 for
diagnosis pursuant to
333-116-0280.
(83) "
Waste
Packaging" means a
facility-specific license issued pursuant to OAR
333-103-0010(2)(gg), authorizing packaging, collection, storage, and transfer
of
radioactive waste. This specific
license does not authorize storage of
radioactive wastes, but does authorize temporary job sites.
(84) "
Well Logging" means a
license issued
pursuant to OAR
333-103-0010(2)(hh) authorizing the possession, use, transfer,
or disposal of sources of
radiation used for well logging activities authorized
by
division 113 of this chapter.
NOTE: Unless specifically authorized in this rule
or in a radioactive materials license that authorizes temporary job sites,
specific licenses must be used only at one authorized site.