CHAPTER 15 – RADIATION PROTECTION
SECTION .0100 – GENERAL PROVISIONS
10A NCAC 15 .0101 SCOPE
(a) Except as otherwise specifically provided these Rules
apply to all persons who receive, possess, use, transfer, own or acquire any
source of radiation within the State of North Carolina.
(b) Nothing in these Rules shall apply to any person to the
extent any person is subject to regulation by the United States Nuclear
Regulatory Commission.
(c) Regulation by the State of North Carolina of source
material, byproduct material, and special nuclear material in quantities not
sufficient to form a critical mass is subject to the provisions of the
"Agreement Between the United States Atomic Energy Commission and the
State of North Carolina for Discontinuance of Certain Commission Regulatory and
Responsibility within the State Pursuant to Section 274 of the Atomic Energy
Act of 1954, as Amended" under provisions of Public Law 86-373, as
amended, and 10 CFR Part 150.
History Note: Authority G.S. 104E-2; 104E-7, 104E-10104E‑7(a)(2);
104E‑12(a);
Eff. February 1, 1980;
Transferred and Recodified from 10 NCAC 3G .2201 Eff.
January 4, 1990;
Amended Eff. June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0101 Eff.
February 1, 2015.
10A NCAC 15 .0102 COMPLIANCE WITH
LAWS
Nothing in these Rules shall relieve any person of
responsibility for complying with other pertinent North Carolina laws and
rules.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Transferred and Recodified from 10 NCAC 3G .2202 Eff.
January 4, 1990;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0102 Eff.
February 1, 2015.
10A NCAC 15 .0103 INTENTIONAL EXPOSURE
Nothing in Sections .0100 to .1000 of this Chapter shall be
interpreted as limiting the intentional exposure of patients to radiation for
the purposes of medical diagnosis and therapy.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Transferred and Recodified from 10 NCAC 3G .2203 Eff.
January 4, 1990;
Transferred and Recodified from 15A NCAC 11 .0103 Eff.
February 1, 2015.
10A NCAC 15 .0104 DEFINITIONS
As used in these Rules, the following definitions apply.
(1) "Absorbed dose" means the energy imparted
by ionizing radiation per unit mass of irradiated material. The units of
absorbed dose are the rad and the gray (Gy).
(2) "Accelerator produced material" means any
material made radioactive by use of a particle accelerator.
(3) "Act" means North Carolina Radiation
Protection Act as defined in G.S. 104E-1.
(4) "Activity" is the rate of disintegration
(transformation) or decay of radioactive material. The units of activity are
the curie (Ci) and the becquerel (Bq).
(5) "Adult" means an individual 18 or more
years of age.
(6) "Agency" means the, North Carolina
Department of Health and Human Services, Division of Health Service Regulation,
Radiation Protection Section.
(7) "Agreement state" has the meaning as
defined in G.S. 104E-5(2).
(8) "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.
(9) "Airborne radioactive material" means any
radioactive material dispersed in the air in the form of dusts, fumes,
particulates, mists, vapors, or gases.
(10) "Airborne radioactivity area" means a
room, enclosure, or area in which airborne radioactive materials, composed
wholly or partly of licensed radioactive material, exist in concentrations:
(a) in excess of the derived air concentrations specified
in Appendix B to 10 CFR 20.1001 - 20.2401; or
(b) to such a degree that an individual present
in the area without respiratory protective equipment could exceed, during the
hours an individual is present in a week, an intake of 0.6 percent of the
annual limit on intake or 12 DAC-hours.
(11) "ALARA" (acronym for "as low as is
reasonably achievable") means making every reasonable effort to maintain
exposures to radiation as far below the dose limits in the rules of this
Chapter 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 benefits to the public health and
safety, and other societal and socioeconomic considerations, and in relation to
utilization of sources of radiation in the public interest.
(12) "Annual limit on intake" (ALI) means the
derived limit for the amount of radioactive material taken into the body of an
adult worker by inhalation or ingestion in a year. ALI is the smaller value of
intake of a given radionuclide in an effective dose equivalent of five rems
(0.05 Sv) or a committed dose equivalent of 50 rems (0.5 Sv) to any individual
organ or tissue. The ALI values for intake by ingestion and by inhalation of
selected radionuclides are given in Table 1, Columns 1 and 2, of Appendix B to
10 CFR 20.1001 - 20.2401.
(13) "Annually" means either:
(a) at intervals not to exceed 12 consecutive
months; or
(b) once per year at the same time each year
(completed during the same month each year over a period of multiple years).
(14) "Assigned protection factor (APF)" means
the expected workplace level of respiratory protection that would be provided
by a properly functioning respirator or a class of respirators to properly
fitted and trained users. APF can be divided into the ambient airborne
concentrations to estimate inhaled air concentrations.
(15) "Atmosphere-supplying respirator" means a
respirator that supplies the respirator user with breathing air from a source
independent of the ambient atmosphere and includes supplied-air respirators and
self-contained breathing apparatus units.
(16) "Authorized representative" means an
employee of the agency, or an individual outside the agency when the individual
is so designated by the agency under Rule .0112 of this Section.
(17) "Authorized user" means an individual who
is authorized by license or registration condition to use a source of
radiation.
(18) "Background radiation" means radiation
from cosmic sources; naturally occurring radioactive materials, including radon
(except as a decay product of source or special nuclear material); and global
fallout as it exists in the environment from the testing of nuclear explosive
devices or from past nuclear accidents such as Chernobyl that are not under the
control of the licensee or registrant. "Background radiation" does
not include sources of radiation regulated by the agency.
(19) "Becquerel" is the SI unit of
radioactivity. One becquerel is equal to one disintegration per second (s-1).
(20) "Bioassay" or "radiobioassay"
means the determination of kinds, quantities or concentrations, and, in some
cases, the locations of radioactive material in the human body, whether by
direct measurement (in vivo counting) or by analysis and evaluation of
materials excreted or removed from the human body.
(21) "Brachytherapy" means a method of
radiation therapy in which sources are used to deliver a radiation dose at a
distance of up to a few centimeters by surface, intracavitary, intraluminal or
interstitial application.
(22) "Brachytherapy source" means a radioactive
source or a manufacturer assembled source train or a combination of these
sources that is designed to deliver a therapeutic dose within a distance of a few
centimeters.
(23) "Byproduct material" has the meaning as
defined in G.S. 104E-5(4), and in addition includes:
(a) 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;
(b) Any discrete source of Radium-226 that is
produced, extracted, or converted after extraction, for use for a commercial,
medical, or research activity;
(c) Any material that:
(i) has been made radioactive by use of a
particle accelerator; or
(ii) is produced, extracted, or converted after
extraction, for use for a commercial, medical, or research activity; and
(d) Any discrete source of naturally occurring
radioactive material, other than source material, that:
(i) the US Nuclear Regulatory Commission, in
consultation with the Administrator of the Environmental Protection, the
Secretary of Energy, the Secretary of Homeland Security, and the head of any
other appropriate federal agency, determines would poses 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
(ii) is extracted or converted after extraction
for use in a commercial, medical, or research activity.
(24) "Class", "lung class" or
"inhalation class" means a classification scheme for inhaled material
according to its rate of clearance from the pulmonary region of the lung.
Materials are classified as D, W, or Y, which applies to a range of clearance
half-times as follows:
CLASSIFICATION OF
INHALED MATERIAL
Class Clearance
half-time
Class D (Day) less
than 10 days
Class W (Weeks) 10
days to 100 days
Class Y (Years) greater
than 100 days
(25) "Clinical procedures manual" means a
collection of procedures governing the medical use of radioactive material not
requiring a written directive that describes each method by which the licensee
performs clinical procedures and includes other instructions and precautions.
Each clinical procedure, including the radiopharmaceutical dosage and route of
administration, shall be approved in writing by an authorized user prior to
inclusion in the manual. The radiation safety officer shall ensure that the
manual includes the approved procedure(s) for all clinical procedures using
radioactive material not requiring a written directive performed at the
facility.
(26) "Collective dose" is 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.
(27) "Commission" has the meaning as defined in
G.S. 104E-5(5).
(28) "Committed dose equivalent" (HT,50)
means the dose equivalent to organs or tissues of reference (T) that will be
received from an intake of radioactive material by an individual during the
50-year period following the intake.
(29) "Committed effective dose equivalent" (HE,50)
is the sum of the products of the weighting factors applicable to each of the
body organs or tissues that are irradiated and the committed dose equivalent to
these organs or tissues (HE,50 = ΣwTHT,50).
(30) "Consortium" means an association of
medical use licensees and a PET radionuclide production facility that jointly
own or share in the operation and maintenance costs 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 consortium's PET radionuclide
production facility must be located at an educational institution, federal or
medical facility.
(31) "Constraint" or "dose constraint"
means a value above which specified licensee actions are required.
(32) "Controlled area" means an area, outside
of a restricted area but inside the site boundary, access to which can be
limited by the licensee or registrant for any reason.
(33) "Critical group" means the group of
individuals reasonably expected to receive the greatest exposure to residual
radioactivity for any applicable set of circumstances.
(34) "Curie" is the special unit of
radioactivity. One curie is equal to 3.7 x 1010 disintegrations per
second = 3.7 x 1010 becquerels = 2.22 x 1012
disintegrations per minute.
(35) "Declared pregnant woman" means a woman
who has voluntarily informed the licensee or registrant, in writing, of her
pregnancy and the estimated date of conception. The declaration remains in
effect until the declared pregnant woman withdraws the declaration in writing
or is no longer pregnant.
(36) "Decommission" means to remove (as a
facility) safely from service and reduce residual radioactivity to a level that
permits release of the property for either unrestricted use and termination of
the license or for restricted use and termination of the license.
(37) "Deep-dose equivalent" (Hd),
which applies to external whole-body exposure, is the dose equivalent at a
tissue depth of one cm (1000 mg/cm2).
(38) "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.
(39) "Department" has the meaning as defined in
G.S. 104E-5(6).
(40) "Depleted uranium" means the source
material uranium in which the isotope uranium-235 is less than 0.711 weight
percent of the total uranium present. Depleted uranium does not include special
nuclear material.
(41) "Derived air concentration" (DAC) means
the concentration of a given radionuclide in air which, if breathed by the
reference man for a working year of 2,000 hours under conditions of light work
(inhalation rate 1.2 cubic meters of air per hour), results in an intake of
ALI. DAC values are given in Table 1, Column 3, of Appendix B to 10 CFR
20.1001 - 20.2401).
(42) "Derived air concentration-hour"
(DAC-hour) is 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 may take 2,000 DAC-hours to represent one ALI, equivalent to a
committed effective dose equivalent of five rems (0.05 Sv).
(43) "Discrete source" means a radionuclide
that has been processed so that its concentration within a material has been
purposely increased for use for commercial, medical, or research activities.
(44) "Disposable respirator" means a respirator
for which maintenance is not intended and that is designed to be discarded
after excessive breathing resistance, sorbent exhaustion, physical damage, or
end-of-service-life renders it unsuitable for use. Examples of this type of
respirator are a disposable half-mask respirator or a disposable escape-only
self-contained breathing apparatus (SCBA).
(45) "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 measurement
technology, survey and statistical techniques as defined in 10 CFR 20.1003.
(46) "Dose" or "radiation dose" is a
generic term that means absorbed dose, dose equivalent, effective dose
equivalent, committed dose equivalent, committed effective dose equivalent, or
total effective dose equivalent, as defined in other Items of this Rule.
(47) "Dose equivalent" (HT) means
the product of the absorbed dose in tissue, quality factor, and all other
necessary modifying factors at the location of interest. The units of dose
equivalent are the rem and sievert (Sv).
(48) "Dose limits" (see "Limits"
defined in this Rule).
(49) "Dosimetry processor" means an individual
or organization that processes and evaluates individual monitoring equipment in
order to determine the radiation dose delivered to the equipment.
(50) "Effective dose equivalent" (HE)
is the sum of the products of the dose equivalent to the organ or tissue (HT)
and the weighting factors (wT)
applicable to each of the body organs or tissues that are irradiated (HE
= ΣwTHT).
(51) "Embryo/fetus" means the developing human
organism from conception until the time of birth.
(52) "Entrance or access point" means any
location through which an individual could gain access to radiation areas or to
a source of radiation. This includes entry or exit portals of sufficient size
to permit human entry, irrespective of their intended use.
(53) "Equipment services" means the selling,
installation, rebuilding, conversion, repair, inspection, testing, survey or
calibration of equipment which can affect compliance with these Rules by a
licensee or registrant.
(54) "Exposure" means being exposed to ionizing
radiation or to radioactive material.
(55) "Exposure rate" means the exposure per
unit of time, such as R/min and mR/h.
(56) "External dose" means that portion of the
dose equivalent received from radiation sources outside the body.
(57) "Extremity" means hand, elbow, arm below
the elbow, foot, knee, or leg below the knee.
(58) "Eye dose equivalent" (See "Lens dose
equivalent" as defined in this Rule).
(59) "Filtering facepiece" or "dust
mask" means a negative pressure particulate respirator with a filter as an
integral part of the facepiece or with the entire facepiece composed of the
filtering medium, not equipped with elastomeric sealing surfaces and adjustable
straps.
(60) "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.
(61) "Fit test" means the use of a protocol to
qualitatively or quantitatively evaluate the fit of a respirator on an
individual.
(62) "Generally applicable environmental radiation
standards" means standards issued by the U.S. Environmental Protection
Agency (EPA) under the authority of the Atomic Energy Act of 1954 (42 U.S.C.
2011 et seq.), as amended, that impose limits on radiation exposures or
levels, or concentrations or quantities of radioactive material, in the general
environment outside the boundaries of locations under the control of persons
possessing or using sources of radiation.
(63) "Gray" (Gy) is the SI unit of absorbed
dose. One gray is equal to an absorbed dose of one joule/kilogram (100 rads).
(64) "Helmet" means a rigid respiratory inlet
covering that also provides head protection against impact and penetration.
(65) "High dose-rate remote afterloader" (HDR)
means a brachytherapy device that remotely delivers a dose rate in excess of 12
gray (1200 rads) per hour at the point or surface where the dose is prescribed.
(66) "High radiation area" means an area,
accessible to individuals, in which radiation levels from sources external to
the body could result in an individual receiving a dose equivalent in excess of
0.1 rem (1 mSv) in one hour at 30 centimeters from the radiation source or from
any surface that the radiation penetrates.
(67) "Hood" means a respiratory inlet covering
that completely covers the head and neck and may also cover portions of the
shoulders and torso.
(68) "Hospital" means a facility that provides
as its primary functions diagnostic services and intensive medical and nursing
care in the treatment of acute stages of illness.
(69) "Human use" means the internal or external
administration of radiation or radioactive materials to human beings.
(70) "Individual" means any human being.
(71) "Individual monitoring" means:
(a) the assessment of dose equivalent by the use
of devices designed to be worn by an individual;
(b) the assessment of committed effective dose
equivalent by bioassay or by determination of the time-weighted air
concentrations to which an individual has been exposed, i.e., DAC-hours;
or
(c) the assessment of dose equivalent by the use
of survey data.
(72) "Individual monitoring devices" or
"individual monitoring equipment" means devices designed to be worn
by a single individual for the assessment of dose equivalent such as film
badges, thermoluminescence dosimeters (TLDs), pocket ionization chambers, and
personal ("lapel") air sampling devices.
(73) "Inhalation class" (see "Class"
defined in this Rule).
(74) "Inspection" means an examination or
observation by the agency to determine compliance with rules, orders,
requirements and conditions of the agency or the Commission.
(75) "Internal dose" means that portion of the
dose equivalent received from radioactive material taken into the body.
(76) "Lens dose equivalent" (LDE) applies to
the external exposure of the lens of the eye and is taken as the dose
equivalent at a tissue depth of 0.3 cm (300 mg/cm2).
(77) "License," except where otherwise
specified, means a license issued pursuant to Section .0300 of this Chapter.
(78) "Licensee" means any person who is
licensed by the agency pursuant to Section .0300 of this Chapter.
(79) "Licensing state" means any state designated
as such by the Conference of Radiation Control Program Directors, Inc. Unless
the context indicates otherwise, use of the term Agreement State
in this Chapter includes licensing state with respect to naturally occurring
and accelerator produced radioactive material (NARM).
(80) "Limits" or "dose limits" means
the permissible upper bounds of radiation doses.
(81) "Loose-fitting facepiece" means a
respiratory inlet covering that is designed to form a partial seal with the
face.
(82) "Lost or missing licensed radioactive
material" means licensed radioactive material whose location is unknown. It
includes material that has been shipped but has not reached its destination and
whose location cannot be readily traced in the transportation system.
(83) "Low dose-rate remote afterloader" (LDR)
means a brachytherapy device that remotely delivers a dose rate of less than or
equal to 2 gray (200 rads) per hour at the point or surface where the dose is
prescribed.
(84) "Lung class" (see "Class" as
defined in this Rule).
(85) "Manual brachytherapy" means a type of
brachytherapy in which the brachytherapy seeds, ribbons) are manually placed
topically on or inserted either into the body cavities that are in close
proximity to a treatment site or directly into the tissue volume.
(86) "Medical event" means an event that meets
the criteria in Rule .0364 of this Chapter.
(87) "Medical use" means the intentional
internal or external administration of radioactive material or the radiation
therefrom to patients or human research subjects under the supervision of an
authorized user.
(88) "Medium dose-rate remote afterloader"
means a brachytherapy device that remotely delivers a dose rate of greater than
2 gray (200 rads), but less than 12 gray (1200 rads) per hour at the point or
surface where the dose is prescribed.
(89) "Member of the public" means any
individual except when that individual is receiving an occupational dose.
(90) "Minor" means an individual less than 18
years of age.
(91) "Mobile nuclear medicine service" means
the transportation and medical use of radioactive material.
(92) "Monitoring," "radiation
monitoring" or "radiation protection monitoring" means the
measurement of radiation levels, concentrations, surface area concentrations or
quantities of radioactive material and the use of the results of these
measurements to evaluate potential exposures and doses.
(93) "Natural radioactivity" means
radioactivity of naturally occurring nuclides.
(94) "Negative pressure respirator" means a
tight-fitting respirator in which the air pressure inside the facepiece is
negative during inhalation with respect to the ambient air pressure outside of
the respirator.
(95) "Nonstochastic effect" or "deterministic
effect" means health effects, the severity of which vary with the dose and
for which a threshold is believed to exist. Radiation-induced cataract
formation is an example of a nonstochastic effect.
(96) "NRC" means the United States Nuclear
Regulatory Commission or its authorized representatives.
(97) "Occupational dose" means the dose
received by an individual in the course of employment in which the individual's
assigned duties involve exposure to radiation or radioactive material from
licensed and unlicensed sources of radiation, whether in the possession of the
licensee or registrant or other person. Occupational dose does not include doses
received from background radiation, as a patient from medical practices, from
exposure to individuals administered radioactive material and released in
accordance with Rule .0358 of this Chapter, from voluntary participation in
medical research programs, or as a member of the public.
(98) "Particle accelerator" means any machine
capable of accelerating electrons, protons, deuterons, or other charged particles,
in a vacuum and of discharging the resultant particulate or other radiation
into a medium at energies usually in excess of one megaelectron volt. For
purposes of this definition, "accelerator" is an equivalent term.
(99) "Patient intervention" means actions by
the patient or human research subject, whether intentional or unintentional,
such as dislodging or removing treatment devices or prematurely terminating the
administration.
(100) "Person" has the meaning as defined in G.S.
104E-5(11).
(101) "Personnel monitoring equipment" means
devices, such as film badges, pocket dosimeters, and thermoluminescent
dosimeters, designed to be worn or carried by an individual for the purpose of
estimating the dose of radiation received by the individual.
(102) "Pharmacist" means a person licensed to
practice pharmacy in North Carolina pursuant to G.S. Chapter 90, Article 4A.
(103) "Physician" means a person licensed to
practice medicine in North Carolina pursuant to G.S. Chapter 90, Article 1.
(104) "Planned special exposure" means an
infrequent exposure to radiation, separate from and in addition to the annual
dose limits as defined in Rule .1608 of this Chapter.
(105) "Positive pressure respirator" means a
respirator in which the pressure inside the respiratory inlet covering exceeds
the ambient air pressure outside the respirator.
(106) "Positron Emission Tomography (PET) radionuclide
production facility" means a facility operating an accelerator or a
cyclotron for the purpose of producing PET radionuclides.
(107) "Powered air-purifying respirator (PAPR)"
means an air-purifying respirator that uses a blower to force the ambient air
through air-purifying elements to the inlet covering.
(108) "Prescribed dosage" means the specified
activity or range of activity of unsealed radioactive material as documented:
(a) In a written directive; or
(b) In accordance with the directions of an
authorized user.
(109) "Prescribed dose" means:
(a) for teletherapy or accelerator radiation:
(i) the total dose; and
(ii) the dose per fraction as documented in the
written directive;
(b) for brachytherapy:
(i) the total source strength and exposure
time; or
(ii) the total dose, as documented in the
written directive;
(c) for gamma stereotactic radiosurgery, the
total dose as documented in the written directive; or
(d) for remote brachytherapy afterloaders, the
total dose and dose per fraction as documented in a written directive.
(110) "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.
(111) "Public dose" means the dose received by a
member of the public from exposure to radiation or radioactive material
released by a licensee or registrant, or another source of radiation within a
licensee's or registrant's control. It does not include occupational dose or
doses received from background radiation, as a patient from medical practices,
from exposure to individuals administered radioactive material and released in
accordance with Rule .0358 of this Chapter, or from voluntary participation in
medical research programs.
(112) "Pulsed dose-rate remote afterloader" means
a type of remote afterloading brachytherapy device that uses a single source
capable of delivering dose rates in the "high dose-rate" range, but:
(a) Is approximately one-tenth of the activity
of typical high dose-rate remote afterloader sources; and
(b) Is used to simulate the radiobiology of a
low dose-rate treatment by inserting the source for a given fraction of each
hour.
(113) "Qualitative fit test" (QLFT) means a
pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's
response to the test agent.
(114) "Quality factor" (Q) means the modifying
factor that is used to derive dose equivalent from absorbed dose. Quality
factors are provided in the definition of rem in this Rule.
(115) "Quantitative fit test" (QNFT) means an
assessment of the adequacy of respirator fit by numerically measuring the
amount of leakage into the respirator.
(116) "Quarter" means a period of time equal to
one-fourth of the year observed by the licensee or registrant (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.
(117) "Quarterly" means either:
(a) at intervals not to exceed 13 weeks; or
(b) once per 13 weeks at about the same time
during each 13 week period (completed during the same month of the quarter
(first month, second month or third month) each quarter over a time period of
several quarters.
(118) "Rad" is the special unit of absorbed dose.
One rad is equal to an absorbed dose of 100 ergs/gram or 0.01 joule/kilogram
(0.01 gray).
(119) "Radiation", except as otherwise defined in
Section .1400 of this Chapter, has the meaning as defined in G.S. 104E-5(12).
(120) "Radiation area" means an area, accessible
to individuals, in which radiation levels could result in an individual
receiving a dose equivalent in excess of 0.005 rem (0.05 mSv) in one hour at 30
centimeters from the radiation source or from any surface that the radiation
penetrates.
(121) "Radiation dose" means dose.
(122) "Radiation machine" has the meaning as
defined in G.S. 104E-5(13).
(123) "Radiation safety officer" means one who has
the knowledge and responsibility to apply appropriate radiation protection
rules.
(124) "Radioactive material" has the meaning as
defined in G.S. 104E-5(14).
(125) "Radioactive waste disposal facility" means
any low-level radioactive waste disposal facility, as defined in G.S. 104E-5(9c),
established for the purpose of receiving low-level radioactive waste, as
defined in Rule .1202 of this Chapter, generated by another licensee for the
purpose of disposal.
(126) "Radioactive waste processing facility"
means any low-level radioactive waste facility, as defined in G.S. 104E-5(9b),
established for the purpose of receiving waste, as defined in this Rule,
generated by another licensee to be stored, compacted, incinerated or treated.
(127) "Radioactivity" means the disintegration of
unstable atomic nuclei by emission of radiation.
(128) "Radiobioassay" means bioassay.
(129) "Reference man" means a hypothetical
aggregation of human physical and physiological characteristics arrived at by
international consensus as published by the International Commission on
Radiological Protection. These characteristics may be used by researchers and
public health workers to standardize results of experiments and to relate
biological insult to a common base.
(130) "Registrant" means any person who is
registered with the agency as required by provisions of these Rules or the Act.
(131) "Registration" means registration with the
agency in accordance with these Rules.
(132) "Regulations of the U.S. Department of
Transportation" means the regulations in 49 CFR Parts 100-189.
(133) "Rem" is the special unit of any of the
quantities expressed as dose equivalent. The dose equivalent in rems is equal
to the absorbed dose in rads multiplied by the quality factor (1 rem = 0.01
sievert). As used in this Chapter, the quality factors for converting absorbed
dose to dose equivalent are as follows:
QUALITY FACTORS AND
ABSORBED DOSE EQUIVALENCIES
TYPE OF RADIATION Quality
Factor Absorbed
(Q) Dose
Equal
to a Unit
Dose Equivalenta
X-, gamma, or beta radiation 1 1
Alpha particles, multiple-charged
particles, fission fragments
and heavy particles of unknown
charge 20 0.05
Neutrons of unknown energy 10 0.1
High-energy protons 10 0.1
a Absorbed dose in rad equal to one rem or the
absorbed dose in gray equal to one sievert.
If it is more convenient to measure the neutron fluence rate
than to determine the neutron dose equivalent rate in rems per hour or sieverts
per hour, one rem (0.01 Sv) of neutron radiation of unknown energies may, for
purposes of the rules of this Chapter, be assumed to result from a total
fluence of 25 million neutrons per square centimeter incident upon the body.
If sufficient information exists to estimate the approximate
energy distribution of the neutrons, the licensee or registrant may use the
fluence rate per unit dose equivalent or the appropriate Q value from the
following table to convert a measured tissue dose in rads to dose equivalent in
rems:
MEAN QUALITY FACTORS,
Q, AND FLUENCE PER UNIT DOSE
EQUIVALENT FOR
MONOENERGETIC NEUTRONS
Neutron Quality Fluence
per Unit
Energy Factora Dose
Equivalentb
(MeV) (Q) (neutrons
cm-2 rem-1)
(thermal) 2.5 x 10-8 2 980
x 106
1 x 10-7 2 980
x 106
1 x 10-6 2 810
x 106
1 x 10-5 2 810
x 106
1 x 10-4 2 840
x 106
1 x 10-3 2 980
x 106
1 x 10-2 2.5 1010
x 106
1 x 10-1 7.5 170
x 106
5 x 10-1 11 39
x 106
1 11 27
x 106
2.5 9 29
x 106
5 8 23
x 106
7 7 24
x 106
10 6.5 24
x 106
14 7.5 17
x 106
20 8 16
x 106
40 7 14
x 106
60 5.5 16
x 106
1 x 102 4 20
x 106
2 x 102 3.5 19
x 106
3 x 102 3.5 16
x 106
4 x 102 3.5 14
x 106
a Value of quality factor (Q) at the point where
the dose equivalent is maximum in a 30-cm diameter cylinder tissue-equivalent
phantom.
b Monoenergetic neutrons incident normally on a
30-cm diameter cylinder tissue-equivalent phantom.
(134) "Research and development" means:
(a) theoretical analysis, exploration, or
experimentation; or
(b) the extension of investigative findings and
theories of a scientific or technical nature into practical application for
experimental and demonstration purposes, including the experimental production
and testing of models, devices, equipment, materials, and processes.
Research and development does not include
the internal or external administration of radiation or radioactive material to
human beings.
(135) "Residual radioactivity" means radioactivity
in structures, materials, soils, groundwater, and other media at a site
resulting from activities under the licensee's control. This includes radioactivity
from all licensed and unlicensed sources used by the licensee, but excludes
background radiation. It also includes radioactive materials remaining at the
site as a result of routine or accidental releases of radioactive material at
the site and previous burials of radioactive materials at the site, even if the
burials were made in accordance with the provisions of Section .1600 of this
Chapter.
(136) "Respiratory protective device" means an
apparatus, such as a respirator, used to reduce the individual's intake of
airborne radioactive materials.
(137) "Restricted area" means an area, access to
which is controlled by the licensee or registrant for purposes of protecting
individuals against undue risks from exposure to radiation and radioactive
materials. Restricted area does not include areas used as residential
quarters, but separate rooms in a residential building may be set apart as a
restricted area.
(138) "Roentgen" (R) means the special unit of
exposure. One roentgen equals 2.58 x 10-4 coulombs/kilogram of air.
(139) "Sanitary sewerage" means a system of public
sewers for carrying off waste water and refuse, but excluding sewage treatment
facilities, septic tanks, and leach fields owned or operated by the licensee.
(140) "Sealed source" means radioactive material
that is encased in a capsule designed to prevent leakage or escape of the
radioactive material.
(141) "Sealed source and device registry" means
the national registry that contains all the registration certificates,
generated by both NRC and the Agreement States, that summarize the radiation
safety information for the sealed sources and devices and describe the
licensing and use conditions approved for the product.
(142) "Self-contained breathing apparatus (SCBA)"
means an atmosphere-supplying respirator for which the breathing air source is
designed to be carried by the user.
(143) "Semiannually" means either:
(a) at intervals not to exceed six months; or
(b) once per six months at about the same time
during each six month period (completed during the sixth month of each six
month period over multiple six month periods).
(144) "Shallow-dose equivalent" (Hs), which applies to the external
exposure of the skin of the whole body or the skin of an extremity, is taken as
the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2).
(145) "SI unit" means a unit of measure from the
International System of Units as established by the General Conference of
Weights and Measures.
(146) "Sievert" is the SI unit of any of the
quantities expressed as dose equivalent. The dose equivalent in sieverts is
equal to the absorbed dose in grays multiplied by the quality factor (1 Sv =
100 rems).
(147) "Site boundary" means that line beyond which
the land or property is not owned, leased, or otherwise controlled by the
licensee or registrant.
(148) "Source material" has the meaning as defined
in G.S. 104E-5(15).
(149) "Source of radiation" means any radioactive
material, or any device or equipment emitting or capable of producing
radiation.
(150) "Special form radioactive material" means
radioactive material which satisfies the following conditions:
(a) It is either a single solid piece or is
contained in a sealed capsule that can be opened only by destroying the
capsule;
(b) The piece or capsule has at least one
dimension not less than five millimeters (0.197 inch); and
(c) It satisfies the test requirements specified
by the U.S. Nuclear Regulatory Commission, Subpart F of 10 CFR Part 71, and the
tests prescribed in Rule .0114 of this Section. A special form encapsulation
designed in accordance with the U.S. Nuclear Regulatory Commission
requirements, Subpart F of 10 CFR Part 71, in effect on June 30, 1984, and
constructed prior to July 1, 1985, may continue to be used. A special form
encapsulation either designed or constructed after June 30, 1985, must meet
requirements of this definition applicable at the time of its design or
construction.
(151) "Special nuclear material" has the meaning
as defined in G.S. 104E-5(16).
(152) "Special nuclear material in quantities not
sufficient to form a critical mass" means uranium enriched in the isotope
uranium-235 in quantities not exceeding 350 grams of contained uranium-235;
uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not
exceeding 200 grams; or any combination of uranium-235, uranium enriched in
uranium-235 and plutonium 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 in this Rule for the
same kind of special nuclear material. The sum of these ratios for all the
kinds of special nuclear material in combination shall not exceed one. For
example, the following quantities in combination would not exceed the
limitations and are within the formula, as follows:
175 (gram contained
U-235) + 50 (grams U-233) + 50 (grams Pu) is <
or = 1
350 200 200
(153) "State" means the State of North Carolina.
(154) "Stereotactic radiosurgery" means the use of
external radiation in conjunction with a stereotactic guidance device to
precisely deliver a therapeutic dose to a tissue volume.
(155) "Stochastic effects" means health effects
that occur 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.
(156) "Supplied-air respirator" (SAR) or "airline
respirator" means an atmosphere-supplying respirator for which the source
of breathing air is not designed to be carried by the user.
(157) "Survey" means an evaluation of the
radiological conditions and potential hazards incident to the production, use,
transfer, release, disposal, or presence of sources of radiation. When
appropriate, such an evaluation includes a physical survey of the location of
sources of radiation and measurements or calculations of levels of radiation,
or concentrations or quantities of radioactive material present.
(158) "Therapeutic dosage" means a dosage of
unsealed radioactive material that is intended to deliver a radiation dose to a
patient or human research subject for palliative or curative treatment.
(159) "These Rules" means Chapter 11 of this
Title.
(160) "Tight-fitting facepiece" means a
respiratory inlet covering that forms a complete seal with the face.
(161) "To the extent practicable" means to the
extent feasible or capable of being done or carried out with reasonable effort,
taking into account the state of technology, the economics of improvements in
relation to benefits to the public health and safety, and other societal and
socioeconomic considerations.
(162) "Total effective dose equivalent" (TEDE)
means the sum of the effective dose equivalent (for external exposures) and the
committed effective dose equivalent (for internal exposures).
(163) "Toxic or hazardous constituent of the
waste" means the nonradioactive content of waste which, notwithstanding
the radioactive content, would be classified as "hazardous waste" as
defined in G.S. 130A-290(8).
(164) "Treatment site" means the anatomical
description of the tissue intended to receive a radiation dose, as described in
a written directive.
(165) "Type A quantity" means a quantity of
radioactive material, the aggregate radioactivity of which does not exceed A1
for special form radioactive material or A2 for normal form
radioactive material, where A1 and A2 are given in Rule
.0113 of this Section or may be determined by procedures described in that
Rule. All quantities of radioactive material greater than a Type A quantity
are Type B.
(166) "Unit dosage" means a dosage intended for
medical use in an individual that has been obtained from a manufacturer or
preparer licensed pursuant to 10 CFR 32.72 or equivalent agreement state
requirements.
(167) "Unrefined and unprocessed ore" means ore in
its natural form prior to any processing, such as grinding, roasting,
beneficiating, or refining.
(168) "Unrestricted area" means an area, access to
which is neither limited nor controlled by the licensee or registrant.
(169) "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.
(170) "Very high radiation area" means an area,
accessible to individuals, in which radiation levels from sources external to
the body could result in an individual receiving an absorbed dose in excess of
500 rads (5 grays) in one hour at one meter from a radiation source or from any
surface that the radiation penetrates. At very high doses received at high
dose rates, units of absorbed dose (e.g., rads and grays) are
appropriate, rather than units of dose equivalent (e.g., rems and
sieverts).
(171) "Waste" means low-level radioactive waste as
defined in G.S. 104E-5(9a) and includes those low-level radioactive wastes
containing source, special nuclear, or radioactive material that are acceptable
for disposal in a land disposal facility. For purposes of this definition,
low-level waste means radioactive waste not classified as high-level
radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material
as defined in this Rule, and licensed naturally occurring and accelerator
produced radioactive material which is not subject to regulation by the U.S.
Nuclear Regulatory Commission under the Atomic Energy Act of 1954, as amended,
except as defined differently in Rule .1202 of this Chapter.
(172) "Week" means seven consecutive days.
(173) "Weighting factor", wT, for an organ or tissue (T) is the proportion of
the risk of stochastic effects resulting from irradiation of that organ or
tissue to the total risk of stochastic effects when the whole body is irradiated
uniformly. For calculating the effective dose equivalent, the values of wT are:
ORGAN DOSE WEIGHTING
FACTORS
Organ or
Tissue wT
Gonads 0.25
Breast 0.15
Red bone marrow 0.12
Lung 0.12
Thyroid 0.03
Bone surfaces 0.03
Remainder 0.30a
Whole body 1.00b
a 0.30 results from 0.06 for each of 5
"remainder" organs (excluding the skin and the lens of the eye) that
receive the highest doses.
b For the purpose of weighting the external whole
body dose (for adding it to the internal dose), a single weighting factor, wT = 1.0, has been specified.
(174) "Whole body" means, for purposes of external
exposure, head, trunk (including male gonads), arms above the elbow, or legs
above the knee.
(175) "Worker" means an individual engaged in work
under a license or registration issued by the agency and controlled by a
licensee or registrant, but does not include the licensee or registrant.
(176) "Working level" (WL) is any combination of
short-lived radon daughters (for radon-222: polonium-218, lead-214,
bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212,
bismuth-212, and polonium-212) in one liter of air that will result in the ultimate
emission of 1.3 x 105 MeV of potential alpha particle energy.
(177) "Working level month" (WLM) means an
exposure to one working level for 170 hours.
(178) "Written directive" means an order in
writing for a specific patient or human research subject dated and signed by an
authorized user prior to the administration of a radiopharmaceutical or
radiation from a licensed source, except as specified in Sub-item (e) of this
definition, containing the patient or human research subject's name and the
following information:
(a) for the administration of greater than 30
microcuries (1.11 Megabecquerels (MBq)) of sodium iodide I-131, the dosage;
(b) for the therapeutic administration of a
radiopharmaceutical other than sodium iodide I-131:
(i) radionuclide;
(ii) dosage; and
(iii) route of administration;
(c) for teletherapy or accelerator radiation
therapy:
(i) total dose;
(ii) dose per fraction;
(iii) treatment site; and
(iv) number of fractions;
(d) for high-dose-rate remote afterloading
brachytherapy:
(i) radionuclide;
(ii) treatment site;
(iii) dose per fraction
(iv) number of fractions; and
(v) total dose;
(e) for all other brachytherapy:
(i) prior to implantation:
(A) radionuclide;
(B) treatment site; and
(C) dose; and
(ii) after implantation:
(A) radionuclide;
(B) treatment site;
(C) number of sources;
(D) total source strength and exposure time; and
(E) total dose; and
(f) for gamma stereotactic radiosurgery:
(i) the total dose;
(ii) treatment site; and
(iii) values for the target coordinate settings
per treatment for each anatomically distinct treatment site.
(179) "Year" means the period of time beginning in
January used to determine compliance with the provisions of Section .1600 of
this Chapter. The licensee or registrant may change the starting date of the
year used to determine compliance by the licensee or registrant provided that
the change is made at the beginning of the year and that no day is omitted or
duplicated in consecutive years.
History Note: Authority G.S. 104E-7(a)(2); 10 CFR 20.1003;
Eff. February 1, 1980;
Amended Eff. November 1, 1989; June 1, 1989; October 1,
1984;
Transferred and Recodified from 10 NCAC 03G .2204 Eff.
January 4, 1990;
Amended Eff. January 1, 1994; May 1, 1992;
Temporary Amendment Eff. August 20, 1994, for a Period of
180 Days or until the permanent rule becomes effective, whichever is sooner;
Amended Eff. October 1, 2013; November 1, 2007; May 1,
2006; January 1, 2005; August 1, 2002; April 1, 1999; August 1, 1998; May 1,
1995;
Transferred and Recodified from 15A NCAC 11 .0104 Eff.
February 1, 2015.
10A NCAC 15 .0105 OTHER DEFINITIONS
Definitions of certain other words and phrases as used in
these Rules are set forth in Sections .0300, .0500, .0600, .0800, .1200, .1300,
.1400, and .1500 of this Chapter. Waste class is defined in Rule .1650 of this
Chapter.
History Note: Authority G.S. 104E-7;
Eff. February 1, 1980;
Amended Eff. June 1, 1989;
Transferred and Recodified from 10 NCAC 03G .2205 Eff.
January 4, 1990;
Amended Eff. October 1, 2013; May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0105 Eff.
February 1, 2015.
10A NCAC 15 .0106 EXEMPTIONS
(a) The agency may, upon application therefore, grant
individual exemptions or exceptions from the requirements of these Rules if it
will not result in radiation dose or contamination in excess of the limits
prescribed in these Rules for the protection of public health, safety or
property.
(b) Except as otherwise provided in this Rule, common and
contract or other carriers, freight forwarders, and warehousemen, who are
subject to the regulations of the U.S. Postal Service (39 CFR Parts 14 and 15),
are exempt from these Rules to the extent that they transport or store sources
of radiation in the regular course of their carriage for another or storage
incident thereto. Common, contract, or other carriers who are not exempt pursuant
to this Rule are subject to the provisions of Rule .0316 of this Chapter.
Notwithstanding these exemptions, common, contract or other carriers are
required to comply with the provisions of Rule .0316(c) of this Chapter to the
extent that these carriers are transporting spent nuclear fuel, as defined in
Rule .0316(c) of this Chapter, upon the highways of North Carolina.
(c) Any U.S. Department of Energy contractor or
subcontractor and any U.S. Nuclear Regulatory Commission contractor or
subcontractor of the following categories operating within this state is exempt
from these Rules to the extent that the contractor or subcontractor under his
contract receives, possesses, uses, transfers or acquires sources of radiation:
(1) prime contractors performing work for the
U.S. Department of Energy at U.S. government‑owned or controlled sites,
including the transportation of sources of radiation to or from such sites and
the performance of contract services during temporary interruptions of such
transportation;
(2) prime contractors of the U.S. Department of
Energy performing research in, or development, manufacture, storage, testing or
transportation of, atomic weapons or components thereof;
(3) prime contractors of the U.S. Department of
Energy using or operating nuclear reactors or other nuclear devices in a United
States government‑owned vehicle or vessel; and
(4) any other prime contractor or subcontractor
of the U.S. Department of Energy or of the U.S. Nuclear Regulatory Commission
when the agency and the U.S. Nuclear Regulatory Commission jointly determine
that:
(A) the exemption of the prime contractor or
subcontractor in Subparagraph (c)(4) of this Rule is authorized by law, and
(B) that under the terms of the contract or subcontract,
there is adequate assurance that the work thereunder can be accomplished
without undue risk to the public health and safety.
History Note: Authority G.S. 104E‑2; 104E‑7;
104E‑15;
Eff. February 1, 1980;
Transferred and Recodified from 10 NCAC 3G .2206 Eff.
January 4, 1990;
Amended Eff. June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0106 Eff.
February 1, 2015.
10A NCAC 15 .0107 INSPECTIONS
Each licensee and registrant shall, upon reasonable notice,
make available to the agency for inspection records maintained pursuant to
provisions of these Rules.
History Note: Authority G.S. 104E‑7; 104E‑11(a);
Eff. February 1, 1980;
Amended Eff. November 1, 1989;
Transferred and Recodified from 10 NCAC 3G .2207 Eff.
January 4, 1990;
Amended Eff. May 1, 1993’
Transferred and Recodified from 15A NCAC 11 .0107 Eff.
February 1, 2015.
10A NCAC 15 .0108 ADDITIONAL REQUIREMENTS
(a) The agency may, by license condition, registration
condition, or order, when not in conflict with any law, waive any requirement
in these Rules or impose additional requirements in accordance with 46 FR 7540 as
it deems appropriate or necessary to minimize danger to public health, safety
or property. Such additional requirements are subject to appeal procedures
contained in Section 15A NCAC 1B .0200.
(b) The Commission may by rule require radioactive material
licensees to procure and file with the department such bond, insurance or other
security as the Commission deems necessary to protect the state from costs for
emergency response and perpetual maintenance.
History Note: Authority G.S. 104E‑7; 104E‑18;
10 C.F.R. Chapter 1, Commission Notices, Policy Statements, Agreement States,
46 F.R. 7540;
Eff. February 1, 1980;
Transferred and Recodified from 10 NCAC 3G .2208 Eff.
January 4, 1990;
Amended Eff. June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0108 Eff.
February 1, 2015.
10A NCAC 15 .0109 IMPOUNDING
Sources of radiation are subject to impounding by authorized
representatives of the agency pursuant to provisions of the Act.
History Note: Authority G.S. 104E‑14;
Eff. February 1, 1980;
Transferred and Recodified from 10 NCAC 3G .2210 Eff.
January 4, 1990;
Transferred and Recodified from 15A NCAC 11 .0109 Eff.
February 1, 2015.
10A NCAC 15 .0110 PROHIBITED USES
(a) Hand‑held fluoroscopic screens shall not be used.
(b) Shoe‑fitting fluoroscopic devices shall not be
used.
(c) Effective February 1, 1981, plastic pointed position
indicating devices on intraoral dental systems shall not be used.
(d) Effective February 1, 1983, mechanical timers on
intraoral dental machines shall not be used.
(e) Dental fluoroscopy without image intensification shall
not be used.
(f) Non‑intensified photofluorographic equipment
shall not be used.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. June 1, 1989;
Transferred and Recodified from 10 NCAC 3G .2211 Eff.
January 4, 1990;
Transferred and Recodified from 15A NCAC 11 .0110 Eff.
February 1, 2015.
10A NCAC 15 .0111 COMMUNICATIONS
(a) Except as provided in Paragraph (b) of this Rule, all
communications and reports concerning these Rules, and applications filed
thereunder, shall be mailed to the agency at Division of Radiation Protection,
1645 Mail Service Center, Raleigh, North Carolina 27699-1645 or delivered to
the agency at its office located at 3825 Barrett Drive, Raleigh, North Carolina
27609-7221.
(b) Except as specifically instructed otherwise by the
agency, immediate telephone notification and reports required by the rules in
this Chapter shall be directed to (919) 571-4141 from 8:00 a.m. to 5:30 p.m. on
workdays.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. June 1, 1989;
Transferred and Recodified from 10 NCAC 3G .2212 Eff.
January 4, 1990;
Amended Eff. August 1, 2002; April 1, 1999; May 1, 1993;
May 1, 1992;
Transferred and Recodified from 15A NCAC 11 .0111 Eff.
February 1, 2015.
10A NCAC 15 .0112 DESIGNATION OF AUTHORIZED
REPRESENTATIVE OF THE AGENCY
(a) When an employee of the agency is qualified and is
specifically designated by the agency, the employee shall be an authorized
representative of the agency to conduct inspections, or tests, or surveys.
(b) When a public employee of other than the agency is
determined by the agency to be qualified, the agency may designate the employee
as an authorized representative of the agency to conduct specified inspections,
or tests, or surveys.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. November 1, 1989;
Transferred and Recodified from 10 NCAC 3G .2213 Eff.
January 4, 1990;
Transferred and Recodified from 15A NCAC 11 .0112 Eff.
February 1, 2015.
10A NCAC 15 .0113 CLASSIFICATION OF RADIOACTIVE MATERIAL
For a single radionuclide of known identity, the values of
A1 and A2 used for determining Type A quantity in the rules of this Chapter are
taken from Appendix A of 10 CFR 71 as revised at 48 Federal Register 35600,
August 5, 1983, and corrections at 48 Federal Register 38449, August 24, 1983.
History Note: Authority G.S. 104E‑15;
Eff. February 1, 1980;
Amended Eff. June 1, 1989;
Transferred and Recodified from 10 NCAC 3G .2214 Eff.
January 4, 1990;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0113 Eff.
February 1, 2015.
10A NCAC 15 .0114 TESTS FOR SPECIAL FORM
Special form radioactive material as defined in Rule .0104
of this Section must satisfactorily pass the following tests:
(1) a free drop through a distance of 30 feet onto a
flat essentially unyielding horizontal surface, striking the surface in such a
position as to suffer maximum damage;
(2) impact of the flat circular end of a one‑inch
diameter steel rod weighing three pounds, dropped through a distance on a sheet
of lead, of hardness number 3.5 to 4.5 on the Vickers scale, and not more than
one inch thick supported by a smooth essentially unyielding surface;
(3) heating in air to a temperature of 1,475 F.
and remaining at that temperature for a period of ten minutes;
(4) immersion for 24 hours in water at room temperature
at pH 6 to pH 8, with a maximum conductivity of ten micromhos per centimeter.
History Note: Authority G.S. 104E‑15;
Eff. February 1, 1980;
Amended Eff. November 1, 1989;
Transferred and Recodified from 10 NCAC 3G .2215 Eff.
January 4, 1990;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0114 Eff.
February 1, 2015.
10A NCAC 15 .0115 RECORDS
Each licensee and registrant shall maintain records showing
the receipt, transfer, and disposal of all sources of radiation. Additional
record requirements are specified elsewhere in these Rules.
History Note: Authority G.S. 104E‑7; 104E‑12(a);
Eff. February 1, 1980;
Transferred and Recodified from 10 NCAC 3G .2216 Eff.
January 4, 1990;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0115 Eff.
February 1, 2015.
10A NCAC 15 .0116 TESTS
Each licensee and registrant shall perform upon instructions
from the agency, or shall permit the agency to perform, such reasonable tests
as the agency deems appropriate or necessary including, but not limited to,
tests of:
(1) sources of radiation;
(2) facilities wherein sources of radiation are used or
stored;
(3) radiation detection and monitoring instruments; and
(4) other equipment and devices used in connection with
utilization or storage of licensed or registered sources of radiation.
History Note: Authority G.S. 104E‑7; 104E‑7(2);
104E‑11(a);
Eff. February 1, 1980;
Transferred and Recodified from 10 NCAC 3G .2217 Eff.
January 4, 1990;
Transferred and Recodified from 15A NCAC 11 .0116 Eff.
February 1, 2015.
10A NCAC 15 .0117 INCORPORATION BY REFERENCE
(a) For the purpose of the rules in this Chapter, the
following rules, standards and other requirements are hereby incorporated by reference
including any subsequent amendments and editions:
(1) Appendix A, Appendix B, Appendix C, and
Appendix G to 10 CFR Parts 20.1001 - 20.2401;
(2) The following parts of 10 CFR:
(A) Part 21;
(B) Parts 30.1, 30.4 and 30.10;
(C) Part 31, except 31.5;
(D) Parts 32.2, 32.13, 32.24, 32.110, 32.201, 32.210;
(E) Subpart J of 10 CFR Part 35, Parts 35.50, 35.51,
35.55, 35.57, 35.59, 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.432,
35.433, 35.457, 35.490, 35.491, 35.500, 35.590, Subpart H of 10 CFR Part 35,
35.1000;
(F) Part 36;
(G) Part 40, except 40.12(b), 40.23, 40.27, 40.28, 40.31
(j through m), 40.32(d) and portions of (e) pertaining to uranium enrichment,
and 40.32(g), 40.33, 40.38, 40.41(d), 40.41(e)(1), 40.41(e)(3), 40.41(g),
40.41(h), 40.51(b)(6), 40.64, 40.66, 40.67;
(H) Part 61 except 61.16, 61.23(i) and (j);
(I) Part 70, except 70.1 (c), (d), (e), 70.13, 70.14,
70.20(a), (b), 70.21(a)(1), (c), (f through h), 70.22(b), (c), (f through n),
70.23 (a)(6 through 12), (b), 70.23a, 70.24, 70.25(a)(1), 70.31(c through e),
70.32(a)(1), (a)(4 through 7), (b)(1), (b)(3), (b)(4)(c through k), 70.37,
70.40, 70.42(b)(6), 70.44, 70.51(c), 70.52, 70.55(c), 70.59-62, 70.64, 70.65,
70.66, 70.72, 70.73, 70.74, 70.76, 70.82;
(J) Parts 71.0, 71.1, 71.2, 71.3, 71.13, 71.4, 71.5,
71.8, 71.14(a), 71.15, 71.17(a) through (e), 71.20, 71.21, 71.22, 71.23, 71.47,
Subpart G of 10 CFR Part 71, 10 CFR 71.101(a) through (c)(1), 71.101(f),
71.101(g), 71.103, 71.105, 71.127, 71.129, 71.131, 71.133, 71.135, 71.137,
Appendix A to 10 CFR Part 71; and
(K) Part 150 except 150.3 Definition: Foreign
Obligations, 150.7, 150.10, 150.14, 150.15, 150.15a, 150.16-17, 150.17a,
150.19, 150.21.
(3) 21 CFR Part 1010, 21 CFR Part 1020 and 21
CFR Part 1040;
(4) 39 CFR Part 14 and 39 CFR Part 15;
(5) Postal Service Manual (Domestic Mail
Manual) Section 124.3 [incorporated by reference in 39 CFR Section 111.11];
(6) 40 CFR Part 261;
(7) 49 CFR Parts 100-189;
(8) "Agreement Between the United States
Atomic Energy Commission and the State of North Carolina for Discontinuance of
Certain Commission Regulatory Authority and Responsibility within the State
Pursuant to Section 274 of the Atomic Energy Act of 1954, as Amended," signed
July 21, 1964;
(9) "Standards and Specifications for
Geodetic Control Networks" (September 1984);
(10) "Geometric Geodetic Survey Accuracy
Standards and Specifications for Geodetic Surveys Using GPS Relative
Positioning Techniques";
(11) "Reference Man: Anatomical,
Physiological and Metabolic Characteristics" (ICRP Publication No. 23) of
the International Commission on Radiological Protection;
(12) "10 CFR, Chapter 1, Commission Notices,
Policy Statements, Agreement States, 46 FR 7540"; and
(13) American National Standard N43.9 "Radiological
Safety for the Design and Construction of Apparatus for Gamma
Radiography".
(b) The rules, standards and other requirements
incorporated by reference in Paragraph (a) of this Rule are available for
inspection at the Agency at the address listed in Rule .0111 of this Section. Except
as noted in the Subparagraphs of this Paragraph, copies of the rules, standards
and other requirements incorporated by reference in Paragraph (a) of this Rule
may be obtained from the Superintendent of Documents, U.S. Government Printing
Office, Washington, D.C. 20402 at a cost as follows:
(1) Three dollars ($3.00) for the appendixes
listed in Subparagraph (a)(1) of this Rule, available from the Agency;
(2) Sixty-Seven dollars ($67.00) for the
regulations listed in Subparagraph (a)(2) of this Rule in a volume containing
10 CFR Parts 1-50;
(3) Sixty-Four dollars ($64.00) for the
regulations listed in Subparagraph (a)(3) of this Rule in a volume containing
10 CFR Parts 51-199;
(4) Sixty-Six dollars ($66.00) for the
regulations listed in Subparagraph (a)(4) of this Rule in a volume containing
21 CFR Parts 800-1299;
(5) Forty-Seven dollars ($47.00) for the
regulations listed in Subparagraph (a)(5) of this Rule in a volume containing 39
CFR;
(6) Thirty-six dollars ($36.00) for the manual
listed in Subparagraph (a)(6) of this Rule;
http://pe.usps.gov/text/dmm300/dmm300_landing.htm;
(7) Fifty-Six dollars ($56.00) for the
regulations listed in Subparagraph (a)(7) of this Rule in a volume containing
40 CFR Parts 260-299;
(8) For the regulations listed in Subparagraph
(a)(8) of this Rule:
(A) Seventy dollars ($70.00) for a volume containing 49
CFR Parts 100-177; and
(B) Seventy dollars ($70.00) for a volume containing 49
CFR Parts 178-199;
(9) One dollar ($1.00) for the agreement in
Subparagraph (a)(9) of this Rule, available from the Agency;
(10) Two dollars and eighty-five cents ($2.85)
for the standards and specifications in Subparagraph (a)(10) of this Rule,
available from the National Geodetic Information Center, N/CG174, Rockwall
Building, Room 24, National Geodetic Survey, NOAA, Rockville, MD 20852;
(11) Two dollars and eighty-five cents ($2.85)
for the standards and specifications in Subparagraph (a)(11) of this Rule,
available from the National Geodetic Information Center, NCG174, Rockwall
Building, Room 24, National Geodetic Survey, NOAA, Rockville, MD 20852;
(12) Two Hundred Eighteen dollars ($218.00) for
the ICRP Publication No. 23 in Subparagraph (a)(12) of this Rule, available from
Pergamon Press, Inc., Maxwell House, Fairview Park, Elmsford, NY 10523;
(13) Two dollars ($2.00) for the document in
Subparagraph (a)(13) of this Rule, available from the Agency; and
(14) Twenty-Five dollars plus five dollars
shipping and handling ($30.00) for the American National Standard N43.9 in
Subparagraph (a)(14) of this Rule, available from the American National
Standards Institute, Inc., 1430 Broadway, New York, New York 10018, telephone
number (212) 642-4900.
(15) The Code of Federal Regulations is available
free of charge on the internet at
http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR.
(c) Nothing in this incorporation by reference of 10 CFR
Part 61 in Subparagraph (a)(3) of this Rule shall limit or affect the continued
applicability of G.S. 104E-25(a) and (b).
History Note: Authority G.S. 104E-7; 104E-15(a); 104E-25(b);
150B-19(5)(b); 150B-21.6;
Eff. June 1, 1993;
Temporary Amendment Eff. August 20, 1994, for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;
Amended Eff. October 1, 2013; November 1, 2007; August 1,
2002; April 1, 1999; August 1, 1998; May 1, 1995;
Transferred and Recodified from 15A NCAC 11 .0117 Eff.
February 1, 2015.
10A NCAC 15 .0118 OPTIONAL EARLY COMPLIANCE WITH SECTION
.1600
Any licensee or registrant may choose to implement the
rules in Section .1600 of this Chapter prior to the January 1, 1994 effective
date of that Section, in lieu of the rules in Section .0400 of this Chapter,
provided such licensee or registrant shall:
(1) implement all rules in Section .1600 of
this Chapter, except as exempted by the provisions of Rule .1602(c) of this
Chapter;
(2) comply with the rules in Section .1600 of
this Chapter in lieu of any rule in Section .0400 of this Chapter that is cited
in license or registration conditions, except as otherwise provided in Rule
.1602 of this Chapter; and
(3) provide written notification of implementation
to the agency at the address in Rule .0111 of this Section.
History Note: Authority G.S. 104E‑7(a)(2); 104E‑12(a);
Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0118 Eff.
February 1, 2015.
SECTION .0200 ‑ REGISTRATION OF RADIATION MACHINES:
FACILITIES AND SERVICES
Codifier's Note: 10 NCAC 03G .2300 was transferred to 15A
NCAC 11 .0200 effective January 4, 1990. Recodification pursuant to G.S.
143B-279.3.
10A NCAC 15 .0201 PURPOSE AND SCOPE
(a) This Section provides for the registration of radiation
machines, radiation machine facilities and persons who provide other
radiological services.
(b) For purposes of this Section, "facility"
means the location at which one or more radiation machines are installed or
located within one building, vehicle, or under one roof and are under the same
administrative control.
(c) In addition to the requirements of this Section, all
registrants are subject to the provisions of the other sections of this
Chapter.
(d) Special requirements for registration of particle
accelerators are provided in Section .0900 of this Chapter and are in addition
to the requirements of this Section.
(e) In addition to the requirements of this Section, all
registrants are subject to the annual fee provisions contained in Section .1100
of this Chapter.
History Note: Authority G.S. 104E‑7; 104E‑9(8);
104E‑19(a);
Eff. February 1, 1980;
Amended Eff. May 1, 1993; July 1, 1982;
Transferred and Recodified from 15A NCAC 11 .0201 Eff.
February 1, 2015.
10A NCAC 15 .0202 EXEMPTIONS
(a) Electronic equipment that produces radiation incidental
to its operation for other purposes is exempt from the registration and
notification requirements of this Section provided that the dose equivalent
rate average over an area of ten square centimeters does not exceed 0.5 mrem
per hour at five centimeters from any accessible surface of the equipment when
any external shielding is removed. The production, testing, or factory
servicing of such equipment are not exempt.
(b) Radiation machines while in transit or storage incident
thereto are exempt from the requirements of this Section.
(c) Domestic television receivers are exempt from the
requirements of this Section.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0202 Eff.
February 1, 2015.
10A NCAC 15 .0203 APPLICATION: REGISTRATION: RADIATION
MACHINES: FACILITIES
(a) Each person having an unregistered radiation machine or
facility shall:
(1) apply for registration of such facility and
each radiation machine within 30 days following initial operation of that
facility and each radiation machine. Application for registration shall be
completed on agency forms and shall contain all information required by the
forms and accompanying instructions. The registration of the first radiation machine
at a facility constitutes registration of the facility itself.
(2) designate on the application form an
individual who shall be responsible for radiation protection.
(b) Agency forms described in Subparagraph (a)(1) of this
Rule require the following and other information:
(1) name, address and telephone number of the
radiation machine facility;
(2) name of the person responsible for
radiation protection in the facility;
(3) name, training and experience of the person
designated in Subparagraph (a)(2) of this Rule;
(4) the manufacturer, model number, serial
number and type of each radiation machine located within the facility;
(5) the date of the application and the
signatures of the persons specified in Subparagraphs (b)(2) and (3) of this
Rule.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. May 1, 1992;
Transferred and Recodified from 15A NCAC 11 .0203 Eff.
February 1, 2015.
10A NCAC 15 .0204 PROHIBITED SERVICES AND INSTALLATION
(a) Except as provided in Paragraph (b) of this Rule or
otherwise authorized in writing by the agency, each person registered pursuant
to Rule .0203 of this Section shall prohibit any person from furnishing
equipment services described in Rule .0205(d) of this Section to his facility
until such person provides evidence that he is currently registered with the
agency as a provider of such services in accordance with Rule .0205 of this
Section.
(b) No person registered pursuant to the provisions of Rule
.0203 of this Section shall perform any services listed in Rule .0205(d) of
this Section in his facility unless such person satisfies the applicable
requirements in Rules .0205, .0213, and .0214 of this Section and has received
written authorization from the agency to perform such services.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .0204 Eff.
February 1, 2015.
10A NCAC 15 .0205 APPLICATION FOR REGISTRATION OF
SERVICES
(a) Each person who is engaged in the business of
installing or offering to install radiation machines and machine components or
is engaged in the business of furnishing or offering to furnish any equipment
services listed in Paragraph (d) of this Rule in this state, to any agency
licensee or registrant, shall apply for registration of such services with the
agency prior to furnishing or offering to furnish any of these services.
(b) Application for registration shall be completed on
appropriate form(s) provided by the agency and shall contain all information
required by the agency as indicated on the form and accompanying instructions.
This information shall include:
(1) the name, address and telephone number of:
(A) the individual or the company to be registered;
(B) the owner(s) of the company;
(2) the description of the services to be
provided;
(3) the name, training and experience of each
person who provides services specified in Paragraph (d) of this Rule;
(4) the date of the application and the
signature of the person responsible for the company; and
(5) any additional information the agency
determines to be necessary for evaluation of the application for registration.
(c) Each person applying for registration under Paragraph
(a) of this Rule shall certify that he has read and understands the
requirements of the rules in this Chapter.
(d) For the purpose of this Section, equipment services
include:
(1) direct sale and transfer of radiation
machines and machine components to end users;
(2) installation or servicing of radiation
machines and associated radiation machine components;
(3) diagnostic radiographic facility and
shielding design;
(4) diagnostic fluoroscopic facility and
shielding design;
(5) diagnostic area radiation survey, e.g.,
shielding evaluation;
(6) radiation instrument calibration;
(7) therapeutic facility and shielding design,
area radiation survey or calibration;
(8) personnel dosimetry services; and
(9) general health physics consulting, e.g.,
independent diagnostic radiation output measurements, dose analysis, design of
safety programs and radiation safety training programs, non‑healing arts
facility and shielding design and area radiation surveys.
(e) Applicants for registration of services are subject to
the applicable requirements of Rules .0213 and .0214 of this Section.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. June 1, 1993; May 1, 1992; June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .0205 Eff.
February 1, 2015.
10A NCAC 15 .0206 REPORTS OF INSTALLATION
(a) Persons, registered pursuant to Rule .0205 of this
Section, who sell, lease, transfer, lend, dispose of, assemble or install
radiation machines in this state shall, within 30 days after each calendar
quarter, notify the agency at the address in Rule .0111 of this Chapter, of:
(1) whether any radiation machines were
installed, transferred, or disposed of during the calendar quarter;
(2) the name and address of persons who
received radiation machines during the calendar quarter;
(3) the manufacturer, model and serial number
of each radiation machine transferred or disposed of;
(4) the date of transfer of each radiation
machine.
(b) The information specified in Subparagraphs (a)(2), (3)
and (4) of this Rule may be omitted from the quarterly reports required in (a)
of this Rule for any diagnostic x‑ray system which contains certified
components when a copy of the assembler's report prepared in compliance with 21
CFR 1020.30(d) is submitted to the agency.
History Note: Authority G.S. 104E‑7; 104E‑12;
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0206 Eff.
February 1, 2015.
10A NCAC 15 .0207 ISSUANCE OF NOTICE OF REGISTRATION
(a) The agency shall issue a notice of registration upon a
determination that an applicant:
(1) is qualified by reason of education,
training or experience in the use and hazards of radiation sources described in
the application for registration;
(2) has facilities and equipment which meet the
requirements in these Rules;
(3) has established a radiation protection
program, appropriate to the registered activities, which assures compliance
with radiation protection requirements in these Rules; and
(4) meets the applicable requirements in this
Chapter.
(b) The agency may, by registration condition or order,
when not in conflict with any law, waive any requirement in these Rules or
impose requirements with respect to the registrant's receipt, possession, use
and transfer of radiation machines as the agency deems appropriate or necessary
for compliance with the rules in this Chapter. Such additional requirements
are subject to appeal under 15A NCAC 1B .0200.
(c) The agency may refuse to grant a registration required
in Rules .0203 and .0205 of this Section to any applicant who does not possess
adequate qualifications or equipment or satisfy the applicable requirements in
this Chapter; provided that, before any order is entered denying an application
for registration, the agency shall give notice and grant a hearing as provided
in G.S. 150B.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. June 1, 1993; June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .0207 Eff.
February 1, 2015.
10A NCAC 15 .0208 PRIOR NOTIFICATION OF TRANSFER
(a) Persons registered pursuant to Rule .0203 of this
Section shall notify the agency in writing prior to transfer of a registered
radiation machine to another person required to be registered pursuant to Rule
.0203(a) of this Section. This Rule does not prohibit transfer without prior
notification to sales and service companies registered pursuant to Rule .0205
of this Section.
(b) The notification shall include:
(1) the name and address of the transferee, and
(2) the manufacturer, model number and serial
number of the radiation machine to be transferred.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0208 Eff.
February 1, 2015.
10A NCAC 15 .0209 REPORT OF CHANGES
Any registrant shall notify the agency in writing when any
change will render the information contained in the application for
registration or notice of registration no longer accurate.
History Note: Authority G.S. 104E‑7; 104E‑12;
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0209 Eff.
February 1, 2015.
10A NCAC 15 .0210 OTHER PROHIBITED ACTIVITIES
(a) No person registered pursuant to Rule .0205 of this
Section for x‑ray sales or installations shall make, sell, lease,
transfer, lend, assemble, or install radiation machines or equipment used in connection
with such machines unless such machines and equipment when placed in operation
shall meet the applicable requirements of these Rules.
(b) No person, in any advertisement, shall refer to the
fact that he or his facility is registered with the agency pursuant to the
provisions of Rule .0203 or .0205 of this Section and no person shall state or
imply that any activity under such registration has been approved by the
agency.
(c) No person registered pursuant to Rule .0205 of this
Section shall install radiation machines which are subject to provisions of
Section .0600 of this Chapter unless the registrant first determines that the
agency has issued written acknowledgement of receipt of any facility and
shielding design required in Rule .0603 of this Chapter.
History Note: Authority G.S. 104E‑7; 104E‑20;
Eff. February 1, 1980;
Amended Eff. May 1, 1993; June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .0210 Eff.
February 1, 2015.
10A NCAC 15 .0211 OUT‑OF‑STATE RADIATION
MACHINES
(a) No person shall bring any radiation machine into the
state, for any temporary use, unless such person has given a written notice to
the agency at least five working days before the machine is to be used in the
state. The notice shall include the type of radiation machine; the nature,
duration, and scope of use; and the exact location(s) where the radiation
machine is to be used. If, for a specific case, the five working day period
would impose an undue hardship on the person, he may, upon application to the
agency, obtain permission to proceed sooner.
(b) The person in Paragraph (a) of this Rule shall:
(1) comply with all applicable rules in this
Chapter, including registration pursuant to Rule .0203 of this Section; and
(2) supply the agency with such other
information as the agency may reasonably request.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .0211 Eff. February
1, 2015.
10A NCAC 15 .0212 MODIFICATIONS: REVOCATION: TERMINATION
OF REGISTRANTS
(a) The terms and conditions of all registrations are
subject to amendment, revision or modification and all registrations are
subject to suspension or revocation by reason of:
(1) rules adopted pursuant to provisions of the
Act; or
(2) orders issued by the agency pursuant to
provisions of the Act and rules adopted pursuant to provisions of the Act.
(b) Any registration may be revoked, suspended or modified
in whole or in part:
(1) for any material false statement in the
application or in any statement of fact required by provisions of this Section;
(2) because of conditions which would warrant
the agency to refuse to grant a registration on original application revealed
by:
(A) the application;
(B) any statement of fact;
(C) any report, record, inspection or other means; or
(3) for violations of, or failure to observe
any of the terms and conditions of the Act, the registration, the rules of this
Chapter, or order of the agency.
(c) Except in cases of willfulness or those in which the
public health, interest or safety requires otherwise, prior to the institution
of proceedings for modification, revocation or suspension of a registrant, the
agency shall:
(1) call to the attention of the registrant in
writing the facts or conduct which may warrant these actions, and
(2) provide an opportunity for the registrant
to demonstrate or achieve compliance with all lawful requirements.
(d) Before any order is entered suspending, revoking or modifying
a registration, the agency shall give notice and grant a hearing as provided in
Chapter 150B of the North Carolina General Statutes.
(e) The agency may terminate a registration upon written
request submitted by the registrant to the agency.
History Note: Authority G.S. 104E‑7; 104E‑13;
Eff. June 1, 1989;
Amended Eff. June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0212 Eff.
February 1, 2015.
10A NCAC 15 .0213 ADDITIONAL REQUIREMENTS: REGISTERED
SERVICES
(a) An applicant for registration of diagnostic area
radiation survey, diagnostic radiation output measurements or therapeutic
calibration services pursuant to Rule .0205 of this Section shall meet the
following additional requirements:
(1) The applicant shall have adequate radiation
survey and radiation measurement equipment appropriate to the services
requested for authorization.
(2) The applicant shall ensure that the
equipment in Subparagraph (a)(1) of this Rule is calibrated at least every 12
months by persons registered to provide such services pursuant to Rule .0205 of
this Section, except as provided in Subparagraph (a)(3) of this Rule. The
agency may approve less frequent calibration of equipment used for therapy
calibration, provided the applicant satisfies the agency that the proposed
frequency and procedures will provide equivalent or better assurance of proper
calibration.
(3) The applicant may perform the equipment
calibrations required in Subparagraph (a)(2) of this Rule provided that:
(A) such calibrations are currently traceable to the
National Institute of Standards and Technology;
(B) the calibration procedures are approved by the
agency;
(C) the radiation sources used for such calibration are
licensed or registered as required by the rules in this Chapter; and
(D) the equipment is labeled to indicate the date of
calibration and records of the calibration are maintained.
(4) The applicant shall submit:
(A) a description of the procedures that will be used in
performing area radiation surveys including a list of all guides and references
to the employed;
(B) a copy of all forms, reports and documents that will
be supplied to customers;
(C) samples of three different types of surveys;
(D) samples of three reports of diagnostic radiation
output measurements; and
(E) samples of three therapeutic calibration reports.
(b) An applicant for registration of services pursuant to
Rule .0205 of this Section who proposes to provide diagnostic radiographic,
fluoroscopic and therapeutic facility and shielding design services shall meet
the following additional requirements:
(1) The applicant shall submit examples of the
facility and shielding design which will be provided to clients.
(2) The applicant shall submit examples of the
calculations which will be performed as part of the facility and shielding
design along with any guides, occupancy factor rationales, and workload
estimation rationales which will be used.
(3) The applicant shall ensure that the
facility and shielding design services provided to licensees and registrants of
the agency satisfy the applicable requirements in this Chapter.
History Note: Authority G.S. 104E‑7;
Eff. June 1, 1989;
Amended Eff. June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0213 Eff.
February 1, 2015.
10A NCAC 15 .0214 TRAINING AND EDUCATIONAL REQUIREMENTS
FOR EQUIPMENT SERVICES
(a) Each person registered pursuant to Rule .0205 of this
Section shall be qualified by reason of education, training and experience to
provide the services for which registration is requested. The following are
minimum qualifications for specific types of services:
(1) Class I ‑ sales of radiation machines
and machine components to end users: The applicant must certify knowledge of
familiarity with the rules which govern the possession, installation and use of
radiation machines in North Carolina.
(2) Class II ‑ installation and service
of radiation machines and machine components including the making of diagnostic
radiation output measurements to verify performance associated with the
installation or service:
(A) manufacturer's equipment school for service,
maintenance and installation for the type of machine use (e.g. dental
intraoral, medical diagnostic or medical fluoroscopic) or equivalent training;
(B) training in principles of radiation protection; and
(C) three months of experience in installation and
service of radiation machines and machine components.
(3) Class III ‑ diagnostic radiographic
facility and shielding design:
(A) training in principles of radiation protection;
(B) training in shielding design; and
(C) one year of experience in diagnostic radiographic
facility and shielding design for the specific type of machine application.
(4) Class IV ‑ diagnostic fluoroscopic
facility and shielding design:
(A) training in principles of radiation protection;
(B) training in shielding design; and
(C) one year of experience in diagnostic fluoroscopic
facility and shielding design for the specific type of machine application.
(5) Class V ‑ diagnostic area radiation survey,
e.g., shielding evaluation:
(A) training in basic radiological health;
(B) training in shielding evaluation; and
(C) one year of experience performing area radiation
surveys.
(6) Class VI ‑ radiation instrument
calibration: The applicant must possess a current radioactive materials
license or registration authorizing radiation instrument calibration.
(7) Class VII ‑ therapeutic facility and
shielding design, area radiation survey, or calibration:
(A) certification by the American Board of Radiology in
therapeutic radiological physics, radiological physics, roentgen‑ray and
gamma ray physics, or x‑ray and radium physics; or certification by the
American Board of Medical Physics; or
(B) having the following minimum training and
experience:
(i) a master's degree in physics, biophysics,
radiological physics or health physics;
(ii) one year of full‑time training in
therapeutic radiological physics
(iii) one year of full‑time experience in a
therapeutic facility including personal calibration and spot‑check of at
least one machine;
(C) shall submit a description of the procedures that
will be utilized in performing therapeutic calibrations including a list of all
guides and references to be employed;
(D) shall submit a copy of all forms, reports and
documents that will be supplied to customers; and
(E) shall submit one sample of each specific type,
e.g., teletherapy, accelerator.
(8) Class VIII ‑ personnel dosimetry
service: The applicant must hold current personnel dosimetry accreditation
from the National Voluntary Laboratory Accreditation Program (NVLAP) of the
National Institute of Standards and Technology or use NVLAP accredited
dosimetry.
(9) Class IX ‑ general health physics
consulting, e.g., independent diagnostic radiation output measurements, dose
analysis, design of safety programs, and radiation safety training programs,
non‑healing arts facility and shielding design, and area radiation
surveys:
(A) baccalaureate degree in a physical science (e.g.
physics, chemistry or radiologic science), engineering or related field and two
years of progressive experience in medical or health physics; graduate training
in medical or health physics may be substituted on a year for year basis; or
(B) certification by the American Board of Radiology in
therapeutic radiological physics, radiological physics, roentgen‑ray and
gamma ray physics, or x‑ray and radium physics; certification by the
American Board of Health Physics in health physics or certification by the
American Board of Medical Physics.
(b) Any person not meeting the requirements in Paragraph
(a) of this Rule may apply to the agency for registration, provided such person
demonstrates education, training and experience which is equivalent to that
required in Paragraph (a) of this Rule.
(c) Any person registered prior to the effective date of
this Rule to provide equipment services pursuant to Rule .0205 of this Section
shall meet the education, training and experience requirements in Paragraph (a)
or (b) of this Rule no later than 24 months after the effective date of this
Rule.
(d) The agency shall initiate action to terminate the
registration of any person who fails to comply with the requirements of
Paragraph (c) of this Rule.
History Note: Authority G.S. 104E‑7; 104E‑13;
Eff. June 1, 1989;
Amended Eff. June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0214 Eff.
February 1, 2015.
SECTION .0300 ‑ LICENSING OF RADIOACTIVE MATERIAL
Codifier's Note: 10 NCAC 03G .2400 was transferred to 15A
NCAC 11 .0300 effective January 4, 1990. Recodification pursuant to G.S. 143B-279.3.
10A NCAC 15 .0301 PURPOSE AND SCOPE
(a) This Section provides for the licensing of radioactive
material. No person shall receive, possess, use, transfer, own, transport,
manufacture and produce, or acquire radioactive material except as authorized
in a specific or general license issued pursuant to, or as otherwise provided
in, this Section.
(b) In addition to the requirements of this Section:
(1) All licensees are subject to the
requirements of Sections .1000, .1100 and .1600 of this Chapter, except as
otherwise provided in the rules of this Section;
(2) Licensees engaged in industrial
radiographic operations are subject to the requirements of Section .0500 of
this Chapter;
(3) Licensees using sealed sources in the
healing arts are subject to the requirements of Section .0700 of this Chapter;
(4) Licensees engaged in the operation of
radioactive waste disposal facilities are subject to the requirements of
Section .1200 of this Chapter; and
(5) Licensees engaged in well-logging
operations are subject to the requirements of Section .1300 of this Chapter.
(c) The rules in this Section do not apply to persons
licensed pursuant to the rules in Section .1200 of this Chapter except as
specifically provided otherwise in Section .1200.
History Note: Authority G.S. 104E-7; 104E-9(8);
104E-10(b);
Eff. February 1, 1980;
Amended Eff. October 1, 2013; August 1, 1998; January 1,
1994; May 1, 1992; June 1, 1989; July 1, 1982;
Transferred and Recodified from 15A NCAC 11 .0301 Eff.
February 1, 2015.
10A NCAC 15 .0302 EXEMPTIONS FOR SOURCE MATERIAL
(a) Any person is exempt from licensure to the extent that
any person receives, possesses, uses, or transfers source material in any
chemical mixture, compound, solution, or alloy in which the source material is
by weight less than 0.05 percent of the mixture, compound, solution, or alloy.
(b) Any person is exempt from licensure to the extent that
any person receives, possesses, uses, or transfers unrefined and unprocessed
ore containing source material; provided that, except as authorized in a
specific license, no person shall refine or process ore containing source
material.
(c) Any person is exempt from licensure to the extent that
any person receives, possesses, uses, or transfers:
(1) any quantities of thorium contained in:
(A) incandescent gas mantles;
(B) vacuum tubes;
(C) welding rods;
(D) electric lamps for illuminating purposes provided
that each lamp does not contain more than 50 milligrams of thorium;
(E) germicidal lamps, sunlamps, and lamps for outdoor
or industrial lighting provided that each lamp does not contain more than two
grams of thorium;
(F) rare earth metals and compounds, mixtures, and
products containing not more than 0.04 percent by weight thorium, uranium or
any combination of these;
(G) personnel neutron dosimeters, provided that each
dosimeter does not contain more than 50 milligrams of thorium;
(2) source material contained in the following
products:
(A) glazed ceramic tableware, provided that the glaze
contains not more than 20 percent by weight source material;
(B) glassware containing not more than ten percent by
weight source material; but not including commercially manufactured glass
brick, pane glass, ceramic tile, or other glass, or ceramic used in
construction;
(C) piezoelectric ceramic containing not more than two
percent by weight source material;
(D) glass enamel or glass enamel frit containing not
more than ten percent by weight source material imported or ordered for
importation into the United States, or initially distributed by manufacturers
in the United States before July 25, 1983;
(3) photographic film, negatives, and prints
containing uranium or thorium;
(4) any finished product or part fabricated of,
or containing, tungsten or magnesium‑thorium alloys; provided that the
thorium content of the alloy does not exceed four percent by weight and that
the exemption contained in this Rule shall not be deemed to authorize the
chemical, physical, or metallurgical treatment or processing of the product or
part;
(5) uranium contained in counterweights
installed in aircraft, rockets, projectiles and missiles, or stored or handled
in connection with installation or removal of the counterweights when:
(A) the counterweights are manufactured in accordance
with a specific license issued by the U.S. Nuclear Regulatory Commission,
authorizing distribution by the licensee pursuant to 10 CFR 40;
(B) each counterweight has been impressed with the
following legend clearly legible through any plating or other covering, which
states, "DEPLETED URANIUM";
(C) each counterweight is durably and legibly labeled or
marked with the identification of the manufacturer and the statement:
"UNAUTHORIZED ALTERATIONS PROHIBITED";
(D) the exemption contained in this Subparagraph shall
not be deemed to authorize the chemical, physical, or metallurgical treatment
or processing of any counterweights other than repair or restoration of any
plating or other covering;
(E) the requirements specified in Subparagraphs
(c)(5)(B) and (C) of this Rule need not be met by counterweights manufactured
prior to December 31, 1969; provided, that the counterweights are impressed
with the legend, "CAUTION ‑ RADIOACTIVE MATERIAL ‑
URANIUM";
(6) natural or depleted uranium metal used as
shielding constituting part of any shipping container; provided that:
(A) The shipping container is conspicuously and legibly
impressed with the legend, "CAUTION ‑ RADIOACTIVE SHIELDING ‑
URANIUM"; and
(B) The uranium metal is encased in mild steel or
equally fire resistant metal with a minimum wall thickness of one‑eighth
inch or 3.2 mm;
(7) thorium contained in finished optical
lenses, provided that each lens does not contain more than 30 percent by weight
of thorium; and that the exemption contained in this Subparagraph shall not be deemed
to authorize either:
(A) the shaping, grinding, or polishing of the lens or
manufacturing processes other than the assembly of the lens into optical
systems and devices without any alteration of the lens; or
(B) the receipt, possession, use, or transfer of thorium
contained in contact lenses, or in spectacles, or in eye pieces in binoculars
or other optical instruments;
(8) uranium contained in detector heads for use
in fire detection units, provided that each detector head contains not more
than 0.005 microcurie of uranium;
(9) thorium contained in any finished aircraft
engine part containing nickel‑thoria alloy, provided that:
(A) The thorium is dispersed in the nickel‑thoria
alloy in the form of finely divided thoria (thorium dioxide);
(B) The thorium content in the nickel‑thoria alloy
does not exceed four percent by weight.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Amended Eff. June 1, 1989; October 1, 1984; October 1,
1980;
Transferred and Recodified from 15A NCAC 11 .0302 Eff.
February 1, 2015.
10A NCAC 15 .0303 EXEMPT CONCENTRATIONS: OTHER THAN
SOURCE MATERIAL
(a) No person shall introduce radioactive material into a
product or material knowing or having reason to believe that it will be
transferred to persons exempt under Paragraph (d) of this Rule or equivalent
regulations of the U.S. Nuclear Regulatory Commission or any agreement state,
except in accordance with a specific license issued by the Nuclear Regulatory
Commission pursuant to 10 CFR 32.11.
(b) A manufacturer, processor, or producer of a product or
material is exempt from the requirements for a license set forth in the rules
of this Section to the extent that this person transfers radioactive material
contained in a product or material in concentrations not in excess of those
specified in Paragraph (d) of this Rule, and introduced into the product or
material by a licensee holding a specific license issued by the U.S. Nuclear
Regulatory Commission expressly authorizing such introduction. This exemption
does not apply to the transfer of byproduct material contained in any food,
beverage, cosmetic, drug, or other commodity designed for ingestion or
inhalation by, or application to, a human being.
(c) This Rule shall not be deemed to authorize the import
of radioactive material or products containing radioactive material.
(d) Except as provided in Paragraph (a) and (b) of this
Rule, any person is exempt from these Rules to the extent that such person
receives, possesses, uses, transfers, owns, or acquires products or materials
containing radioactive material in concentrations not in excess of those listed
in the following table:
EXEMPT CONCENTRATIONS
Column II
Column I Liquid
and
Gas solid
Element concentration concentration
(atomic number) Isotope microcurie/ml microcurie/ml
Antimony (51) Sb 122 3X10-4
Sb 124 2X10-4
Sb 125 1X10-3
Argon (18) Ar 37 1X10-3
Ar 41 4X10-7
Arsenic (33) As 73 5X10-3
As 74 5X10-4
As 76 2X10-4
As 77 8X10-4
Barium (56) Ba 131 2X10-3
Ba 140 3X10-4
Beryllium (4) Be 7 2X10-2
Bismuth (83) Bi 206 4X10-4
Bromine (35) Br 82 4X10-7 3X10-3
Cadmium (48) Cd 109 2X10-3
Cd 115m 3X10-4
Cd 115 3X10-4
Calcium (20) Ca 45 9X10-5
Ca 47 5X10-4
Carbon (6) C 14 1X10-6 8X10-3
Cerium (58) Ce 141 9X10-4
Ce 143 4X10-4
Ce 144 1X10-4
Cesium (55) Cs 131 2X10-2
Cs 134m 6X10-2
Cs 134 9X10-5
Chlorine (17) Cl 38 9X10-7 4X10-3
Chromium (24) Cr 51 2X10-2
Cobalt (27) Co 57 5X10-3
Co 58 1X10-3
Co 60 5X10-4
Copper (29) Cu 64 3X10-3
Dysprosium (66) Dy 165 4X10-3
Dy 166 4X10-4
Erbium (68) Er 169 9X10-4
Er 171 1X10-3
Europium (63) Eu 152 6X10-4
(Half-life =9.2
Hrs.)
Eu 155 2X10-3
Fluorine (9) F 18 2X10-6 8X10-3
Gadolinium (64) Gd 153 2X10-3
Gd 159 8X10-4
Gallium (31) Ga 72 4X10-4
Germanium (32) Ge 71 2X10-2
Gold (79) Au
196 2X10-3
Au 198 5X10-4
Au 199 2X10-3
Hafnium (72) Hf 181 7X10-4
Hydrogen (1) H 3 5X10-6 3X10-2
Indium (49) In 113m 1X10-2
In 114m 2X10-4
Iodine (53) I 126 3X10-9 2X10-5
I 131 3X10-9 2X10-5
I 132 8X10-8 6X10-4
I 133 1X10-8 7X10-5
I 134 2X10-7 1X10-3
Iridium (77) Ir 190 2X10-3
Ir 192 4X10-4
Ir 194 3X10-4
Iron (26) Fe
55 8X10-3
Fe 59 6X10-4
Krypton (36) Kr 85m 1X10-6
Kr 85 3X10-6
Lanthanum (57) La 140 2X10-4
Lead (82) Pb
203 4X10-3
Lutetium (71) Lu 177 1X10-3
Manganese (25) Mn 52 3X10-4
Mn 54 1X10-3
Mn 56 1X10-3
Mercury (80) Hg 197m 2X10-3
Hg 197 3X10-3
Hg 203 2X10-4
Molybdenum (42) Mo 99 2X10-3
Neodymium (60) Nd 147 6X10-4
Nd 149 3X10-3
Nickel (28) Ni 65 1X10-3
Niobium (Columbium)(41) Nb 95 1X10-3
Nb 97 9X10-3
Osmium (76) Os 185 7X10-4
Os 191m 3X10-2
Os 191 2X10-3
Os 193 6X10-4
Palladium (46) Pd 103 3X10-3
Pd 109 9X10-4
Phosphorus (15) P 32 2X10-4
Platinum (78) Pt 191 1X10-3
Pt 193m 1X10-2
Pt 197m 1X10-2
Pt 197 1X10-3
Potassium (19) K 42 3X10-3
Praseodymium (59) Pr 142 3X10-4
Pr 143 5X10-4
Promethium (61) Pm 147 2X10-3
Pm 149 4X10-4
Rhenium (75) Re 183 6X10-3
Re 186 9X10-4
Re 188 6X10-4
Rhodium (45) Rh 103m 1X10-1
Rh 105 1X10-3
Rubidium (37) Rb 86 7X10-4
Ruthenium (44) Ru 97 4X10-4
Ru 103 8X10-4
Ru 105 1X10-3
Ru 106 1X10-4
Samarium (62) Sm 153 8X10-4
Scandium (21) Sc 46 4X10-4
Sc 47 9X10-4
Sc 48 3X10-4
Selenium (34) Se 75 3X10-3
Silicon (14) Si
31 9X10-3
Silver (47) Ag
105 1X10-3
Ag 110m 3X10-4
Ag 111 4X10-4
Sodium (11) Na 24 2X10-3
Strontium (38) Sr 85 1X10-4
Sr 89 1X10-4
Sr 91 7X10-4
Sr 92 7X10-4
Sulfur (16) S 35 9X10-8 6X10-4
Tantalum (73) Ta 182 4X10-4
Technetium (43) Tc 96m 1X10-1
Tc 96 1X10-3
Tellurium (52) Te 125m 2X10-3
Te 127m 6X10-4
Te 127 3X10-3
Te 129m 3X10-4
Te 131m 6X10-4
Te 132 3X10-4
Terbium (65) Tb 160 4X10-4
Thallium (81) Tl 200 4X10-3
Tl 201 3X10-3
Tl 202 1X10-3
Tl 204 1X10-3
Thulium (69) Tm 170 5X10-4
Tm 171 5X10-3
Tin (50) Sn
113 9X10-4
Sn 125 2X10-4
Tungsten (Wolfram) (74) W 181 4X10-3
W 187 7X10-4
Vanadium (23) V 48 3X10-4
Xenon (54) Xe
131m 4X10-6
Xe 133 3X10-6
Xe 135 1X10-6
Ytterbium (70) Yb 175 1X10-3
Yttrium (39) Y 90 2X10-4
Y 91m 3X10-2
Y 91 3X10-4
Y 92 6X10-4
Y 93 3X10-4
Zinc (30) Zn
65 1X10-3
Zn 69m 7X10-4
Zn 69 2X10-2
Zirconium (40) Zr 95 6X10-4
Zr 97 2X10-4
Beta or gamma emitting 1X10-10 1X10-6
radioactive material not
listed above with half-life
less than 3 years
(e) In Column I of the table, in Paragraph (d) of this
Rule, values are given only for those materials normally used as gases.
(f) In Column II of the table, in Paragraph (d) of this
Rule, the units, microcuries per gram, are used for solids.
(g) Many radioisotopes disintegrate into isotopes which are
also radioactive. In expressing the concentrations in Paragraph (d) of this
Rule, the activity stated is that of the parent isotope and takes into account
the daughters.
(h) For purposes of this Rule, where a combination of
isotopes is involved, the limit for the combination shall be derived as
follows: Determine for each isotope in the product the ratio between the
concentration present in the product and the exempt concentration established
in Paragraph (d) of this Rule for the specific isotope when not in combination.
The sum of the ratios shall not exceed unity. An example of this is:
Concentration
of Isotope A in Product +
Exempt concentration of Isotope A
Concentration
of Isotope B in Product less than or equal to 1
Exempt
concentration of Isotope B
History Note: Authority G.S. 104E-7; 104E-10; 104E-20; 10
CFR 30.70;
Eff. February 1, 1980;
Amended Eff. October 1, 2013; May 1, 1993; June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .0303 Eff.
February 1, 2015.
10A NCAC 15 .0304 EXEMPT QUANTITIES: OTHER THAN SOURCE
MATERIAL
(a) Any person who possesses radioactive material received
or acquired under the general license formerly provided in Rule .0303(b) of
this Section is exempt from the requirements for a license set forth in this
Section to the extent that such person possesses, uses, transfers or owns such
radioactive material.
(b) This Rule does not authorize the production, packaging
or repackaging of radioactive material for purposes of commercial distribution,
or the incorporation of radioactive material into products intended for
commercial distribution.
(c) No person shall, for the purposes of commercial
distribution, transfer individual quantities of radioactive materials to
persons exempt from regulation in Paragraph (a) of this Rule except in
accordance with a specific license issued by the U.S. Nuclear Regulatory
Commission pursuant to Section 32.18 of 10 CFR Part 32 for source and byproduct
material.
(d) Licensees for commercial distribution shall not
transfer the quantities of radioactive material to persons exempt under
Paragraph (f) of this Rule if the licensee knows or has reason to believe that
the recipient will redistribute the quantities to persons exempt under
Paragraph (f) of this Rule.
(e) No person may, for purposes of producing an increased
radiation level, combine quantities of radioactive material covered by this
exemption so that the aggregate quantity exceeds the limits in Paragraph (f) of
this Rule, except for radioactive material combined within a device placed in
use before May 3, 1999, or as otherwise permitted by the rules in this Section.
(f) Except as provided in Paragraphs (b) and (c) of this
Rule, any person is exempt from the rules of this Chapter to the extent that
such person receives, possesses, uses, transfers, owns or acquires radioactive
material in individual quantities each of which does not exceed the applicable
quantity set forth in the following table:
EXEMPT QUANTITIES
Radioactive
Material Microcuries
Antimony-122 (Sb
122) 100
Antimony-124 (Sb
124) 10
Antimony-125 (Sb
125) 10
Arsenic-73 (As
73) 100
Arsenic-74 (As
74) 10
Arsenic-76 (As
76) 10
Arsenic-77 (As
77) 100
Barium-131 (Ba
131) 10
Barium-133 (Ba
133) 10
Barium-140 (Ba
140) 10
Bismuth-210 (Bi
210) 1
Bromine-82 (Br
82) 10
Cadmium-109 (Cd
109) 10
Cadmium-115m (Cd
115m) 10
Cadmium-115 (Cd
115) 100
Calcium-45 (Ca
45) 10
Calcium-47 (Ca
47) 10
Carbon-14 (C 14) 100
Cerium-141 (Ce
141) 100
Cerium-143 (Ce
143) 100
Cerium-144 (Ce
144) 1
Cesium-129 (Cs
129) 100
Cesium-131 (Cs
131) 1,000
Cesium-134m (Cs
134m) 100
Cesium-134 (Cs
134) 1
Cesium-135 (Cs
135) 10
Cesium-136 (Cs
136) 10
Cesium-137 (Cs
137) 10
Chlorine-36 (Cl
36) 10
Chlorine-38 (Cl
38) 10
Chromium-51 (Cr
51) 1,000
Cobalt-57 (Co
57) 100
Cobalt-58m (Co
58m) 10
Cobalt-58 (Co
58) 10
Cobalt-60 (Co
60) 1
Copper-64 (Cu
64) 100
Dysprosium-165
(Dy 165) 10
Dysprosium-166
(Dy 166) 100
Erbium-169 (Er
169) 100
Erbium-171 (Er
171) 100
Europium-152 (Eu
152) 9.2h 100
Europium-152 (Eu
152) 13 yr 1
Europium-154 (Eu
154) 1
Europium-155 (Eu
155) 10
Fluorine-18 (F
18) 1,000
Gadolinium-153
(Gd 153) 10
Gadolinium-159
(Gd 159) 100
Gallium-67 (Ga
67) 100
Gallium-72 (Ga
72) 10
Germanium-68 (Ge
68) 10
Germanium-71 (Ge
71) 100
Gold-195 (Au
195) 10
Gold-198 (Au
198) 100
Gold-199 (Au
199) 100
Hafnium-181 (Hf
181) 10
Holmium-166 (Ho
166) 100
Hydrogen-3 (H 3) 1,000
Indium-111 (In
111) 100
Indium-113m (In
113m) 100
Indium-114m (In
114m) 10
Indium-115m (In
115m) 100
Indium-115 (In
115) 10
Iodine-123 (I
123) 100
Iodine-125 (I
125) 1
Iodine-126 (I
126) 1
Iodine-129 (I
129) 0.1
Iodine-131 (I
131) 1
Iodine-132 (I
132) 10
Iodine-133 (I
133) 1
Iodine-134 (I
134) 10
Iodine-135 (I
135) 10
Iridium-192 (Ir
192) 10
Iridium-194 (Ir
194) 100
Iron-52 (Fe 52) 10
Iron-55 (Fe 55) 100
Iron-59 (Fe 59) 10
Krypton-85 (Kr
85) 100
Krypton-87 (Kr
87) 10
Lanthanum-140
(La 140) 10
Lutetium-177 (Lu
177) 100
Manganese-52 (Mn
52) 10
Manganese-54 (Mn
54) 10
Manganese-56 (Mn
56) 10
Mercury-197m (Hg
197m) 100
Mercury-197 (Hg
197) 100
Mercury-203 (Hg
203) 10
Molybdenum-99
(Mo 99) 100
Neodymium-147
(Nd 147) 100
Neodymium-149
(Nd 149) 100
Nickel-59 (Ni
59) 100
Nickel-63(Ni 63) 10
Nickel-65 (Ni
65) 100
Niobium-93m (Nb
93m) 10
Niobium-95 (Nb
95) 10
Niobium-97 (Nb
97) 10
Osmium-185 (Os
185) 10
Osmium-191m (Os
191m) 100
Osmium-191 (Os
191) 100
Osmium-193 (Os
193) 100
Palladium-103
(Pd 103) 100
Palladium-109
(Pd 109) 100
Phosphorus-32 (P
32) 10
Platinum-191 (Pt
191) 100
Platinum-193m
(Pt 193m) 100
Platinum-193 (Pt
193) 100
Platinum-197m
(Pt 197m) 100
Platinum-197 (Pt
197) 100
Polonium-210 (Po
210) 0.1
Potassium-42 (K
42) 10
Potassium-43 (K
43) 10
Praseodymium-142
(Pr 142) 100
Praseodymium-143
(Pr 143) 100
Promethium-147
(Pm 147) 10
Promethium-149
(Pm 149) 10
Rhenium-186 (Re
186) 100
Rhenium-188 (Re
188) 100
Rhodium-103m (Rh
103m) 100
Rhodium-105 (Rh
105) 100
Rubidium-81 (Rb
81) 10
Rubidium-86 (Rb
86) 10
Rubidium-87 (Rb
87) 10
Ruthenium-97 (Ru
97) 100
Ruthenium-103
(Ru 103) 10
Ruthenium-105 (Ru
105) 10
Ruthenium-106
(Ru 106) 1
Samarium-151 (Sm
151) 10
Samarium-153 (Sm
153) 100
Scandium-46 (Sc
46) 10
Scandium-47 (Sc
47) 100
Scandium-48 (Sc
48) 10
Selenium-75 (Se
75) 10
Silicon-31 (Si
31) 100
Silver-105 (Ag
105) 10
Silver-110m (Ag
110m) 1
Silver-111 (Ag
111) 100
Sodium-22 (Na
22) 10
Sodium-24 (Na
24) 10
Strontium-85 (Sr
85) 10
Strontium-89 (Sr
89) 1
Strontium-90 (Sr
90) 0.1
Strontium-91 (Sr
91) 10
Strontium-92 (Sr
92) 10
Sulfur-35 (S 35) 100
Tantalum-182 (Ta
182) 10
Technetium-96
(Tc 96) 10
Technetium-97m
(Tc 97m) 100
Technetium-97
(Tc 97) 100
Technetium-99m
(Tc 99m) 100
Technetium-99
(Tc 99) 10
Tellurium-125m
(Te 125m) 10
Tellurium-127m
(Te 127m) 10
Tellurium-127
(Te 127) 100
Tellurium-129m
(Te 129m) 10
Tellurium-129
(Te 129) 100
Tellurium-131m
(Te 131m) 10
Tellurium-132
(Te 132) 10
Terbium-160 (Tb
160) 10
Thallium-200 (Tl
200) 100
Thallium-201 (Tl
201) 100
Thallium-202 (Tl
202) 100
Thallium-204 (Tl
204) 10
Thulium-170 (Tm
170) 10
Thulium-171 (Tm
171) 10
Tin-113 (Sn 113) 10
Tin-125 (Sn 125) 10
Tungsten-181 (W
181) 10
Tungsten-185 (W
185) 10
Tungsten-187 (W
187) 100
Vanadium-48 (V
48) 10
Xenon-131m (Xe
131m) 1,000
Xenon-133 (Xe
133) 100
Xenon-135 (Xe
135) 100
Ytterbium-175
(Yb 175) 100
Yttrium-87 (Y
87) 10
Yttrium-88 (Y
88) 10
Yttrium-90 (Y
90) 10
Yttrium-91 (Y
91) 10
Yttrium-92 (Y
92) 100
Yttrium-93 (Y
93) 100
Zinc-65 (Zn 65) 10
Zinc-69m (Zn
69m) 100
Zinc-69 (Zn 69) 1,000
Zirconium-93 (Zr
93) 10
Zirconium-95 (Zr
95) 10
Zirconium-97 (Zr
97) 10
Any radioactive
material
not listed above
other than
alpha emitting
radioactive
material 0.1
History Note: Authority G.S. 104E-7; 104E-10(b); 104E-20;
10 CFR 30.71;
Eff. February 1, 1980;
Amended Eff. October 1, 2013; May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0304 Eff.
February 1, 2015.
10A NCAC 15 .0305 EXEMPT ITEM CONTAINING OTHER THAN
SOURCE MATERIAL
(a) Authority must be obtained from the U.S. Nuclear
Regulatory Commission to transfer possession or control by the manufacturer,
processor, or producer of any equipment, device, commodity, or other product
containing source, byproduct, or special nuclear material whose subsequent
possession, use, transfer, and disposal are exempted from the rules of this
Chapter.
(b) Except for persons who apply radioactive material to,
or persons who incorporate radioactive material into, the following products, or
persons who initially transfer for sale or distribution the following products,
any person is exempt from the rules of this Chapter to the extent that he
receives, possesses, uses, transfers, owns, or acquires the following products:
(1) Timepieces or hands or dials containing not
more than the following quantities of radioactive material and not exceeding
the following levels of radiation:
(A) 25 millicuries of tritium per timepiece;
(B) five millicuries of tritium per hand;
(C) 15 millicuries of tritium per dial (bezels when used
shall be considered as part of the dial);
(D) 100 microcuries of promethium-147 per watch or 200
microcuries of promethium-147 per any other timepiece;
(E) 20 microcuries of promethium-147 per watch hand or
40 microcuries of promethium-147 per other timepiece hand;
(F) 60 microcuries of promethium-147 per watch dial or
120 microcuries of promethium-147 per other timepiece dial (bezels when used
shall be considered as part of the dial);
(G) the levels of radiation from hands and dials
containing promethium-147, when measured through 50 milligrams per square
centimeter of absorber:
(i) for wrist watches, 0.1 millirad per hour at 10
centimeters from any surface;
(ii) for pocket watches, 0.1 millirad per hour at
one centimeter from any surface;
(iii) for any other timepiece, 0.2 millirad per hour
at 10 centimeters from any surface; or
(iv) one microcurie of radium-226 per timepiece in
intact timepieces manufactured prior to November 30, 2007.
(2) Balances of precision containing not more
than one millicurie of tritium per balance or not more than 0.5 millicurie of
tritium per balance part manufactured before December 17, 2007;
(3) Marine compasses containing not more than
750 millicuries of tritium gas and other marine navigational instruments
containing not more than 250 millicuries of tritium gas manufactured before
December 17, 2007;
(4) Ionization chamber smoke detectors
containing not more than one microcurie of americium-241 per detector in the
form of a foil and designed to protect life and property from fires.
(5) Electron tubes, provided that each tube
does not contain more than one of the following specified quantities of
radioactive material and provided further, that the levels of radiation from
each electron tube containing radioactive material does not exceed one millirad
per hour at one centimeter from any surface when measured through seven
milligrams per square centimeter of absorber. For purposes of this
Subparagraph, "electron tubes" include spark gap tubes, power tubes,
gas tubes including glow lamps, receiving tubes, microwave tubes, indicator
tubes, pickup tubes, radiation detection tubes and any other completely sealed
tube that is designed to conduct or control electrical currents:
(A) 150 millicuries of tritium per microwave receiver
protector tube or 10 millicuries of tritium per any other electron tube;
(B) one microcurie of cobalt-60;
(C) five microcuries of nickel-63;
(D) 30 microcuries of krypton-85;
(E) five microcuries of cesium-137; and
(F) 30 microcuries of promethium-147; and
(6) Ionizing radiation measuring instruments
containing for purposes of internal calibration or standardization, sources of
radioactive material each not exceeding the applicable quantity set forth in
Rule .0304(f) of this Section, and each instrument contains no more than 10 exempt
quantities.
(c) For purposes of Subparagraph (b)(5) of this Rule, where
there is involved a combination of radionuclides, the limit for the combination
shall be derived as follows:
(1) Determine for each radionuclide in an
ionizing radiation measuring instrument the ratio between the quantity present
in the instrument and the exempt quantity established in Rule .0304 (f) of this
Section for the specific radionuclide when not in combination;
(2) No ratio shall exceed one and the sum of
such ratios shall not exceed 10; and
(3) For the purpose of Part (b)(8), 0.05
microcurie of americium-241 is considered an exempt quantity under Rule .0304
of this Section.
(d) Self-luminous products are exempt as provided in this
Paragraph.
(1) Except for persons who manufacture,
process, or produce self-luminous products containing tritium, krypton-85, or
promethium-147, any person is exempt from the rules of this Chapter to the
extent that the person receives, possesses, uses, transfers, owns, or acquires
tritium, krypton-85 or promethium-147 in self-luminous products manufactured,
processed, produced, imported, or transferred in accordance with a specific
license issued by the U.S. Nuclear Regulatory Commission pursuant to Section
32.22 of 10 CFR Part 32, which license authorizes the transfer of the product
to persons who are exempt from regulatory requirements.
(2) The exemption in Subparagraph (d)(1) of
this Rule does not apply to tritium, krypton-85, or promethium-147 used in
products for frivolous purposes or in toys or adornments.
(e) Gas and aerosol detectors are exempt as provided in
this Paragraph.
(1) Except for persons who manufacture,
process, produce, or initially transfer for sale or distribution gas and
aerosol detectors containing radioactive material, any person is exempt from
the rules of this Chapter to the extent that the person receives, possesses,
uses, transfers, owns or acquires radioactive material in gas and aerosol
detectors designed to protect life or property from fires and airborne hazards
provided that detectors containing radioactive material shall be manufactured, processed,
produced, or initially transferred in accordance with a specific license issued
by the U.S. Nuclear Regulatory Commission pursuant to Section 32.26 of 10 CFR
32, which authorizes the transfer of the detectors to persons who are exempt
from regulatory requirements.
(2) Gas and aerosol detectors previously
manufactured and distributed to general licensees before November 30, 2007 in
accordance with a specific license issued by an agreement state are exempt from
the rules in this Chapter, provided that the devices are labeled in accordance
with the specific license authorizing distribution of the general licensed
device, and providing further that the devices meet the requirements of Rule
.0327 of this Section.
(f) Except as follows, any person is exempt from the
requirements for a license set forth in this Section provided that such person
receives, possesses, uses, transfers, owns or acquires capsules containing
approximately one microcurie (37kBq) Carbon-14 urea each for
"in-vivo" diagnostic use for humans:
(1) Any person who desires to use the capsules
for research involving human subjects shall apply for and receive a specific
license from the agency; and
(2) Any person who desires to manufacture,
prepare, process, produce, package, repackage, or transfer for commercial
distribution such capsules shall apply for and receive a specific license from
the U.S. Nuclear Regulatory Commission.
(g) Nothing in this Rule relieves persons from complying
with applicable FDA and other federal regulations, and North Carolina
requirements governing the receipt, administration, and use of drugs.
History Note: Authority G.S. 104E-7; 104E-10(b); 104E-20;
10 CFR 30.15; 10 CFR 30.19; 10 CFR 30.20;
Eff. February 1, 1980;
Amended Eff. October 1, 2013; April 1, 1999; June 1,
1993; October 1, 1982; September 1, 1981;
Transferred and Recodified from 15A NCAC 11 .0305 Eff.
February 1, 2015.
10A NCAC 15 .0306 TYPES OF LICENSES: GENERAL AND
SPECIFIC
(a) General licenses provided in this Section are effective
without the filing of applications with the agency or the issuance of licensing
documents to the general licensee, although registration with the agency may be
required by the particular general license. The general license is subject to
all other applicable rules in this Chapter and any limitations contained in a
general license document, if issued.
(b) Specific licenses require the submission of an
application to the agency and the issuance of a licensing document by the
agency. The licensee is subject to all applicable rules of this Chapter as
well as any limitations and requirements specified in the licensing document.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Amended Eff. January 1, 2005;
Transferred and Recodified from 15A NCAC 11 .0306 Eff.
February 1, 2015.
10A NCAC 15 .0307 GENERAL LICENSES: SOURCE MATERIAL
(a) A general license shall be issued authorizing use and
transfer of not more than 15 pounds of source material at any one time by
persons in the following categories:
(1) pharmacists using the source material
solely for the compounding of medicinals;
(2) physicians using the source material for
medicinal purposes;
(3) persons receiving possession of source
material from pharmacists and physicians in the form of medicinals or drugs;
(4) commercial and industrial firms, and
research, educational, and medical institutions, and state and local
governmental agencies for research, development, educational, commercial or
operational purposes.
(b) Pursuant to this general license no person shall
receive more than a total of 150 pounds of source material in any one calendar
year.
(c) Persons who receive, possess, use, or transfer source
material pursuant to the general license issued in Paragraph (a) of this Rule
are exempt from the provisions of Sections .1000 and .1600 of this Chapter to
the extent that the receipt, possession, use, or transfer is within the terms
of the general license, provided that this exemption shall not be deemed to
apply to any person who is also in possession of source material under a
specific license issued pursuant to the rules in this Section.
(d) A general license shall be issued authorizing the
receipt of title to source material without regard to quantity. This general
license does not authorize any person to receive, possess, use, or transfer
source material.
(e) A general license shall be issued to receive, acquire,
possess, use, or transfer in accordance with the provisions of Subparagraphs
(e)(2), (3), (4) and (5) of this Rule, depleted uranium contained in industrial
products or devices for the purpose of providing a concentrated mass in a small
volume of the product or device.
(1) The general license in Paragraph (e) of
this Rule applies only to industrial products or devices which have been
manufactured either in accordance with a specific license issued to the
manufacturer of the products or devices pursuant to Rule .0336 of this Section
or in accordance with a specific license issued to the manufacturer by the U.S.
Nuclear Regulatory Commission or an agreement state which authorizes
manufacture of the products or devices for distribution to persons generally
licensed by the U.S. Nuclear Regulatory Commission or an agreement state.
(2) Persons who receive, acquire, possess, or
use depleted uranium pursuant to the general license established by Paragraph
(e) of this Rule shall file with the agency appropriate form(s) provided by the
agency. The form shall be submitted within 30 days after the first receipt or
acquisition of such depleted uranium. The registrant shall furnish on
appropriate form(s) provided by the agency the following information and such
other information as may be required by that form:
(A) name and address of the registrant;
(B) a statement that the registrant has developed and
will maintain procedures designed to establish physical control over the
depleted uranium described in Paragraph (e) of this Rule and designed to
prevent transfer of such depleted uranium in any form, including metal scrap,
to persons not authorized to receive the depleted uranium; and
(C) name, title, address, and telephone number of the
individual duly authorized to act for and on behalf of the registrant in
supervising the procedures identified in Part (e)(2)(B) of this Rule.
(3) The registrant possessing or using depleted
uranium under the general license established by Paragraph (e) of this Rule
shall report in writing to the agency any changes in information furnished by
him on the appropriate form(s) provided by the agency. The report shall be
submitted within 30 days after the effective date of such change.
(4) A person who receives, acquires, possesses,
or uses depleted uranium pursuant to the general license established by
Paragraph (e) of this Rule shall:
(A) not introduce such depleted uranium, in any form,
into a chemical, physical or metallurgical treatment or process, except a
treatment or process for repair or restoration of any plating or other covering
of the depleted uranium;
(B) not abandon such depleted uranium;
(C) transfer or dispose of such depleted uranium only by
transfer in accordance with the provisions of Rule .0343 of this Section;
(i) In the case where the transferee receives the
depleted uranium pursuant to the general license established by Paragraph (e)
of this Rule, the transferor shall furnish the transferee a copy of this Rule
and a copy of the appropriate agency form described in Subparagraph (e)(2) of
this Rule;
(ii) In the case where the transferee receives the
depleted uranium pursuant to a general license contained in the U.S. Nuclear
Regulatory Commission or agreement state regulations equivalent to Paragraph
(e) of this Rule, the transferor shall furnish the transferee a copy of this
Rule and a copy of the appropriate agency form accompanied by a note explaining
that use of the product or device is regulated by the U.S. Nuclear Regulatory
Commission or agreement state under requirements substantially the same as
those in this Rule;
(D) within 30 days of any transfer, report in writing to
the agency the name and address of the person receiving the depleted uranium
pursuant to such transfer;
(E) not export such depleted uranium except in
accordance with a license issued by the U.S. Nuclear Regulatory Commission
pursuant to 10 CFR Part 110.
(5) Any person receiving, acquiring,
possessing, using, or transferring depleted uranium pursuant to the general
license established by Paragraph (e) of this Rule is exempt from the
requirements of Sections .1000 and .1600 of this Chapter with respect to the
depleted uranium covered by that general license.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Amended Eff. January 1, 1994; May 1, 1992;
Transferred and Recodified from 15A NCAC 11 .0307 Eff.
February 1, 2015.
10A NCAC 15 .0308 GENERAL LICENSES: OTHER THAN SOURCE
MATERIAL
(a) A general license shall be issued to transfer, receive,
acquire, own, possess, and use radioactive material incorporated in the
following devices or equipment which have been manufactured, tested and labeled
by the manufacturer in accordance with a specific license issued to the
manufacturer by the U.S. Nuclear Regulatory Commission for use pursuant to
Section 31.3 of 10 CFR Part 31:
(1) static elimination devices designed for use
as static eliminators which contain as a sealed source or sources, radioactive
material consisting of a total of not more than 500 microcuries of polonium‑210
per device;
(2) ion generating tube designed for ionization
of air and containing, as a sealed source or sources, radioactive material
consisting of a total of not more than 500 microcuries of polonium‑210
per device or a total of not more than 50 millicuries of hydrogen‑3
(tritium) per device.
(b) The general license in Paragraph (a) of this Rule is
subject to the provisions of Rules .0107 to .0111, .0303(a), .0338, .0342,
.0343 and .0345 of this Chapter and to labeling requirements in Section .1600
of this Chapter.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Amended Eff. January 1, 2005; January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0308 Eff.
February 1, 2015.
10A NCAC 15 .0309 GENERAL LICENSES: MEASURING GAUGING:
CONTROLLING DEVICES
(a) A general license shall be issued to acquire, receive,
possess, use, or transfer in accordance with Paragraphs (b), (c), and (d) of
this Rule, radioactive material contained in devices designed and manufactured
for the purpose of detecting, measuring, gauging, or controlling thickness,
density, level, interface location, radiation leakage, or qualitative or
quantitative chemical composition, or for producing light or an ionized atmosphere
to:
(1) commercial and industrial firms;
(2) research, educational and medical
institutions;
(3) individuals in the conduct of their
business; and
(4) federal, state, or local government
agencies.
(b) The general license in Paragraph (a) of this Rule
applies only to radioactive material contained in devices which have been:
(1) manufactured or initially transferred and
labeled in accordance with the specifications contained in a specific license
issued pursuant to Rule .0328 of this Section or in accordance with the
specifications contained in a specific license issued by the U.S. Nuclear
Regulatory Commission or an agreement state which authorizes distribution of
the devices to persons generally licensed pursuant to equivalent regulations;
and
(2) received from one of the specific licensees
referenced in Subparagraph (b)(1) of this Rule or through a transfer completed
in accordance with Subparagraph (c)(8) or (c)(9) of this Rule.
(c) Any person who acquires, receives, possesses, uses or
transfers radioactive material in a device pursuant to the general license
issued under Paragraph (a) of this Rule shall:
(1) assure that all labels, affixed to the
device at the time of receipt and bearing a statement that removal of the label
is prohibited, are maintained thereon and shall comply with all instructions
and precautions provided by the labels;
(2) assure that the device is tested for
leakage of radioactive material and proper operation of the on-off mechanism
and indicator, if any, at six-month intervals or at alternative intervals as
are specified in the label, except as follows:
(A) Devices containing only krypton need not be tested
for leakage of radioactive material; and
(B) Devices containing only tritium or not more than 100
microcuries of other beta, gamma, or beta and gamma emitting material or 10
microcuries of alpha emitting material and devices held in storage in the
original shipping container prior to initial installation need not be tested
for any purpose;
(3) assure that the tests required by
Subparagraph (c)(2) of this Rule and other testing, installation, servicing and
removal from installation involving the radioactive materials, its shielding or
containment are performed:
(A) in accordance with the instructions provided on
labels affixed to the device, except that tests for leakage or contamination
may be performed by the general licensee using leak test kits provided and
analyzed by a specific licensee who is authorized to provide leak test kit
services; or
(B) by a person holding a specific license or
registration which authorizes the providing of services required by this Rule
and which is issued pursuant to Rules .0205 and .0306 of this Chapter or
equivalent regulations of the U.S. Nuclear Regulatory Commission or an
agreement state;
(4) maintain records, showing compliance with
the requirements in Subparagraphs (c)(2) and (3) of this Rule, including:
(A) the name of the person(s) performing the test(s) and
the date(s) of the test(s);
(B) the name of the person(s) performing installation,
servicing and removal of any radioactive material, shielding or containment;
(C) the retention of leakage or contamination, on-off
mechanism and on-off indicator test records shall be retained for three years
after the required test is performed or until the sealed source is disposed of
or transferred; and
(D) the retention of other records of tests required in
Subparagraph (c)(3) of this Rule shall be retained for three years from the
date of the recorded test or until the device is disposed of or transferred.
(5) upon the occurrence of a failure of or
damage to, or any indication of a possible failure of or damage to, the
shielding of the radioactive material or the on-off mechanism or indicator, or
upon the detection of 0.005 microcurie or more removable radioactive material,
immediately suspend operation of the device until it has been:
(A) repaired by the manufacturer or other person
authorized to repair the device(s) by a specific license issued by the agency,
the U.S. Nuclear Regulatory Commission, or an agreement state; or
(B) disposed of by transfer to a person authorized by a
specific license to receive the radioactive material contained in the device;
and within 30 days, the transferor will furnish to the agency at the address in
Rule .0111 of this Chapter a report containing a description of the event and
the remedial action taken. If 0.005 microcurie or more of removable
radioactive contamination is detected, or if the failure of or damage to a
source of radiation is likely to result in the contamination of the facility or
the environment, a plan for ensuring that the facility and the environment are
acceptable for unrestricted use shall be submitted to the agency at the address
in Rule .0111 of this Chapter.
(6) not abandon the device containing
radioactive material;
(7) except as provided in Subparagraph (c)(8) or
(c)(9) of this Rule, transfer or dispose of the device containing radioactive
material only by export in accordance with 10 CFR Part 110 or by transfer to a
person holding a specific license authorizing receipt of the device; and, within
30 days after transfer of a device to a specific licensee or export of a
device, shall furnish to the agency at the address in Rule .0111 of this
Chapter, a report that contains:
(A) the identification of the device by manufacturer's
or initial transferor's name, model number, and serial number;
(B) the name, address and specific license number of the
person receiving the device (the license number not applicable if exported);
and
(C) the date of the transfer; and
(8) obtain written approval by the Agency
before transferring the device to any other specific licensee not identified in
this Rule. However, a holder of a specific license may transfer a device for
possession and use under its own specific license without prior approval, if
the holder:
(A) verifies that the specific license authorizes the
possession and use, or applies for and obtains an amendment to the license
authorizing the possession and use;
(B) removes, alters, covers, or clearly and
unambiguously augments as defined in 10 CFR 31.5 the existing label otherwise
required by Paragraph (c)(1) of this Rule so that the device is labeled in
compliance with Rule .0328(a)(3) of this Chapter; however, the manufacturer,
model number, and serial number must be retained;
(C) obtains the manufacturer's or initial transferor's
information concerning maintenance that are applicable under the specific
license (such as leak testing procedures); and
(D) reports the transfer under Subparagraph (c)(7) of
this Rule.
(9) transfer or dispose of the device by export
as provided by Subparagraph (c)(7) of this Rule, or by transfer to another
general licensee only where the device:
(A) remains in use at a particular location. The
transferor shall give the transferee a copy of this Rule and any safety
documents identified in the label of the device. The transferor shall, within
30 days of the transfer, report to the agency at the address in Rule .0111 of
this Chapter the manufacturer's or initial transferor's name, serial number,
and model number of device transferred; the name and mailing address of the
transferee; and the name, title, and telephone number of the individual
identified by the transferee pursuant to Subparagraph (c)(11) of this Rule; or
(B) is held in storage by the licensee or an
intermediate person in the original shipping container at its intended location
of use prior to initial use by a general licensee;
(10) comply with the provisions of Sections .0100
and .1600 of this Chapter for reporting radiation incidents, theft or loss of
licensed material, but is exempt from the other requirements of Section .1600
of this Chapter;
(11) appoint an individual responsible for having
knowledge of the requirements contained in these Rules and the authority for
taking the actions required to comply with these Rules. The general licensee,
through this individual, shall ensure the day-to-day compliance with these
Rules. The appointment of such an individual does not relieve the general
licensee of any of its responsibility in this regard;
(12) register, when required by the agency, any
source of radiation subject to a general license in accordance with the rules
in this Section. Each address for a location of use represents a separate
general license and requires a separate registration action;
(13) register, on an annual basis, all devices
containing, based on the activity indicated on the label, at least 10 mCi (370
MBq) of cesium-137, 0.1 mCi (3.7 MBq) of strontium-90, 1 mCi (37MBq) of
cobalt-60, 1 mCi (37 MBq) of americium-241, 0.1 mCi (3.7 MBq) of radium-226, or
any other transuranic isotope. Each address for a location of use represents a
separate general license and requires a separate registration action. Annual
registration consists of verifying, correcting, or adding to the information
provided in a request for annual registration within 30 days of a request from
the agency. The general licensee shall furnish the following information for
annual registration:
(A) the name and mailing address of the general
licensee;
(B) information about each device to include the
manufacturer or initial transferor, model number, serial number, the
radioisotope, and the activity indicated on the label;
(C) the name, title, and telephone number of the
responsible person designated as a representative of the general licensee in
accordance with Subparagraph (c)(11) of this Rule;
(D) the address or location at which the device(s) are
to be used or stored. For portable devices that are granted a general license
by the agency, the address of the primary place of storage;
(E) certification by the responsible person designated
by the general licensee that the information concerning the device(s) has been
verified through a physical inventory and a check of label information; and
(F) certification by the responsible person designated
by the general licensee that they are aware of the requirements of the general
license;
(14) report changes to the mailing address to the
agency within 30 days of the effective date of the change;
(15) report changes to the name of the general licensee
to the agency within 30 days of the effective date of the change;
(16) respond to written requests from the agency
to provide information relating to the general license within 30 calendar days
of the date of the request, or other time specified in the request. If the
general licensee cannot provide the requested information within the allotted
time, it shall, within that same time period, request a longer period to supply
the information by providing the agency a written justification for the request;
(17) not hold devices that are not in use for
longer than two years. If devices that have shutters are not in use, the
shutter shall be locked in the closed position. Leak testing is not required
during the period of storage; however, when devices are returned to service or
transferred to another person, the devices must be tested for leakage and
shutter operation. Devices kept in standby for future use shall be excluded
from the two year time limit if quarterly physical inventories of these devices
are performed while in standby.
(d) The general license in Paragraph (a) of this Rule does
not authorize the manufacture or import of devices containing radioactive
material.
(e) The general license in Paragraph (a) of this Rule is
subject to the provisions of Rules .0107 to .0111, .0303(a), .0338, .0342,
.0343 and .0345 of this Chapter and to labeling requirements in Section .1600
of this Chapter.
History Note: Authority G.S. 104E-7; 104E-10(b);
Eff. February 1, 1980;
Amended Eff. October 1, 2013; January 1, 2005; January 1,
1994; June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .0309 Eff.
February 1, 2015.
10A NCAC 15 .0310 GENERAL LICENSES: MANUFACTURE,
TRANSFER, INSTALL GENERALLY LICENSED DEVICES
Any person who is authorized to manufacture, install or
service a device described in Rule .0309 of this Section pursuant to a specific
license issued by the agency, the U.S. Nuclear Regulatory Commission or an
agreement state is hereby granted a general license to install and service the
device described in Rule .0309, provided the following requirements are met:
(1) The person shall file a report with the agency
within 30 days after the end of each calendar quarter in which any device is
transferred to or installed in this state. Each report shall identify each
general licensee, to whom the device is transferred by name and address, the
type of device transferred, and the quantity and type of radioactive material
contained in the device;
(2) The device is manufactured, labeled, installed, and
serviced in accordance with applicable provisions of the specific license
issued to the person by the U.S. Nuclear Regulatory Commission or an agreement
state;
(3) The person shall assure that any labels satisfy the
requirements in Rule .0309 of this Section and shall furnish to each general
licensee, to whom he transfers a device or on whose premises he installs a
device, a copy of the general license contained in Rule .0309 of this Section;
(4) The person shall ensure that each device having a
separable source housing that provides the primary shielding for the source
also bears, on the source housing, a durable label containing the device model
and serial number, the isotope and quantity, the words "Caution:
Radioactive Material," the radiation symbol described in Rule .1623 of
this Chapter, and the name of the manufacturer or initial transferor;
(5) The person shall ensure that each device meeting
the criteria of Rule .0309 of this Chapter bears a permanently embossed,
etched, stamped or engraved label affixed to the source housing, if separable,
or the device if the source housing is not separable. The label shall include
the words, "Caution: Radioactive Materials," and, if space and
accessibility permit, the radiation symbol described in Rule .1623 of this
Chapter;
(6) If a device is to be transferred for use under the
general license granted in Rule .0309(c)(12) of this Chapter, each person that
is licensed under this Rule shall provide the following information to each
person to whom the device is being transferred prior to the device being
transferred. In the case of a transfer through an intermediate person, the information
shall also be provided to the intended user prior to the initial transfer to
the intermediate person. The required information includes:
(a) a copy of the general license document
referenced in Rule .0306 of this Chapter or if no license document is issued, a
copy of the letter issued by the agency indicating a license exists in
accordance with Rule .0309 of this Chapter. If the prospective general
licensee is in the jurisdiction of the Nuclear Regulatory Commission or another
Agreement State, the notification shall include a statement advising the
person receiving the device of the agency that has jurisdiction over the
device;
(b) a copy of Rule .0309 of this Section. If
the prospective general licensee is in the jurisdiction of the Nuclear Regulatory
Commission or another Agreement State, the notification of transfer shall
include the name or title, address, and telephone number of the contact at the
proper regulatory agency that has jurisdiction over the person receiving the
device;
(c) a list of services, as provided by the
manufacturer, that can be performed only by a specific licensee;
(d) information on acceptable disposal options,
including estimated cost of disposal; and
(e) a statement that loss or improper disposal
of the device may result in formal enforcement actions.
(7) Each device transferred after January 1, 2005 shall
meet the labeling requirements;
(8) Each person specifically licensed to initially
transfer generally licensed devices to other persons shall comply with the
requirements of this Paragraph.
(a) The person shall report, on a quarterly
basis, all transfers of devices to persons for use under a general license and
all receipts of devices from generally licensed persons. For devices
transferred for use under the general license granted in Rule .0309(c)(12) of
this Chapter, the reports shall be provided to the agency at the address listed
in Rule .0111. For devices transferred outside the jurisdiction of the agency,
the reports shall be provided to the Nuclear Regulatory Commission or to the Agreement
State which has jurisdiction over the general licensee. The information shall
be provided either on the Nuclear Regulatory Commission's Form 653 "Transfers
of Industrial Devices Report" or in a clear and legible report that contains
all of the information required by the form. The required information
includes:
(i) the identity of each general licensee by
name and mailing address for the location of use. If there is no mailing
address at the location of use, an alternate address for the general licensee
shall be submitted along with the information on the actual location of use;
(ii) the name, title and telephone number of the
person identified by the general licensee as having knowledge of, and authority
to ensure compliance with, these rules;
(iii) the date of transfer;
(iv) the type, model number, and serial number of
the device transferred; and
(v) the quantity and type of radioactive
material contained in the device.
(b) If one or more intermediate persons will
temporarily possess the device at the intended use location prior to its use by
the end user, the report shall include the same information for both the
intended end user and each intermediate person, and designate the intermediate
person(s).
(c) If the licensee makes changes to a device
possessed by a general licensee such that the label must be changed to update
required information, the report shall identify the general licensee, the
device, and the changes to the information on the label.
(d) The report shall cover a calendar quarter
and must be filed within 30 days of the end of the calendar quarter. The
report shall identify the period covered by the report.
(e) The report shall identify the specific
licensee submitting the report and include the license number of the specific
licensee.
(f) In providing information on devices
received from a general licensee, the report shall include the identity of the
general licensee by name and address, the type, model number and serial number
of the device received, and, in the case of devices not initially transferred
by the licensee submitting the report, the name of the manufacturer or initial
transferor.
(g) If no transfers have been made to or from
persons generally licensed during the reporting period, the report shall so
indicate.
(9) The person providing the reports shall maintain all
information concerning the transfers and receipts of devices required by this
Rule for a period of three years following the date of the recorded event.
History Note: Authority G.S. 104E‑7; 104E-10(b);
Eff. February 1, 1980;
Amended Eff. January 1, 2005;
Transferred and Recodified from 15A NCAC 11 .0310 Eff.
February 1, 2015.
10A NCAC 15 .0311 GENERAL LICENSES: LUMINOUS SAFETY
DEVICES
(a) A general license shall be issued to own, receive,
acquire, possess, and use tritium or promethium‑147 contained in luminous
safety devices for use in aircraft, provided:
(1) each device contains not more than ten
curies of tritium or 300 millicuries of promethium‑147; and
(2) each device has been manufactured,
assembled or imported in accordance with a specific license issued by the U.S.
Nuclear Regulatory Commission, or each device has been manufactured or
assembled in accordance with the specifications contained in a specific license
issued by the agency or an agreement state to the manufacturer or assembler of
the device pursuant to licensing requirements equivalent to those in Section 32.53
of 10 CFR Part 32 of the regulations of the U.S. Nuclear Regulatory Commission.
(b) Persons who own, receive, acquire, possess, or use
luminous safety devices pursuant to the general license in Paragraph (a) of
this Rule are exempt from the requirements of Sections .1000 and .1600 of this
Chapter except for Rules .1645 and .1646 of this Chapter.
(c) This general license does not authorize the
manufacture, assembly, or repair of luminous safety devices containing tritium
or promethium‑147.
(d) This general license does not authorize the ownership,
receipt, acquisition, possession or use of promethium‑147 contained in
instrument dials.
(e) The general license provided in Paragraphs (a) and (b)
of this Rule are subject to the provisions of Rules .0107 to .0111, .0303(a),
.0338, .0343, .0344 and .0346 of this Chapter.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0311 Eff.
February 1, 2015.
10A NCAC 15 .0312 GENERAL LICENSES: CALIBRATION AND
REFERENCE
(a) A general license shall be issued to those persons
listed below to own, receive, acquire, possess, use and transfer, in accordance
with the provisions in Paragraphs (c) and (d) of this Rule, americium‑241
in the form of calibration or reference sources:
(1) any person who holds a specific license
issued by the agency which authorizes receipt, possession, use, and transfer of
radioactive material; and
(2) any person who holds a specific license
issued by the U.S. Nuclear Regulatory Commission which authorizes receipt,
possession, use, and transfer of special nuclear material.
(b) A general license to own, receive, possess, use, and
transfer plutonium in the form of calibration or reference sources in
accordance with the provisions in Paragraphs (c) and (d) of this Rule is hereby
issued to any person who holds a specific license which is issued by the agency
and which authorizes receipt, possession, use, and transfer of radioactive
material.
(c) The general licenses in Paragraphs (a) and (b) of this
Rule apply only to calibration or reference sources which have been
manufactured in accordance with the specifications contained in a specific
license issued to the manufacturer or importer of the sources by the U.S.
Nuclear Regulatory Commission pursuant to Section 32.57 of 10 CFR Part 32 or
Section 70.39 of 10 CFR Part 70 or which have been manufactured in accordance
with the specifications contained in a specific license issued to the manufacturer
by the agency or an agreement state pursuant to licensing requirements
equivalent to those contained in Section 32.57 of 10 CFR Part 32 or Section
70.39 of 10 CFR Part 70 of the regulations of the U.S. Nuclear Regulatory
Commission.
(d) The general license provided in Paragraphs (a) and (b)
of this Rule are subject to the provisions of Rules .0107 to .0111, .0303(a),
.0337, .0342, .0343 and .0345 of this Chapter and Sections .1000 and .1600 of
this Chapter. In addition, persons who own, receive, acquire, possess, use, or
transfer one or more calibration or reference sources pursuant to this Rule:
(1) shall not possess at any one time, at any
one location of storage or use, more than five microcuries of americium‑241
and five microcuries of plutonium in the calibration and reference sources;
(2) shall not receive, possess, use, or
transfer a calibration or reference source unless the source, or the storage
container, bears a label which includes the following statement or a
substantially similar statement which contains the information called for in
the following statement:
The receipt, possession, use and transfer of this source,
Model _________________, Serial No. __________________, are subject to a
general license and the regulations of the U.S. Nuclear Regulatory Commission
or of a state with which the Commission has entered into an agreement for the
exercise of regulatory authority. Do not remove this label.
CAUTION -
RADIOACTIVE MATERIAL
THIS SOURCE
CONTAINS
(name of
appropriate radioisotope)
DO NOT TOUCH RADIOACTIVE PORTION OF
THIS SOURCE.
______________________________________________________
(Name of manufacturer or importer)
(3) shall not transfer, abandon, or dispose of
a calibration or reference source except by transfer to a person authorized by
a license issued by the agency, the U.S. Nuclear Regulatory Commission, or an
agreement state and authorizing receipt of the source;
(4) shall store each source, except when being
used, in a closed container adequately designed and constructed to contain
americium‑241 or plutonium which might otherwise escape during storage;
and
(5) shall not use a calibration or reference
source for any purpose other than the calibration of radiation detectors or the
standardization of other sources.
(e) The general licenses in Paragraphs (a) and (b) of this
Rule do not authorize the manufacture or calibration of reference sources
containing americium‑241 or plutonium.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0312 Eff.
February 1, 2015.
10A NCAC 15 .0313 OWNERSHIP OF RADIOACTIVE MATERIAL
A general license shall be issued to own radioactive
material without regard to quantity. This general license does not authorize
the manufacture, production, transfer, receipt, possession or use of radioactive
material.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0313 Eff.
February 1, 2015.
10A NCAC 15 .0314 GENERAL LICENSES: IN VITRO CLINICAL OR
LABORATORY TESTING
(a) A general license shall be issued to any physician,
veterinarian in the practice of veterinary medicine, clinical laboratory or
hospital to receive, acquire, possess, transfer or use the following
radioactive materials for IN VITRO clinical or laboratory tests not involving
internal or external administration of radioactive material, or radiation
therefrom, to human beings or animals:
(1) iodine‑125 in units not exceeding ten
microcuries each;
(2) iodine‑131 in units not exceeding ten
microcuries each;
(3) carbon‑14 in units not exceeding ten
microcuries each;
(4) hydrogen‑3 (tritium) in units not
exceeding 50 microcuries each;
(5) iron‑59 in units not exceeding 20
microcuries each;
(6) cobalt‑57 in units not exceeding ten
microcuries each;
(7) selenium‑75 in units not exceeding
ten microcuries each;
(8) mock iodine‑125 reference or
calibration sources in units not exceeding 0.05 microcuries of iodine‑129
and 0.005 microcurie of americium‑241 each. This general license is
subject to the provisions of Paragraphs (b) to (f) of this Rule.
(b) No person shall receive, acquire, possess, use or
transfer radioactive material pursuant to the general license established in
Paragraph (a) of this Rule until he has filed agency form "Certificate IN
VITRO Testing with Radioactive Material Under General License", with the
agency and received from the agency a validated copy of the agency form with
certification number assigned. The physician, clinical laboratory or hospital
shall furnish on the agency form the following information and such other
information as may be required by the form:
(1) name and address of the physician, clinical
laboratory or hospital;
(2) the location of use;
(3) a statement that the physician, clinical
laboratory or hospital has appropriate radiation measuring instruments to carry
out IN VITRO clinical or laboratory tests with radioactive material as
authorized under the general license in Paragraph (a) of this Rule and that
these tests will be performed only by personnel competent in the use of the
instruments and in the handling of the radioactive material.
(c) A person who receives, acquires, possesses or uses
radioactive material pursuant to the general license established in Paragraph
(a) of this Rule:
(1) shall not possess at any one time, pursuant
to the general license in Paragraph (a) of this Rule at any one location of
storage or use a total amount of iodine‑125, iodine‑131, and iron‑59
in excess of 200 microcuries;
(2) shall store the radioactive material, until
used, in the original shipping container or in a container providing equivalent
radiation protection;
(3) shall use the radioactive material only for
the uses authorized in Paragraph (a) of this Rule;
(4) shall not transfer the radioactive material
to a person who is not authorized to receive it pursuant to a license issued by
the agency, the U.S. Nuclear Regulatory Commission, or an agreement state, nor
transfer the radioactive material in any manner other than in the unopened,
labeled shipping container as received from the supplier; and
(5) shall dispose of the mock iodine‑125
reference or calibration sources described in Subparagraph (a)(8) of this Rule
as required by Rule .1628 of this Chapter.
(d) The general licensee shall not receive, acquire,
possess, or use radioactive material pursuant to Paragraph (a) of this Rule:
(1) except as prepackaged units which are
labeled in accordance with the provisions of a specific license issued by the U.S.
Nuclear Regulatory Commission, or an agreement state which authorizes the
manufacture and distribution of iodine‑125, iodine‑131, carbon‑14,
hydrogen‑3 (tritium), selenium‑75, mock iodine‑125 (of iodine‑129
and americium‑241), or iron‑59 for distribution to persons
generally licensed under Paragraph (a) of this Rule or its equivalent; and
(2) unless the following statement, or a
substantially similar statement which contains the information called for in
the following statement, appears on a label affixed to each prepackaged unit or
appears in a leaflet or brochure which accompanies the package:
(A) This radioactive material may be received, acquired,
possessed, and used only by physicians, clinical laboratories, or hospitals and
only for IN VITRO clinical or laboratory tests not involving internal or
external administration of the material, or the radiation therefrom, to human
beings or animals.
(B) Its receipt, acquisition, possession, use, and
transfer are subject to the regulations and a general license of the United
States Nuclear Regulatory Commission, or, of a state with which the Commission
has entered into an agreement for the exercise of regulatory authority. (Name
of Manufacturer).
(e) The physician, clinical laboratory or hospital
possessing or using radioactive material under the general license in Paragraph
(a) of this Rule shall report in writing to the agency, any changes in the
information furnished in the "Certificate IN VITRO Testing with
Radioactive Material Under General License" agency form within 30 days
after the effective date of the changes.
(f) Any person using radioactive material pursuant to the
general license in Paragraph (a) of this Rule is exempt from the requirements
of Sections .1000 and .1600 of these Rules with respect to radioactive material
covered by the general license. The new drug provisions of the Federal Food,
Drug, and Cosmetic Act also govern the availability and use of any specific
diagnostic drugs in interstate commerce.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0314 Eff.
February 1, 2015.
10A NCAC 15 .0315 GENERAL LICENSES: ICE DETECTION
DEVICES
(a) A general license shall be issued to own, receive,
acquire, possess, use, and transfer strontium‑90 contained in ice
detection devices, provided each device contains not more than 50 microcuries
of strontium‑90 and each device has been manufactured in accordance with
a specific license issued by the U.S. Nuclear Regulatory Commission or in
accordance with the specifications contained in a specific license issued by
the agency or an agreement state to the manufacturer of the device pursuant to
licensing requirements equivalent to those in Section 32.61 of 10 CFR Part 32
of the regulations of the U.S. Nuclear Regulatory Commission.
(b) Persons who own, receive, acquire, possess, use, or transfer
strontium‑90 contained in ice detection devices pursuant to the general
license in Paragraph (a) of this Rule:
(1) shall, upon occurrence of visually
observable damage, such as a bend or crack or discoloration from overheating to
the device, discontinue use of the device until it has been inspected, tested
for leakage and repaired by a person holding a specific license from the U.S.
Nuclear Regulatory Commission or an agreement state authorizing manufacture or
servicing of the devices; or shall dispose of the device pursuant to the
provisions of Rule .1628 of this Chapter;
(2) shall assure that all labels affixed to the
device at the time of receipt, and bearing a statement which prohibits removal
of the labels, are maintained thereon; and
(3) are exempt from the requirements of
Sections .1000 and .1600 of this Chapter except that such persons shall comply
with the provisions of Rules .1628, .1645 and .1646 of this Chapter.
(c) This general license does not authorize the
manufacture, assembly, disassembly or repair of ice detection devices
containing strontium‑90.
(d) This general license is subject to the provisions of
Rules .0107 to .0111 of this Chapter and Rules .0303(a), .0337, .0342, .0343,
and .0345 of this Section.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0315 Eff.
February 1, 2015.
10A NCAC 15 .0316 GENERAL LICENSES: TRANSPORTATION
(a) Except for persons exempt from these Rules, a general
license is hereby issued to any common, contract or other carrier to transport
and store radioactive material in the regular course of their carriage for
another or storage incident thereto; provided the transportation and storage is
in accordance with the applicable requirements of the regulations appropriate
to the mode of transport of the U.S. Department of Transportation in 49 CFR
Part 170‑189 and the U.S. Postal Service in the Postal Service Manual,
(Domestic Mail Manual), Section 124.3; insofar as, such regulations relate to
the packaging of radioactive material, marking and labeling of the package,
loading and storage of packages, placarding of the transportation vehicle,
monitoring requirements and accident reporting. Any common, contract or other
carrier transporting nuclear waste or spent nuclear fuel under this general
license shall comply with the provisions in Paragraph (c) of this Rule.
Persons who transport and store radioactive material pursuant to the general
license in this Paragraph are exempt from the requirements of Sections .1000
and .1600 of this Chapter.
(b) Except for persons exempt from these Rules, a general
license is hereby issued to any private carrier to transport radioactive
material; provided, the transportation is in accordance with the applicable
requirements of the regulations, appropriate to the mode of transport of the
U.S. Department of Transportation in 49 CFR Part 170‑189 and the U.S.
Postal Service in the Postal Service Manual, (Domestic Mail Manual), Section
124.3; insofar as, such regulations relate to the packaging, loading and
storage of packages, placarding of the transportation vehicle, monitoring requirements
and accident reporting. The following exemptions and requirements shall apply
to transportation of radioactive material under this general license:
(1) Persons who transport radioactive material
pursuant to the license in Paragraph (b) of this Rule are exempt from the
requirements in Sections .1000 and .1600 of this Chapter to the extent that
they transport radioactive material. Any notification of incidents referred to
in those requirements shall be filed with, or made to, the agency.
(2) Physicians, as defined in Rule .0104 of
this Chapter, are exempt from the requirements in Paragraph (b) of this Rule to
the extent that they transport in their private vehicle radioactive material
for use in the practice of medicine.
(3) Any person who transports nuclear waste
within or through this state under this general license shall comply with the
provisions in Paragraph (c) of this Rule.
(c) No carrier shall transport within or through this state
any nuclear waste or spent nuclear fuel unless the shipper has notified the
"governor's designee" in accordance with the requirements of 10 CFR
Part 71.97 for nuclear waste and 10 CFR 73.37(f) for spent nuclear fuel. The
governor's designee and contact information is as follows:
(1) designee: N.C. Highway Patrol
Headquarters, Operations Officer;
(2) mailing address: P.O. Box 27687, Raleigh,
North Carolina 27611‑7687;
(3) telephone 919/733‑4030 from 8 a.m. to
5 p.m. workdays and 919/733‑3861 all other times.
(d) As used in Paragraphs (a) through (c) of this Rule:
(1) "Shipment" means any single
vehicle carrying one or more containers of nuclear waste.
(2) "Nuclear Waste" means:
(A) any quantity of radioactive material required by 10
CFR Part 71 to be in Type B packaging or subject to advance notification requirements
of 10 CFR §§ 71.97 while transported within or through this state to a disposal
site, or to a collection point for transport to a disposal site; or
(B) any quantity of irradiated fuel required by 10 CFR
Part 71 to be in Type B packaging while transported within or through this
state irrespective of destination if the quantity of irradiated fuel is less
than that subject to advance notification requirements of 10 CFR Part 73.
(3) "Spent Nuclear Fuel" means a
quantity of irradiated reactor fuel in excess of 100 grams in net weight of
irradiated fuel exclusive of cladding or other structural or packaging material
which has a total external radiation dose rate in excess of 100 rems per hour
at a distance of three feet from any accessible surface without intervening
shielding.
History Note: Authority G.S. 20‑167.1; 104E‑7;
104E‑10(b); 104E‑15(a); 150B‑21.6;
Eff. February 1, 1980;
Amended Eff. January 1, 1994; May 1, 1992; October 1,
1982;
Transferred and Recodified from 15A NCAC 11 .0316 Eff.
February 1, 2015.
10A NCAC 15 .0317 SPECIFIC
LICENSES: FILING APPLICATION AND GENERAL REQUIREMENT
(a) Applications for specific licenses shall be filed on an
agency form. Completed applications shall include the following information
and other information necessary for the agency to determine if the applicant
meets the requirements for that license:
(1) name, address and use location of the
applicant;
(2) training and experience of radioactive
material users and of the person responsible for radiation protection;
(3) types, quantities and uses of radioactive
materials;
(4) description of facilities, equipment and
safety program;
(5) procedures for disposal of radioactive material;
and
(6) how facility design and procedures for
operation will minimize, to the extent practicable, contamination of the
facility and the environment, facilitate eventual decommissioning, and
minimize, to the extent practical, the generation of radioactive waste.
(b) The agency may at any time after the filing of the
original application, and before the expiration of the license, require further
statements in order to enable the agency to determine whether the application
should be granted or denied or whether a license should be modified or revoked.
(c) Each application shall be signed by the applicant or
licensee or a person authorized to act on his behalf.
(d) An application for a license may include a request for
a license authorizing one or more activities.
(e) An application for a specific license to use byproduct
material in the form of a sealed source or in a device that contains the sealed
source must:
(1) identify the source or device by
manufacturer and model number as registered with the US Nuclear Regulatory
Commission under 10 CFR 32.210, with an Agreement State. A source or device
containing radium-226 or accelerator-produced radioactive material must
identify the manufacturer and model number if registered with a state under
provisions comparable to 10 CFR 32.210;
(2) contain the information identified in 10
CFR 32.210(c); or
(3) for sources or devices containing naturally
occurring or accelerator-produced radioactive material manufactured prior to
November 30, 2007 that are not registered with the U.S. Nuclear Regulatory
Commission under 10 CFR 32.210 or with an Agreement State, and for which the
applicant is unable to provide all categories of information specified in 10
CFR 32.210(c), the applicant must provide:
(A) all available information identified in 10 CFR
32.210(c) concerning the source, and, if applicable, the device; and
(B) sufficient additional information to demonstrate
that there is reasonable assurance that the radiation safety properties of the
source or device are adequate to protect health and minimize danger to life and
property. Such information must include a description of the source or device,
a description of radiation safety features, the intended use and associated
operating experience, and the results of a recent leak test.
(f) Applications and documents submitted to the agency shall
be made available for public inspection except as are determined otherwise by
the agency pursuant to the provisions of G.S. 104E-9(4).
(g) A license application shall be approved if the agency
determines that:
(1) the applicant is qualified by reason of
training and experience to use the material in question for the purpose
requested in accordance with these Rules in such a manner as to minimize danger
to public health and safety or property;
(2) the applicant's proposed equipment,
facilities, and procedures are adequate to protect public health from radiation
hazards and minimize radiological danger to life or property;
(3) the issuance of the license will not be
inimical to the health and safety of the public; and
(4) the applicant satisfies any applicable
special requirements in Rules .0318 to .0336 of this Section.
(h) If required by Rule .0353 of this Section, applications
for specific licenses filed under this Section must contain a proposed
decommissioning funding plan or a certification of financial assurance for
decommissioning.
History Note: Authority G.S. 104E-7; 104E-10(b); 104E-12;
104E-18;
Eff. February 1, 1980;
Amended Eff. October 1, 2013; April 1, 1999; May 1, 1992;
November 1, 1989;
Transferred and Recodified from 15A NCAC 11 .0317 Eff.
February 1, 2015.
10A NCAC 15 .0318 SPECIFIC LICENSES: GENERAL
REQUIREMENTS FOR HUMAN USE
(a) For the purposes of this Rule, "Authorized medical
physicist" means an individual who:
(1) Meets the requirements in 10 CFR 35.51(a)
and 35.59; or
(2) Is identified as an authorized medical
physicist or teletherapy physicist on:
(A) A specific medical use license issued by the U.S.
Nuclear Regulatory Commission or Agreement State;
(B) A medical use permit issued by the U.S. Nuclear
Regulatory Commission master material licensee;
(C) A permit issued by a U.S. Nuclear Regulatory
Commission or Agreement State broad scope medical use licensee; or
(D) A permit issued by a U.S. Nuclear Regulatory
Commission master material license broad scope medical use permittee.
(b) For the purposes of this Rule, "Authorized nuclear
pharmacist" means a pharmacist who:
(1) Meets the requirements in 10 CFR 35.55(a)
and 35.59; or
(2) Is identified as an authorized nuclear
pharmacist on:
(A) A specific license issued by the U.S. Nuclear
Regulatory Commission or Agreement State that authorizes medical use or the
practice of nuclear pharmacy;
(B) A permit issued by the U.S. Nuclear Regulatory
Commission master material licensee that authorizes medical use or the practice
of nuclear pharmacy;
(C) A permit issued by a U.S. Nuclear Regulatory
Commission or Agreement State broad scope medical use license that authorizes
medical use or the practice of nuclear pharmacy; or
(D) A permit issued by a U.S. Nuclear Regulatory
Commission 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 by the
U.S. Nuclear Regulatory Commission or Agreement State to identify authorized
nuclear pharmacists; or
(4) Is designated as an authorized nuclear
pharmacist in accordance with 10 CFR 32.72(b)(4).
(c) For the purposes of this Rule, "Authorized
user" means a physician, dentist, or podiatrist who:
(1) Meets the requirements in 10 CFR 35.59 and either
35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.396(a), 35.490(a),
35.590(a), or 35.690(a); or
(2) Is identified as an authorized user on:
(A) A U.S. Nuclear Regulatory Commission or Agreement
State license that authorizes medical use of radioactive material;
(B) A permit issued by a U.S. Nuclear Regulatory
Commission master material licensee that is authorized to permit the medical
use of radioactive material;
(C) A permit issued by a U.S. Nuclear Regulatory
Commission or Agreement State specific licensee of broad scope that is
authorized to permit the medical use of radioactive material; or
(D) A permit issued by a U.S. Nuclear Regulatory
Commission master material license broad scope permittee that is authorized to
permit the medical use of byproduct material.
(d) For the purposes of this Section, "Radiation
safety officer" means an individual who:
(1) Meets the requirements in 10 CFR 35.50(a)
or (c)(1) and 10 CFR 35.59; or
(2) Is identified as a Radiation Safety Officer
on:
(A) A specific medical use license issued by the U.S. Nuclear
Regulatory Commission, or an Agreement State; or
(B) A medical use permit issued by a U.S. Nuclear
Regulatory Commission master material licensee.
(e) License required:
(1) A person shall not manufacture, produce,
acquire, receive, possess, use or transfer radioactive material for medical use
except in accordance with a specific license issued by the agency or as allowed
pursuant to Subparagraphs (e)(2) and (e)(3) of this Rule.
(2) An individual may receive, possess, use, or
transfer radioactive material in accordance with the rules of this Section
under the supervision of an authorized user as provided in this Section unless
prohibited by license condition.
(3) An individual may prepare unsealed
radioactive material for medical use in accordance with the rules of this
Section under the supervision of a pharmacist who is an authorized nuclear
pharmacist or physician who is an authorized user as provided in this Section
unless prohibited by license condition.
(f) A license application for human use of radioactive
material shall be approved if the agency determines that:
(1) The applicant is qualified by reason of
training and experience to use the material in question for the purpose
requested in accordance with these Rules;
(2) The applicant's proposed equipment,
facilities, and procedures are adequate to protect public health from radiation
hazards and minimize radiological danger to life or property;
(3) The issuance of the license will not be
inimical to the health and safety of the public;
(4) The following training and supervisory
relationship are adhered to:
(A) The user of radioisotopes applied to humans for
diagnostic, therapeutic, or investigational purposes shall be a physician
authorized by a condition of a specific license, including a specific license
of broad scope.
(B) An authorized physician may delegate the following only
to persons who are physicians under the supervision of the authorized physician:
(i) The approval of procedures involving the
administration to patients of radiopharmaceuticals or the application to
patients of radiation from radioisotope sources;
(ii) The prescription of the radiopharmaceutical or
source of radiation and the dose or exposure to be administered;
(iii) The determination of the route of
administration; and
(iv) The interpretation of the results of diagnostic
procedures in which radiopharmaceuticals are administered.
(C) The authorized physician shall review the work of
the supervised individual as it pertains to the delegated work in Subparagraph (f)(4)
of this Rule and the records kept reflecting that work; and
(5) the applicant satisfies any applicable
requirements in Rules .0319 to .0322 of this Section.
(g) Subject to the provisions of Subparagraph (f)(4) and
Paragraphs (h) through (k) of this Rule, an authorized physician may permit
technicians and other paramedic personnel to perform the following activities:
(1) Preparation and quality control testing of
radiopharmaceuticals and sources of radiation;
(2) Measurement of radiopharmaceutical doses
prior to administration;
(3) Use of instrumentation for the collection
of data to be used by the physician;
(4) Administration of radiopharmaceuticals and
radiation from radioisotope sources to patients.
(h) Authorized physicians who permit activities to be
performed by technicians and other paramedical personnel pursuant to Paragraph (g)
of this Rule shall:
(1) Prior to giving permission, determine that
the technicians and other paramedical personnel have been properly trained to
perform their duties with training in the following subjects, as applicable to
the duties assigned:
(A) General characteristics of radiation and radioactive
materials;
(B) Physical, chemical, and pharmaceutical
characteristics of each radiopharmaceutical to be used;
(C) Mathematics and calculations basic to the use and
measurement of radioactivity, Radioactivity, including units of radiation dose
and radiation exposure;
(D) Use of radiation instrumentation for measurements
and monitoring including operating procedures, calibration of instruments, and
limitations of instruments;
(E) Principles and practices of radiation protection; and
(F) Additional training in the above subjects, as
appropriate, when new duties are added;
(2) Assure that the technicians and other
paramedical personnel receive retraining in the subjects listed in Subparagraph
(h)(1) of this Rule to maintain proficiency and to keep abreast of developments
in the field of nuclear medical technology;
(3) Keep records showing the bases for the
determinations of proper training;
(4) Retain responsibility as licensee or
authorized user for the satisfactory performance of the activities; and
(5) Review the work of the supervised
individual and the records kept reflecting that work.
(i) Certification in nuclear medicine technology by the
American Registry of Radiologic Technologists or in nuclear medicine technology
by the Nuclear Medicine Technologist Certification Board or the Society of
Nuclear Medicine shall be deemed to satisfy the training requirements in
Subparagraphs (h)(1) and (2) of this Rule.
(j) An applicant for an initial, amended or renewed license
shall state whether he desires to permit technicians or other paramedical
personnel to perform activities pursuant to Paragraph (g) of this Rule. If the
applicant intends to do so, the application shall include a statement of the
activities to be so performed and a description of an adequate program for
training the personnel, including retraining as required to keep abreast of
developments in technology, or for otherwise determining that the personnel are
properly trained to perform their duties.
(k) Whenever a technician or other paramedical person
administers a radiopharmaceutical to a patient by injection, a physician shall
be accessible. That physician is not required to be authorized by the agency
to be a user of radioisotopes.
(l) A licensee that permits the receipt, possession, use,
or transfer of radioactive material by an individual under the supervision of
an authorized user shall:
(1) In addition to the requirements in Rule
.1003 of this Chapter, instruct the supervised individual in the licensee's
written radiation protection procedures, written directive procedures, this
Chapter, and license conditions with respect to the use of radioactive
material; and
(2) Require the supervised individual to follow
the instructions of the supervising authorized user for medical uses of
radioactive material, written radiation protection procedures established by
the licensee, written directive procedures, rules of this Chapter, and license
conditions with respect to the medical use of radioactive material.
(m) A licensee that permits the preparation of radioactive
material for medical use by an individual under the supervision of an
authorized nuclear pharmacist or physician who is an authorized user shall:
(1) In addition to the requirements in
Paragraph (h) of this Rule and Rule .1003 of this Chapter, instruct the
supervised individual in the preparation of radioactive material for medical
use, as appropriate to that individual's involvement with radioactive material;
and
(2) Require the supervised individual to follow
the instructions of the supervising authorized user or authorized nuclear
pharmacist regarding the preparation of radioactive material for medical use,
written radiation protection procedures established by the licensee, the rules
of this Chapter, and license conditions.
(n) A licensee that permits supervised activities under
Paragraphs (g) and (h) of this Rule is responsible for the acts and omissions
of the supervised individual.
(o) A licensee's management shall appoint a Radiation
Safety Officer (RSO) who agrees in writing to be responsible for implementing
the radiation safety program. The licensee, through the RSO, shall ensure that
radiation safety activities are being performed in accordance with approved
procedures and regulatory requirements in the daily operation of the licensee's
radioactive material program.
(p) A licensee shall establish in writing the authority,
duties and responsibilities of the Radiation Safety Officer.
(q) A licensee shall provide the Radiation Safety Officer
sufficient authority, organizational freedom, and management prerogative to:
(1) Identify radiation safety problems;
(2) Investigate radiation safety problems such
as overexposures, accidents, spills, losses, thefts, unauthorized receipts,
uses, transfers, disposals, medical events, and other deviations from approved
radiation safety procedures and implement corrective actions as necessary;
(3) Initiate, recommend or provide corrective
actions for radiation safety problems;
(4) Verify implementation of corrective
actions; and
(5) Retain records of items required by this
Paragraph.
(r) In addition to the requirements in Rule .1003 of this
Chapter, the licensee shall provide radiation safety instruction, initially and
at least annually, to personnel caring for patients or human research subjects
who cannot be released in accordance with the requirements of Rule .0358 of
this Section. To satisfy this requirement, the instruction must be
commensurate with the duties of the personnel and include:
(1) Patient or human research subject control;
(2) Visitor control, including:
(A) Routine visitation to hospitalized individuals in
accordance with the provisions of Rule .1611(a)(1) of this Chapter; and
(B) Visitation authorized by Rule .1611(e) of this
Chapter;
(3) Contamination control;
(4) Waste control; and
(5) Notification of the Radiation Safety
Officer, or his designee, and an authorized user if the patient or the human
research subject has a medical emergency or dies.
(s) The licensee shall retain records of the radiation
safety instructions required by Paragraphs (l), (m), and (r) for three years.
The record must include:
(1) A list of topics covered;
(2) The date of the instruction;
(3) The name(s) of the attendee(s); and
(4) The name(s) of the individual(s) who
provided the instruction.
History Note: Authority G.S. 104E-7; 104E-10(b); 10 CFR
35.2;
Eff. February 1, 1980;
Amended Eff. October 1, 2013; November 1, 2007; April 1,
1999; May 1, 1993; November 1, 1989;
Transferred and Recodified from 15A NCAC 11 .0318 Eff.
February 1, 2015.
10A NCAC 15 .0319 SPECIFIC LICENSES: HUMAN USE IN
HOSPITALS
(a) Except as provided in Rules .0302 to .0315 and .0320 of
this Section, all receipt, possession, use, storage and disposal of radioactive
material in a hospital shall be pursuant to the provisions of a specific
license issued to the hospital.
(b) An application by a hospital for a specific license for
human use of radioactive material will be approved if:
(1) the applicant satisfies the general
requirements in Rule .0318 of this Section;
(2) the applicant has appointed a medical
isotopes committee of at least three members to evaluate all proposals for
research, diagnostic and therapeutic use of radioisotopes within the hospital;
(3) membership of the committee required in
Subparagraph (b)(2) of this Rule includes an authorized user from each
department where radioactive material is used, a representative of the nursing
staff, a representative of the institution's management and a person trained in
radiation safety;
(4) the applicant possesses adequate facilities
for the clinical care of patients;
(5) the physician designated on the application
as the individual user has substantial experience in the proposed use, handling
and administration of radioisotopes and, where applicable, the clinical
management of radioactive patients; and
(6) when the application is for a license to
use unspecified quantities or multiple types of radioactive material, the
applicant has previously received a reasonable number of licenses for a variety
of radioactive materials for a variety of human uses.
History Note: Authority G.S. 104E‑7(2);
Eff. February 1, 1980;
Amended Eff. October 1, 1984;
Transferred and Recodified from 15A NCAC 11 .0319 Eff.
February 1, 2015.
10a ncac 15 .0320 SPECIFIC LICENSES: HUMAN USE BY
INDIVIDUAL PHYSICIANS
(a) An application by an individual physician or a group of
physicians for a specific license for human use of radioactive material shall
be approved if:
(1) the applicant satisfies the general
requirements in Rule .0318 of this Section;
(2) The application is for use in the
applicant's practice in an office(s) outside a medical institution;
(3) the applicant has access to a hospital
possessing adequate facilities to hospitalize and monitor the applicant's
radioactive patients whenever it is advisable;
(4) the applicant has experience, which meets
the requirements of the applicable sections of 10 CFR Part 35, in the proposed
use, the handling and administration of radioisotopes, and where applicable,
the clinical management of radioactive patients; and
(5) the physician(s) furnishes suitable
evidence of experience along with the application, except that a statement from
the medical isotope committee in the hospital where the applicant acquired
experience, indicating its amount and nature, may be submitted as evidence of
experience. 10 CFR Part 35 provides the requirements that meet the test for
suitable evidence of experience.
(b) The agency shall not approve an application by an individual
physician or group of physicians for a specific license to receive, possess or
use radioactive material on the premises of a hospital unless:
(1) The use of radioactive material is limited
to:
(A) the administration of radiopharmaceuticals for
diagnostic or therapeutic purposes;
(B) the performance of diagnostic studies on patients to
whom a radiopharmaceutical has been administered;
(C) the performance of IN VITRO diagnostic studies; or
(D) the calibration and quality control checks of
radioactive assay instrumentation, radiation safety instrumentation and
diagnostic instrumentation;
(2) The physician brings the radioactive
material with him and removes the radioactive material when he departs;
(3) No radioactive material is received,
possessed or stored in the hospital other than the amount of material remaining
in the patient; and
(4) The hospital does not hold a radioactive
material license under Rule .0319 of this Section.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Amended Eff. November 1, 2007; August 1, 2002; November
1, 1989;
Transferred and Recodified from 15A NCAC 11 .0320 Eff.
February 1, 2015.
10A NCAC 15 .0321 SPECIFIC
LICENSES: general requirements for human use of unsealed radioactive materials
(a) An application for a specific license pursuant to Rule
.0318 of this Section for any diagnostic or therapeutic use of unsealed
radioactive material shall be approved if:
(1) the applicant satisfies the requirements in
Rule .0319 or Rule .0320 of this Section;
(2) the applicant's proposed radiation
detection instrumentation is adequate for conducting the diagnostic or
therapeutic procedure(s) requested;
(3) the physicians designated in the
application as individual users have clinical experience as required by Rule
.0117(a)(2) of this Chapter;
(4) the physicians and all other personnel who
will be involved in the preparation and use of radioactive material have
training and experience in the handling of unsealed radioactive material
appropriate to their use of radioactive material and as required by Rule
.0117(a)(2) of this Chapter;
(5) the applicant has radiation safety
operating procedures for handling and disposal of the radioactive material that
provide protection to the workers, the public and the environment from
radiation exposure and radioactive contamination; and
(6) the applicant has a clinical procedures
manual appropriate for the licensed activities.
(b) Any person authorized by Rules .0318, .0319, .0320,
.0322, or .0324 of this Section for medical use of radioactive material may
receive, possess and use any of the following radioactive material for check,
calibration, transmission and reference use:
(1) Sealed sources not exceeding 30 millicuries
(mCi)(1.11 Gigabecquerel (GBq)) each, manufactured and distributed by a person
licensed under 10 CFR 32.74 or equivalent Agreement State regulations;
(2) Sealed sources, not exceeding 30 mCi (1.11
GBq) each, redistributed by a licensee authorized to redistribute the sealed
sources manufactured and distributed by a person licensed under 10 CFR 32.74,
providing the redistributed sealed sources are in the original packaging and
shielding and are accompanied by the manufacturer's approved instructions;
(3) Any radioactive material with a half-life
not longer than 120 days in individual amounts not to exceed 15 mCi (0.56 GBq);
(4) Any radioactive material with a half-life
greater than 120 days in individual amounts not to exceed the smaller of 200
microcuries (µCi) (7.4 Megabecquerel (MBq)) or 1000 times the quantities in
Appendix C of 10 CFR Part 20; and
(5) Technetium-99m in amounts as needed.
(c) Any licensee who possesses sealed sources as
calibration and reference sources pursuant to Paragraph (b) of this Rule shall
test each source for leakage and contamination prior to initial use and at
intervals not to exceed six months or at longer intervals as approved by the
U.S. Nuclear Regulatory Commission or an Agreement State in the source specific
Sealed Source and Device Registry sheet. If there is reason for the licensee to
suspect that a sealed source may have been damaged, or might be leaking, it
shall be tested for leakage before further use.
(d) Leak test results shall be recorded in units of
microcuries and maintained for inspection by the agency.
(e) Any licensee who possesses and uses calibration and
reference sources pursuant to Paragraph (b) of this Rule shall:
(1) follow the radiation safety and handling
instructions that are required by the licensing agency to be furnished by the
manufacturer on the label attached to the source or permanent container thereof
or in the leaflet or brochure that accompanies the source;
(2) maintain such instructions in a legible and
conveniently available form; and
(3) conduct a quarterly physical inventory to
account for all sources received and possessed under the license. Records of
the inventories shall be maintained for inspection by the agency and shall
include the quantities and kinds of radioactive material, location of the
sources and the date of the inventory.
(f) Any licensee who is licensed pursuant to Rules .0318,
.0319, .0320, or .0324 of this Section for medical use of unsealed radioactive
material also is authorized to use radioactive material under the general
license in Rule .0314 of this Chapter for the specified in vitro uses without
filing agency forms as required by Rule .0314(b) of the Chapter, provided that
the licensee is subject to the other provisions of that Rule.
(g) For each individual receiving radiopharmaceutical
therapy and hospitalized because the individual cannot be released in
accordance with Rule .0358 of this Section, a licensee shall:
(1) provide a private room with a private
sanitary facility;
(2) post on the individual's door a
"Radioactive Materials" sign and note on the door or the individual's
chart, where and how long visitors may stay in the individual's room;
(3) either monitor material or items removed
from the individual's room to determine that their radioactivity cannot be
distinguished from the natural background radiation level with a radiation detection
survey instrument set on its most sensitive scale and with no interposed
shielding, or handle them as radioactive waste; and
(4) notify the Radiation Safety Officer and
authorized user as soon as feasible if the individual has a medical emergency
and immediately after the determination that the patient died.
History Note: Authority G.S. 104E-7; 104E-10(b);
Eff. February 1, 1980;
Amended Eff. October 1, 2013; November 1, 2007; August 1,
2002; April 1, 1999; May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0321 Eff.
February 1, 2015.
10A NCAC 15 .0322 SPECIFIC LICENSES: HUMAN USE OF SEALED
SOURCES
(a) In addition to the requirements set forth in Rule
.0318, .0319, or .0320 of this Section, a specific license for human use of
sealed sources shall be issued only if the applicant, or if the application is
made by an institution, the individual user:
(1) Has training and experience as required by 10
CFR 35.490 or 10 CFR 35.690; and
(2) Is a physician.
(b) The licensee shall comply with the provisions of
Section .0700 of this Chapter and the requirements of Subpart H of 10 CFR Part
35.
(c) For medical use, a licensee may only use:
(1) Sealed sources or devices manufactured,
labeled, packaged and distributed in accordance with a license issued under 10
CFR Part 30 and 10 CFR 32.74 or equivalent requirements of an Agreement State;
(2) Sealed sources or devices noncommercially
transferred from a licensee licensed pursuant to Section .0300 of this Chapter,
10 CFR Part 35, or an Agreement State medical use licensee;
(3) Teletherapy sources manufactured and
distributed in accordance with 10 CFR Part 30 or the equivalent requirements of
an Agreement State; or
(4) Brachytherapy sources, photon emitting
remote afterloader units, teletherapy units or gamma stereotactic radiosurgery
units for therapeutic medical uses;
(A) As approved in the Sealed Source and Device
Registry; or
(B) In research in accordance with an active
Investigational Device Exemption (IDE) application accepted by the FDA provided
the requirements of 10 CFR 35.49(a) are met.
(d) In addition to the requirements in Rule .1003 of this
Chapter, the licensee shall provide radiation safety instruction prior to
assignment and at least annually, to personnel caring for patients or human
research subjects who are receiving brachytherapy and cannot be released in
accordance with Rule .0358 of this Section. To satisfy this requirement the
instruction must be commensurate with the duties of the personnel and include:
(1) Size and appearance of the brachytherapy
sources;
(2) Safe handling and shielding instructions;
(3) Patient or human research subject control;
(4) Visitor control, including both:
(A) Routine visitation to hospitalized individuals in
accordance with the provisions of Rule .1611(a)(1) of this Chapter;
(B) Visitation authorized by Rule .1611(e) of this Chapter;
and
(5) Notification of the Radiation Safety
Officer, or his designee, and an authorized user if the patient or the human
research subject has a medical emergency or dies.
(e) The licensee shall retain records of the radiation
safety instruction required in Paragraph (d) of this Rule for three years. The
record must include:
(1) A list of topics covered;
(2) The date of the instruction;
(3) The name(s) of the attendee(s); and
(4) The name(s) of the individual(s) who
provided the instruction.
History Note: Authority G.S. 104E-7; 104E-10(b);
Eff. February 1, 1980;
Amended Eff. October 1, 2013; November 1, 2007;
Transferred and Recodified from 15A NCAC 11 .0322 Eff.
February 1, 2015.
10A NCAC 15 .0323 SPECIFIC LICENSES: SEALED SOURCES IN
INDUSTRIAL RADIOGRAPHY
In addition to the requirements set forth in Rule .0317 of
this Section, a specific license for use of sealed sources in industrial
radiography shall be issued if:
(1) The applicant has a program for training
radiographers and radiographers' assistants to meet the requirements of this
Rule and Rule .0510 of this Chapter and submits to the agency a schedule or
description of such program which specifies the:
(a) initial training;
(b) periodic training;
(c) on‑the‑job training;
(d) means to be used by the licensee to
determine the radiographer's knowledge and understanding of and ability to
comply with agency regulations and licensing requirements, and the operating
and emergency procedures of the applicant; and
(e) means to be used by the licensee to
determine the radiographer's assistant's knowledge and understanding of and
ability to comply with the operating and emergency procedures of the applicant;
(2) The applicant has established and submits to the
agency satisfactory written operating and emergency procedures described in
Rule .0513 of this Chapter;
(3) The applicant has established and submits to the
agency a description of its inspection program which is adequate to ensure that
each radiographer and radiographer assistant follows the rules in this Chapter
and the applicant's operating and emergency procedures.
(4) The inspection program described in the applicant's
procedures shall include:
(a) observation of the performance of each
radiographer and radiographer's assistant during an actual industrial
radiographic operation at the intervals not to exceed six months; provided
that, if a radiographer or a radiographer's assistant has not participated in a
radiographic operation for more than six months since the last inspection, that
individual's performance must be observed and recorded by a practical
examination before the individual participates in a radiographic operation;
(b) in those operations where a single individual
serves as both radiographer and Radiation Safety Officer, and performs all
radiography operations, an inspection program is not required; and
(c) the retention of inspection records on the
performance of radiographers or radiographers' assistants for three years;
(5) The applicant submits to the agency a description
of his overall organizational structure pertaining to the industrial
radiography program, including specified delegations of authority and
responsibility for operation of the program;
(6) The applicant who desires to conduct his own leak
tests has established procedures to be followed in leak testing sealed sources
for possible leakage and contamination sufficient to detect 0.005 microcuries
of removable contamination on the source, and submits to the agency a
description of the procedures, including:
(a) instrumentation to be used;
(b) method of performing tests, e.g., points on
equipment to be tested and method of taking tests; and
(c) pertinent experience of the person who will
perform the test; and
(7) The licensee conducts a program for inspection and
maintenance of radiographic exposure devices and storage containers to assure
proper functioning of components important to safety.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Amended Eff. April 1, 1999; June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .0323 Eff.
February 1, 2015.
10A NCAC 15 .0324 SPECIFIC LICENSES: BROAD SCOPE
(a) In addition to the requirements set forth in Rule .0317
of this Section, a specific license of broad scope for radioactive material
will be issued if:
(1) the applicant has engaged in a wide variety
of activities involving the use of many different types of radioactive material
in a variety of physical and chemical forms; and
(2) the applicant has established
administrative controls and provisions relating to organization and management,
procedures, record keeping, material control and accounting, and management
review that are necessary to assure safe operations, including:
(A) the establishment of a radiation safety committee
composed of such persons as a radiation safety officer, a representative of management,
and persons trained and experienced in the safe use of radioactive material;
(B) the appointment of a radiation safety officer who is
qualified by training and experience in radiation protection, and who is
available for advice and assistance on radiation safety measures; and
(C) the establishment of appropriate administrative
procedures to assure:
(i) control of procurement and use of radioactive
material;
(ii) completion of safety evaluations of proposed
uses of radioactive material which takes into consideration such matters as the
adequacy of facilities and equipment, training and experience of the user, and
the operating or handling procedures; and
(iii) review, approval, and recording by the
radiation safety committee of safety evaluations of proposed uses prepared in
accordance with Part (a)(2)(C) of this Rule prior to use of the radioactive
material.
(3) Unless specifically authorized pursuant to
other rules of this Section, persons licensed under this Rule shall not:
(A) conduct tracer studies in the environment involving
direct release of radioactive material;
(B) receive, acquire, own, possess, use, or transfer
devices containing 100,000 curies or more of byproduct material in sealed
sources used for irradiation of materials;
(C) conduct activities for which a specific license
issued by the agency under the rules of this Section is required; or
(D) add or cause the addition of radioactive material to
any food, beverage, cosmetic, drug, or other product designed for ingestion or
inhalation by, or application to, a human being.
(4) Each specific license of broad scope issued
under this Rule shall be subject to the condition that radioactive material
possessed under the license may only be used by, or under the direct
supervision of, individuals approved by the licensee's radiation safety
committee.
(b) In addition to the requirements set forth in Rule .0319
of this Section, a specific license of broad scope for radioactive material,
human use, will be issued only if:
(1) the applicant has appointed a radiation
safety committee as required in Part (a)(2)(A) of this Rule, except that this
committee shall evaluate all proposals for research, diagnostic and therapeutic
use of radioactive material within the medical facility;
(2) membership of the committee consists of
physicians specializing in nuclear medicine, diagnostic radiology, clinical
pathology, and a pharmacist specializing in radiopharmacy, someone competent in
radiation safety and a representative of the hospital management; and
(3) the applicant for a medical radioactive
materials license of broad scope has an ongoing teaching program with interns
and residents associated with a four‑year medical school.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Amended Eff. June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0324 Eff.
February 1, 2015.
10A NCAC 15 .0325 SPECIFIC LICENSES: PRODUCTS WITH
EXEMPT CONCENTRATIONS
10A NCAC 15 .0326 SPECIFIC LICENSES: EXEMPT DISTRIBUTION
History Note: Authority G.S. 104E-7; 104E-10(b);
Eff. February 1, 1980;
Amended Eff. June 1, 1993; May 1, 1993;
Repealed Eff. October 1, 2013;
Transferred and Recodified from 15A NCAC 11 .0325 and 15A
NCAC .0326 Eff. February 1, 2015.
10A NCAC 15 .0327 SPECIFIC LICENSES: EXEMPT GAS AND
AEROSOL DETECTORS
An application for a specific license authorizing the
incorporation of radioactive material other than source material into gas and
aerosol detectors to be distributed to persons exempt under Rule .0305(d) of
this Section will be approved if the application satisfies requirements
contained in Section 32.26 of 10 CFR Part 32 for source and byproduct material.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0327 Eff.
February 1, 2015.
10A NCAC 15 .0328 SPECIFIC LICENSES: MANUFACTURE DEVICES
TO PERSONS LICENSED
(a) An application for a specific license to manufacture or
distribute devices containing radioactive material, excluding special nuclear
material, to persons generally licensed under Rule .0309 of this Section or
equivalent regulations of the U.S. Nuclear Regulatory Commission or an
agreement state shall be approved if:
(1) the applicant satisfies the general
requirements of Rule .0317 of this Section;
(2) the applicant submits sufficient
information relating to the design, manufacture, prototype testing, quality
control, labels, proposed uses, installation, servicing, leak testing,
operating and safety instructions, and potential hazards of the device to
provide reasonable assurance that:
(A) the device can be safely operated by persons not
having training in radiological protection;
(B) under ordinary conditions of handling, storage, and
use of the device, the radioactive material contained in the device will not be
released or inadvertently removed from the device, and it is unlikely that any
person will receive in any period of one calendar year a dose in excess of 10
percent of the limits specified in the table of Rule .1604 of this Chapter; and
(C) under accident conditions (such as fire and
explosion) associated with handling, storage, and use of the device, it is
unlikely that any person would receive an external radiation dose or dose
commitment in excess of the following organ doses:
(i) whole body, head and trunk, active blood-forming
organs, gonads, or lens of eye: 15 rems;
(ii) hands and forearms, feet and ankles, localized
areas of skin averaged over areas no larger than one square centimeter: 200
rems; or
(iii) other organs: 50 rems; and
(3) each device bears a durable, legible,
visible label or labels approved by the agency, which contain in a clearly
visible and separate statement:
(A) instructions and precautions necessary to assure
safe installation, operation, and servicing of the device (documents such as
operating and service manuals may be identified in the label and used to
provide this information);
(B) the requirement, or lack of requirement, for leak
testing, or for testing any on‑off mechanism and indicator, including the
maximum time interval for such testing, and the identification of radioactive
material by isotope, quantity of radioactivity, and date of determination of
the quantity; and
(C) the information called for in the following
statement in the same or substantially similar form: "The receipt,
possession, use, and transfer of this device Model __________________, Serial No.
__________________, are subject to a general license or the equivalent and the
regulations of the U.S. Nuclear Regulatory Commission or an agreement state.
This label shall be maintained on the device in a legible condition. Removal
of this label is prohibited."
"CAUTION ‑
RADIOACTIVE MATERIAL
(name of manufacturer
or distributor)"
The model, serial number, and name of
manufacturer or distributor may be omitted from this label provided they are
elsewhere specified in labeling affixed to the device.
(b) If the applicant desires that the device be tested at
intervals longer than six months, either for proper operation of any on‑off
mechanism and indicator, or for leakage of radioactive material, he or she shall
include in his or her application sufficient information to demonstrate that a longer
interval is justified by performance characteristics of the device or similar
devices and by design features which have a bearing on the probability or
consequences of leakage of radioactive material from the device or failure of
the on-off mechanism and indicator. In determining the acceptable interval for
the test for leakage of radioactive material, the agency shall consider
information which includes:
(1) primary containment (source capsule);
(2) protection of primary containment;
(3) method of sealing containment;
(4) containment construction materials;
(5) form of contained radioactive material;
(6) maximum temperature withstood during
prototype test;
(7) maximum pressure withstood during prototype
tests;
(8) maximum quantity of contained radioactive
material;
(9) radiotoxicity of contained radioactive
material; and
(10) the applicant's operating experience with
identical devices or similarly designed and constructed devices.
(c) If the applicant desires that the general licensee
under Rule .0309 of this Section, or under equivalent regulations of the U.S.
Nuclear Regulatory Commission or an agreement state, be authorized to install
the device, collect the sample for analysis by a specific licensee for leakage
of radioactive material, service the device, test the on-off mechanism and
indicator, or remove the device from installation, he or she shall include in
his or her application:
(1) Written instructions for each activity to
be followed by the general licensee;
(2) Estimated calendar year doses associated
with the activity or activities by an individual untrained in radiological
protection, in addition to other handling, storage and use of devices under the
general license; and
(3) information to demonstrate that performance
of the activity or activities is unlikely to cause that individual to receive a
calendar year dose in excess of 10 percent of the limits specified in Rule
.1604 of this Chapter.
(d) Each person licensed under this Rule to distribute
devices shall furnish a copy of the general license contained in Section 31.5
of 10 CFR Part 31 to each person to whom he or she directly or through an
intermediate person transfers radioactive material in a device for use pursuant
to the general license contained in Rule .0309 of this Section, or equivalent
regulations of the U.S. Nuclear Regulatory Commission or an agreement state. The
copy of Section 31.5 of 10 CFR Part 31 shall be accompanied by a note
explaining that the use of the device is regulated by agreement states under
requirements substantially the same as those in Section 31.5 of 10 CFR Part 31.
Alternatively, when transferring the devices to persons in a specific
agreement state, a copy of that agreement state's equivalent regulations shall
be furnished by the licensee.
(e) Each person licensed under this Rule to distribute devices
shall report to the agencies specified in Subparagraphs (e)(1), (2) and (3) of
this Rule all transfers of the devices to persons generally licensed under the
rules of those agencies. The reports shall cover each calendar quarter and
shall be filed within 30 days thereafter. If no transfers have been made to
generally licensed persons during the reporting period, the reports shall so
indicate. Such reports shall identify each general licensee by name and
address, an individual by name or position who may constitute a contact with
the general licensee, the type and model number of the device transferred, and
the quantity and type of radioactive material contained in the device. If one
or more intermediate persons will possess the device at the intended place of
use prior to its possession by the user, the reports shall include
identification of each intermediate person by name, address, contact and
relationship to the intended user. The reports shall be submitted to:
(1) the agency for devices transferred to
persons generally licensed under Rule .0309 of this Section;
(2) each agreement state for devices
transferred to persons generally licensed under rules equivalent to Rule .0309
of this Section; and
(3) the U.S. Nuclear Regulatory Commission for
devices transferred to persons generally licensed under Section 31.5 of 10 CFR
Part 31.
(f) Each person licensed under this Rule to distribute devices
shall maintain for agency inspection either copies of all reports required in
Paragraph (e) of this Rule or a record containing the same information. Such
copies or records of transfer shall be maintained for at least five years after
the date of each transfer of a device to a generally licensed person.
History Note: Authority G.S. 104E-7; 104E-10(b);
Eff. February 1, 1980;
Amended Eff. October 1, 2013; January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0328 Eff.
February 1, 2015.
10A NCAC 15 .0329 SPECIFIC LICENSES: LUMINOUS SAFETY
DEVICES IN AIRCRAFT
An application for a specific license to manufacture,
assemble, or repair luminous safety devices containing tritium or promethium‑147
for use in aircraft, for distribution to persons generally licensed under Rule
.0311 of this Section will be approved subject to the following conditions:
(1) the applicant satisfies the general requirements
specified in Rule .0317 of this Section; and
(2) the applicant satisfies the requirements of
Sections 32.53, 32.54, 32.55, 32.56, and 32.101 of 10 CFR Part 32 or their
equivalent.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0329 Eff.
February 1, 2015.
10A NCAC 15 .0330 SPECIFIC LICENSES: MANUFACTURE OF
CALIBRATION SOURCES
An application for a specific license to manufacture
calibration sources containing americium‑241 and plutonium for
distribution to persons generally licensed under Rule .0312 of this Section
will be approved subject to the following conditions:
(1) the applicant satisfies the general requirements of
Rule .0317 of this Section; and
(2) the applicant satisfies the requirements of
Sections 32.57, 32.58, 32.59, 32.60 and 32.102 of 10 CFR Part 32 and Section
70.39 of 10 CFR Part 70 or their equivalent.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0330 Eff.
February 1, 2015.
10A NCAC 15 .0331 SPECIFIC LICENSES‑MANUFACTURE OF
IN VITRO TEST KITS
An application for a specific license to manufacture or
distribute radioactive material for use under the general license in Rule .0314
of this Section shall be approved if all of the following requirements are
satisfied:
(1) The applicant satisfies the general requirements
specified in Rule .0317 of this Section.
(2) The radioactive material is to be prepared for
distribution in prepackaged units of:
(a) iodine-125 in units not exceeding 10
microcuries each;
(b) iodine-131 in units not exceeding 10 microcuries
each;
(c) carbon-14 in units not exceeding 10
microcuries each;
(d) hydrogen-3 (tritium) in units not exceeding
50 microcuries each;
(e) iron-59 in units not to exceed 20
microcuries each;
(f) cobalt-57 in units not to exceed 10
microcuries each;
(g) selenium-75 in units not exceeding 10
microcuries each; or
(h) mock iodine-125 in units not exceeding 0.05
microcurie of iodine-129 and 0.005 microcurie of americium-241 each.
(3) Each prepackaged unit bears a durable, visible
label:
(a) identifying the radioactive contents as to
chemical form and radionuclide, and indicating that the amount of radioactivity
does not exceed the appropriate limit in Item (2) of this Rule; and
(b) displaying the radiation caution symbol
described in Rule .1623 of this Chapter and the words, "CAUTION,
RADIOACTIVE MATERIAL," and "NOT FOR INTERNAL OR EXTERNAL USE IN
HUMANS OR ANIMALS."
(4) The following statement, or a statement which
contains the information called for in the following statement, appears on a
label affixed to each prepackaged unit or appears in a leaflet or brochure
which accompanies the package:
This radioactive material may be received, acquired,
possessed, and used only by physicians, clinical laboratories or hospitals and
only for in vitro clinical or laboratory tests not involving internal or
external administration of the material, or the radiation therefrom, to human
beings or animals. Its receipt, acquisition, possession, use, and transfer are
subject to the regulations and a general license of the U.S. Nuclear Regulatory
Commission or a state with which the Commission has entered into an agreement
for the exercise of regulatory authority. (Name of Manufacturer.)
(5) The label affixed to the unit, or the leaflet or
brochure which accompanies the package, contains information as to the
precautions to be observed in handling and storing such radioactive material.
In the case of the mock iodine-125 reference or calibration source, the
information accompanying the source must also contain directions to the licensee
regarding the waste disposal requirements set out in Rule .1628 of this
Chapter.
History Note: Authority G.S. 104E-7; 104E-10(b);
Eff. February 1, 1980;
Amended Eff. October 1, 2013; January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0331 Eff.
February 1, 2015.
10A NCAC 15 .0332 SPECIFIC LICENSES: MANUFACTURE OF ICE
DETECTOR DEVICES
An application for a specific license to manufacture and
distribute ice detection devices to persons generally licensed under Rule .0315
of this Section will be approved subject to the following conditions:
(1) the applicant satisfies the general requirements of
Rule .0317 of this Section, and
(2) the applicant satisfies the requirements of
Sections 32.61, 32.62, 32.63 and 32.103 of 10 CFR Part 32 or their equivalent.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0332 Eff.
February 1, 2015.
10A NCAC 15 .0333 SPECIFIC LICENSES: MANUFACTURE OF
RADIOPHARMACEUTICALS
(a) An application for a specific license to manufacture
and distribute radiopharmaceuticals containing radioactive material for use by
persons licensed pursuant to Rules .0318, .0319, or .0320 of this Section for medical
use shall be approved if the applicant meets the following conditions:
(1) the applicant satisfies the requirements of
Rule .0317 of this Section; and
(2) the applicant meets the applicable
requirements in Section 32.72 of 10 CFR Part 32, and Section 30.32(j) of 10 CFR
Part 30.
(b) Authorization under this Rule to produce Positron
Emission Tomography (PET) radioactive drugs for noncommercial transfer to
medical use licensees in its consortium does not relieve the licensee from
complying with applicable FDA, other Federal, and State requirements governing
radioactive drugs.
(c) Each licensee authorized under this Rule to produce PET
radioactive drugs for noncommercial transfer to medical use licensees in its
consortium shall:
(1) satisfy the labeling requirements in Rule
.1626 of this Chapter for each PET radioactive drug transport radiation shield
and each syringe, vial, or other container used to hold a PET radioactive drug
intended for noncommercial distribution to members of its consortium; and
(2) possess and use instrumentation to measure
the radioactivity of the PET radioactive drugs intended for noncommercial
distribution to members of its consortium and meet the procedural,
radioactivity measurement, instrument test, instrument check, and instrument
adjustment requirements in this Rule.
(d) A licensee that is a pharmacy authorized under Rule
.0333 of this Section to produce PET radioactive drugs for noncommercial
transfer to medical use licensees in its consortium shall require that any
individual that prepares PET radioactive drugs be:
(1) an authorized nuclear pharmacist that meets
the requirements in Rule .0318 of this Section; or
(2) an individual under the supervision of an
authorized nuclear pharmacist as specified in Rule .0318 of this Section.
(e) A pharmacy authorized under this Rule to produce PET
radioactive drugs for noncommercial transfer to medical use licensees in its
consortium that allows an individual to work as an authorized nuclear
pharmacist shall meet the requirements of Rule .0318 of this Section.
History Note: Authority G.S. 104E-7; 104E-10(b);
Eff. February 1, 1980;
Amended Eff. October 1, 2013; November 1, 2007;
Transferred and Recodified from 15A NCAC 11 .0333 Eff.
February 1, 2015.
10A NCAC 15 .0334 SPECIFIC LICENSES: GENERATORS AND
REAGENT KITS
An application for a specific license to manufacture and
distribute generators and reagent kits containing radioactive material for
preparation of radiopharmaceuticals by persons licensed pursuant to Rule .0321
of this Section for the generators, reagent kits and associated medical uses shall
be approved if the applicant meets the following conditions:
(1) the applicant satisfies the general requirements of
Rule .0317 of this Section; and
(2) the applicant satisfies the applicable requirements
in Section 32.73 of 10 CFR Part 32 or their agreement state equivalent.
History Note: Authority G.S. 104E-7; 104E-10(b);
Eff. February 1, 1980;
Amended Eff. October 1, 2013;
Transferred and Recodified from 15A NCAC 11 .0334 Eff.
February 1, 2015.
10A NCAC 15 .0335 SPECIFIC LICENSES: PRODUCTS CONTAINING
DEPLETED URANIUM
(a) An application for a specific license to manufacture
industrial products and devices containing depleted uranium for use pursuant to
Rule .0307(e) of this Section or equivalent regulations of the U.S. Nuclear
Regulatory Commission or an agreement state will be approved if:
(1) the applicant satisfies the general
requirements specified in Rule .0317 of this Section;
(2) the applicant submits sufficient
information relating to the design, manufacture, prototype testing, quality
control procedures, labeling or marking, proposed uses, and potential hazards
of the industrial product or device to provide reasonable assurance that
possession, use, or transfer of the depleted uranium in the product or device
is not likely to cause any individual to receive in any period of one calendar
quarter a radiation dose in excess of ten percent of the limits specified in
Rule .1604 of this Chapter; and
(3) the applicant submits sufficient information
regarding the industrial product or device and the presence of depleted uranium
for a mass‑volume application in the product or device to provide
reasonable assurance that unique benefits will accrue to the public because of
the usefulness of the product or device.
(b) In the case of an industrial product or device whose
unique benefits are questionable, the agency will approve an application for a
specific license under this Rule only if the product or device is found to
combine a high degree of utility and low probability of uncontrolled disposal
and dispersal of significant quantities of depleted uranium into the
environment.
(c) The agency may deny any application for a specific
license under this Rule if the end use(s) of the industrial product or device
cannot be reasonably foreseen.
(d) Each person licensed pursuant to Paragraph (a) of this
Rule shall:
(1) maintain the level of quality control
required by the license in the manufacture of the industrial product or device,
and in the installation of the depleted uranium into the product or device;
(2) label or mark each unit to:
(A) identify the manufacturer of the product or device
and the number of the license under which the product or device was
manufactured, the fact that the product or device contains depleted uranium,
and the quantity of depleted uranium in each product or device; and
(B) state that the receipt, possession, use, and
transfer of the product or device are subject to a general license or the
equivalent and the regulations of the U.S. Nuclear Regulatory Commission or of
an agreement state;
(3) assure that the depleted uranium before
being installed in each product or device has been impressed with the following
legend clearly legible through any plating or other covering: "Depleted
Uranium".
(e) Each person, licensed under this Rule to distribute
devices, shall furnish a copy of the general license contained in Section 40.25
of 10 CFR Part 40 to each person to whom he directly or through an intermediate
person transfers radioactive material in a device for use pursuant to the
general license contained in Rule .0307(e) of this Section, or equivalent
regulations of the U.S. Nuclear Regulatory Commission or an agreement state.
The copy of Section 40.25 of 10 CFR Part 40 shall be accompanied by a note
explaining that the use of the device is regulated by agreement states under
requirements substantially the same as those in Section 40.25 of 10 CFR Part
40. Alternatively, when transferring the devices to persons in a specific
agreement state, a copy of that agreement state equivalent regulations shall be
furnished.
(f) Each person, licensed under this Rule to distribute
devices, shall report to the agencies specified in Subparagraphs (f)(1),(2) and
(3) of this Rule all transfers of the devices to persons generally licensed
under the rules of those agencies. Such reports shall identify each general
licensee by name and address, an individual by name or position who may
constitute a contact with the general licensee, the type and model number of
the device transferred, and the quantity and type of radioactive material
contained in the device. If one or more intermediate persons will temporarily
possess the device at the intended place of use prior to its possession by the
user, the reports shall include identification of each intermediate person by
name, address, contact and relationship to the intended user. If no transfers
have been made to generally licensed persons during the reporting period, the
reports shall so indicate. The reports shall cover each calendar quarter and
shall be filed within 30 days thereafter. The reports shall be submitted to:
(1) the agency for devices transferred to
persons generally licensed under Rule .0307(e) of this Section;
(2) each agreement state for devices
transferred to persons generally licensed under rules equivalent to Rule
.0307(e) of this Section; and
(3) the U.S. Nuclear Regulatory Commission for
devices transferred to persons generally licensed under Section 40.25 of 10 CFR
Part 40.
(g) Each person, licensed under this Rule to distribute
devices, shall maintain for agency inspection either copies of all reports
required in Paragraph (f) of this Rule or a record containing substantially the
same information. Such copies or records of transfer shall be maintained for
at least five years after the date of each transfer of a device to a generally
licensed person.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0335 Eff.
February 1, 2015.
10A NCAC 15 .0336 COPIES OF APPLICABLE FEDERAL
REGULATIONS
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Repealed Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0336 Eff.
February 1, 2015.
10A NCAC 15 .0337 ISSUANCE OF SPECIFIC LICENSES
(a) Upon a determination that an application meets the
requirements of the Act and the rules of this Section, the agency will issue a
specific license authorizing the proposed activity in such form and containing
such conditions and limitations as it deems appropriate or necessary.
(b) The agency may amend any license, when not in conflict
with any law, to waive any requirement in these Rules or to impose additional
requirements in accordance with 46 FR 7540, with respect to the licensee's
receipt, possession, use and transfer of radioactive material subject to the
rules in this Chapter as it deems appropriate or necessary in order to:
(1) minimize danger to public health and safety
or property;
(2) require such reports and the keeping of
such records, and provide for such inspections of activities under the license
as may be appropriate or necessary; and
(3) prevent loss or theft of radioactive
material subject to this Section.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
10 C.F.R. Chapter 1, Commission Notices, Policy Statements,
Agreement States, 46 F.R. 7540;
Eff. February 1, 1980;
Amended Eff. June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0337 Eff.
February 1, 2015.
10A NCAC 15 .0338 SPECIFIC TERMS AND CONDITIONS OF
LICENSES
(a) Each person licensed by the agency pursuant to this
Section shall confine his or her use and possession of the radioactive material
licensed to the locations and purposes authorized in the license.
(b) Each licensee shall notify the agency in writing
immediately following the filing of a voluntary or involuntary petition for
bankruptcy under any Chapter of Title 11 (Bankruptcy) of the United States Code
by or against:
(1) the licensee;
(2) an entity [as that term is defined in 11
U.S.C. 101(14)] controlling the licensee or listing the license or licensee as
property of the estate; or
(3) an affiliate [as that term is defined in 11
U.S.C. 101(2)] of the licensee.
(c) The notification in Paragraph (b) of this Rule shall
indicate:
(1) the bankruptcy court in which the petition
for bankruptcy was filed; and
(2) the date of the filing of the petition.
(d) Licensees required to submit emergency plans pursuant
to Rule .0352 of this Section shall follow the emergency plan approved by the
agency. The licensees may change the approved plan without prior agency
approval only if the licensee believes the changes do not decrease the
effectiveness of the plan and are submitted to the agency no later than 20
calendar days after the changes are made. The licensee shall furnish the
change to affected off-site response organizations within six months after the
change is made. Proposed changes that the licensee believes are likely to
decrease, or may potentially decrease, the effectiveness of the approved
emergency plan shall not be implemented without prior application to and
approval by the agency.
(e) Each licensee preparing technetium-99m
radiopharmaceuticals from molybdenum-99/technetium-99m generators or
rubidium-82 from strontium-82/rubidium-82 generators shall test the generator
eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85
contamination, respectively, in accordance with Rule .0361 of this Section. The
licensee shall record the results of each test and retain each record for three
years after the record is made.
(f) Each portable nuclear gauge licensee shall use at least
two independent physical controls that form tangible barriers to secure
portable gauges from unauthorized removal whenever portable gauges are not
under the control and constant surveillance of the licensee.
History Note: Authority G.S. 104E-7; 104E-10(b);
Eff. February 1, 1980;
Amended Eff. October 1, 2013; May 1, 1993; May 1, 1992;
June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .0338 Eff.
February 1, 2015.
10A NCAC 15 .0339 EXPIRATION AND TERMINATION OF LICENSES
AND DECOMMISSIONING
(a) Each specific license expires at the end of the day on
the expiration date stated in the license unless the licensee has filed an
application for renewal, as required in Rule .0340 of this Section, not less
than 30 days before the expiration date stated in the existing license. If an
application for renewal has been filed at least 30 days prior to the expiration
date stated in the existing license, the existing license expires at the end of
the day on which the agency makes a final determination to deny the renewal
application or, if the determination states an expiration date, the expiration
date stated in the determination.
(b) Each specific license revoked by the agency, as
provided for in Rule .0344 of this Section, expires at the end of the day on
the date of the agency's final determination to revoke the license, or on the
expiration date stated in the determination, or as otherwise provided by agency
order.
(c) Each specific license continues in effect, beyond the
expiration date if necessary, with respect to possession of residual
radioactive material present as contamination until the agency notifies the
licensee in writing that the license is terminated. During this time, the
licensee shall:
(1) limit actions involving radioactive
material to those related to decommissioning; and
(2) continue to control entry to restricted
areas until they are suitable for release for unrestricted use and the agency
notifies the licensee in writing that the license is terminated.
(d) Within 60 days of the occurrence of any of the
following, each licensee shall provide notification to the agency in writing of
such occurrence, and either begin decommissioning its site, or any separate
building or outdoor area that contains residual radioactivity so that the
building or outdoor area is suitable for release in accordance with Commission
requirements, or submit within 12 months of notification a decommissioning
plan, if required by Subparagraph (g)(1) of this Rule, and begin
decommissioning upon approval of that plan if:
(1) The license has expired pursuant to
Paragraphs (a) or (b) of this Rule;
(2) The licensee has decided to permanently
cease principal activities at the entire site or in any separate building or
outdoor area that contains residual radioactivity such that the building or
outdoor area is unsuitable for release in accordance with Commission
requirements;
(3) No principal activities under the license
have been conducted for a period of 24 months; or
(4) No principal activities have been conducted
for a period of 24 months in any separate building or outdoor area that
contains residual radioactivity such that the building or outdoor area is
unsuitable for release in accordance with Commission requirements.
(e) Coincident with the notification requirements set forth
in Paragraph (d) of this Rule, the licensee shall maintain in effect all
decommissioning financial assurances established by the licensee pursuant to
Rule .0353 of this Section in conjunction with a license issuance or renewal,
or as required by this Rule. The amount of the financial assurance must be
increased, or may be decreased, as appropriate, to cover the detailed cost
estimate for decommissioning established in Paragraph (g) of this Rule.
(1) Any licensee who has not provided financial
assurance to cover the detailed cost estimate submitted with the
decommissioning plan shall do so when this Rule becomes effective.
(2) Following agency approval of the decommissioning
plan, a licensee may reduce the amount of the financial assurance as
decommissioning proceeds and radiological contamination is reduced at the site
with the approval of the agency.
(f) The agency may grant a request to extend the time
periods required in Paragraph (d) of this Rule if the agency determines that
this relief is not detrimental to the public health and safety and is otherwise
in the public interest. The request shall be submitted to the agency no later
than 30 days before notification pursuant to Paragraph (d) of this Rule. The
schedule for decommissioning set forth in Paragraph (d) of this Rule may not
commence until the agency has made a determination on the licensee's request.
(g) A decommissioning plan shall be submitted if required
by license condition or if the procedures and activities necessary to carry out
decommissioning of the site or separate building or outdoor area have not been
previously approved by the agency and these procedures could increase potential
health and safety impacts to workers or to the public, such as in any of
following cases:
(1) Procedures would involve techniques not
applied routinely during cleanup or maintenance operations;
(2) Workers would be entering areas not
normally occupied where surface contamination and radiation levels are
significantly higher than routinely encountered during operation;
(3) Procedures could result in significantly
greater airborne concentrations of radioactive materials than are present
during operation; or
(4) Procedures could result in significantly
greater releases of radioactive material to the environment than those
associated with operation. For the purpose of Subparagraphs (g)(2)-(4) of this
Rule, significantly higher or significantly greater is defined as an increase
likely to result in either an increase in radiation exposure to workers or the
public in excess of one percent of their respective annual radiation exposure
limit.
(h) The agency may approve an alternate schedule for
submittal of a decommissioning plan required pursuant to Paragraph (d) of this
Rule if the agency determines that the alternative schedule is necessary to the
effective conduct of decommissioning operations and presents no undue risk from
radiation to the public health and safety and is otherwise in the public
interest.
(i) Procedures such as those listed in Paragraph (g) of
this Rule with potential health and safety impacts may not be carried out prior
to agency approval of the decommissioning plan.
(j) The proposed decommissioning plan for the site or
separate building or outdoor area shall include:
(1) A description of the conditions of the site
or separate building or outdoor area sufficient to evaluate the acceptability
of the plan;
(2) A description of planned decommissioning
activities;
(3) A description of methods used to ensure
protection of workers and the environment against radiation hazards during
decommissioning;
(4) A description of the planned final
radiation survey;
(5) An updated detailed cost estimate for
decommissioning, comparison of that estimate with present funds set aside for
decommissioning, and a plan for assuring the availability of adequate funds for
completion of decommissioning; and
(6) For decommissioning plans calling for
completion of decommissioning later than 24 months after plan approval, the
plan shall include a justification for the delay based on the criteria in
Paragraph (m) of this Rule.
(k) The proposed decommissioning plan shall be approved by
the agency if the information therein demonstrates that the decommissioning
will be completed as soon as practicable and that the health and safety of
workers and the public will be protected.
(l) Except as provided in Paragraph (m) of this Rule,
licensees shall complete decommissioning of the site or separate building or
outdoor area as soon as practicable but no later than 24 months following the
initiation of decommissioning. Except as provided in Paragraph (m) of this
Rule, when decommissioning involves the entire site, the licensee shall request
license termination as soon as practicable but no later than 24 months
following the initiation of decommissioning.
(m) The agency may approve a request for an alternative
schedule for completion of decommissioning of the site or separate building or
outdoor area, and license termination if appropriate, if the agency determines
that the alternative is warranted by consideration of the following:
(1) Whether it is technically feasible to
complete decommissioning within the allotted 24 month period;
(2) Whether sufficient waste disposal capacity
is available to allow completion of decommissioning within the allotted 24
month period;
(3) Whether a significant volume reduction in
wastes requiring disposal will be achieved by allowing short-lived
radionuclides to decay;
(4) Whether a significant reduction in
radiation exposure to workers can be achieved by allowing short-lived
radionuclides to decay; and
(5) Other site-specific factors which the
agency may consider appropriate on a case-by-case basis, such as:
(A) regulatory requirements of other government
agencies;
(B) lawsuits;
(C) ground-water treatment activities;
(D) monitored natural ground-water restoration;
(E) actions that could result in more environmental
harm than deferred cleanup; and
(F) other factors beyond the control of the licensee.
(n) As the final step in decommissioning, the licensee
shall:
(1) Certify the disposition of all licensed
material, including accumulated wastes, by submitting a completed
"Certificate of Disposition"; and
(2) Conduct a radiation survey of the premises
where the licensed activities were carried out and submit a report of the
results of this survey unless the licensee demonstrates that the premises are
suitable for release in some other manner. The licensee shall, as appropriate:
(A) Report levels of gamma radiation in units of
microrem (millisieverts) per hour at one meter from surfaces;
(B) Report levels of radioactivity, including alpha and
beta, in units of microcuries per 100 square centimeters (or disintegrations
per minute), removable and fixed, for surfaces; microcuries per milliliter for
water; and picocuries per gram for solids such as soils or concrete; and
(C) Specify the survey instrument(s) used and certify
that each instrument is properly calibrated and tested.
(o) Specific licenses shall be terminated by written notice
to the licensee when the agency determines that:
(1) radioactive material has been properly
disposed;
(2) reasonable effort has been made to
eliminate residual radioactive contamination, if present; and
(3) a radiation survey has been performed which
demonstrates that the premises are suitable for release in accordance with the
requirements for decommissioning described in Rule .1653 of this Chapter, or
other information submitted by the licensee is sufficient to demonstrate that
the premises are suitable for release in accordance with the requirements for
decommissioning described in Rule .1653 of this Chapter.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
104E‑18;
Eff. February 1, 1980;
Amended Eff. April 1, 1999; August 1, 1998; May 1, 1992;
Transferred and Recodified from 15A NCAC 11 .0339 Eff.
February 1, 2015.
10A NCAC 15 .0340 RENEWAL OF LICENSES
Applications for renewal of specific licenses shall be filed
in accordance with Rule .0317 of this Section.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Amended Eff. August 1, 1998;
Transferred and Recodified from 15A NCAC 11 .0340 Eff.
February 1, 2015.
10A NCAC 15 .0341 AMENDMENT OF LICENSES AT REQUEST OF
LICENSEE
Applications for amendment of a license shall be filed in
accordance with Rule .0317 of this Section and shall specify the respects in
which the licensee desires his license to be amended and the grounds for such
amendment. The applicant shall submit such other supporting information as
required by the agency.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0341 Eff.
February 1, 2015.
10A NCAC 15 .0342 AGENCY ACTION ON APPLICATIONS TO RENEW
OR AMEND
In considering an application by a licensee to renew or
amend his license, the agency shall apply the criteria set forth in the
applicable rules of this Section.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0342 Eff.
February 1, 2015.
10A NCAC 15 .0343 TRANSFER OF MATERIAL
(a) No licensee shall transfer radioactive material except
as authorized pursuant to this Section.
(b) Except as otherwise provided in his license and subject
to the provisions of Paragraphs (c), (d) and (e) of this Rule any licensee may
transfer radioactive material to:
(1) the agency;
(2) the U.S. Department of Energy;
(3) any person exempt from the rules in this
Section to the extent permitted under the exemption;
(4) any person authorized to receive the radioactive
material under terms of a general license or its equivalent, or a specific
license or equivalent licensing document, issued by the agency, the U.S.
Nuclear Regulatory Commission, or an agreement state, or any person otherwise
authorized to receive the radioactive material by the federal government or any
agency thereof, the agency, or an agreement state; or
(5) as otherwise authorized by the agency in
writing.
(c) A licensee may transfer material to the agency only
after receiving prior approval from the agency.
(d) Before transferring radioactive material to a specific
licensee of the agency, the U.S. Nuclear Regulatory Commission, or an agreement
state, or to a general licensee who is required to register with the agency,
the U.S. Nuclear Regulatory Commission, or an agreement state prior to receipt
of the radioactive material, the licensee transferring the material shall
verify that the transferee's license authorizes the receipt of the type, form,
and quantity of radioactive material to be transferred.
(e) The following methods for the verification required by
Paragraph (d) of this Rule are acceptable:
(1) The transferor may have in his possession,
and read, a current copy of the transferee's specific license or registration
certificate;
(2) The transferor may have in his possession a
written certificate by the transferee that he is authorized by license or
registration certificate to receive the type, form, and quantity of radioactive
material to be transferred, specifying the license or registration certificate
number, issuing agency, and expiration date;
(3) For emergency shipments the transferor may
accept oral certification by the transferee that he is authorized by license or
registration certificate to receive the type, form, and quantity of radioactive
material to be transferred, specifying the license or registration certificate
number, issuing agency, and expiration date; provided the oral certification is
confirmed in writing within 10 days after the date of the oral certification;
(4) The transferor may obtain other sources of
information compiled by a reporting service from official records of the
agency, the U.S. Nuclear Regulatory Commission, or the licensing agency of an
agreement state as to the identity of licensees and the scope and expiration
dates of licenses and registration; or
(5) When none of the methods of verification
described in this Rule are readily available or when a transferor desires to
verify that information received by one of the methods is correct or updated,
the transferor may obtain and record confirmation from the agency, the U.S.
Nuclear Regulatory Commission, or the licensing agency of an agreement state
that the transferee is licensed to receive the radioactive material.
(f) Preparation for shipment and transport of radioactive
material shall be in accordance with the provisions of Rule .0346 of this
Section.
History Note: Filed as a Temporary Amendment Eff.
August 20, 1994 for a period of 180 days or until the
permanent rule becomes effective, whichever is sooner;
Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Amended Eff. May 1, 1995; May 1, 1993; June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .0343 Eff.
February 1, 2015.
10A NCAC 15 .0344 MODIFICATION: REVOCATION: AND
TERMINATION OF LICENSES
(a) The terms and conditions of all licenses are subject to
amendment, revision or modification and all licenses are subject to suspension
or revocation by reason of:
(1) amendments to the Act,
(2) rules adopted pursuant to provisions of the
Act, or
(3) orders issued by the agency pursuant to
provisions of the Act and rules adopted pursuant to provisions of the Act.
(b) Any license may be revoked, suspended, or modified, in
whole or in part:
(1) for any material false statement in the
application or in any statement of fact required by provisions of this Section;
(2) because of conditions which would warrant
the agency to refuse to grant a license or an original application revealed by:
(A) the application;
(B) any statement of fact;
(C) any report, record, inspection or other means; or
(3) for violation of, or failure to observe any
of the terms and conditions of the Act, the license, the rules of this Chapter,
or order of the agency.
(c) Except in cases of willfulness or those in which the
public health, interest or safety requires otherwise, prior to the institution
of proceedings for modification, revocation, or suspension of a license, the
agency shall:
(1) call to the attention of the licensee in
writing the facts or conduct which may warrant these actions, and
(2) provide an opportunity for the licensee to
demonstrate or achieve compliance with all lawful requirements.
(d) The agency may terminate a specific license upon
request submitted by the licensee to the agency in writing.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
104E‑13;
Eff. February 1, 1980;
Amended Eff. June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0344 Eff.
February 1, 2015.
10A NCAC 15 .0345 RECIPROCAL RECOGNITION OF LICENSES
(a) Subject to these Rules, any person who holds a specific
license from the U.S. Nuclear Regulatory Commission or an agreement state, and
issued by the agency having jurisdiction where the licensee maintains an office
for directing the licensed activity and at which radiation safety records are
normally maintained, is hereby granted a general license to conduct the
activities authorized in such licensing document within this state for a period
not in excess of 180 days in any calendar year provided that the following
requirements are satisfied:
(1) The licensing document does not limit the
activity authorized by such document to specified installations or locations;
(2) The out‑of‑state licensee notifies
the agency in writing at least three days prior to engaging in such activity;
such notification shall indicate the location, period, and type of proposed
possession and use within the state, and shall be accompanied by a copy of the
pertinent licensing document; if, for a specific case, the three day period
would impose an undue hardship on the out‑of‑state licensee,
including but not limited to adverse impact on the business of the licensee or
his customer, he may upon application to the agency, obtain permission to
proceed sooner; the agency may waive the requirement for filing additional
written notifications during the remainder of the calendar year following the
receipt of the initial notification from a person engaging in activities under
the general license provided in this Rule if the agency determines that such
written notifications are not necessary to ensure compliance with the rules in
this Chapter or to protect the public;
(3) The out‑of‑state licensee
complies with all applicable rules of the agency and with all the terms and
conditions of his licensing document, except any such terms and conditions
which may be inconsistent with applicable rules of the agency;
(4) The out‑of‑state licensee
supplies such other information as the agency may request; and
(5) The out‑of‑state licensee shall
not transfer or dispose of radioactive material possessed or used under the
general license provided in this Rule except by transfer to a person:
(A) specifically licensed by the agency or by the U.S.
Nuclear Regulatory Commission to receive the material, or
(B) exempt from the requirements for a license for the
material under Rule .0303 of this Section.
(b) Additional reciprocity is provided in Rule .0310 of
this Section.
(c) The agency may withdraw, limit, or qualify its
acceptance of any specific license or equivalent licensing document issued by
another agency, or any product distributed pursuant to such licensing document,
upon determining that the action is necessary in order to prevent undue hazard
to public health and safety or property.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
Eff. February 1, 1980;
Amended Eff. June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0345 Eff.
February 1, 2015.
10A NCAC 15 .0346 PREPARATION OF RADIOACTIVE MATERIAL
FOR TRANSPORT
(a) No licensee shall deliver any radioactive material to a
carrier for transport, unless:
(1) The licensee complies with the applicable
requirements of the regulations, appropriate to the mode of transport, of the
U.S. Department of Transportation insofar as such regulations relate to the
packing of radioactive material, and to the monitoring, marking and labeling of
those packages;
(2) The licensee has established procedures for
opening and closing packages in which radioactive material is transported to
provide safety and to assure that, prior to the delivery to a carrier for
transport, each package is properly closed for transport; and
(3) Prior to delivery of a package to a carrier
for transport, the licensee shall assure that any special instructions needed
to safely open the package are sent to, or have been available to the
consignee.
(b) For the purpose of this Rule, a licensee who transports
his own licensed material as a private carrier is considered to have delivered
the material to a carrier for transport.
(c) In addition to the requirements of Paragraphs (a) and
(b) of this Rule, prior to the transport of any nuclear waste, as defined in
Part (d)(2)(A) of Rule .0316 of this Section, outside the confines of the
licensee's facility or other place of use or storage, or prior to the delivery
of any nuclear waste to a carrier for transport, each licensee shall provide
advance notification of such transport to the governor's designee of each state
through which the waste will be transported.
(d) Each advance notification required by Paragraph (c) of
this Rule shall contain the following information:
(1) the name, address, and telephone number of
the shipper, carrier and receiver of the shipment;
(2) a description of the nuclear waste
contained in the shipment as required by the regulations of the U.S. Department
of Transportation in 49 CFR 172.202 and 172.203(d);
(3) the point of origin of the shipment and the
seven‑day period during which departure of the shipment is estimated to
occur;
(4) the seven‑day period during which
arrival of the shipment at state boundaries is estimated to occur;
(5) the destination of the shipment, and the
seven‑day period during which arrival of the shipment is estimated to
occur; and
(6) a point of contact with a telephone number
for current shipment information.
(e) The notification required by Paragraph (c) of this Rule
shall be made in writing to the office of each appropriate governor or
governor's designee. A notification delivered by mail must be postmarked at
least seven days before the beginning of the seven‑day period during
which departure of the shipment is estimated to occur. A notification
delivered by messenger must reach the office of the governor or governor's
designee at least four days before the beginning of the seven‑day period
during which departure of the shipment is estimated to occur. A copy of the
notification shall be retained by the licensee for one year.
(f) The licensee shall notify each appropriate governor or
governor's designee of any changes to schedule information provided pursuant to
Paragraph (c) of this Rule. Such notification shall be by telephone to a
responsible individual in the office of the governor or governor's designee of
the appropriate state or states. The licensee shall maintain for one year a
record of the name of the individual contacted.
(g) Each licensee who cancels a nuclear waste shipment for
which advance notification has been sent shall send a cancellation notice to
the governor or governor's designee of the appropriate state or states. A copy
of the notice shall be retained by the licensee for one year.
(h) A list of governors or governors' designees for other
states is available from the agency by contacting the North Carolina Division
of Radiation Protection, P.O. Box 27687, Raleigh, North Carolina 27611‑7687,
Phone No. 919/571-4141 or facsimile number 919/571-4148. For the notification
required in Paragraphs (c) through (g) of this Rule in North Carolina:
(1) governor's designee is the North Carolina
Highway Patrol, Operations Office;
(2) mailing address: P. O. Box 27687, Raleigh,
North Carolina 27611‑7687;
(3) telephone 919/733‑4030 from 8 a.m. to
5 p.m. workdays, and 919/733‑3861 all other times.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
104E‑15(a);
Eff. February 1, 1980;
Amended Eff. May 1, 1993; November 1, 1989; October 1,
1982;
Transferred and Recodified from 15A NCAC 11 .0346 Eff.
February 1, 2015.
10A NCAC 15 .0347 SECURITY REQUIREMENTS
History Note: Authority G.S. 104E‑18;
Eff. February 1, 1980;
Repealed Eff. May 1, 1992;
Transferred and Recodified from 15A NCAC 11 .0347 Eff.
February 1, 2015.
10A NCAC 15 .0348 SPECIFIC LICENSES: CERTAIN INCINERATOR
FACILITIES
(a) In addition to the requirements set forth in Rule .0317
of this Section, an application for a license authorizing construction and
operation of an incinerator as part of a radioactive waste processing facility
as defined in Rule .0104 of this Chapter shall include an environmental
assessment that addresses the following topics:
(1) description of the applicant:
(A) the company or corporate structure with the names,
addresses and titles of officers;
(B) present products and activities;
(C) prior experience in the use, processing and disposal
of radioactive material;
(D) financial and technical ability to construct,
operate and decommission the proposed radioactive waste processing facility;
(2) description of the site:
(A) physical location and general description to include
nearest buildings, residences, schools, hospitals, etc.;
(B) populations and land use in the general area to
include nearest buildings, residences, schools, hospitals, etc.;
(C) geological and hydrological characterization of the
site to include soil type, topography, past and projected seismic activity,
groundwater, aquifers and surface waters;
(D) meteorology to include climate, distribution of wind
speed and direction, atmospheric stability and dispersion characteristics, and
data on precipitation, floods, hurricanes and tornados;
(E) background radiation and radioactivity;
(F) transportation routes;
(3) incinerator design:
(A) general description;
(B) manufacturer, basis for selecting the proposed
incinerator design and identification of operating incinerators of the same or
similar design;
(C) maximum capacity, minimum chamber temperatures,
minimum chamber residence times, residual ash collection and effluent controls
(e.g., scrubber filters and stack);
(D) decontamination, maintenance and anticipated
operating life;
(E) waste handling, storage and injection systems;
(F) instrumentation and controls;
(G) minimum performance specifications for the incinerator
and effluent control systems, and preoperational testing/certification program;
(4) facility design:
(A) compartmentalization/zoning, waste storage and
handling areas, waste flow, ventilation and contamination control/containment;
(B) sanitary sewer, drains, holdup systems, showers and
other liquid handling systems;
(5) management and staffing:
(A) structure of facility organization showing line
configuration of the radiation safety officer;
(B) qualifications of management, supervisory and safety
personnel;
(C) staff training program;
(6) description of waste:
(A) general chemical, physical and radiological
properties;
(B) maximum quantity of each radionuclide to be
incinerated per year;
(C) maximum quantity of each radionuclide to be stored
on‑site at any one time;
(D) maximum quantity of each toxic or hazardous
constituent of the waste to be incinerated per year;
(E) maximum quantity of each toxic or hazardous
constituent of the waste to be stored on‑site at any one time;
(F) acceptance and rejection criteria for waste to be
received for incineration;
(7) treatment of waste to be shipped off‑site:
(A) classification;
(B) immobilization;
(C) packaging;
(D) storage;
(E) shipment;
(F) disposal;
(G) processing and disposal of ash;
(8) prelicensing and operational public
information program:
(A) state and local government;
(B) media and public;
(9) plan for maintaining radiation exposures
and releases of radioactivity as low as reasonably achievable (ALARA):
(A) procedures, systems and criteria to maintain whole
body, thyroid, and other organ radiation doses of the off‑site public as
low as reasonably achievable below the limits stated in Section .1600 of this
Chapter;
(B) procedures, systems and criteria to maintain whole
body, thyroid, and other organ radiation doses of on‑site personnel as
low as reasonably achievable below the limits established in Section .1600 of
this Chapter;
(10) off‑site impact assessment for routine
operation:
(A) maximum quantity and concentration of each
radionuclide and toxic or hazardous constituent of the waste released annually
to the air, to the water and to the soil;
(B) maximum radiation doses to off‑site
populations to include dose to the nearest resident, a description of
computational models, sample computations and a summary of any previous
experience;
(C) maximum off‑site radionuclide concentrations
in air, soil, water and food;
(11) monitoring programs and systems:
(A) analytical and portable monitoring equipment for
radiological and chemical measurements;
(B) inspection, monitoring and analysis of waste
containers and waste prior to incineration;
(C) alarms, area monitors, stack/effluent monitors and
facility shutdown mechanisms to include action levels, reset and restart
procedures and criteria;
(D) personnel monitoring and bioassay;
(E) preoperational environmental monitoring;
(F) operational environmental monitoring, to include,
if available, a copy of the last environmental monitoring report filed with the
U.S. Nuclear Regulatory Commission or agreement state program;
(12) other rules, standards and permits:
(A) federal, state and local regulations and standards
which will apply to the proposed facility or would apply to the facility in the
absence of the radioactive content of the waste;
(B) other permits which are required to include the
current status of applications for and issuance of such permits;
(13) accident analysis:
(A) identification of accident modes;
(B) major credible accidents and projected potential off‑site
impacts;
(C) mitigation of accidents and protection of the
public;
(14) emergency response plan:
(A) on‑site response;
(B) local and county;
(C) state and regional;
(D) training and public information;
(E) if available, copies of most current emergency
response plans submitted to the U.S. Nuclear Regulatory Commission or an
agreement state;
(15) decontamination and decommissioning:
(A) schedule;
(B) procedure;
(C) radioactive waste disposal plan.
(b) The applicant shall submit to the agency ten copies of
the license application, environmental assessment, and other information
required in Paragraph (a) of this Rule and Rule .0317 of this Section.
History Note: Authority G.S. 104E‑7(2); 104E‑7(a)(8);
104E‑10(b);
Eff. October 1, 1984;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0348 Eff.
February 1, 2015.
10A NCAC 15 .0349 EXEMPTIONS: WASTE MANAGEMENT BY
GENERATORS
(a) Subject to the limitations in Paragraphs (b) and (c) of
this Rule, any licensee is exempt from the provisions of G.S. 104E‑6.1,
G.S. 104E‑10.1, G.S. 104E-20(b), G.S. 104E-25, and G.S. 104E-26 with
respect to the following waste management practices:
(1) storage of waste incidental to transfer to
a licensed low‑level radioactive waste facility authorized to receive
such waste;
(2) storage of waste to allow for total decay
of contained radioactive material prior to disposal as nonradioactive waste;
(3) storage of waste to allow for partial decay
of contained radioactive material prior to disposal, incineration or other
treatment; or
(4) compaction, incineration, treatment,
packaging or disposal of waste as provided in the rules in Section .1600 of
this Chapter.
(b) Except as provided in Paragraph (c) of this Rule, the
exemptions in Paragraph (a) of this Rule shall apply only to a licensee:
(1) who possesses and uses radioactive material
pursuant to specific licenses issued by the agency and only to management by
the licensee of waste generated incidental to such possession and use;
(2) who is determined by the agency to be
using sound waste management practices;
(3) who is determined by the agency to be
managing such low volumes or activity of waste that such exemptions will not
endanger the public health or safety or the environment; and
(4) whose combined waste management activities
do not cause a radiation dose to the off‑site public in excess of the
limits stated in Rule .1223 of this Chapter.
(c) The exemptions in Paragraph (a) of this Rule shall also
apply to on‑site disposal of waste by persons who generate waste pursuant
to a license issued by the U.S. Nuclear Regulatory Commission, provided that:
(1) the U.S. Nuclear Regulatory Commission
determines that such on‑site disposal is subject to regulation by the
agency;
(2) such persons satisfy the requirements in
Subparagraphs (b)(2) and (b)(3) of this Rule;
(3) such persons do not receive waste,
generated by others or generated at other sites for the purpose of disposal;
(4) such persons shall limit off‑site
dose to the public, resulting from all activities authorized by the agency and
the U.S. Nuclear Regulatory Commission, to the limits stated in Rule .1223 of
this Chapter or as prescribed by the U.S. Nuclear Regulatory Commission, 10 CFR
Part 50 for U.S. Nuclear Regulatory Commission regulated activities, whichever
is more restrictive;
(5) such persons apply for and receive a
specific radioactive material license, issued by the agency pursuant to the
rules in this Section, which authorizes such disposal pursuant to Rule .1628 of
this Chapter; and
(6) such persons provide notification to the
agency prior to each disposal made pursuant to any radioactive material license
described in Subparagraph (c)(5) of this Rule.
History Note: Filed as a Temporary Amendment Eff.
November 22, 1995, for a period of 180 days or until
the permanent rule becomes effective, whichever is
sooner;
Authority G.S. 104E‑7(a)(10);
Eff. June 1, 1989;
Amended Eff. May 1, 1996; January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0349 Eff.
February 1, 2015.
10A NCAC 15 .0350 RECORDS AND REPORTS OF
MISADMINISTRATION
History Note: Authority G.S. 104E‑7(a)(2);
Eff. June 1, 1989;
Temporary Amendment Eff. August 20, 1994 for a period of
180 days or until the
permanent rule becomes effective, whichever is sooner;
Amended Eff. May 1, 1995; May 1, 1992;
Repealed Eff. November 1, 2007;
Transferred and Recodified from 15A NCAC 11 .0350 Eff.
February 1, 2015.
10A NCAC 15 .0351 SPECIFIC LICENSES: MOBILE NUCLEAR
MEDICINE SERVICES
(a) Provided that mobile nuclear medicine services shall be
limited to clients who do not have a specific radioactive material license for
the same services, unless the client's specific license specifically authorizes
the use of such mobile services, the agency will license a mobile nuclear
medicine service for the following services:
(1) uptake, dilution and excretion;
(2) imaging and localization;
(3) sealed sources for diagnosis; and
(4) certain in vitro clinical or laboratory
testing.
(b) The mobile nuclear medicine service licensee shall:
(1) obtain a letter signed by the management of
each client for which services are rendered that authorizes the licensee to use
radioactive material at the client's address of use;
(2) retain the letter for two years after the
last provision of service;
(3) not order radioactive material to be
delivered directly from the manufacturer or distributor to the client's address
of use;
(4) transport to each address of use only
syringes or vials containing prepared radiopharmaceuticals or
radiopharmaceuticals that are intended for reconstitution of
radiopharmaceuticals kits;
(5) bring into each address of use of all
radioactive material to be used and before leaving, remove all unused
radioactive material and all associated waste;
(6) secure or keep under constant surveillance
and immediate control all radioactive material when in transit or at an address
of use;
(7) check survey instruments, dose calibrators
and all other transported equipment for proper function before medical use at
each address of use;
(8) carry a radiation detection survey meter in
each vehicle that is being used to transport radioactive material and, before
leaving a client address of use, survey all radiopharmaceutical areas of use
with a radiation detection survey meter to ensure that all radiopharmaceuticals
and all associated waste have been removed; and
(9) retain a record of each survey required in
Subparagraph (b)(8) of this Rule for two years, where such records shall
include:
(A) the date of the survey,
(B) a plan of each area that was surveyed,
(C) the measured dose rate at several points in each
area of use expressed in millirem per hour,
(D) the instrument used to make the survey; and
(E) the initials of the individual who performed the
survey.
History Note: Filed as a Temporary Amendment Eff.
August 20, 1994 for a period of 180 days or until the
permanent rule becomes effective, whichever is sooner;
Authority G.S. 104E‑7(a)(2); 104E‑10(b);
Eff. June 1, 1989;
Amended Eff. May 1, 1995;
Transferred and Recodified from 15A NCAC 11 .0351 Eff.
February 1, 2015.
10A NCAC 15 .0352 EMERGENCY PLANS
(a) Each application to possess radioactive materials in
unsealed form, on foils or plated sources, or sealed in glass in excess of the
quantities in the table in Subparagraph (e)(1) of this Rule must contain
either:
(1) an evaluation showing that the maximum dose
to a person off-site due to a release of radioactive materials would not exceed
one rem effective dose equivalent or five rems to the thyroid; or
(2) an emergency plan for responding to a
release of radioactive material.
(b) The following factors shall be used to support an
evaluation submitted under Subparagraph (a)(1) of this Rule:
(1) the radioactive material is physically
separated so that only a portion could be involved in an accident;
(2) all or part of the radioactive material is
not subject to release during an accident because of the way it is stored or
packaged;
(3) the release fraction in the respirable size
range would be lower than the release fraction shown in Subparagraph (e)(1) of
this Rule due to the chemical or physical form of the material;
(4) the solubility of the radioactive material
would reduce the dose received;
(5) the facility design or engineered safety
features in the facility would cause the release fraction to be lower than
shown in Subparagraph (e)(1) of this Rule; and
(6) the operating restrictions or procedures
would prevent a release fraction as large as that shown in Subparagraph (e)(1)
of this Rule; or
(7) the factors appropriate for the specific
facility.
(c) An emergency plan for responding to a release of
radioactive material submitted under Subparagraph (a)(2) of this Rule must
include the following information:
(1) a description of the licensee's facility
and potentially impacted area;
(2) the identification of each type of
radioactive materials accident for which protective actions may be needed;
(3) the classification system for classifying
accidents as alerts or site area emergencies;
(4) the identification of the means of
detecting each type of accident in a timely manner quickly enough to mitigate
off-site consequences;
(5) a description of the means and equipment
for mitigating the consequences of each type of accident, including those
provided to protect workers on-site, and a description of the program for
maintaining the equipment;
(6) a description of the methods and equipment
to assess releases of radioactive materials;
(7) a description of the responsibilities of
licensee personnel, should an accident occur, including identification of
personnel responsible for notifying off-site response organizations and the
agency, and responsibilities for developing, maintaining, and updating the
plan;
(8) a description of notification and
coordination, to include a commitment to and a brief description of the means
to notify off-site response organizations and request off-site assistance,
including medical assistance for the treatment of contaminated injured on-site
workers when needed, provided that:
(A) a control point is established;
(B) the notification and coordination is planned so that
unavailability of some personnel, parts of the facility, and some equipment
will not prevent the notification and coordination;
(C) the licensee commits to notify the agency after
notification of the appropriate off-site response organizations, within one
hour after the licensee declares an emergency; and
(D) the reporting requirements in this Subparagraph do
not substitute for or relieve the licensee from responsibility for complying
with the requirements in the Emergency Planning and Community Right-to-Know Act
of 1986, Title III, Public Law 99-499 or other State or federal reporting
requirements;
(9) description of the types of information on
facility status, radioactive releases, and recommended protective actions, if
necessary, to be given to off-site response organizations and to the agency;
(10) description of the frequency, performance
objectives and plans for the training that the licensee will provide to workers
on how to respond to an emergency, including any instructions and orientation
tours the licensee offers to fire, police, medical and other emergency
personnel, where such training shall:
(A) familiarize personnel with site-specific emergency
procedures; and
(B) prepare site personnel for their responsibilities in
the event of accident scenarios postulated as most probable for the specific
site, including the use of team training for such scenarios;
(11) description of the means of restoring the
facility to a safe condition after an accident;
(12) description of provisions for conducting
quarterly communications checks with off-site response organizations and
biennial on-site exercises to test response to simulated emergencies where such
provisions meet the following requirements:
(A) quarterly communications checks with off-site
response organizations include the check and update of all necessary telephone
numbers;
(B) while participation of off-site response
organizations in biennial exercises is not required, the licensee shall invite
off-site response organizations to participate in the biennial exercises;
(C) accident scenarios for biennial exercises are not known
to most exercise participants;
(D) critique of each exercise using individuals who do not
have direct implementation responsibility for the plan. Critiques of exercises
evaluate the appropriateness of the plan, emergency procedures, facilities,
equipment, training of personnel, and overall effectiveness of the response;
and
(E) deficiencies found by the critiques in Part
(c)(12)(D) of this Rule are corrected; and
(13) certification that the applicant has met its
responsibilities under the Emergency Planning and Community Right-to-Know Act
of 1986, Title III, Public Law 99-499, if applicable to the applicant's
activities at the proposed place of use of the radioactive material.
(d) The licensee shall submit the emergency plan to allow
the off-site response organizations expected to respond in case of an accident
60 days to comment on the licensee's emergency plan before submitting the plan
to the agency. The licensee shall provide any comments received within the 60
day comment period to the agency with the emergency plan.
(e) Quantities of radioactive material requiring an
emergency plan for responding to a release as used in this Rule and
instructions for use are:
TABLE
RADIOACTIVE MATERIAL RELEASE QUANTITY
FRACTION (CURIES)
Actinium-228 0.001 4,000
Americium-241 .001 2
Americium-242 .001 2
Americium-243 .001 2
Antimony-124 .01 4,000
Antimony-126 .01 6,000
Barium-133 .01 10,000
Barium-140 .01 30,000
Bismuth-207 .01 5,000
Bismuth-210 .01 600
Cadmium-109 .01 1,000
Cadmium-113 .01 80
Calcium-45 .01 20,000
Californium‑252 .001 9
(20 mg)
Carbon-14 (NON CO2) .01 50,000
Cerium-141 .01 10,000
Cerium-144 .01 300
Cesium-134 .01 2,000
Cesium-137 .01 3,000
Chlorine-36 .5 100
Chromium-51 .01 300,000
Cobalt-60 .001 5,000
Copper-64 .01 200,000
Curium-242 .001 60
Curium-243 .001 3
Curium-244 .001 4
Curium-245 .001 2
Europium-152 .01 500
Europium-154 .01 400
Europium-155 .01 3,000
Germanium-68 .01 2,000
Gadolinium-153 .01 5,000
Gold-198 .01 30,000
Hafnium-172 .01 400
Hafnium-181 .01 7,000
Holmium-166m .01 100
Hydrogen-3 .5 20,000
Iodine-125 .5 10
Iodine-131 .5 10
Iodine-114m .01 1,000
Iridium-192 .001 40,000
Iron-55 .01 40,000
Iron-59 .01 7,000
Krypton-85 1.0 6,000,000
Lead-210 .01 8
Manganese-56 .01 60,000
Mercury-203 .01 10,000
Molybdenum-99 .01 30,000
Neptunium-237 .001 2
Nickel-63 .01 20,000
Niobium-94 .01 300
Phosphorus-32 .5 100
Phosphorus-33 .5 1,000
Polonium-210 .01 10
Potassium-42 .01 9,000
Promethium-145 .01 4,000
Promethium-147 .01 4,000
Radium-226 .001 100
Ruthenium-106 .01 200
Samarium-151 .01 4,000
Scandium-46 .01 3,000
Selenium-75 .01 10,000
Silver-110m .01 1,000
Sodium-22 .01 9,000
Sodium-24 .01 10,000
Strontium-89 .01 3,000
Strontium-90 .01 90
Sulfur-35 .5 900
Technetium-99 .01 10,000
Technetium-99m .01 400,000
Tellurium-127m .01 5,000
Tellurium-129m .01 5,000
Terbium-160 .01 4,000
Thulium-170 .01 4,000
Tin-113 .01 10,000
Tin-123 .01 3,000
Tin-126 .01 1,000
Titanium-44 .01 100
Vanadium-48 .01 7,000
Xenon-133 1.0 900,000
Yttrium-91 .01 2,000
Zinc-65 .01 5,000
Zirconium-93 .01 400
Zirconium-95 .01 5,000
Any other beta-gamma emitter .01 10,000
Mixed fission products .01 1,000
Mixed corrosion products .01 10,000
Contaminated equipment beta-gamma .001 10,000
Irradiated material, any form
other than solid noncombustible .01 1,000
Irradiated material, solid
noncombustible .001 10,000
Mixed radioactive waste
Beta-gamma .01 1,000
Packaged mixed waste, beta-gamma .001 10,000
Any other alpha emitter .001 2
Contaminated equipment, alpha .0001 20
Packaged waste, alpha .0001 20
(f) For combinations of radioactive materials, an emergency
plan is required if the sum of the ratios of the quantity of each radioactive material
authorized to the quantity listed for that material in the table in Paragraph
(e) of this Rule exceeds one.
(g) Waste packaged in Type B containers, as defined in 10
CFR Part 71.4, does not require an emergency plan.
History Note: Authority G.S. 104E-7; 104E-18; 10 CFR
30.72;
Eff. May 1, 1992;
Amended Eff. October 1, 2013; May 1, 1993; October 1,
1992;
Transferred and Recodified from 15A NCAC 11 .0352 Eff.
February 1, 2015.
10A NCAC 15 .0353 FINANCIAL ASSURANCE AND RECORD‑KEEPING
FOR DECOMMISSIONING
(a) For the purposes of this Rule, R is defined as the sum
of the ratios of the quantity of each isotope with half-life greater than 120
days to the applicable value in the table in Appendix C to 10 CFR §§ 20.1001 –
20.2401, as shown in the following formula:
(b) For unsealed radioactive materials, other than source
material, the quantities requiring financial assurance and the financial
assurance amounts are as follows:
(1) If R divided by 105 is greater
than one, then the minimum financial assurance amount is one million one
hundred twenty-five thousand dollars ($1,125,000) and shall be as stated in a
decommissioning funding plan as described in Paragraph (i) of this Rule;
(2) If R divided by 104 is greater
than one, but R divided by 105 is less than or equal to one, then
the financial assurance amount is one million one hundred twenty-five thousand
dollars ($1,125,000); or
(3) If R divided by 103 is greater
than one, but R divided by 104 is less than or equal to one, then
the financial assurance amount is two hundred twenty-five thousand dollars
($225,000).
(c) For sealed radioactive materials, the quantities
requiring financial assurance and the financial assurance amounts are as
follows:
(1) If R divided by 1012 is greater
than one, the licensee shall submit a decommissioning funding plan in
accordance with Paragraph (i) of this Rule; or
(2) If R divided by 1010 is greater
than one, but R divided by 1012 is less than or equal to one, then
the financial assurance amount is one hundred thirteen thousand dollars
($113,000).
(d) For source material in a readily dispersible form, the
quantities requiring financial assurance and the financial assurance amounts
are as follows:
(1) If a specific license authorizes possession
and use of more than 100 millicuries, then the minimum financial assurance
amount is one million one hundred twenty-five thousand dollars ($1,125,000) and
shall be as stated in a decommissioning funding plan as described in Paragraph
(i) of this Rule; or
(2) If a specific license authorizes possession
and use of more than 10 millicuries, but less than or equal to 100 millicuries,
then the licensee shall either:
(a) submit a decommissioning funding plan in accordance
with Paragraph (i) of this Rule; or
(b) submit certification of financial assurance in the
amount of two hundred twenty-five thousand dollars ($225,000).
(e) Each applicant for a specific license authorizing
possession and use of radioactive material of half‑life greater than 120
days and in quantities specified in Paragraphs (b) or (c) or source material in
quantities specified in Paragraph (d) of this Rule shall either:
(1) submit a decommissioning funding plan as
described in Paragraph (i) of this Rule; or
(2) submit a certification that financial
assurance for decommissioning has been provided in the amount prescribed by
Paragraphs (b) through (d) of this Rule using one of the methods described in
Rule .0354 of this Section. For an applicant, this certification may state
that the appropriate assurance will be obtained after the application has been
approved and the license issued but prior to the receipt of licensed material.
As part of the certification, the applicant shall submit to this agency, a copy
of the financial instrument obtained to satisfy the requirements of Paragraph (i)
of this Rule.
(f) Each holder of a specific license issued before the
effective date of this Rule, and of a type described in Paragraphs (b)(1),
(b)(2), (c)(1), or (d)(1) of this Rule shall submit, no later than May 1, 2007,
a certification of financial assurance for decommissioning or a decommissioning
funding plan in accordance with the criteria set forth in this Rule.
(g) Each holder of a specific license issued before the
effective date of this Rule, and of a type described in Paragraphs (b)(3),
(c)(2) or (d)(2) of this Rule shall submit, no later than November 1, 2007, a
certification of financial assurance in accordance with the criteria set forth
in this Rule.
(h) Each holder of a specific license issued on or after
the effective date of this Rule, which is of a type described in Paragraphs (b)
through (d) of this Rule, shall provide financial assurance for decommissioning
in accordance with the criteria set forth in this Rule.
(i) Each decommissioning funding plan shall contain a cost
estimate for decommissioning and documentation of an approved method assuring
funds for decommissioning as referenced in Rule .0354 of this Section, including
means of adjusting cost estimates and associated funding levels at intervals
not to exceed three years.
(j) Each person licensed under this Section of this Chapter
shall keep records of information important to the safe and effective
decommissioning of the facility in an identified location until the license is
terminated by the agency. If records of relevant information are kept for
other purposes, reference to these records and their locations may be used.
Information the agency considers important to decommissioning includes:
(1) Records of spills or other occurrences
involving the spread of contamination in and around the facility, equipment, or
site.
(A) These records may be limited to instances when
contamination remains after any cleanup procedures or when there is reasonable
likelihood that contaminants may have spread to inaccessible areas as in the
case of possible seepage into porous materials such as concrete.
(B) These records shall include any known information on
identification of involved nuclides, quantities, forms, and concentrations.
(2) As‑built drawings and modifications
of structures and equipment in restricted areas where radioactive materials are
being used or stored, and of locations of possible inaccessible contamination
such as buried pipes which may be subject to contamination.
(A) If required drawings are referenced, each relevant
document need not be indexed individually.
(B) If drawings are not available, the licensee shall
substitute records of available information concerning these areas and
locations.
(3) Records of the cost estimate performed for
the decommissioning funding plan or of the amount certified for
decommissioning, and records of the funding method used for assuring funds if
either a funding plan or certification is used.
(4) Except for areas containing only sealed
sources (provided the sealed sources have not leaked or no contamination
remains after cleanup of any leak) or radioactive materials having only
half-lives of less than 65 days, or depleted uranium used only for shielding,
licensees shall be required to establish and maintain a list, contained in a
single document. The list shall be updated every two years, and include the
following information:
(A) All areas designated and formerly designated as restricted
areas as defined in Rule .0104 of this Chapter;
(B) All areas outside of restricted areas that require
documentation under Paragraph (j) of this Rule;
(C) All areas outside of restricted areas where current
and previous wastes have been buried as documented in Rule .1642 of this
Chapter; and
(D) All areas outside of restricted areas which contain
material that, if the license expired, the licensee would be required to
decontaminate either the area to unrestricted release levels or to apply to the
agency for approval for disposal as required in Rule .1629 of this Chapter.
(k) Prior to license termination, each licensee authorized
to possess radioactive material in an unsealed form, shall forward to the
agency the records required in Paragraph (j) of this Rule.
(l) Before licensed activities are transferred, licensees
shall transfer all records required in Paragraph (j) of this Rule. In this
case, the new licensee shall maintain the records until the license is
terminated.
History Note: Authority G.S. 104E‑7; 104E‑18;
Eff. May 1, 1992;
Amended Eff. May 1, 2006; April 1, 1999; August 1, 1998;
January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0353 Eff.
February 1, 2015.
10A NCAC 15 .0354 METHODS OF FINANCIAL ASSURANCE FOR
DECOMMISSIONING
(a) Financial assurance for decommissioning as required by
Rule .0353 of this Section must be provided by one or more of the following
methods:
(1) prepayment, where:
(A) Prepayment is the deposit prior to the start of
operation into an account segregated from licensee assets and outside the
licensee's administrative control of cash or liquid assets such that the amount
of funds would be sufficient to pay decommissioning costs; and
(B) Prepayment may be in the form of a trust, escrow
account, government fund, certificate of deposit, or deposit of government
securities.
(2) a surety method, insurance, or other
guarantee method, where:
(A) These methods guarantee that decommissioning costs will
be paid should the licensee default;
(B) A surety method may be in the form of a surety bond,
letter of credit, or line of credit;
(C) A parent company guarantee of funds for
decommissioning costs based on a financial test may be used if the parent company
and guarantee meet the criteria contained in Rule .0355 of this Section;
(D) A parent company guarantee may not be used in
combination with other financial methods to satisfy the requirements of this
Section; and
(E) Any surety method or insurance used to provide
financial assurance for decommissioning shall contain the following conditions:
(i) The surety method or insurance shall be open‑ended
or, if written for a specified term, such as five years, shall be renewed
automatically unless 90 days or more prior to the renewal date, the issuer
notifies the agency, the beneficiary, and the licensee of its intention not to
renew;
(ii) The surety method or insurance shall provide
that the full face amount be paid to the beneficiary automatically prior to the
expiration date without proof of forfeiture if the licensee fails to provide a
replacement acceptable to the agency within 30 days after receipt of
notification of cancellation;
(iii) The surety method or insurance shall be payable
to a trust established for decommissioning costs. The trustee and trust shall
be acceptable to the agency. An acceptable trust includes an appropriate state
or federal government agency or an entity which has the authority to act as a
trustee and whose trust operations are regulated and examined by a federal or
state agency;
(iv) The surety method or insurance shall remain in
effect until the agency has terminated the license.
(3) an external sinking fund where:
(A) Deposits are made at least annually, coupled with a
surety method or insurance, the value of which may decrease by the amount being
accumulated in the sinking fund;
(B) An external sinking fund is a fund established and
maintained by setting aside funds periodically in an account segregated from
licensee assets and outside the licensee's administrative control in which the
total amount of funds would be sufficient to pay decommissioning costs at the
time termination of operation is expected;
(C) An external sinking fund may be in the form of a
trust, escrow account, government fund, certificate of deposit or deposits of
government securities; and
(D) The surety or insurance provisions shall be as
stated in Subparagraph (a)(2) of this Rule.
(4) in the case of federal, state or local
government licensees, a statement of intent containing a cost estimate for
decommissioning or an amount based on the provisions of Rule .0353 of this
Section, and indicating that funds for decommissioning shall be obtained when
required by the agency.
History Note: Authority G.S. 104E‑7; 104E‑18;
Eff. May 1, 1992;
Transferred and Recodified from 15A NCAC 11 .0354 Eff.
February 1, 2015.
10A NCAC 15 .0355 FIN. TESTS‑ PARENT CO.
GUARANTEES: DECOMMISSIONING FUNDING
(a) An applicant or licensee may provide reasonable
assurance of the availability of funds for decommissioning based on obtaining a
parent company guarantee that funds will be available for decommissioning costs
and on a demonstration that the parent company passes a financial test. This
Rule establishes criteria for passing the financial test and for obtaining the
parent company guarantee.
(b) To pass the financial test, the parent company shall
meet the criteria of either Subparagraph (b)(1) or (b)(2) of this Rule as
follows:
(1) The parent company shall have:
(A) two of the following three ratios: A ratio of total
liabilities to net worth less than 2.0; a ratio of the sum of net income plus
depreciation, depletion, and amortization to total liabilities greater than
0.1; and a ratio of current assets to current liabilities greater than 1.5; and
(B) net working capital and tangible net worth each at
least six times the current decommissioning cost estimates (or prescribed
amount if a certification is used); and
(C) tangible net worth of at least ten million dollars
($10,000,000); and
(D) assets located in the United States amounting to at
least 90 percent of total assets or at least six times the current
decommissioning cost estimates (or prescribed amount if a certification is
used).
(2) The parent company shall have:
(A) a current rating for its most recent bond issuance
of AAA, AA, A or BBB as issued by Standard and Poor's or Aaa, Aa, A or Baa as
issued by Moody's; and
(B) tangible net worth at least six times the current
decommissioning cost estimate (or prescribed amount if a certification is
used); and
(C) tangible net worth of at least ten million
($10,000,000); and
(D) assets located in the United States amounting to at
least 90 percent of total assets or at least six times the current
decommissioning cost estimates (or prescribed amount if certification is used).
(c) The parent company's independent certified public accountant
shall have compared the data used by the parent company in the financial test,
which is derived from the independently audited, year end financial statements
for the latest fiscal year, with the amounts in such financial statement. In
connection with that procedure the licensee shall inform the agency within 90
days of any matters coming to the auditor's attention which cause the auditor
to believe that the data specified in the financial test should be adjusted and
that the company no longer passes the test.
(d) After the initial financial test, the parent company
shall repeat the passage of the test within 90 days after the close of each
succeeding fiscal year.
(e) If the parent company no longer meets the requirements
of Paragraph (b) of this Rule, the licensee shall send notice to the agency of
intent to establish alternate financial assurance as specified in this
Section. The notice shall be sent by certified mail within 90 days after the
end of the fiscal year for which the year end financial data show that the
parent company no longer meets the financial test requirements. The licensee
shall provide alternate financial assurance within 120 days after the end of
such fiscal year.
(f) The terms of a parent company guarantee which an
applicant or licensee obtains shall provide that:
(1) the parent company guarantee will remain in
force unless the guarantor sends notice of cancellation by certified mail to
the licensee and the agency. Cancellation shall not occur, however, during the
120 days beginning on the date of receipt of the notice of cancellation by both
the licensee and the agency, as evidenced by the return receipts.
(2) if the licensee fails to provide alternate
financial assurance as specified in this Section within 90 days after receipt
by the licensee and the agency of a notice of cancellation of the parent
company guarantor, the guarantor will provide such alternative financial
assurance in the name of the licensee.
(g) The parent company guarantee and financial test
provisions shall remain in effect until the agency has terminated the license.
(h) If a trust is established for decommissioning costs,
the trustee and trust shall be acceptable to the agency. An acceptable trustee
includes an appropriate state or federal agency or an entity to act as a
trustee whose trust operations are regulated and examined by a federal or state
agency.
History Note: Authority G.S. 104E‑7; 104E‑18;
Eff. May 1, 1992;
Transferred and Recodified from 15A NCAC 11 .0355 Eff.
February 1, 2015.
10A NCAC 15 .0356 procedures for administrations
requiring a written directive
(a) For any administration requiring a written directive,
the licensee shall develop, implement, and maintain written procedures to
provide that:
(1) The patient or human research subject's
identity is verified before each administration; and
(2) Each administration is in accordance with
the written directive.
(b) The procedures required by Paragraph (a) of this Rule
must address the following items that are applicable to the licensee's use of
radioactive material:
(1) Verify the identity of the patient or human
research subject;
(2) Verify that the administration is in
accordance with the treatment plan, if applicable, and the written directive;
(3) Check both manual and computer-generated
dose calculations; and
(4) Verify that any computer-generated dose
calculations are correctly transferred into the consoles of therapeutic medical
units.
(c) A licensee shall retain a copy of the procedures
required under Paragraph (a) until the agency terminates the pertinent license.
(d) If, because of the emergent nature of the patient's
condition, a delay in order to provide a written directive would jeopardize the
patient's health, an oral directive is acceptable. The information contained in
the oral directive shall be documented as soon as possible in writing in the
patient's record. A written directive must be prepared within 48 hours of the
oral directive.
(e) A revision to an existing written directive may be
made:
(1) if the revision is dated and signed by an
authorized user before the administration of the dosage of unsealed radioactive
material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the
teletherapy dose, or the next fractional dose, or
(2) if, because of the patient's condition, a
delay in order to provide a written revision to an existing written directive
would jeopardize the patient's health, an oral revision to an existing written
directive is acceptable. The oral revision must be documented as soon as
possible in the patient's record. A revised written directive must be signed by
the authorized user within 48 hours of the oral revision.
(f) The licensee shall retain a record of the written
directive and any revisions to the written directive for three years.
History Note: Authority G.S. 104E-7; 104E-10(b);
Temporary Adoption Eff. August 20, 1994 for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;
Eff. May 1, 1995;
Amended Eff. November 1, 2007;
Transferred and Recodified from 15A NCAC 11 .0356 Eff.
February 1, 2015.
10A NCAC 15 .0357 REPORTING REQUIREMENTS
(a) Immediate report. Each licensee shall notify the
agency as soon as possible but not later than four hours after the discovery of
an event that prevents immediate protective actions necessary to avoid exposures
to sources of radiation that could exceed regulatory limits or releases of
licensed radioactive material that could exceed regulatory limits. These
events include but are not limited to fires, explosions and toxic gas releases.
(b) Twenty-four hour report. Each licensee shall notify the
agency within 24 hours after the discovery of any of the following events
involving licensed radioactive material:
(1) an unplanned contamination event that:
(A) requires access to the contaminated area, by workers
or the public, to be restricted for more than 24 hours by imposing additional
radiological controls or by prohibiting entry into the area;
(B) involves a quantity of material greater than five
times the lowest annual limit on intake specified in Appendix B to 10 CFR §§
20.1001-20.2401 for the material; and
(C) causes the licensee to restrict access to the area
for a reason other than to allow isotopes with a half-life of less than 24
hours to decay prior to decontamination;
(2) an event in which equipment is disabled or
fails to function as designed when:
(A) the equipment is required by rule or license
condition to:
(i) prevent releases exceeding regulatory limits;
(ii) prevent exposures to sources of radiation
exceeding regulatory limits; or
(iii) to mitigate the consequences of an accident;
(B) the equipment is required to be available and
operable at the time that it is disabled or fails to function; and
(C) no redundant equipment is available and operable to
perform the required safety function;
(3) an event that requires unplanned medical
treatment at a medical facility of an individual with removable radioactive
contamination on the individual's clothing or body; or
(4) an unplanned fire or explosion damaging any
licensed material or any device, container or equipment containing licensed
radioactive material when:
(A) the quantity of material involved is greater than
five times the lowest annual limit on intake specified in Appendix B to 10 CFR
§§ 20.1001-20.2401 for the material; and
(B) the damage affects the integrity of the licensed
radioactive material or its container.
(c) Preparation and submission of reports. Reports made by
licensees in response to the requirements of this Rule shall be made as
follows:
(1) Licensees shall make reports required by
Paragraphs (a) and (b) of this Rule by telephone as specified in Rule .0111(b)
of this Chapter. To the extent that the information is available at the time
of notification, the information provided in these reports shall include:
(A) the caller's name and call back telephone number;
(B) a description of the event, including date and time;
(C) the exact location of the event;
(D) the isotopes, quantities, and chemical and physical
form of the licensed radioactive material involved; and
(E) any personnel radiation exposure data available.
(2) Each licensee who makes a report required
by Paragraph (a) or (b) of this Rule shall submit a written follow-up report
within 30 days of the initial report. Written reports prepared pursuant to
other rules may be submitted to fulfill this requirement if the reports contain
all of the necessary information and the appropriate distribution is made.
These written reports shall be submitted to the agency as specified in Rule
.0111(a) of this Chapter. The reports shall include the following:
(A) a description of the event, including the probable
cause and the manufacturer and model number, if applicable, of any equipment
that failed or malfunctioned;
(B) the exact location of the event;
(C) the isotopes, quantities and chemical and physical
form of the licensed material involved;
(D) the date and time of the event;
(E) the corrective actions taken or planned and the
result of any evaluations or assessments; and
(F) the extent of exposure of individuals to sources of
radiation without identification of individuals by name.
History Note: Authority G.S. 104E-7(a)(2); 104E-10(b);
Temporary Adoption Eff. August 20, 1994 for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;
Eff. May 1, 1995;
Transferred and Recodified from 15A NCAC 11 .0357 Eff.
February 1, 2015.
10A NCAC 15 .0358 RELEASE
OF PATIENTS CONTAINING RADIOPHARMACEUTICALS OR PERMANENT IMPLANTS
(a) A licensee may authorize the release from its control
any individual who has been administered radiopharmaceuticals or permanent
implants containing radioactive material if the total effective dose equivalent
to any other individual from exposure to the released individual is not likely
to exceed 500 millirem (5 mSv).
(b) The licensee shall provide the released individual, or
the individual's parent or guardian, with oral and written instructions, on
actions recommended to maintain doses to other individuals as low as reasonably
achievable if the total effective dose equivalent to any other individual is
likely to exceed 100 millirem (1 mSv). If the dose to a breast-feeding infant
or child could exceed 100 millirem (1 mSv) if there is no interruption of
breast-feeding, the instructions shall include:
(1) Guidance on the interruption or discontinuation
of breast-feeding; and
(2) Information on the consequences of failure
to follow the guidance.
(c) The licensee shall maintain a record of the basis for
authorizing the release of an individual for three years after the date of
release, if the total effective dose equivalent is calculated by:
(1) Using the retained activity rather than the
activity administered;
(2) Using an occupancy factor less than 0.25 at
one meter;
(3) Using the biological or effective half-life;
or
(4) Considering the shielding by tissue.
(d) The licensee shall maintain a record for three years
after the date of the release that instructions were provided to a
breast-feeding woman if the radiation dose to the infant or child from
continued breast-feeding could result in a total effective dose equivalent
exceeding 100 millirem (1 mSv).
History Note: Authority G.S. 104E-7(a)(8); 104E-12;
Eff. August 1, 1998;
Amended Eff. October 1, 2013;
Transferred and Recodified from 15A NCAC 11 .0358 Eff.
February 1, 2015.
10A NCAC 15 .0359 MEASUREMENTS/DOSAGES OF UNSEALED
RADIOACTIVE MATERIAL FOR MEDICAL USE
(a) A licensee shall possess and use a dose calibrator to
measure the radioactivity of dosages of photon-emitting radionuclides prior to
administration to each individual. A licensee shall:
(1) develop, maintain, and implement written
procedures for use of the dose calibrator;
(2) calibrate each dose calibrator in
accordance with the requirements of 10 CFR 35.60(b).
(b) A licensee shall retain a record of each check, test,
and calibration performed in accordance with this Rule for a period of three
years following the test.
History Note: Authority G.S. 104E-7; 104E-10(b);
104E-12;
Eff. April 1, 1999;
Amended Eff. November 1, 2007;
Transferred and Recodified from 15A NCAC 11 .0359 Eff.
February 1, 2015.
10A NCAC 15 .0360 SURVEYS OF RADIOPHARMACEUTICAL AREAS
FOR RADIATION EXPOSURE RATE
(a) A licensee shall survey with a radiation detection
survey instrument at the end of each day of use all areas where
radiopharmaceuticals are routinely prepared for use or administered.
(b) A licensee shall conduct the survey required by
Paragraph (a) of this Rule so as to be able to detect dose rates as low as 0.1
millirem (1 microsievert) per hour.
(c) A licensee shall establish radiation dose rate trigger
levels for the surveys required by Paragraph (a) of this Rule. A licensee
shall require the individual performing the survey to promptly notify the
Radiation Safety Officer if a dose rate exceeds a trigger level.
(d) A licensee shall retain a record of the survey required
by this Rule for three years. The record shall include:
(1) the date of the survey;
(2) a plan of each area surveyed;
(3) the trigger level established for each
area;
(4) the detected dose rate at several points in
each area surveyed expressed in millirem (or microsievert) per hour;
(5) the instrument used to make the survey; and
(6) the initials of the individual who
performed the survey.
(e) Any licensee authorized by the rules of this Chapter to
manufacture, produce, acquire, receive, possess, use or transfer radioactive
material for medical use shall have in its possession a calibrated portable
radiation survey instrument capable of detecting dose rates over the range of
0.1 millirem per hour (1 microsievert per hour) to 100 millirem per hour (.01
millisievert per hour), and a portable radiation survey instrument capable of
measuring dose rates over the range of one millirem per hour (.01 millisievert
per hour) to 1,000 millirem per hour (10 millisievert per hour). A licensee
shall calibrate the survey instruments used to show compliance with this
Section before first use, annually, and following repair. The licensee shall:
(1) calibrate all scales with readings up to
1,000 millirem (10 millisievert) per hour with a radiation source;
(2) calibrate two separated readings on each
scale that must be calibrated; and
(3) conspicuously note on the instrument the
apparent exposure rate from a dedicated check source as determined at the time
of calibration, and the date of calibration.
(f) When calibrating a survey instrument, the licensee
shall consider a point as calibrated if the indicated exposure rate differs
from the calculated exposure rate by not more than 20 percent.
(g) A licensee shall check each survey instrument for
proper operation with the dedicated check source each day of use. A licensee is
not required to keep records of these checks.
(h) A licensee shall retain a record of each survey
instrument calibration for three years. The record must include:
(1) a description of the calibration procedure;
and
(2) the date of the calibration, a description
of the source used and the certified exposure rates from the source, and the
rates indicated by the instrument being calibrated, the correction factors
deduced from the calibration data, and the identity of the individual who
performed the calibration.
History Note: Authority G.S. 104E-7; 104E-10(b);
104E-12;
Eff. April 1, 1999;
Amended Eff. November 1, 2007;
Transferred and Recodified from 15A NCAC 11 .0360 Eff.
February 1, 2015.
10A NCAC 15 .0361 MEDICAL USE OF UNSEALED RADIOACTIVE
MATERIAL
(a) A licensee may use any unsealed radioactive material
prepared for use for uptake, dilution, or excretion studies, imaging and
localization studies, and use requiring a written directive as set forth in
Rule .0104 of this Chapter that is:
(1) Obtained from a manufacturer or preparer
licensed under 10 CFR 32.72 or equivalent Agreement State requirements;
(2) Obtained from a positron emission
tomography (PET) radioactive drug producer licensed under 10 CFR 30.32(j), 15A
NCAC 11 .0333, or equivalent Agreement State requirements;
(3) Excluding production of PET radionuclides,
prepared by:
(A) An authorized nuclear pharmacist;
(B) A physician is an authorized user identified on a
North Carolina Radioactive Materials License, an Agreement State Radioactive Materials
License, or a license issued by the U.S. Nuclear Regulatory Commission or who
meets the requirements in 15A NCAC 11 .0318(c); or
(C) An individual under the supervision, as specified in
Rule .0318 of this Section, of the authorized nuclear pharmacist in Part
(a)(3)(A) of this Rule or the physician who is an authorized user in Part
(a)(3)(B) of this Rule;
(4) Obtained from and prepared by an NRC or
Agreement State licensee for use in research in accordance with a Radioactive
Drug Research Committee-approved protocol or an Investigational New Drug (IND)
protocol accepted by the FDA; or
(5) Prepared by the licensee for use in
research in accordance with a Radioactive Drug Research Committee-approved
protocol or an Investigational New Drug (IND) protocol accepted by the FDA.
(b) A licensee shall not administer to humans a
radiopharmaceutical that contains;
(1) more than 0.15 microcurie (0.15
kilobecquerel) of molybdenum-99 per millicurie (megabecquerel) of
technetium-99m; or
(2) more than 0.02 microcurie (0.02
kilobecquerel) of strontium-82 per millicurie (megabecquerel) of rubidium-82
chloride, or 0.2 microcurie (0.2 kilobecquerel) of strontium-85 per millicurie
(megabecquerel) of rubidium-82 chloride.
(c) A licensee that uses molybdenum-99/technetium-99m
generators for preparing a technetium-99 radiopharmaceutical shall measure the
molybdenum-99 concentration in the first eluate after receipt of a generator to
demonstrate compliance with Paragraph (b) of this Rule.
(d) A licensee that uses strontium-82/rubidium-82
generators for preparing a rubidium-82 radiopharmaceutical shall measure the
concentrations of strontium-82 and strontium-85 before the first patient use of
the day to demonstrate compliance with Paragraph (b) of this Rule.
(e) A licensee that must measure molybdenum-99 or
strontium-82 and strontium-85 concentration shall retain a record of each
measurement for three years. The record shall include:
(1) for each measured elution of
technetium-99m: the ratio of the measures expressed as microcuries of
molybdenum-99 per millicurie of technetium-99m (or kilobecquerels of
molybdenum-99 per megabecquerel of technetium-99m);
(2) for each measured elution of rubidium-82:
the ratio of the measures expressed as microcuries of strontium-82 and strontium-85
per millicurie of rubidium-82 (or kilobecquerel strontium-82 and strontium-85
per megabecquerel rubidium-82); and
(3) the time and date of the measurement; and
(4) the initials of the individual who made the
measurement.
History Note: Authority G.S. 104E-7(a)(2); 104E-10(b);
104E-12;
Eff. April 1, 1999;
Amended Eff. October 1, 2013; November 1, 2007;
Transferred and Recodified from 15A NCAC 11 .0361 Eff.
February 1, 2015.
10A NCAC 15 .0362 DECAY-IN-STORAGE
(a) A licensee may hold radioactive material with a
physical half-life of less than 275 days for decay-in-storage before disposal
in ordinary trash and is exempt from the requirements of Rule .1628 of this
Chapter if the licensee:
(1) holds radioactive material for decay a
minimum of 10 half-lives;
(2) monitors radioactive material at the container
surface before disposal as ordinary trash and determines that its radioactivity
cannot be distinguished from the background radiation level with a radiation
detection survey meter capable of detecting a dose rate of 0.1 millirem (1
microsievert) per hour and with no interposed shielding; and
(3) removes or obliterates all radiation
labels.
(b) A licensee shall retain a record of each disposal
permitted under Paragraph (a) of this Rule for three years. The record shall include:
(1) the date of the disposal;
(2) the date the radioactive material was
placed in storage;
(3) the radionuclides disposed;
(4) the survey instrument used;
(5) the background dose rate used; and
(6) the dose rate measured at the surface of
each waste container.
History Note: Authority G.S. 104E-7(a)(2); 104E-10(b); 104E-12;
Eff. April 1, 1999;
Amended Eff. October 1, 2013;
Transferred and Recodified from 15A NCAC 11 .0362 Eff.
February 1, 2015.
10A NCAC 15 .0363 provisions for the protection of human
research subjects
(a) A licensee may conduct research involving human
research subjects only if it uses the radioactive materials specified on its
license for the uses authorized on its license.
(b) If the research is conducted, funded, supported, or
regulated by a Federal agency that has implemented the Federal Policy for the
Protection of Human Research Subjects (Federal Policy), the licensee shall,
before conducting research:
(1) Obtain review and approval of the research
from an "Institutional Review Board" as defined and prescribed in the
Federal Policy; and
(2) Obtain "informed consent" as
defined and described in the Federal Policy, from the human research subject.
(c) If the research will not be conducted, funded,
supported, or regulated by a Federal agency that has implemented the Federal
Policy, the licensee shall, before conducting research, apply for and receive a
specific amendment to its medical use license. The amendment request must
include a written commitment that the licensee will, before conducting
research:
(1) Obtain review and approval of the research
from an "Institutional Review Board" as defined and described in the
Federal Policy; and
(2) Obtain "informed consent," as described
in the Federal Policy, from the human research subject.
(d) Nothing in this Rule relieves licensees from complying
with the other requirements in this Chapter or with any other applicable Rules
and Laws in the State of North Carolina.
History Note: Authority G.S. 104E-7; 104E-10(b);
104E-12;
Eff. November 1, 2007;
Transferred and Recodified from 15A NCAC 11 .0363 Eff.
February 1, 2015.
10A NCAC 15 .0364 MEDICAL EVENTS
(a) A licensee shall report any event, except for an event
that results from patient intervention, in which the administration of
radioactive material or radiation from radioactive material results in:
(1) A dose that differs from the prescribed
dose or dose that would have resulted from the prescribed dosage by more than 5
rem (0.05 Sievert (Sv)) effective dose equivalent, 50 rem (0.5 Sv) to an organ
or tissue, or 50 rem (0.5 Sv) shallow dose equivalent to the skin; and
(A) The total dose delivered differs from the prescribed
dose by 20 percent or more;
(B) The total dosage delivered differs from the
prescribed dosage by 20 percent or more or falls outside the prescribed dosage
range; or
(C) The fractionated dose delivered differs from the
prescribed dose, for a single fraction, by 50 percent or more.
(2) A dose that exceeds 5 rem (0.05 Sv)
effective dose equivalent, 50 rem (0.5 Sv) to an organ or tissue, or 50 rem
(0.5 Sv) shallow dose equivalent to the skin from any of the following:
(A) An administration of a wrong radioactive drug
containing radioactive material;
(B) An administration of a radioactive drug containing
radioactive material by the wrong route of administration;
(C) An administration of a dose or dosage to a wrong
individual or human research subject;
(D) An administration of a dose or dosage delivered by
the wrong mode of treatment; or
(E) A leaking sealed source.
(3) A dose to the skin or an organ or tissue
other than the treatment site that exceeds by 50 rem (0.5 Sv) and 50 percent or
more of the dose expected from the administration defined in the written
directive (excluding, for permanent implants, seeds that were implanted in the
correct site but migrated outside the treatment site).
(b) A licenses shall report any event resulting from
intervention of a patient or human research subject in which the administration
of radioactive material or radiation from radioactive material results or will
result in an unintended permanent functional damage to an organ or a
physiological system, as determined by a physician.
(c) The licensee shall notify by telephone the agency no
later than the next calendar day after discovery of the medical event.
(d) The licensee shall submit a written report to the
agency at the address listed in Rule .0111 of this Chapter within 15 days of
the discovery of the medical event. The written report must include:
(1) The licensee's name;
(2) The name of the prescribing physician;
(3) A brief description of the event;
(4) Why the event occurred;
(5) The effect, if any, on the individual(s)
who received the administration;
(6) What actions, if any, have been taken or
are planned to prevent recurrence; and
(7) Certification that the licensee notified
the individual (or the individual's responsible relative or guardian) and if
not, why not.
The report may not contain the individual's name or any
other information that could lead to identification of the individual.
(e) The licensee shall provide notification of the event to
the referring physician and also notify the individual who is the subject of
the medical event no later than 24 hours after its discovery unless the
referring physician personally informs the licensee either that he or she will
inform the individual or that based on medical judgment, telling the individual
would be harmful. The licensee 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 licensee
shall notify the individual as soon as possible thereafter. The licensee may
not delay any appropriate medical care for the individual, including any
necessary remedial care as a result of the medical event, because of any delay
in notification. To meet the requirements of this Paragraph, the notification
of the individual who is the subject of the medical event may be made instead
to that individual's responsible relative or guardian. If a verbal
notification is made, the licensee shall inform the individual, or responsible
relative or guardian, that a written description of the event can be obtained
from the licensee upon request. The licensee shall provide such a written
description if requested.
(f) Aside from the notification requirement, nothing in
this Section affects any rights or duties of licensees and physicians in
relation to each other, to individuals affected by the medical event, or to
that individual's responsible relatives or guardians.
(g) A licensee shall:
(1) Annotate a copy of the report provided to
the agency with the:
(A) Name of the individual who is the subject of the
event; and
(B) Social security number or other identification
number, if one has been assigned, of the individual who is the subject of the
medical event; and
(2) Provide a copy of the annotated report to
the referring physician if other than the licensee, no later than 15 days after
the discovery of the event.
History Note: Authority G.S. 104E-7(a)(2); 104E-10(b);
104E-12;
Eff. November 1, 2007;
Transferred and Recodified from 15A NCAC 11 .0364 Eff.
February 1, 2015.
10A NCAC 15 .0365 REPORT AND NOTIFICATION OF A DOSE TO
AN EMBRYO/FETUS OR A NURSING CHILD
(a) A licensee shall report any dose to an embryo/fetus
that is greater than 5 rem (50 mSv) dose equivalent that is a result of an
administration of radioactive material or radiation from radioactive material
to a pregnant individual unless the dose to the embryo/fetus was specifically
approved, in advance, by that authorized user.
(b) A licensee shall report any dose to a nursing child
that is a result of administration of radioactive material to a breast-feeding
individual, that:
(1) Is greater than 5 rem (50 mSv) total
effective dose equivalent; or
(2) Has resulted in unintended permanent
functional damage to an organ or a physiological system of the child, as determined
by a physician.
(c) The licensee shall notify by telephone the agency no
later than the next calendar day after discovery of a dose to the embryo/fetus
or nursing child that requires a report in Paragraphs (a) or (b) of this Rule.
(d) The licensee shall submit a written report to the
agency at the address listed in Rule .0111 of this Chapter within 15 days after
discovery of a dose to the embryo/fetus or nursing child that requires a report
in Paragraphs (a) or (b) in this Rule.
(1) The written report must include:
(A) The licensee'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, on the embryo/fetus or the
nursing child;
(F) What actions, if any, have been taken or are
planned to prevent recurrence; and
(G) Certification that the licensee notified the
pregnant individual or mother (or the mother's or child's responsible relative
or guardian), and if not, why not.
(2) The report must not contain the individual's
or child's name or any other information that could lead to identification of
the individual or child.
(e) The licensee shall provide notification of the event to
the referring physician and also notify the pregnant individual or mother, both
hereafter referred to as the mother, no later than 24 hours after discovery of
an event that would require reporting under Paragraphs (a) or (b) of this Rule,
unless the referring physician personally informs the licensee either that he
or she will inform the mother or that, based on medical judgment, telling the
mother would be harmful. The licensee is not required to notify the mother
without first consulting with the referring physician. If the referring
physician or mother cannot be reached within 24 hours, the licensee shall make
the appropriate notifications as soon as possible thereafter. The licensee may
not delay any appropriate medical care for the embryo/fetus or for the nursing
child, including any necessary remedial care as a result of the event, because
of any delay in notification. To meet the requirements of this Paragraph, the
notification may be made to the mother's or child's responsible relative or
guardian instead of the mother. If a verbal notification is made, the licensee
shall inform the mother, or the mother's or child's responsible guardian, that
a written description of the event can be obtained from the licensee upon
request, The licensee shall provide such a written description if requested.
(f) A licensee shall:
(1) Annotate a copy of the report provided to
the agency with the:
(A) Name of the pregnant individual or the nursing child
who is the subject of the event; and
(B) Social security number or other identification
number, if one has been assigned, of the pregnant individual or the nursing
child who is the subject of the event; and
(2) Provide a copy of the annotated report to
the referring physician, if other than the licensee, no later than 15 days
after the discovery of the event.
History Note: Authority G.S. 104E-7; 104E-10(b);
104E-12;
Eff. November 1, 2007;
Transferred and Recodified from 15A NCAC 11 .0365 Eff.
February 1, 2015.
SECTION .0400 ‑ STANDARDS FOR PROTECTION AGAINST
RADIATION
Codifier's Note: 10 NCAC 03G .2500 was transferred to 15A
NCAC 11 .0400 effective January 4, 1990. Recodification pursuant to G.S.
143B-279.3.
10A NCAC 15 .0401 PURPOSE AND SCOPE
10A NCAC 15 .0402 RADIATION DOSE TO INDIVIDUALS IN
RESTRICTED AREAS
10A NCAC 15 .0403 DETERMINATION OF PRIOR DOSE
10A NCAC 15 .0404 CONCENTRATIONS IN A RESTRICTED AREA
10A NCAC 15 .0405 EXPOSURE OF MINORS
10A NCAC 15 .0406 PERMISSIBLE LEVELS IN UNRESTRICTED
AREAS
10A NCAC 15 .0407 CONCENTRATION IN EFFLUENTS TO
UNRESTRICTED AREAS
10A NCAC 15 .0408 BIOASSAY SERVICES
10A NCAC 15 .0409 SURVEYS
10A NCAC 15 .0410 PERSONNEL MONITORING
10A NCAC 15 .0411 CAUTION SIGNS: LABELS: AND SIGNALS
10A NCAC 15 .0412 EXCEPTIONS FROM POSTING AND LABELING
10A NCAC 15 .0413 INSTRUCTION OF PERSONNEL
10A NCAC 15 .0414 STORAGE OF SOURCES OF RADIATION
10A NCAC 15 .0415 PICKING UP: RECEIVING: AND OPENING
PACKAGES
10A NCAC 15 .0416 WASTE DISPOSAL
10A NCAC 15 .0417 RECORDS
10A NCAC 15 .0418 REPORTS OF THEFT OR LOSS
10A NCAC 15 .0419 NOTIFICATION OF INCIDENTS
10A NCAC 15 .0420 OVEREXPOSURES AND EXCESSIVE LEVELS AND
CONCENTRATIONS
10A NCAC 15 .0421 VACATING PREMISES
10A NCAC 15 .0422 NOTIFICATION AND REPORTS TO
INDIVIDUALS
10A NCAC 15 .0423 REFERENCE CONCENTRATIONS IN AIR AND
WATER
10A NCAC 15 .0424 REFERENCE FOR LABELING AND DISPOSAL
REQUIREMENTS
History Note: Authority G.S. 104E‑7;
104E-7(2),(5); 104E-12(a); 104E-12(a)(1),(2); 104E-12(b);
Eff. February 1, 1980;
Amended Eff. May 1, 1992; June 1, 1989; October 1, 1984;
September 1, 1981;
October 1, 1980;
Repealed Eff. August 1, 1998;
Transferred and Recodified from 15A NCAC 11 .0401-.0424
Eff. February 1, 2015.
10A NCAC 15 .0425 CLASSIFICATION/RADIOACTIVE WASTE FOR
NEAR‑SURFACE DISPOSAL
10A NCAC 15 .0426 RADIOACTIVE WASTE CHARACTERISTICS
10A NCAC 15 .0427 LABELING
10A NCAC 15 .0428 TRANSFER OF RADIOACTIVE WASTE FOR
DISPOSAL AND MANIFESTS
History Note: Authority G.S. 104E‑7(2),(3);
104E-12(a);
Eff. October 1, 1984;
Amended Eff. June 1, 1989;
Repealed Eff. August 1, 1998;
Transferred and Recodified from 15A NCAC 11 .0425-.0428
Eff. February 1, 2015.
SECTION .0500 ‑ SAFETY REQUIREMENTS FOR INDUSTRIAL
RADIOGRAPHY OPERATIONS
Codifier's Note: 10 NCAC 03G .2600 was transferred to 15A
NCAC 11 .0500 effective January 4, 1990. Recodification pursuant to G.S.
143B-279.3.
10A NCAC 15 .0501 PURPOSE AND SCOPE
(a) The rules in this Section establish radiation safety
requirements for persons utilizing sources of radiation for industrial
radiography. The requirements of this Section are in addition to and not in
substitution for the other requirements of this Chapter.
(b) The rules in this Section apply to all licensees or
registrants who use sources of radiation for industrial radiography; provided,
however that nothing in this Section shall apply to the use of sources of
radiation in the healing arts.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0501 Eff.
February 1, 2015.
10A NCAC 15 .0502 DEFINITIONS
In addition to terms found in Rule .0104 of this Chapter and
10 CFR 34.3, the following definitions shall apply to this Section. 10 CFR
34.3 is incorporated by reference to include subsequent amendments and
editions, and can be accessed at:
http://www.nrc.gov/reading-rm/doc-collections/cfr/part034/part034-0003.html at
no cost:
(1) "Collimator" means a radiation shield
that is placed on the end of the guide tube or directly onto a radiographic
exposure device to limit the size, shape, and direction of the primary
radiation when the sealed source is cranked into position to make a
radiographic exposure.
(2) "Control device," commonly called a
crank-out, means the control cable, the protective sheath, and control drive
mechanism used to move the sealed source from the shielded position in the
radiographic device or camera to an unshielded position outside the device for
the purpose of making a radiographic exposure.
(3) "Field examination" means a practical
examination.
(4) "Independent certifying organization"
means an independent organization that meets all of the requirements of Rule
.0525 of this Section.
(5) "Periodic training" means instruction provided
at least every 12 months by the licensee or registrant for operators and
individuals subject to the requirements of Rule .1003 of this Chapter on
radiation safety aspects of radiography. The topics shall include the results
of internal inspections, new procedures or equipment, accidents or errors that
have been observed, and opportunities for employees to ask safety questions.
(6) "Projection sheath" means a guide tube.
(7) "Radiation safety officer" means an
individual named by the licensee or registrant who has knowledge of and
responsibility for the overall radiation safety program on behalf of the
licensee or registrant and who meets the requirements of Rule .0510(h) of this
Section.
History Note: Authority G.S. 104E-7; 10 CFR 34.3;
Eff. February 1, 1980;
Amended Eff. January 1, 1994; June 1, 1989;
Temporary Amendment Eff. August 20, 1994, for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;
Amended Eff. April 1, 1999; May 1, 1995;
Transferred and Recodified from 15A NCAC 11 .0502 Eff.
February 1, 2015;
Amended Eff. October 1, 2015.
10A NCAC 15 .0503 EQUIPMENT RADIATION LEVEL LIMITS
The maximum exposure rate limits for source changers and
storage containers are 200 millirem (2 millisieverts) per hour at any exterior
surface, and 10 millirem (0.1 millisieverts) per hour at one meter from any
exterior surface. The radiation levels specified are with the sealed source in
the shielded position.
History Note: Filed as a Temporary Amendment Eff.
August 20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;
Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. April 1, 1999; May 1, 1995; May 1, 1992;
Transferred and Recodified from 15A NCAC 11 .0503 Eff.
February 1, 2015.
10A NCAC 15 .0504 RADIOGRAPHIC EXPOSURE DEVICES AND
STORAGE CONTAINERS
(a) Each radiographic exposure device shall have a lock or
outer locked container designed to prevent unauthorized or accidental removal
of the sealed source from its shielded position. The exposure device or its
container shall be kept locked when not under the direct surveillance of a
radiographer or a radiographer's assistant or as otherwise may be authorized in
Rule .0515 of this Section. If the exposure device or container is secured
with a keyed lock, the key shall be removed at all times when the device or
container is not being used. In addition, during radiographic operations, the
sealed source assembly shall be manually secured in the shielded position each
time the sealed source is returned to that position in those devices
manufactured prior to the effective date of this Rule.
(b) Each sealed source storage container and source changer
shall have a lock or outer locked container designed to prevent unauthorized or
accidental removal of the sealed source from its shielded position. Storage
containers and source changers shall be kept locked when containing sealed
sources except when under the direct surveillance of a radiographer or a
radiographer's assistant.
(c) Prior to moving a radiographic exposure device, source
changer or storage container from one temporary jobsite to another, the
licensee shall:
(1) perform a survey to ensure that the sealed
source is in the shielded position;
(2) disassemble the radiographic exposure
device, source changer or storage container from associated equipment;
(3) apply safety plugs or covers;
(4) lock the radiographic exposure device,
source changer or storage container; and
(5) physically secure the radiographic exposure
device, source changer or storage container to prevent accidental loss,
tampering or removal of sealed sources.
History Note: Filed as a Temporary Amendment Eff.
August 20, 1994 for a period of 180 days or until the
permanent rule becomes effective, whichever is sooner;
Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. May 1, 1995;
Transferred and Recodified from 15A NCAC 11 .0504 Eff.
February 1, 2015.
10A NCAC 15 .0505 STORAGE, LABELS AND TRANSPORTATION
PRECAUTIONS
(a) Security precautions during storage or transportation:
(1) Locked radiographic exposure devices and
storage containers shall be physically secured to prevent tampering or removal
by unauthorized personnel. The licensee shall store sealed sources in a manner
which will minimize danger from explosion or fire.
(2) The licensee shall lock and physically
secure the transport package containing sealed sources in the transporting
vehicle to prevent accidental loss, tampering or unauthorized removal of the
sealed sources from the vehicle.
(b) Labels:
(1) The licensee shall not use a source changer
or storage container to store sealed sources unless the source changer or the
storage container has securely attached to it a durable, legible, and clearly
visible label. The label shall contain the radiation symbol specified in Rule
.1623 of this Chapter and the wording:
CAUTION (OR
DANGER)
RADIOACTIVE
MATERIAL-- DO NOT HANDLE
NOTIFY CIVIL
AUTHORITIES (OR NAME OF COMPANY)
(2) The licensee shall not transport sealed
sources unless the material is packaged, labeled, marked, and accompanied with
the appropriate shipping papers in accordance with regulations set out in 10
CFR Part 71, including documentation of the Quality Assurance program
requirements outlined in 10 CFR 71.105.
History Note: Filed as a Temporary Amendment Eff.
August 20, 1994 for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;
Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. May 1, 1995;
Transferred and Recodified from 15A NCAC 11 .0505 Eff.
February 1, 2015.
10A NCAC 15 .0506 SURVEY INSTRUMENTS
(a) The licensee or registrant shall maintain sufficient
calibrated and operable radiation survey instruments at each temporary jobsite
and at any location where sealed sources or radiation machines are used or
stored to make physical radiation surveys as required by this Rule and Rules
.1613 and .1627 of this Chapter.
(b) Each radiation survey instrument required by Paragraph
(a) of this Rule shall be calibrated:
(1) at intervals not to exceed six months and
after each instrument servicing except for battery change;
(2) at the following points for each
instrument, as applicable:
(A) linear scale instruments shall be calibrated at two
points located approximately 1/3 and 2/3 of full-scale on each scale;
(B) logarithmic scale instruments shall be calibrated at
the midrange of each decade and at two points in the same decade for at least
one decade; and
(C) digital instruments shall be calibrated in
accordance with procedures that include the following calibration points:
(i) 2 mR/hr or 0.02 mSv/hr;
(ii) 5 mR/hr or 0.05 mSv/hr;
(iii) 50 mR/hr or 0.5 mSv/hr;
(iv) 500 mR/hr or 5 mSv/hr; and
(v) 1 R/hr or 0.01 Sv/hr;
(3) so that an accuracy within plus or minus 20
percent of the calibration standard can be demonstrated on each scale.
(c) Instrumentation required by this Rule shall have a
range such that two milliroentgens (0.02 millisieverts) per hour through one
roentgen (0.01 sievert) per hour can be measured.
(d) Survey instruments shall be checked for operability
prior to use. This may be accomplished by evaluating the instrument response
to the previously measured fields at the projection sheath port or the control
cable sheath port on a radiographic exposure device.
(e) The licensee or registrant shall maintain records of
the results of the instrument calibrations in accordance with Rule .0523 of
this Section.
History Note: Filed as A Temporary Amendment Eff.
August 20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;
Authority G.S. 104E‑7; 104E‑12(a)(1);
Eff. February 1, 1980;
Amended Eff. April 1, 1999; May 1, 1995; January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0506 Eff.
February 1, 2015.
10A NCAC 15 .0507 LEAK TESTING AND REPLACEMENT OF SEALED
SOURCES
(a) The replacement of any sealed source fastened to or
contained in a radiographic exposure device and leak testing of any sealed
source shall be performed only by persons specifically authorized by the agency
to do so pursuant to the rules in this Section.
(b) The opening, repair, or modification of any sealed
source shall be performed only by persons specifically named in a license
condition to perform that function.
(c) Each sealed source shall be tested for leakage at
intervals not to exceed six months. In the absence of a certificate from a
transferor that a test has been made within the six months prior to the
transfer, the sealed source shall not be put into use until tested.
(d) The wipe of a sealed source shall be performed using a
leak test kit or similar materials and methods. The wipe sample shall be taken
from the nearest accessible point to the sealed source. The wipe sample shall
be analyzed for radioactive contamination. The analysis shall be capable of
detecting 0.005uCi (185 Bq) of radioactive material on the test sample and
shall be performed by persons licensed or registered by the agency to perform
such a service.
(e) Any test conducted pursuant to Paragraphs (c) and (d)
of this Rule which reveals the presence of 0.005 microcurie (185 Bq) or more of
removable radioactive material shall be considered evidence that the sealed
source is leaking. The licensee shall immediately withdraw the equipment
involved from use and shall cause it to be decontaminated and repaired or to be
disposed of, in accordance with these Rules. A report describing the equipment
involved, the test results, and the corrective action taken shall be submitted
in writing to the agency at the address in Rule .0111 of this Chapter within
five days after the test.
(f) The licensee shall maintain records of the leak test
results in accordance with Rule .0523 of this Section.
History Note: Filed as a Temporary Amendment Eff.
August 20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;
Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. April 1, 1999; May 1, 1995; June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0507 Eff.
February 1, 2015.
10A NCAC 15 .0508 QUARTERLY INVENTORY
(a) Each licensee shall conduct a quarterly physical
inventory to account for all sealed sources and devices containing depleted
uranium received and possessed under the license.
(b) The licensee shall maintain records of the quarterly
inventory in accordance with Rule .0523 of this Section.
History Note: Filed as a Temporary Amendment Eff.
August 20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;
Authority G.S. 104E‑7; 104E‑12(a)(1);
Eff. February 1, 1980;
Amended Eff. April 1, 1999; May 1, 1995;
Transferred and Recodified from 15A NCAC 11 .0508 Eff.
February 1, 2015.
10A NCAC 15 .0509 UTILIZATION LOGS
Each licensee or registrant shall maintain current
utilization logs for inspection by the agency at the address specified in the
license, showing for each sealed source and radiation machine the information
required by Rule .0523(a)(6) of this Section.
History Note: Filed as a Temporary Amendment Eff.
August 20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;
Authority G.S. 104E‑7; 104E‑12(a)(1);
Eff. February 1, 1980;
Amended Eff. April 1, 1999; May 1, 1995;
Transferred and Recodified from 15A NCAC 11 .0509 Eff.
February 1, 2015.
10A NCAC 15 .0510 LIMITATIONS
(a) The licensee or registrant shall not permit any person
to act as a radiographer until the person:
(1) has been instructed in the subjects
outlined in Rule .0519 of this Section and has demonstrated understanding
thereof by successful completion of a written test. The
person shall also have a minimum of two months of on-the-job training, and be
certified through a radiography certification program by a certifying entity in
accordance with the requirements of Rule .0525 of this Section;
(2) has received copies of and instruction in
the rules contained in this Section and in the applicable rules of Sections .0200,
.0300, .0900 and .1600 of this Chapter, in applicable U.S. Department of
Transportation regulations referenced in Rule .0117 of this Chapter, and the
licensee's or registrant's operating and emergency procedures, and has
demonstrated understanding thereof by successful completion of a written test;
(3) has received training in the use of the
licensee or registrant's radiographic exposure devices, sealed sources, in the
daily inspection of devices and associated equipment, and in the use of
radiation survey instruments;
(4) has demonstrated competence to use the
radiographic exposure devices, sealed sources, related handling tools,
radiation machines and survey instruments which will be employed in his
assignment by successful completion of a practical examination covering this
material; and
(5) has demonstrated understanding of the
instructions in Paragraph (a) of this Rule by successful completion of a
written test on the subjects covered.
(b) The licensee or registrant shall not permit any person
to act as a radiographer's assistant until the person:
(1) has received copies of and instructions in
the licensee's or registrant's operating and emergency procedures, and has
demonstrated understanding thereof by successful completion of a written or
oral test and practical examination on the subjects covered;
(2) has demonstrated competence to use under
the personal supervision of the radiographer, the radiographic exposure
devices, sealed sources, related handling tools, radiation machines and
radiation survey instruments which will be employed in his assignment; and
(3) has demonstrated understanding of the
instructions in Paragraph (b) of this Rule by successfully completing a written
or oral test and a field examination on the subjects covered.
(c) Records of the training including copies of written
tests and dates of oral tests and field examinations shall be maintained in
accordance with Rule .0523 of this Section.
(d) Each licensee or registrant shall conduct an internal
audit program to ensure that the agency's radioactive material license,
registration conditions and the licensee's or registrant's operating and
emergency procedures are followed by each radiographer and radiographer's
assistant. These internal audits shall be performed and records maintained by
the licensee or registrant as specified in Items (3) and (4) of Rule .0323 of
this Chapter.
(e) The licensee or registrant shall provide periodic
training for radiographers and radiographer's assistants at least once during
every 12 months.
(f) Whenever radiography is performed outside of a
permanent radiographic installation, the radiographer shall be accompanied by
another radiographer or an individual with, at least, the qualifications of a
radiographer's assistant. This person's responsibilities shall include but not
be limited to observing the operations and being capable and prepared to
provide immediate assistance to prevent unauthorized entry.
(g) A licensee or registrant may conduct lay-barge,
off-shore platform, or underwater radiography only if procedures have been
developed and submitted to the agency that ensure radiation exposure to the
workers and the public are ALARA during the radiographic operation.
(h) The radiation safety officer shall ensure that
radiation safety activities are being performed in accordance with approved
procedures and regulatory requirements in the daily operation of the licensee's
or registrant's program.
(1) The radiation safety officer's
qualifications shall include:
(A) completion of the training and testing requirements
of Paragraph (a) of this Rule; and
(B) Two thousand hours documented experience in
industrial radiographic operations, with at least 40 hours of classroom
training with respect to the establishment and maintenance of radiation protection
programs; or
(C) an equivalent combination of education and
experience.
(2) The specific duties and authorities of the
radiation safety officer shall include, but are not limited to the following:
(A) to establish and oversee operating, emergency and ALARA
procedures, and to review them at least annually to assure that the procedures
are current and conform with these Rules and to the license conditions;
(B) to oversee and approve all phases of the training of
radiographic personnel so that appropriate and effective radiation protection
practices are taught;
(C) to ensure that required radiation surveys and leak
tests are performed and documented in accordance with this Rule, including any
corrective measures when levels of radiation exceed established limits;
(D) to ensure that personnel monitoring devices are
calibrated and used properly by occupationally-exposed personnel, that records
are kept of the monitoring results, and that timely notifications are made as
required by Rule .1646 of this Chapter;
(E) to assure that operations are conducted safely and
to assume control and have the authority to institute corrective actions
including stopping of operations when necessary in emergency situations or
unsafe conditions.
History Note: Authority G.S. 104E-7; 10 C.F.R. Chapter
1, Commission Notices, Policy Statements, Agreement States, 46 F.R. 7540; 10
C.F.R. 34.43; 10 C.F.R. Appendix A;
Eff. February 1, 1980;
Amended Eff. June 1, 1993; June 1, 1989;
Temporary Amendment Eff. August 20, 1994, for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;
Amended Eff. January 1, 2005; April 1, 1999; May 1, 1995;
June 1, 1993; June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .0510 Eff.
February 1, 2015.
10A NCAC 15 .0511 INSPECTION AND MAINTENANCE
(a) Prior to use each day, the licensee or registrant shall
visually check for obvious defects in radiographic exposure devices, storage
containers, source changers, radiation machines and associated equipment. The
purpose of the visual check is to assure that the radiographic exposure
devices, storage containers, source changers, radiation machines and associated
equipment are in good working condition and that the required labeling is
present. If defects are found, the affected radiographic exposure devices,
storage containers, source changers, radiation machines and associated
equipment shall be removed from service until repaired and a record shall be
made in accordance with Rule .0523 of this Section.
(b) Each exposure device using depleted uranium (DU)
shielding and an "S" tube configuration shall be tested for DU
contamination at intervals not to exceed 12 months. This test shall be
performed by the licensee using procedures approved by the agency pursuant to
Rule .0323 of this Chapter or by the licensee returning the exposure device to
the manufacturer for such testing. If the test reveals the presence of DU
contamination, the exposure device shall be removed from use and arrangements
for proper disposal shall be made.
(c) Each licensee or registrant shall have written
procedures for:
(1) inspection and maintenance or radiographic
exposure devices, transport and storage containers, source changers, survey
instruments, radiation machines and associated equipment at intervals not to
exceed three months or prior to the first use thereafter to assure proper
functioning of components important to safety. Records of these inspections
and maintenance shall be made in accordance with Rule .0523 of this Section. If
defects are found, the affected radiographic exposure and associated equipment
shall be removed from service until repaired and a record made in accordance
with Rule .0523 of this Section.
(2) inspection and maintenance necessary to
maintain Type B packaging used to transport radioactive materials. The
inspection and maintenance program shall include procedures to assure that Type
B packages are shipped and maintained in accordance with the certificate of
compliance or other approval.
(d) Records of equipment problems and of any maintenance
performed under Paragraphs (a) and (b) of this Rule shall be made in accordance
with Rule .0523 of this Section.
History Note: Filed as a Temporary Amendment Eff.
August 20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;
Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. April 1, 999; May 1, 1995; October 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0511 Eff.
February 1, 2015.
10A NCAC 15 .0512 PERSONNEL MONITORING
(a) The licensee or registrant shall not permit any
individual to act as a radiographer or a radiographer's assistant unless, at
all times during radiographic operations, each such individual wears on the
trunk of the body a direct reading pocket dosimeter, an operating alarm
ratemeter, and a personnel dosimeter that is processed and evaluated by an
accredited National Voluntary Laboratory Accreditation Program (NVLAP)
processor. At permanent radiography facilities where other alarming or warning
devices are in routine use, the wearing of an alarming ratemeter is not
required. Direct reading pocket dosimeters shall have a range from zero to 200
milliroentgens (2 millisieverts) and shall be recharged at the start of each
shift. Each personnel dosimeter shall be assigned to and worn by only one
individual. Film badges shall be exchanged at least monthly, and other
personnel dosimeters that are processed and evaluated by an accredited NVLAP
processor shall be exchanged at least once each three months. Each film badge
or other personnel dosimeter shall be submitted for processing within 30 days
of replacement.
(b) Electronic personal dosimeters may be used in place of
direct reading ion-chamber pocket dosimeters.
(c) Direct reading dosimeters such as electronic personal
dosimeters or pocket dosimeters shall be read and exposures recorded at the
beginning and end of each shift.
(d) Direct reading dosimeters such as pocket dosimeters or
electronic personal dosimeters shall be checked at periods not to exceed 12
months for correct response to radiation. Acceptable dosimeters shall read
within plus or minus 20 percent of the true radiation exposure.
(e) If an individual's pocket dosimeter is found to be
off-scale or if the individual's electronic personal dosimeter reads greater
than 200 millirem (2 millisieverts), and the possibility of radiation exposure
cannot be ruled out as the cause, the individual's personnel dosimeter shall be
immediately sent for processing. In addition, the individual shall not work
with sealed sources until a determination of his radiation exposure has been
made by the radiation safety officer or his designee.
(f) If a personnel dosimeter is lost or damaged, the worker
shall cease work immediately until a replacement personnel dosimeter is
provided and exposure is calculated for the time period from issuance to loss
or damage of the personnel dosimeter.
(g) Each alarm ratemeter shall:
(1) be checked to ensure that the alarm
functions properly prior to use at the start of each shift;
(2) be set to give an alarm signal at a preset
rate not to exceed 500 mR/hr or 5 mSv/hr;
(3) require special means to change the preset
alarm function;
(4) alarm within plus or minus 20 percent of
the true radiation rate;
(5) be calibrated at periods not to exceed one
year for correct response to radiation.
(h) Records of daily dosimeter readings, determination of
exposure as a result of a lost or damaged personnel dosimeter, 12 month
response checks on dosimeters and results from the accredited NVLAP personnel
dosimeter processor shall be maintained in accordance with Rule .0523 of this
Section.
(i) Notwithstanding the requirements of Paragraph (a) of
this Rule, the agency may approve a higher pocket dosimeter range upon written
request by the licensee or registrant if the agency determines that the
requested range shall afford the protection required by the rules in this
Chapter.
History Note: Authority G.S. 104E‑7; 104E‑12(a)(2);
Eff. February 1, 1980;
Temporary Amendment Eff. August 20, 1994, for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;
Amended Eff. January 1, 2005; April 1, 1999; May 1, 1995;
Transferred and Recodified from 15A NCAC 11 .0512 Eff.
February 1, 2015.
10A NCAC 15 .0513 OPERATING AND EMERGENCY PROCEDURES
The licensee's or registrant's operating and emergency
procedures shall include instructions in at least the following:
(1) the handling and use of licensed sealed sources of
radiation and radiographic exposure devices to be employed such that no
individual is likely to be exposed to radiation doses in excess of the limits
established in Rule .1604 of this Chapter;
(2) methods and occasions for conducting radiation
surveys;
(3) methods for controlling access to radiographic
areas;
(4) methods and occasions for locking and securing
radiographic exposure devices, transport and storage containers and sealed
sources of radiation;
(5) personnel monitoring and the use of personnel
monitoring equipment;
(6) transportation of sealed sources to field
locations, including packing of radiographic exposure devices, and storage
containers in the vehicles, placarding of vehicles, and control of sealed
sources during transportation;
(7) minimizing exposure of individuals in the event of
an accident;
(8) the procedure for notifying proper personnel in the
event of an accident;
(9) maintenance of records;
(10) the inspection and maintenance and operability
checks of radiographic exposure devices, radiation machines, survey
instruments, transport containers, and storage containers;
(11) steps that shall be taken immediately by radiography
personnel in the event a pocket dosimeter is found to be off scale or an alarm
ratemeter alarms unexpectedly; and
(12) sealed source recovery procedure if the licensee
will perform sealed source recovery.
History Note: Filed as a Temporary Amendment Eff.
August 20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;
Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. April 1, 1999; May 1, 1995; January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0513 Eff.
February 1, 2015.
10A NCAC 15 .0514 SECURITY
During each radiographic operation the radiographer or
radiographer's assistant shall maintain a continuous direct surveillance of the
operation to protect against unauthorized entry into a high radiation area, as
defined in Rule .0104 of this Chapter, except where the high radiation area:
(1) is equipped with a control device or an alarm
system as described in Rule .1615 of this Chapter, or
(2) is locked to protect against unauthorized or
accidental entry.
History Note: Filed as a Temporary Amendment Eff.
August 20, 1994 for a period of 180 days or until the
permanent rule becomes effective, whichever is sooner;
Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. May 1, 1995; January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0514 Eff.
February 1, 2015.
10A NCAC 15 .0515 RADIATION SURVEYS AND SURVEY RECORDS
(a) No radiographic operation shall be conducted unless
calibrated and operable radiation survey instrumentation as described in Rule
.0506 of this Section is available and used at each site where radiography is
performed, including sealed source exchange and at the storage area whenever a
radiographic exposure device, a storage container or sealed source is being
placed in storage.
(b) A survey with a radiation detection instrument shall be
made after each radiographic exposure to determine that the sealed source has
returned to its shielded position in the radiographic exposure device or the
radiation machine is off. For sealed sources, the licensee shall conduct a
survey of the guide tube as the radiographer or radiographer's assistant
approaches the camera. The survey must determine that the sealed source has
returned to its shielded position prior to exchanging films, repositioning the
exposure head or dismantling the radiographic exposure device and associated
equipment.
(c) When the use of a radiographic exposure device or
storage container is to be terminated at the end of a work period, a survey
with a radiation detection instrument shall be made of the locked radiography
device or storage container to determine that the sealed source is in its
shielded position.
(d) A survey of the radiographic exposure device and source
changer shall be performed with a radiation detection instrument any time the
sealed source is exchanged and whenever a radiographic exposure device is
placed in a storage area.
(e) An area survey of the perimeter of the restricted area
with a radiation detection instrument shall be made with the sealed source
exposed or the radiation machine on before or during the initial radiographic
exposure on each shift and when the sealed source or the radiation machine
target configuration for an exposure is different from that of the preceding
exposure such that the radiation exposure rate at the perimeter of the
restricted area is likely to increase by a measurable amount using a radiation
detection instrument. These surveys are not required for radiography performed
in a permanent radiographic installation.
(f) Records of surveys required by this Rule shall be
maintained in accordance with the requirements of Rule .0523 of this Section.
History Note: Filed as a Temporary Amendment Eff.
August 20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;
Authority G.S. 104E‑7; 104E‑12(a)(1);
Eff. February 1, 1980;
Amended Eff. April 1, 1999; May 1, 1995;
Transferred and Recodified from 15A NCAC 11 .0515 Eff.
February 1, 2015.
10A NCAC 15 .0516 POSTING
Notwithstanding any provisions in Rule .1625 of this
Chapter, areas in which radiography is being performed shall be conspicuously
posted as required by Rule .1624 of this Chapter. The exception listed in Rule
.1625 of this Chapter does not apply to industrial radiography.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. April 1, 1999; January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0516 Eff.
February 1, 2015.
10A NCAC 15 .0517 SUPERVISION OF RADIOGRAPHERS'
ASSISTANTS
(a) Whenever a radiographer's assistant uses radiographic
exposure devices or radiation machines, uses sealed sources or related source
handling tools, or conducts radiation surveys required by Rule .0515(b) and (c)
of this Section to determine that the exposure has been terminated and, if
applicable, the sealed source has returned to the shielded position after an
exposure, the assistant shall be under the personal supervision of a
radiographer.
(b) The personal supervision shall include:
(1) the radiographer's physical presence at the
site where the sealed sources or radiation machines are being used;
(2) the availability of the radiographer to
give immediate assistance, if required; and
(3) the radiographer's direct observation of
the assistant's performance of the operations referred to in this Section.
History Note: Filed as a Temporary Amendment Eff.
August 20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;
Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. April 1, 1999; May 1, 1995;
Transferred and Recodified from 15A NCAC 11 .0517 Eff.
February 1, 2015.
10A NCAC 15 .0518 RADIATION MACHINES
History Note: Authority G.S. 104E‑7; 104E‑12(a)(1);
Eff. February 1, 1980;
Amended Eff. June 1, 1993;
Temporary Amendment Eff. August 20, 1994 for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;
Amended Eff. May 1, 1995;
Transferred and Recodified from 15A NCAC 11 .0518 Eff.
February 1, 2015;
Repealed Eff. October 1, 2015.
10A NCAC 15 .0519 SUBJECTS TO BE COVERED DURING
INSTRUCTION OF RADIOGRAPHERS
The following subjects shall be covered in the instructions
of radiographers:
(1) fundamentals of radiation safety:
(a) characteristics of gamma and x‑radiation;
(b) units of radiation dose (mrem, sievert) and
quantity of radioactivity (curie, becquerel);
(c) hazards of exposure of radiation;
(d) levels of radiation from sources of
radiation;
(e) methods of controlling radiation dose:
(i) working time,
(ii) working distances,
(iii) shielding,
(2) radiation detection instrumentation to be used:
(a) use of radiation survey instruments:
(i) operation,
(ii) calibration,
(iii) limitations,
(b) survey techniques;
(c) use of personnel monitoring equipment;
(i) film badges,
(ii) pocket dosimeters,
(iii) pocket chambers,
(3) radiographic equipment to be used:
(a) remote handling equipment;
(b) radiographic exposure devices, radiation
machines and sealed sources;
(c) storage containers;
(d) operation and control of radiography
equipment;
(e) storage, control and disposal of sealed
sources;
(4) the requirements of pertinent federal and state
regulations;
(5) the licensee's or registrant's written operating
and emergency procedures;
(6) inspection and maintenance performed by
radiographers;
(7) case histories of radiography accidents;
(8) the conditions of the license or registration
issued by the agency.
History Note: Filed as a Temporary Amendment Eff.
August 20, 1994 for a period of 180 days or until the
permanent rule becomes effective, whichever is sooner;
Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. May 1, 1995;
Transferred and Recodified from 15A NCAC 11 .0519 Eff.
February 1, 2015.
10A NCAC 15 .0520 PERMANENT RADIOGRAPHIC INSTALLATIONS
(a) Permanent radiographic installations having high
radiation area entrance controls of the types described in Subparagraphs
(a)(1), (2) and (3) of Rule .1615 of this Chapter shall also meet the following
special requirements:
(1) Each entrance that is used for personnel
access to the high radiation area in a permanent radiographic installation to
which this Section applies shall have both visible and audible warning signals
to warn of the presence of radiation.
(2) The visible signal shall be actuated by
radiation whenever the sealed source is exposed.
(3) The audible signal shall be actuated when
an attempt is made to enter the installation while the sealed source is
exposed.
(b) The alarm system shall be tested for proper operation
with a radiation source at the beginning of each day of equipment use. The
daily test shall include a check of the visible and audible signals by exposing
the sealed source or operating the radiation machine prior to use of the room.
Entrance control devices that reduce the radiation level upon entry as required
in Paragraph (a) of this Rule shall be tested monthly. If a control device or
alarm is operating improperly, it shall immediately be labeled as defective and
repaired within seven calendar days. The facility may continue to to be used
during this seven day period, provided the licensee or registrant implements
continuous surveillance to protect against unauthorized entry and uses an
alarming ratemeter.
(c) Records of test of alarm functions shall be maintained
in accordance with Rule .0523 of this Section.
History Note: Filed as a Temporary Amendment Eff.
August 20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;
Authority G.S. 104E‑7; 104E‑12(a)(1);
Eff. October 1, 1980;
Amended Eff. April 1, 1999; May 1, 1995; January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0520 Eff.
February 1, 2015.
10A NCAC 15 .0521 PERFORMANCE REQUIREMENTS FOR
RADIOGRAPHY EQUIPMENT
Equipment used in industrial radiographic operations shall
meet the following minimum criteria:
(1) Each radiographic exposure device, source assembly
or sealed source, and all associated equipment shall meet the requirements
specified in American National Standard N432-1980 "Radiological Safety for
the Design and Construction of Apparatus for Gamma Radiography". This
publication is incorporated by reference in Rule .0117 of this Chapter.
(2) Engineering analysis may be submitted to the agency
to demonstrate the applicability of previously performed testing on similar
individual radiography equipment components. Upon review by the agency, this
may be an acceptable alternative to actual testing of the component pursuant to
the above referenced standard.
(3) In addition to the requirements specified in Item
(1) of this Rule, the following requirements apply to radiographic exposure
devices, source changers, source assemblies, and sealed sources:
(a) Each radiographic exposure device shall have
attached to it by the user a durable, legible, clearly visible label bearing
the following:
(i) Chemical symbol and mass number of the
radionuclide in the device;
(ii) Activity and the date on which this
activity was last measured;
(iii) Model number (or product code) and serial
number of the sealed source;
(iv) Manufacturer's identity of the sealed
source; and
(v) Licensee's name, address, and telephone
number.
(b) Radiographic exposure devices intended for
use as Type B transport containers shall meet the applicable requirements of
10 CFR Part 71.
(c) Modification of radiographic exposure
devices, source chargers and source assemblies and associated equipment is
prohibited, unless the design of any replacement component, including sealed
source holder, source assembly, controls or guide tubes would not compromise
the design safety features of the system.
(4) In addition to the requirements specified in Items
(1) and (3) of this Rule, the following requirements apply to radiographic
exposure devices, source assemblies, and associated equipment that allow the
sealed source to be moved out of the device for radiographic operations or to
source changers.
(a) The coupling between the source assembly and
the control cable shall be designed in such a manner that the source assembly
will not become disconnected if cranked outside the guide tube. The coupling
shall be such that it cannot be unintentionally disconnected under normal and
reasonably foreseeable abnormal conditions.
(b) The device shall automatically secure the
source assembly when it is cranked back into the fully shielded position within
the device. This securing system shall be designed to only allow release of the
sealed source by means of a deliberate operation on the exposure device.
(c) The outlet fittings, lock box, and drive
cable fittings on each radiographic exposure device shall be equipped with
safety plugs or covers which shall be installed during storage and
transportation to protect the source assembly from water, mud, sand or other
foreign matter.
(d) Each sealed source or source assembly shall
have attached to it or engraved in it, a durable, legible, visible label with
the words: "DANGER--RADIOACTIVE." The label shall not interfere with
the safe operation of the exposure device or associated equipment.
(e) The guide tube must be able to withstand a
crushing test that closely approximates the crushing forces that are likely to
be encountered during use, and be able to withstand a kinking resistance test
that closely approximates the kinking forces that are likely to be encountered
during use.
(f) Guide tubes shall be used when moving the
sealed source out of the device.
(g) An exposure head or similar device designed
to prevent the source assembly from passing out of the end of the guide tube
shall be attached to the outermost end of the guide tube during radiographic
operations.
(h) The guide tube exposure head connection
shall be able to withstand the tensile test for control units specified in ANSI
N432.
(i) Source changers shall provide a system for
assuring that the sealed source will not be accidentally withdrawn from the
changer when connecting or disconnecting the drive cable to or from a source
assembly.
(5) All associated equipment acquired after January 10,
1996 shall be labeled to identify that the components have met the requirements
of this Rule.
History Note: Filed as a Temporary Adoption Eff. August
20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;
Authority G.S. 104E-7;
Eff. May 1, 1995;
Amended Eff. April 1, 1999;
Transferred and Recodified from 15A NCAC 11 .0521 Eff.
February 1, 2015.
10A NCAC 15 .0522 REPORTING REQUIREMENTS
(a) In addition to the reporting requirements specified in
other rules of this Chapter, each licensee or registrant shall provide a
written report to the agency at the address specified in Rule .0111 of this Chapter
within 30 days of the occurrence of any of the following incidents involving
radiographic equipment:
(1) unintentional disconnection of the source
assembly from the control cable;
(2) inability to retract the source assembly to
its fully shielded position and secure it in this position; or
(3) failure of any component critical to safe
operation of the device to properly perform its intended function.
(b) The licensee or registrant shall include the following
information in each report required by Paragraph (a) of this Rule, and in each
report of overexposure submitted pursuant to Section .1600 which involves
failure of safety components of radiography equipment:
(1) a description of the equipment problem;
(2) cause of each incident, if known;
(3) manufacturer and model number of equipment
involved in the incident;
(4) place, time and date of the incident;
(5) actions taken to establish normal
operations;
(6) corrective actions taken or planned to
prevent recurrence; and
(7) qualifications of personnel involved in the
incident.
(c) Any licensee or registrant conducting radiographic
operations or storing radioactive material at any location not listed on the
license for a period in excess of 180 days in a calendar year, shall notify the
agency prior to exceeding the 180 days.
History Note: Authority G.S. 104E-7;
Temporary Adoption Eff. August 20, 1994, for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;
Eff. May 1, 1995;
Amended Eff. April 1, 1999;
Transferred and Recodified from 15A NCAC 11 .0522 Eff.
February 1, 2015.
10A NCAC 15 .0523 RECORDS OF INDUSTRIAL RADIOGRAPHY
(a) Each licensee or registrant shall maintain, for a
period of three years after the record is made, the following records for
inspection by the agency:
(1) copies of the following documents:
(A) radioactive materials license or registration issued
by the agency;
(B) the complete application submitted for the license
or registration that includes all amendments; and
(C) current operating and emergency procedures;
(2) records showing the receipt and transfer of
all sealed sources and devices using depleted uranium (DU) for shielding that
include:
(A) date;
(B) individual making the record;
(C) radionuclide;
(D) activity in curies or becquerel or mass for depleted
uranium; and
(E) make, model and serial number of each sealed source
and device;
(3) records of the calibrations of radiation
detection instrumentation;
(4) records of leak tests for sealed sources
and devices containing depleted uranium in units of microcuries or becquerel;
(5) records of quarterly inventories that
include:
(A) radionuclide;
(B) activity in curies or becquerel;
(C) specific information on each sealed source and the
radiographic exposure device, storage container or source changer which
contains the sealed source to include:
(i) model numbers;
(ii) serial numbers; and
(iii) manufacturers names;
(D) location of sealed sources;
(E) name of the individual conducting the inventory;
and
(F) the date of the inventory;
(6) records of utilization logs showing the
following information:
(A) a description of each radiographic exposure device,
radiation machine or transport or storage container in which the sealed source
is located that includes:
(i) make;
(ii) model number; and
(iii) serial number;
(B) the identity and signature of the radiographer to
whom assigned;
(C) the plant or site where used; and
(D) dates of use that includes the dates removed and
returned to storage;
(7) records of inspection and maintenance of
radiographic exposure devices, transport and storage containers, associated
equipment, source changers and radiation machines. The record shall include:
(A) date of the check;
(B) name of the individual performing the check;
(C) equipment involved;
(D) any problems found in daily checks and quarterly
inspections; and
(E) any repairs or maintenance made and name of
individual or company performing the repair;
(8) records of alarm system tests for permanent
radiographic installations;
(9) records of the training and certification
of each radiographer and radiographer's assistant as follows:
(A) radiographer certification documents and
verification of certification status;
(B) for initial training, copies of written tests; dates
and results of oral tests and field examinations; and names of individuals
conducting and receiving the oral test or field examination;
(C) for periodic training and semi-annual inspections of
job performance, list of topics discussed; date(s) of the review; and names of
the instructors and the attendees; and
(D) for inspections of job performance, the records
shall also include a list showing the items checked and any noncompliance
observed by the Radiation Safety Officer.
(10) records for pocket dosimeters to include
daily exposure readings and yearly operability checks;
(11) records of reports received from the
accredited National Voluntary Laboratory Accreditation Program (NVLAP)
personnel dosimetry processor. These records, as well as any records of
exposure estimates required as a result of off-scale direct reading dosimeters,
or lost or damaged personnel dosimeters, shall be maintained until the agency
terminates the license or registration or until authorized by the agency;
(12) records of exposure device surveys performed
at the end of the work day and prior to placing the device in storage;
(13) records of area surveys required by Rule
.0515 of this Section;
(14) copy of current operating and emergency
procedures until the agency terminates the license or registration and copies
of superseded material shall be retained for three years after the change is
made; and
(15) evidence of the latest calibrations of alarm
ratemeters and operability checks of pocket dosimeters or electronic personal
dosimeters.
(b) Each licensee or registrant conducting operations at
temporary jobsites shall maintain copies of the following documents and records
at the temporary jobsite until the radiographic operation is completed:
(1) operating and emergency procedures required
by Rule .0513 of this Section;
(2) radioactive materials license or
registration;
(3) evidence of training of the radiographers
and radiographer's assistants. The individuals shall either be listed on the
radioactive materials license or registration and offer identification or shall
have certification of his training and offer identification;
(4) evidence of the latest calibration of the
radiation detection instrumentation in use at the site as required by Rule
.0506 of this Section;
(5) evidence of the latest leak test of the
sealed source required by Rule .0507 of this Section;
(6) records of the latest surveys required by
Rule .0515 of this Section;
(7) records of current direct reading
dosimeters such as pocket dosimeter or electronic personal dosimeter readings;
(8) shipping papers for the transportation of
radioactive materials required by 10 CFR Part 71.5; and
(9) records of area surveys required by Rule
.0515 of this Section;
(10) a copy of Section .0500 of this Chapter;
(11) utilization records for each radiographic
exposure device dispatched from that location as required by Subparagraph (a)
of Rule .0523 of this Section;
(12) records of equipment problems identified in
daily checks of equipment; and
(13) when operating under reciprocity, a copy of
the Nuclear Regulatory Commission or agreement state license authorizing the
use of radioactive material.
(c) Each record required by this Rule shall be legible
throughout the specified retention period. The record may be an original, a
reproduced copy or microform provided that the copy or microform is authenticated
by the licensee and the microform is capable of reproducing a clear copy
throughout the required record retention period. The record may also be stored
in electronic media with the capability for producing legible, accurate and
complete records during the required record retention period. Records, such as
letters, drawings and specifications shall include all pertinent information,
such as stamps, initials and signatures. The licensee or registrant shall
maintain safeguards against tampering with and loss of records.
History Note: Authority G.S. 104E-7;
Temporary Adoption Eff. August 20, 1994, for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;
Eff. May 1, 1995;
Amended Eff. January 1, 2005; April 1, 1999;
Transferred and Recodified from 15A NCAC 11 .0523 Eff.
February 1, 2015.
10A NCAC 15 .0524 SPECIFIC LICENSE FOR INDUSTRIAL
RADIOGRAPHY
An application for a specific license for the use of
licensed material in industrial radiography shall be approved if the applicant
meets the following requirements:
(1) the applicant satisfies the general requirements
specified in Rules .0317 and .0323 of this Chapter for radioactive material, as
appropriate, and any special requirements contained in this Section;
(2) the applicant submits a program for training
radiographers and radiographers' assistants, that meets the requirements of
Rule .0323 of this Chapter and Rule .0510 of this Section.
(3) the applicant submits procedures for verifying and
documenting the certification status of radiographers and for ensuring that the
certification of individuals acting as radiographers remains valid;
(4) the applicant submits written operating and
emergency procedures as described in Rule .0323 of this Chapter and Rule .0513
of this Section;
(5) the applicant submits a description of a program
for inspections of the job performance of each radiographer and radiographers'
assistant at intervals not to exceed six months as described in Rule .0323 of
this Chapter;
(6) the applicant submits a description of the
applicant's overall organizational structure as it applies to the radiation
safety responsibilities in industrial radiography, including specified
delegation of authority and responsibility;
(7) the applicant identifies and lists the
qualifications of the individual(s) designated as the radiation safety officer
and potential designees responsible for ensuring that the licensee's radiation
safety program is implemented in accordance with the requirements of this
Chapter;
(8) If an applicant intends to perform leak testing of
sealed sources or exposure devices containing depleted uranium shielding, the
applicant shall describe the procedures for performing and the qualifications
of the person(s) authorized to do the leak testing. If the applicant intends
to analyze its own wipe samples, the application shall include a description of
the procedures to be followed. The description shall include the:
(a) instruments to be used;
(b) methods of performing the analysis; and
(c) pertinent experience of the person who will
analyze the wipe samples;
(9) If the applicant intends to perform
"in-house" calibrations of survey instruments, the applicant shall
describe methods to be used and the relevant experience of the person(s) who
will perform the calibrations. All calibrations shall be performed according
to the procedures described and at the intervals prescribed in Rule .0506 of
this Section;
(10) The applicant identifies and describes the
location(s) of all field stations and permanent radiographic installations; and
(11) The applicant identifies the locations where all
records required by this Section and other Sections of this Chapter will be
maintained.
History Note: Authority G.S. 104E-7; 104E-10(b);
Eff. April 1, 1999;
Transferred and Recodified from 15A NCAC 11 .0524 Eff.
February 1, 2015.
10A NCAC 15 .0525 RADIOGRAPHER CERTIFICATION
(a) An independent certifying organization shall:
(1) be an organization such as the American
Society of Nondestructive Testing (ASNT) or other society or association, whose
members participate in, or have an interest in, the field of industrial
radiography;
(2) make its membership available to the
general public nationwide that is not restricted because of race, color,
religion, sex, age, national origin or disability;
(3) have a certification open to nonmembers, as
well as members;
(4) be an incorporated, nationally recognized
organization, such as ASNT, that is involved in setting national standards of
practice within its field of expertise;
(5) have staff, a viable system for financing
its operations, and policy and decision-making review board;
(6) have a set of written organizational
by-laws and policies that provide assurance of lack of conflict of interest and
a system for monitoring and enforcing those by-laws and policies;
(7) have a committee, whose members can carry
out their responsibilities impartially, to review and approve the certification
guidelines and procedures, and to advise the organization's staff in
implementing the certification program;
(8) have a committee, whose members can carry
out their responsibilities impartially, to review complaints against certified
individuals and to determine appropriate sanctions;
(9) have written procedures describing all
aspects of its certification program, maintain records of the current status of
each individual's certification and the administration of its certification
program;
(10) have procedures to ensure that certified
individuals are provided due process with respect to the administration of its
certification program, including the process of becoming certified and any
sanctions imposed against certified individuals;
(11) have procedures for proctoring examinations,
including qualifications for proctors;
(12) ensure that the procedures in Subparagraph
(a)(11) of this Paragraph require that the individuals proctoring each
examination are not employed by the same company or corporations (or a
wholly-owned subsidiary of such company or corporation) as any of the
examinees;
(13) exchange information about certified
individuals with the agency and other independent certifying organizations or
the U.S. Nuclear Regulatory Commission and other agreement states, and allow
periodic review of its certification program and related records; and
(14) provide a description to the agency of its
procedures for choosing examination sites and for providing an environment
suitable for examination.
(b) All certification programs shall:
(1) require applicants for certification to
receive training in the topics set forth in Rule .0519 of this Section and
satisfactorily complete a written examination covering the topics in Rule .0519
of this Section;
(2) require applicants for certification to
provide documentation that demonstrates that the applicant has:
(A) received training in the topics set forth in Rule
.0519 of this Section; or
(B) satisfactorily completed a minimum period of
on-the-job training; and
(C) received verification by an agreement state or a
Nuclear Regulatory Commission licensee that the applicant has demonstrated the
capability of independently working as a radiographer;
(3) include procedures to ensure that all
examination questions are protected for disclosure;
(4) include procedures for denying an
application, and for revoking, suspending, and reinstating a certification;
(5) provide a certification period of not less
than three years and not more than five years;
(6) include procedures for renewing
certifications and, if the procedures allow renewals without examination,
require evidence of recent full-time employment and annual refresher training;
and
(7) provide a timely response to inquiries by
telephone or letter, from members of the public, about an individual's
certification status.
(c) All examinations shall be:
(1) designed to test an individual's knowledge
and understanding of the topics set forth in Rule .0519 of this Section;
(2) written in a multiple-choice format; and
(3) have test items drawn from a question list
based on the material contained in Rule .0519 of this Section.
History Note: Authority G.S. 104E-7; 104E-10(b); 10
C.F.R. 34.43; 10 C.F.R. 34, Appendix A;
Eff. April 1, 1999;
Transferred and Recodified from 15A NCAC 11 .0525 Eff.
February 1, 2015.
SECTION .0600 ‑ X‑RAYS IN THE HEALING ARTS
Codifier's Note: 10 NCAC 03G .2700 was transferred to 15A
NCAC 11 .0600 effective January 4, 1990. Recodification pursuant to G.S.
143B-279.3.
10A NCAC 15 .0601 PURPOSE AND SCOPE
This Section establishes requirements for use of x‑ray
equipment by or under the supervision of an individual authorized by and
licensed in accordance with state statutes to engage in the healing arts or
veterinary medicine. The provisions of this Section are in addition to, and not
in substitution for, the provisions of Sections .0100, .0200, .0900, .1000, and
.1600 of this Chapter.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0601 Eff.
February 1, 2015.
10A NCAC 15 .0602 DEFINITIONS
(a) As used in this Section, the following definitions
shall apply:
(1) "Accessible surface" means the
external surface of the enclosure or housing provided by the manufacturer.
(2) "Added filter" means the filter
added to the inherent filtration.
(3) "Aluminum equivalent" means the
thickness of aluminum, type 1100 alloy, affording the same attenuation, under
specified conditions, as the material in question. The nominal composition of
type 1100 aluminum alloy is 99.00 percent minimum aluminum and 0.12 percent
copper.
(4) "Attenuation block" means a block
or stack, having dimensions 20 cm by 20 cm by 3.8 cm, of type 1100 aluminum
alloy or other materials having equivalent attenuation.
(5) "Automatic exposure control"
means a device which automatically controls one or more technique factors in
order to obtain, at a preselected location(s), a required quantity of
radiation. Phototimer is described separately.
(6) "Beam axis" means a line from the
source of x‑rays through the centers of the x‑ray fields.
(7) "Beam‑limiting device"
means a device which provides a means to restrict the dimensions of the x‑ray
field.
(8) "Cephalometric device" means a
device intended for the radiographic visualization and measurement of the
dimensions of the human head.
(9) "Changeable filters" means any
added filter which can be removed from the useful x‑ray beam through any
electronic, mechanical or physical process.
(10) "Contact therapy system" means
that the x‑ray tube target is put within five centimeters of the surface
being treated.
(11) "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.
(12) "Cooling curve" means the
graphical relationship between heat units stored and cooling time.
(13) "Dead‑man switch" means a
switch so constructed that a circuit closing contact can be maintained only by
continuous pressure on the switch by the operator.
(14) "Diagnostic source assembly" means
the tube housing assembly with a device attached.
(15) "Diagnostic‑type protective tube
housing" means a tube housing so constructed that the leakage radiation
measured at a distance of one meter from the source does not exceed 100 mR in one
hour when the tube is operated at its leakage technique factors.
(16) "Diagnostic x‑ray system"
means an x‑ray system designed for irradiation of any part of the human
body for the purpose of diagnosis or visualization.
(17) "Direct scattered radiation" means
that radiation which has been deviated in direction by materials irradiated by
the useful beam.(See also scattered radiation).
(18) "Entrance exposure rate" means the
roentgens per unit time at the point where the center of the useful beam enters
the patient.
(19) "Exposure" means the quotient of
dQ by dm where "dQ" is the absolute value of the total charge of the
ions of one sign produced in air when all the electrons, negatrons and
positrons, liberated by photons in a volume element of air having mass
"dm" are completely stopped in air. The special unit of exposure is
the roentgen.
(20) "Field emission equipment" means
equipment which uses an x‑ray tube in which electron emission from the
cathode is due solely to the action of an electric field.
(21) "Filter" means material placed in
the useful beam to preferentially attenuate selected radiations.
(22) "Fluoroscopic imaging assembly"
means a subsystem in which x‑ray photons produce a fluoroscopic image.
It includes the image receptor(s) such as the image intensifier and spot‑film
device, electrical interlocks and structural material providing linkage between
the image receptor and the diagnostic source assembly.
(23) "General purpose radiographic x‑ray
system" means any radiographic x‑ray system which, by design, is not
limited to radiographic examination of specific anatomical regions.
(24) "Gonad shield" means a protective
barrier used to reduce exposure to the testes or ovaries.
(25) "Half‑value layer (HVL)"
means the thickness of specified material which attenuates the beam of
radiation to an extent such that the exposure rate is reduced to one‑half
of its original value. In this definition the contribution of all scattered
radiation, other than any which might be present initially in the beam concerned,
is deemed to be excluded.
(26) "Healing arts mass screening"
means the examination of human beings using x‑rays 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 who is
legally authorized to prescribe such x‑ray tests for the purpose of
diagnosis or treatment. It does not include the use of x‑ray tests as a
requirement for hospital admission or as a condition of employment.
(27) "Image intensifier" means a
device, including housing, which converts an x‑ray pattern into a
corresponding light image of higher energy density.
(28) "Image receptor" means any device,
such as fluorescent screen or radiographic film, which transforms incident x‑ray
photons either into a visible image or into another form which can be made into
a visible image by further transformations.
(29) "Inherent filtration" means the
filtration permanently in the useful beam; it includes the window of the x‑ray
tube and any permanent tube or source enclosure.
(30) "Installation" means the act of
physical movement of a radiographic system from one location to another in
conjunction with a change of ownership.
(31) "Lead equivalent" means the
thickness of lead affording the same attenuation, under specified conditions,
as the material in question.
(32) "Leakage radiation" means
radiation emanating from a diagnostic or therapeutic source assembly except
for:
(A) the useful beam and
(B) radiation produced when the exposure switch or timer
is not activated.
(33) "Leakage technique factors" means
the technique factors associated with the diagnostic or therapeutic source
assembly (i.e., tube housing and beam limiting device) which are used in
measuring leakage radiation. They are defined as follows:
(A) for diagnostic source assemblies intended for
capacitor energy storage equipment, the maximum rated peak tube potential and
the maximum rated number of exposures in an hour for operation at the maximum
rated peak tube potential with the quantity of charge per exposure being 10
millicoulombs (mC) or the minimum obtainable from the unit, whichever is
larger;
(B) 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; and
(C) for all other diagnostic or therapeutic source
assemblies, the maximum rated peak tube potential and the maximum rated continuous
tube current for the maximum rated peak tube potential.
(34) "Light field" means that area of
the intersection of the light beam from the beam‑limiting device and one
of the set of planes parallel to and including the plane of the image receptor,
whose perimeter is the locus of points at which the illumination is one‑fourth
of the maximum in the intersection.
(35) "Maximum line current" means the
rms (root‑mean‑square) current in the supply line of an x‑ray
machine operating at its maximum rating.
(36) "Mobile equipment" (see x‑ray
equipment).
(37) "Peak tube potential" means the
maximum value of the potential difference across the x‑ray tube during an
exposure.
(38) "Phototimer" means a method for
controlling radiation exposures to image receptors by the amount of radiation
which reaches a radiation monitoring device(s). The radiation monitoring
device(s) is part of an electronic circuit which controls the duration of time
the tube is activated (see also "Automatic exposure control").
(39) "Portable equipment" (see x‑ray
equipment).
(40) "Position indicating device (PID)"
means a device on dental x‑ray equipment used to indicate the beam
position and to establish a definite source‑skin distance. It may or may
not incorporate or serve as a beam‑limiting device.
(41) "Primary protective barrier" means
the material, excluding filters, placed in the useful beam, for radiation
protection purposes, to reduce the radiation exposure.
(42) "Protective apron" means an apron
made of radiation attenuating materials used to reduce radiation exposure.
(43) "Protective barrier" means a
barrier of radiation attenuating material(s) used to reduce radiation
exposure. Types of protective barriers are defined in other items of this
Rule.
(44) "Protective glove" means a glove
made of radiation attenuating materials used to reduce radiation exposure.
(45) "Qualified expert" means an
individual who is registered pursuant to Rule .0205 of this Chapter.
(46) "Radiograph" means an image
receptor on which the image has been created directly or indirectly by an x‑ray
pattern and results in a permanent record.
(47) "Radiographic imaging system"
means any system whereby a permanent or semi‑permanent image is recorded
on an image receptor by the action of ionizing radiation.
(48) "Rating" means the operating
limits as specified by the component manufacturer.
(49) "Recording" means producing a
permanent form of an image resulting from x‑ray photons such as film and
video tape.
(50) "Registrant", as used in this
Section, means any person who owns or possesses and administratively controls
an x‑ray system which is used to deliberately expose humans or animals to
the useful beam of the system and is required by the provisions contained in
Sections .0100 and .0200 of this Chapter to register with the agency.
(51) "Response time" means the time
required for an instrument system to reach 90 percent of its final reading when
the radiation‑sensitive volume of the instrument system is exposed to a
step change in radiation flux from zero sufficient to provide a steady state
mid‑scale reading.
(52) "Scattered radiation" means
radiation that, during passage through matter, has been deviated in direction.
(See also "direct scattered radiation".)
(53) "Secondary protective barrier"
means a barrier sufficient to attenuate the stray radiation to the required
degree.
(54) "SID" means source‑image
receptor distance.
(55) "Source" means the focal spot of
the x‑ray tube.
(56) "Source‑image receptor distance
(SID)" means the distance from the source to the center of the input
surface of the image receptor.
(57) "Spot film" means a radiograph
which is made during a fluoroscopic examination to permanently record
conditions which exist during that fluoroscopic procedure.
(58) "Stationary equipment" (see x‑ray
equipment).
(59) "Stray radiation" means the sum of
leakage and scattered radiation.
(60) "Technique factors" means the
conditions of operation. They are specified as follows:
(A) for capacitor energy storage equipment, peak tube
potential in kV and quantity of charge in mAs;
(B) for field emission equipment rated for pulsed
operation, peak tube potential in kV and number of x‑ray pulses; and
(C) for all other equipment, peak tube potential in kV
and either tube current in mA and exposure time in seconds, or the product of
tube current and exposure time in mAs.
(61) "Therapeutic‑type protective tube
housing" means the tube housing with tube installed, and it includes high
voltage and filament transformers and other appropriate elements when they are
contained within that housing.
(62) "Transportation equipment" means x‑ray
equipment which is installed in a vehicle or trailer.
(63) "Tube" means an x‑ray tube,
unless otherwise specified.
(64) "Tube housing assembly" means the
tube housing with tube installed. It includes high‑voltage and filament
transformers and other appropriate elements when they are contained within the
tube housing.
(65) "Tube rating chart" means the set
of curves which specify the rated limits of operation of the tube in terms of
the technique factors.
(66) "Useful beam" means the radiation
which passes through the tube housing port and the aperture of the beam‑limiting
device when the exposure switch or timer is activated.
(67) "Variable‑aperture beam‑limiting
device" means a beam‑limiting device which has capacity for stepless
adjustment of the x‑ray field size at the given SID.
(68) "Visible area" means that portion
of the input surface of the image receptor over which incident x‑ray
photons produce a visible image.
(69) "X‑ray control" means a
device which 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.
(70) "X‑ray equipment" means an x‑ray
system, subsystem or component thereof.
(A) "Mobile equipment" means x‑ray
equipment mounted on a permanent base with wheels or casters for moving while
completely assembled.
(B) "Portable equipment" means x‑ray equipment
designed to be hand‑carried.
(C) "Stationary equipment" means x‑ray
equipment which is installed in a fixed location.
(71) "X‑ray field" means that
area of the intersection of the useful beam and any 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 exposure rate is one‑fourth of the
maximum in the intersection.
(72) "X‑ray high‑voltage
generator" means a device which transforms electrical energy from the
potential supplied by the x‑ray control to the tube operating potential.
The device may also include means for transforming alternating current to
direct current, filament transformers for the x‑ray tube(s), high‑voltage
switches, electrical protective devices and other appropriate elements.
(73) "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 which function with the system
are considered integral parts of the system.
(74) "X‑ray subsystem" means any
combination of two or more components of an x‑ray system for which there
are requirements specified in this Section.
(75) "X‑ray tube" means an
electron tube which is designed for the conversion of electrical energy into x‑ray
energy.
(b) Other definitions applicable to this Section may be
found in Sections .0100 and .0200 of this Chapter.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. June 1, 1993; May 1, 1992; October 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0602 Eff.
February 1, 2015.
10A NCAC 15 .0603 GENERAL REQUIREMENTS
(a) Administrative controls
(1) The registrant shall be responsible for
directing the operation of the x‑ray machines which he has registered
with the agency. He or his agent shall assure that the following provisions
are met in the operation of the x‑ray machine(s):
(A) An x‑ray machine which does not meet the
provisions of these Rules shall not be operated for diagnostic or therapeutic
purposes, if so ordered by the agency in accordance with Rules .0109 and .0110
of this Chapter.
(B) Individuals who will be operating the x‑ray
equipment shall be instructed in the safe operating procedures and use of the
equipment and demonstrate an understanding thereof to the registrant.
(C) In the vicinity of each diagnostic x‑ray
system's control panel, a chart shall be provided, which specifies for all
usual examinations and associated projections which are performed by that
system, a listing of information including patient's anatomical size versus
technique factors to be utilized at a given source to image receptor distance.
The chart shall also provide:
(i) type and size of the film or film‑screen
combination to be used,
(ii) type and ratio of grid to be used, if any, and
focal spot to film distance,
(iii) type and placement of gonad shielding to be
used.
(D) Written safety procedures and rules shall be
established and made available to each individual operating x‑ray
equipment under his control. The operator shall be familiar with these rules.
(E) Only the professional staff and ancillary personnel
required for the medical procedure or for training shall be in the room during
the radiographic exposure. Other than the patient being examined:
(i) All individuals shall be positioned such that
no part of the body including the extremities which is not protected by 0.5 mm
lead equivalent will be exposed to the useful beam.
(ii) Professional staff and ancillary personnel
shall be protected from the direct scatter radiation by protective aprons or
whole body protective barriers of not less than 0.25 mm lead equivalent.
(iii) Patients who cannot be removed from the room
shall be protected from the direct scatter radiation by whole body protective
barriers of 0.25 mm lead equivalent or shall be so positioned that the nearest
portion of the body is at least six feet from both the tube head and the
nearest edge of the image receptor.
(iv) When a portion of the body of a non-
occupationally exposed professional staff or ancillary personnel is potentially
subjected to stray radiation which would result in that individual receiving
one‑fourth of the maximum permissible dose as defined in Rule .1604 of
this Chapter, additional protective measures shall be employed.
(v) Upon written application to the agency, the
agency may waive the requirements in Subparts (a)(1)(E)(ii) and (a)(1)(E)(iii)
of this Rule if the registrant demonstrates that such waiver is necessary for
best management of patients and will not result in violation of the public and
occupational dose limits established in the rules in this Chapter.
(F) Gonad shielding of not less than 0.5 mm lead
equivalent shall be used for potentially procreative patients during
radiographic procedures in which the gonads are in the direct, or useful beam,
except for cases in which this would interfere with the diagnostic procedures.
(G) Individuals shall not be exposed to the useful beam
except for healing arts purposes. Such exposures shall have been authorized by
a licensed practitioner of the healing arts. This provision specifically prohibits
deliberate exposure of an individual for training, demonstration or other
nonhealing arts purposes.
(H) When a patient or film must be provided with
auxiliary support during a radiographic exposure:
(i) Mechanical holding devices shall be used whenever
medical circumstances permit. Written safety procedures, as required in Part
(a)(1)(D) of this Rule shall indicate the requirements for selecting a holder;
(ii) If a human holder is required, written safety
procedures as required in Part (a)(1)(D) of this Rule, shall indicate the
instructions provided to the holder;
(iii) The human holder shall be protected as required
in Part (a)(1)(E) of this Rule;
(iv) No individual shall be used routinely to hold
patients or film.
(I) Procedures and auxiliary equipment designed to
minimize patient and personnel exposure commensurate with the needed diagnostic
information shall be utilized. This includes, but is not limited to, the
following requirements:
(i) The speed of film or screen and film
combinations shall be the fastest speed consistent with the diagnostic
objective of the examinations.
(ii) The radiation exposure to the patient shall be
the minimum exposure required to produce images of good diagnostic quality.
(iii) Portable or mobile equipment shall be used only
for examinations where it is impractical for medical reasons to transfer the
patient to a stationary radiographic installation.
(J) All persons who are associated with the operation
of an x‑ray system are subject to the occupational exposure limits as
defined in Rules .1604 and .1638 of this Chapter, and personnel monitoring
procedures in Rule .1614 of this Chapter. In addition, when protective
clothing or equipment is worn on portions of the body and a monitoring
device(s) is required, at least one such monitoring device shall be utilized as
follows:
(i) When an apron is worn the monitoring device
shall be worn at the collar outside the apron.
(ii) The dose to the whole body shall be recorded in
the reports required in Rule .1640 of this Chapter. If more than one device is
used, each dose shall be identified with the area where the device was worn on
the body.
(2) The registrant shall maintain at least the
following information for each x‑ray machine:
(A) current registration information and other correspondence
with the agency regarding that machine;
(B) records of surveys and calibrations;
(C) records of maintenance or modifications which affect
the useful beam after the effective date of these Rules, along with the names
of persons who performed the service.
(b) Plans Review. Prior to construction or structural
modification, the floor plans and equipment arrangement of all installations
utilizing x‑rays for diagnostic or therapeutic purposes shall be reviewed
by a qualified expert. The registrant shall submit recommendations of the
expert to the agency.
(c) Radiation Survey
(1) For installations of x‑ray equipment
after the effective date of this Rule, an area radiation survey shall be
performed within 30 days following initial operation of each radiation machine
to show compliance with Rule .0604(b) of this Section. This survey shall
include:
(A) a drawing of the room in which a stationary x‑ray
system is located and radiation levels in adjacent areas; and
(B) the name of the person approved by the agency
performing the survey and the date the survey was performed.
(2) Any modification to the x‑ray room or
adjacent areas which could increase the radiation dosage to any individual
shall require a new survey.
(3) Records of this survey shall be maintained
in accordance with Subparagraph (a)(2) of this Rule.
History Note: Authority G.S. 104E‑7; 104E‑12(a);
Eff. February 1, 1980;
Amended Eff. January 1, 1994; October 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0603 Eff.
February 1, 2015.
10A NCAC 15 .0604 GENERAL REQUIREMENTS FOR ALL
DIAGNOSTIC SYSTEMS
(a) In addition to other requirements of this Section, all
diagnostic x‑ray systems shall meet the following requirements:
(1) The control panel containing the main power
switch shall bear the warning statement, legible and accessible to view:
"WARNING: This x‑ray unit may be dangerous to patient and operator
unless safe exposure factors and operation instructions are observed."
(2) Equivalent wording may be used on battery‑powered
generators; visual means shall be provided on the control panel to indicate
whether the battery is in a state of charge adequate for proper operation.
(3) The leakage radiation from the diagnostic
source assembly measured at a distance of one meter in any direction from the
source shall not exceed 100 millirem in one hour when the x‑ray tube is
operated at its leakage technique factors. Compliance shall be determined by
measurements averaged over an area of 100 square centimeters with no linear
dimension greater than 20 centimeters.
(4) The radiation emitted by a component other
than the diagnostic source assembly shall not exceed two millirem in one hour
at five centimeters from any accessible surface of the component when it is
operated in an assembled x‑ray system under any conditions for which it
was designed. Compliance shall be determined by measurements averaged over an
area of 100 square centimeters with no linear dimension greater than 20
centimeters.
(5) Beam Quality
(A) Half‑Value Layer
(i) The half‑value layer (HVL) of the useful
beam for a given x‑ray tube potential shall not be less than the
appropriate value shown in the following table. "Specified Dental
System" is any dental x‑ray system designed for use with intraoral
image receptors and manufactured after December 1, 1980. "Other X‑Ray
Systems" shall be all other x‑ray systems subject to this Section.
X‑Ray Tube
Voltage (kilovolt peak) Minimum
HVL Minimum HVL
(millimeters (millimeters
of
Aluminum) of Aluminum)
Measured Specified Other
Designed
operating Operating Dental X‑ray
range Potential Systems Systems
Below 50‑‑‑‑‑‑‑‑‑‑‑‑ 30 1.5 0.3
40 1.5 0.4
49 1.5 0.5
50 to 70‑‑‑‑‑‑‑‑‑‑‑‑ 50 1.5 1.2
60 1.5 1.2
70 1.5 1.5
Above 70‑‑‑‑‑‑‑‑‑‑‑‑ 71 2.1 2.1
80 2.3 2.3
90 2.5 2.5
100 2.7 2.7
110 3.0 3.0
120 3.2 3.2
130 3.5 3.5
140 3.8 3.8
150 4.1 4.1
If it is necessary to determine such half‑value layer
at an x‑ray tube potential which is not listed in the table, linear
interpolation or extrapolation may be made. Positive means shall be provided
to insure that at least the minimum filtration needed to achieve the above beam
quality requirements is in the useful beam during each exposure.
(ii) The requirements of Subpart (a)(5)(A)(i) of
this Rule shall be considered to be met if it can be demonstrated that the
aluminum equivalent of the total filtration in the primary beam is not less
than that shown in the following table:
Filtration Required versus Operating
Voltage
Minimum
total filtration
Operating Voltage (kVp)
(inherent plus added)
(millimeters
aluminum
equivalent)
Below 50 0.5
millimeters
50 ‑ 70 1.5
millimeters
Above 70 2.5
millimeters
(iii) Notwithstanding the requirements of Subpart
(a)(5)(A)(ii) of this Rule, all intraoral dental systems manufactured after
December 1, 1980, shall have a minimum of 1.5 mm aluminum equivalent filtration
permanently installed in the useful beam.
(iv) Beryllium window tubes shall have a minimum of
0.5 mm aluminum equivalent filtration permanently mounted in the useful beam.
(v) For capacitor energy storage equipment,
compliance shall be determined with the maximum quantity of charge per
exposure.
(vi) The required minimum aluminum equivalent
filtration shall include the filtration contributed by all materials which are
always present between the focal spot of the tube and the patient, such as a
tabletop when the tube is mounted under the table and inherent filtration of
the tube.
(B) For new x‑ray systems installed after the effective
date of these Rules and which have variable kVp and selectable filtration for
the useful beam, a device shall link the kVp selector with the filter(s), so
that the minimum filtration is always present for the kVp selected.
(6) Where two or more radiographic tubes are
controlled by one exposure switch, the tube or tubes which have been selected
and their location shall be clearly indicated on the master control panel prior
to initiation of the exposure.
(7) The tube housing assembly supports shall be
adjusted such that the tube housing assembly will remain stable during an
exposure unless the tube housing movement is a design function of the x‑ray
system.
(8) The location of the focal spot may be
indicated on a readily visible area of the x‑ray source housing in the
plane parallel to the image receptor when the image receptor is perpendicular
to the beam axis.
(9) Technique Indicators
(A) The technique factors to be used during an exposure
shall be indicated before the exposure begins, except when automatic exposure
controls are used, in which case the technique factors which are set prior to
the exposure shall be indicated.
(B) Indication of technique factors shall be visible
from the operator's position except in the case of spot films made by the fluoroscopist.
(C) On equipment having fixed technique factors, the
recommendation in Part (a)(9)(A) of this Rule may be met by permanent markings.
(b) Structural Shielding
(1) For stationary diagnostic systems, except
for intraoral dental systems which shall meet the requirements of Rule .0607(j)
of this Section, structural shielding shall be provided to assure compliance
with Rules .1604 and .1611 of this Chapter. The following shall be provided:
(A) All wall, floor and ceiling areas exposed to the
useful beam shall have primary barriers. Primary barriers in walls shall
extend to a minimum height of 84 inches above the floor;
(B) Secondary barriers in the wall, floor and ceiling
areas not having a primary barrier or where the primary barrier requirements are
lower than the secondary barrier requirements; and
(C) A window of lead‑equivalent glass equal to
that required by the adjacent barrier or a mirror system shall be provided
large enough and so placed that the operator can see the patient without having
to leave the protected area during exposures.
(2) When a mobile system is used routinely in
one location, the structural shielding in that location shall meet the
requirements for stationary diagnostic systems in Subparagraph (b)(1) of this
Rule.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. January 1, 1994; October 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0604 Eff.
February 1, 2015.
10A NCAC 15 .0605 FLUOROSCOPIC X‑RAY SYSTEMS
All fluoroscopic x‑ray systems shall meet the
following requirements:
(1) Limitation of useful beam
(a) The fluoroscopic tube shall not produce x‑rays
unless the primary protective barrier is in position to intercept the entire
useful beam at all times.
(b) The entire cross section of the useful beam
shall be intercepted by the primary protective barrier of the fluoroscopic
image assembly at any SID.
(c) Limitation to the Imaging Surface
(i) The x‑ray field produced by
fluoroscopic equipment without image intensification shall not extend beyond
the entire visible area of the image receptor. This requirement applies to
field size during both fluoroscopic procedures and spot‑filming
procedures.
(ii) Image‑intensified fluoroscopy and
spot‑filming shall comply with the following:
(A) During fluoroscopic or spot‑filming
procedures, neither the length nor the width of the x‑ray field in the
plane of the image receptor shall exceed the visible area of the image receptor
by more than three percent of the SID. The sum of the excess length and the
excess width shall be no greater than four percent of the SID.
(B) Compliance shall be determined with the beam
axis perpendicular to the image receptor. For rectangular x‑ray fields
used with circular image reception, the error in alignment shall be determined
along the length and width dimensions of the x‑ray field which pass
through the center of the visible area of the image receptor.
(iii) In addition to other requirements of this
Rule, equipment manufactured after the effective date of these Rules shall
comply with the following:
(A) Means shall be provided between the source
and the patient for adjustment of the x‑ray field size in the plane of
the film to the size of that portion of the film which has been selected on the
spot‑film selector. This adjustment shall be automatically accomplished
except when the x‑ray field size in the plane of the film is smaller than
that of the selected portion of the film.
(B) It shall be possible to adjust the x‑ray
field size in the plane of the film to a size smaller than the selected portion
of the film. The minimum field size at the greatest SID, shall be equal to or
less than five centimeters by five centimeters.
(C) The center of the x‑ray field in the
plane of the film shall be aligned with the center of the selected portion of
the film to within two percent of the SID.
(2) X‑ray production in the fluoroscopic mode
shall be controlled by a device which requires continuous pressure by the
fluoroscopist for the entire time of any exposure. When recording serial
fluoroscopic images, the fluoroscopist shall be able to terminate the x‑ray
exposure(s) at any time, but means may be provided to permit completion of any
single exposure of the series in process.
(3) Entrance exposure rates shall be limited as
required in the following:
(a) Fluoroscopic equipment shall not be operated
at any combination of tube potential and current which will result in an
exposure rate in excess of ten roentgens per minute at the point where the
center of the useful beam enters the patient, except:
(i) during recording of fluoroscopic images; or
(ii) when provided with optional high level
control, the equipment shall not be operable at any combination of tube
potential and current which will result in an exposure rate in excess of five
roentgens per minute at the point where the center of the beam enters the
patient unless the high level control is activated. Special means of
activation of high level controls, such as additional pressure applied
continuously by the operator, shall be required to avoid accidental use. A
continuous signal audible to the fluoroscopist shall indicate that the high
level control is being employed.
(b) In addition to the other requirements of
this Rule equipment manufactured after August, 1974, which does not incorporate
an automatic exposure control (e.g., automatic brightness control or ionization
chamber control) shall not be operated at any combination of tube potential and
current which will result in an exposure rate in excess of five roentgens per
minute at the point where the center of the useful beam enters the patient
except during the recording of fluoroscopic images or when provided with an
optional high level control.
(c) Compliance with the provisions of Item (3)
of this Rule shall be determined as follows:
(i) Movable grids and compression devices shall
be removed from the useful beam during the measurement.
(ii) If the source is below the table, the
exposure rate shall be measured one centimeter above the tabletop or cradle.
(iii) If the source is above the table, the
exposure rate shall be measured at 30 centimeters above the tabletop with the
end of the beam‑limiting device or spacer positioned as closely as
possible to the point of measurement.
(iv) In a C‑arm type fluoroscope, the
exposure rate shall be measured 30 centimeters from the input surface of the
fluoroscopic imaging assembly.
(d) Periodic measurement of entrance exposure
rate limits shall comply with the following:
(i) Such measurements shall be made every two
years or after any maintenance of the system which might affect the exposure
rate.
(ii) Results of these measurements shall be
available or posted where any fluoroscopist may have ready access to them and
shall be in the record required in Rule .0603(a)(2)(B) of this Section.
Results of the measurements shall include the exposure rate, as well as the
physical factors used to determine all data; the name of the person approved by
the agency performing the measurements and the date the measurements were
performed.
(iii) Entrance exposure rate shall be determined
with the attenuation block in Rule .0602(a) in the primary beam.
(4) Radiation transmitted through the primary
protective barrier of the fluoroscopic imaging assembly shall comply with the
following requirements:
(a) The exposure rate resulting from
transmission through the primary protective barrier with the attenuation block
in the useful beam, combined with radiation from the image intensifier, if
provided, shall not exceed two milliroentgens per hour at ten centimeters from
any accessible surface of the fluoroscopic imaging assembly beyond the plane of
the image receptor for each roentgen per minute of entrance exposure rate.
(b) Measurements to determine compliance with
Sub-item (4)(a) of this Rule shall be in accordance with the following:
(i) The exposure rate resulting from
transmission through the primary protective barrier combined with radiation
from the image intensifier shall be determined by measurements averaged over an
area of 100 square centimeters with no linear dimension greater than 20
centimeters;
(ii) If the source is below the tabletop, the
measurement shall be made with the input surface of the fluoroscopic imaging
assembly, positioned 30 centimeters above the tabletop.
(iii) If the source is above the tabletop and the
SID is variable, the measurement shall be made with the end of the beam‑limiting
device or spacer as close to the tabletop as it can be placed, provided that it
shall not be closer than 30 centimeters;
(iv) Movable grids and compression devices shall
be removed from the useful beam during the measurement;
(v) The attenuation block shall be positioned in
the useful beam ten centimeters from the point of measurement of entrance
exposure rate and between this point and the input surface of the fluoroscopic
imaging assembly.
(5) During fluoroscopy and cinefluorography, x‑ray
tube potential and current shall be continuously indicated.
(6) The source‑skin distance shall not be less
than:
(a) 38 centimeters on stationary fluoroscopes,
(b) 30 centimeters on all mobile fluoroscopes,
or
(c) 20 centimeters for image intensified
fluoroscopes during surgical application.
(7) Fluoroscopic timers shall meet the following requirements:
(a) Means shall be provided to preset the
cumulative on‑time of the fluoroscopic tube. The maximum cumulative time
of the timing device shall not exceed five minutes without resetting.
(b) A signal audible to the fluoroscopist shall
indicate the completion of any preset cumulative on‑time. Such signal
shall continue to sound while x‑rays are produced until the timing device
is reset.
(8) Mobile fluoroscopes, in addition to the other
requirements of this Rule, shall provide image intensification.
(9) Scattered radiation shall be controlled in
accordance with the following requirements:
(a) A shielding device of at least 0.25 mm lead
equivalent for covering the Bucky slot during fluoroscopy shall be provided.
(b) A shield of at least 0.25 mm lead
equivalent, such as overlapping protective drapes or hinged or sliding panels,
shall be provided to intercept scattered radiation which would otherwise reach
the fluoroscopist and others near the machine.
(c) Upon application to the agency with adequate
justification, exceptions from Sub-items (9)(a) or (9)(b) of this Rule may be
made in some special procedures where a sterile field will not permit the use
of the normal protective barriers or where the protective barriers would
interfere with the procedures.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. May 1, 1993; May 1, 1992; October 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0605 Eff.
February 1, 2015.
10A NCAC 15 .0606 SYSTEMS OTHER THAN FLUOROSCOPIC AND
DENTAL INTRAORAL
(a) Unless specifically provided otherwise by the rules in
this Chapter, the requirements in this Rule shall apply to all x‑ray
systems, except for fluoroscopic and dental intraoral x‑ray systems. The
useful beam of x‑ray systems subject to provisions of this Rule shall be
limited to the area of clinical interest or the image receptor, whichever is
smaller.
(1) General purpose stationary and mobile x‑ray
systems shall meet the following special requirements:
(A) There shall be provided a means for stepless
adjustment of the size of the x‑ray field. The minimum field size at a
SID of 100 centimeters shall be equal to or less than five centimeters by five
centimeters.
(B) Means shall be provided for visually defining the
perimeter of the x‑ray field. The total misalignment of the edges of the
visually defined field with the respective edges of the x‑ray field along
either the length or width of the visually defined field shall not exceed two
percent of the distance from the source to the center of the visually defined
field when the surface upon which it appears is perpendicular to the axis of
the x‑ray beam.
(C) Notwithstanding Parts (a)(1)(A) and (B) of this
Rule, equipment manufactured before August 1, 1974 may employ fixed cones and
diaphragms or variable collimators without beam defining lights.
(2) In addition to the requirements of
Subparagraph (a)(1) of this Rule, all stationary x‑ray systems, except
equipment originally manufactured before the effective date of this Rule, shall
meet the following requirements:
(A) Means shall be provided to indicate when the axis of
the x‑ray beam is perpendicular to the plane of the image receptor, to
align the center of the x‑ray field with respect to the center of the
image receptor to within two percent of the SID, and to indicate the SID to
within two percent;
(B) The beam limiting device shall numerically indicate
the field size in the plane of the image receptor to which it is adjusted;
(C) Indication of field size dimensions and SID's shall
be specified in inches or centimeters and shall be such that aperture
adjustments result in x‑ray field dimensions in the plane of the image
receptor which correspond to those of the image receptor to within two percent
of the SID when the beam axis is perpendicular to the plane of the image
receptor.
(3) Radiographic equipment designed for only
one image receptor size at a fixed SID shall be provided with means to limit
the field at the plane of the image receptor to dimensions no greater than
those of the image receptor and to align the center of the x‑ray field
with the center of the image receptor to within two percent of the SID.
(4) Special purpose x‑ray systems shall
meet the following requirements:
(A) These systems shall be provided with means to limit
the x‑ray field in the plane of the image receptor so that such field
does not exceed each dimension of the image receptor by more than two percent
of the SID when the axis of the x‑ray beam is perpendicular to the plane
of the image receptor.
(B) Such systems shall also be provided with means to
align the center of the x‑ray field with the center of the image receptor
to within two percent of the SID.
(C) The requirements in Parts (a)(4)(A) and (B) of this
Rule may be met with a system that meets the requirements for a general purpose
x‑ray system as specified in Subparagraph (a)(1) of this Rule or, when
alignment means are also provided, as follows:
(i) an assortment of removable, fixed‑aperture,
beam‑limiting devices sufficient to meet the requirement for each
combination of image receptor size and SID for which the unit is designed,
where each device has clear and permanent markings to indicate the image
receptor size and SID for which it is designed; or
(ii) a beam‑limiting device having multiple
fixed apertures sufficient to meet the requirement for each combination of
image receptor size and SID for which the unit is designed, where the device
has permanent, clearly legible, markings indicating image receptor size and SID
for which the unit is designed, where the device has permanent, clearly
legible, markings indicating image receptor size and SID for which each
aperture is designated and indicating which aperture is in position for use.
(b) Radiation exposure control devices shall meet the
following requirements:
(1) Means shall be provided to terminate the
exposure after a preset time interval, preset product of current and time, a
preset number of pulses or a preset radiation exposure to the image receptor.
In addition:
(A) Termination of exposure shall cause automatic
resetting of the timer to its initial setting or to zero except during serial
radiography, and
(B) It shall not be possible to make an exposure when
the timer is set to a zero or "off" position if either position is
provided.
(2) Control over x‑ray exposures shall be
in accordance with the following requirements:
(A) A control shall be incorporated into each x‑ray
system such that the operator can terminate an exposure at any time except for
serial radiography where means may be provided to permit completion of any
single exposure of the series in process.
(B) Each x‑ray control shall be located in such a
way as to meet the following criteria.
(i) For stationary x‑ray systems, the control
shall be permanently mounted in a protected area so that the operator is
required to remain in that protected area during the entire exposure; and
(ii) The x‑ray control shall provide visual
indication observable at or from the operator's protected position whenever x‑rays
are produced. In addition, except for equipment originally manufactured before
the effective date of this Rule, a signal audible to the operator shall
indicate that the exposure has terminated.
(3) When an automatic exposure control (e.g.,
phototimer) is provided the following requirements shall be met, except
equipment originally manufactured before the effective date of this Rule:
(A) Indication shall be made on the control panel when
this mode of operation is selected;
(B) When the x‑ray tube potential is equal to or
greater than 50 kVp, the minimum exposure time for field emission equipment
rated for pulsed operation shall be equal to or less than a time interval
equivalent to two pulses;
(C) The minimum exposure time for all equipment other
than that specified in Part (b)(3)(B) of this Rule shall be equal to or less
than 1/60 second or a time interval required to deliver five mAs, whichever is
greater;
(D) Either the product of peak x‑ray tube
potential, current and exposure time shall be limited to not more than 60 kWs
per exposure or the product of x‑ray tube current and exposure time shall
be limited to not more than 600 mAs per exposure except when the x‑ray
tube potential is less than 50 kVp, in which case the product of x‑ray
tube current and exposure time shall be limited to not more than 2000 mAs per
exposure; and
(E) A visible signal shall indicate when an exposure
has been terminated at the limits described in Part (b)(3)(D) of this Rule and
manual resetting shall be required before further automatically timed exposures
can be made.
(4) When four timer tests are performed at
identical timer setting equal to 5.0 seconds or less, the average time period
(T) shall be greater than five times the difference between the maximum period
(Tmax) and the minimum period (Tmin) in accordance with the formula:
T > 5(Tmax‑Tmin)
(c) Source‑skin or source‑image receptor
distance shall meet the following requirement:
All radiographic systems shall be provided with a durable,
securely fastened means to limit the source‑skin distance to at least 30
centimeters. This is considered to be met when the collimator or cone provides
the required limits.
(d) The exposure produced shall be reproducible to within
the following criteria:
When all technique factors are held constant, the
coefficient of variation shall not exceed 0.10. This shall be deemed to be met
if, when four exposures at identical technique factors are made, the value of
the average exposure (E)is greater than five times the difference between the
maximum exposure (Emax) and the minimum exposure (Emin) in accordance with the
formula:
E > 5(Emax‑Emin)
(e) Standby radiation from capacitor energy storage
equipment, when the exposure switch or timer is not activated, shall not exceed
a rate of two milliroentgens per hour at five centimeters from any accessible
surface of the diagnostic source assembly with the beam‑limiting device
fully open.
(f) Linearity
(1) When the equipment allows a choice of x‑ray
tube current settings, the average ratios of exposure to the indicated
milliampere‑seconds product, i.e., mR/mAs, obtained at any two
consecutive tube current settings shall not differ by more than 0.10 times
their sum, i.e., /mean of x1‑ x2/ < minus 0.10 mean of (x1+ x2), where
the mean of x1 and x2 are the average mR/mAs values obtained at each of two
consecutive tube current settings.
(2) Compliance shall be determined at the most
commonly used mA stations by measuring mR/mAs at those stations and at one
adjacent station to each.
(g) Timer accuracy
(1) For indicated values of 0.10 seconds and
above, the measured value shall be within plus or minus 15 percent of the
indicated values for equipment manufactured before August 1, 1974.
(2) For equipment manufactured after August 1,
1974, the deviation of measured values from indicated values shall not exceed
the limits specified for that system by its manufacturer.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. May 1, 1993; November 1, 1989; October 1,
1980;
Transferred and Recodified from 15A NCAC 11 .0606 Eff.
February 1, 2015.
10A NCAC 15 .0607 INTRAORAL DENTAL RADIOGRAPHIC SYSTEMS
(a) In addition to the provisions of Rules .0603 and .0605
of this Section, the requirements of this Rule apply to x‑ray equipment
and associated facilities used for dental radiography. Criteria for extraoral
dental radiographic systems are covered in Rule .0606 of this Section.
(b) X‑ray systems designed for use with an intraoral
image receptor shall be provided with means to limit source‑skin distance
to not less than:
(1) 18 centimeters, if operated above 50
kilovolts peak; or
(2) ten centimeters, if operated at or below 50
kilovolts peak.
(c) The size of the direct radiation beam shall be limited
in accordance with the following rules:
(1) Radiographic systems designed for use with
an intraoral image receptor shall be provided with means to limit the x‑ray
beam such that:
(A) If the source‑skin distance (SSD) is 18
centimeters or more, the x‑ray field at the SSD shall be containable in a
circle having a diameter of no more than seven centimeters; and
(B) If the SSD is less than 18 centimeters, the x‑ray
field at the SSD shall be containable in a circle having a diameter of no more
than six centimeters.
(2) Effective February 1, 1981, equipment
manufactured prior to August 1974 shall be equipped with a lead line open
position indicating device with at least 0.79 mm lead.
(d) The timing device shall comply with the following
requirements:
(1) Termination of the exposure after a preset
interval;
(2) Termination of exposure shall cause
automatic resetting of the timer to its initial setting or to zero;
(3) It shall not be possible to make an
exposure when the timer is set to a zero or "off" position if either
position is provided; and
(4) When four timer tests are performed at
identical timer settings equal to five seconds or less, the average time period
(T) shall be greater than five times the difference between the maximum period
(Tmax) and the minimum period (Tmin) in accordance with the formula:
T > 5(Tmax‑
Tmin)
(5) Effective February 1, 1983, intraoral
dental radiographic systems shall be equipped with an electronic timer.
(6) Timer accuracy
(A) For indicated values of 0.10 seconds and above, the
measured value shall be within plus or minus 15 percent of the indicated values
for equipment manufactured before August 1, 1974.
(B) For equipment manufactured after August 1, 1974, the
deviation of measured values from indicated values shall not exceed the limits
specified for that system by its manufacturer.
(e) The exposure switch shall comply with the following
requirements:
(1) A control shall be incorporated into each x‑ray
system such that an exposure can be terminated at any time, except for
exposures of one‑half second or less.
(2) Each x‑ray control shall be located
in such a way as to meet the following criteria:
(A) For stationary x‑ray systems installed after
the effective date of this Rule, the exposure switch shall be permanently
mounted in a protected area (e.g., corridor outside the room) so that the
operator is required to remain in that protected area during the entire
exposure.
(B) For stationary x‑ray systems without a
protected area and installed before the effective date of this Rule, the
exposure switch shall be such that the operator shall stand at least six feet
away from the tube and out of the direct beam.
(C) For mobile and portable x‑ray systems the
switch shall meet the requirements of Part (e)(2)(B) of this Rule.
(3) For equipment manufactured after August 1,
1974, the x‑ray control shall provide visual indication observable at or
from the operator's protected position whenever x‑rays are produced. In
addition, a signal audible to the operator shall indicate that the exposure has
terminated.
(f) The exposure produced shall be reproducible to within
the following criteria:
When all technique factors are held constant, the
coefficient of variation shall not exceed 0.10. This shall be deemed to be met
if, when four exposures at identical technique factors are made, the value of
the average exposure (E) is greater than five times the difference between the
maximum exposure (Emax) and the minimum exposure (Emin) in accordance with the
formula:
E > 5(Emax‑
Emin)
(g) Patient and film holding devices shall be used when the
techniques permit.
(h) Neither the tube housing nor the position indicating
device shall be hand‑held during an exposure.
(i) Dental fluoroscopy without image intensification shall
not be used.
(j) Structural shielding
(1) All wall, floor and ceiling areas shall
have protective barriers sufficient to meet the requirements of Rules .1604 and
.1611 of this Chapter.
(2) When intraoral x‑ray systems are
installed in adjacent rooms or areas, protective barriers as specified in
Subparagraph (j)(1) of this Rule shall be provided between the rooms or areas.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. January 1, 1994; October 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0607 Eff.
February 1, 2015.
10A NCAC 15 .0608 THERAPEUTIC X‑RAY INSTALLATIONS:
LESS THAN ONE MEV
(a) Unless specifically provided otherwise by the rules in
this Chapter, the requirements in this Rule shall apply only to therapeutic x‑ray
installations which are not capable of operating at or above one MeV.
Therapeutic x‑ray equipment subject to the provisions of this Rule shall
comply with the following requirements:
(1) When the tube is operated at its leakage
technique factors, the leakage radiation in any direction shall not exceed the
value specified at the distance specified for the classification of that x‑ray
system.
(A) For contact therapy systems, the leakage radiation
shall not exceed 100 mR/hr at five centimeters from the tube housing.
(B) Systems operating from zero to 150 kVp which are
manufactured or installed prior to the effective date of this Rule shall have a
leakage radiation which does not exceed one R in one hour at one meter from the
source.
(C) Systems operating from zero to 150 kVp which are
manufactured on or after the effective date of this Rule shall have a leakage
radiation which does not exceed 100 mR in one hour at one meter from the
source.
(D) Systems operating from 151 to 999 kVp shall have
leakage radiation which does not exceed one R in one hour at one meter from the
source, except systems which operate in excess of 500 kVp may have a leakage
radiation in one hour at one meter from the source equivalent to 0.1 percent of
the exposure in the useful beam in one hour at a distance of one meter from the
source.
(2) Permanent beam limiting devices used for
collimating the useful beam shall provide the same or higher degree of
protection as that required by the tube housing assembly.
(3) Adjustable or removable beam limiting
devices shall transmit not more than five percent of the useful beam as
determined at the maximum tube potential and maximum treatment filter.
(4) The filter system shall be so designed
that:
(A) Filters cannot be accidentally displaced from the
useful beam at any tube orientation;
(B) Each filter is marked as to its material of
construction and its thickness or wedge angle for wedges;
(C) It shall be possible for the operator to determine
the presence of and identify each filter and the orientation of each wedge
filter in the useful beam when the operator is positioned at the control panel
either by display at the control panel or by direct observation;
(D) The filters and filter insertion slot opening shall
be so designed that the radiation at five centimeters from the filter insertion
slot opening does not exceed 30 roentgens per hour under all operating
conditions; and
(E) Each machine equipped with a beryllium or other low
filtration window shall be clearly labeled as such upon the tube head housing
and upon the control panel.
(5) The tube housing assembly shall be
immobilized during stationary treatments.
(6) The tube housing assembly shall be so
marked that it is possible to determine the location of the focal spot to
within five millimeters and such marking shall be readily accessible.
(7) Equipment of greater than 150 kVp installed
after the effective date of this Rule shall be provided with a beam monitor
system.
(8) The exposure timer shall meet the following
requirements:
(A) A timer shall be provided which has a display at the
treatment control panel. The timer shall have a preset time selector and shall
terminate irradiation when a preselected time has elapsed.
(B) The timer shall switch on and off with the radiation
and retain its reading after irradiation is interrupted or terminated.
(9) The control panel shall have:
(A) an indication of whether electrical power is present
and activation of the x‑ray tube is possible;
(B) an indication of whether x‑rays are being
produced;
(C) the means for indicating kVp and x‑ray tube current;
(D) the means for terminating an exposure at any time;
(E) a locking device which will prevent unauthorized
use of the x‑ray system and, for systems not having a lock at the control
panel, an alternate method of preventing unauthorized use, shall be provided;
(F) for equipment manufactured after the effective date
of this Rule, a positive display of specific filter(s) in the beam.
(10) When a control panel may energize more than
one x‑ray tube:
(A) It shall be possible to activate only one x‑ray
tube during any one time interval;
(B) There shall be an indication at the control panel
identifying which x‑ray tube can be energized; and
(C) There shall be an indication at the x‑ray tube
if that tubehead can be energized.
(11) There shall be means of determining the
target to patient distance to within one centimeter.
(12) If exposures are controlled by a timer, that
timer:
(A) shall permit the setting of exposure times at least
as short as one second, and
(B) shall not permit an exposure if set at zero or "off".
(13) Unless it is possible to bring the x‑ray
exposure rate to its prescribed value within five seconds of actuating the x‑ray
"on" control, the tube housing shall be fitted with a shutter
operable only from the control panel, and of lead equivalent not less than that
of the tube housing. In addition:
(A) The status of the shutter "Beam On",
"Beam Off" or "Shutter Open", "Shutter Closed" or
equivalent description, shall be indicated at the control panel.
(B) It shall not be possible to initiate an exposure
sequence unless the shutter has first been placed in the "Beam Off"
or "Shutter Closed" position.
(C) The shutter shall automatically go to the "Beam
Off" or "Shutter Closed" position if the exposure is terminated
by:
(i) the operation of the timer,
(ii) the dose monitoring system, if provided,
(iii) the operation of a safety interlock, or
(iv) a power failure.
(b) In addition to shielding adequate to meet requirements
of Section .1600 of this Chapter, the following treatment room design
requirements shall be met:
(1) Treatment room entrances shall be provided
with warning lights in a readily observable position, which will indicate when
the useful beam is "on".
(2) Provision shall be made for two‑way
communication with the patient from the control room.
(3) A system shall be provided to permit
continuous observation of the patient during irradiation and shall be so
located that the operator may see the patient and the control panel from the
same position.
(4) Facilities which contain an x‑ray
system which may be operated above 150 kVp shall:
(A) have all necessary shielding, except for any beam
interceptor, provided by fixed barriers;
(B) have the control panel in a protected area which is
outside the treatment room;
(C) have all entrance doors to the treatment room
electrically connected such that the x‑ray production cannot be initiated
unless all doors are closed and shall cease if any door is opened during x‑ray
production;
(D) if the radiation output of the x‑ray tube is
affected by any door opening, be so designed that it is possible to initiate x‑ray
production only by:
(i) closing all doors and, subsequently,
(ii) reinitiating the exposure by manual action at
the control panel.
(c) Operating procedures, surveys, and calibration shall
comply with the following requirements:
(1) All new facilities and existing facilities
not previously surveyed shall have a radiation protection survey made by, or
under the direction of, a qualified expert. This shall also be done after any
change in the facility which might produce a radiation hazard. The expert
shall report his findings in writing to the person in charge of the facility,
and a copy of this report shall be transmitted by the registrant to the agency
at the address in Rule .0111 of this Chapter.
(2) The radiation output of each therapeutic x‑ray
machine shall be calibrated by, or under the direction of a qualified expert
who is physically present at the facility during the calibration procedure.
The calibration shall be repeated after any change, in or replacement of,
components of the x‑ray generating equipment which could cause a change
in x‑ray output. Calibration of the therapy beam shall be performed with
a measurement instrument, the calibration of which is traceable to national
standards for exposure or absorbed dose, and which shall have been calibrated
within the preceding 12 months. Records of radiation outputs shall be provided
to and maintained by the registrant.
(3) Each therapeutic x‑ray machine shall
be calibrated as described in Subparagraph (c)(2) of this Rule at time
intervals not exceeding one year. The calibration shall include at least the
following determinations:
(A) the accurate determination of the air exposure rate
or the dose rate at a reference point within a suitable phantom, as
appropriate;
(B) the congruence between the radiation field and light
localizer, when such is used;
(C) the half‑value layer for every combination of
kVp and filter used for radiation therapy.
(4) Therapeutic x‑ray systems capable of
operation at greater than 150 kVp, in addition to the annual calibration
required in Subparagraphs (c)(2) and (3) of this Rule, shall have spot checks
performed.
(A) The spot check methods and frequency shall be
designed and in writing by a qualified expert. Spot checks shall include
verification of continued congruency between the radiation field and the
localizing device where an optical field illuminator is used.
(B) Whenever a spot check indicates a significant change
in the operating characteristics of a machine, as specified in the qualified
expert's spot check design, the machine shall be recalibrated as required.
(C) A log shall be kept of all spot check measurements.
(5) Therapeutic x‑ray machines shall not
be left unattended unless the locking device required by Part (a)(10)(E) of
this Rule is set to prevent activation of the useful beam.
(6) Except as provided in Rule .0603(a)(1)(H)
of this Section, no individual other than the patient shall be in the treatment
room during exposures unless he is protected by a barrier sufficient to meet
the requirements of Rule .1604 of this Chapter, and no individual other than
the patient shall be in the treatment room when the kVp exceeds 150 during
exposures.
(7) The tube housing assembly shall not be held
by hand during operation unless the system is designed to require such holding
and the peak tube potential of the system does not exceed 50 kVp. In such
cases the holder shall wear protective gloves and apron of not less than 0.5 mm
lead equivalency at 100 kVp.
History Note: Authority G.S. 104E‑7; 104E‑12(a);
Eff. February 1, 1980;
Amended Eff. January 1, 1994; May 1, 1992; November 1,
1989;
Transferred and Recodified from 15A NCAC 11 .0608 Eff.
February 1, 2015.
10A NCAC 15 .0609 X‑RAY AND ELECTRON THERAPY
INSTALLATIONS ONE MEV AND ABOVE
(a) The requirements in Paragraphs (b) to (e) of this Rule
shall apply only to medical facilities using medical x‑ray and electron
therapy equipment with energies one MeV and above. In addition, such medical
facilities shall also comply with the requirements in Section .0900 of this
Chapter.
(b) Equipment requirements are as follows:
(1) For existing equipment and new equipment
manufactured or installed after the effective date of these Rules:
(A) The leakage radiation, excluding neutrons, at a
distance of one meter from the source shall not exceed 0.1 percent of the
useful beam dose rate at one meter from the source for any of its operating
conditions.
(B) Within one year after the effective date of these
Rules the registrant shall determine or obtain from the manufacturer for each
machine the leakage radiation specifications for electrons, x‑rays and
neutrons existing at the points specified in Part (b)(1)(A) of this Rule for
specified operating conditions. Records on radiation leakage shall be
maintained at the installation.
(C) For equipment from which neutron leakage may be a
hazard, a qualified expert shall specify such additional requirements as may be
necessary to protect health or minimize danger to life or property. The
adequacy of these additional requirements shall be confirmed by a survey.
Survey records shall be maintained by the registrant.
(2) Adjustable or interchangeable beam limiting
devices shall be provided and shall meet the following requirements:
(A) For existing equipment and new equipment
manufactured or installed after the effective date of these Rules:
(i) Adjustable or interchangeable beam limiting
devices shall attenuate the radiation incident on the beam limiting devices
such that the dose equivalent in rems at any distance from the source does not
exceed two percent of the maximum dose equivalent in the useful beam measured
at an equal distance from the radiation source.
(ii) If the beam limiting device does not meet the
specifications in Subpart (b)(2)(A)(i) of this Rule, the agency may accept
auxiliary equipment or methods for accomplishing attenuation.
(B) Dose equivalent measurements may be averaged over an
area up to but not exceeding 100 square centimeters at a distance of one meter
from the target.
(3) In equipment which uses a system of wedge
filters, interchangeable field flattening filters or beam scattering devices:
(A) Irradiation shall not be possible until a selection
of filter has been made at the treatment control panel;
(B) An interlock system shall be provided to prevent
irradiation if the filter is not in the correct position;
(C) An indication of the orientation of the wedge filter
with respect to the treatment field shall be provided when wedge filters are
used; and
(D) A display shall be provided at the treatment control
panel showing the filter(s) in use, including an indication of "no
filters".
(4) Equipment installed after the effective
date of these Rules shall be provided with at least one radiation detector in
the radiation head. This detector shall be incorporated into a primary
system.
(A) Each primary system shall have a detector which is a
transmission detector and is a full beam detector and is placed on the patient side
of any fixed added filters other than a wedge filter;
(B) The detector(s) shall be removable only with tools
or shall be interlocked to prevent incorrect positioning.
(C) Each detector shall be capable of independently
monitoring and turning "off" the useful beam.
(D) Each detector shall form part of a dose monitoring
system from whose readings in dose monitor units the absorbed dose at a
reference point in the treatment volume can be calculated.
(E) Each dose monitoring system shall have a legible
display at the treatment control panel which shall:
(i) maintain a reading until intentionally reset;
(ii) in the event of power failure, have the
capability of retrieving the information displayed at the time of failure.
(5) Selection and display of dose monitor units
shall comply with the following requirements:
(A) Irradiation shall not be possible until a selection
of a number of dose monitor units has been made at the treatment control panel.
(B) After useful beam termination, it shall be necessary
to reset the preselected dose monitor units before treatment can be
reinitiated.
(C) The preselected number of dose monitor units shall
be displayed at the treatment control panel until reset for the next
irradiation.
(6) Automatic termination of irradiation by the
dose monitoring system shall comply with the following requirements:
(A) Each of the monitoring systems shall be capable of
independently terminating irradiation. Provisions shall be made to test the
correct operation of each system.
(B) Each primary system shall terminate irradiation when
the preselected number of dose monitor units have been reached, and each
secondary system shall be used as a backup.
(7) It shall be possible to terminate
irradiation and equipment movements or to go from an interruption condition to
termination conditions at any time from the treatment control panel.
(8) 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 pre‑selected value during an interruption the
equipment shall go to termination condition.
(9) A timer shall be provided and shall meet the
following requirements:
(A) The timer shall have a display at the treatment
control panel. The timer shall have a preset time selector and an elapsed time
indicator.
(B) The timer shall be a cumulative timer which switches
"on" and "off" with the radiation and retains its reading
after irradiation is interrupted or terminated. It shall be necessary to zero
the elapsed time indicator and the preset time selector after irradiation is
terminated, before reactivation is possible.
(C) To guard against failure of the dose monitoring
systems, the timer shall terminate irradiation when a preselected time has
elapsed.
(10) In equipment capable of both x‑ray
therapy and electron therapy:
(A) Irradiation shall not be possible until a selection
of radiation type, x‑rays or electrons, has been made at the treatment
control panel;
(B) An interlock system shall 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;
(C) An interlock system shall be provided to prevent
irradiation with x‑rays when electron applicators are fitted and
irradiation with electrons when x‑ray wedge filters are fitted; and
(D) The radiation type selected shall be displayed at
the treatment control panel before and during irradiation.
(11) In equipment capable of generating radiation
beams of different energies:
(A) Irradiation shall not be possible until a selection
of energy has been made at the treatment control panel;
(B) An interlock system shall be provided to insure that
the equipment emits primarily the energy of radiation which has been selected;
(C) An interlock system shall 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;
and
(D) The energy selected shall be displayed at the
treatment control panel before and during irradiation.
(12) In equipment capable of both stationary‑beam
therapy and moving‑beam therapy:
(A) Irradiation shall not be possible until a selection
of stationary‑beam therapy or moving‑beam therapy has been made at
the treatment control panel;
(B) An interlock system shall 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;
(C) An interlock system shall be provided to terminate
irradiation if the movement stops during moving‑beam therapy;
(D) Moving‑beam therapy shall be so controlled
that the required dose monitor units per degree of rotation is obtained; and
(E) The mode of operation shall be displayed at the
treatment control panel.
(13) The registrant shall determine or obtain
from the manufacturer the location with reference to an accessible point on the
radiation head of:
(A) the x‑ray target and the virtual source of x‑rays;
(B) the electron window or the scattering foil; and
(C) all possible orientations of the useful beam.
(14) Means shall be provided so that all
radiation safety interlocks can be checked. When preselection of any of the
operating conditions requires action in the treatment room and at the treatment
control panel selection at one location shall not give a display at the other
location until the requisite selection operations in both locations have been
completed.
(c) Facility shielding shall be adequate to meet the
requirements of Section .1600 of this Chapter.
(d) Facility design shall meet the following requirements:
(1) Except for entrance doors, all required
barriers shall be fixed barriers.
(2) The control panel shall be located outside
the treatment room. The door must be closed during radiation production.
(3) A viewing system shall be provided to
permit continuous observation of the patient during irradiation and shall be so
located that the operator may see the patient and the control panel from the
same position. When the viewing system is by electronic means (e.g.,
television), an alternate viewing system shall be available.
(4) Provision shall be made for two‑way
aural communication with the patient from the control room, however, where
excessive noise levels make aural communication impractical, other methods of
communication shall be used.
(5) Treatment rooms to which access is possible
through more than one entrance shall be provided with warning lights, in a
readily observable position near the outside of all access doors, preferably at
eye level, which will indicate when the useful beam is "on".
(6) Have all entrance doors to the treatment
room electrically connected such that the x‑ray production cannot be
initiated unless all doors are closed and shall cease if any door is opened
during x‑ray production.
(e) The operating procedures which follow are in addition
to those in Rule .0908 of this Chapter.
(1) Radiation protection surveys shall comply
with the following requirements:
(A) All new facilities and existing facilities not
previously surveyed shall have a radiation protection survey made by, or under
the direction of, a qualified expert. This shall also be done after any change
in the facility or equipment which might cause a significant increase in
radiation hazard.
(B) The expert shall report his findings in writing to
the person in charge of the facility, and a copy of the report shall be
transmitted by the registrant to the agency at the address in Rule .0111 of
this Chapter.
(2) No person other than the patient shall be
in the treatment room during treatment. When a patient must be held in position
for radiation therapy, mechanical supporting or restraining devices shall be
used.
(3) The output of each therapeutic x‑ray
machine shall be calibrated by, or under the direct supervision of a qualified
expert, before it is first used for medical purposes. Calibrations shall be
repeated at least once every 12 months and after any change which might
significantly increase radiation hazards. Calibration of the therapy beam
shall be performed with measurement instruments, the calibration of which is
traceable to national standards for exposure or absorbed dose and which shall
have been calibrated within the preceding 12 months. Records of calibrations
shall be provided to and maintained by the registrant. The calibration shall
include at least the following determinations:
(A) the exposure rate or dose rate as appropriate for
the field sizes used and for each effective energy and for each treatment
distance used for radiation therapy;
(B) the beam quality (e.g., half‑value layer when
appropriate) for every proposed combination of operating conditions used for
radiation therapy;
(C) the congruence between the radiation field and the
field indicated by the localized device when used;
(D) verification that the equipment is operating in
compliance with the design specifications concerning the light localizer, the
side light and backpointer alignment with the isocenter, when applicable,
variation in the axis of rotation for the table, gantry and jaw system and beam
flatness and symmetry in air or at the specified depths in a water phantom.
(4) Spot checks shall be performed monthly.
(A) The spot check methods shall be in writing and shall
be designed by a qualified expert.
(B) Whenever a spot check indicates a significant change
(as specified in the qualified expert's spot check design) in the operating
characteristics of a machine, the machine shall be recalibrated as required in
Subparagraph (e)(3) of this Rule.
(C) A log shall be kept of all spot check measurements.
History Note: Authority G.S. 104E‑7; 104E‑12(a);
Eff. February 1, 1980;
Amended Eff. January 1, 1994; November 1, 1989;
Transferred and Recodified from 15A NCAC 11 .0609 Eff.
February 1, 2015.
10A NCAC 15 .0610 VETERINARY MEDICINE RADIOGRAPHIC
INSTALLATIONS
(a) The provisions of this Rule shall apply only to
veterinary medicine radiographic installations. Radiographic equipment used in
veterinary medicine radiographic installations shall meet the following
requirements:
(1) The protective tube housing shall be of the
diagnostic type.
(2) Diaphragms or cones shall be provided for
collimating the useful beam to the area of the image receptor and shall provide
the same degree of protection as is required in the housing.
(3) The total filtration permanently in the
useful beam shall not be less than 0.5 millimeters aluminum equivalent for
machines operating up to 50 kVp, 1.5 millimeters aluminum equivalent for
machines operating between 50‑70 kVp, and 2.5 millimeters aluminum
equivalent for machines operating above 70 kVp.
(4) A device shall be provided to terminate the
exposure after a preset time or exposure.
(5) A dead‑man type of exposure switch
shall be provided, together with an electrical cord of sufficient length, so
that the operator can stand out of the useful beam and at least six feet from
the animal during all x‑ray exposures or behind a protective barrier
adequate to assure compliance with Rules .1604 and .1611 of this Chapter.
(b) All wall, ceiling and floor areas shall be equivalent
to or provided with primary and secondary protective barriers necessary to
comply with Rules .1604 and .1611 of this Chapter.
(c) Operating procedures shall meet the following
requirements:
(1) The operator shall stand well away from the
useful beam and the animal during radiographic exposures.
(2) No individual other than the operator shall
be in the x‑ray room while exposures are being made unless such
individual's assistance is required.
(3) When an animal must be held in position
during radiography, mechanical supporting or restraining devices shall be used;
except if the animal must be held by an individual, that individual shall be
protected with appropriate shielding devices, such as protective gloves and
apron, and shall be so positioned that no part of the individual's body will be
struck by the useful beam. The exposure of any professional staff or ancillary
personnel used for this purpose shall be monitored and permanently recorded.
Exposures shall comply with Rules .1604 and .1609 of this Chapter.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. January 1, 1994; November 1, 1989;
Transferred and Recodified from 15A NCAC 11 .0610 Eff.
February 1, 2015.
SECTION .0700 ‑ USE OF SEALED RADIOACTIVE SOURCES IN THE
HEALING ARTS
Codifier's Note: 10 NCAC 03G .2800 was transferred to 15A
NCAC 11 .0700 effective January 4, 1990. Recodification pursuant to G.S.
143B-279.3.
10A NCAC 15 .0701 SCOPE
The provisions of this Section apply to all licensees who
use sealed sources in the healing arts and are in addition to, and not in
substitution for, other applicable provisions of the rules of this Chapter.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0701 Eff.
February 1, 2015.
10A NCAC 15 .0702 manual brachytherapy
(a) Accountability, storage and transit
(1) Each licensee shall provide accountability
of sealed sources and shall keep a record of the issue and return of all sealed
sources. A physical inventory shall be made at least quarterly and a written
record of the inventory maintained.
(2) When not in use, sealed sources and
applicators containing sealed sources shall be kept in a protective enclosure
of such material and wall thickness as necessary to assure compliance with the
provisions of Rules .1604, .1609 and .1611 of this Chapter.
(b) Testing sealed sources for leakage and contamination
(1) All sealed sources with a half‑life
greater than 30 days and in any form other than gas shall be tested for leakage
and contamination prior to initial use and at intervals not to exceed six
months or at other intervals approved by the U.S. Nuclear Regulatory Commission
or an Agreement State in the Sealed Source and Device Registry. If there is
reason to suspect that a sealed source might have been damaged, or might be
leaking, it shall be tested for leakage before further use.
(2) Leak tests shall be capable of detecting
the presence of 0.005 microcurie of radioactive material on the test sample, or
in the case of radium, the escape of radon at rate of 0.001 microcurie per 24
hours. Any test conducted pursuant to Subparagraph (b)(1) of this Rule which
reveals the presence of 0.005 microcurie or more of removable contamination or,
in the case of radium, the escape of radon at the rate of 0.001 microcurie or
more per 24 hours shall be considered evidence that the sealed source is
leaking. The licensee shall immediately withdraw the source from use and shall
cause it to be decontaminated and repaired or to be disposed of in accordance
with applicable provisions of Section .1600 of this Chapter. A report
describing the sealed sources involved, the test results and the corrective
action taken shall be submitted in writing to the agency at the address stated
in Rule .0111 of this Chapter within five days after the test.
(3) Leak test results shall be recorded in
units of microcuries and maintained for inspection by the agency.
(c) Radiation surveys
(1) Immediately after implanting sources in an
individual the licensee shall make a radiation survey of the individual and the
area of use to confirm that no source has been misplaced. The licensee shall
make a record of each survey.
(2) Immediately after removing the last
temporary implant source from an individual, the licensee shall make a
radiation survey of the individual with a radiation detection survey instrument
to confirm that all sources have been removed. The licensee may not release
from confinement for medical care an individual treated by temporary implant
until all sources have been removed.
(d) A licensee shall maintain accountability for all
brachytherapy sources in storage or in use. After removing sources from an
individual, a licensee shall return brachytherapy sources to the storage area.
A licensee shall ensure that all sources taken from the storage area have been
returned, and shall make a record of the source accountability and retain the
record for three years.
(e) For temporary implants, the record shall include:
(1) the number and activity of sources removed
from storage;
(2) the date and time the sources were removed
from storage;
(3) the name of the individual who removed the
sources from storage;
(4) the location of use;
(5) the number and activity of sources returned
to storage;
(6) the date and time the sources were returned
to storage; and
(7) the name of the individual who returned the
sources to storage.
(f) For permanent implants, the record shall include:
(1) the number and activity of sources removed
from storage;
(2) the date and time the sources were removed
from storage;
(3) The name of the individual who removed the
sources from storage;
(4) the number and activity of sources not
implanted;
(5) the date the sources were returned to
storage; and
(6) the name of the individual who returned the
sources to storage.
(g) For each patient or human research subject who is
receiving brachytherapy and cannot be released under Rule .0358 of this
Section, a licensee shall:
(1) Not quarter the patient or human research
subject in the same room as an individual who is not receiving brachytherapy;
(2) Visibly post the patient's or human
research subject's room with a "Radioactive Materials" sign; and
(3) Note on the door or in the patient's or
human research subject's chart where and how long visitors may stay in the
patient's or human research subject's room.
(h) A licensee shall have applicable emergency response
equipment available near each treatment room to respond to a source;
(1) Dislodged from the patient; or
(2) Lodged within the patient following removal
of the source applicators.
(i) A licensee shall notify the Radiation Safety Officer or
his or her designee, and an authorized user as soon as possible if the patient
or human research subject has a medical emergency or dies.
History Note: Authority G.S. 104E‑7; 104E‑12(a);
Eff. February 1, 1980;
Amended Eff. November 1, 2007; January 1, 2005; April 1,
1999; January 1, 1994; October 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0702 Eff.
February 1, 2015.
10A NCAC 15 .0703 TELETHERAPY
History Note: Authority G.S. 104E‑7(a)(2); 10
C.F.R. Chapter 1, Commission Notices, Policy Statements, Agreement States, 46
F.R. 7540;
Eff. February 1, 1980;
Amended Eff. April 1, 1999; June 1, 1993; May 1, 1992;
October 1, 1984; October 1, 1980;
Repealed Eff. November 1, 2007;
Transferred and Recodified from 15A NCAC 11 .0703 Eff.
February 1, 2015.
SECTION .0800 - REQUIREMENTS FOR NON-HUMAN USE OF RADIATION
GENERATING DEVICES
10A NCAC 15 .0801 PURPOSE AND SCOPE
(a) This Section provides special requirements for use of
ionizing radiation generating devices (RGDs) operating above five thousand
electron volts (5 keV), but below one million electron volts (1 MeV) that are
in addition to requirements in the other sections of this Chapter.
(b) This Section does not pertain to radiation safety
requirements for x-ray equipment that is covered in other sections of this
Chapter (e.g., x-rays in the healing arts in Section .0600 of this Chapter, and
particle accelerators in Section .0900 of this Chapter).
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0801 Eff.
February 1, 2015;
Amended Eff. October 1, 2015.
10A NCAC 15 .0802 DEFINITIONS
In addition to terms found in Rule .0104 of this Chapter the
following definitions shall apply to this Section:
(1) "Accredited bomb squad" means a law
enforcement agency utilizing certified bomb technicians.
(2) "Analytical RGD equipment" means
equipment that uses electronic means to generate ionizing radiation for the
purpose of examining the microstructure of materials, i.e. x-ray diffraction
and x-ray spectroscopy.
(3) "Analytical RGD system" means a group of
local and remote components utilizing x-rays to determine the elemental
composition or to examine the microstructure of materials.
(4) "Bomb detection RGDs" means RGDs used for
the sole purpose of remotely detecting explosive devices.
(5) "Certified bomb technician" means a
member of an accredited bomb squad who has completed the FBI Hazardous Devices
School. Information pertaining to this program can be found on the school
website at http://www.fbi.gov/about-us/cirg/hazardous-devices.
(6) "Certifiable cabinet x-ray system" means
an existing uncertified RGD that has been modified to meet the certification
requirements specified in 21 CFR 1020.40 as incorporated by reference in Rule
.0117 of this Chapter.
(7) "Certified cabinet x-ray system" means an
RGD utilized in an enclosed, interlocked cabinet, such that the radiation
machine will not operate unless all openings are securely closed. These systems
shall be certified in accordance with 21 CFR 1010.2 as incorporated by
reference in Rule .0117 of this Chapter, as being manufactured and assembled
pursuant to the provisions of 21 CFR 1020.40 as incorporated by reference in
Rule .0117 of this Chapter.
(8) "Collimator" means a device or mechanism
by which the x-ray beam is restricted in size.
(9) "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.
(10) "Electron Beam Device" means any device
using electrons below 1MeV to heat, join, or otherwise irradiate materials.
(11) "Enclosed beam RGD" means an RGD with all
possible x-ray beam paths contained in a chamber, coupled chambers, or other
beam-path-confinement devices to prevent any part of the body from intercepting
the beam during normal operations. Normal access to the primary beam path, such
as a sample chamber door, shall be interlocked with the high voltage of the
x-ray tube or the shutter for the beam to be considered "enclosed."
An open-beam device placed in an interlocked enclosure is considered an "enclosed
beam" unless there are provisions for routine bypassing of the interlocks.
(12) "Fail-safe characteristics" means a design
feature that causes the radiation beam to terminate, port shutters to close, or
otherwise prevents emergence of the primary beam, upon the failure of a safety
or warning device. For example, if an "X-ray On" light indicator or
shutter indicator or interlock fails, the radiation beam shall terminate.
(13) "Hand-held x-ray system" means any device
or equipment that is portable and used for similar purposes as analytical RGD
equipment.
(14) "Hybrid gauge" means an x-ray gauge device
utilizing both x-ray and radioactive sources.
(15) "Industrial radiography" means RGDs used
to make radiographic images to examine the structure of materials by
nondestructive methods. These RGDs shall not be contained in a cabinet and are
not permanent installations.
(16) "Ion implantation equipment, low-energy"
means any closed device operating below 1MeV used to accelerate elemental ions
and implant them in other materials.
(17) "Leakage radiation" means radiation
emanating from the source assembly housing except for:
(A) the primary beam;
(B) scatter radiation emanating from other
components (e.g., shutter or collimator); and
(C) radiation produced when the beam on switch or
timer is not activated.
(18) "Local components" means part of an RGD
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.
(19) "Mobile RGD" means RGD equipment mounted
on a permanent base with wheels or casters for moving while assembled.
(20) "Normal operating procedures" means
step-by-step instructions necessary to accomplish a task. These procedures
shall include sample insertion and manipulation, equipment alignment, routine
maintenance by the registrant, and data recording procedures that are related
to radiation safety.
(21) "Open-beam RGD" means a device or system
designed in such a way that the primary beam is not completely enclosed during
normal operation and used for analysis, gauging, or imaging in which an
individual could accidentally place some part of their body in the primary beam
or stray radiation path during normal operation.
(22) "Permanent radiographic installation"
means an RGD utilized in an enclosed shielded room, cell, or vault that allows
entry when the RGD is not energized.
(23) "Portable RGD" means RGD equipment
designed to be carried.
(24) "Primary beam" means radiation that passes
through an aperture of the source assembly housing by a direct path from the
radiation source.
(25) "Radiation generating device (RGD)" means
any system, device, subsystem, or machine component that may generate by
electronic means x-rays or particle radiation above 5 keV, but below 1 MeV, and
not used for healing arts on humans or animals. Examples of RGDs are the
following:
(A) analytical RGD equipment;
(B) certified and certifiable cabinet x-ray
systems;
(C) gauging devices using x-ray sources;
(D) hybrid gauging devices;
(E) e-beam welders;
(F) baggage scanners;
(G) industrial radiography RGDs; and
(H) permanent radiographic installations.
(26) "Remote components" means parts of an RGD
x-ray system that are not struck by x-rays such as power supplies,
transformers, amplifiers, readout devices, and control panels.
(27) "Scattered radiation" means radiation,
other than leakage radiation, that during passage through matter, has been
deviated in direction or has been modified by a decrease in energy.
(28) "Shutter" means an adjustable device,
generally made of lead or other high atomic number material, fixed to a source
assembly housing to intercept, block, or collimate the primary beam.
(29) "Source" means the point of origin of the
radiation, such as the focal spot of an x-ray tube.
(30) "Stationary RGD" means RGD equipment that
is installed or placed in a fixed location.
(31) "Stray radiation" means the sum of leakage
and scatter radiation emanating from the source assembly or other components
except for the primary beam, and radiation produced when the beam on switch or
timer is not activated.
(32) "X-ray generator" means the part of an
x-ray system that provides the accelerating (high) voltage and current for the
x-ray tube.
(33) "X-ray gauge" means an x-ray producing
device designed and manufactured for the purpose of detecting, measuring,
gauging, or controlling thickness, density, level, or interface location of
manufactured products.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0802 Eff.
February 1, 2015;
Amended Eff. October 1, 2015.
10A NCAC 15 .0803 EQUIPMENT REQUIREMENTS
(a) Certified cabinet x-ray systems shall meet the
requirements of 21 CFR 1020.40 as incorporated by reference in Rule .0117(a)(3)
of this Chapter.
(b) All certified and certifiable cabinet x-ray systems
shall:
(1) be constructed so that, the radiation
emitted from the system shall not exceed an exposure of 0.5 milliroentgen (mR)
in one hour at any point five centimeters outside the external surface; and
(2) have a fail-safe interlock that prevents
irradiation when the cabinet, chamber, or coupled chambers are open.
(c) Open-beam analytical RGD systems shall be equipped with
a safety device that prevents the entry of any portion of an individual's body
into the primary x-ray beam path that causes the beam to be shut off upon entry
into its path.
(d) Open‑beam analytical RGDs shall be provided with
a visible and legible indication of:
(1) x-ray tube status (ON‑OFF) located
near the radiation source housing, if the primary beam is controlled in this
manner; or
(2) shutter status (OPEN‑CLOSED) or beam
status (ON-OFF) located near each port on the radiation source housing, if the
primary beam is controlled in this manner.
(e) Warning devices on open-beam analytical RGDs shall be
labeled so that their purpose is identified. On open-beam analytical RGDs
installed after February 1, 1980, warning devices and lights shall have
fail-safe characteristics.
(f) Unused ports on radiation source housings for open-beam
RGDs shall be secured in the closed position in a manner that will prevent
unintended opening.
(g) Each port on the radiation source housing on open‑beam
analytical RGDs installed after February 1, 1980 and designed to accommodate
interchangeable components shall be equipped with a shutter that cannot be
opened unless a collimator or a component coupling is connected to the port.
(h) Portable open-beam analytical RGDs that shall be
manufactured to be used hand-held without safety devices are exempt from the
requirements of Paragraph (c) of this Rule and shall be constructed according
to International Standard IEC 62495 that is incorporated by reference and
includes subsequent amendments. This standard can be downloaded for one hundred
twenty-one dollars ($121.00) at the following website:
http://webstore.ansi.org/FindStandards.aspx?SearchString=IEC+62495+Ed.+1.0+en%3a2011&SearchOption=0&PageNum=0&SearchTermsArray=null%7cIEC+62495+Ed.+1.0+en%3a2011%7cnull.
(i) A registrant may apply to the agency, as defined in
Rule .0104 of this Chapter, for an exemption from the requirement of a safety
device. This request shall include:
(1) a description of the safety devices;
(2) the reason safety devices cannot be used;
and
(3) a description of the alternative methods
that will be employed to minimize the possibility of an accidental exposure,
including procedures to assure that operators and others in the area will be
informed of the absence of safety devices.
(j) Analytical RGDs shall be provided with a visible and
legible label(s) bearing the radiation symbol and the words:
(1) "CAUTION ‑ HIGH INTENSITY X-RAY
BEAM," or words having a similar meaning, near the exit port to identify
the location of the beam; and
(2) "CAUTION ‑ RADIATION ‑
THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED", or words having a
similar meaning, near any switch that energizes an x-ray tube, if the radiation
source is an x-ray tube.
(k) Warning lights labeled with the words "X-RAYS
ON," or other words having similar meaning, shall be located:
(1) near any switch that activates the high
voltage to energize an x-ray tube; or
(2) in a conspicuous location near the
radiation source housing and radiation beam(s) and visible from all instrument
access areas.
(l) Warning lights shall activate when the x-ray tube is
energized.
(m) Each x-ray tube housing shall be:
(1) constructed that when all shutters are
closed the leakage radiation measured at a distance of five centimeters from
its surface is not capable of producing an exposure in excess of 2.5 millirem
(mrem)/ (25 microsieverts µSv) in one hour; and
(2) if the tube housing is the primary
shielding for the x-ray tube, does not produce x-rays when the housing is
opened or disassembled.
(n) Each x-ray generator shall be supplied with a
protection cabinet which limits leakage radiation measured at a distance of
five centimeters from its surface such that it is not capable of producing an
exposure in excess of 0.25 mrem/2.5µSv in one hour.
(o) Permanent radiographic installations and industrial
radiography RGDs shall comply with the requirements of Rule .0807 of this
Section.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0803 Eff.
February 1, 2015;
Amended Eff. October 1, 2015.
10A NCAC 15 .0804 AREA REQUIREMENTS
(a) The local components of RGDs shall be located and
arranged to include sufficient shielding or access control to ensure no
radiation levels exist in any area surrounding the local components that could
result in a dose to an individual present in excess of the dose limits given in
Rule .1611(a) of this Chapter.
(b) Survey Requirements
(1) Radiation surveys, as set forth in Rule
.1613(a) and (b) of this Chapter, of all RGDs sufficient to show compliance
with Paragraph (a) of this Rule, shall be performed:
(A) within 30 days after initial operation of the
device;
(B) prior to use following any change in the initial
arrangement, including the number or type of local components in the system; and
(C) prior to use following any maintenance requiring the
disassembly or removal of a local component in the system that could affect the
radiation exposure to personnel.
(2) A registrant may apply to the agency for
approval of procedures differing from those in Subparagraph (b)(1) of this
Rule, provided that the registrant demonstrates satisfactory compliance with
Paragraph (a) of this Rule.
(3) Surveys shall be performed with a radiation
survey instrument capable of the following:
(A) measuring the radiation energies of the system
surveyed;
(B) confirming that the radiation limits of this Section
are met; and
(C) calibrated according to the manufacture's
recommended frequency or at least annually when a frequency is not recommended.
(c) Each area of use or room containing RGDs shall be
conspicuously posted with caution signs in accordance with the requirements of
Rule .1623 of this Chapter, bearing the radiation caution symbol and the words
"CAUTION ‑ X-RAY EQUIPMENT," or words having a similar meaning.
History Note: Authority G.S. 104E‑7(a)(2);
Eff. February 1, 1980;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0804 Eff.
February 1, 2015;
Amended Eff. October 1, 2015.
10A NCAC 15 .0805 OPERATING REQUIREMENTS
(a) RGDs shall be operated by individuals that have
completed the training requirements of Rule .0806 of this Section.
(b) Normal operating procedures shall be written and
available to all RGD operators and support staff.
(c) No individual shall be permitted to operate RGDs in any
manner other than that specified in the operating procedures unless the person
has obtained written approval of the individual responsible for radiation
safety, or Radiation Safety Officer (RSO) as defined in Rule .0104 of this
Chapter.
(d) No individual shall bypass a safety device unless the
person has obtained the approval of the person responsible for radiation safety
or RSO. This process shall be incorporated into the radiation protection
program by the RSO, as set forth in Rule .1613(a) of this Chapter, and the
operating procedures as set forth in Rule .0603(a)(1)(B) of this Chapter. The
written approval, as granted by the RSO, shall include an expiration date. When
a safety device has been bypassed, a legible sign bearing the words
"SAFETY DEVICE NOT WORKING," or words having a similar meaning shall
be placed on the radiation source housing and the control panel during the bypassing
period.
(e) Prior to an individual modifying the:
(1) x-ray tube system, resulting in the removal
of tube housings, covers, or shielding materials;
(2) shutters;
(3) collimators; or
(4) beam stops;
the individual shall determine the tube is off and will
remain off until safe conditions have been restored.
(f) Safety devices including interlocks, shutters, and
warning lights shall be tested for proper operation on all RGDs in operation
once annually. Records of the testing shall be retained by the registrant for
three years.
(g) Individuals shall not hold a sample or object being
irradiated.
History Note: Authority G.S. 104E‑7; 104E-12;
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0805 Eff.
February 1, 2015;
Amended Eff. October 1, 2015.
10A NCAC 15 .0806 PERSONNEL REQUIREMENTS
(a) Personnel operating or maintaining RGDs shall comply
with the following:
(1) No person shall be permitted to operate or
maintain RGDs unless the person has received instruction in the operating and
emergency procedures for the RGD and instruction that is in accordance with
Rule .1003 of this Chapter.
(2) Each registrant operating or maintaining
RGDs shall maintain, for inspection by the agency, records of training that demonstrate
the requirements of this Rule have been satisfied.
(b) The registrant shall provide ring or wrist personnel
monitoring equipment to:
(1) individuals using open-beam RGDs not
equipped with a safety device; and
(2) individuals maintaining RGDs if the
maintenance procedures require the presence of a primary x-ray beam when any
local component in the RGD is disassembled or removed.
History Note: Authority G.S. 104E‑7; 104E-11;
104E-12;
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0806 Eff.
February 1, 2015;
Amended Eff. October 1, 2015.
10A NCAC 15 .0807 PERMANENT RADIOGRAPHIC INSTALLATIONS
AND INDUSTRIAL RADIOGRAPHY RGDS
(a) Permanent radiographic installations and industrial
radiography RGDs are exempt from the requirements of the rules of this Section
except Rule .0802 and Rule .0804(a), (b)(1)(A), (b)(1)(C), (b)(2), and (b)(3).
(b) Permanent radiographic installations and industrial
radiography RGDs shall comply with the following rules of this Chapter:
(1) .0501;
(2) .0502;
(3) .0506;
(4) .0509-.0520;
(5) .0522;
(6) .0523(a)(1);
(7) .0523(a)(3);
(8) .0523(a)(6) -.0523(a)(15);
(9) .0523(b)(1) -.0523(b)(4);
(10) .0523(b)(6) -.0523(b)(7);
(11) .0523(b)(9) -.0523(b)(12);
(12) .0523(c); and
(13) .0525.
History Note: Authority G.S. 104E‑7;
Eff. October 1, 2015.
10A NCAC 15 .0808 APPLICABLE RULES FOR BOMB DETECTION
RGDS
Bomb detection RGDs utilized by accredited bomb squads and
certified bomb technicians shall comply with the following rules of this
Chapter:
(1) .0501;
(2) .0502;
(3) .0509;
(4) .0511-.0520 except for the requirements for a
direct reading pocket dosimeter and operating alarm ratemeter in .0512(a);
(5) .0522;
(6) .0523(a)(1);
(7) .0523(a)(3);
(8) .0523(a)(6) -.0523(a)(15);
(9) .0523(b)(1) -.0523(b)(4);
(10) .0523(b)(6) -.0523(b)(7);
(11) .0523(b)(9) -.0523(b)(12);
(12) .0523(c); and
(13) .0525.
History Note: Authority G.S. 104E‑7;
Eff. October 1, 2015.
SECTION .0900 ‑ REQUIREMENTS FOR PARTICLE ACCELERATORS
Codifier's Note: 10 NCAC 03G .3000 was transferred to 15A
NCAC 11 .0900 effective January 4, 1990. Recodification pursuant to G.S.
143B-279.3.
10A NCAC 15 .0901 PURPOSE AND SCOPE
(a) This Section establishes procedures for the licensing
and the use of particle accelerators.
(b) In addition to the requirements of this Section, all
licensees are subject to the requirements of Sections .0100, .0200, .1000, and
.1600 of this Chapter. Licensees engaged in industrial radiographic operations
are subject to the requirements of Section .0500 of this Chapter, and licensees
engaged in the healing arts are subject to Rule .0350 of this Chapter and the
applicable requirements of Section .0600 of this Chapter. Licensees engaged in
the production of radioactive material or possessing radioactive material
incidental to an accelerator are subject to the requirements of Section .0300
of this Chapter.
(c) In addition to the requirements of this Section, all
particle accelerator licensees are subject to the annual fee provisions
contained in Section .1100 of this Chapter.
History Note: Authority G.S. 104E‑7; 104E‑9(a)(8);
104E‑19(a);
Eff. February 1, 1980;
Amended Eff. January 1, 1994; June 1, 1989; July 1, 1982;
Transferred and Recodified from 15A NCAC 11 .0901 Eff.
February 1, 2015.
10A NCAC 15 .0902 LICENSING REQUIREMENTS
No person shall receive, possess, use, transfer, own, or
acquire a particle accelerator except as authorized in a license issued
pursuant to these Rules or as otherwise provided for in these Rules. The
general procedures for licensing of particle accelerator facilities are
included in Section .0903 of this Chapter.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0902 Eff.
February 1, 2015.
10A NCAC 15 .0903 REQUIREMENTS FOR ISSUANCE OF A LICENSE
FOR ACCELERATORS
Application for use of a particle accelerator will be
approved only if the agency determines that:
(1) The applicant and his operators are qualified by
reason of training and experience to use the accelerator in such a manner as to
minimize danger to public health and safety or property;
(2) The applicant's proposed equipment, facilities,
operating and emergency procedures are adequate to protect health and minimize
danger to public health and safety or property;
(3) The applicant has appointed a radiation safety
officer;
(4) The applicant has established a radiation safety
committee to approve that the operation of the particle accelerator is in
accordance with applicable radiation protection Sections of this Chapter; and
(5) The applicant for the use of a particle accelerator
in the healing arts shall be a physician licensed to practice medicine in the
state of North Carolina. The individuals designated on the application as users
shall have substantial training and experience in deep therapy techniques or in
the use of particle accelerators to treat humans.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0903 Eff.
February 1, 2015.
10A NCAC 15 .0904 LIMITATIONS
(a) No licensee shall permit any person to act as a
particle accelerator operator until such person:
(1) has been instructed in radiation safety and
shall have demonstrated an understanding thereof;
(2) has received copies of, and instruction in,
this Section and the applicable requirements of this Chapter, pertinent
licensing conditions and the licensee's operating and emergency procedures; and
(3) has demonstrated competence to use the
particle accelerator, related equipment, and survey instruments which will be
employed in his assignment.
(b) Either the radiation safety committee or the radiation
safety officer shall have the authority to terminate the operations at a
particle accelerator facility if this action is deemed necessary to minimize
danger to public health and safety or property.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0904 Eff.
February 1, 2015.
10A NCAC 15 .0905 SHIELDING AND SAFETY DESIGN
(a) A qualified expert registered by the agency pursuant to
Rule .0205 of this Chapter, shall be consulted in the design of a particle
accelerator installation. A qualified expert shall perform a radiation survey
when the accelerator is first capable of producing radiation to verify that
radiation levels and shielding effectiveness meet the applicable requirements
in this Chapter. A copy of the survey shall be submitted to the agency by the
licensee prior to its use for its licensed purpose.
(b) Plans for construction of accelerator installations
shall be submitted to the agency.
(c) Each particle accelerator installation shall be
provided with such primary and secondary barriers as are necessary to assure
compliance with Rules .1604 and .1611 of this Chapter.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0905 Eff.
February 1, 2015.
10A NCAC 15 .0906 CONTROLS AND INTERLOCK SYSTEMS
(a) Instrumentation, readouts and controls on the particle
accelerator control console shall be clearly identified and easily discernible.
(b) All entrances into a target room or other high
radiation area shall conform to the requirements of Rule .1615 of this Chapter.
(c) When an interlock system has been tripped, it shall
only be possible to resume operation of the accelerator by manually resetting
controls at the position where the interlock has been tripped and, subsequently
at the main control console.
(d) Each safety interlock shall operate independently of
all other safety interlocks.
(e) All safety interlocks shall be fail‑safe, i.e.,
designed so that any defect or component failure in the interlock system
prevents operation of the accelerator.
(f) A "Scram button" or other emergency power cut‑off
switch shall be located and easily identifiable in all high radiation areas and
at the control console. Such a cut‑off switch shall include a manual reset
so that the accelerator cannot be restarted from the accelerator control
console without first manually resetting the cut‑off switch.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0906 Eff.
February 1, 2015.
10A NCAC 15 .0907 WARNING DEVICES
(a) All locations designated as high radiation areas, and
entrances to such locations shall be equipped with easily observable warning
lights that operate when, and only when, radiation is being produced.
(b) Except in facilities designed for human exposure, each
high radiation area shall have an audible warning device which shall be
activated for 15 seconds prior to the possible creation of such high radiation
area. This warning device shall be clearly discernible in all high radiation
areas and all radiation areas.
(c) Barriers, temporary or otherwise, and pathways leading
to high radiation areas shall be identified in accordance with Rule .1624 of
this Chapter.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .0907 Eff.
February 1, 2015.
10A NCAC 15 .0908 OPERATING PROCEDURES
(a) Particle accelerators, when not in operation, shall be
secured to prevent unauthorized use.
(b) Only a switch on the accelerator control console shall
be routinely used to turn the accelerator beam "on" and "off".
The safety interlock system shall not be used to turn off the accelerator beam
except in an emergency.
(c) All safety and warning devices, including interlocks
shall be checked for proper operability at least every six months unless more
frequent checks are required by the agency. Results of such tests shall be
maintained for two years at the accelerator facility for inspection by the
agency.
(d) Electrical circuit diagrams of the accelerator, and the
associated interlock systems, shall be kept current and maintained for
inspection by the agency.
(e) If, for any reason, it is necessary to intentionally
bypass a safety interlock or interlocks, such action shall be:
(1) authorized by the radiation safety officer;
(2) recorded in a permanent log and a notice
posted at the accelerator control console and at the location of the bypassed
interlock; and
(3) terminated as soon as possible.
(f) A copy of the current operating and the emergency
procedures shall be maintained at the accelerator control panel.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0908 Eff.
February 1, 2015.
10A NCAC 15 .0909 RADIATION MONITORING REQUIREMENTS
(a) Portable monitoring equipment shall be available at
each particle accelerator facility. Such equipment shall be tested for proper
operation monthly and calibrated at intervals not to exceed one year, and after
each servicing and repair.
(b) A radiation protection survey shall be performed and
documented by a qualified expert registered by the agency pursuant to Rule
.0205 of this Chapter, when changes have been made in shielding, operation,
equipment, or occupancy of adjacent areas. The licensee shall submit the
report of the qualified expert to the agency at the address found in Rule .0111
of this Chapter.
(c) Except for facilities designed for human exposure,
radiation levels in all high radiation areas shall be continuously monitored.
The monitoring devices shall be electrically independent of the accelerator
control and interlock systems and capable of providing a remote and local
readout with visual or audible alarms at the control panel and other
appropriate locations.
(d) All area monitors shall be tested for proper operation
at least every six months unless more frequent checks are required by the
agency.
(e) Whenever applicable, periodic surveys shall be made to
determine the amount of airborne particulate radioactivity present in areas of
airborne hazards.
(f) Whenever applicable, periodic smear surveys shall be
made to determine the degree of contamination in target and other pertinent
areas.
(g) All area surveys shall be made in accordance with the
written procedures established by a qualified expert registered by the agency
pursuant to Rule .0205 of this Chapter, or the radiation safety officer of the
particle accelerator facility.
(h) Records of all radiation protection surveys,
calibration results, instrumentation tests, and smear results shall be kept
current and on file at each accelerator facility for two years for inspection
by the agency.
History Note: Authority G.S. 104E‑7; 104E‑12(a);
Eff. February 1, 1980;
Amended Eff. October 1, 1980;
Transferred and Recodified from 15A NCAC 11 .0909 Eff.
February 1, 2015.
10A NCAC 15 .0910 VENTILATION SYSTEMS
(a) Adequate ventilation shall be provided in areas where
airborne radioactivity may be produced to comply with Rule .1604 of this
Chapter.
(b) The licensee shall not vent, release or otherwise
discharge airborne radioactive material to an unrestricted area in excess of
the limits specified in Rule .1611 of this Chapter.
History Note: Authority G.S. 104E‑7;
Eff. February 1, 1980;
Amended Eff. January 1, 1994; May 1, 1992;
Transferred and Recodified from 15A NCAC 11 .0910 Eff.
February 1, 2015.
SECTION .1000 ‑ NOTICES: INSTRUCTIONS: REPORTS AND
INSPECTIONS
Codifier's Note: 10 NCAC 03G .3100 was transferred to 15A
NCAC 11 .1000 effective January 4, 1990. Recodification pursuant to G.S.
143B-279.3.
10A NCAC 15 .1001 SCOPE
This Section establishes requirements for notices,
instructions and reports by licensees or registrants to individuals engaged in
work under a license or registration and options available to such individuals
in connection with agency inspections of licensees or registrants to ascertain
compliance with the provisions of the Act and rules, orders and licenses issued
thereunder regarding radiological working conditions. The rules in this
Section apply to all persons who receive, possess, use, own or transfer sources
of radiation licensed by or registered with the agency pursuant to the rules in
Sections .0200, .0300, .0900 and .1200 of this Chapter.
History Note: Authority G.S. 104E‑7; 104E‑12;
Eff. February 1, 1980;
Amended Eff. May 1, 1993; June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1001 Eff.
February 1, 2015.
10A NCAC 15 .1002 POSTING OF NOTICES TO WORKERS
(a) Each licensee or registrant shall post current copies
of the following documents:
(1) the rules in this Section and in Section
.1600 of this Chapter;
(2) the license, certificate of registration, conditions
or documents incorporated into the license by reference and amendments thereto;
(3) the operating procedures applicable to work
under the license or registration;
(4) any notice of violation involving
radiological working conditions, any order issued pursuant to Section .0100 of
this Chapter and any response from the licensee or registrant.
(b) If posting of a document specified in Subparagraphs
(a)(1), (2) or (3) of this Rule is not practicable, the licensee or registrant
may post a notice which describes the document and states where it may be
examined.
(c) The agency form "Notice to Employees" shall
be posted by each licensee or registrant wherever individuals work in or
frequent any portion of a restricted area.
(d) The agency form "Notice to Employees"
contains information to employees regarding employer's responsibility, worker's
responsibility, the subjects covered by this Section, reports on radiation
exposure history, inspections, and any other information that the agency may
include.
(e) Documents, notices or forms posted pursuant to this
Rule shall appear in a sufficient number of places to permit individuals
engaged in work under the license or registration to observe them on the way to
or from any particular work location to which the document applies, shall be
conspicuous, and shall be replaced if defaced or altered.
(f) Agency documents posted pursuant to Subparagraph (a)(4)
of this Rule shall be posted within two working days after receipt of the
documents from the agency; the licensee's or registrant's response, if any,
shall be posted within two working days after dispatch from the licensee or
registrant. Such documents shall remain posted for a minimum of five working
days or until action correcting the violation has been completed, whichever is
later.
History Note: Authority G.S. 104E‑7; 104E‑10;
Eff. February 1, 1980;
Amended Eff. January 1, 1994; May 1, 1992;
Transferred and Recodified from 15A NCAC 11 .1002 Eff.
February 1, 2015.
10A NCAC 15 .1003 INSTRUCTIONS TO WORKERS
(a) All individuals who, in the course of employment, are
likely to receive in a year an occupational dose in excess of 100 millirem (1
millisievert) shall be kept informed of the storage, transfer, or use of radioactive
material or of radiation in such portions of the restricted area; shall be
instructed in the health protection problems associated with exposure to such
radioactive material or radiation, in precautions or procedures to minimize
exposure, and in the purposes and functions of protective devices employed;
shall be instructed in, and instructed to observe, to the extent within the
worker's control, the applicable provisions of this Chapter and licenses for
the protection of personnel from exposures to radiation or radioactive
material occurring in such areas; shall be instructed of their responsibility
to report promptly to the licensee or registrant any condition which may lead
to or cause a violation of rules in this Chapter and licenses or unnecessary
exposure to radiation or radioactive material; shall be instructed in the
appropriate response to warnings made in the event of any unusual occurrence or
malfunction that may involve exposure to radiation or radioactive material; and
shall be advised as to the radiation exposure reports which workers may request
pursuant to Rule .1004 of this Section. The extent of these instructions shall
be commensurate with potential radiological health protection problems in the
restricted area.
(b) In determining those individuals subject to the
requirements of Paragraph (a) of this Rule, licensees or registrants shall take
into consideration assigned activities during normal and abnormal situations
involving exposure to all sources of radiation and radioactive material which
can reasonably be expected to occur during the life of the licensed or
registered facility. The extent of these instructions shall be commensurate
with the potential radiological health protection problems present in the
workplace.
History Note: Authority G.S. 104E‑7; 104E‑10;
104E‑12;
Eff. February 1, 1980;
Amended Eff. April 1, 1999;
Transferred and Recodified from 15A NCAC 11 .1003 Eff.
February 1, 2015.
10A NCAC 15 .1004 NOTIFICATIONS AND REPORTS TO
INDIVIDUALS
(a) Radiation exposure data for an individual and the
results of any measurements, analyses, and calculations of radioactive material
deposited or retained in the body of any individual shall be reported to the
individual as specified in this Rule. The information reported shall include
data and results obtained pursuant to rules of this Chapter, orders, or license
conditions, as shown in records maintained by the licensee or registrant
pursuant to provisions of this Chapter. Each notification and report shall:
(1) be in writing;
(2) include identifying data such as the name
of the licensee or registrant, the name of the individual, and the individual's
social security number;
(3) include the individual's exposure
information; and
(4) contain the following statement: This
report is furnished to you under the provisions of Section 15A NCAC 11 .1000:
NOTICES: INSTRUCTIONS: REPORTS AND INSPECTIONS. You should preserve this
report for further reference.
(b) Each licensee or registrant shall make dose information
available to workers as shown in records maintained by the licensee or
registrant under the provisions of Rule .1640 of this Chapter. The licensee or
registrant shall provide an annual report to each individual monitored under
Rule .1614 of this Chapter of the dose received in that monitoring year if:
(1) the individual's occupational dose exceeds
1 mSv (100 mrem) TEDE or 1 mSv (100 mrem) to any individual organ or tissue; or
(2) the individual requests his or her annual
dose report.
(c) At the request of a worker formerly engaged in work
controlled by the licensee or the registrant, each licensee or registrant shall
furnish to the worker a report of the worker's radiation dosage and exposure to
radioactive materials. The report shall:
(1) be furnished within 30 days from the time
any request is made, or within 30 days after the information has been obtained
by the licensee or registrant, whichever is later;
(2) cover, within the period of time specified
in the request, each calendar quarter in which the worker's activities involved
exposure to radiation from radioactive material licensed by, or radiation
machines registered with the agency; and
(3) include the dates and locations of work
under the license or registration in which the worker participated during this
period.
(d) When a licensee or registrant is required pursuant to Rules
.1646, .1647, or .1648 of this Chapter to report to the agency any overexposure
of an individual to radiation or radioactive material, the licensee or the
registrant shall also provide the individual a report on his or her exposure
data included in the report to the agency. The reports shall be transmitted at
a time no later than the transmittal to the agency.
History Note: Authority G.S. 104E-7; 104E-10(b); 104E-12;
Eff. February 1, 1980;
Amended Eff. October 1, 2013; January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1004 Eff. February
1, 2015.
10A NCAC 15 .1005 PRESENCE OF REPRESENTATIVES DURING
INSPECTIONS
(a) Each licensee or registrant shall afford to the agency
at all reasonable times opportunity to inspect radioactive materials, radiation
machines, activities, facilities, premises, and records required to be
maintained by provisions of this Chapter.
(b) During an inspection, agency inspectors may consult
privately with workers as specified in Rule .1006 of this Section. The
licensee or registrant may accompany agency inspectors during other phases of
an inspection.
(c) If, at the time of inspection, an individual has been
authorized by the workers to represent them during agency inspections, the
licensee or registrant shall notify the inspectors of such authorization and
shall give the workers' representative an opportunity to accompany the
inspectors during the inspection of physical working conditions.
(d) Each workers' representative shall be routinely engaged
in work under control of the licensee or registrant and shall have received
instructions as specified in Rule .1003 of this Section.
(e) Different representatives of licensees or registrants
and workers may accompany the inspectors during different phases of an
inspection if there is no resulting interference with the conduct of the
inspection.
(f) A consultant or representative to the licensee,
registrant, or workers shall be afforded the opportunity to accompany the
agency inspectors during the inspection of physical working conditions.
(g) Notwithstanding the other provisions of this Rule,
agency inspectors are authorized to refuse to permit accompaniment by any
individual who deliberately interferes with a fair and orderly inspection.
With regard to any area containing proprietary information, the workers'
representative for that area shall be an individual previously authorized by
the licensee or registrant to enter that area.
History Note: Authority G.S. 104E‑7; 104E‑10;
104E‑11;
Eff. February 1, 1980;
Transferred and Recodified from 15A NCAC 11 .1005 Eff.
February 1, 2015.
10A NCAC 15 .1006 CONSULTATION WITH WORKERS
(a) Agency inspectors may consult privately with workers
concerning matters of occupational radiation protection and other matters
related to applicable provisions of this Chapter and licenses to the extent the
inspectors deem necessary for the conduct of an effective and thorough
inspection.
(b) During the course of an inspection any worker may bring
privately to the attention of the inspectors, either orally or in writing, any
past or present condition which he has reason to believe may have contributed
to or caused any violation of the Act, provisions of this Chapter, or license
condition, or any unnecessary exposure of an individual to radiation from
licensed radioactive material or a registered radiation machine under the
licensee's or registrant's control. Any such notice in writing shall comply
with the requirements of Rule .1007 of this Section.
(c) The provisions of Paragraph (b) of this Rule shall not
be interpreted as authorization to disregard instructions pursuant to Rule
.1003 of this Section.
History Note: Authority G.S. 104E‑7; 104E‑10;
Eff. February 1, 1980;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1006 Eff.
February 1, 2015.
10A NCAC 15 .1007 REQUESTS FOR INSPECTIONS
(a) Any worker or representative of workers who believes
that a violation of the Act, provisions of this Chapter or license conditions
exists or has occurred in work under a license or registration with regard to
radiological working conditions in which the worker is engaged, may request an
inspection by giving notice of the alleged violation to the Director of the
Division of Radiation Protection, P.O. Box 27687, Raleigh, North Carolina
27611‑7687. Any such notice shall be in writing, shall set forth the
specified grounds for the notice, and shall be signed by the worker or
representative of the workers. A copy shall be provided to the licensee or
registrant by the Director of the Division of Radiation Protection no later
than at the time of inspection except that, upon request of the worker giving
such notice, his name and the name of individuals referred to therein shall not
appear in such copy or on any record published, released, or made available by
the agency, except for good cause shown.
(b) If, upon receipt of such notice, the Director of the
Division of Radiation Protection determines that the complaint meets the
requirements set forth in Paragraph (a) of this Rule and that there are
reasonable grounds to believe that the alleged violation exists or has
occurred, he shall cause an inspection to be made as soon as practicable, to
determine if such alleged violation exists or has occurred. Inspections
pursuant to this Rule need not be limited to matters referred to in the
complaint.
(c) No licensee or registrant shall discharge or in any
manner discriminate against any worker because such worker has filed any
complaint or instituted or caused to be instituted any proceeding under this
Chapter or has testified or is about to testify in any such proceeding or
because of the exercise by such worker on behalf of himself or others of any
option afforded by this Section.
History Note: Authority G.S. 104E‑7; 104E‑10;
Eff. February 1, 1980;
Amended Eff. May 1, 1992; November 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1007 Eff.
February 1, 2015.
10A NCAC 15 .1008 INSPECTIONS NOT WARRANTED
(a) If the Director of the Division of Radiation Protection
determines, with respect to a complaint under Rule .1007 of this Section that
an inspection is not warranted because there are no reasonable grounds to
believe that a violation exists or has occurred, the Director of the Division
of Radiation Protection shall notify the complainant in writing of such
determination. The complainant may obtain review of such determination by
submitting a written statement of position with the Secretary, Department of
Environment, Health, and Natural Resources, P.O. Box 27687, Raleigh, North
Carolina 27611‑7687, who will provide the licensee or registrant with a
copy of such statement by certified mail, excluding, at the request of the
complainant, the name of the complainant. The licensee or registrant may
submit an opposing written statement of position with the Secretary, Department
of Environment, Health, and Natural Resources who will provide the complainant
with a copy of such statement by certified mail. Upon the request of the
complainant, the Secretary, Department of Environment, Health, and Natural
Resources may hold an informal conference in which the complainant and the
licensee or registrant may orally present their views. An informal conference
may also be held at the request of the licensee or registrant, but disclosure
of the identity of the complainant will be made only following receipt of
written authorization from the complainant. After considering all written or
oral views presented, the Secretary, Department of Environment, Health, and
Natural Resources shall affirm, modify, or reverse the determination of the
Director of the Division of Radiation Protection and furnish the complainant
and the licensee or registrant a written notification of his decision and the
reason therefor.
(b) If the Director of the Division of Radiation Protection
determines that an inspection is not warranted because the requirements of Rule
.1007(a) of this Section have not been met, he shall notify the complainant in
writing of such determination. Such determination shall be without prejudice
to the filing of a new complaint meeting the requirements of Rule .1007(a) of
this Section.
History Note: Authority G.S. 104E‑7; 104E‑10;
Eff. February 1, 1980;
Amended Eff. May 1, 1992; November 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1008 Eff.
February 1, 2015.
SECTION .1100 ‑ FEES
Codifier's Note: 10 NCAC 03G .3200 was transferred to 15A
NCAC 11 .1100 effective January 4, 1990. Recodification pursuant to G.S.
143B-279.3.
10A NCAC 15 .1101 PURPOSE AND SCOPE
(a) This Section establishes annual fees to cover the
anticipated costs of inspection, educational and training activities of the
agency.
(b) The fees are imposed on persons registered pursuant to
provisions of Section .0200 of this Chapter, on persons licensed pursuant to
provisions of Sections .0300 and .0900 of this Chapter, and on certain persons
applying for out‑of‑state reciprocal recognition.
(c) Notwithstanding Paragraph (b) of this Rule, no fee
shall be imposed on any person in conjunction with the person's possession and
use of any luminous safety device or luminous gunsight pursuant to the general
licenses in Rules .0309 and .0311 of this Chapter. For purposes of this
Section, "luminous safety device" means an exit marker, hazard
warning sign, safety related marker, or other safety equipment containing one
or more radioactive material powered light sources for the purpose of improving
legibility or visibility.
History Note: Authority G.S. 104E‑9(8); 104E‑19(a);
Eff. July 1, 1982;
Amended Eff. July 1, 1989; May 1, 1983;
Transferred and Recodified from 15A NCAC 11 .1101 Eff.
February 1, 2015.
10A NCAC 15 .1102 PAYMENT DUE
(a) All fees established in this Section shall be due on
the first day of July of each year.
(b) Notwithstanding Paragraph (a) of this Rule, when a new
license or registration is issued by the agency after the effective date of
this Rule or after the first day of July of any subsequent year, the initial
fee shall be due on the date of issuance of the license or registration.
(c) The initial fee in Paragraph (b) of this Rule shall be
computed as follows:
(1) When any new license or registration is
issued before the first day of January of any year, the initial fee shall be
the full amount specified in Rule .1105 or .1106 of this Section; and
(2) When any new license or registration is
issued on or after the first day of January of any year, the initial fee shall
be one-half of the amount specified in Rule .1105 or .1106 of this Section.
(d) All fees received by the agency pursuant to provisions
of this Section shall be nonrefundable.
(e) Each licensee or registrant shall pay all fees by check
or money order made payable to "Radiation Protection Section" and
mail such payment to: Radiation Protection Section, Division of Environmental
Health, Department of Environment and Natural Resources, 1645 Mail
Service Center, Raleigh, North Carolina 27699-1645. Such payment may be
delivered to the agency at its office located at 3825 Barrett Drive, Raleigh,
North Carolina 27609-7221.
History Note: Authority G.S. 104E-9(a)(8); 104E-19(a);
Eff. July 1, 1982;
Amended Eff. May 1, 1993; May 1, 1992; July 1, 1989;
Temporary Amendment Eff. June
30, 2002;
Temporary Amendment Expired on March 28, 2003;
Findings of need for Emergency Rule disapproved by
Codifier on June 8, 2007;
Emergency Amendment Eff. June 19, 2007 pursuant to G.S.
150B-21.1A(b);
Amended Eff. August 1, 2007;
Transferred and Recodified from 15A NCAC 11 .1102 Eff.
February 1, 2015.
10A NCAC 15 .1103 NOTICES OF PAYMENT DUE
Within five days after the due dates established in
Paragraphs (a) and (b) of Rule .1102 of this Section, the agency shall mail to
each licensee and registrant, who has not already submitted payment, a notice
which indicates the due date, delinquent date and the amount of fees due.
History Note: Authority G.S. 104E‑9(8); 104E‑19(a);
Eff. July 1, 1982;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1103 Eff.
February 1, 2015.
10A NCAC 15 .1104 DELINQUENT AND UNCOLLECTIBLE FEES
(a) Payment of fees established in this Section shall be
delinquent, if not received by the agency within 60 days after the due date
specified in Paragraphs (a) and (b) of Rule .1102 of this Section.
(b) If a licensee or registrant remits a fee in the form of
a check or other instrument which is uncollectible from the paying institution,
the agency shall notify the licensee or registrant by certified mail and allow
the licensee or registrant 15 days to correct the matter, which includes
payment of any fee charged to the agency by a banking institution.
(c) If payment of fees is uncollectible from the paying
institution or not submitted to the agency by the delinquent date, the agency
may institute legal action to collect.
History Note: Authority G.S. 104E‑9(8); 104E‑19(a);
Eff. July 1, 1982;
Amended Eff. August 1, 2007; May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1104 Eff.
February 1, 2015.
10A NCAC 15 .1105 X-RAY FEE AMOUNTS
(a) Annual fees for persons registered pursuant to
provisions of Section .0200 of this Chapter are as listed in the following
table:
Type of Registered
Facility
Letters Appearing in Registration Number
Facility Plus First
X-ray Tube
Each Additional
X-ray Tube
Chiropractors
C
$ 180.00
$ 24.00
Dentists
D
$ 180.00
$ 24.00
Educational
E
$ 130.00
$ 22.00
Government
G
$ 130.00
$ 22.00
Podiatrists
H
$ 180.00
$ 24.00
Industrial
I
$ 180.00
$ 24.00
Industrial Medical
IM
$ 260.00
$ 33.00
Health Departments
L
$ 260.00
$ 33.00
Hospitals
M
$ 390.00
$ 44.00
Physicians
P
$ 180.00
$ 24.00
Industrial Radiography
R
$ 380.00
$ 44.00
Services
S
$ 260.00
$ 0.00
Therapy
T
$ 400.00
$ 50.00
Veterinarians
V
$ 130.00
$ 22.00
Other
Z
$ 180.00
$ 24.00
(b) Annual fees for out-of-state persons granted permission
to use sources of radiation in this state pursuant to provisions of Rule .0211
of this Chapter are the same as that provided for in the applicable category
specified in Paragraph (a) of this Rule.
History Note: Authority G.S. 104E-9(a)(8); 104E-19(a);
Eff. July 1, 1982;
Amended Eff. July 1, 2011; August 1, 2007; August 1,
2002; July 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1105 Eff.
February 1, 2015.
10A NCAC 15 .1106 RADIOACTIVE MATERIALS AND ACCELERATOR
FEE AMOUNTS
(a) Annual fees for persons licensed pursuant to provisions
of Section .0300 of this Chapter are as listed in the following table:
Type of Radioactive Material
License Annual Fee
Specific license of broad scope
-Medical Broad $
5,250.00
-Academic Broad $
3,500.00
-Research and Development Broad $
3,000.00
Specific license
-industrial radiography (with
temporary subsites) $ 3,500.00
-industrial radiography (in plant
only) $
2,600.00
-medical institution other than
teletherapy $
2,900.00
-medical private practice $
950.00
-mobile medical practice (home
office including 1 client site) $ 1,600.00
-mobile medical practice (per
additional client location) $ 350.00
-medical teletherapy $
2,100.00
-fixed industrial gauges $
550.00
-portable gauges $
425.00
-gas chromatographs $
375.00
-manufacture or distribute $
2,250.00
-irradiator >100,000Ci $
8,500.00
-irradiator ≤100,000Ci $
4,500.00
-educational institutions $
1,900.00
-water remediation activities
(home office including 1 client site) $ 1,350.00
-water remediation activities (per
additional client location) $ 280.00
-services/consultants $
400.00
-other $
500.00
General licenses
-licenses subject to annual
registration requirements $ 325.00
-licenses not subject to annual
registration requirements $ 200.00
(b) Annual fees for persons licensed pursuant to provisions
of Section .0900 of this Chapter are as listed in the following table:
Type of Accelerator License Annual
Fee
-Medical (home office including 1
unit) $
2,000.00
-Medical (per additional unit) $
200.00
-Industrial/Manufacturing (home
office including 1 unit) $ 2,000.00
-Industrial/Manufacturing (per
additional unit) $ 200.00
-Sales, Service, Refurbishment,
Manufacture $ 2,000.00
(c) Annual fees for out-of-state persons granted permission
to use sources of radiation in this state pursuant to provisions of Rule .0345
of this Chapter are the same as that provided for in the applicable category
specified in Paragraphs (a) and (b) of this Rule. Such fees are due when
application for reciprocal recognition of out-of-state license or registration
is made in the same manner as for a new license or registration as specified in
Rule .1102.
History Note: Authority G.S. 104E-9(a)(8); 104E-19(a);
Eff. August 1, 2007;
Amended Eff. July 1, 2011;
Transferred and Recodified from 15A NCAC 11 .1106 Eff.
February 1, 2015.
SECTION .1200 ‑ LAND DISPOSAL OF RADIOACTIVE WASTE
Codifier's Note: 10 NCAC 03G .3300 was transferred to 15A
NCAC 11 .1200 effective January 4, 1990. Recodification pursuant to G.S.
143B-279.3.
10A NCAC 15 .1201 PURPOSE AND SCOPE
(a) This Section establishes the procedures, criteria, and
terms and conditions upon which the agency issues licenses authorizing land
disposal of low‑level radioactive waste received from other persons for
disposal. Disposal of low‑level radioactive waste by the specific
licensee who generates such waste is subject to the provisions of Rule .1628 of
this Chapter.
(b) The rules in this Section do not apply to the disposal
of:
(1) low‑level radioactive waste which is
higher than Class C waste as defined in Rule .1628 of this Chapter;
(2) byproduct material as defined in Section
11e.(2) of the Atomic Energy Act of 1954, as amended, in quantities greater
than 10,000 kilograms and containing more than five millicuries of radium‑226;
or
(3) licensed radioactive material pursuant to
provisions of Rule .1628 of this Chapter.
(c) Nothing in this Section shall relieve any person of
responsibility for complying with other applicable North Carolina laws and
rules.
(d) This Section is designed to fulfill two objectives:
(1) to meet the requirement of compatibility
with the U.S. Nuclear Regulatory Commission regulations, and
(2) to provide general guidance for the design,
operation, closure and institutional control of a low‑level radioactive
waste disposal facility that has features to enhance its performance and
provide additional confidence in its integrity.
As described in 10 CFR Part 61, Section 61.7 Concepts, land
disposal is intended to further four safety objectives:
(1) protection of the public from releases of
radioactivity,
(2) protection of an inadvertent intruder,
(3) protection of workers at the facility, and
(4) assurance of long‑term stability
after closure. There is every indication in research reports and environmental
impact statements that land disposal with attention to site selection, waste
classification, waste form, segregation and stability will limit radiation
doses to those within the cited performance objectives of 10 CFR Part 61.
Supplementary engineered barriers are included in the rules for North Carolina,
however, to fulfill a further objective, viz,
(5) protection against the possibility of
unforeseen differences between expected and actual behavior of the disposal
system.
The five goals are to be sought through the design,
construction, and operation of a system that involves a carefully chosen
combination of features that are described in existing rules plus additional
requirements for engineered barriers. The total system will make use of
selected processes and structures, such as compaction, solidification,
packaging in high‑integrity containers, placement of wastes, use of
concrete for walls or fill, special trench covers, drainage systems, or other
devices. The facility design objectives are to minimize contact of water with
wastes, facilitate detection of water and contamination, retard release of
radioactive materials, suppress the migration of wastes in the geologic medium,
and accommodate timely recovery of wastes if necessary. Account is to be taken
of radiation dose limits for facility workers and the public, and efforts are
to be made to reduce costs without sacrificing safety.
The concept of "reasonable assurance" is used
throughout this Section. Reasonable assurance is to be understood as placing
primary emphasis on protection of public health and the environment. The cost
of achieving reasonable assurance will be only a secondary consideration.
(e) Persons licensed pursuant to the provisions of this
Section are also subject to the rules in Sections .0100, .0300, .1000, .1100,
and .1600 of this Chapter, except as provided otherwise in this Section.
History Note: Authority G.S. 104E‑2; 104E‑3;
104E‑7; 104E‑10; 104E‑10.1; 104E‑10.2; 104E‑25;
104E‑26;
Eff. December 1, 1987;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1201 Eff.
February 1, 2015.
10A NCAC 15 .1202 DEFINITIONS
As used in this Section, the following definitions shall
apply.
(1) "Active maintenance" means any
significant remedial activity needed during the period of institutional control
to maintain a reasonable assurance that the performance objectives in Rules
.1223 and .1224 of this Section are met. Such active maintenance includes
ongoing activities such as the pumping and treatment of water from a disposal
unit or one‑time measures such as replacement of a disposal unit cover.
Active maintenance does not include custodial activities such as repair of
fencing, repair or replacement of monitoring equipment, revegetation, minor
additions to soil cover, minor repair of disposal unit covers, and general
disposal site upkeep such as mowing grass.
(2) "Buffer zone" is a portion of the
disposal site that is controlled by the licensee and that lies under the
disposal units and between the disposal units and the boundary of the site.
(3) "Chelating agent" means amine
polycarboxylic acids (e.g., EDTA, DTPA), hydroxy‑carboxylic acids, and
polycarboxylic acids (e.g., citric acid, carbolic acid, and gluconic acid).
(4) "Commencement of construction" means
clearing of land, excavation, or other substantial action that would adversely
affect the environment of a land disposal facility. The term does not mean
disposal site exploration, necessary roads for disposal site exploration,
borings to determine foundation conditions, or other preconstruction monitoring
or testing to establish background information related to the suitability of
the disposal site or the protection of environmental values.
(5) "Custodial agency" means the North
Carolina Low‑Level Radioactive Waste Management Authority.
(6) "Disposal" means the isolation of waste
from the biosphere inhabited by man and his food chains by emplacement in a
land disposal facility.
(7) "Disposal site" means that portion of a
land disposal facility which is used for disposal of waste. It consists of
disposal units and a buffer zone.
(8) "Disposal system" means the components
relied on to ensure that the land disposal facility meets the performance
objectives and other requirements of this Section. These components include
the site and its characteristics, the facility and disposal unit design, and
engineered barriers therein, the waste, facility operations and closure,
intruder barriers and institutional control.
(9) "Disposal unit" means a discrete portion
of the disposal site into which waste is placed for disposal. For near‑surface
disposal, the disposal unit is usually a trench.
(10) "Engineered barrier" means engineered
barrier as defined in G.S. 104E‑5(7a).
(11) "Explosive material" means any chemical
compound, mixture, or device, which produces a substantial instantaneous
release of gas and heat spontaneously or by contact with sparks or flame.
(12) "Government agency" means any executive
department, commission, independent establishment, or corporation, wholly or
partly owned by the United States of America or the State of North Carolina and
which is an instrumentality of the United States or the State of North
Carolina; or any board, bureau, department, division, service, office, officer,
authority, administration, or other establishment in the executive branch of
the government.
(13) "Hazardous waste" means those wastes
designated as hazardous by U.S. Environmental Protection Agency regulations in
40 CFR Part 261.
(14) "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.
(15) "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 the
person might be unknowingly exposed to radiation from the waste.
(16) "Intruder barrier" means a sufficient
depth of cover over the waste that inhibits contact with waste and helps to
ensure that radiation exposures to an inadvertent intruder will meet the
performance objectives set forth in this Section, or engineered structures that
provide equivalent protection to the inadvertent intruder.
(17) "Institutional control" means control of
the site after the site is closed and stabilized and responsibility for all
disposed waste and site maintenance is assumed by the custodial agency.
(18) "Land disposal facility" means low‑level
radioactive waste disposal facility as defined in G.S. 104E‑5(9c).
(19) "Low‑level radioactive waste" means
low‑level radioactive waste as defined in G.S. 104E‑5(9a) and
includes naturally occurring and accelerator produced radioactive material
which is not subject to regulation by the U.S. Nuclear Regulatory Commission
under the Atomic Energy Act of 1954, as amended, and is suitable for land
disposal under the provisions in this Section.
(20) "Mixed waste" means waste that satisfies
the definition of low‑level radioactive waste in Item (19) of this Rule
and contains hazardous waste that either:
(a) is listed as a hazardous waste in Subpart D
of 40 CFR Part 261 or
(b) causes the low‑level radioactive waste
to exhibit any of the hazardous waste characteristics identified in Subpart C
of 40 CFR Part 261.
(21) "Monitoring" means observing and making
measurements to provide data to evaluate the performance and characteristics of
the disposal site.
(22) "Near‑surface disposal facility"
means a land disposal facility in which waste is disposed of within
approximately the upper 30 meters of the earth's surface.
(23) "Reconnaissance level information" is any
information or analysis that can be retrieved or generated without the
performance of new comprehensive site‑specific investigations.
Reconnaissance level information includes but is not limited to drilling
records required by state agencies, other Divisions of this Department, and
other relevant published scientific literature.
(24) "Retrieval" means a remedial action for
removal of Class B and C waste from a disposal unit.
(25) "Shallow land burial" means shallow land
burial as defined in G.S. 104E‑5(14a).
(26) "Site closure and stabilization" means
those actions that are taken upon completion of operations that prepare the
disposal site for custodial care and that assure that the disposal site will
remain stable and will not need ongoing active maintenance.
(27) "State" means the State of North Carolina.
(28) "Surveillance" means monitoring and
observation of the disposal site for purposes of visual detection of need for
maintenance, custodial care, evidence of intrusion, and compliance with other
license and regulatory requirements.
(29) "Waste" means low‑level radioactive
waste that is acceptable for disposal in a land disposal facility. For the
purpose of this Section, the words "waste" and "low‑level
radioactive waste" have the same meaning.
History Note: Authority G.S. 104E‑5; 104E‑7;
104E‑10; 104E‑25;
Eff. December 1, 1987;
Amended Eff. May 1, 1993; May 1, 1992; June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1202 Eff.
February 1, 2015.
10A NCAC 15 .1203 LICENSE REQUIRED
(a) No person may receive, possess, and dispose of waste
from other persons at a land disposal facility unless authorized by a license
issued by the agency pursuant to the rules in this Section and the rules in
Section .0300 of this Chapter.
(b) Each person shall file an application with the agency
pursuant to Rule .0317 of this Chapter and obtain a license as provided in this
Section before commencement of construction of a land disposal facility.
Failure to comply with this requirement may be grounds for denial of a license.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
104E‑25; 104E‑26;
Eff. December 1, 1987;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1203 Eff.
February 1, 2015.
10A NCAC 15 .1204 CONTENT OF APPLICATION
An application for a license to receive waste from other
persons and possess and dispose of wastes containing or contaminated with
radioactive material by land disposal shall consist of general information, specific
technical information, environmental information, technical and environmental
analyses, institutional information, and financial information as set forth in
Rules .1205 through .1210 of this Section.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
104E‑25; 104E‑26;
Eff. December 1, 1987;
Transferred and Recodified from 15A NCAC 11 .1204 Eff.
February 1, 2015.
10A NCAC 15 .1205 GENERAL INFORMATION
(a) The general information shall include each of the
following:
(1) identity of the applicant including:
(A) the full name, address, telephone number, and
description of the business or occupation of the applicant;
(B) if the applicant is a partnership, the name and
address of each partner and the principal location where the partnership does
business;
(C) if the applicant is a corporation or an
unincorporated association,
(i) the state where it is incorporated or organized
and the principal location where it does business, and
(ii) the names and addresses of its directors and
principal officers;
(D) if the applicant is acting as an agent or
representative of another person in filing the application, all information required
under this Paragraph shall be supplied with respect to the other person; and
(E) if the applicant proposes to contract the operation
of the disposal facility to another person, the full name, address, and
telephone number of the management contractor, the full name and address of
each applicable principal, partner, or director of the contractor, the state
where it is organized, and the principal location where it does business;
(2) qualifications of the applicant:
(A) the applicable organizational structure of the
applicant, both off site and on site, including a description of lines of
authority and assignments of responsibilities, whether in the form of
administrative directives, contract provisions, or otherwise;
(B) the technical qualifications, including training,
experience, and professional licensure, registration or certification of the
applicant and members of the applicant's staff to engage in the proposed
activities, to include the minimum training, experience, and professional
licensure, registration or certification requirements for personnel filling key
positions described in Part (a)(2)(A) of this Rule;
(C) a description of the applicant's personnel training
program;
(D) the plan to maintain an adequate complement of
trained personnel on site to carry out waste receipt, handling, and disposal
operations in a safe manner;
(E) prior experience in the generation, processing,
use, transportation or disposal of radioactive material or in the treatment,
storage, transportation or disposal of hazardous waste including copies of all
notices of violations; assessments of any administrative, civil, criminal or
other penalties in connection therewith; and all information as to any finding
or determination that the applicant engaged in any of the above mentioned
activities without having in effect any license or permit required for such
activity;
(F) disclosure of any prior determination of civil or
criminal liability with respect to any other federal or state law or
regulation, including but not limited to any law or regulation governing the
transfer of securities, which may reflect on the applicant's character,
reputation or ability to comply with all requirements imposed on a licensee;
and
(G) upon request by the agency, a copy of any
application which the applicant may previously have submitted for any license
or permit required for any activity listed in Part (a)(2)(E) of this Rule;
information as to the disposition of such application including a copy of the
license or permit, information as to any restriction, suspension, revocation or
cancellation of any such license or permit; and any other information which may
be requested by the agency as to the applicant's experience and operating
practices with respect to the activities listed in Part (a)(2)(E) of this Rule;
(3) a description of:
(A) the location of the proposed disposal site;
(B) the general character of the proposed activities;
(C) the types and quantities of waste to be received,
possessed, and disposed of;
(D) plans for use of land disposal facility for purposes
other than disposal of wastes during operation, after closure or both;
(E) the proposed facilities and equipment;
(F) the proposed manifest and recording system;
(G) the treatment of any waste to be shipped off site;
(H) anticipated operating life of the facility; and
(I) the prelicensing and operational public
information program which addresses
(i) state and local government;
(ii) media and public;
(iii) acceptability within the community where the
facility is to be located; and
(iv) the program being implemented to ensure concerns
of the public are being met; and
(4) proposed time schedules for construction,
receipt of waste, and first emplacement of waste at the proposed land disposal
facility.
(b) The following are additional requirements applicable to
the information required in Parts (a)(2)(E) through (G) of this Rule:
(1) All information will be provided by the
applicant with respect to the applicant itself, any predecessor or parent
entity, any officer, director, partner or other principal of the applicant; any
stockholder or other entity holding five percent or more of the stock of, or
other interest in, the applicant; and any subsidiary or other entity in which
the applicant has an interest.
(2) All information will be provided for a
period of not less than 20 years or as may be determined by the agency, with
respect to a particular applicant or class of information, to be necessary to
discharge agency responsibility in G.S. 104E‑10.1(a).
(3) With the approval of the agency, the
applicant may submit any of the information, except as to the disposal of low‑level
radioactive waste, in summary form; provided that any summary must fairly and
accurately reflect the applicant's experience and operating practices and must
indicate the nature and extent of all violations of law and applicable rules.
(4) The agency may request that the applicant
provide any supplemental information needed to effect the purpose of Parts
(a)(2)(E) through (G) of this Rule. All such supplementary information
provided by or on behalf of the applicant will become a part of the
application.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
104E‑10.1; 104E‑25; 104E‑26;
Eff. December 1, 1987;
Amended Eff. June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1205 Eff.
February 1, 2015.
10A NCAC 15 .1206 SPECIFIC TECHNICAL INFORMATION
(a) The specific technical information shall include the
following information needed for demonstration that the performance objectives
and the applicable technical requirements of this Section will be met:
(1) a description of the principal design
criteria and their relationship to the performance objectives, along with
identification of operating facilities of the same or similar design;
(2) a description of the design basis natural
events or phenomena and their relationship to the principal design criteria;
(3) a description of codes and standards which
the applicant has applied to the design and which will apply to construction of
the land disposal facility;
(4) a description of the design features of the
land disposal facility, the disposal units and engineered barriers, to include
those design features related to:
(A) infiltration of water;
(B) leachate collection and removal;
(C) integrity of covers for disposal units and
structural stability of backfill, engineered barriers, and covers;
(D) contact of wastes with standing water and
groundwater;
(E) disposal site drainage;
(F) disposal site closure and stabilization;
(G) elimination to the extent practicable of long‑term
disposal site maintenance, inadvertent intrusion, occupational exposures, and
disposal site monitoring;
(H) adequacy of the size of the buffer zone for
monitoring and potential mitigative measures; and
(I) retrieval;
(5) a description of the construction and
operation of the land disposal facility, to include, as a minimum:
(A) the methods of construction of disposal units and
engineered barriers;
(B) waste emplacement;
(C) the procedures for and areas of waste segregation;
(D) accurate drawings and descriptions of on‑site
buildings including, but not limited to, construction, foundation details,
ventilation, plumbing and fire suppression systems, and proximity to creeks or
culverts;
(E) types of intruder barriers;
(F) on‑site traffic and drainage systems;
(G) physical security system;
(H) survey control program;
(I) methods and areas of waste storage;
(J) facilities for and methods of handling waste
including improperly packaged shipments;
(K) methods to control surface water and groundwater
access to the wastes;
(L) methods to be employed in the handling and disposal
of wastes containing chelating agents or other nonradiological substances that
might affect the meeting of the performance objectives of this Section; and
(M) a flow diagram of waste handling and disposal
operations, a description and accurate drawings of handling equipment, and any
special handling techniques to be employed;
(6) a description of the types, chemical and
physical forms, quantities, classification, and specifications of the
radioactive material proposed to be received, possessed, handled, and disposed
of at the land disposal facility, which shall include:
(A) estimated volume and activity of each waste class to
be received annually at the facility, and
(B) method for control of the rate at which waste is received;
(7) a description of the quality control
program, including audits and managerial controls, for the determination of
natural disposal site characteristics and for quality control during the
design, construction, operation, and closure of the land disposal facility and
during the receipt, handling, and emplacement of waste;
(8) a description of the radiation safety
program for control and monitoring of radioactive effluents to ensure
compliance with the performance objective in Rule .1223 of this Section and
occupational radiation exposure to ensure compliance with the requirements of
Section .1600 of this Chapter and to control contamination of personnel,
vehicles, equipment, buildings, and the disposal site; which description shall
address
(A) both routine operations and accidents; and
(B) procedures, instrumentation, facilities, and
equipment;
(9) an emergency response plan which addresses:
(A) on‑site response;
(B) public alert and notification;
(C) roles of local, county, state and regional agencies;
(D) training and public information; and
(E) if available, copies of most current emergency
response plans submitted to the U.S. Nuclear Regulatory Commission or an
agreement state;
(10) a manual of operating procedures and
emergency procedures including, but not limited to, those for fires, spills or
other events which result in contamination;
(11) a description of the administrative
procedures that the applicant will apply to control activities at the land
disposal facility including hours of proposed operation;
(12) a description of the radiation protection
program including provisions for keeping radiation doses to workers and to
members of the public as low as reasonably achievable (ALARA) and within
applicable limits specified in the rules of this Chapter;
(13) a description of the natural and demographic
disposal site characteristics as determined by disposal site selection and
characterization activities where the description must include geologic,
geotechnical, hydrologic, meteorologic, climatologic, air quality, natural
radiation background and biotic features of the disposal site and vicinity;
where the site characterization shall include sufficient and suitable data for
design and performance analysis; and where the minimum requirements include,
but are not limited to, the following:
(A) geologic description to include:
(i) regional geologic framework including
stratigraphy, tectonics, structure, physiography, seismology and geomorphology;
(ii) site specific stratigraphy, lithology,
structural geology, geochemistry, topography, and an analysis of landforms
including any evidence of destructive geomorphic processes;
(iii) a regional geologic map at a scale of 1:62,500;
(iv) a site specific topographic map at a scale of
1:1,200; and
(v) a site specific geologic map at a scale of
1:1,200 with accompanying cross‑sections;
(B) geotechnical description to include:
(i) soil and saprolite characteristics related to
slope stability, cover integrity, erosion, compaction characteristics for
backfill materials, foundation analyses, gradations for proposed filler
material, and possible interactions between the soils and waste containers; and
(ii) bedrock characteristics related to foundation
analyses and hydrology;
(C) hydrologic description to include:
(i) surface water hydrology including the upstream
drainage area contributing flow across the site and the downstream drainage
area to a distance of approximately ten miles;
(ii) an inventory of existing surface water users
and public water supplies within approximately ten miles downstream of the
site;
(iii) an inventory of potential surface water
impoundments that will be precluded by siting of a disposal facility;
(iv) an inventory and description of all significant
hydrologic units underlying the site to a depth of 100 feet below the level of
waste disposal;
(v) site specific data sufficient to describe the
characteristics, present water quality, occurrence and movement of water in
both the unsaturated and saturated zones;
(vi) an inventory of existing groundwater users
within approximately two miles of the site, both from groundwater wells and at
points of groundwater discharge, e.g. springs;
(vii) identification of the nearest downgradient
groundwater users and the nearest municipal supply relying on groundwater; and
(viii) an inventory of potential groundwater supplies
that will be precluded by siting of a disposal facility;
(D) meteorologic description to include:
(i) determination of a water budget for the
disposal site;
(ii) typical weather patterns; and
(iii) determination of the frequency, probability,
and potential consequences of severe meteorological phenomena;
(E) climatologic description to include:
(i) normal seasonal fluctuations and extremes
predicated from historical records;
(ii) air temperatures and soil temperatures;
(iii) frost penetration; and
(iv) solar radiation;
(F) air quality description to include:
(i) measurement of suspended particulates; and
(ii) the level of airborne radionuclides contributed
by atmospheric fallout, natural radiation released from the soil, and
agricultural activities;
(G) natural radiation background description to include:
(i) sampling of air, soil (both on and off site),
water (both on and off site), flora, fauna, and farm products (including grains
and milk); and
(ii) both total background and contribution from
individual radionuclides; and
(H) biotic description to include:
(i) an accurate, site‑specific inventory of
flora and fauna in and within three miles of the site;
(ii) inventory and distribution of livestock and
crops within three miles of the site;
(14) an identification of the known natural
resources at the disposal site, whose exploitation could result in inadvertent
intrusion into the wastes after removal of active institutional control;
(15) a description of baseline, operational, and
long‑term environmental monitoring programs to include:
(A) inspection and monitoring of waste packages prior to
disposal;
(B) criteria and procedures to stop acceptance of waste
at the facility, including action levels; and
(C) if available, a copy of the last environmental
monitoring reports filed with the U.S. Nuclear Regulatory Commission or
agreement state program or other authorities;
(16) decontamination, decommissioning and site
closure plans, including:
(A) those design features which are intended to
facilitate disposal site closure and to eliminate the need for ongoing active
maintenance;
(B) schedule;
(C) procedure, including documentation that procedure is
effective; and
(D) radioactive waste disposal plan; and
(17) a description of an action plan which would
be implemented in the event of unforeseen differences between expected and
actual behavior of the disposal system and which includes:
(A) a description of conditions which require remedial
action, such as:
(i) erosion and other damage to the stability of
the site;
(ii) failure of physical security features,
equipment or procedures;
(iii) deterioration of trench or disposal unit
covers;
(iv) deterioration of leachate collection system;
(v) clogging or siltation of monitoring and
observation wells;
(vi) the presence of leachate in individual disposal
units;
(vii) the migration of disposed radioactive material;
(viii) changes in site characteristics or other events
which cause or threaten to cause failure of the facility to meet the
performance objectives of this Section;
(ix) specific action levels, events or other
conditions for which the licensee will institute specific remedial actions; and
(x) presence of radioactive concentrations in
groundwater above preoperationally determined background;
(B) provisions for early identification of conditions
requiring remedial action, such as:
(i) detection of water in any disposal unit;
(ii) detection of radioactive contamination in
groundwater with sufficient sampling locations and frequencies to permit
identification of the disposal unit(s) causing the contamination;
(iii) establishment of specific sampling locations,
sampling frequencies and sample types as part of the licensee's environmental
monitoring program;
(iv) methods and frequencies for detection of water
or leachate in disposal units or trenches;
(v) any methods and associated frequencies for
inspecting, testing, maintaining or otherwise assessing the condition and
performance of disposal units, trenches and covers;
(vi) method and frequency for monitoring condition
and physical stability of the site;
(vii) any special monitoring, inspection or testing
which the licensee will institute in response to specific natural or man‑made
occurrences which may affect the ability of the facility to meet the
performance objectives of this Section; and
(viii) any periodic or ongoing evaluation of site
characteristics or changes in site characteristics which relate to the ability
of the facility to meet the performance objectives of this Section;
(C) a description of the corrective measures that will
be taken to correct the condition and otherwise assure compliance with the
performance objectives and technical requirements of this Section, such as:
(i) continued vigilance;
(ii) water and leachate detention;
(iii) pumping or repair of the disposal unit;
(iv) procedures for timely repair or waste retrieval
after problem detection;
(v) redesign of disposal units;
(vi) repair or redesign of engineered barriers;
(vii) revision of site operating procedures, site
personnel training, waste segregation practices, and monitoring and testing
programs;
(viii) revision of disposal methodology; and
(ix) revision of site waste acceptability criteria;
and
(D) identification of facility features which facilitate
remedial actions, such as:
(i) design of disposal units and engineered
barriers which allows access for remedial action; and
(ii) other features necessary to implement the
action plan.
(b) Prior to implementation of detailed site investigations,
the applicant or the North Carolina Low‑Level Radioactive Waste
Management Authority shall develop a site characterization plan and submit it
for approval by the agency to ensure that:
(1) all available data on the site is obtained;
(2) unnecessary laboratory and field
investigations are not done;
(3) required or desired data is obtained;
(4) a proper sequencing and timely acquisition
of the required or desired data is planned and executed;
(5) site survey data stations will be designed
and located, insofar as feasible, so as to serve as planned permanent
monitoring stations as necessary; and
(6) technical and administrative coordination
of laboratory and field efforts is planned and executed.
(c) As site characterization proceeds, the applicant or the
North Carolina Low‑Level Radioactive Waste Management Authority and the
agency shall together review the site characterization results and the site
characterization plan at least once every 90 days to ensure that the plan is
still valid. The site characterization plan shall be modified as required by
the agency.
(d) Time‑variant site characteristics that require
site‑specific measurements shall be measured at such frequency and
duration so as to adequately define the seasonal range of the values. The
minimum period of measurement shall be one year and shall be supplemented,
where possible, with regional data covering a longer time period.
History Note: Authority G.S. 104E‑7; 104E‑9(3);
104E‑10(b); 104E‑25; 104E‑26;
Eff. December 1, 1987;
Amended Eff. January 1, 1994; May 1, 1992;
Transferred and Recodified from 15A NCAC 11 .1206 Eff.
February 1, 2015.
10A NCAC 15 .1207 ENVIRONMENTAL INFORMATION
A license application for land disposal of waste shall
include site‑specific environmental information (or reconnaissance level
information when appropriate) which addresses and quantifies to the extent practicable,
but is not limited to, the following:
(1) statement of need and a description of the proposed
activities identifying the location of the proposed site, the character of the
proposed activities, and any plans for use of the facility for purposes other
than handling and disposal of waste;
(2) area and site characteristics including:
(a) historical and cultural landmarks, state and
national parks, wilderness and wilderness study areas, archaeology, and
demography;
(b) all buildings to a three mile radius;
(c) existing and projected populations and land
use in the general area to a ten mile radius;
(d) nearby drinking water supply watersheds,
groundwater recharge areas, flood plains, wetland areas and other natural
resources such as endangered species habitats, proximity to parks, forests,
wilderness areas and historical sites, and air quality; and
(e) proximity to other low‑level
radioactive waste or hazardous waste facilities;
(3) any irreversible or irretrievable commitments of
natural resources which would be involved should the area be developed as a
disposal site;
(4) to the extent performed by the applicant, site
selection process, including considerations of alternative sites and the
interrelationships between location of waste generators, transportation costs
and means, site characteristics, and compatibility with current land uses;
(5) to the extent performed or selected by the
applicant, project alternatives, including a discussion of the alternatives
considered by the applicant for handling and disposal of waste;
(6) radiological and nonradiological impacts of the
proposed action, including:
(a) surface and groundwater impacts;
(b) socioeconomic impacts;
(c) short‑ and long‑term impacts on
public health and safety;
(d) impacts resulting from irreversible or
irretrievable commitments of resources; and
(e) aesthetic factors such as the visibility,
appearance and noise level of the facility;
(7) transportation routes, route safety, method of
transportation, and environmental effects of postulated operational and
transportation accidents to include:
(a) identification of accident modes with
complete failure modes and effects analysis;
(b) all credible accidents and projected off‑site
impacts, including those occurring in transportation of the waste to or from
the facility; and
(c) mitigation of accidents and protection of
the public;
(8) a list of all governmental permits, licenses,
approvals, and other entitlements obtained or which must be obtained in
connection with the proposed action along with the current status of
applications for and issuance of such permits, licenses, approvals, and other
entitlements;
(9) a description of the maximum projected quantity and
concentration of each radionuclide and toxic or hazardous constituent of the
waste released annually to the air, to the water and to the soil;
(10) a description of the maximum projected radiation
doses to off‑site populations; and
(11) a description of the maximum projected off‑site
radionuclide concentrations in air, soil, water and food.
History Note: Authority G.S. 104E‑7; 104E‑9(3);
104E‑10(b); 104E‑15; 104E‑25; 104E‑26;
Eff. December 1, 1987;
Transferred and Recodified from 15A NCAC 11 .1207 Eff.
February 1, 2015.
10A NCAC 15 .1208 TECHNICAL AND ENVIRONMENTAL ANALYSES
The specific technical and environmental information shall
also include the following analyses needed to demonstrate that the performance
objectives of this Section will be met:
(1) pathways analyzed in demonstrating protection of
the general population from releases of radioactivity shall include air, soil,
groundwater, surface water, plant uptake, and exhumation by burrowing animals.
The analyses shall:
(a) clearly identify and differentiate between
the roles performed by the natural disposal site characteristics and design
features in isolating and segregating the wastes; and
(b) clearly demonstrate that there is reasonable
assurance that the potential exposures to humans from the release of radioactivity
will not exceed the limits set forth in Rule .1223 of this Section.
(2) Analyses of the protection of individuals from
inadvertent intrusion shall include demonstration that there is reasonable
assurance that the waste classification and segregation requirements will be
met and that adequate barriers to inadvertent intrusion will be provided.
(3) Analyses of the protection of individuals during
operations shall include assessments of expected exposures due to routine
operations and likely accidents during handling, storage, and disposal of
waste. The analyses shall provide reasonable assurance that exposures will be
controlled to meet the requirements of Section .1600 of this Chapter.
(4) Analyses of the long‑term stability of the
disposal site and the need for ongoing active maintenance after closure shall
be based upon analyses of active natural processes such as erosion, mass
wasting, slope failure, settlement of wastes and backfill, infiltration through
covers over disposal units and adjacent soils, and surface drainage of the
disposal site. The analyses shall provide reasonable assurance that there will
not be a need for ongoing active maintenance of the disposal site following
closure.
History Note: Authority G.S. 104E‑7; 104E‑9(3);
104E‑10(b); 104E‑25; 104E‑26;
Eff. December 1, 1987;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1208 Eff.
February 1, 2015.
10A NCAC 15 .1209 INSTITUTIONAL INFORMATION
The institutional information shall include:
(1) a certification by the custodial agency or federal
government which owns the disposal site that the custodial agency or federal
government is prepared to accept transfer of the license when the provisions of
Rule .1220 of this Section are met, and will assume responsibility for
custodial care after site closure and postclosure observation and maintenance;
(2) evidence that arrangements have been made for
assumption of ownership in fee by the state or federal government before the
agency issues a license where the proposed disposal site is on land not owned
by the state or federal government;
(3) a description of the ownership of the land and
fixtures that are part of the proposed disposal site; which description must
include a plat plan describing the site and identifying the ownership of the
surface and subsurface estates included, and, where portions of the site have
been leased or will be leased to others, the terms of the lease agreement; and
(4) a description of the contractual terms and
conditions of any agreement for the management or operation of the proposed
disposal site.
History Note: Authority G.S. 104E‑6.1; 104E‑7;
104E‑10(b); 104E‑10.2; 104E‑25; 104E‑26;
Eff. December 1, 1987;
Transferred and Recodified from 15A NCAC 11 .1209 Eff.
February 1, 2015.
10A NCAC 15 .1210 FINANCIAL INFORMATION
(a) The financial information shall be sufficient to
demonstrate that the financial qualifications of the applicant are adequate to
carry out the activities for which the license is sought and meet other
financial assurance requirements of this Section. In addition to information
required in Rule .1205 of this Section, the applicant shall provide the
following financial information:
(1) financial organization of the company;
(2) a list of all subsidiary companies and
their locations;
(3) audited financial statements for the most
recent calendar or fiscal year;
(4) interim statements, if it has been six
months or more since the end of the reporting year;
(5) a detailed schedule of liability insurance
coverage applicable to low‑level radioactive waste, listing:
(A) each insurance company's name,
(B) amount of coverage,
(C) any limitations on coverage,
(D) duration of insurance policies, and
(E) whether the company is licensed by the North
Carolina Insurance Commissioner;
(6) status and nature of any outstanding civil
action to which the applicant is a party, and of any administrative or criminal
proceeding against the applicant; and the same information with respect to any
corporation, partnership, firm, company or association which holds an interest
of five percent or more in the applicant, or in which the applicant holds any
interest; subject to the following provisions:
(A) upon request by the agency, the information required
by this Subparagraph shall include a copy of any document which is a part of
public record in any such action or proceeding;
(B) with the approval of the agency, the applicant may
submit any of the information required by this Subparagraph in summary form,
provided that any summary must fairly and accurately reflect the scope and
content of such information;
(C) with the approval of the agency, the applicant may
exclude information which would otherwise be required by this Subparagraph
provided that the applicant identifies the types of information to be omitted
and satisfies the agency that such types of information are not material to the
applicant's ability to operate a facility under this Section; and
(D) unless specifically requested by the agency, the
following types of actions if brought in North Carolina, or equivalent types of
actions if brought in any other jurisdiction, are excluded from the reporting
requirements of this Subparagraph:
(i) small claims actions as defined in G.S. 7A‑210,
(ii) infractions as defined in G.S. 14‑3.1,
and
(iii) misdemeanors under Chapter 20 (Motor Vehicles)
of the General Statutes; and
(7) details of any other resources such as
reserves or bonds to cover potential damages.
(b) The applicant shall describe the financial
responsibility and liability coverage for:
(1) all injuries to public, property, workers
and environment;
(2) failure to operate as designed; and
(3) post‑closure monitoring and
surveillance.
(c) The information required in Paragraphs (a) and (b) of
this Rule shall be updated annually to the extent that such information is not
provided in the annual certified financial statement required in Rule .1238 of
this Section.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
104E‑10.1; 104E‑25; 104E‑26;
Eff. December 1, 1987;
Amended Eff. June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1210 Eff.
February 1, 2015.
10A NCAC 15 .1211 FILING AND DISTRIBUTION OF APPLICATION
(a) An application for a license under this Section, and
any amendments thereto, shall be filed with the agency, and shall be signed
under oath by the applicant or the applicant's authorized representative who
shall furnish documentation conferring authority. The application filed with
the agency shall consist of one signed original and 12 true copies.
(b) Additional copies of the application shall be retained
by the applicant for distribution in accordance with written instructions from
the agency.
History Note: Authority G.S. 104E‑7; 104E‑10;
104E‑25;
Eff. December 1, 1987;
Transferred and Recodified from 15A NCAC 11 .1211 Eff.
February 1, 2015.
10A NCAC 15 .1212 ELIMINATION OF REPETITION
In its application, the applicant may incorporate, by
reference, information contained in previous applications, statements, or
reports filed with the agency if these references are clear and specific.
History Note: Authority G.S. 104E‑7; 104E‑9(3);
104E‑25;
Eff. December 1, 1987;
Transferred and Recodified from 15A NCAC 11 .1212 Eff.
February 1, 2015.
10A NCAC 15 .1213 UPDATING OF APPLICATION
(a) The application shall be as complete as possible in the
light of information that is available at the time of submittal.
(b) It shall be the responsibility of the applicant to
supplement its application in a timely manner in order to reflect any material
changes in the information required as a part of the application or available
to the applicant, so as to permit the agency to review any such information
prior to issuance of a license.
History Note: Authority G.S. 104E‑7; 104E‑9(3);
104E‑25; 104E‑26;
Eff. December 1, 1987;
Transferred and Recodified from 15A NCAC 11 .1213 Eff.
February 1, 2015.
10A NCAC 15 .1214 STANDARDS FOR ISSUANCE OF A LICENSE
A license for the receipt, possession, and disposal of waste
containing or contaminated with radioactive material shall be issued by the
agency upon finding that the issuance of the license and operation of the
facility will not constitute an unreasonable risk to the health and safety of
the public or have a long‑term detrimental impact on the environment, and
that:
(1) The applicant is qualified by reason of training
and experience to carry out the disposal operations requested in a manner that
adequately protects public health and minimizes danger to life, property or the
environment;
(2) The applicant's proposed disposal site, disposal
design, land disposal facility operations (including equipment, facilities, and
procedures), disposal site closure, and postclosure institutional care are
adequate to protect the public health and safety in that they provide
reasonable assurance that the general population will be protected from
releases of radioactivity as specified in this Section;
(3) The applicant's proposed disposal site, disposal
site design, land disposal facility operations (including equipment,
facilities, and procedures), disposal site closure, and postclosure
institutional control are adequate to protect the public health and safety in
that they will provide reasonable assurance that individual inadvertent
intruders are protected in accordance with this Section;
(4) The applicant's proposed land disposal facility
operations (including equipment, facilities, and procedures) are adequate to
protect the public health and safety in that they will provide assurance that
the standards for radiation protection set out in Section .1600 of this Chapter
will be met;
(5) The applicant's proposed disposal site, disposal
site design, land disposal facility operations, disposal site closure, and
postclosure institutional control are adequate to protect the public health and
safety and the environment in that they will provide reasonable assurance that long‑term
stability of the disposed waste and the disposal site will be achieved and will
eliminate to the extent practicable the need for ongoing active maintenance of
the disposal site following closure;
(6) The applicant has provided reasonable assurance that
the applicable technical requirements of this Section will be met;
(7) The applicant's proposal for institutional control
provides reasonable assurance that such control will be provided for the length
of time found necessary to ensure the findings in Items (2) through (5) of this
Rule and that the institutional control meets the requirements in this Section;
(8) The information on financial assurances meets the
requirements of this Section;
(9) Any additional information as requested by the
agency pursuant to Rule .0317 of this Chapter is adequate; and
(10) The requirements of this Section have been met; and
(11) The applicant proposes a facility to be operated
pursuant to G.S. 104G.
History Note: Authority G.S. 104E‑7; 104E‑9(a)(3);
104E‑10(b); 104E‑12; 104E‑13(a); 104E‑18;
104E‑25; 104E‑26;
Eff. December 1, 1987;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1214 Eff.
February 1, 2015.
10A NCAC 15 .1215 CONDITIONS OF LICENSE
(a) A license issued under this Section, or any right
thereunder, may not be transferred, assigned, or in any manner disposed of,
either voluntarily or involuntarily, directly or indirectly, through transfer
of control of the license to any person, unless the agency finds, after
securing full information, that the transfer is in accordance with the
provisions of the North Carolina Radiation Protection Act (Act) and gives its
consent in writing in the form of a license amendment.
(b) At any time before termination of the license, the
licensee shall submit written statements under oath upon request of the agency
to enable the agency to determine whether or not the license should be
modified, suspended, or revoked.
(c) The license shall be transferred to the custodial
agency only on the full implementation of the final closure plan as approved by
the agency, including postclosure observation and maintenance.
(d) The licensee shall be subject to the provisions of the
Act now or hereafter in effect, and to all rules and orders of the agency.
(e) Any license may be revoked, suspended or modified in
whole or in part for any material false statement in the application or any
misstatement of fact required under the Act, or because of conditions revealed
by any application or statement of fact or any report, record, or inspection or
other means which would warrant the agency to refuse to grant a license on the
original application, or for failure to operate the facility in accordance with
the terms of the license, or for any violation of, or failure to observe any of
the terms and conditions of the Act, or any rule, license or order of the
agency.
(f) Each person licensed by the agency pursuant to the
rules in this Section shall confine possession and use of radioactive materials
to the locations and purposes authorized in the license.
(g) No waste may be disposed of until the agency has
inspected the land disposal facility and has found it to be in conformance with
the description, design, and construction described in the application for a
license.
(h) The agency may, in accordance with 46 FR 7540,
incorporate in any license at the time of issuance, or thereafter, by
appropriate order, additional requirements and conditions with respect to the
licensee's receipt, possession, and disposal of waste as it deems appropriate
or necessary in order to:
(1) protect the health and safety of the public
and the environment, or minimize danger to life or property; and
(2) require reports and the keeping of records,
and to provide for inspections of activities under the license that may be
necessary or appropriate to effectuate the purposes of the Act and rules
thereunder.
(i) The agency may incorporate in any license at
the time of issuance, or thereafter, by appropriate order, a requirement that
the licensee provide the agency with continuing information with respect to any
information required as a part of the license application.
(j) Except as provided otherwise by the agency pursuant to
Paragraph (h) of this Rule and consistent with G.S. 104E‑25(h), the
licensee shall not accept or dispose of:
(1) liquid waste which has not been solidified
in a manner deemed acceptable by the agency as meeting the requirements in G.S.
104E‑25(h);
(2) any waste containing chelating agents in
concentrations greater than one‑tenth of one percent by weight unless:
(A) the chelating agent content does not exceed eight
percent by weight, and
(B) the waste has been solidified and meets the
stability requirements for class B and C waste as may be specified by the
agency after consideration of current regulatory guides on waste form of the
U.S. Nuclear Regulatory Commission, provided however that high integrity
containers alone are not acceptable to achieve this stability requirement; and
(3) such other waste as the agency may prohibit
as necessary to ensure that the performance objectives of this Section will be
met.
(k) Each license will be issued for a period of five years
from the date of issuance. The authority to dispose of wastes expires on the
date stated in the license except as provided in Rule .1217 of this Section.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
104E‑12; 104E‑13(a); 104E‑25; 104E‑26; 10 C.F.R.
Chapter 1, Commission Notices, Policy Statements, Agreement States, 46 F.R.
7540;
Eff. December 1, 1987;
Amended Eff. June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1215 Eff.
February 1, 2015.
10A NCAC 15 .1216 AMENDMENT OF LICENSE
(a) An application for amendment of a license shall be
filed in accordance with Rules .1211, .1212 and .1213 of this Section, and
shall fully describe the changes desired.
(b) In determining whether an amendment to a license will
be approved, the agency will apply the criteria set forth in Rule .1214 of this
Section.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
104E‑25;
Eff. December 1, 1987;
Transferred and Recodified from 15A NCAC 11 .1216 Eff.
February 1, 2015.
10A NCAC 15 .1217 APPLICATION FOR RENEWAL OR CLOSURE
(a) Any expiration date on a license applies only to the
above ground activities and to the authority to dispose of waste. Failure to
renew the license shall not relieve the licensee of responsibility for
implementing site closure, postclosure observation, and transfer of the license
to the custodial agency. An application for renewal or an application for
closure under Rule .1218 of this Section shall be filed at least 90 days prior
to license expiration.
(b) Applications for renewal of a license shall be filed in
accordance with Rules .1204 through .1213 of this Section. Applications for
closure shall be filed in accordance with Rules .1211, .1212, .1213 and .1218
of this Section.
(c) In any case in which a licensee has timely filed an
application for renewal of a license, the license for continued receipt and
disposal of licensed materials shall not expire until the agency has taken
final action on the application for renewal.
(d) In determining whether a license will be renewed, the
agency will apply the criteria set forth in Rule .1214 of this Section.
(e) Upon approval of an application for renewal pursuant to
provisions of this Rule, the agency will issue the license renewal amendment to
expire five years from the date of final agency action on the application for
renewal.
History Note: Authority G.S. 104E‑7; 104E‑10;
104E‑10.1; 104E‑18; 104E‑25;
Eff. December 1, 1987;
Transferred and Recodified from 15A NCAC 11 .1217 Eff.
February 1, 2015.
10A NCAC 15 .1218 CONTENTS OF APPLICATION FOR CLOSURE
(a) Prior to final closure of the disposal site, or as
otherwise directed by the agency, the applicant shall submit an application to
amend the license for closure. This closure application shall include a final
revision and specific details of the disposal site closure plan included as
part of the license application submitted under Rule .1206 of this Section that
includes each of the following:
(1) any additional geologic, geochemical,
hydrologic, or other data obtained during the operational period pertinent to
the long‑term containment of emplaced wastes;
(2) the results of tests, experiments, or any
other analyses relating to backfill of excavated areas, closure and sealing,
waste migration and interaction with emplacement media, or any other tests,
experiments, or analyses pertinent to the long‑term containment of
emplaced waste within the disposal site;
(3) any proposed revision of plans for:
(A) decontamination and dismantlement of surface facilities;
(B) backfilling of excavated areas; or
(C) stabilization of the disposal site for postclosure
care; and
(4) any significant new information regarding
the environmental impact of closure activities and long‑term performance
of the disposal site.
(b) Upon review and consideration of an application to
amend the license for closure submitted in accordance with Paragraph (a) of
this Rule, the agency may issue an amendment authorizing closure if there is
reasonable assurance that the long‑term performance objectives of this
Section will be met.
History Note: Authority G.S. 104E‑7; 104E‑9(3);
104E‑10; 104E‑10.1; 104E‑18; 104E‑25;
104E‑26; 104G‑13; 104G‑14;
Eff. December 1, 1987;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1218 Eff.
February 1, 2015.
10A NCAC 15 .1219 POSTCLOSURE OBSERVATION AND
MAINTENANCE
Following completion of closure authorized in Rule .1218 of
this Section, the licensee shall observe, monitor, and carry out necessary
maintenance and repairs at the disposal site until the site closure is complete
and the license is transferred by the agency in accordance with Rule .1220 of
this Section. Responsibility for the disposal site shall be maintained by the
licensee for five years. A shorter or longer time period for postclosure observation
and maintenance may be established and approved as part of the site closure
plan, based on site‑specific conditions.
History Note: Authority G.S. 104E‑7; 104E‑10;
104E‑10.1; 104E‑18; 104E‑25; 104G‑13; 104G‑14;
Eff. December 1, 1987;
Transferred and Recodified from 15A NCAC 11 .1219 Eff.
February 1, 2015.
10A NCAC 15 .1220 TRANSFER OF LICENSE
Following closure and the period of postclosure observation
and maintenance, the licensee may apply for an amendment to transfer the
license to the custodial agency. The license shall be transferred when the
agency finds:
(1) that the closure of the disposal site has been made
in conformance with the licensee's disposal site closure plan, as amended and
approved as part of the license;
(2) that reasonable assurance has been provided by the
licensee that the performance objectives of this Section are met;
(3) that any funds and necessary records for care will
be transferred to the Long‑Term Care Fund and the custodial agency,
respectively;
(4) that sufficient funds have accumulated in the Long‑Term
Care Fund to support anticipated agency and custodial agency costs for all
future observation, monitoring, maintenance and remedial actions;
(5) that the postclosure monitoring program is
operational for implementation by the custodial agency; and
(6) that the custodial agency or the federal agency
which will assume responsibility for institutional control of the disposal site
is prepared to assume responsibility and ensure that the institutional
requirements found necessary under Item (7) of Rule .1214 of this Section will be
met.
History Note: Authority G.S. 104E‑7; 104E‑10;
104E‑10.1; 104E‑12; 104E‑16; 104E‑18; 104E‑25;
104E‑26; 104G‑13; 104G‑14;
Eff. December 1, 1987;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1220 Eff.
February 1, 2015.
10A NCAC 15 .1221 TERMINATION OF LICENSE
(a) Following any period of institutional control needed to
meet the requirements found necessary under Rule .1214 of this Section, the
custodial agency may apply for an amendment to terminate the license.
(b) This application shall be filed, and will be reviewed,
in accordance with the provisions of Rule .1211 of this Section and Paragraph
(a) of this Rule.
(c) A license will be terminated only when the agency
finds:
(1) that the institutional control requirements
found necessary under Item (7) of Rule .1214 of this Section have been met; and
(2) that any additional requirements resulting
from new information developed during the institutional control period have
been met, and that permanent monuments or markers warning against intrusion
have been installed.
History Note: Authority G.S. 104E‑7; 104E‑10;
104E‑25; 104G‑13; 104G‑14;
Eff. December 1, 1987;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1221 Eff.
February 1, 2015.
10A NCAC 15 .1222 PERFORMANCE OBJECTIVES: GENERAL
REQUIREMENT
Land disposal facilities shall be sited, designed, operated,
closed, and controlled after closure so that reasonable assurance exists that
exposures to humans do not exceed the limits established in the performance
objectives in Rules .1223 through .1225 of this Section.
History Note: Authority G.S. 104E‑7; 104E‑10;
104E‑25; 104E‑26;
Eff. December 1, 1987;
Transferred and Recodified from 15A NCAC 11 .1222 Eff.
February 1, 2015.
10A NCAC 15 .1223 PROTECTION OF POPULATION FROM RELEASES
OF RADIOACTIVITY
(a) The design goal of the engineered barrier and other
requirements in this Section is confinement of the disposed waste and contained
radioactivity for at least the designed life of the required engineered
barriers, with reasonable assurance that any release of radioactivity or
radiation will not exceed the limits stated in Paragraph (b) of this Rule and
will be as low as reasonably achievable as provided in Paragraph (c) of this Rule.
(b) Land disposal facilities shall not cause external
radiation levels or release concentrations of radioactive material to the
general environment in groundwater, surface water, air, soil, plants, or
animals that result in an annual equivalent dose to any member of the public,
above background as determined in accordance with Rule .1231 of this Section,
exceeding:
(1) 25 millirems to the whole body,
(2) 75 millirems to the thyroid, or
(3) 25 millirems to any other organ.
(c) In accordance with the ALARA plan required by Rule
.1206 of this Section, the licensee shall maintain releases of radioactivity in
effluents to the general environment and resultant radiation dose to the public
as low as reasonably achievable below the limits imposed in Paragraph (b) of
this Rule.
History Note: Authority G.S. 104E‑7; 104E‑10;
104E‑25; 104E‑26;
Eff. December 1, 1987;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1223 Eff.
February 1, 2015.
10A NCAC 15 .1224 PROTECTION OF INDIVIDUALS FROM
INADVERTENT INTRUSION
Design, operation, and closure of the land disposal facility
shall ensure protection of any individual inadvertently intruding into the
disposal site and occupying the site or contacting the waste at any time after
active institutional controls over the disposal site are removed.
History Note: Authority G.S. 104E‑7; 104E‑10;
104E‑25; 104E‑26;
Eff. December 1, 1987;
Transferred and Recodified from 15A NCAC 11 .1224 Eff.
February 1, 2015.
10A NCAC 15 .1225 PROTECTION OF INDIVIDUALS DURING
OPERATIONS
(a) Operations at the land disposal facility shall be
conducted in compliance with the standards for radiation protection set out in
Section .1600 of this Chapter, except as provided in Rule .1223 of this Section
for the off‑site public.
(b) In accordance with the ALARA plan required by Rule
.1206 of this Section, the licensee shall maintain occupational radiation doses
as low as reasonably achievable below the occupational radiation dose limits
established in Section .1600 of this Chapter.
History Note: Authority G.S. 104E‑7; 104E‑10;
104E‑25; 104E‑26;
Eff. December 1, 1987;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1225 Eff.
February 1, 2015.
10A NCAC 15 .1226 STABILITY OF THE DISPOSAL SITE AFTER
CLOSURE
The disposal facility shall be sited, designed, used,
operated, and closed to achieve long‑term stability of the disposal site
and to eliminate to the extent practicable the need for ongoing active
maintenance of the disposal site following closure so that only surveillance,
monitoring, and minor custodial care are required.
History Note: Authority G.S. 104E‑7; 104E‑10;
104E‑25; 104E‑26;
Eff. December 1, 1987;
Transferred and Recodified from 15A NCAC 11 .1226 Eff.
February 1, 2015.
10A NCAC 15 .1227 TECHNICAL REQUIREMENTS FOR LAND
DISPOSAL FACILITIES
The technical requirements for land disposal facilities are
set forth in Rules .1228 through .1234 of this Section.
History Note: Authority G.S. 104E‑7; 104E‑10;
104E‑25; 104E‑26;
Eff. December 1, 1987;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1227 Eff.
February 1, 2015.
10A NCAC 15 .1228 DISPOSAL SITE SUITABILITY REQUIREMENTS
(a) The disposal site shall be capable of being
characterized, modeled, analyzed, and monitored.
(b) Within the region where the facility is to be located,
a disposal site should be selected so that projected population growth and
future developments are not likely to affect the ability of the disposal
facility to meet the performance objectives of this Section.
(c) Areas shall be avoided having known natural resources
which, if exploited, would result in failure to meet the performance objectives
of this Section.
(d) The disposal site shall be well drained and free of
areas of flooding or frequent ponding. Waste disposal shall not take place in
a 100‑year flood plain, coastal high‑hazard area or wetland, as
defined in Executive Order 11988, "Floodplain Management Guidelines."
(e) Upstream drainage areas shall be minimized to decrease
the amount of runoff which could erode or inundate disposal units.
(f) The disposal site shall provide sufficient depth to the
water table that groundwater intrusion, perennial or otherwise, into the waste
will not occur, provided however that the depth to the water table shall be
sufficient to ensure that the bottom of the disposal facility may be at least
seven feet above the seasonal high water table as provided in G.S. 104E‑25(j).
(g) Areas shall be avoided that are the recharge areas of
sole source aquifers or drinking water supply watersheds unless it can be
demonstrated with reasonable assurance that the disposal site will be designed,
constructed, operated, and closed without an unreasonable risk to an aquifer or
drinking water supplies.
(h) Waste disposal shall not take place within 1000 feet of
drinking water wells, except for on‑site wells controlled by the licensee
and used to supply water solely to the facility. This minimum distance may be
increased in any lateral direction when required by site‑specific
conditions.
(i) The hydrogeologic unit used for disposal shall not
discharge groundwater to the surface within the disposal site.
(j) Areas shall be avoided where tectonic processes such as
faulting, folding, seismic activity, or vulcanism may occur with such frequency
and extent to significantly affect the ability of the disposal site to meet the
performance objectives of this Section, or may preclude defensible modeling and
prediction of long‑term impacts.
(k) Areas shall be avoided where surface geologic processes
such as mass wasting, erosion, slumping, landsliding, or weathering occur with
such frequency and extent to significantly affect the ability of the disposal
site to meet the performance objectives of this Section, or may preclude
defensible modeling of long‑term impacts.
(l) The disposal site shall not be located where nearby
facilities or activities could adversely impact the ability of the site to meet
the performance objectives of this Section or significantly mask the
environmental monitoring program.
History Note: Authority G.S. 104E‑7; 104E‑10;
104E‑25; 104E‑26;
Eff. December 1, 1987;
Transferred and Recodified from 15A NCAC 11 .1228 Eff.
February 1, 2015.
10A NCAC 15 .1229 SITE DESIGN FOR LAND DISPOSAL
(a) Shallow land burial is prohibited as provided in G.S.
104E‑20(b).
(b) Site design features shall be directed toward long‑term
isolation and avoidance of the need for continuing active maintenance after
site closure.
(c) The disposal site design and operation shall be
compatible with the disposal site closure and stabilization plan and lead to
disposal site closure that provides reasonable assurance that the performance
objectives of this Section will be met.
(d) The disposal site shall be designed to complement and
improve, where appropriate, the ability of the disposal site's natural
characteristics to assure that the performance objectives of this Section will
be met.
(e) Covers shall be designed to minimize water
infiltration, to direct percolating or surface water away from the disposed
waste, and to resist degradation by surface geologic processes and biotic
activity.
(f) Surface features shall direct surface water drainage
away from disposal units at velocities and gradients which will not result in
erosion that will require ongoing active maintenance.
(g) The disposal site shall be designed to minimize the
contact of water with waste during storage, the contact of standing water with
waste during disposal, and the contact of percolating or standing water with
wastes after disposal.
(h) The disposal units shall incorporate engineered
barriers. The disposal units and incorporated engineered barriers shall be
designed and constructed to meet the performance objectives, technical
requirements and design criteria in G.S. 104E‑25 and the following
additional requirements:
(1) The engineered barriers shall provide
reasonable assurance that they will complement, and where appropriate improve,
the land disposal facility's ability to isolate the radioactive waste through
the institutional control period;
(2) Engineered barrier structural integrity
shall be maintained under normal and abnormal conditions of operation;
(3) Engineered barriers shall prevent contact
between the surrounding earth and the waste, except for earth that may be used
as fill material within the disposal unit; and
(4) The disposal units shall be constructed or
emplaced in a manner which will ensure that the bottom of the disposal facility
is at least seven feet above the seasonal high water table or more if necessary
to meet the performance objectives of this Section.
(i) The licensee shall develop, operate and maintain the
site in a manner that will not diminish the hydrogeological performance of the
site below the requirements contained in the rules of this Section.
History Note: Authority G.S. 104E‑7; 104E‑10;
104E‑25; 104E‑26;
Eff. December 1, 1987;
Amended Eff. May 1, 1993; May 1, 1992;
Transferred and Recodified from 15A NCAC 11 .1229 Eff.
February 1, 2015.
10A NCAC 15 .1230 FACILITY OPERATION AND DISPOSAL SITE
CLOSURE
(a) Wastes designated as Class A pursuant to Rule .1650 of
this Chapter shall be segregated from other wastes by placement in disposal
units which are sufficiently separated from disposal units for the other waste
classes so that any interaction between Class A wastes and other wastes will
not result in the failure to meet the performance objectives of this Section.
This segregation is not necessary for Class A wastes if they meet the stability
requirements in Rule .1651(b) of this Chapter.
(b) Wastes designated as Class C pursuant to Rule .1650 of
this Chapter shall be disposed of so that the top of the waste is a minimum of
five meters below the top surface of the cover or shall be disposed of with
intruder barriers that are designed to protect against an inadvertent intrusion
for at least 500 years.
(c) Wastes shall be emplaced in a manner that maintains the
package integrity during emplacement, minimizes the void spaces between packages,
and permits the void spaces to be filled.
(d) Void spaces between waste packages shall be filled with
earth or other material to reduce future subsidence within the fill.
(e) Waste shall be placed and covered in a manner that
limits the radiation dose rate at the surface of the cover to levels that at a
minimum will permit the licensee to comply with all provisions of Rule .1611 of
this Chapter at the time the license is transferred pursuant to Rule .1220 of
this Section.
(f) The boundaries and locations of each disposal unit
shall be accurately located and mapped by means of land survey. Disposal units
shall be marked in such a way that the boundaries of each unit can be easily
defined. Three permanent survey marker control points, referenced to the North
American Datum of 1983 (NAD83) and the current North American Vertical Datum
(NAVD), as defined and maintained by the National Geodetic Survey, shall be
established on the site to facilitate surveys. The three established control
stations shall be positioned both horizontally and vertically by surveys tied
to the NAD83 and NAVD as maintained in the North Carolina Geodetic Survey
record files. All such surveys shall comply with standards and specifications
in "Standards and Specifications for Geodetic Control Networks (September
1984)" and "Geometric Geodetic Survey Accuracy Standards and
Specifications for Geodetic Surveys using GPS Relative Positioning
Techniques" of the Federal Geodetic Control Committee, as approved by
North Carolina Geodetic Survey.
(g) A buffer zone of land shall be maintained between any
buried waste and the disposal site boundary and beneath the disposed waste.
The buffer zone shall be of adequate dimensions to carry out environmental
monitoring activities specified in Rule .1231(c) of this Section and to permit
mitigative measures if needed.
(h) Closure and stabilization measures as set forth in the
approved site closure plan shall be carried out as each disposal unit is filled
and covered.
(i) Active waste disposal operations shall not have an
adverse effect on completed closure and stabilization measures.
(j) Mixed waste is prohibited. The Radiation Protection
Commission may waive the prohibition of disposal of mixed waste provided the
Radiation Protection Commission determines that the following conditions are
met:
(1) The disposal will conform to all other
rules in this Section; and
(2) The disposal will conform to all
requirements of the federal Low‑Level Radioactive Waste Policy Amendments
Act of 1985, G.S. 104E as amended, G.S. 130A Article 9 as amended, and
regulations issued pursuant thereunto.
History Note: Authority G.S. 104E‑7; 104E‑10;
104E‑25; 104E‑26; 150B‑19(6);
Eff. December 1, 1987;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1230 Eff.
February 1, 2015.
10A NCAC 15 .1231 ENVIRONMENTAL MONITORING
(a) A preoperational monitoring program shall be conducted
to provide basic environmental data on the disposal site characteristics and to
determine the pre‑existing background radiation levels. At the time a license
application is submitted, a preoperational monitoring program shall have been
conducted to provide basic environmental data on the disposal site
characteristics. The data shall include information about the ecology,
meteorology, climate, hydrology, geology, geochemistry, and seismology of the
disposal site. For those characteristics that are subject to seasonal
variation, data must cover at least a 12 month period.
(b) During the land disposal facility site construction and
operation, the licensee shall maintain a monitoring program where:
(1) Measurements and observations shall be made
and recorded to provide data to evaluate the potential health and environmental
impacts during both the construction and the operation of the facility, and to
enable the evaluation of long‑term effects and the need for mitigative
measures; and
(2) The monitoring program shall be capable of
providing early warning of releases of radionuclides before they reach the
disposal site boundary.
(c) After the disposal site is closed, the licensee
responsible for postoperational surveillance of the disposal site shall
maintain a monitoring program where:
(1) The monitoring program is based on the
operating history and the closure and stabilization of the disposal site; and
(2) The monitoring program shall be capable of
providing early warning of releases of radionuclides before they reach the
disposal site boundary, and shall include sufficient numbers, types and
locations of wells to permit detection of groundwater radioactive
contamination.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
104E‑25; 104E‑26;
Eff. December 1, 1987;
Transferred and Recodified from 15A NCAC 11 .1231 Eff.
February 1, 2015.
10A NCAC 15 .1232 VARIANCE
History Note: Authority G.S. 104E‑7; 104E‑9(3);
104E‑10(b); 104E‑25; 104E‑26;
Eff. December 1, 1987;
Repealed Eff. July 1, 1990 in accordance with G.S. 150B‑59(c);
Transferred and Recodified from 15A NCAC 11 .1232 Eff.
February 1, 2015.
10A NCAC 15 .1233 WASTE CLASSIFICATION AND
CHARACTERISTICS
(a) Waste shall be classified in accordance with provisions
of Rule .1650 of this Chapter.
(b) Waste shall meet the applicable characteristics
prescribed in Rule .1651 of this Chapter.
(c) Each container of waste shall be labelled in accordance
with provisions of Rule .1652 of this Chapter.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
104E‑25; 104E‑26;
Eff. December 1, 1987;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1233 Eff.
February 1, 2015.
10A NCAC 15 .1234 INSTITUTIONAL REQUIREMENTS
(a) Disposal of waste received from other persons may be
permitted only on land owned in fee simple by the State of North Carolina or
the federal government at a facility which is sited and operated pursuant to
provisions of G.S. 104G.
(b) The custodial agency shall conduct an institutional
control program to physically control access to the disposal site following
transfer of control of the disposal site from the disposal site operator.
(c) The institutional control program shall also include,
but not be limited to, conducting an environmental monitoring program at the
disposal site, periodic surveillance, minor custodial care, and other
requirements as determined by the agency; and administration of funds to cover
the costs for these activities.
(d) The period of institutional controls will be determined
by the agency, but shall be no less than 100 years following transfer of
control of the disposal site to the custodial agency.
(e) Notwithstanding the period of institutional control
which may be required by the agency pursuant to Paragraph (d) of this Rule,
such institutional control may not be relied upon for the purpose of meeting
site performance criteria for more than 100 years following transfer of control
of the disposal site to the custodial agency.
History Note: Authority G.S. 104E‑6.1; 104E‑7;
104E‑10.2; 104E‑16; 104E‑18; 104E‑25;
104E‑26;
Eff. December 1, 1987;
Transferred and Recodified from 15A NCAC 11 .1234 Eff.
February 1, 2015.
10A NCAC 15 .1235 APPLICANT QUALIFICATIONS AND
ASSURANCES
The applicant shall show that it either possesses the
necessary funds or has reasonable assurance of obtaining the necessary funds,
or by a combination of the two, to cover the estimated costs of conducting all
licensed activities over the planned operating life of the project.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
104E‑10.1; 104E‑25; 104E‑26;
Eff. December 1, 1987;
Transferred and Recodified from 15A NCAC 11 .1235 Eff.
February 1, 2015.
10A NCAC 15 .1236 FUNDING OF CLOSURE: STABILIZATION:
INSTITUTIONAL CONTROLS
(a) The applicant shall provide assurances prior to the
commencement of operations that sufficient funds will be available to carry out
disposal site closure, stabilization and institutional controls, including:
(1) decontamination or dismantlement of land
disposal facility structures; and
(2) closure and stabilization of the disposal
site so that following transfer of the disposal site to the custodial agency,
the need for ongoing active maintenance is eliminated to the extent practicable
and only minor custodial care, surveillance, and monitoring are required.
(b) The amount of the assurances in Paragraph (a) of this
Rule shall be established by the Commission and shall be based on agency‑approved
cost estimates reflecting the agency‑approved plan for disposal site
closure and stabilization and agency estimates of the costs which may be
associated with the period of institutional controls. In estimating such
costs, the agency shall consider applicant‑prepared cost estimates which
shall take into account total costs that would be incurred if an independent
contractor were hired to perform the closure and stabilization work.
(c) The licensee shall submit the financial or surety arrangements
annually for review by the agency to assure that sufficient funds will be
available for completion of the closure plan and for anticipated institutional
care.
(d) The amount of the licensee's financial or surety
arrangement shall change in accordance with changes in the predicted costs of
closure, stabilization and institutional care. Factors affecting closure,
stabilization and institutional care cost estimates include inflation,
increases in the amount of disturbed land, changes in engineering plans,
closure and stabilization that has already been accomplished, and any other
conditions affecting costs. The financial or surety arrangements shall be
sufficient at all times to cover the costs of closure, stabilization and
institutional care of the disposal units that are expected to be used before
the next license renewal.
(e) The amount of the licensee's financial and surety
arrangements as determined in Paragraph (d) of this Rule may be reduced
annually by the actual amount of funds deposited by the licensee in the Long‑Term
Care Fund pursuant to such fees as may be established by the North Carolina Low‑Level
Radioactive Waste Management Authority under the provisions of G.S. 104G‑15.
(f) The financial or surety arrangement shall be written for
a specified period of time, shall run in favor of the Long‑Term Care
Fund, and shall be automatically renewed unless the person who issues the
surety notifies the agency, the site owner, and the principal (the licensee)
not less than 90 days prior to the renewal date of its intention not to renew.
In such a situation, the licensee must submit a replacement surety within 30
days after notification of cancellation. If the licensee fails to provide a
replacement surety acceptable to the agency within 30 days after notification
of cancellation, the agency may require the North Carolina Low‑Level
Radioactive Waste Management Authority to collect on the original surety for
deposit in the Long‑Term Care Fund.
(g) Proof of forfeiture shall not be necessary to collect
the surety so that, in the event that the licensee does not provide an
acceptable replacement surety within the required time, the surety shall be
automatically collected prior to its expiration. The conditions described in
this Paragraph and in Paragraph (f) of this Rule shall be clearly stated on any
surety instrument.
(h) Financial or surety arrangements generally acceptable
to the Commission and agency include: surety bonds, cash deposits,
certificates of deposit, deposits of government securities, escrow accounts,
irrevocable letters or lines of credit, trust funds, and combinations of the
above or such other types of arrangements as may be approved by the agency,
consistent with provisions of G.S. 104E‑18. Self‑insurance, or any
arrangement which essentially constitutes self‑insurance, will not
satisfy the surety requirement for private sector applicants.
(i) The licensee's financial or surety arrangement shall
remain in effect until the closure and stabilization program has been completed
and approved by the agency, custody of the site and disposed waste has been
accepted by the custodial agency, and the license has been terminated by the
agency.
(j) In order to avoid unnecessary duplication of expense,
the agency will accept sureties that have been consolidated with earmarked
financial or surety arrangements established to meet requirements of federal or
other state agencies for such decontamination, closure, and stabilization. The
agency will accept these arrangements only if they are considered adequate to
satisfy the requirements of Paragraphs (a) to (i) of this Rule and that portion
of the surety which covers the closure of the disposal site is clearly
identified and committed for use in accomplishing these activities.
History Note: Authority G.S. 104E‑7; 104E‑16;
104E‑17; 104E‑18; 104E‑19(b); 104E‑25;
104E‑26;
Eff. December 1, 1987;
Transferred and Recodified from 15A NCAC 11 .1236 Eff.
February 1, 2015.
10A NCAC 15 .1237 RECORDS: REPORTS: TESTS: AND
INSPECTIONS
Requirements for records, reports, tests and inspections are
described in Rules .1238 through .1241 of this Section.
History Note: Authority G.S. 104E‑7; 104E‑11;
104E‑12; 104E‑25; 104E‑26;
Eff. December 1, 1987;
Transferred and Recodified from 15A NCAC 11 .1237 Eff.
February 1, 2015.
10A NCAC 15 .1238 MAINTENANCE OF RECORDS: REPORTS AND
TRANSFERS
(a) Each licensee shall maintain any records and make any
reports in connection with the licensed activities, as may be required by the
conditions of the license or by the rules.
(b) Records which are required by the rules or by license
conditions shall be maintained for a period specified by the appropriate rules
or by license conditions. If a retention period is not otherwise specified,
these records shall be maintained and transferred to the agency as specified in
the rules in Section .1600 of this Chapter as a condition of license
termination unless the agency otherwise authorizes their disposition.
(c) Records which shall be maintained pursuant to this
Section may be the original or a copy or microfilm, provided the records are
capable of being clearly and legibly reproduced. The following records shall
be maintained in a permanent form specified by or approved by the agency in
writing:
(1) the location and inventory of disposed waste,
to include generator‑specific and other information which may be required
by the agency;
(2) personnel exposure, bioassay and other
personnel dose assessment records;
(3) geologic, hydrologic and other site
characterization records; and
(4) any other records that the agency deems
appropriate to be maintained in a permanent form based on a determination that
retention of the records is necessary to ensure protection of the public and
environment during the institutional control period.
(d) If there is a conflict between the agency's rules or
license conditions pertaining to the retention period for the same type of
record, the longer retention period specified takes precedence.
(e) Notwithstanding Paragraphs (a) through (d) of this
Rule, copies of records of the location and the quantity of wastes contained in
the disposal site shall be transferred to the agency upon transfer of the
license to the custodial agency or upon termination of the license.
(f) Following receipt and acceptance of a shipment of
waste, the licensee shall record the date of receipt and disposal of the waste,
the location in the disposal site, the condition of the waste packages as
received, any discrepancies between materials listed on the manifest and those
received, and any evidence of leaking or damaged packages or radiation or
contamination levels in excess of limits specified in U.S. Department of
Transportation and agency rules. The licensee shall briefly describe any
repackaging operations of any of the waste packages included in the shipment,
plus any other information required by the agency as a license condition.
(g) Each licensee authorized to dispose of waste received
from other persons shall file a copy of its financial report or a certified
financial statement annually with the agency in order to update the information
base for determining financial qualifications.
(h) Each licensee authorized to dispose of waste materials
received from other persons pursuant to this Section shall submit annual
reports to the agency in accordance with Subparagraphs (h)(1) through (h)(4) of
this Rule.
(1) Reports shall be submitted by the end of
the first calendar quarter of each year for the preceding year.
(2) If the quantities of radioactive materials
released during the reporting period, monitoring results, or maintenance
performed are significantly different from those expected in the materials
previously reviewed as part of the licensing action, the reports shall cover
this specifically.
(3) The reports shall include:
(A) specification of the quantity of each of the
principal radionuclides released to unrestricted areas in liquid and in
airborne effluents during the preceding year;
(B) the results of the environmental monitoring program;
(C) a summary of licensee disposal unit survey and
maintenance activities;
(D) the location and inventory of disposed waste,
including location of each discrete waste shipment or portion thereof;
(E) a summary, by waste class, of activities and
quantities of radionuclides disposed of;
(F) any instances in which observed site
characteristics were significantly different from those described in the
application for a license; and
(G) any other information the agency may require.
(4) Reports shall be submitted in duplicate to
the agency. The agency shall transfer one copy of each report to the State
Records Center for permanent retention.
(i) Any transfer of radioactive materials by the licensee
is subject to the requirements in Rule .0343 of this Chapter.
History Note: Authority G.S. 104E‑7; 104E‑9(a)(3);
104E‑12; 104E‑15; 104E‑25; 104E‑26;
Eff. December 1, 1987;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1238 Eff.
February 1, 2015.
10A NCAC 15 .1239 TESTS AT LAND DISPOSAL FACILITIES
Each licensee shall perform, or permit the agency to
perform, any tests the agency deems appropriate or necessary for the
administration of the rules of this Section, including tests of:
(1) wastes and facilities used for the receipt,
storage, handling, and disposal of wastes;
(2) radiation detection and monitoring instruments; and
(3) other equipment and devices used in connection with
the receipt, possession, handling, storage, or disposal of waste.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
104E‑25; 104E‑26;
Eff. December 1, 1987;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1239 Eff.
February 1, 2015.
10A NCAC 15 .1240 AGENCY INSPECTIONS OF LAND DISPOSAL
FACILITIES
(a) Each licensee shall afford to the agency at all
reasonable times opportunity to inspect:
(1) waste not yet disposed of;
(2) the premises, equipment, operations, and
facilities in which wastes are received, possessed, handled, treated, stored or
disposed of; and
(3) records kept by the licensee pursuant to
the applicable rules of this Chapter.
(b) Authorized representatives of the agency may copy and
take away copies of, for the agency's use, any record required to be kept
pursuant to provisions of this Section.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
104E‑11; 104E‑12; 104E‑25; 104E‑26;
Eff. December 1, 1987;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1240 Eff.
February 1, 2015.
10A NCAC 15 .1241 INSPECTION
(a) The agency may require at any disposal site that the
licensee provide appropriate office and storage space for a resident inspector
who is employed by the agency.
(b) The agency may require the licensee to refuse acceptance
of low‑level radioactive waste from any generator, if the agency makes
one or more of the following determinations:
(1) the generator has shipped waste to the
licensee's facility without filing the manifest required in Rule .1633 of this
Chapter;
(2) the generator has improperly described
waste in a manifest contrary to the requirements in Rule .1633 of this Chapter;
(3) the generator has shipped to the licensee's
facility waste which is prohibited by any rule of this Chapter or by condition
of the site operator's license;
(4) the generator has shipped to the licensee's
facility improperly labeled or packaged containers of waste; or
(5) the generator has failed to comply with
applicable rules of this Chapter.
(c) In the event that the agency prohibits the licensee
from receiving waste from any generator pursuant to Paragraph (b) of this Rule,
the agency shall notify the licensee and the generator both verbally and in
writing, stating the nature and basis for the prohibition, the corrective actions
required to terminate the prohibition and the rights of the affected persons
regarding the prohibition.
History Note: Authority G.S. 104E‑7; 104E‑10(b);
104E‑11; 104E‑12; 104E‑25; 104E‑26;
Eff. December 1, 1987;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1241 Eff.
February 1, 2015.
10A NCAC 15 .1242 NOTIFICATIONS AND REPORTS
(a) The licensee shall submit to the agency monthly reports
of all containers or shipments of waste which arrive at the site and are found
by licensee personnel to be in violation of any provision of the rules of this
Chapter. The monthly reports shall include the name, mailing address,
telephone number, radioactive material license number, and description and date
of the violation; shall cover a period of one calendar month; and shall be
submitted to the agency within 20 days after the end of the calendar month
covered by the report.
(b) The licensee shall immediately notify the agency in the
event that the licensee determines that the limits imposed in Paragraph (b) of
Rule .1223 of this Chapter have been exceeded.
(c) The licensee shall notify the agency within 30 days
after the licensee determines that on‑site migration in groundwater of
disposed radioactivity has occurred along with an explanation of the remedial
actions taken in accordance with applicable requirements in this Section.
(d) The licensee shall notify the agency within 24 hours
after the licensee determines that off‑site migration of disposed
radioactivity has occurred.
(e) The licensee shall also notify the agency in accordance
with applicable requirements in Section .1600 of this Chapter.
History Note: Authority G.S. 104E‑7; 104E‑9(3);
104E‑10(b); 104E‑25; 104E‑26;
Eff. December 1, 1987;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1242 Eff.
February 1, 2015.
SECTION .1300 ‑ REQUIREMENTS FOR WIRELINE‑SERVICE
OPERATORS AND SUBSURFACE‑TRACER STUDIES
Codifier's Note: 10 NCAC 03G .3400 was transferred to 15A
NCAC 11 .1300 effective January 4, 1990. Recodification pursuant to G.S.
143B-279.3.
10A NCAC 15 .1301 PURPOSE AND SCOPE
(a) The rules in this Section apply to all licensees who
use sources of radiation for wireline‑service operations including
mineral logging, radioactive markers, or subsurface tracer studies.
(b) The requirements of this Section are in addition to,
and not in substitution for, the requirements of Sections .0100, .0300, .0900,
.1000, .1100 and .1600 of this Chapter.
History Note: Authority G.S. 104E‑7;
Eff. June 1, 1989;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1301 Eff.
February 1, 2015.
10A NCAC 15 .1302 DEFINITIONS
As used in this Section, the following definitions apply:
(1) "Energy compensation sources (ECS)" means
a sealed source, with an activity not exceeding 100 microcuries (3.7 MBq), used
within a logging tool or other tool components, to provide a reference standard
to maintain the tool's calibration when in use.
(2) "Field station" means a facility where
radioactive sources may be stored or used and from which equipment is
dispatched to temporary jobsites.
(3) "Injection tool" means a device used for
controlled subsurface injection of radioactive tracer material.
(4) "Logging supervisor" means the individual
who provides personal supervision of the utilization of sources of radiation at
the well site.
(5) "Logging tool" means a device used
subsurface to perform well-logging.
(6) "Mineral logging" means any logging
performed for the purpose of mineral exploration other than oil or gas.
(7) "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.
(8) "Radioactive marker" means radioactive
material placed subsurface or on a structure intended for subsurface use for
the purpose of depth determination or direction orientation.
(9) "Source holder" means a housing or
assembly into which a radioactive source is placed for the purpose of
facilitating the handling and use of the source in well-logging operations.
(10) "Subsurface-tracer study" means the
release of a substance tagged with radioactive material for the purpose of
tracing the movement or position of the tagged substance in the well-bore or
adjacent formation.
(11) "Temporary jobsite" means a location to
which radioactive materials have been dispatched to perform wireline-service
operations or subsurface-tracer studies.
(12) "Tritium neutron generator target source"
means a tritium source used within a neutron generator tube to produce neutrons
for use in well logging applications.
(13) "Well-bore" means a drilled hole in which
wireline-service operations and subsurface-tracer studies are performed.
(14) "Well-logging" means the lowering and
raising of measuring devices or tools which may contain sources of radiation
into well-bores or cavities for the purpose of obtaining information about the
well or adjacent formations.
(15) "Wireline" means a cable containing one or
more electrical conductors which is used to lower and raise logging tools in
the well-bore.
(16) "Wireline-service operations" means any
evaluation or mechanical service which is performed in the well-bore using
devices on a wireline.
History Note: Authority G.S. 104E‑7;
Eff. June 1, 1989;
Amended Eff. January 1, 2005;
Transferred and Recodified from 15A NCAC 11 .1302 Eff.
February 1, 2015.
10A NCAC 15 .1303 WRITTEN AGREEMENTS REQUIRED
No licensee shall perform wireline‑service operations
with a sealed source unless, prior to commencement of the operation, the
licensee has a written agreement with the well operator, well owner, drilling contractor,
or land owner. The written agreement required in this Rule shall certify that:
(1) In the event a sealed source is lodged downhole, a
reasonable effort to recover the source will be made; and
(2) In the event a decision is made to abandon the sealed
source downhole, the requirements of Rule .1324(c) and (d) of this Section
shall be met.
History Note: Authority G.S. 104E‑7;
Eff. June 1, 1989;
Amended Eff. November 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1303 Eff.
February 1, 2015.
10A NCAC 15 .1304 LIMITS ON LEVELS OF RADIATION
Sources of radiation shall be used, stored, and transported
in such a manner that the transportation requirements of Section .0300 of this
Chapter and the dose limitation requirements of Section .1600 of this Chapter
are met.
History Note: Authority G.S. 104E‑7;
Eff. June 1, 1989;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1304 Eff.
February 1, 2015.
10A NCAC 15 .1305 STORAGE PRECAUTIONS
(a) Each source of radiation, except accelerators, shall be
provided with a storage and transport container. The container shall be
provided with a lock, or tamper seal for calibration sources, to prevent unauthorized
removal of or exposure to the source of radiation.
(b) Sources of radiation shall be stored in a manner which
will minimize the danger from explosion or fire.
History Note: Authority G.S. 104E‑7;
Eff. June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1305 Eff.
February 1, 2015.
10A NCAC 15 .1306 TRANSPORT PRECAUTIONS
Transport containers shall be physically secured to the
transporting vehicle to prevent accidental loss, tampering, or unauthorized
removal.
History Note: Authority G.S. 20‑167.1; 104E‑7;
104E‑10(b); 104E‑15(a);
Eff. June 1, 1989;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1306 Eff.
February 1, 2015.
10A NCAC 15 .1307 RADIATION SURVEY INSTRUMENTS
(a) The licensee shall maintain sufficient calibrated and
operable radiation survey instruments at each field station and temporary
jobsite to make physical radiation surveys as required by this Section and by
Section .1600 of this Chapter. Instrumentation shall be capable of measuring beta
and gamma radiation from 0.1 milliroentgen per hour through at least 50
milliroentgens per hour.
(b) Each radiation survey instrument shall be calibrated:
(1) at intervals not to exceed six months and
after each instrument servicing;
(2) at energies and radiation levels
appropriate for use; and
(3) so that accuracy within plus or minus 20
percent of the true radiation level can be demonstrated on each scale.
(c) Calibration records shall be maintained for a period of
three years for inspection by the agency.
History Note: Authority G.S. 104E‑7; 104E‑12(a)(1);
Eff. June 1, 1989;
Amended Eff. January 1, 2005; January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1307 Eff.
February 1, 2015.
10A NCAC 15 .1308 LEAK TESTING OF SEALED SOURCES
(a) Each licensee using sealed sources of radioactive
material shall have the sources tested for leakage. Records of leak test
results shall be kept in units of microcuries and maintained for inspection by
the agency for six months after the next required leak test is performed or
until transfer or disposal of the sealed source.
(b) Tests for leakage shall be performed using a leak test
kit or method approved by the agency in accordance with these Rules and only by
persons specifically authorized to perform such tests by the agency, the U.S.
Nuclear Regulatory Commission, an agreement state, or a licensing state. The
test sample shall be taken from the surface of the source, source holder, or
from the surface of the device in which the source is stored or mounted and on
which one might expect contamination to accumulate. The test sample shall be
analyzed for radioactive contamination, and the analysis shall be capable of
detecting the presence of 0.005 microcurie of radioactive material on the test
sample.
(c) Each sealed source of radioactive material, with the
exception of energy compensation sources (ECSs), shall be tested at intervals
not to exceed six months. Each ECS source that is not exempted from leak
testing pursuant to Paragraph (e) of this Rule shall be tested at intervals not
to exceed three years. In the absence of a certificate from a transferor
indicating that a test has been made prior to the transfer, the sealed source
shall not put into use until tested. If, for any reason, it is suspected that
a sealed source may be leaking, it shall be removed from service immediately
and tested for leakage as soon as practical.
(d) If the test reveals the presence of 0.005 microcurie or
more of leakage or contamination, the licensee shall immediately withdraw the
source from use and shall cause it to be decontaminated, repaired, or disposed
of in accordance with these Rules. A report describing the equipment involved,
the test results, and the corrective action taken shall be filed with the
agency.
(e) The following sources are exempt from the periodic leak
test and notification requirements of this Rule:
(1) hydrogen‑3 (tritium) sources;
(2) sources of radioactive material with a half‑life
of 30 days or less;
(3) sealed sources of radioactive material in
gaseous form;
(4) sources of beta‑ or gamma‑emitting
radioactive material with an activity of 100 microcuries or less; and
(5) sources of alpha- or neutron-emitting
radioactive material with an activity of ten microcuries or less.
History Note: Authority G.S. 104E‑7; 104E‑12(a);
Eff. June 1, 1989;
Amended Eff. January 1, 2005; May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1308 Eff.
February 1, 2015.
10A NCAC 15 .1309 QUARTERLY INVENTORY
Each licensee shall conduct a quarterly physical inventory
to account for all sources of radiation. Records of inventories shall be
maintained for two years from the date of the inventory for inspection by the
agency and shall include the quantities and kinds of sources of radiation, the
location where sources of radiation are assigned, the date of the inventory,
and the name of the individual conducting the inventory.
History Note: Authority G.S. 104E‑7; 104E‑12(a)(1);
Eff. June 1, 1989;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1309 Eff.
February 1, 2015.
10A NCAC 15 .1310 UTILIZATION RECORDS
(a) Each licensee shall maintain current utilization
records showing the following information for each source of radiation:
(1) make, model number, and a serial number or
a description of each source of radiation used;
(2) the identity of the well‑logging
supervisor or field unit to whom assigned;
(3) locations where used and dates of use; and
(4) in the case of tracer materials and
radioactive markers, the radionuclide and activity used in a particular well.
(b) The licensee shall maintain the utilization records,
required in Paragraph (a) of this Rule, for inspection by the agency for a
period of two years from the date of the recorded event(s).
History Note: Authority G.S. 104E‑7; 104E‑12(a)(1);
Eff. June 1, 1989;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1310 Eff.
February 1, 2015.
10A NCAC 15 .1311 DESIGN: PERFORMANCE: AND CERTIFICATION
CRITERIA
(a) Each sealed source used in downhole operations, except
those containing radioactive material in gaseous form, shall meet the following
minimum criteria:
(1) be of doubly encapsulated construction;
(2) contain radioactive material whose chemical
and physical forms are as insoluble and non‑dispersible as practical; and
(3) meet the requirements in Paragraphs (b),
(c) and (d) of this Rule.
(b) For a sealed source manufactured on or before July 14,
1989, a licensee may use the sealed source for downhole operations if it meets
the requirements of USASI N5.10-1968, "Classification of Sealed
Radioactive Sources," or the requirements in Paragraphs (c) and (d) of
this Rule.
(c) For a sealed source manufactured after July 14, 1989, a
licensee may use the sealed source for downhole operations if it meets the
oil-well logging requirements of ANSI/HPS N43.6-1977, "Sealed Radioactive
Sources, Classification."
(d) For a sealed source manufactured after July 14, 1989, a
licensee may use the source for downhole operations if the sealed source's
prototype has been tested and found to maintain its integrity after being
subjected to each of the following tests:
(1) The
test source shall be held at -40° C for
20 minutes, 600° C for one hour, and
then be subjected to a thermal shock test with a temperature drop from 600° C to 20°
C within 15 seconds;
(2) A
5 kg steel hammer, 2.5 cm in diameter, shall be dropped from a height of 1
meter onto the test source;
(3) The
test source shall be subjected to a vibration from 25 Hz to 500 Hz at 5 g
amplitude for 30 minutes;
(4) A
1 gram hammer and pin, 0.3 cm pin diameter, shall be dropped from a height of 1
meter onto the test source; and
(5) The
test source shall be subjected to an external pressure of 24,600 pounds per
square inch absolute (1.695x107 pascals).
(e) The requirements of Paragraphs (a) through (d) of this
Rule do not apply to energy compensation sources (ECSs).
History Note: Authority G.S. 104E‑7;
Eff. June 1, 1989;
Amended Eff. January 1, 2005;
Transferred and Recodified from 15A NCAC 11 .1311 Eff.
February 1, 2015.
10A NCAC 15 .1312 LABELING
(a) General requirements are as follows:
(1) Each source, source holder, or logging tool
containing radioactive material shall bear a durable, legible, and clearly
visible marking or label, which has, as a minimum, the standard radiation
caution symbol, without the conventional color requirement, and the following
wording:
CAUTION
RADIOACTIVE
MATERIAL
(2) The marking or labeling required in
Subparagraph (a)(1) of this Rule shall be on the smallest component transported
as a separate piece of equipment.
(3) Each transport container shall have
permanently attached to it a durable, legible, and clearly visible label which
has, as a minimum, the standard radiation caution symbol and the following
wording:
CAUTION
RADIOACTIVE
MATERIAL
NOTIFY CIVIL
AUTHORITIES (OR NAME OF COMPANY)
(4) Each
uranium sinker bar used by the licensee in downhole operations shall be legibly
impressed with the following wording:
CAUTION
RADIOACTIVE
DEPLETED URANIUM
NOTIFY
CIVIL AUTHORITIES (OR NAME OF COMPANY)
(b) The word "danger" may be substituted for the
word "caution" in the signs described in this Rule.
History Note: Authority G.S. 104E‑7; 104E‑12(a)(1);
Eff. June 1, 1989;
Amended Eff. January 1, 2005;
Transferred and Recodified from 15A NCAC 11 .1312 Eff.
February 1, 2015.
10A NCAC 15 .1313 INSPECTION AND MAINTENANCE
(a) Each licensee shall conduct, at intervals not to exceed
six months, a program of inspection and maintenance of source holders, logging
tools, source handling tools, storage containers, transport containers, and
injection tools to assure proper labeling and proper physical condition. The
licensee shall maintain records of inspection and maintenance for a period of
two years for inspection by the agency.
(b) If any inspection conducted pursuant to Paragraph (a)
of this Rule reveals damage to labeling or components critical to radiation
safety, the licensee shall remove the device from service until repairs have
been made.
(c) The repair, opening, or modification of any sealed
source shall be performed only by persons specifically authorized to do so by
the agency, the U.S. Nuclear Regulatory Commission, an agreement state, or a
licensing state.
History Note: Authority G.S. 104E‑7;
Eff. June 1, 1989;
Amended Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1313 Eff.
February 1, 2015.
10A NCAC 15 .1314 TRAINING REQUIREMENTS
(a) No licensee shall permit any individual to act as a
logging supervisor until such individual has:
(1) received, in a course recognized by the
agency, the U.S. Nuclear Regulatory Commission, an agreement state, or a
licensing state, instruction in the subjects outlined in Rule .1325 of this
Section and demonstrated an understanding thereof;
(2) read, received instruction in and
demonstrated an understanding of the rules contained in this Section and the
applicable rules in Sections .0100, .1000, and .1600 of this Chapter or their
equivalent, conditions of appropriate license or certificate of registration,
and the licensee's operating and emergency procedures; and
(3) demonstrated competence to use sources of
radiation, related handling tools, and radiation survey instruments which will
be used on the job.
(b) No licensee shall permit any individual to assist in
the handling of sources of radiation until such individual has:
(1) read or received instruction in the
licensee's operating and emergency procedures and demonstrated an understanding
thereof; and
(2) demonstrated competence to use, under the
personal supervision of the logging supervisor, the sources of radiation,
related handling tools, and radiation survey instruments which will be used on
the job.
(c) The licensee shall provide safety reviews for logging
supervisors and logging assistants at least once during each calendar year.
(d) The licensee shall maintain employee training records
for inspection by the agency for two years following termination of employment.
History Note: Authority G.S. 104E‑7; 104E‑12(a)(1);
10 C.F.R. Chapter 1, Commission Notices,
Policy Statements, Agreement States, 46 F.R. 7540;
Eff. June 1, 1989;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1314 Eff.
February 1, 2015.
10A NCAC 15 .1315 OPERATING AND EMERGENCY PROCEDURES
The licensee's operating and emergency procedures shall
include instructions in at least the following:
(1) handling and use of sources of radiation to be
employed so that no individual is likely to be exposed to radiation doses in
excess of the standards established in Section .1600 of this Chapter;
(2) methods and occasions for conducting radiation
surveys;
(3) methods and occasions for locking and securing
sources of radiation;
(4) personnel monitoring and the use of personnel
monitoring equipment;
(5) transportation to temporary jobsites and field
stations, including the packaging and placing of sources of radiation in
vehicles, placarding of vehicles, and securing sources of radiation during
transportation;
(6) minimizing exposure of individuals in the event of
an accident;
(7) procedure for notifying proper personnel in the
event of an accident;
(8) maintenance of records;
(9) inspection and maintenance of source holders,
logging tools, source handling tools, storage containers, transport containers,
and injection tools;
(10) procedure to be followed in the event a sealed
source is lodged downhole; and
(11) procedures to be used for picking up, receiving, and
opening packages containing radioactive materials.
History Note: Authority G.S. 104E‑7;
Eff. June 1, 1989;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1315 Eff.
February 1, 2015.
10A NCAC 15 .1316 PERSONNEL MONITORING
(a) No licensee shall permit any individual to act as a
logging supervisor or to assist in the handling of sources of radiation unless
each such individual wears a personnel dosimeter that is processed and
evaluated by an accredited National Voluntary Laboratory Accreditation Program
(NVLAP) processor.
(b) Each personnel dosimeter required in Paragraph (a) of
this Rule shall be assigned to and worn by only one individual.
(c) Each film badge shall be replaced at least monthly and
other personnel dosimeters shall be replaced at least quarterly. Each film
badge or other personnel dosimeter shall be submitted for processing within 30
days of replacement.
(d) The licensee shall maintain personnel monitoring
records for inspection until the agency terminates each pertinent license or
registration requiring the record.
History Note: Authority G.S. 104E‑7; 104E‑12(a)(2);
Eff. June 1, 1989;
Amended Eff. January 1, 2005;
Transferred and Recodified from 15A NCAC 11 .1316 Eff.
February 1, 2015.
10A NCAC 15 .1317 SECURITY
During each logging or tracer application, the logging
supervisor or other designated employee of the licensee shall maintain direct
surveillance of the operation to protect against unauthorized or unnecessary
entry into a restricted area, as defined in Section .0100 of this Chapter.
History Note: Authority G.S. 104E‑7;
Eff. June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1317 Eff.
February 1, 2015.
10A NCAC 15 .1318 HANDLING TOOLS
The licensee shall provide and require the use of tools that
will assure remote handling of sealed sources other than low‑activity
calibration sources.
History Note: Authority G.S. 104E‑7;
Eff. June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1318 Eff.
February 1, 2015.
10A NCAC 15 .1319 SUBSURFACE‑TRACER STUDIES
(a) Protective gloves and other appropriate protective
clothing and equipment shall be used by all personnel handling radioactive
tracer material. Precautions shall be taken to avoid ingestion or inhalation
of radioactive material.
(b) No licensee shall cause the injection of radioactive
material as part of a subsurface‑tracer element study without prior
written authorization from any other agency which may regulate or require prior
approval for such injection.
History Note: Authority G.S. 104E‑7;
Eff. June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1319 Eff.
February 1, 2015.
10A NCAC 15 .1320 PARTICLE ACCELERATORS
No licensee shall permit above‑ground testing of
particle accelerators, designed for use in well‑logging, which results in
the production of radiation, except in areas of facilities controlled or
shielded so that the applicable requirements of Rules .1604 and .1611 of this
Chapter are met.
History Note: Authority G.S. 104E‑7;
Eff. June 1, 1989;
Amended Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1320 Eff.
February 1, 2015.
10A NCAC 15 .1321 RADIATION SURVEYS
(a) The licensee shall make and record radiation surveys
and calculations for each area where radioactive materials are stored.
(b) The licensee shall make and record radiation surveys
and calculations for the radiation levels in occupied positions and on the
exterior of each vehicle used to transport radioactive material. Such surveys
and calculations shall include each source of radiation or combination of
sources to be transported in the vehicle.
(c) After removal of the sealed source from the logging
tool and before departing the jobsite, the licensee shall use the logging tool
detector or a survey meter to assure that the logging tool is free of
contamination.
(d) The licensee shall make and record radiation surveys at
the jobsite or well‑head for each tracer operation, except those using
hydrogen‑3, carbon‑14, and sulfur‑35. These surveys shall
include measurements of radiation levels before and after the operation.
(e) Records required pursuant to Paragraphs (a) through (d)
of this Rule shall include the dates, the identification of individual(s)
making the survey, the identification of survey instrument(s) used, and an
exact description of the location of the survey. The licensee shall maintain
records of these surveys for inspection by the agency for two years after
completion of the survey.
History Note: Authority G.S. 104E‑7; 104E‑12(a)(1);
Eff. June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1321 Eff.
February 1, 2015.
10A NCAC 15 .1322 DOCUMENTS AND RECORDS REQUIRED AT
FIELD STATIONS
Each licensee shall maintain at any field station, for
inspection by the agency, the following documents and records for the specific
devices, sources and personnel used at the field station:
(1) appropriate license or equivalent document;
(2) operating and emergency procedures;
(3) applicable regulations;
(4) records of the latest survey instrument
calibrations made pursuant to Rule .1307 of this Section;
(5) results of the most recent leak test performed
pursuant to Rule .1308 of this Section;
(6) quarterly inventories required in Rule .1309 of
this Section;
(7) utilization records required in Rule .1310 of this
Section;
(8) records of inspection and maintenance required in
Rule .1313 of this Section;
(9) survey records required in Rule .1321 of this
Section; and
(10) certificate or authorization documents.
History Note: Authority G.S. 104E‑7;
Eff. June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1322 Eff.
February 1, 2015.
10A NCAC 15 .1323 DOCUMENTS AND RECORDS REQUIRED AT
TEMPORARY JOBSITES
Each licensee conducting operations at a temporary jobsite
shall have the following documents and records available at that site for
inspection by the agency:
(1) operating and emergency procedures;
(2) survey records required in Rule .1321 of this
Section for the period of operation at the site;
(3) evidence of current calibration for the radiation
survey instruments in use at the site;
(4) when operating in the state under reciprocity, a
copy of the appropriate license, certificate of registration, or equivalent
documents(s); and
(5) certificate of training and/or document showing
authorized use of material.
History Note: Authority G.S. 104E‑7;
Eff. June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1323 Eff.
February 1, 2015.
10A NCAC 15 .1324 NOTIFICATION OF INCIDENTS:
ABANDONMENT: AND LOST SOURCES
(a) The licensee shall comply with the applicable
notification requirements in Section .1600 of this Chapter for incidents and
sources lost in other than downhole logging operations.
(b) Whenever a sealed source or device containing
radioactive material is lodged downhole, the licensee shall:
(1) monitor at the surface for the presence of
radioactive contamination with a radiation survey instrument or logging tool
during logging tool recovery operations; and
(2) notify the agency immediately by telephone
if radioactive contamination is detected at the surface or if the source
appears to be damaged.
(c) When it becomes apparent that efforts to recover the
radioactive source will not be successful, the licensee shall:
(1) advise the well‑operator of the rules
of the appropriate state agency with jurisdiction over abandonment and
appropriate method of abandonment, which shall include:
(A) the immobilization and sealing in place of the
radioactive source with a concrete plug;
(B) a means of preventing inadvertent intrusion on the
source, unless the source is not accessible to any subsequent drilling
operations; and
(C) the mounting of a permanent identification plaque,
at the surface of the well, containing the information required by Paragraph
(d) of this Rule;
(2) notify the agency by telephone, giving the
circumstances of the loss and requesting approval of the proposed abandonment
procedures; and
(3) file a written report with the agency
within 30 days of the abandonment, setting forth the following information:
(A) date of occurrence and a brief description of
attempts to recover the source; and
(B) a description of the radioactive source involved,
including radionuclide, quantity, and chemical and physical form;
(i) surface location and identification of well,
(ii) results of efforts to immobilize and set the
source in place,
(iii) depth of the radioactive source,
(iv) depth of the top of the cement plug,
(v) depth of the well, and
(vi) information contained on the permanent
identification plaque.
(d) Whenever a sealed source containing radioactive
material is abandoned downhole, the licensee shall provide a permanent plaque
for posting the well or well‑bore. This plaque shall:
(1) be constructed of long‑lasting
material, such as stainless steel, brass, bronze, or monel;
(2) be at least 7 inches (17 cm) square and 1/8
inch (3mm) thick; and
(3) contain the following information engraved
on its face;
(A) the word "CAUTION";
(B) the radiation symbol without the conventional color
requirement;
(C) the date of abandonment;
(D) the name of the well‑operator or well owner;
(E) the well name and well identification number(s) or
other designation;
(F) the sealed source(s) by radionuclide and quantity
of activity;
(G) the source depth and the depth to the top of the
plug; and
(H) an appropriate warning, depending on the specific
circumstances of each abandonment, which may include:
(i) "Do not drill below plug back depth",
(ii) "Do not enlarge casing", or
(iii) "Do not re-enter the hole" before
contacting the agency at the address in Rule .0111 of this Chapter.
(e) The licensee shall immediately notify the agency by
telephone and subsequently by confirming letter if the licensee knows or has
reason to believe that radioactive material has been lost in or to an
underground potable water source. Such notice shall designate the well
location and shall describe the magnitude and extent of loss of radioactive
material, assess the consequences of such loss, and explain efforts planned or
being taken to mitigate the consequences.
History Note: Authority G.S. 104E‑7;
Eff. June 1, 1989;
Amended Eff. January 1, 2005; January 1, 1994; May 1,
1992;
Transferred and Recodified from 15A NCAC 11 .1324 Eff.
February 1, 2015.
10A NCAC 15 .1325 SUBJECTS IN TRAINING COURSES FOR
LOGGING SUPERVISORS
Training courses for logging supervisors shall address at
least the following subjects:
(1) fundamentals of radiation safety:
(a) characteristics of radiation;
(b) units of radiation dose and quantity of
radioactivity;
(c) significance of radiation dose:
(i) radiation protection standards,
(ii) biological effects of radiation dose,
(d) levels of radiation from sources of
radiation;
(e) methods of minimizing radiation dose:
(i) working time,
(ii) working distance,
(iii) shielding,
(2) radiation detection instrumentation to be used:
(a) use of radiation survey instruments;
(b) operation;
(c) calibration;
(d) limitations;
(e) survey techniques;
(f) use of personnel monitoring equipment;
(3) equipment to be used:
(a) handling equipment;
(b) sources of radiation;
(c) storage and control of equipment;
(d) operation and control of equipment;
(4) the requirements of pertinent federal and state
regulations;
(5) the licensee's written operating and emergency
procedures;
(6) the licensee's record keeping procedures.
History Note: Authority G.S. 104E‑7;
Eff. June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1325 Eff.
February 1, 2015.
10A NCAC 15 .1326 ENERGY COMPENSATION SOURCES
The licensee shall use an energy compensation source (ECS)
which is contained within a logging tool, or other tool components, only if the
ECS contains quantities of licensed material not exceeding 100 microcuries (3.7
MBq).
(1) For
downhole operations utilizing a surface casing for protecting fresh water
aquifers, use of the ECS is subject only to the requirements of Rules .1308,
.1309, .1310, and .1323 of this Section.
(2) For
downhole operations without a surface casing for protecting fresh water
aquifers, use of the ECS is subject only to the requirements of Rules .1303,
.1308, .1309, .1310, .1323, and .1324 of this Section.
History Note: Authority G.S. 104E‑7;
Eff. January 1, 2005;
Transferred and Recodified from 15A NCAC 11 .1326 Eff.
February 1, 2015.
10A NCAC 15 .1327 TRITIUM NEUTRON GENERATOR TARGET
SOURCES
(a) The use of a tritium neutron generator target source
containing quantities of radioactive material not exceeding 30 Curies (1,110
MBq) in a well with a surface casing to protect fresh water aquifers is subject
to the requirements of this Section excluding Rules .1303, .1311, and .1324.
(b) The use of a tritium neutron generator target source
which contains quantities of radioactive material exceeding 30 Curies (1,110
MBq) or which is used in a well without a surface casing to protect fresh water
aquifers is subject to the requirements of this Section excluding Rule .1311.
History Note: Authority G.S. 104E‑7;
Eff. January 1, 2005;
Transferred and Recodified from 15A NCAC 11 .1327 Eff.
February 1, 2015.
SECTION .1400 ‑ TANNING FACILITIES
Codifier's Note: 10 NCAC 03G .3500 was transferred to 15A
NCAC 11 .1400 effective January 4, 1990. Recodification pursuant to G.S.
143B-279.3.
10A NCAC 15 .1401 PURPOSE AND SCOPE
(a) This Section provides for the registration and
regulation of facilities and equipment which employ ultraviolet and other lamps
for the purpose of tanning the skin of the living human body through the
application of ultraviolet radiation.
(b) Except as otherwise provided in this Section, tanning
facilities are exempt from the Rules in Sections .0100 through .1300 of this
Chapter to the extent that such facilities do not receive, own, possess or use
radioactive material or other sources of ionizing radiation as defined in G.S.
104E‑5.
(c) Nothing in this Section shall be interpreted as
limiting the intentional exposure of patients to ultraviolet radiation for the
purpose of treatment or therapy other than skin tanning, provided such
treatment or therapy is supervised by a licensed practitioner of the healing
arts in the lawful practice of their profession, in accordance with the
requirements of their professional licensing board to prescribe and supervise
such treatment.
History Note: Authority G.S. 104E‑7(a)(7);
Eff. June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1401 Eff.
February 1, 2015.
10A NCAC 15 .1402 COMPLIANCE WITH OTHER LAWS
Nothing in this Section shall relieve any person of
responsibility for complying with other pertinent North Carolina laws and
regulations.
History Note: Authority G.S. 104E‑7(a)(7);
Eff. June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1402 Eff.
February 1, 2015.
10A NCAC 15 .1403 DEFINITIONS
As used in this Section, the following definitions shall
apply:
(1) "Agency" means the North Carolina
Department of Environment and Natural Resources.
(2) "Consumer" means any individual who is
provided access to a tanning facility which is required to be registered
pursuant to provisions of this Section.
(3) "Formal Operator Training" is a course of
study approved by this agency as meeting the requirements in Paragraph (h) of
Rule .1418 in this Section.
(4) "Individual" means any human being.
(5) "Inspection" means an official
examination or observation to determine compliance with the rules in this
Section, and orders, requirements and conditions of the agency.
(6) "Minor" means any individual less than 18
years of age.
(7) "Medical Lamps" means any lamp that is
specifically designed or labeled for medical use only.
(8) "Operator" means any individual
designated by the registrant to operate or to assist and instruct the consumer
in the operation and use of the tanning facility or tanning equipment. Under
this definition, the term "operator", includes, but is not limited
to, any such individual who conducts one or more of the following activities:
(a) determining consumer's skin type;
(b) determining the suitability of prospective
consumers for tanning equipment use;
(c) informing the consumer of dangers of
ultraviolet radiation exposure including photoallergic reactions and
photosensitizing agents;
(d) assuring that the consumer reads and
properly signs all forms as required by the rules in this Section;
(e) maintaining required consumer exposure
records;
(f) recognizing and reporting consumer injuries
or alleged injuries to the registrant;
(g) determining the consumer's exposure
schedule;
(h) setting timers which control the duration of
exposure; and
(i) instructing the consumer in the proper use
of protective eyewear.
(9) "Person", as defined in G.S. 104E-5(11),
means any individual, corporation, partnership, firm, association, trust,
estate, public or private institution, group, agency, political subdivision of
this state, any other state or political subdivision or agency thereof, and any
legal successor, representative, agent or agency of these entities.
(10) "Registrant" means any person who is
registered with the agency as required by provisions of this Section.
(11) "Registration" means registration with the
agency in accordance with provisions of this Section.
(12) "Tanning components" means any constituent
tanning equipment part, to include ballasts, starters, lamps, reflectors,
acrylic shields, timers, and airflow cooling systems.
(13) "Tanning equipment" means ultraviolet or
other lamps and equipment containing such lamps intended to induce skin tanning
through the irradiation of any part of the living human body with ultraviolet
radiation, e.g., beds, booths, facials and wands.
(14) "Tanning equipment services" means the
installation, sales and servicing of tanning equipment and associated tanning
components; calibration of equipment used in surveys to measure radiation and
timer accuracy; tanning health physics consulting, e.g. radiation output
measurements, design of safety programs, training seminars for tanning
operators and service personnel.
(15) "Tanning facility" means any location,
place, area, structure or business which provides consumers access to tanning
equipment. For the purpose of this definition tanning equipment registered to
different persons at the same location and tanning equipment registered to the
same person, but at separate locations, shall constitute separate tanning
facilities.
(16) "Ultraviolet radiation" means
electromagnetic radiation with wavelengths in air between 200 nanometers and
400 nanometers.
History Note: Authority G.S. 104E‑7(a)(7);
Eff. June 1, 1989;
Amended Eff. August 1, 2002; May 1, 1993; May 1, 1992;
Transferred and Recodified from 15A NCAC 11 .1403 Eff.
February 1, 2015.
10A NCAC 15 .1404 EXEMPTIONS
(a) Any person is exempt from the provisions of this
Section to the extent that such person:
(1) uses equipment which emits ultraviolet
radiation incidental to its proper operation, and
(2) does not use the equipment in Subparagraph
(a)(1) of this Rule to deliberately expose parts of the living human body to
ultraviolet radiation for the purpose of skin tanning.
(b) Any individual is exempt from the provisions of this
Section to the extent that such individual owns tanning equipment exclusively
for personal use.
(c) Tanning equipment while in transit or storage
incidental thereto is exempt from the provisions of this Section.
History Note: Authority G.S. 104E‑7(a)(7);
Eff. June 1, 1989;
Amended Eff. November 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1404 Eff.
February 1, 2015.
10A NCAC 15 .1405 APPLICATION FOR REGISTRATION OF
TANNING FACILITIES
(a) Each person having a tanning facility on the effective
date of this Rule shall apply for registration of such facility no later than
60 days following the effective date of this Rule.
(b) Each person acquiring or establishing a tanning
facility after the effective date of this Rule shall have a certificate of
registration issued by the agency for such facility prior to beginning
operation.
(c) The application required in Paragraphs (a) and (b) of
this Rule shall be completed on forms provided by the agency.
(d) The agency shall require at least the following
information on the forms provided for applying for registration of tanning
facilities:
(1) name, physical address, mail address and
telephone number of the tanning facility;
(2) name(s), mail address(es) and telephone
number(s) of the owner(s) of the tanning facility;
(3) each facility shall submit a copy of the
tanning operator training certificate for each of the tanning facility
operator(s) with the initial application in accordance with the provisions of
the rules of this Section;
(4) the manufacturer(s), model number(s) and
type(s) of ultraviolet lamp(s) or tanning equipment located at the tanning
facility;
(5) name(s) of the tanning equipment
supplier(s), installer(s) and service agent(s);
(6) certification that the applicant has read
and understands the requirements of the rules in this Section, such
certification to be signed and dated by the manager and the owner of the
tanning facility; and
(7) certification that each person operating a
tanning facility shall not allow any individual under 18 years of age to be the
operator of tanning equipment.
History Note: Authority G.S. 104E‑7(a)(7);
Eff. June 1, 1989;
Amended Eff. August 1, 2002; June 1, 1993; May 1, 1992;
Transferred and Recodified from 15A NCAC 11 .1405 Eff.
February 1, 2015.
10A NCAC 15 .1406 ISSUANCE OF CERTIFICATE OF
REGISTRATION
(a) Upon determination that an application meets the
requirements of this Section, the agency will issue a certificate of
registration.
(b) The agency may incorporate in the certificate of registration,
at the time of issuance or thereafter by appropriate rule or order, such
additional requirements and conditions with respect to the registrant's
receipt, possession, use and transfer of tanning equipment and tanning
facilities as the agency deems appropriate or necessary.
History Note: Authority G.S. 104E‑7(a)(7);
Eff. June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1406 Eff.
February 1, 2015.
10A NCAC 15 .1407 EXPIRATION OF CERTIFICATE OF
REGISTRATION
Except as provided in Rule .1408(b) of this Section, each
certificate of registration shall expire at midnight on the expiration date
stated therein.
History Note: Authority G.S. 104E‑7(a)(7);
Eff. June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1407 Eff.
February 1, 2015.
10A NCAC 15 .1408 RENEWAL OF CERTIFICATE OF REGISTRATION
(a) The registrant shall file applications for renewal in
accordance with Rule .1405 of this Section.
(b) Provided that a registrant files with the agency an
application for renewal in proper form for renewal by August 29 of each
calendar year, such certificate of registration shall not expire pending final
action on the application by the agency.
History Note: Authority G.S. 104E‑7(a)(7);
Eff. June 1, 1989;
Amended Eff. August 1, 2002;
Transferred and Recodified from 15A NCAC 11 .1408 Eff.
February 1, 2015.
10A NCAC 15 .1409 REPORT OF CHANGES
The registrant shall notify the agency in writing within 30
calendar days after making any change which would render the information
contained in the application for registration or the certificate of
registration no longer accurate.
History Note: Authority G.S. 104E‑7(a)(7);
Eff. June 1, 1989;
Amended Eff. August 1, 2002;
Transferred and Recodified from 15A NCAC 11 .1409 Eff.
February 1, 2015.
10A NCAC 15 .1410 TRANSFER OF CERTIFICATE OF
REGISTRATION
No certificate of registration may be transferred from one
person to another person or from one tanning facility to another tanning
facility.
History Note: Authority G.S. 104E‑7(a)(7);
Eff. June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1410 Eff.
February 1, 2015.
10A NCAC 15 .1411 APPROVAL NOT IMPLIED
No person, in any advertisement, shall refer to the fact
that such person or such person's facility is registered with the agency
pursuant to the provisions of this Section, and no person shall state or imply
that any activity under such registration has been approved by the agency.
History Note: Authority G.S. 104E‑7(a)(7);
Eff. June 1, 1989;
Amended Eff. November 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1411 Eff.
February 1, 2015.
10A NCAC 15 .1412 DENIAL: REVOCATION: TERMINATION OF
REGISTRATION
(a) The agency may deny, suspend or revoke a certificate of
registration applied for or issued pursuant to this Section:
(1) for any material false statement in the
application for registration or in any statement of fact required by provisions
of this Section;
(2) because of conditions revealed by the
application or any report, record, inspection or other means which would
warrant the agency to refuse to grant a certificate of registration on an
original application;
(3) for operation of the tanning facility in a
manner that causes or threatens to cause hazard to the public health or safety;
(4) for failure to allow authorized
representatives of the agency to enter the tanning facility at reasonable times
for the purpose of determining compliance with the provisions of this Section,
conditions of the certificate of registration or an order of the agency;
(5) for violation of or failure to observe any
of the terms and conditions of the certificate of registration, the rules in
this Section, or an order of the agency; or
(6) for failure to pay a fee within 15 days of
becoming delinquent as described in Paragraph (h) of Rule .1423 or for failure
to correct payment of a fee in the form of a check or other instrument which is
uncollectible from the paying institution within the timeframe specified in
accordance with the provisions of the rules of this Section.
(b) Except in cases of willfulness or those in which the
public health, interest or safety requires otherwise, prior to the institution
of proceedings for suspension or revocation of a certificate of registration,
the agency shall:
(1) call to the attention of the registrant, in
writing, the facts or conduct which may warrant such actions, and
(2) provide reasonable opportunity for the
registrant to demonstrate or achieve compliance with all lawful requirements.
(c) Any person aggrieved by a decision by the agency to
deny a certificate of registration or to suspend or revoke a certificate of
registration after issuance may request a hearing under provisions of G.S.
150B, Article 3.
(d) The agency may terminate a certificate of registration
upon receipt of a written request for termination from the registrant.
History Note: Authority G.S. 104E‑7(a)(7); 104E‑11(a);
Eff. June 1, 1989;
Amended Eff. August 1, 2002; June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1412 Eff.
February 1, 2015.
10A NCAC 15 .1413 CONSTRUCTION AND OPERATION OF TANNING
EQUIPMENT
Except as otherwise ordered or approved by the agency, each
tanning facility shall be constructed, operated and maintained in accordance
with the requirements in Rules .1414 to .1418 of this Section.
History Note: Authority G.S. 104E‑7(a)(7);
Eff. June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1413 Eff.
February 1, 2015.
10A NCAC 15 .1414 WARNING SIGNS REQUIRED
(a) The registrant shall post the warning sign described in
Paragraph (b) of this Rule within one meter of each tanning station and in such
a manner that the sign is clearly visible, not obstructed by any barrier,
equipment or other object, and can be easily viewed by the consumer before the
tanning equipment is energized.
(b) The warning sign in Paragraph (a) of this Rule shall
use upper and lower case letters which are at least seven millimeters and three
and one-half millimeters in height, respectively, and shall have the following
wording:
DANGER
‑ ULTRAVIOLET RADIATION
‑Follow instruction.
‑Avoid overexposure. As
with natural sunlight, overexposure can cause eye and skin injury and allergic
reactions. REPEATED EXPOSURE MAY CAUSE PREMATURE AGING OF THE SKIN AND SKIN
CANCER.
‑Wear protective eyewear.
FAILURE TO USE PROTECTIVE EYEWEAR
MAY RESULT IN SEVERE BURNS OR LONG‑TERM INJURY TO THE EYES.
‑Medications
or cosmetics may increase your sensitivity to the ultraviolet radiation.
Consult a physician before using sunlamp or tanning equipment if you are using
medication or have a history of skin problems or believe yourself to be
especially sensitive to sunlight.
‑If you do not tan in the
sun, you are unlikely to tan from the use of this product.
-Consumers should report to the
agency any injury for which medical attention is sought or obtained resulting
from the use of registered tanning equipment. This report should be made
within five working days after the occurrence.
(c) Warning signs shall include the current address of the
agency.
History Note: Authority G.S. 104E‑7(a)(7);
Eff. June 1, 1989;
Amended Eff. August 1, 2002; June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1414 Eff.
February 1, 2015.
10A NCAC 15 .1415 EQUIPMENT AND CONSTRUCTION
REQUIREMENTS
(a) The registrant shall use only tanning equipment
manufactured in accordance with the specifications set forth in 21 Code of
Federal Regulations (CFR) Part 1040, Section 1040.20, "Sunlamp products
and ultraviolet lamps intended for use in sunlamp products". The standard
of compliance shall be the standards in effect at the time of manufacture as
shown on the equipment identification label required by 21 CFR Part 1010,
Section 1010.3.
(b) Each assembly of tanning equipment shall be designed
for use by only one consumer at a time.
(c) Each assembly of tanning equipment shall be equipped
with a timer which complies with the requirements of 21 CFR Part 1040, Section
1040.20(c)(2). The maximum timer interval shall not exceed the manufacturer's
maximum recommended exposure time. No timer interval shall have an error
exceeding plus or minus 10 percent of the maximum timer interval for the
product.
(d) Tanning equipment shall include physical barriers to
protect consumers from injury induced by touching or breaking the lamps.
(e) All tanning equipment labeling required in Paragraph
(a) of this Rule shall be legible and accessible to view.
(f) The timer intervals shall be numerically indicated on
the face of the timer.
(g) The timer shall not automatically reset and cause
radiation emission to resume for a period greater than the unused portion of
the timer cycle, when emission from the tanning device has been interrupted.
(h) Each assembly of tanning equipment shall be provided
with a control on the equipment to enable the consumer to manually terminate
radiation emission from the equipment at any time without disconnecting the
electrical plug or removing any ultraviolet lamp.
(i) The timer for the tanning devices shall be remotely
located outside the room where the tanning equipment is located. The remote
timer shall be set by a certified tanning operator. Effective August 1, 2004,
all tanning facilities shall be equipped with remote timers.
(j) The registrant shall ensure that tests are performed
annually on each assembly of tanning equipment and documented in writing for
agency review during inspections to ensure the timer is accurate to within 10
percent as specified in Paragraph (c) of Rule .1415 of this Section and the
consumer is able to terminate the radiation manually in accordance with this
Rule.
(k) Medical lamps shall not be used for commercial cosmetic
tanning purposes.
History Note: Authority G.S. 104E‑7(a)(7);
Eff. June 1, 1989;
Amended Eff. August 1, 2002; June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1415 Eff.
February 1, 2015.
10A NCAC 15 .1416 ADDITIONAL REQUIREMENTS FOR STAND‑UP
BOOTHS
Tanning booths designed for stand‑up use shall also
comply with the following additional requirements:
(1) Booths shall have physical barriers or other means,
such as handrails or floor markings, to indicate the proper exposure distance
between ultraviolet lamps and the consumer's skin.
(2) Booths shall be constructed with sufficient
strength and rigidity to withstand the stress of use and the impact of a
falling person.
(3) Access to booths shall be of rigid construction
with doors which are non‑latching and open outwardly.
(4) Booths shall be equipped with handrails and non‑slip
floors.
History Note: Authority G.S. 104E‑7(a)(7);
Eff. June 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1416 Eff.
February 1, 2015.
10A NCAC 15 .1417 PROTECTIVE EYEWEAR REQUIRED
(a) The registrant shall provide protective eyewear to each
consumer for use during any use of tanning equipment.
(b) The protective eyewear in Paragraph (a) of this Rule
shall meet the requirements of 21 CFR Part 1040, Section 1040.20(c)(4).
(c) Tanning facility operators shall instruct the consumer
in the proper utilization of the protective eyewear required by this Rule.
(d) The registrant shall ensure that the protective eyewear
required by this Rule is sanitized before each use and shall not rely upon
exposure to the ultraviolet radiation produced by the tanning equipment itself
to provide such sanitizing.
History Note: Authority G.S. 104E‑7(a)(7);
Eff. June 1, 1989;
Amended Eff. August 1, 2002; November 1, 1989;
Transferred and Recodified from 15A NCAC 11 .1417 Eff.
February 1, 2015.
10A NCAC 15 .1418 RECORDS: REPORTS AND OPERATING
REQUIREMENTS
(a) Prior to initial exposure, the tanning facility
operator shall provide each consumer the opportunity to read a copy of the
warning specified in Rule .1414(b) of this Section and request that the
consumer sign a statement that the information has been read and understood.
For illiterate or visually impaired persons unable to sign their name, the
warning statement shall be read by the operator, in the presence of a witness,
and the witness and the operator shall sign the statement.
(b) The registrant shall maintain a record of each
consumer's total number of tanning visits including dates and durations of
tanning exposures.
(c) The registrant shall submit to the agency a written
report of injury for which medical attention was sought or obtained from the
use of registered tanning equipment within five working days after occurrence.
The report shall include:
(1) the name of the affected individual;
(2) the name and location of the tanning facility
involved;
(3) the nature of the actual or alleged injury;
and
(4) any other information relevant to the
actual or alleged injury, to include the date and duration of exposure and any
documentation of medical attention sought or obtained.
(d) The registrant shall not allow individuals under the
age of 18 to use tanning equipment unless the individual provides a consent
form and a statement, described in Paragraph (a) of this Rule, signed by that
individual's parent or legal guardian.
(e) The registrant shall not allow minors to remain in the
tanning room while the tanning equipment is in operation except as provided for
in this Rule.
(f) The registrant shall replace defective or burned out
lamps, bulbs or filters with a type intended for use in the affected tanning
equipment as specified by the manufacturer's product label and having the same
spectral distribution (certified equivalent lamp).
(g) The registrant shall replace ultraviolet lamps and
bulbs, which are not otherwise defective or damaged, at such frequency or after
such duration of use as may be recommended by the manufacturer of such lamps
and bulbs.
(h) The registrant shall certify that all tanning equipment
operators are trained in at least the following:
(1) the requirements of this Section;
(2) procedures for correct operation of the
tanning facility and tanning equipment;
(3) recognition of injury or overexposure to
ultraviolet radiation;
(4) the tanning equipment manufacturer's
procedures for operation and maintenance of the tanning equipment;
(5) the determination of skin type of customers
and appropriate determination of duration of exposure to registered tanning
equipment; and
(6) emergency procedures to be followed in case
of injury.
(i) The registrant shall allow operation of tanning
equipment only by and in the physical presence of persons who have successfully
completed formal training courses which meet the requirements of Subparagraphs
(h)(1) to (6) of this Rule.
(j) The registrant shall maintain a record of operator training
required in Paragraphs (h)and (i) of this Rule for inspection by authorized
representatives of the agency.
(k) No registrant shall possess, use, operate or transfer
tanning equipment or their ultraviolet radiation sources in such a manner as to
cause any individual under 18 years of age to be exposed to radiation emissions
from such equipment except in accordance with Paragraph (d) of this Rule.
(l) Each registrant shall make available to all employees
current copies of the following documents:
(1) the facility's certificate of registration;
and
(2) conditions or documents incorporated into
the registration by reference and amendments thereto.
History Note: Authority G.S. 104E‑7(a)(7);
Eff. June 1, 1989;
Amended Eff. August 1, 2002; May 1, 1993; May 1, 1992;
Transferred and Recodified from 15A NCAC 11 .1418 Eff.
February 1, 2015.
10A NCAC 15 .1419 COMMUNICATIONS WITH THE AGENCY: AGENCY
ADDRESS
Applications for registration, reports, notifications and
other communications required by this Section shall be mailed to the Division
of Radiation Protection, 1645 Mail Service Center, Raleigh, North Carolina
27699-1645 or delivered to the agency at its office located at 3825 Barrett
Drive, Raleigh, North Carolina 27609‑7221.
History Note: Authority G.S. 104E‑7(a)(7);
Eff. June 1, 1989;
Amended Eff. August 1, 2002; May 1, 1992;
Transferred and Recodified from 15A NCAC 11 .1419 Eff.
February 1, 2015.
10A NCAC 15 .1420 PROPOSED SERVICING
Effective August 1, 1993, each person registered pursuant to
Rule .1405 of this Section shall prohibit any person from furnishing tanning
equipment services to their tanning equipment or facility until such person provides
evidence that they are registered with the agency as a provider of services in
accordance with the provisions of Rule .1421 of this Section.
History Note: Authority G.S. 104E-7(a)(7);
Eff. May 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1420 Eff.
February 1, 2015.
10A NCAC 15 .1421 APPLICATION FOR REGISTRATION OF
SERVICING OR SERVICES
(a) Each person who offers tanning equipment services to
any agency registrant, shall apply for registration of such services with the
agency within 60 days following the effective date of this Rule or, thereafter,
prior to furnishing or offering to furnish any of these services.
(b) The application for registration required in Paragraph
(a) of this Rule shall be completed on an approved agency form.
(c) Persons applying for registration under Paragraph (a)
of this Rule shall certify that they have read and understand the requirements
of the rules in this Section.
History Note: Authority G.S. 104E-7(a)(7);
Eff. June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .1421 Eff. February
1, 2015.
10A NCAC 15 .1422 REPORTS AND INSTALLATION
(a) Persons registered pursuant to Rule .1421 of this
Section, who sell, lease, transfer, lend, dispose of, assemble or install
tanning equipment in this state shall, within 30 days after each calendar
quarter, notify the agency at the address in Rule .1419 of this Section, of:
(1) whether any tanning equipment was
installed, transferred, or disposed of during the calendar quarter;
(2) the name and address of persons who receive
tanning equipment during the calendar quarter;
(3) the manufacturer, model and serial number
of tanning equipment transferred or otherwise disposed of; and
(4) the date of transfer of any tanning
equipment.
(b) No person shall make, sell, lease, transfer, lend,
repair, assemble, or install tanning equipment or the supplies used in
connection with such equipment unless such supplies and equipment when properly
placed in operation and used shall meet the requirements of the rules in this
Section and the regulations of 21 CFR 1040.20.
History Note: Authority G.S. 104E-7(a)(7);
Eff. May 1, 1993;
Amended Eff. August 1, 2002;
Transferred and Recodified from 15A NCAC 11 .1422 Eff.
February 1, 2015.
10A NCAC 15 .1423 FEES AND PAYMENT
(a) This Rule establishes fees for persons registered
pursuant to the provisions of this Section to cover the anticipated costs of
tanning equipment inspection and enforcement activities of the agency.
(b) Annual fees established in this Rule are due on the
first day of July of each year.
(c) Notwithstanding Paragraph (b) of this Rule, when a new
registration is issued by the agency after the first day of July of any year,
the initial fee is due on the date of issuance of the registration.
(d) The initial fee in Paragraph (c) of this Rule shall be
computed as follows:
(1) When any new registration is issued before
the first day of January of any year, the initial fee is the full amount
specified in this Rule; and
(2) When any new registration is issued on or
after the first day of January of any year, the initial fee is one-half of the
amount specified in this Rule.
(e) All fees received by the agency pursuant to provisions
of this Rule are nonrefundable.
(f) Each registrant may pay all fees by cash, check or
money order provided:
(1) Checks or money orders shall be made
payable to "Radiation Protection Section", and mailed to 1645 Mail
Service Center, Raleigh, NC 27699-1645 or delivered to the agency office at
3825 Barrett Drive, Raleigh, NC 27609-7221; and
(2) Cash payments shall be made only by
appointment by calling the agency at 919/571-4141 and delivered to the agency
office at 3825 Barrett Drive, Raleigh, NC 27609-7221.
(g) Within five days after the due dates established in
Paragraphs (b) and (c) of this Rule, the agency shall mail to each registrant,
who has not already submitted payment, a notice which indicates the due date,
the amount of fees due, and the delinquent date.
(h) Payment of fees established in this Rule is delinquent,
if not received by the agency within 60 days after the due date specified in
Paragraphs (b) and (c) of this Rule.
(i) If a registrant remits a fee in the form of a check or
other instrument which is uncollectible from the paying institution, the agency
shall notify the registrant by certified mail and allow the registrant 15 days
to correct the matter, which includes payment of any fee charged to the agency
by a banking institution.
(j) If payment of fees is uncollectible from the paying
institution or not submitted to the agency by the delinquent date, the agency
may institute legal action to collect.
(k) Annual fees for persons registered pursuant to
provisions of this Section are as listed in the following table:
Type of registered facility
Letters appearing
in registration number
Facility plus first
piece of tanning equipment
Each additional piece
of tanning equipment
Tanning Facility
B
$200.00
$30.00
Tanning Equipment
Services
F
$200.00
NA
History Note: Authority G.S. 104E-9(a)(8); 104E-19(a);
Eff. July 1, 1994;
Amended Eff. July 1, 2011; August 1, 2007; August 1,
2002;
Transferred and Recodified from 15A NCAC 11 .1423 Eff.
February 1, 2015.
SECTION .1500 ‑ LICENSES FOR DISPOSAL SITE ACCESS
10A NCAC 15 .1501 PURPOSE AND SCOPE
(a) This Section establishes the procedures, criteria, and
terms and conditions upon which the agency issues site access licenses required
pursuant to the provisions of G.S. 104E‑10.3 and G.S. 104E‑27.
(b) No person shall transfer waste to a disposal facility
located in North Carolina unless such person holds a valid site access license
issued by the agency pursuant to the rules in this Section.
(c) The agency shall issue a site access license to an
applicant only after the agency determines that the applicant:
(1) has implemented best management practices,
including prevention, minimization, reduction, segregation and hold‑for‑decay
storage as required by the rules in this Section; and
(2) is reducing waste volume to the extent
technologically and economically feasible.
(d) Site access licenses issued pursuant to the rules in
this Section shall authorize access only to disposal facilities operated
pursuant to the provisions of G.S. 104G and licensed pursuant to the rules in
Section .1200 of this Chapter. Upon issuance of a site access license pursuant
to the rules in this Section, the agency shall certify to the North Carolina
Low‑Level Radioactive Waste Management Authority that a generator is
reducing waste volume to the extent technologically and economically feasible.
(e) Nothing in this Section or in site access licenses
issued pursuant to this Section shall relieve any person from responsibility
for complying with the conditions of the applicant's existing license for the
possession and use of radioactive materials or any applicable requirements in
the other sections of this Chapter or in state and federal laws and
regulations, including, but not limited to, those of the U.S. Department of
Transportation, the U.S. Nuclear Regulatory Commission, the North Carolina
Department of Transportation, the Southeast Interstate Low‑Level
Radioactive Waste Management Compact, and the North Carolina Low‑Level
Radioactive Waste Management Authority.
(f) The rules in this Section are applicable to generators,
collectors and processors of low‑level radioactive waste which will be
transferred to a low‑level radioactive waste disposal facility located
within the State of North Carolina for disposal.
(g) The rules in this Section are applicable to those waste
forms deemed acceptable according to the North Carolina low‑level
radioactive disposal facility license as issued by the agency. The rules in
this Section shall not be construed to authorize the disposal of any waste that
is not authorized for disposal under Section .1200 of this Chapter.
(h) The agency shall not issue any site access license
prior to January 1, 1995 or prior to the agency issuing an operating license
for a low‑level radioactive waste disposal facility in North Carolina
pursuant to Section .1200 of this Chapter, whichever is the later.
History Note: Authority G.S. 104E‑10.3; 104E‑27;
Eff. January 1, 1995;
Transferred and Recodified from 15A NCAC 11 .1501 Eff.
February 1, 2015.
10A NCAC 15 .1502 DEFINITIONS
(a) As used in this Section, the following definitions
shall apply.
(1) "Carrier" means any person
transporting radioactive waste in North Carolina for the purpose of disposal at
a low‑level radioactive waste disposal facility located in North
Carolina.
(2) "Collector" means any person who
collects or consolidates prepared packages of low‑level radioactive
waste from another site access licensee and arranges for the transportation of
such waste to a disposal facility located in North Carolina.
(3) "Generator" means any person who
produces low‑level radioactive waste which will be transferred for
disposal at a low‑level radioactive waste disposal facility located in
North Carolina, including indirect transfer through collectors or processors.
(4) "Low‑level radioactive
waste" means low‑level radioactive waste as defined in Rule .1202 of
this Chapter.
(5) "Low‑Level radioactive waste
disposal facility" means any facility operated pursuant to G.S. 104G for
the purpose of low‑level radioactive waste disposal and licensed pursuant
to Section .1200 of this Chapter.
(6) "Manifest" means the document
used for identifying the quantity, composition, origin and destination of low‑level
radioactive waste during its transport to a disposal facility.
(7) "Processor" means any person who
receives low‑level radioactive waste or radioactively contaminated
material from another site access licensee for the purpose of repackaging or
treatment, including, but not limited to, compaction, incineration,
decontamination or resource recovery, prior to transfer to a disposal facility
located in North Carolina.
(8) "Radioactive material license"
means any license issued by the agency, an agreement state or the U. S. Nuclear
Regulatory Commission which authorizes activities which may generate waste.
(9) "Shipment" means the total low‑level
radioactive waste transported in a single conveyance as defined in 49 CFR §
173.403.
(10) "Shipper" means any person who
holds a valid site access license and prepares low‑level radioactive
waste for transport to a low‑level radioactive waste disposal facility
located in North Carolina.
(11) "Site access license" means a
license issued pursuant to the rules in this Section.
(12) "Solidifying" means that process
by which liquid wastes or wastes containing liquids are converted into an
acceptable stable form as defined in Rule .1651 of this Chapter.
(13) "Southeast Compact" means the
Southeast Interstate Low‑Level Radioactive Waste Management Compact as
set out in G.S. 104F.
(14) "Stabilizing" means that process
by which radioactive wastes are prepared to meet the stability requirements as
defined in Rule .1651 of this Chapter.
(15) "Transport" means the movement of
low‑level radioactive waste in North Carolina for the purpose of disposal
at a low‑level radioactive waste disposal facility located in North
Carolina.
(16) "Waste" means "low‑level
radioactive waste".
(b) Definitions of other words and phrases used in this
Section are set forth in other sections of this Chapter.
History Note: Authority G.S. 104E‑5; 104E‑7;
104E‑10.3; 104E‑27;
Eff. January 1, 1995;
Transferred and Recodified from 15A NCAC 11 .1502 Eff.
February 1, 2015.
10A NCAC 15 .1503 LICENSE REQUIRED
(a) No person shall ship or transfer waste to a low‑level
radioactive waste disposal facility located in North Carolina, except as
authorized by a valid site access license issued, prior to shipment or
transfer, pursuant to the rules in this Section.
(b) A separate site access license is required for each
generator, collector and processor facility from which waste, which will be
transferred to a low‑level radioactive waste disposal facility located in
North Carolina, is shipped.
(c) The agency shall not issue any site access license
authorizing disposal of waste generated outside the Southeast Compact region
unless:
(1) the U.S. Nuclear Regulatory Commission has
granted emergency access as authorized under the Low‑Level Radioactive
Waste Policy Amendments Act of 1985, provided that access shall be limited to
that granted by the U.S. Nuclear Regulatory Commission and complies with Rule
.1517 of this Section; or
(2) access has been granted by the Southeast
Compact Commission in accordance with provisions of G.S. 104F and complies with
all rules of this Section.
History Note: Authority G.S. 104E‑10.3; 104E‑27;
Eff. January 1, 1995;
Transferred and Recodified from 15A NCAC 11 .1503 Eff.
February 1, 2015.
10A NCAC 15 .1504 APPLICATION FOR SITE ACCESS LICENSE:
GENERAL REQUIREMENTS
(a) Each applicant for a site access license shall file a
completed agency application form. The completed application shall include the
following information:
(1) name, address, telephone number, and
description of the business of the applicant;
(2) a list of radioactive material licenses
issued to the applicant along with the name of the regulatory agency that
issued each license;
(3) name, address and telephone number of the
facility for which a site access license is requested;
(4) name and telephone number of the person who
is responsible for the applicant's waste management plan;
(5) organization chart which depicts the
relationship among senior level management, managers of waste generating and
waste management activities, and the person identified in Subparagraph (a)(4)
of this Rule;
(6) general transportation routing information,
within the State of North Carolina, of waste shipments, including but not
limited to waste transported for processing and waste transported for disposal
at the North Carolina disposal facility;
(7) certifications and additional information
required by other applicable rules in this Section; and
(8) other relevant information necessary for the
agency to determine compliance with these Rules.
(b) The agency may at any time after the filing of the
application, and before the expiration of a site access license, require
further statements and information to enable the agency to determine whether to
grant, deny, modify, suspend or revoke a site access license.
(c) Each application for a site access license shall be
signed by the manager of the facility for which the site access license is
requested or by his designee, provided that such designation shall be confirmed
to the agency, in writing, by the manager.
(d) Except as provided in Paragraph (e) of this Rule,
applications and documents submitted to the agency are public documents and
shall be made available for public inspection.
(e) Notwithstanding Paragraph (d) of this Rule, the
applicant may request that specific parts of the application and supporting
documents which consist of proprietary information be withheld from public
inspection. Such request shall include a detailed justification for each part
which is proposed to be withheld. The agency may approve such requests in
whole or in part, if the agency determines that public disclosure is not
required in the public interest and would adversely affect the interest of the
applicant. All agency approvals shall be made in writing and shall be
available for public inspection.
(f) The applicant shall submit the application for a site
access license required by this Section to the agency at the address in Rule
.0111 of this Chapter.
(g) If the facility is not located in North Carolina, the
applicant shall also submit a copy of the application to the state radiation
protection regulatory agency in, or if none, to such other state agency
designated by the state in which the facility is located.
(h) If the facility is licensed by the U.S. Nuclear
Regulatory Commission, the applicant shall also submit a copy of the
application to the U.S. Nuclear Regulatory Commission.
History Note: Authority G.S. 104E‑10.3; 104E‑27;
104E‑29; 132‑1.2;
Eff. January 1, 1995;
Transferred and Recodified from 15A NCAC 11 .1504 Eff.
February 1, 2015.
10A NCAC 15 .1505 APPLICATION FOR SITE ACCESS LICENSE ‑
WASTE GENERATORS
If the applicant for a site access license is a waste
generator, the application required in Rule .1504 of this Section shall include
the following additional information:
(1) general description of the activities which involve
the production of waste along with the radioactive material license numbers
under which such activities are conducted;
(2) general description of existing on‑site waste
management, to include facilities, equipment, procedures and programs for:
(a) limiting the production of contaminated
material and contained radioactivity which must be managed, and the estimated
annual impact on the amount of material and radioactivity;
(b) reducing the volume and contained
radioactivity of waste which will be shipped, or transferred to collectors for
shipment, to off‑site disposal facilities, and the estimated annual
impact on the volume and contained radioactivity shipped or transferred;
(c) classifying, stabilizing, solidifying
liquids, packaging and monitoring waste prior to shipment or transfer to a
collector for shipment to a disposal facility located in North Carolina; and
(d) quality assurance and quality control;
(3) description of existing off‑site waste
management, to include:
(a) name, address, telephone number, type of
processing and radioactive material license number of each off‑site
processor to which waste referenced in Sub-Item (2)(b) of this Rule will be
shipped; and
(b) estimated annual impact on the volume and
contained radioactivity which will ultimately be shipped to a disposal facility
located in North Carolina;
(4) description of planned changes in on‑site and
off‑site management described in Items (2) and (3) of this Rule, to
include anticipated date for implementation and estimated annual impact on the
volume and contained radioactivity of waste which will be disposed at a
disposal facility located in North Carolina;
(5) history of off‑site waste disposal for the
past five years, to include:
(a) identification of all disposal facilities
which received waste for disposal; and
(b) the total volume and contained radioactivity
of waste disposed each year;
(6) description of the projected waste which will be
disposed at a disposal facility located in North Carolina for each of the next
five years, to include the projected volume and contained radioactivity for
Class A, Class B and Class C waste;
(7) any regulatory notices of violation and corrective
actions related to on‑site and off‑site management described in
Items (2) and (3) of this Rule during the past five years; and
(8) description of the applicant's notification and
emergency response program in the event of accidents during transportation.
This description shall include the qualifications and responsibilities of the
driver.
History Note: Authority G.S. 104E‑10.3; 104E‑27;
Eff. January 1, 1995;
Transferred and Recodified from 15A NCAC 11 .1505 Eff.
February 1, 2015.
10A NCAC 15 .1506 CONTENT OF APPLICATION FOR WASTE
COLLECTORS
If the applicant for a site access license is a waste
collector, the application required in Rule .1504 of this Section shall include
the following additional information:
(1) radioactive material license numbers under which
waste collection activities are conducted;
(2) complete description of the applicant's current
waste collection and handling program, to include:
(a) a list of the states in which waste
collection services will be provided;
(b) a list of the waste processors and waste
disposal facilities to which collected waste may be shipped;
(c) procedures for:
(i) waste collection at customer facilities;
(ii) handling, identifying, accounting for, and
segregating the waste shipped to waste processors and waste disposal
facilities;
(iii) ensuring that waste shipped to a waste
disposal facility located in North Carolina is collected only from persons who
hold a currently valid site access license issued pursuant to the rules in this
Section;
(iv) ensuring that packages, labels, vehicles,
placards, and radiation and contamination levels comply with applicable state
and federal regulations;
(v) quality assurance and quality control;
(vi) notifications and emergency response in the
event of accidents during transportation, including the qualifications and
responsibilities of the driver;
(3) a list of the waste processing and disposal
facilities to which collected waste was shipped during the past five years; and
(4) any regulatory notices of violation and corrective
actions related to on‑site and off‑site management described in
Items (2) and (3) of this Rule during the past five years.
History Note: Authority G.S. 104E‑10.3; 104E‑27;
Eff. January 1, 1995;
Transferred and Recodified from 15A NCAC 11 .1506 Eff.
February 1, 2015.
10A NCAC 15 .1507 CONTENT OF APPLICATION FOR WASTE
PROCESSORS
If the applicant for a site access license is a waste
processor, the application required in Rule .1504 of this Section shall include
the following additional information:
(1) the applicable information required by Rule .1505
of this Section, if the waste processor is located within the Southeast Compact
and generates waste which will be disposed at a disposal facility located in
North Carolina;
(2) a list of the states from which waste may be
received for processing;
(3) description of waste processing services and
management, to include:
(a) the radioactive material license numbers
under which such activities are conducted;
(b) the types of waste processing services,
description of the wastes which may be processed and the estimated impact of
the processing on:
(i) volume and contained radioactivity of
processed waste which will be shipped to off‑site disposal facilities;
and
(ii) suitability of processed waste for
disposal;
(c) procedures and program for:
(i) handling, identifying, accounting for, and
segregating waste attendant to processing and shipment to off‑site waste
disposal facilities;
(ii) ensuring that processed waste shipped to a
waste disposal facility located in North Carolina is waste generated by persons
who hold a currently valid site access license issued pursuant to the rules in
this Section;
(iii) classifying, stabilizing, solidifying
liquids, packaging and monitoring waste prior to shipment, or transfer to a
collector or the generator for shipment, to a disposal facility located in
North Carolina;
(iv) preparing manifests and correlating
manifests with the original manifests prepared by the waste generators for
processed waste which will be disposed at a disposal facility located in North
Carolina;
(v) ensuring that packages, labels, and
radiation and contamination levels comply with applicable state and federal
regulations;
(vi) quality assurance and quality control; and
(vii) ensuring that waste generated by the
processor is residual waste resulting from the processor's activities and that
such waste can not be identified as waste attributed to a particular generator;
(4) a list of the waste disposal facilities to which
processed waste was shipped during the past five years;
(5) for each of the past five years, a summary of the
volumes and types of waste processed and the resulting volumes of processed
waste shipped off‑site;
(6) description of the applicant's notification and
emergency response program in the event of accidents during transportation.
This description shall include the qualifications and responsibilities of the
driver; and
(7) any regulatory notices of violation and corrective
actions related to on‑site and off‑site management described in
Items (2) and (3) of this Rule during the past five years.
History Note: Authority G.S. 104E‑10.3; 104E‑27;
Eff. January 1, 1995;
Transferred and Recodified from 15A NCAC 11 .1507 Eff.
February 1, 2015.
10A NCAC 15 .1508 CERTIFICATION OF COMPLIANCE WITH
APPLICABLE REQUIREMENTS
(a) Each shipper who prepares packages of waste for
shipment to a disposal facility located in North Carolina shall certify that:
(1) the packages and contained waste comply
with all disposal site restrictions and acceptance criteria and with all
applicable state and federal laws and regulations including, but not limited
to, those governing manifests, labeling, radiation and contamination levels and
package design and performance; and
(2) the prior notification required by Rule
.1509 of this Section will be made for each shipment of waste.
(b) Each shipper who transports packages of waste, using
shipper‑controlled drivers or vehicles, to a disposal facility located in
North Carolina shall certify that such transportation, transport vehicles,
placarding, and driver training will comply with all applicable disposal
facility license conditions and acceptance criteria, and state and federal laws
and regulations.
(c) The certification requirements specified in this Rule
shall be in written form and shall accompany each separate shipment of waste
shipped to the North Carolina disposal facility.
(d) The disposal facility operator shall provide to the
agency for each shipment of accepted waste at the North Carolina disposal
facility a copy of the written certification that accompanied each shipment of
waste.
History Note: Authority G.S. 104E‑10.3; 104E‑27;
Eff. January 1, 1995;
Transferred and Recodified from 15A NCAC 11 .1508 Eff.
February 1, 2015.
10A NCAC 15 .1509 PRIOR NOTIFICATION FOR WASTE SHIPMENTS
(a) Prior to each shipment of waste to a disposal facility
located in North Carolina, both the agency and the facility operator shall
receive written notice from the shipper no less than 72 hours and no earlier
than 30 days before the expected date of arrival of the shipment at the
disposal facility.
(b) The prior notification required in Paragraph (a) of
this Rule shall be filed on a "Radioactive Waste Shipment Prior
Notification Form", or appropriate form(s) approved by the agency and
which shall include the following:
(1) name and address of shipper;
(2) person responsible for waste shipment,
including:
(A) name;
(B) title; and
(C) telephone number;
(3) site access license number of the shipper and
the site access license number of any other generator, processor, or collector
involved with the waste;
(4) shipment identification number originated
by and obtained from the disposal facility operator;
(5) location from which waste will be shipped;
(6) name and address of consignee;
(7) scheduled date of departure of shipment;
(8) estimated date of arrival of shipment;
(9) carrier;
(10) trailer number and owner, if available;
(11) type of transport vehicle;
(12) transportation route;
(13) type of package or cask model number;
(14) type of container in cask;
(15) package or cask specification;
(16) complete waste description;
(17) physical and chemical form;
(18) total number of packages;
(19) prominent radionuclides;
(20) total curies;
(21) waste class and stability;
(22) total cubic feet;
(23) U.S. Department of Transportation Sub Type ,
such as Low Specific Activity;
(24) U.S. Department of Transportation
Identification Number;
(25) indication of highway route controlled
quantity;
(26) such other relevant information necessary
for the agency to determine compliance with these Rules;
(27) signature block certifying validity of
information provided; and
(28) signature block for consignee.
(c) The shipper shall immediately notify the agency and the
facility operator of any cancellations or changes in the prior notification
form which may occur immediately prior to the shipment departing from the
facility enroute to the disposal facility; including, but not limited to the
date of arrival, total number of packages, curie content, volume, or waste
classification. This notification may be transmitted via documented telephone
conversation, or the use of telecopy or facsimile machine.
(d) No shipment of waste to a disposal facility in North
Carolina shall commence until the shipper has received and documented
confirmation from the operator of the disposal facility that the information
provided on the prior notification form and any changes, as identified by the
requirements in Paragraph (c) of this Rule, comply with the conditions of the
facility operator's license.
(e) With each separate shipment of waste to the North
Carolina disposal facility the shipper shall provide to the carrier a copy of
the prior notification form required by Paragraph (a) of this Rule for delivery
to the disposal facility operator. This copy shall reflect any changes made
pursuant to Paragraph (c) of this Rule.
(f) Following the acceptance of each shipment of waste at
the North Carolina disposal facility, the disposal facility operator shall sign
the prior notification form and submit signed copies to the agency and to the
shipper within one week after acceptance.
(g) The prior notification form required in this Rule is in
addition to the manifest requirements in Rule .1510 of this Section.
History Note: Authority G.S. 104E‑10.3; 104E‑27;
Eff. January 1, 1995;
Transferred and Recodified from 15A NCAC 11 .1509 Eff.
February 1, 2015.
10A NCAC 15 .1510 RADIOACTIVE SHIPMENT MANIFEST
(a) A manifest completed by the shipper, on forms supplied
by the disposal facility operator, shall accompany each shipment of waste to a
disposal facility located in North Carolina and shall include all information
and certifications required by the rules in this Chapter and the disposal
facility operator's license conditions.
(b) If the shipper is a waste processor, the manifest
required in Paragraph (a) of this Rule shall reflect any consolidation of the
original waste generator manifests and any residual waste generated by the
processor.
History Note: Authority G.S. 104E‑10.3; 104E‑27;
Eff. January 1, 1995;
Transferred and Recodified from 15A NCAC 11 .1510 Eff.
February 1, 2015.
10A NCAC 15 .1511 FINANCIAL QUALIFICATIONS AND
REQUIREMENTS
(a) The purpose of this Rule is to defray expenses incurred
by the State of North Carolina for any project or activity for emergency
response to and decontamination of radioactive waste transportation accidents
involving the possible or actual release of radioactive materials and to defray
the costs to the State for performing or supervising decontamination and to
otherwise protect the public health and safety.
(b) The agency shall not issue a site access license until
the applicant has satisfied the surety bond or insurance requirements in this
Rule.
(c) The applicant must deposit and maintain with the agency
a minimum cash or corporate surety bond in the amount of five hundred thousand
dollars ($500,000), or provide the agency satisfactory evidence of liability
insurance or provide a certificate of insurance as an added insured on a policy
held by a site access licensee that satisfies the insurance requirements of
this Rule.
(1) For purposes of the rules in this Section,
liability insurance shall mean coverage of one million ($1,000,000) per
occurrence and five million ($5,000,000) aggregate;
(2) Any insurance carried pursuant to Section
.2210 of Title 42 of the United States Code and 10 CFR 140 shall be sufficient
to meet the requirements of this Rule; and
(3) Liability insurance shall be specific to
the packaging, transportation, storage and delivery of radioactive waste.
(d) An applicant maintaining liability insurance for the
purpose of this Rule shall provide to the agency a certificate of insurance
from their insurer indicating the policy number, limits of liability, policy
date and specific coverage for packaging, transportation, storage and delivery
of radioactive waste.
(e) A cash or corporate surety bond previously posted for
the purposes of this Rule shall be returned to the site access licensee upon
written notification to the agency of his intention to cease shipments of
radioactive waste to the North Carolina disposal facility, provided such bond
shall be returned only after the last such shipment has been accepted safely at
the disposal facility.
(f) Agencies of the State of North Carolina shall not be
subject to the requirements of this Rule.
(g) Notwithstanding Paragraph (c) of this Rule, the agency
may require greater surety bond or insurance, based on agency analysis of the
potential cost to the State for the activities in Paragraph (a) of this Rule,
provided that:
(1) the agency shall provide written
notification to the site access licensee or applicant for a site access license
of the proposed amount and agency analysis; and
(2) the agency shall provide 30 days from the
date of notification for the site access licensee or applicant for a site
access license to submit a proposed alternate amount and basis for
consideration by the agency.
(h) The indemnitor on such a bond or an insurance company
for any purpose of this Rule shall be licensed to do business in the State of
North Carolina.
History Note: Authority G.S. 104E‑10.3; 104E‑18;
104E‑27;
Eff. January 1, 1995;
Transferred and Recodified from 15A NCAC 11 .1511 Eff.
February 1, 2015.
10A NCAC 15 .1512 WASTE MANAGEMENT AND REDUCTION
REQUIREMENTS
(a) The purpose of this Rule is to define those elements
which may constitute a sound waste management program and to require each
applicant for a site access license or renewal of an existing site access
license to explain how each element is implemented or, if not implemented, why
its omission is justified.
(b) Those elements and sub‑elements which constitute
sound waste management practices include, but are not limited to, the
following:
(1) waste avoidance:
(A) process controls;
(B) training;
(C) material selection;
(D) leak prevention;
(E) segregation;
(F) recycling;
(G) reduction in size of facility contaminated areas;
and
(H) radionuclide selection;
(2) volume or activity reduction:
(A) storage for decay:
(i) waste containing no radionuclides with a
radioactive half‑life exceeding 90 days:
(I) hold for decay of contained radioactivity
and subsequent disposal as non low‑level radioactive waste; and
(II) hold for partial decay;
(ii) waste containing radionuclides with a
radioactive half‑life exceeding 90 days ‑ hold for partial decay;
(B) decontamination of equipment, materials or other
items:
(i) on‑site; and
(ii) off‑site;
(C) sorting:
(i) on‑site; and
(ii) off‑site;
(D) compaction:
(i) on‑site:
(I) super compaction; and
(II) other compaction;
(ii) off‑site super compaction;
(E) incineration:
(i) on‑site; and
(ii) off‑site.
(c) The applicant shall indicate the extent to which each
of the elements and sub‑elements listed in Paragraph (b) of this Rule and
any other waste management practices are being employed in the applicant's
waste management program.
(d) For each element and sub‑element listed in
Paragraph (b) of this Rule that is not employed in the applicant's waste
management program, the applicant shall provide a justification for its
omission which shall include an evaluation of the omission in accordance with
the ALARA principle and shall include a schedule for implementation, if future
implementation is planned.
History Note: Authority G.S. 104E‑10.3; 104E‑27;
Eff. January 1, 1995;
Transferred and Recodified from 15A NCAC 11 .1512 Eff.
February 1, 2015.
10A NCAC 15 .1513 ISSUANCE AND EXPIRATION OF SITE ACCESS
LICENSES
(a) The agency will issue a site access license only after
the following determinations are made and upon agency certification to the
North Carolina Low‑Level Radioactive Waste Management Authority that the
generator is reducing waste volume to the extent technologically and
economically feasible:
(1) The applicant has submitted a license
application which adequately demonstrates the applicant's ability to satisfy
all requirements in the rules of this Section;
(2) The applicant has a waste management
program which incorporates best management practices, including prevention,
minimization, reduction, segregation, and hold for decay storage, as provided
in Rule .1512 of this Section;
(3) The applicant is reducing waste volume and
contained radioactivity to the extent technologically and economically
feasible, including off‑site processing, before waste is disposed at a
disposal facility located in North Carolina, or has made a commitment to institute
such methods in accordance with a timetable specifically approved by the
agency;
(4) The applicant has filed the bonds,
insurance or other security with the agency as required in Rule .1511 of this
Section; and
(5) The applicant will ship waste to a disposal
facility located in North Carolina only when such waste is generated in the
Southeast Compact region, except as provided otherwise for waste generated by
waste processors and authorized pursuant to Item (1) of Rule .1507 of this
Section or as provided in Rule .1503(c) of this Section.
(b) Except as provided in Rules .1514 and .1517 of this
Section, a site access license shall be effective for a period of five years
subject to payment of applicable fees imposed by the rules in Section .1100 of
this Chapter.
(c) Notwithstanding the provisions of Paragraph (b) of this
Rule, any site access license is subject to modification, revocation or
suspension in accordance with provisions of Rule .1516 of this Section.
(d) The licensee shall apply for amendment of the site
access license in accordance with Rule .1515 of this Section prior to making
changes in the waste management program described in the license application
that would diminish the effectiveness of the waste management program,
including but not limited to, any change resulting in an increase of waste
volume and radiation exposure.
(e) If any information required by Paragraph (a) of Rule
.1504 changes, the licensee shall notify the agency of such changes in writing
no later than 60 days after the change and file an application for amendment,
if so directed by the agency.
History Note: Authority G.S. 104E‑10.3; 104E‑27;
Eff. January 1, 1995;
Transferred and Recodified from 15A NCAC 11 .1513 Eff.
February 1, 2015.
10A NCAC 15 .1514 SITE ACCESS LICENSE RENEWAL
(a) An application for renewal of a site access license
shall be filed in accordance with Rule .1504 of this Section.
(b) When a site access licensee has filed an application in
proper form for renewal not less than 30 days prior to expiration of his
existing license, the existing site access license shall not expire until the
agency has taken final action on the application.
(c) When a site access licensee files an application for
renewal less than 30 days prior to expiration of his existing site access
license, the licensee shall not have access to a disposal facility located in
North Carolina after the expiration date until the agency has issued final
approval of the application.
(d) As a precondition for renewal of a site access license,
the applicant shall satisfy the provisions of Rule .1512 of this Section.
History Note: Authority G.S. 104E‑10.3; 104E‑27;
Eff. January 1, 1995;
Transferred and Recodified from 15A NCAC 11 .1514 Eff.
February 1, 2015.
10A NCAC 15 .1515 SITE ACCESS LICENSE AMENDMENT
(a) An application for amendment of a site access license
shall be filed in accordance with Rule .1504 of this Section and shall specify
the manner in which the licensee desires the site access license to be amended
and the grounds for the amendment.
(b) In determining whether an amendment to a site access
license will be approved, the agency shall apply the criteria set forth in Rule
.1513 of this Section.
History Note: Authority G.S. 104E‑10.3; 104E‑27;
Eff. January 1, 1995;
Transferred and Recodified from 15A NCAC 11 .1515 Eff.
February 1, 2015.
10A NCAC 15 .1516 MODIFICATION, REVOCATION, AND
TERMINATION OF LICENSES
Site access licenses are subject to modification,
suspension, revocation and termination in accordance with the provisions of
Rule .0344 of this Chapter.
History Note: Authority G.S. 104E‑10.3; 104E‑27;
Eff. January 1, 1995;
Transferred and Recodified from 15A NCAC 11 .1516 Eff.
February 1, 2015.
10A NCAC 15 .1517 TEMPORARY OR EMERGENCY ACCESS
(a) The agency may grant temporary or emergency access to a
disposal facility located in North Carolina to a generator in the Southeast
Compact region, only if:
(1) access is necessary in order to eliminate
an immediate and serious threat to the public health and safety;
(2) the determination is made that the threat
cannot be mitigated by any other alternative consistent with the public health
and safety, including ceasing the activities that generate the waste; and
(3) the waste form and content of the waste to
be disposed, meets all acceptability requirements as stated in the facility
operator's license.
(b) The agency may grant temporary or emergency access to a
disposal facility located in North Carolina to a generator outside the
Southeast Compact region, only after:
(1) Such access has been granted by the U.S.
Nuclear Regulatory Commission in accordance with applicable provisions of
federal regulations and of the Low‑Level Radioactive Waste Policy Amendments
Act of 1985; and
(2) The agency has reviewed the U.S. Nuclear
Regulatory Commission's decision to grant temporary or emergency access.
(c) Temporary or emergency access to a disposal facility
located in North Carolina is subject to the applicable site access licensing
requirements in this Section and to the fee requirements in Section .1100 of
this Chapter.
(d) Notwithstanding the provisions of Rule .1513 of this
Section, a site access license, authorizing temporary or emergency access,
shall be effective only for the period of time and the specific waste for which
temporary or emergency access was granted.
History Note: Authority G.S. 104E‑10.3; 104E‑27;
Eff. January 1, 1995;
Transferred and Recodified from 15A NCAC 11 .1517 Eff.
February 1, 2015.
SECTION .1600 - STANDARDS FOR PROTECTION AGAINST RADIATION
10A NCAC 15 .1601 PURPOSE AND SCOPE
(a) The rules in this Section establish standards for
protection against ionizing radiation resulting from activities conducted under
licenses and registrations issued by the agency pursuant to the rules in this
Chapter.
(b) It is the purpose of the rules in this Section to
control the receipt, possession, use, transfer, and disposal of sources of
radiation by any licensee or registrant in such a manner that the total dose to
an individual, including doses resulting from all sources of radiation other
than background radiation, does not exceed the standards for protection against
radiation prescribed in the rules in this Section. However, nothing in this
Section shall be construed as limiting actions that may be necessary to protect
health and safety.
(c) The rules in this Section apply to persons licensed or
registered by the agency to receive, possess, use, transfer, or dispose of
radioactive material or other sources of radiation. The limits in this Section
do not apply to doses due to background radiation, to exposure of patients to
radiation for the purpose of medical diagnosis or therapy, to voluntary
participation in medical research programs, or to exposure from individuals
administered radioactive material and released in accordance with Rule .0358 of
this Chapter.
(d) Nothing in this Section shall relieve a licensee
engaged in operation of a radioactive waste disposal facility, as defined in
Rule .0104 of this Chapter, from responsibility for complying with the
requirements in Section .1200 of this Chapter.
(e) Effective January 1, 1994 all licensees and registrants
shall comply with the rules in this Section and cease to comply with the requirements
in Section .0400 of this Chapter, except as provided otherwise in Rule .1602 of
this Section.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Amended Eff. August 1, 1998;
Transferred and Recodified from 15A NCAC 11 .1601 Eff. February
1, 2015.
10A NCAC 15 .1602 IMPLEMENTATION
(a) If the requirements of this Section are more
restrictive than a license or registration condition established prior to
January 1, 1994, the licensee or registrant shall comply with this Section
unless exempted by Paragraph (c) of this Rule.
(b) If any existing license or registration condition is
more restrictive than a requirement in this Section, the licensee or registrant
shall comply with such condition until there is a license or registration
amendment or license or registration renewal that modifies or removes the
condition.
(c) If a license or registration condition established
prior to January 1, 1994 exempts a licensee or registrant from a requirement in
this Section, the exemption shall remain in effect until there is a license or
registration amendment or license or registration renewal that modifies or
removes the condition.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1602 Eff.
February 1, 2015.
10A NCAC 15 .1603 RADIATION PROTECTION PROGRAMS
(a) Each licensee or registrant shall develop, document,
and implement a radiation protection program commensurate with the scope and
extent of licensed or registered activities and sufficient to ensure compliance
with the provisions of this Section. Recordkeeping requirements relating to
these programs are provided in Rule .1636 of this Section.
(b) The licensee or registrant shall use procedures and
engineering controls based upon sound radiation protection principles to
achieve occupational doses and doses to members of the public and releases of
radioactive materials in effluents to unrestricted areas that are as low as is
reasonably achievable (ALARA).
(c) The licensee or registrant shall annually review the
radiation protection program content and implementation.
(d) To implement the ALARA requirements of Paragraph (b) of
this Rule, and notwithstanding the requirements of Rule .1611 of this Section,
a constraint on air emissions of radioactive material to the environment,
excluding Radon-222 and its daughters, shall be established by licensees such
that the individual member of the public likely to receive the highest dose
will not be expected to receive a total effective dose equivalent in excess of
0.01 rem (0.1 mSv) per year from these emissions. If a licensee subject to
this requirement exceeds this dose constraint, the licensee shall report the
exceedance as provided in Rule .1647 of this Section and promptly take
appropriate corrective action to ensure against recurrence.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Amended Eff. August 1, 1998;
Transferred and Recodified from 15A NCAC 11 .1603 Eff.
February 1, 2015.
10A NCAC 15 .1604 OCCUPATIONAL DOSE LIMITS FOR ADULTS
(a) A licensee or registrant shall limit the occupational
dose to individual adults, except for planned special exposures as provided in
Rule .1608 of this Section, to the following dose limits:
(1) an annual limit, which is the more limiting
of:
(A) the total effective dose equivalent being equal to
five rems (0.05Sv); or
(B) the sum of the deep-dose equivalent and the committed
dose equivalent to any individual organ or tissue other than the lens of the
eye being equal to 50 rems (0.5 Sv); and
(2) the annual limits to the lens of the eye,
the skin of the whole body, and the skin of the extremities which are:
(A) an eye dose equivalent of 15 rems (0.15 Sv); and
(B) a shallow-dose equivalent of 50 rems (0.50 Sv) to
the skin of the whole body or to the skin of any extremity.
(b) Doses received in excess of the annual limits,
including doses received during accidents, emergencies, and planned special
exposures, shall be subtracted from the limits for planned special exposures
that the individual may receive during the current year and during the
individual's lifetime. Dose limits for planned special exposures are provided
in Item (5) of Rule .1608 of this Section.
(c) When the external exposure is determined by measurement
with an external personal monitoring device, the deep-dose equivalent must be
used in place of the effective dose equivalent unless the effective dose
equivalent is determined by a dosimetry method approved by the agency as
consistent with this Chapter. The assigned deep-dose equivalent must be for
the part of the body receiving the highest exposure. The assigned shallow-dose
equivalent must be the dose averaged over the contiguous 10 square centimeters
of skin receiving the highest exposure. The deep-dose equivalent, lens-dose
equivalent, and shallow-dose equivalent may be assessed from surveys or other
radiation measurements for the purpose of demonstrating compliance with the
occupational dose limits if the individual monitoring device was not in the
region of highest potential exposure or the results of individual monitoring
are unavailable.
(d) Derived air concentration (DAC) and annual limit on
intake (ALI) values are presented in Table 1 of Appendix B to 10 CFR 20.1001 -
20.2401 and may be used to determine the individual's dose and to demonstrate
compliance with the occupational dose limits.
(e) In addition to the annual dose limits, the licensee
shall limit the soluble uranium intake by an individual to 10 milligrams in a
week in consideration of chemical toxicity. Requirements for annual limits on
intake for uranium are provided in Appendix B to 10 CFR 20.1001 - 20.2401.
(f) The licensee or registrant shall reduce the dose that
an individual may be allowed to receive in the current year by the amount of prior
or current occupational dose received while employed by any other person.
Requirements for determining prior occupational exposure are provided in Rule
.1638(e) of this Section.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Amended Eff. October 1, 2013; May 1, 2006;
Transferred and Recodified from 15A NCAC 11 .1604 Eff.
February 1, 2015.
10A NCAC 15 .1605 REQUIREMENTS FOR SUMMATION OF
EXTERNAL, INTERNAL DOSES
(a) If the licensee is required to monitor under both Items
(1) and (2) of Rule .1614 of this Section, the licensee shall demonstrate
compliance with the dose limits by summing external and internal doses. If the
licensee is required to monitor only by Rule .1614(1) of this Section or only
by Rule .1614(2) of this Section, then summation is not required to demonstrate
compliance with the dose limits. The licensee may demonstrate compliance with
the requirements for summation of external and internal doses by meeting one of
the conditions specified in Paragraph (b) of this Rule and the conditions in
Paragraphs (c) and (d) of this Rule. The dose equivalents for the lens of the eye,
the skin, and the extremities are not included in the summation, but are
subject to separate limits.
(b) If the only intake of radionuclides is by inhalation,
the total effective dose equivalent limit is not exceeded if the sum of the
deep-dose equivalent divided by the total effective dose equivalent limit, and
one of the following, does not exceed unity:
(1) the sum of the fractions of the inhalation
ALI for each radionuclide, or
(2) the total number of derived air
concentration-hours (DAC-hours) for all radionuclides divided by 2,000, or
(3) the sum of the calculated committed
effective dose equivalents to all significantly irradiated organs or tissues
(T) calculated from bioassay data using appropriate biological models and
expressed as a fraction of the annual limit. For the purposes of this Rule an
organ or tissue is deemed to be significantly irradiated if, for that organ or
tissue, the product of the weighing factors, wT, and the committed dose
equivalent, HT,50 per unit intake is greater than 10 percent of the maximum
weighted value of HT,50 (i.e., wTHT,50) per unit intake for any organ or
tissue.
(c) If the occupationally exposed individual also receives
an intake of radionuclides by oral ingestion greater than 10 percent of the
applicable oral ALI, the licensee shall account for this intake and include it
in demonstrating compliance with the limits.
(d) The licensee shall evaluate and, to the extent
practical, account for intakes through wounds or skin absorption. The intake
through intact skin has been included in the calculation of DAC for hydrogen-3
and does not need to be further evaluated.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1605 Eff.
February 1, 2015.
10A NCAC 15 .1606 EXTERNAL DOSE FROM AIRBORNE
RADIOACTIVE MATERIAL
Licensees shall, when determining the dose from airborne
radioactive material, include the contribution to the deep-dose equivalent, eye
dose equivalent, and shallow-dose equivalent from external exposure to the
radioactive cloud. Airborne radioactivity measurements and DAC values shall
not be used as the primary means to assess the deep-dose equivalent when the
airborne radioactive material includes radionuclides other than noble gases or
if the cloud of airborne radioactive material is not relatively uniform. The
determination of the deep-dose equivalent to an individual shall be based upon
measurements using instruments or individual monitoring devices.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1606 Eff.
February 1, 2015.
10A NCAC 15 .1607 DETERMINATION OF INTERNAL EXPOSURE
(a) For purposes of assessing dose used to determine
compliance with occupational dose equivalent limits, the licensee shall, when
required by Rule .1614 of this Section, take suitable and timely measurements
of:
(1) concentrations of radioactive materials in
air in work areas; or
(2) quantities of radionuclides in the body; or
(3) quantities of radionuclides excreted from
the body; or
(4) combinations of these measurements.
(b) Unless respiratory protective equipment is used, as
provided in Rule .1620 of this Section, or the assessment of intake is based
on bioassays, the licensee shall assume that an individual inhales radioactive
material at the airborne concentration in which the individual is present.
(c) When specific information on the physical and
biochemical properties of the radionuclides taken into the body or the behavior
of the material in an individual is known, the licensee may:
(1) use that information to calculate the
committed effective dose equivalent, provided the licensee documents that
information in the individual's record; and
(2) upon prior approval of the agency, adjust
the DAC or ALI values to reflect the actual physical and chemical
characteristics of airborne radioactive material (e.g., aerosol size
distribution or density); and
(3) separately assess the contribution of
fractional intakes of Class D, W, or Y compounds of given radionuclide to the
committed effective dose equivalent. Requirements for annual limits on intake
are provided in Appendix B to 10 CFR §§ 20.1001 - 20.2401.
(d) If the licensee chooses to assess intakes of Class Y
material using the measurements given in Subparagraph (a)(2) or (3) of this
Rule, the licensee may delay the recording and reporting of the assessments for
periods up to seven months, unless otherwise required by Rules .1646 or .1647
of this Section, in order to permit the licensee to make additional
measurements basic to the assessments.
(e) If the identity and concentration of each radionuclide
in a mixture are known, the fraction of the DAC applicable to the mixture for
use in calculating DAC-hours shall be either:
(1) the sum of the ratios of the concentration
to the appropriate DAC value (e.g., D, W, Y) from Appendix B to 10 CFR §§ 20.1001
- 20.2401 for each radionuclide in the mixture; or
(2) the ratio of the total concentration for
all radionuclides in the mixture to the most restrictive DAC value for any
radionuclide in the mixture.
(f) If the identity of each radionuclide in a mixture is
known, but the concentration of one or more of the radionuclides in the mixture
is not known, the DAC for the mixture shall be the most restrictive DAC of any
radionuclide in the mixture.
(g) When a mixture of radionuclides in air exists, licensees
may disregard certain radionuclides in the mixture if:
(1) the licensee uses the total activity of the
mixture in demonstrating compliance with the dose limits in Rule .1604 of this
Section and in complying with the monitoring requirements in Rule .1614 of this
Section;
(2) the concentration of any radionuclide
disregarded is less than 10 percent of its DAC; and
(3) the sum of these percentages for all of the
radionuclides disregarded in the mixture does not exceed 30 percent.
(h) In order to calculate the committed effective dose
equivalent, the licensee may assume that the inhalation of one ALI, or an
exposure of 2,000 DAC-hours, results in a committed effective dose equivalent
of five rems (0.05 Sv) for radionuclides that have their ALIs or DACs based on
the committed effective dose equivalent.
(i) When the ALI and the associated DAC are determined by
the nonstochastic organ dose limit of 50 rems (0.5 Sv), the stochastic ALI,
which is the intake of radionuclides that would result in a committed effective
dose equivalent of five rems (0.05 Sv), is listed in parentheses in Table 1 of
Appendix B to 10 CFR §§ 20.1001 - 20.2401. In this case, the licensee may, as
a simplifying assumption, use the stochastic ALIs to determine committed
effective dose equivalent. However, if the licensee uses the stochastic ALIs,
the licensee shall also demonstrate that the limit in Part (a)(1)(B) of Rule
.1604 of this Section is met.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1607 Eff.
February 1, 2015.
10A NCAC 15 .1608 PLANNED SPECIAL EXPOSURES
A licensee or registrant may authorize an adult worker to
receive doses in addition to and accounted for separately from the doses
received under the limits specified in Rule .1604 of this Section provided that
each of the following conditions is satisfied:
(1) The licensee or registrant authorizes a planned
special exposure only in an exceptional situation when alternatives that might
avoid the dose estimated to result from the planned exposure are unavailable or
impractical.
(2) The licensee or registrant, and employer if the
employer is not the licensee or registrant, specifically authorizes the planned
special exposure, in writing, before the exposure occurs.
(3) Before a planned special exposure, the licensee or
registrant ensures that the individuals involved are:
(a) informed of the purpose of the planned
operation;
(b) informed of the estimated doses and
associated potential risks and specific radiation levels or other conditions
that might be involved in performing the task; and
(c) instructed in the measures to be taken to
keep the dose ALARA considering other risks that may be present.
(4) Prior to permitting an individual to participate in
a planned special exposure, the licensee or registrant ascertains prior doses
as required by Rule .1638(b) of this Section during the lifetime of the
individual for each individual involved.
(5) Subject to Rule .1604(b) of this Section, the
licensee or registrant does not authorize a planned special exposure that would
cause an individual to receive a dose such that the individual's dose from all
planned special exposures and all doses in excess of the limits would exceed:
(a) the numerical values of any of the dose
limits in Rule.1604(a) of this Section in any year; and
(b) five times the annual dose limits in Rule
.1604(a) of this Section during the individual's lifetime.
(6) The licensee or registrant maintains records of the
conduct of a planned special exposure in accordance with Rule .1639 of this
Section and submits a written report in accordance with Rule .1648 of this
Section.
(7) The licensee or registrant records the best
estimate of the dose resulting from the planned special exposure in the
individual's record and informs the individual, in writing, of the dose within
30 days from the date of the planned special exposure. The dose from planned
special exposures is not to be considered in controlling future occupational
dose of the individual under Rule .1604(a) of this Section but is to be
included in evaluations required by Items (4) and (5) of this Rule.
History Note: Authority G.S. 104E-7(a)(2); 104E-12;
Eff. January 1, 1994;
Amended Eff. August 1, 2002;
Transferred and Recodified from 15A NCAC 11 .1608 Eff.
February 1, 2015.
10A NCAC 15 .1609 OCCUPATIONAL DOSE LIMITS FOR MINORS
The annual occupational dose limits for minors are 10
percent of the annual dose limits specified for adult workers in Rule .1604 of
this Section.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1609 Eff.
February 1, 2015.
10a ncac 15 .1610 DOSE EQUIVALENT TO AN EMBRYO/FETUS
(a) The licensee or registrant shall ensure that the dose
equivalent to an embryo/fetus during the entire pregnancy, due to occupational
exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv).
Recordkeeping requirements for doses to an embryo/fetus are provided in Rule
.1640 of this Section.
(b) The licensee or registrant shall make efforts to avoid
variation above a uniform monthly exposure rate to a declared pregnant woman so
as to satisfy the limit in Paragraph (a) of this Rule.
(c) The dose equivalent to an embryo/fetus shall be taken
as the sum of:
(1) the deep-dose equivalent to the declared
pregnant woman; and
(2) the dose equivalent to the embryo/fetus
from radionuclides in the embryo/fetus and radionuclides in the declared
pregnant woman.
(d) If the dose equivalent to the embryo/fetus is found to
have exceeded 0.45 rem (4.5 mSv) by the time the woman declares the pregnancy
to the licensee or registrant, the licensee or registrant shall be deemed to be
in compliance with Paragraph (a) of this Rule if the additional dose to the
embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the
pregnancy.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Amended Eff. August 1, 2002;
Transferred and Recodified from 15A NCAC 11 .1610 Eff.
February 1, 2015.
10A NCAC 15 .1611 DOSE LIMITS FOR INDIVIDUAL MEMBERS OF
THE PUBLIC
(a) Each licensee or registrant shall conduct operations so
that:
(1) The total effective dose equivalent to
individual members of the public from the licensed or registered operation does
not exceed 0.1 rem (1 mSv) in a year exclusive of the dose contribution from
background radiation from the licensee's disposal of radioactive material into
sanitary sewerage in accordance with Rule .1630 of this Section, from any
medical administration the individual has received, from exposure to
individuals administered radioactive material and released in accordance with
Rule .0358 of this Chapter and from voluntary participation in medical research
programs; and
(2) The dose in any unrestricted area from
external sources of radiation, exclusive of the dose contribution from patients
administered radioactive material and released in accordance with Rule .0358 of
this Chapter, does not exceed 0.002 rem (0.02 mSv) in any one hour.
(b) If the licensee or registrant permits members of the
public to have access to controlled areas, the limits for members of the public
continue to apply to those individuals.
(c) A licensee, registrant, license applicant or
registration applicant may apply for and must receive agency authorization to
operate up to an annual dose limit for an individual member of the public of
0.5 rem (5 mSv). The licensee, registrant, license applicant or registration
applicant shall include the following information in this application:
(1) demonstration of the need for and the
expected duration of operations in excess of the limit in Paragraph (a) of this
Rule;
(2) the licensee's program to assess and
control dose within the 0.5 rem (5 mSv) annual limit; and
(3) the procedures to be followed to maintain
the dose as low as is reasonably achievable.
(d) The agency may impose additional restrictions on
radiation levels in unrestricted areas and on the total quantity of
radionuclides that a licensee may release in effluents in order to maintain the
collective dose as low as reasonably achievable.
(e) Notwithstanding Subparagraph (a)(1) of this Rule, a
licensee may permit visitors to an individual who cannot be released in
accordance with Rule .0358 of this Section to receive a dose in excess of 0.1
rem (1 mSv) if:
(1) The radiation dose received does not exceed
0.5 rem (5 mSv); and
(2) The authorized user, as defined in Section
.0300 of this Chapter had determined before the visit that it is appropriate.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Amended Eff. November 1, 2007; August 1, 1998;
Transferred and Recodified from 15A NCAC 11 .1611 Eff.
February 1, 2015.
10A NCAC 15 .1612 COMPLIANCE WITH DOSE LIMITS FOR
MEMBERS OF THE PUBLIC
(a) The licensee or registrant shall make or cause to be
made, as appropriate, surveys of radiation levels in unrestricted and
controlled areas and measurements and surveys of radioactive materials in
effluents released to unrestricted and controlled areas to demonstrate
compliance with the dose limits for individual members of the public in Rule
.1611 of this Section.
(b) A licensee or registrant shall show compliance with the
annual dose limit in Rule .1611 of this Section by:
(1) demonstrating by measurement or calculation
that the total effective dose equivalent to the individual likely to receive
the highest dose from the licensed or registered operation does not exceed the
annual dose limit; or
(2) demonstrating that:
(A) The annual average concentrations of radioactive
material released in gaseous and liquid effluents at the boundary of the
unrestricted area do not exceed the values specified in Table 2 of Appendix B
to 10 CFR §§ 20.1001 - 20.2401; and
(B) If an individual were continually present in an
unrestricted area, the dose from external sources of radiation would not exceed
0.002 rem (0.02 mSv) in an hour and 0.05 rem (0.5 mSv) in a year.
(c) Upon approval from the agency, the licensee may adjust
the effluent concentration values in Appendix B to 10 CFR §§ 20.1001 - 20.2401,
Table 2, for members of the public, to take into account the actual physical
and chemical characteristics of the effluents (e.g., aerosol size distribution,
solubility, density, radioactive decay equilibrium, chemical form).
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1612 Eff.
February 1, 2015.
10a ncac 15 .1613 SURVEYS
(a) Each licensee or registrant shall make or cause to be
made, surveys that:
(1) may be necessary for the licensee or
registrant to comply with the rules in this Section; and
(2) are reasonable under the circumstances to evaluate:
(A) the magnitude and extent of radiation levels;
(B) concentrations or quantities of radioactive
material; and
(C) the potential radiological hazards that could be
present.
(b) The licensee or registrant shall ensure that
instruments and equipment used for quantitative radiation measurements (e.g.,
dose rate and effluent monitoring) are calibrated at the frequency committed to
in accordance with the requirements of Rules .0207 or .0317 of this Chapter for
the radiation measured.
(c) All personnel dosimeters (except for direct and
indirect reading pocket ionization chambers and those dosimeters used to
measure the dose to the extremities) that require processing to determine the
radiation dose and that are used by licensees or registrants to comply with
Rule .1604 of this Section, with other applicable provisions of this Chapter,
or with conditions specified in a license shall be processed and evaluated by a
dosimetry processor:
(1) Holding current personnel dosimetry
accreditation from the National Voluntary Laboratory Accreditation Program
(NVLAP) of the National Institute of Standards and Technology; and
(2) Approved in this accreditation process for
the type of radiation or radiations included in the NVLAP program that most
closely approximates the type of radiation or radiations for which the
individual wearing the dosimeter is monitored.
(d) Exposure of a personnel monitoring device to deceptively
indicate a dose delivered to an individual is prohibited.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Amended Eff. August 1, 2002;
Transferred and Recodified from 15A NCAC 11 .1613 Eff.
February 1, 2015.
10A NCAC 15 .1614 MONITORING OF EXTERNAL AND INTERNAL
OCCUPATIONAL DOSE
Each licensee or registrant shall monitor exposures to
radiation and radioactive material at levels sufficient to demonstrate
compliance with the occupational dose limits of this Section. As a minimum:
(1) Each licensee or registrant shall monitor
occupational exposure to radiation and shall supply and require the use of
individual monitoring devices by:
(a) adults likely to receive, in one year from
sources external to the body, a dose in excess of 10 percent of the limits in
Rule .1604(a) of this Section;
(b) minors likely to receive, in one year, from
sources of radiation, a deep dose equivalent in excess of 0.1 rem (1 mSv), a
lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose
equivalent in excess of 0.5 rem (5 mSv);
(c) declared pregnant women likely to receive,
during the entire pregnancy, from sources of radiation external to the body, a
deep dose equivalent in excess of 0.1 rem (1 mSv); and
(d) individuals entering a high or very high
radiation area.
(2) Each licensee shall monitor the occupational intake
of radioactive material by and assess the committed effective dose equivalent
to:
(a) adults likely to receive, in one year, an
intake in excess of 10 percent of the applicable ALI(s) in Table 1, Columns 1
and 2, of Appendix B to 10 CFR 20.1001 - 20.2402; and
(b) minors likely to receive, in one year, a
committed effective dose equivalent in excess of 0.1 rem (1mSv); and
(c) declared pregnant women likely to receive,
during the entire pregnancy, a committed effective dose equivalent in excess of
0.1 rem (1mSv).
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Amended Eff. January 1, 2005; August 1, 2002;
Transferred and Recodified from 15A NCAC 11 .1614 Eff.
February 1, 2015.
10A NCAC 15 .1615 CONTROL OF ACCESS TO HIGH RADIATION
AREAS
(a) The licensee or registrant shall ensure that each
entrance or access point to a high radiation area has at least one of the
following features:
(1) a control device that, upon entry into the
area, causes the level of radiation to be reduced below that level at which an
individual might receive a deep-dose equivalent of 0.1 rem (1 mSv) in one hour
at 30 centimeters from the radiation source or from any surface that the
radiation penetrates;
(2) a control device that energizes a
conspicuous visible or audible alarm signal so that the individual entering the
high radiation area and the supervisor of the activity are made aware of the
entry; or
(3) entryways that are locked, except during
periods when access to the areas is required, with positive control over each
individual entry.
(b) In place of the controls required by Paragraph (a) of
this Rule for a high radiation area, the licensee or registrant may substitute
continuous direct or electronic surveillance that is capable of preventing
unauthorized entry.
(c) Any licensee, registrant or applicant for a license or
registration may apply to the agency for approval of alternative methods for
controlling access to high radiation areas. The agency will approve
alternatives if the licensee, registrant or applicant demonstrates that the
alternative methods of control will prevent unauthorized entry into a high
radiation area.
(d) The licensee or registrant shall establish the controls
required by Paragraphs (a) and (c) of this Rule in a way that does not prevent
individuals from leaving a high radiation area.
(e) Control is not required for each entrance or access
point to a room or other area that is a high radiation area solely because of
the presence of radioactive materials prepared for transport and packaged and
labeled in accordance with the regulations of the U.S. Department of
Transportation provided that:
(1) the packages do not remain in the area
longer than three days; and
(2) the dose rate at one meter from the
external surface of any package does not exceed 0.01 rem (0.1 mSv) per hour.
(f) Control of entrance or access to rooms or other areas
in hospitals is not required solely because of the presence of patients
containing radioactive material, provided that there are personnel in
attendance who will take the necessary precautions to prevent the exposure of
individuals to radiation or radioactive material in excess of the limits
established in this Section and to operate within the ALARA provisions of the
licensee's radiation protection program.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1615 Eff.
February 1, 2015.
10A NCAC 15 .1616 CONTROL OF ACCESS TO VERY HIGH
RADIATION AREAS
In addition to the requirements in Rule .1615 of this
Section, the licensee or registrant shall also institute the additional
measures required in Rule .1617 of this Section to ensure that an individual is
not able to gain unauthorized or inadvertent access to very high radiation
areas.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1616 Eff.
February 1, 2015.
10A NCAC 15 .1617 ACCESS TO VERY HIGH RADIATION AREAS:
IRRADIATORS
(a) Each area in which there may exist radiation levels in
excess of 500 rads (5 grays) in one hour at one meter from a source of
radiation that is used to irradiate materials shall meet the following
requirements:
(1) Each entrance or access point shall be
equipped with entry control devices which:
(A) function automatically to prevent any individual
from inadvertently entering the area when very high radiation levels exist;
(B) permit deliberate entry into the area only after a
control device is actuated that causes the radiation level within the area,
from the source of radiation, to be reduced below that at which it would be
possible for an individual to receive a deep-dose equivalent in excess of 0.1
rem (1 mSv) in one hour; and
(C) prevent operation of the source of radiation if the
source would produce radiation levels in the area that could result in a
deep-dose equivalent to an individual in excess of 0.1 rem (1 mSv) in one hour.
(2) Additional control devices shall be
provided so that, upon failure of the entry control devices to function as
required by Subparagraph (a)(1) of this Rule:
(A) The radiation level within the area, from the source
of radiation, is reduced below that at which it would be possible for an
individual to receive a deep-dose equivalent in excess of 0.1 rem (1 mSv) in
one hour; and
(B) Conspicuous visible and audible alarm signals are
generated to make an individual attempting to enter the area aware of the hazard
and at least one other authorized individual, who is physically present,
familiar with the activity, and prepared to render or summon assistance, aware
of the failure of the entry control devices.
(3) The licensee or registrant shall provide
control devices so that, upon failure or removal of physical radiation barriers
other than the shielded storage container:
(A) The radiation level from the source of radiation is
reduced below that at which it would be possible for an individual to receive a
deep-dose equivalent in excess of 0.1 rem (1 mSv) in one hour; and
(B) Conspicuous visible and audible alarm signals are
generated to make potentially affected individuals aware of the hazard and the
licensee or registrant or at least one other individual, who is familiar with
the activity and prepared to render or summon assistance, aware of the failure
or removal of the physical barrier.
(4) When the shield for the stored source of
radiation is a liquid, the licensee or registrant shall provide means to
monitor the integrity of the shield and to signal, automatically, loss of
adequate shielding.
(5) Physical radiation barriers that comprise
permanent structural components, such as walls, that have no credible
probability of failure or removal in ordinary circumstances need not meet the
requirements of Subparagraphs (a)(3) and (4) of this Rule.
(6) Each area shall be equipped with a clearly
identified control device which can prevent the source of radiation from being
put into operation.
(7) Each area shall be equipped with devices
that will automatically generate conspicuous visible and audible alarm signals
to alert personnel in the area before the source of radiation can be put into
operation and in sufficient time for any individual in the area to operate the
control device required by Subparagraph (a)(6) of this Rule.
(8) Each area shall be controlled by use of
such administrative procedures and such devices as are necessary to ensure that
the area is cleared of personnel prior to each use of the source of radiation.
(9) Each area shall be checked by a radiation
measurement to ensure that, prior to the first individual's entry into the area
after any use of the source of radiation, the radiation level from the source
in the area is below that at which it would be possible for an individual to
receive a deep-dose equivalent in excess of 0.1 rem (1 mSv) in one hour.
(10) The entry control devices required in
Subparagraph (a)(1) of this Rule shall have been tested for proper
functioning. Recordkeeping requirements relating to these tests are provided
in Rule .1643 of this Section.
(A) Testing shall be conducted prior to initial
operation of the source of radiation on any day, unless operations were
continued uninterrupted from the previous day;
(B) Testing shall be conducted prior to resumption of
operation of the source of radiation after any unintended interruption; and
(C) The licensee or registrant shall submit and adhere
to a schedule for periodic tests of the entry control and warning systems.
(11) The licensee or registrant shall not conduct
operations, other than those necessary to place the source of radiation in safe
condition or to effect repairs on controls, unless control devices are
functioning properly.
(12) Entry and exit portals that are used in
transporting materials to and from the irradiation area, and that are not
intended for use by individuals, shall be controlled by such devices and
administrative procedures as are necessary to physically protect and warn
against inadvertent entry by any individual through these portals. Exit
portals for processed materials shall be equipped to detect and signal the
presence of any loose radiation sources that are carried toward such an exit
and to automatically prevent loose radiation sources from being carried out of
the area.
(b) Any licensee, registrant or applicant for a license or
registration for sources of radiation that are subject to Paragraph (a) of this
Rule and that will be used in a variety of positions or in locations, such as
open fields or forests, that make it impracticable to comply with certain
requirements of Paragraph (a) of this Rule, such as those for the automatic
control of radiation levels, may apply to the agency for approval of the use of
alternative safety measures. Any alternative safety measures shall provide a
degree of personnel protection at least equivalent to those specified in
Paragraph (a) of this Rule. At least one of the alternative measures shall
include an entry-preventing interlock control based on a measurement of the radiation
that ensures the absence of high radiation levels before an individual can gain
access to the area where such radiation sources are used.
(c) The entry control devices required by Paragraphs (a)
and (b) of this Rule shall be established in such a way that no individual will
be prevented from leaving the area.
(d) This Rule applies to radiation from non-self-shielded
irradiators. This Rule does not apply to sources of radiation that are used in
therapy, in radiography, or in completely self-shielded irradiators in which
the source of radiation is both stored and operated within the same shielding
radiation barrier and, in the designed configuration of the irradiator, is
always physically inaccessible to any individual and cannot create high levels
of radiation in an area that is accessible to any individual. This Rule also
does not apply to sources of radiation from which the radiation is incidental
to some other use.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1617 Eff.
February 1, 2015.
10A NCAC 15 .1618 USE OF PROCESS OR OTHER ENGINEERING
CONTROLS
The licensee shall use, to the extent practicable, process
or other engineering controls (e.g., containment, decontamination, or
ventilation) to control the concentrations of radioactive material in air.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Amended Eff. January 1, 2005;
Transferred and Recodified from 15A NCAC 11 .1618 Eff.
February 1, 2015.
10A NCAC 15 .1619 USE OF OTHER CONTROLS TO RESTRICT
INTERNAL EXPOSURE
(a) When it is not practicable to apply process or other
engineering controls to control the concentrations of radioactive material in
air to values below those that define an airborne radioactivity area, the
licensee shall, consistent with maintaining the total effective dose equivalent
ALARA, increase monitoring and limit intakes of radionuclides by one or more of
the following means:
(1) the control of access to the area;
(2) the limitation of exposure times of personnel in
the area;
(3) the use of respiratory protection equipment; or
(4) other controls.
(b) If the licensee performs ALARA analyses to determine
whether or not respirators are to be used, the licensee may consider safety
factors other than radiological factors. The licensee shall also consider the
impact of respirator use on workers' industrial health and safety.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Amended Eff. January 1, 2005;
Transferred and Recodified from 15A NCAC 11 .1619 Eff.
February 1, 2015.
10A NCAC 15 .1620 USE OF INDIVIDUAL RESPIRATORY
PROTECTION EQUIPMENT
(a) If the licensee uses respiratory protection equipment
to limit intakes of radioactive material, the licensee shall:
(1) use respiratory protection equipment that
is tested and certified by the National Institute for Occupational Safety and
Health (NIOSH);
(2) if the licensee wishes to use any equipment
that has not been tested or certified by NIOSH, or for which there is no
schedule for testing or certification, submit an application to the agency for
authorized use of that equipment, including a demonstration by testing, or a
demonstration on the basis of reliable test information, that the material and
performance characteristics of the equipment are capable of providing the proposed
degree of protection under anticipated conditions of use;
(3) implement and maintain a respiratory
protection program that includes:
(A) air sampling sufficient to identify the potential
hazard, permit proper equipment selection, and estimate exposures;
(B) surveys and bioassays, as appropriate, to evaluate
actual intakes;
(C) testing of respirators for operability immediately
prior to each use;
(D) written procedures regarding: monitoring, including
air sampling and bioassays; supervision and training of respirator users; fit
testing; respirator selection; breathing air quality; inventory and control;
storage, issuance, maintenance, repair, testing, and quality assurance of
respiratory protection equipment; recordkeeping; and limitations on periods of
respirator use and relief from respirator use;
(E) determination by a physician prior to initial
fitting of a face sealing respirator, prior to the first field use of a
non-face sealing respirator, and at least every 12 months thereafter or
periodically at a frequency determined by a physician, that the individual user
is physically able to use the respiratory protection equipment; and
(F) Fit testing, with fit factor ³ 10 times the APF for negative pressure
devices, and a fit factor ³ 500 for any
positive pressure, continuous flow, and pressure-demand devices, before the
first field use of tight fitting, face sealing respirators and annually
thereafter. Fit testing must be performed with the facepiece operating in the
negative pressure mode.
(4) advise each respirator user that the user
may leave the area at any time for relief from respirator use in the event of
equipment malfunction, physical or psychological distress, procedural or
communication failure, significant deterioration of operating conditions, or
any other conditions that might require such relief;
(5) use equipment within limitations for type
and mode of use and provide for vision correction, effective communication, low
temperature work environments, the concurrent use of other safety or radiological
protection equipment, and assurance that other such equipment will be used in
such a way as not to interfere with proper operation of the respirator.
(6) provide standby rescue personnel whenever
one-piece atmosphere-supplying suits, or any combination of supplied air
respiratory protection devices and personnel protective equipment are used from
which an unaided individual would have difficulty extricating himself or
herself. The standby rescue personnel shall:
(A) be equipped with
respiratory protection devices or other apparatus appropriate for the potential
hazards identified by the licensee;
(B) observe or
otherwise maintain continuous communication with the workers through visual,
voice, signal line, telephone, radio, or other means suitable for the
environment;
(C) be immediately
available to assist workers in the event of a failure of the air supply or for
any other reason that requires relief from distress;
(D) be immediately
available in sufficient number to assist all users of this type of equipment
and to provide effective emergency rescue, if needed.
(7) provide atmosphere-supplying respirators
with respirable air of grade D quality or better as defined by the Compressed
Gas Association in publication G-7.1, "Commodity Specification for Air,"
1997 and included in Title 29 CFR 1910.134(i)(1)(ii)(A) – (E) of the
Occupational Safety and Health Administration. Grade D quality air criteria
include:
(A) Oxygen content of
19.5% - 23.5%;
(B) condensed
Hydrocarbon content of 5 milligrams per cubic meter of air or less;
(C) Carbon Monoxide
(CO) content of 10 ppm or less;
(D) Carbon Dioxide
content of 1,000 ppm or less; and
(E) lack of
noticeable odor.
(8) ensure that no objects, materials or
substances, such as facial hair, or any conditions that interfere with the
face-to-facepiece seal or valve function, and that are under the control of the
respirator wearer, are present between the skin of the wearer's face and the
sealing surface of a tight-fitting respirator facepiece.
(b) In estimating the dose to individuals from intake of
airborne radioactive materials, the concentration of radioactive material in
the air that is inhaled when respirators are worn is initially assumed to be
the ambient concentration in air without respiratory protection, divided by the
assigned protection factor. If the dose is later found to be greater than the
estimated dose, the corrected value must be used. If the dose is later found
to be less than the estimated dose, the corrected value may be used.
(c) The licensee shall obtain authorization, in writing,
from the agency before using assigned protection factors in excess of those
specified in Appendix A to 10 CFR Part 20. The agency may authorize the use of
higher assigned protection factors upon receipt of an application that:
(1) describes the
situation for which a need exists for higher protection factors; and
(2) demonstrates
that the respiratory equipment provides the higher protection factors under the
proposed conditions of use.
History Note: Authority G.S. 104E-7(a)(2); 104E-12(a);
Eff. January 1, 1994;
Amended Eff. January 1, 2005; August 1, 1998;
Transferred and Recodified from 15A NCAC 11 .1620 Eff.
February 1, 2015.
10A NCAC 15 .1621 RESTRICTIONS ON THE USE OF RESPIRATORY
PROTECTION EQUIPMENT
The agency may impose restrictions in addition to those in
Rules .1619 and .1620 of this Section, and Appendix A to 10 CFR 20.1001 -
20.2401 when the agency determines that such requirements are necessary to:
(1) ensure that the respiratory protection program of
the licensee is adequate to limit exposures of individuals to airborne
radioactive materials to levels that maintain the total effective dose
equivalent ALARA; and
(2) limit the extent to which a licensee may use
respiratory protection equipment instead of process or other engineering
controls when process or other engineering controls are appropriate to limit
exposures of individuals to airborne radioactive materials to the levels
prescribed in this Section.
History Note: Authority G.S. 104E-7(a)(2); 10 C.F.R.
Chapter 1, Commission Notices, Policy Statements, Agreement States,
46 F.R. 7540;
Eff. January 1, 1994;
Amended Eff. January 1, 2005;
Transferred and Recodified from 15A NCAC 11 .1621 Eff.
February 1, 2015.
10A NCAC 15 .1622 SECURITY OF SOURCES OF RADIATION
(a) The licensee or registrant shall secure from
unauthorized removal or access sources of radiation that are stored in
controlled or unrestricted areas.
(b) The licensee or registrant shall control and maintain
constant surveillance of sources of radiation that are in a controlled or
unrestricted area and that are not in storage.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1622 Eff.
February 1, 2015.
10A NCAC 15 .1623 CAUTION SIGNS
(a) Unless otherwise authorized by the agency, the symbol
prescribed by the rules of this Chapter shall use the colors magenta, or
purple, or black on yellow background. The radiation symbol prescribed by the
rules of this Chapter is the standard three-bladed design.
(1) The blades and interior circle shall be
magenta, purple, or black; and
(2) The background shall be yellow.
(b) Notwithstanding the requirements of Paragraph (a) of
this Rule, licensees and registrants are authorized to label sources, source
holders, or device components containing sources of radiation that are
subjected to high temperatures, with conspicuously etched or stamped radiation
caution symbols and without a color requirement.
(c) In addition to the contents of signs and labels
prescribed in the rules of this Chapter, the licensee or registrant may
provide, on or near the required signs and labels, additional information, as
appropriate, to make individuals aware of potential radiation exposures and to
minimize the exposures.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1623 Eff.
February 1, 2015.
10A NCAC 15 .1624 POSTING REQUIREMENTS
(a) The licensee or registrant shall post each radiation
area with a conspicuous sign or signs bearing the radiation symbol and the
words:
CAUTION
RADIATION AREA
(b) The licensee or registrant shall post each high
radiation area with a conspicuous sign or signs bearing the radiation symbol
and the words:
CAUTION
HIGH RADIATION
AREA
or the words:
DANGER
HIGH RADIATION
AREA
(c) The licensee or registrant shall post each very high
radiation area with a conspicuous sign or signs bearing the radiation symbol
and words:
GRAVE DANGER
VERY HIGH
RADIATION AREA
(d) The licensee shall post each airborne radioactivity
area with a conspicuous sign or signs bearing the radiation symbol and the
words:
CAUTION
AIRBORNE RADIOACTIVITY
AREA
or the words:
DANGER
AIRBORNE
RADIOACTIVITY AREA
(e) The licensee shall post each area or room in which
there is used or stored an amount of licensed radioactive material exceeding 10
times the quantity of such material specified in Appendix C to 10 CFR §§
20.1001 - 20.2401 with a conspicuous sign or signs bearing the radiation symbol
and the words:
CAUTION
RADIOACTIVE MATERIAL(S)
or the words:
DANGER
RADIOACTIVE MATERIAL(S)
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1624 Eff.
February 1, 2015.
10A NCAC 15 .1625 EXCEPTIONS TO POSTING REQUIREMENTS
(a) A licensee is not required to post caution signs in
areas or rooms containing radioactive materials for periods of less than eight
hours, if each of the following conditions is met:
(1) The materials are constantly attended
during these periods by an individual who takes the precautions necessary to
prevent the exposure of individuals to radiation or radioactive materials in
excess of the limits established in the rules in this Section; and
(2) The area or room is subject to the
licensee's control.
(b) Rooms or other areas in hospitals that are occupied by
patients are not required to be posted with caution signs pursuant to Rule
.1624 of this Section provided that:
(1) The patient is being treated with sealed
sources or has been treated with unsealed radioactive material in quantities
less than 30 millicuries (110 MBq), or the measured dose rate at one meter from
the patient is less than 0.005 rem (0.05 mSv) per hour; and
(2) There are personnel in attendance who will
take the necessary precautions to prevent the exposure of individuals to
radiation or radioactive material in excess of the limits established in this
Section and to operate within the ALARA provisions of the licensee's radiation
protection program.
(c) A room or area is not required to be posted with a
caution sign because of the presence of a sealed source provided the radiation
level at 30 centimeters from the surface of the source container or housing
does not exceed 0.005 rem (0.05 mSv) per hour.
(d) Rooms or other areas in medical facilities that are
occupied by patients while being treated with radiation from an accelerator are
not required to be posted with a caution sign pursuant to Rule .1624(c) of this
Section provided that:
(1) access to the room or area is posted in
accordance with Rule .1624(b) of this Section; and
(2) there are personnel in attendance who shall
provide assurance that:
(A) continuous audio and visual observation of the
patient is maintained during treatment;
(B) all provisions of Subparagraph (b)(2) of this Rule
are met; and
(C) the accelerator is secured in the "beam
off" status at the end of each patient's treatment.
(e) Rooms or other areas in medical facilities that are
occupied by patients while being treated with radiation from a teletherapy
source are not required to be posted with a caution sign pursuant to Rule
.1624(c) of this Section provided that:
(1) access to the room or area is posted in
accordance with Rule .1624(b) of this Section; and
(2) there are personnel in attendance who shall
take the necessary precautions to prevent the inadvertent exposures of workers,
other patients, and members of the public to radiation in excess of the limits
established in the rules of this Section.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Temporary Amendment Eff. August 20, 1994 for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;
Amended Eff. August 1, 2002; May 1, 1995;
Transferred and Recodified from 15A NCAC 11 .1625 Eff.
February 1, 2015.
10A NCAC 15 .1626 LABELING REQUIREMENTS AND EXEMPTIONS
(a) The licensee shall ensure that:
(1) each container of licensed radioactive
material bears a durable, visible label bearing the radiation symbol and the
words:
(A) CAUTION
RADIOACTIVE MATERIAL; or
(B) DANGER
RADIOACTIVE MATERIAL
The label shall also
provide sufficient information (such as the radionuclide(s) present, an
estimate of the quantity of radioactivity, the date for which the activity is
estimated, radiation levels, kinds of materials, and mass enrichment) to permit
individuals handling or using the containers, or working in the vicinity of the
containers, to take precautions to avoid or minimize exposures; and
(2) each syringe and vial that contains
unsealed radioactive material for medical use is labeled to identify the
radioactive drug. Each syringe shield and vial shield must also be labeled
unless the label on the syringe or vial is visible when shielded.
(b) Each licensee shall, prior to removal or disposal of
empty uncontaminated containers to unrestricted areas, remove or deface the
radioactive material label or otherwise indicate that the container no longer
contains radioactive materials.
(c) Except as required in Subparagraph (a)(2) of this Rule,
a licensee is not required to label:
(1) containers holding licensed radioactive
material in quantities less than the quantities listed in Appendix C to 10 CFR
20.1001 - 20.2401;
(2) containers holding licensed radioactive
material in concentrations less than those specified in Table 3 of Appendix B
to 10 CFR 20.1001 - 20.2401;
(3) containers attended by an individual who
takes the precautions to prevent the exposure of individuals in excess of the
limits established by this Section;
(4) containers when they are in transport and
packaged and labeled in accordance with the regulations of the U.S. Department
of Transportation;
(5) containers that are accessible only to
individuals authorized to handle or use them or to work in the vicinity of the containers
if the contents are identified to these individuals by a readily available
written record (for example, containers in locations such as water-filled
canals, storage vaults, or hot cells, provided the record shall be retained as
long as the containers are in use for the purpose indicated on the record); or
(6) installed manufacturing or process
equipment, such as piping and tanks.
History Note: Authority G.S. 104E-7(a)(2); 104E-15;
Eff. January 1, 1994;
Amended Eff. October 1, 2013;
Transferred and Recodified from 15A NCAC 11 .1626 Eff.
February 1, 2015.
10A NCAC 15 .1627 PROCEDURES FOR RECEIVING AND OPENING
PACKAGES
(a) Each licensee who expects to receive a package
containing quantities of radioactive material in excess of a Type A quantity,
as defined in Rule .0104 of this Chapter, shall make arrangements to receive:
(1) the package when the carrier offers it for
delivery; or
(2) notification of the arrival of the package
at the carrier's terminal and to take possession of the package expeditiously.
(b) Each licensee, upon receipt of a package containing
radioactive material, shall monitor:
(1) external surfaces of a package labeled as
containing radioactive material for radioactive contamination unless the
package contains only radioactive material in the form of a gas or in special
form as defined in 10 C.F.R 71.4;
(2) external surfaces of a package labeled as
containing radioactive material for radiation levels unless the package
contains quantities of radioactive material that are less than or equal to the
Type A quantity, as defined in 10 C.F.R 71.4 and Appendix A to Part 71; and
(3) all packages known to contain radioactive
material for radioactive contamination and radiation levels if there is
evidence of degradation of package integrity, such as packages that are
crushed, wet, or damaged.
(c) The licensee shall perform the monitoring required by
Paragraph (b) of this Rule as soon as practicable after receipt of the package,
but not later than three hours after the package is received at the licensee's
facility if it is received during the licensee's normal working hours, or not
later than three hours from the beginning of the next working day if it is
received after working hours.
(d) The licensee shall immediately notify the final
delivery carrier and, by telephone and telegram, mailgram, or facsimile, the
agency when:
(1) removable radioactive surface contamination
exceeds the limits of 10 CFR 71.87(i); or
(2) external radiation levels exceed the limits
of 10 CFR 71.47.
(e) Each licensee shall:
(1) establish, maintain, and retain written
procedures for safely opening packages in which radioactive material is
received; and
(2) ensure that the procedures are followed and
that due consideration is given to special instructions for the type of package
being opened.
(f) Licensees transferring special form sources in
licensee-owned or licensee-operated vehicles to and from a work site are exempt
from the contamination monitoring requirements of Paragraph (b) of this Rule,
but are not exempt from the survey requirement in Paragraph (b) of this Rule
for measuring radiation levels that is required to ensure that the source is
still properly lodged in its shield.
History Note: Authority G.S. 104E-7(a)(2); 104E-12(a);
Eff. January 1, 1994;
Amended Eff. August 1, 2002;
Transferred and Recodified from 15A NCAC 11 .1627 Eff.
February 1, 2015.
10A NCAC 15 .1628 GENERAL REQUIREMENTS FOR WASTE
DISPOSAL
(a) A licensee shall dispose of licensed radioactive
material only:
(1) by transfer to an authorized recipient as
provided in Section .0300 of this Chapter;
(2) by decay in storage;
(3) by release in effluents within the limits
in Rule .1611 of this Section; or
(4) as authorized by Rules .1629, .1630, .1631,
or .1632 of this Section; or
(5) a land disposal facility licensed under
Section .1200 of this Chapter or equivalent regulations of the U.S. Nuclear
Regulatory Commission or an agreement state.
(b) Except as provided in Section .1200 of this Chapter, no
licensee shall receive radioactive waste from other persons for:
(1) treatment prior to disposal;
(2) treatment or disposal by incineration;
(3) decay in storage; or
(4) disposal.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1628 Eff.
February 1, 2015.
10A NCAC 15 .1629 METHOD FOR OBTAINING APPROVAL OF
DISPOSAL PROCEDURES
A licensee or applicant for a license may apply to the
agency for approval of proposed procedures, not otherwise authorized in this
Section, to dispose of licensed radioactive material generated in the
licensee's activities. Each application shall include:
(1) a description of the waste containing licensed
radioactive material to be disposed of, including the physical and chemical
properties important to risk evaluation, and the proposed manner and conditions
of waste disposal;
(2) an analysis and evaluation of pertinent information
on the nature of the environment;
(3) the nature and location of other potentially
affected licensed and unlicensed facilities; and
(4) analyses and procedures to ensure that doses are
maintained ALARA and within the dose limits in this Section.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1629 Eff.
February 1, 2015.
10A NCAC 15 .1630 DISPOSAL BY RELEASE INTO SANITARY
SEWERAGE
(a) A licensee may discharge licensed radioactive material
into sanitary sewerage if each of the following conditions is satisfied:
(1) The material is readily soluble in water or
is biological material that is readily dispersible in water; and
(2) The quantity of licensed or other
radioactive material that the licensee releases into the sewer in one month
divided by the average monthly volume of water released into the sewer by the
licensee does not exceed the concentration listed in Table 3 of Appendix B to
10 CFR §§ 20.1001 - 20.2401; and
(3) If more than one radionuclide is released,
the following conditions shall also be satisfied:
(A) The licensee shall determine the fraction of the
limit in Table 3 of Appendix B to 10 CFR §§ 20.1001 - 20.2401 represented by
discharges into sanitary sewerage by dividing the actual monthly average
concentration of each radionuclide released by the licensee into the sewer by
the concentration of that radionuclide listed in Table 3 of Appendix B to 10
CFR §§20.1001 - 20.2401; and
(B) The sum of the fractions for each radionuclide
required by Part (a)(3)(A) of this Rule does not exceed unity; and
(4) The total quantity of licensed and other
radioactive material that the licensee releases into the sanitary sewerage
system in a year does not exceed five curies (185 GBq) of hydrogen-3, one curie
(37 GBq) of carbon-14, and one curie (37 GBq) of all other radioactive
materials combined.
(b) Excreta from individuals undergoing medical diagnosis
or therapy with radioactive material is not subject to the limitations
contained in Paragraph (a) of this Rule.
History Note: Authority G.S. 104E-7(a)(2);
104E-7(a)(5);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1630 Eff.
February 1, 2015.
10A NCAC 15 .1631 TREATMENT OR DISPOSAL BY INCINERATION
A licensee may treat or dispose of licensed radioactive
material by incineration only in the amounts and forms specified in Rule .1632
or as specifically approved by the agency pursuant to Rule .1629 of this
Section.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1631 Eff.
February 1, 2015.
10A NCAC 15 .1632 DISPOSAL OF SPECIFIC WASTES
(a) A licensee may dispose of the following licensed
radioactive material without regard to its radioactivity:
(1) 0.05 microcurie (1.85 kBq), or less, of
hydrogen-3, carbon-14 or iodine-125 per gram of medium used for liquid
scintillation counting; and
(2) 0.05 microcurie (1.85 kBq), or less, of
hydrogen-3, carbon-14 or iodine-125 per gram of animal tissue, averaged over
the weight of the entire animal.
(b) A licensee may not dispose of tissue pursuant to
Subparagraph (a)(2) of this Rule in a manner that would permit its use either
as food for humans or as animal feed.
(c) The licensee shall maintain records of disposals made
pursuant to Subparagraph (a)(2) of this Rule in accordance with Rule .1642 of this
Section.
History Note: Authority G.S. 104E-7(a)(2);
104E-7(a)(5); 104E-12(a);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1632 Eff.
February 1, 2015.
10A NCAC 15 .1633 TRANSFER FOR DISPOSAL AND MANIFESTS
(a) The requirements of this Rule and Appendix G to 10 CFR Part
20, incorporated by reference in Rule .0117 of this Chapter, are designed to:
(1) control transfers of low-level radioactive
waste by any waste generator, waste collector, or waste processor licensee, as
defined in Appendix G to 10 CFR Part 20, who ships low-level waste either
directly, or indirectly through a waste collector or waste processor, to a
licensed low-level waste disposal facility, as defined in Rule .1202 of this
Chapter;
(2) establish a manifest tracking system; and
(3) supplement existing requirements concerning
transfers and recordkeeping for those wastes.
(b) Any licensee shipping radioactive waste intended for
ultimate disposal at a licensed land disposal facility shall document the
information required on the U.S. Nuclear Regulatory Commission's Uniform
Low-Level Radioactive Waste Manifest and transfer this recorded manifest
information to the intended consignee in accordance with this Rule and Appendix
G to 10 CFR Part 20.
(c) Each shipment manifest shall include a certification by
the waste generator as specified in Appendix G to 10 CFR Part 20.
(d) Each person involved in the transfer for disposal and
disposal of waste, including the waste generator, waste collector, waste
processor, and disposal facility operator, shall comply with the requirements
specified in this Rule and Appendix G to 10 CFR Part 20.
(e) Reports and notifications required to be made to the
nearest regional administrator by Appendix G to 10 CFR Part 20 shall be made to
the agency instead.
(f) Any licensee shipping radioactive material as defined
in Rule .0104 of this Chapter intended for ultimate disposal at a land disposal
facility as defined in Rule .1202 of this Chapter must document the information
required on the U.S. Nuclear Regulatory Commission's Uniform Low-Level
Radioactive Waste Manifest and transfer this recorded manifest information to
the intended consignee in accordance with appendix G to 10 CFR Part 20.
(g) Radioactive material as defined in Rule .0104 of this
Chapter may be disposed of in accordance with Rule .1628 of this Section. Any
licensed radioactive material being disposed of at a facility, or transferred
for ultimate disposal at a facility licensed under 10 CFR Part 61, must meet
the requirements of this Rule.
(h) A licensee may dispose of radioactive material as
defined in Rule .0104 of this Chapter at a disposal facility authorized to
dispose of such material in accordance with any Federal or State solid or
hazardous waste law, including the Solid Waste Disposal Act established by the
Energy Policy Act of 2005.
History Note: Authority G.S. 104E-7(a)(2),(a)(3); 104E-12(a);
Eff. January 1, 1994;
Amended Eff. October 1, 2013; April 1, 1999;
Transferred and Recodified from 15A NCAC 11 .1633 Eff.
February 1, 2015.
10A NCAC 15 .1634 COMPLIANCE WITH ENV. AND HEALTH
PROTECTION REGULATIONS
Nothing in this Section relieves the licensee from complying
with other applicable federal, state, and local regulations governing any other
toxic or hazardous properties of materials that may be disposed of under this
Section.
History Note: Authority G.S. 104E-7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1634 Eff.
February 1, 2015.
10A NCAC 15 .1635 GENERAL PROVISIONS FOR RECORDS
(a) Each licensee or registrant shall use the units: curie,
rad and rem, including multiples and subdivisions thereof, and shall clearly
indicate the units of all quantities on records required by this Section.
(b) Notwithstanding the requirements of Paragraph (a) of
this Rule, when recording information on shipping manifests, as required by
Rule .1633 of this Section and Appendix G to 10 CFR 20, information shall be
recorded in the International System of Units (SI) or SI and units as specified
in Paragraph (a) of this Rule. For records other than shipping manifests, the
licensee or registrant may record quantities in SI units in parenthesis
following each of the units specified in Paragraph (a) of this Rule; however
all quantities shall be recorded as stated in Paragraph (a) of this Rule.
(c) The licensee or registrant shall make a clear
distinction whether the quantities entered on the records required by this
Section are total effective dose equivalent, shallow-dose equivalent, eye dose
equivalent, deep-dose equivalent, or committed effective dose equivalent.
(d) The discontinuance or curtailment of activities does
not relieve the licensee or registrant of responsibility for retaining all
records required by the rules in this Section.
History Note: Authority G.S. 104E-7(a)(2); 104E-12(a);
Eff. January 1, 1994;
Amended Eff. August 1, 2002; April 1, 1999;
Transferred and Recodified from 15A NCAC 11 .1635 Eff.
February 1, 2015.
10A NCAC 15 .1636 RECORDS OF RADIATION PROTECTION
PROGRAMS
(a) Each licensee or registrant shall maintain records of
the radiation protection program, including:
(1) The provisions of the program; and
(2) Audits and other reviews of program content
and implementation.
(b) The licensee or registrant shall retain the records
required by Subparagraph (a)(1) of this Rule until the agency terminates each
pertinent license or registration requiring the record. The licensee or
registrant shall retain the records required by Subparagraph (a)(2) of this
Rule for three years after the record is made.
History Note: Authority G.S. 104E-7(a)(2); 104E-12(a);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1636 Eff.
February 1, 2015.
10A NCAC 15 .1637 RECORDS OF SURVEYS
(a) Each licensee or registrant shall maintain records
showing the results of surveys and calibrations required by Rules .1613 and
.1627(b) of this Section. The licensee or registrant shall retain these
records for three years after the record is made.
(b) The licensee or registrant shall retain each of the
following records until the agency terminates each pertinent license or
registration requiring the record:
(1) records of the results of surveys to
determine the dose from external sources and used, in the absence of or in
combination with individual monitoring data, in the assessment of individual
dose equivalents;
(2) records of the results of measurements and
calculations used to determine individual intakes of radioactive material and
used in the assessment of internal dose;
(3) records showing the results of air
sampling, surveys, and bioassays required pursuant to Rule .1620(a) of this
Section; and
(4) Records of the results of measurements and
calculations used to evaluate the release of radioactive effluents to the
environment.
History Note: Authority G.S. 104E-7(a)(2); 104E-12(a);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1637 Eff.
February 1, 2015.
10A NCAC 15 .1638 DETERMINATION OF PRIOR OCCUPATIONAL
DOSE
(a) For each individual who may enter the licensee's or
registrant's restricted or controlled area and is likely to receive, in a year,
an occupational dose requiring monitoring pursuant to Rule .1614 of this
Section, the licensee or registrant shall:
(1) determine the occupational radiation dose
received during the current year; and
(2) attempt to obtain the records of lifetime
cumulative occupational radiation dose.
(b) Prior to permitting an individual to participate in a
planned special exposure, the licensee or registrant shall determine:
(1) the internal and external doses from all
previous planned special exposures; and
(2) all doses in excess of the limits received
during the lifetime of the individual, including doses received during
accidents and emergencies.
(c) In complying with the requirements of Paragraph (a) of
this Rule, a licensee or registrant may:
(1) accept, as a record of the occupational
dose that the individual received during the current year, a written signed
statement from the individual, or from the individual's most recent employer
for work involving radiation exposure, that discloses the nature and the amount
of any occupational dose that the individual may have received during the
current year;
(2) accept, as the record of lifetime
cumulative radiation dose, an up-to-date agency form for recording occupational
radiation dose history, or equivalent, signed by the individual and
counter-signed by an appropriate official of the most recent employer for work
involving radiation exposure, or the individual's current employer if the
individual is not employed by the licensee or registrant; or
(3) obtain reports of the individual's dose
equivalent(s) by telephone, telegram, electronic media, or letter from the most
recent employer for work involving radiation exposure, or the individual's
current employer if the individual is not employed by the licensee or
registrant. The licensee or registrant shall request a written verification of
the dose data if the authenticity of the transmitted report cannot be
established.
(d) The licensee or registrant shall record the exposure
history, as required by Paragraph (a) of this Rule, on the agency form for
recording occupational radiation dose history, or other clear and legible
record of all the information required on that form. The form or record shall
show each period in which the individual received occupational exposure to
radiation or radioactive material and shall be signed by the individual who
received the exposure. For each period for which the licensee or registrant
obtains reports, the licensee or registrant shall use the dose shown in the
report in preparing the agency form for recording occupational radiation dose
history. For any period in which the licensee or registrant does not obtain a
report, the licensee or registrant shall place a notation on the agency form
for recording occupational radiation dose history indicating the periods of
time for which data are not available. Licensees or registrants are not
required to reevaluate the separate external dose equivalents and internal
committed dose equivalents or intakes of radionuclides assessed prior to
January 1, 1994 under Section .0400 of this Chapter. Further, occupational
exposure histories obtained and recorded before January 1, 1991, may not have
included effective dose equivalent, but may be used in the absence of specific
information on the intake of radionuclides by the individual.
(e) If the licensee or registrant is unable to obtain a
complete record of an individual's current and previously accumulated
occupational dose, the licensee or registrant shall assume:
(1) in establishing administrative controls
under Rule .1604(f) of this Section for the current year, that the allowable
dose limit for the individual is reduced by 1.25 rems (12.5 mSv) for each
quarter for which records were unavailable and the individual was engaged in
activities that could have resulted in occupational radiation exposure; and
(2) that the individual is not available for
planned special exposures.
(f) The licensee or registrant shall retain the records on
the agency form for recording occupational radiation dose history or equivalent
until the agency terminates each pertinent license or registration requiring
this record. The licensee or registrant shall retain records used in preparing
the agency form for recording occupational radiation dose history for three
years after the record is made.
History Note: Authority G.S. 104E-7(a)(2); 104E-12(a);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1638 Eff.
February 1, 2015.
10A NCAC 15 .1639 RECORDS OF PLANNED EXPOSURES
(a) For each use of the provisions of Rule .1608 of this
Section for planned special exposures, the licensee or registrant shall
maintain records that describe:
(1) the exceptional circumstances requiring the
use of a planned special exposure;
(2) the name of the management official who
authorized the planned special exposure and a copy of the signed authorization;
(3) what actions were necessary;
(4) why the actions were necessary;
(5) how doses were maintained ALARA; and
(6) what individual and collective doses were
expected to result, and the doses actually received in the planned special
exposure.
(b) The licensee or registrant shall retain the records
until the agency terminates each pertinent license or registration requiring
these records.
History Note: Authority G.S. 104E-7(a)(2); 104E-12(a);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1639 Eff.
February 1, 2015.
10A NCAC 15 .1640 RECORDS OF INDIVIDUAL MONITORING
RESULTS
(a) Each licensee or registrant shall maintain records of
doses received by all individuals for whom monitoring was required pursuant to
Rule .1614 of this Section, and records of doses received during planned
special exposures, accidents, and emergency conditions. These records shall
include, when applicable:
(1) the deep-dose equivalent to the whole body,
eye dose equivalent, shallow-dose equivalent to the skin, and shallow-dose
equivalent to the extremities;
(2) the estimated intake of radionuclides (see
Rule .1605 of this Section);
(3) the committed effective dose equivalent
assigned to the intake or body burden of radionuclides;
(4) the specific information used to calculate
the committed effective dose equivalent pursuant to Rule .1607(c) of this
Section and when required by Rule .1614 of this Section;
(5) the total effective dose equivalent when
required by Rule .1605 of this Section; and
(6) the total of the deep-dose equivalent and
the committed dose to the organ receiving the highest total dose.
(b) The licensee or registrant shall make entries of the
records specified in Paragraph (a) of this Rule at least annually.
(c) The licensee or registrant shall maintain the records
specified in Paragraph (a) of this Rule on the agency form for recording
occupational radiation doses, in accordance with the instructions provided with
the form, or in clear and legible records containing all the information
required by the agency form for recording occupational radiation doses.
(d) Assessments of dose equivalent and records made using
units in effect before the licensee's or registrant's implementation of the
rules in this Section need not be changed.
(e) The records required under this Rule may be protected
from public disclosure because of their personal privacy nature; however, the
limitations in this Paragraph are subject to, and do not limit federal and
state laws that may require disclosure.
(f) The licensee or registrant shall maintain the records
of dose to an embryo/fetus with the records of dose to the declared pregnant
woman. The declaration of pregnancy shall also be kept on file, but may be
maintained separately from the dose records.
(g) The licensee or registrant shall retain each required
form or record until the agency terminates each pertinent license or
registration requiring the record.
History Note: Authority G.S. 104E-7(a)(2); 104E-12(a);
Eff. January 1, 1994;
Amended Eff. August 1, 2002;
Transferred and Recodified from 15A NCAC 11 .1640 Eff.
February 1, 2015.
10A NCAC 15 .1641 RECORDS OF DOSE TO INDIVIDUAL MEMBERS
OF THE PUBLIC
(a) Each licensee or registrant shall maintain records
sufficient to demonstrate compliance with the dose limit for individual members
of the public required by Rule .1611 of this Section. These records may
include such things as survey results, monitoring results, calculations and
other documents pertaining to the determination of doses to individual members
of the public.
(b) The licensee or registrant shall retain the records required
by Paragraph (a) of this Rule until the agency terminates each pertinent
license or registration requiring the record.
History Note: Authority G.S. 104E-7(a)(2); 104E-12(a);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1641 Eff.
February 1, 2015.
10A NCAC 15 .1642 RECORDS OF WASTE DISPOSAL
(a) Each licensee shall maintain records of the disposal of
licensed radioactive materials made pursuant to Rules .1629, .1630, .1631,
.1632 and .1633 of this Section, and disposal by burial in soil.
(b) The licensee shall retain the records required by
Paragraph (a) of this Rule until the agency terminates each pertinent license
requiring the record.
History Note: Authority G.S. 104E-7(a)(2); 104E-12(a);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1642 Eff.
February 1, 2015.
10A NCAC 15 .1643 RECORDS OF TESTING ENTRY CONTROL
DEVICES
(a) Each licensee or registrant shall maintain records of
tests made pursuant to Subparagraph (a)(10) of Rule .1617 of this Section on
entry control devices for very high radiation areas. These records shall
include the date, time, and results of each such test of function.
(b) The licensee or registrant shall retain the records
required by Paragraph (a) of this Rule for three years after the record is
made.
History Note: Authority G.S. 104E-7(a)(2); 104E-12(a);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1643 Eff.
February 1, 2015.
10A NCAC 15 .1644 FORM OF RECORDS
Each record required by this Section shall be legible
throughout the specified retention period. The record may be the original or a
reproduced copy or a microform provided that the copy or microform is
authenticated by authorized personnel and that the microform is capable of
producing a clear copy throughout the required retention period. The record
may also be stored in electronic media with the capability for producing
legible, accurate, and complete records during the required retention period.
Records, such as letters, drawings, and specifications, shall include all
pertinent information, such as stamps, initials, and signatures. The licensee
or registrant shall maintain adequate safeguards against tampering with and
loss of records.
History Note: Authority G.S. 104E-7(a)(2); 104E-12(a);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1644 Eff.
February 1, 2015.
10A NCAC 15 .1645 REPORTS OF THEFT OR LOSS OF LICENSED
RADIOACTIVE MATERIAL
(a) Each licensee shall report by telephone as follows:
(1) immediately after its occurrence becomes
known to the licensee, any lost, stolen, or missing licensed radioactive material
in an aggregate quantity equal to or greater than 1,000 times the quantity
specified in Appendix C to 10 CFR §§ 20.1001 - 20.2401 under such circumstances
that it appears to the licensee that an exposure could result to persons in
unrestricted areas; or
(2) within 30 days after the occurrence of any
lost, stolen, or missing licensed radioactive material becomes known to the
licensee, all licensed radioactive material in a quantity greater than 10 times
the quantity specified in Appendix C to 10 CFR §§ 20.1001 - 20.2401 that is
still missing at this time.
(b) Telephone reports in Paragraph (a) of this Rule shall
be made to the agency as specified in Rule .0111 of this Chapter.
(c) Each licensee required to make a report under Paragraph
(a) of this Rule shall, within 30 days after making the telephone report, make
a written report setting forth the following information:
(1) a description of the licensed radioactive
material involved, including kind, quantity, and chemical and physical form;
(2) a description of the circumstances under
which the loss or theft occurred;
(3) a statement of disposition, or probable
disposition, of the licensed radioactive material involved;
(4) exposures of individuals to radiation,
circumstances under which the exposures occurred, and the possible total
effective dose equivalent to persons in unrestricted areas;
(5) actions that have been taken, or will be
taken, to recover the material; and
(6) Procedures or measures that have been, or
will be, adopted to ensure against a recurrence of the loss or theft of
licensed radioactive material.
(d) Written reports shall be addressed to the agency as
specified in Rule .0111 of this Chapter.
(e) Subsequent to filing the written report, the licensee
shall also report any additional substantive information on the loss or theft
within 30 days after the licensee learns of such information.
(f) The licensee shall prepare any report filed with the
agency pursuant to this Rule so that names of individuals who may have received
exposure to radiation are stated in a separate and detachable part of the
report.
History Note: Authority G.S. 104E-7(a)(2); 104E-12(a);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1645 Eff.
February 1, 2015.
10A NCAC 15 .1646 NOTIFICATION OF INCIDENTS
(a) Notwithstanding any other requirements for
notification, each licensee or registrant shall immediately report any event
involving a source of radiation possessed by the licensee or registrant that
may have caused or threatens to cause any of the following conditions:
(1) an individual to receive:
(A) a total effective dose equivalent of 25 rems (0.25
Sv) or more; or
(B) an eye dose equivalent of 75 rems (0.75 Sv) or more;
or
(C) a shallow-dose equivalent to the skin or extremities
of 250 rads (2.5 Gy) or more; or
(2) the release of radioactive material, inside
or outside of a restricted area, except locations where personnel are not
normally stationed during routine operations, such as hot-cells or process enclosures,
so that, had an individual been present for 24 hours, the individual could have
received an intake five times the occupational annual limit on intake; or
(3) a loss of one working week or more of the
operation of any facilities affected; or
(4) damage to property in excess of $200,000.
(b) Each licensee or registrant shall, within 24 hours of
discovery of the event, report any event involving loss of control of any
source of radiation possessed by the licensee or registrant that may have
caused, or threatens to cause, any of the following conditions:
(1) an individual to receive, in a period of 24
hours:
(A) a total effective dose equivalent exceeding five
rems (0.05 Sv);
(B) an eye dose equivalent exceeding 15 rems (0.15 Sv);
or
(C) a shallow-dose equivalent to the skin or extremities
exceeding 50 rems (0.5 Sv);
(2) the release of radioactive material, inside
or outside of a restricted area, except locations where personnel are not
normally stationed during routine operations, such as hot-cells or process
enclosures, so that, had an individual been present for 24 hours, the
individual could have received an intake in excess of one occupational annual
limit on intake;
(3) a loss of one day or more of the operation
of any facilities affected; or
(4) damage to property in excess of $2,000.
(c) The licensee or registrant shall prepare any report
filed with the agency pursuant to this Rule so that names of individuals who
have received exposure to radiation or radioactive material are stated in a
separate and detachable part of the report.
(d) Reports made by licensees or registrants in response to
the requirements of this Rule shall be addressed to the agency as specified in
Rule .0111 of this Chapter.
(e) The provisions of this Rule do not include doses that
result from planned special exposures, that are within the limits for planned
special exposures, and that are reported pursuant to Rule .1648 of this
Section.
History Note: Authority G.S. 104E-7(a)(2); 104E-12(a);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1646 Eff.
February 1, 2015.
10A NCAC 15 .1647 REPORTS OF RADIATION EXCEEDING THE
LIMITS
(a) In addition to the notification required by Rule .1646
of this Section, each licensee or registrant shall submit a written report
within 30 days after learning of any of the following occurrences:
(1) any incident for which notification is
required by Rule .1646 of this Section;
(2) doses in excess of any of the following:
(A) the occupational dose limits for adults in Rule
.1604 of this Section;
(B) the occupational dose limits for a minor in Rule
.1609 of this Section;
(C) the limits for an embryo/fetus of a declared
pregnant woman in Rule .1610 of this Section;
(D) the limits for an individual member of the public in
Rule .1611 of this Section;
(E) any applicable limit in the license; or
(F) The ALARA constraints for air emissions established
in Rule .1603 of this Section;
(3) levels of radiation or concentrations of
radioactive material in:
(A) a restricted area in excess of any applicable limit
in the license; or
(B) an unrestricted area in excess of 10 times any
applicable limit set forth in this Section or in the license, whether or not
involving exposure of any individual in excess of the limits in Rule .1611 of
this Section.
(b) Each report required by Paragraph (a) of this Rule shall
describe the extent of exposure of individuals to radiation and radioactive
material, including, as appropriate:
(1) estimates of each individual's dose;
(2) the levels of radiation and concentrations
of radioactive material involved;
(3) the cause of the elevated exposures, dose
rates, or concentrations; and
(4) corrective steps taken or planned to ensure
against a recurrence, including the schedule for achieving conformance with
applicable limits, ALARA constraints, generally applicable environmental
standards, and associated license conditions.
(c) Each report filed pursuant to Paragraph (a) of this
Rule shall include for each occupationally overexposed individual: the name,
social security account number, and date of birth. With respect to the limit
for the embryo/fetus required by Rule .1610 of this Section, the identifying
information shall be that of the declared pregnant woman. The report shall be
prepared so that this information is stated in a separate and detachable part
of the report.
(d) Reports made by licensees or registrants in response to
the requirements of this Rule shall be addressed to the agency as specified in
Rule .0111 of this Chapter.
(e) Any reports made by licensees or registrants in
response to the requirements of this Rule shall also be provided to the exposed
individual. The copy submitted to the exposed individual shall be transmitted
at a time no later than the transmittal to the agency.
History Note: Authority G.S. 104E-7(a)(2); 104E-12(a);
Eff. January 1, 1994;
Amended Eff. April 1, 1999; August 1, 1998;
Transferred and Recodified from 15A NCAC 11 .1647 Eff.
February 1, 2015.
10A NCAC 15 .1648 REPORTS OF PLANNED SPECIAL EXPOSURES
(a) The licensee or registrant shall submit a written
report to the agency within 30 days following any planned special exposure
conducted in accordance with Rule .1608 of this Section, informing the agency
the date the special planned exposure was conducted and including the
information required by Rule .1639 of this Section.
(b) When a licensee or registrant is required by this Rule
to report to the agency any exposure of an identified specially exposed
individual, the licensee or registrant shall also provide the individual a
report on his or her exposure data included in the report to the agency. This
report must be transmitted no later than the transmittal to the agency.
History Note: Authority G.S. 104E-7(a)(2); 104E-12(a);
Eff. January 1, 1994;
Amended Eff. October 1, 2013;
Transferred and Recodified from 15A NCAC 11 .1648 Eff.
February 1, 2015.
10A NCAC 15 .1649 REPORTS OF INDIVIDUAL MONITORING
The agency may require by license condition, registration
condition, or order pursuant to Rule .0108 of this Chapter, annual reports of
the results of individual monitoring carried out by the licensee or registrant
for each individual for whom monitoring was required by Rule .1614 of this
Section.
History Note: Authority G.S. 104E-7(a)(2); 104E-12(a);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1649 Eff.
February 1, 2015.
10A NCAC 15 .1650 CLASSIFICATION/RADIOACTIVE WASTE FOR
NEAR‑SURFACE DISPOSAL
(a) The following are definitions of and special
requirements applicable to the different classes of waste:
(1) "Class A Waste" means radioactive
waste that is usually segregated from other waste classes at the disposal site.
The physical form and characteristics of Class A waste shall meet the minimum
requirements set forth in Rule .1651(a) of this Section. If Class A waste also
meets the stability requirements set forth in Rule .1651(b) of this Section, it
is not necessary to segregate the waste for disposal.
(2) "Class B Waste" means radioactive
waste that must meet more rigorous requirements on waste form to ensure
stability after disposal. The physical form and characteristics of Class B
waste shall meet both the minimum requirements and stability requirements set
forth in Rule .1651 of this Section.
(3) "Class C Waste" means radioactive
waste that not only must meet more rigorous requirements on waste form to
ensure stability, but also requires additional measures at the disposal
facility to protect against inadvertent human intrusion. The physical form and
characteristics of Class C waste shall meet both the minimum requirements and
stability requirements set forth in Rule .1651 of this Section.
(b) If the waste contains only radionuclides listed in the
table in Subparagraph (b)(5) of this Rule, the licensee shall determine the
classification as follows:
(1) If the concentration does not exceed 0.1
times the value in the table in Subparagraph (b)(5) of this Rule, the waste is
Class A waste.
(2) If the concentration exceeds 0.1 times the
value in the table in Subparagraph (b)(5) of this Rule, the waste is Class C
waste.
(3) If the concentration exceeds the value in
the table in Subparagraph (b)(5) of this Rule, the waste is not generally
acceptable for near‑surface disposal.
(4) For wastes containing mixtures of
radionuclides listed in the table in Subparagraph (b)(5) of this Rule, the
licensee shall determine the concentration by the "sum of fractions
rule" described in Paragraph (f) of this Rule.
(5) The following is the table of long‑lived
radionuclides and concentrations for use in conjunction with waste
classification rules of this Section:
Radionuclide
Concentration
carbon 14 8 curies/cubic
meter
carbon 14 in
activated metal 80 curies/cubic
meter
nickel 59 in
activated metal 220 curies/cubic
meter
niobium 94 in
activated metal 0 .2curies/cubic
meter
technetium 99 3 curies/cubic
meter
iodine 129 0.08 curies/cubic
meter
radium, and alpha
emitting
transuranic
radionuclides
with half‑lives
greater
than five
years 100 nanocuries/gram
plutonium 241 3,500 nanocuries/gram
curium 242 20,000 nanocuries/gram
(c) If the waste does not contain any of the radionuclides
listed in the table in Subparagraph (b)(5) of this Rule, the licensee shall use
the data for short‑lived radionuclides and concentrations in the table in
Subparagraph (c)(7) of this Rule to determine the classification as follows:
(1) If the concentration does not exceed the
value in column 1, the waste is Class A waste.
(2) If the concentration exceeds the value in
column 1, but does not exceed the value in column 2, the waste is Class B
waste.
(3) If the concentration exceeds the value in
column 2, but does not exceed the value in column 3, the waste is Class C
waste.
(4) If the concentration exceeds the value in
column 3, the waste is not generally acceptable for near‑surface
disposal.
(5) For wastes containing mixtures of the
radionuclides listed in the table in Subparagraph (c)(7) of this Rule, the
total concentration shall be determined by the "sum of the fractions
rule" described in Paragraph (f) of this Rule.
(6) In determining the waste classifications in
Subparagraphs (c)(1) through (5) of this Rule, the licensee may disregard any
radionuclides not listed in the tables in Subparagraphs (b)(5) and (c)(7) of
this Rule.
(7) The following is the table of short‑lived
radionuclides for use in conjunction with the waste classification rules of
this Section:
concentration
in curies/cubic meter
radionuclide column
1 column 2 column 3
total of all
radionuclides
with less than
5‑year
half‑life 700 see
(c)(8) see (c)(8)
hydrogen 3 40 see
(c)(8) see (c)(8)
cobalt 60 700 see
(c)(8) see (c)(8)
nickel 63 3.5 70 700
nickel 63 in
activated metal 35 700 7000
strontium 90 0.04 150 7000
cesium 137
1 44 4600
(8) There are no limits established for the
radionuclides noted by "see (c)(8)" in the table in Subparagraph
(c)(7) of this Rule for Class B or C wastes. Practical considerations such as
the effects of external radiation and internal heat generation or
transportation, handling, and disposal will limit the concentrations for these
wastes. The licensee shall classify these wastes as Class B, unless the
concentrations of other radionuclides in the table in Subparagraph (c)(7) of
this Rule dictate classification as Class C waste independent of these
radionuclides.
(d) If waste contains a mixture of radionuclides, some of
which are listed in the table in Subparagraph (b)(5) of this Rule and some of
which are listed in the table in Subparagraph (c)(7) of this Rule, the licensee
shall determine the classification and suitability for near‑surface disposal
as follows:
(1) In accordance with Paragraph (b) of this
Rule, determine the class and suitability for near‑surface disposal for
only the radionuclides in the mixture which are listed in the table in
Subparagraph (b)(5) of this Rule;
(2) In accordance with Paragraph (c) of this
Rule, determine the class and suitability for near‑surface disposal for
only the radionuclides in the mixture which are listed in the table in
Subparagraph (c)(7) of this Rule; and
(3) Classify the waste as the more restrictive
of the two determinations in Subparagraphs (d)(1) and (d)(2) of this Rule where
"not generally suitable for near‑surface disposal" is the most
restrictive and "Class A" is the least restrictive.
(e) If waste contains none of the radionuclides listed in the
tables in Subparagraphs (b)(5) and (c)(7) of this Rule, the licensee shall
determine the waste to be Class A waste.
(f) When required in Paragraphs (b) and (c) of this Rule,
the licensee shall use the "sum of the fractions rule" described in
Subparagraph (f)(1) of this Rule.
(1) For determining the classification for
waste that contains a mixture of radionuclides, the licensee shall determine
the sum of the fractions by dividing the concentration of each radionuclide by
the appropriate limit, where the appropriate limits shall all be taken from the
same column of the same table, and by adding the resultant values. The sum of
the fractions for the column must be less than 1.0, if the waste class is to be
determined by that column.
(2) The following is an example calculation:
(A) A waste contains strontium‑90 with a
concentration of 50 curies per cubic meter and cesium‑137 with a
concentration of 22 curies per cubic meter.
(B) Since the concentrations of both exceed the values
in column 1 of the table in Subparagraph (c)(7) of this Rule, they must be
compared with the values in column 2.
(C) The strontium‑90 fraction is 50/150 or 0.33,
the cesium‑137 fraction is 22/44 or 0.5, and the sum of the fractions is
0.83; therefore, since the sum is less than 1.0, the waste is Class B waste.
(g) Provided that there is reasonable assurance that an
indirect method can be correlated with actual measurements, the licensee may
determine radionuclide concentrations by indirect methods such as use of
scaling factors which relate the inferred concentration of one radionuclide to
another that is measured or use of radioactive material accountability
records. The licensee may average a radionuclide concentration over the volume
of the waste or over the weight of the waste in the case of radionuclides with
nanocurie per gram limits specified in the table in Subparagraph (b)(5) of this
Rule.
History Note: Authority G.S. 104E‑7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1650 Eff.
February 1, 2015.
10A NCAC 15 .1651 RADIOACTIVE WASTE CHARACTERISTICS
(a) The following are minimum requirements for all classes
of radioactive waste and are intended to facilitate handling and to provide
protection of health and safety of personnel at the radioactive waste disposal
site. The licensee shall:
(1) package wastes in conformance with the
conditions of the license issued to the site operator to which the waste will
be shipped to the extent that such conditions are more restrictive or in
addition to the requirements contained in this Rule;
(2) not package wastes for disposal in
cardboard or fiberboard boxes;
(3) package liquid waste in sufficient
absorbent material to absorb twice the volume of the liquid;
(4) limit the volume of freestanding liquid in
solid wastes containing liquid to as little freestanding and non‑corrosive
liquid as is reasonably achievable, but in no case to more than one percent of
the volume;
(5) limit wastes to those which are not readily
capable of detonation or of explosive decomposition or reaction at normal
pressures and temperatures, or of explosive reaction with water;
(6) except for radioactive gaseous waste
packaged in accordance with Subparagraph (a)(8) of this Rule, limit wastes to
those which do not contain, or are not capable of generating quantities of
toxic gases, vapors, or fumes harmful to persons transporting, handling, or
disposing of the waste;
(7) treat, prepare and package pyrophoric
materials contained in waste in a manner to render them nonflammable;
(8) package wastes in a gaseous form at an
absolute pressure that does not exceed 1.5 atmospheres at 20 degrees C and
limit the total activity to no more than 100 curies per container; and
(9) treat wastes containing hazardous,
biological, pathogenic, or infectious material to reduce the potential hazard
from the non‑radiological material to the maximum extent practicable.
(b) Stability is intended to ensure that the waste does not
degrade and affect overall stability of the site through slumping, collapse, or
other failure of the disposal unit and thereby lead to water infiltration.
Stability is also a factor in limiting exposure to an inadvertent intruder,
since it provides a recognizable and nondispersible waste. The licensee shall
comply with the following requirements, which are intended to provide stability
of waste, when the waste is either Class B or Class C waste.
(1) The licensee shall ensure that the waste
has structural stability. A structurally stable waste form will generally
maintain its physical dimensions and its form under the expected disposal
conditions such as weight of overburden and compaction equipment, the presence
of moisture and microbial activity, and internal factors such as radiation
effects and chemical changes. Structural stability can be provided by the waste
form itself, processing the waste to a stable form, or placing the waste in a
disposal container or structure that provides stability after disposal.
(2) Notwithstanding the provisions in
Subparagraphs (a)(3) and (4) of this Rule, the licensee shall convert liquid
wastes or wastes containing liquids into a form that contains as little
freestanding and noncorrosive liquid as is reasonably achievable; but in no
case more than one percent of the volume of the waste when the waste is in a
disposable container designed to ensure stability; or 0.5 percent of the volume
of the waste for waste processed to a stable form.
(3) The licensee shall reduce void spaces
within the waste and between the wastes and its package to the extent
practicable.
History Note: Authority G.S. 104E‑7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1651 Eff.
February 1, 2015.
10A NCAC 15 .1652 LABELING
The licensee shall clearly label each package of waste to
identify the waste as Class A, Class B or Class C waste as determined in
accordance with the provisions of Rule .1650 of this Section.
History Note: Authority G.S. 104E‑7(a)(2);
Eff. January 1, 1994;
Transferred and Recodified from 15A NCAC 11 .1652 Eff.
February 1, 2015.
10A NCAC 15 .1653 RADIOLOGICAL REQUIREMENTS FOR LICENSE
TERMINATION
(a) General provisions and scope:
(1) The requirements in this Rule apply to the
decommissioning of facilities licensed under the rules of this Chapter. For
low-level radioactive waste disposal facilities licensed under Section .1200 of
this Chapter, the requirements apply only to ancillary surface facilities that
support radioactive waste disposal facilities.
(2) The requirements in this Rule do not apply
to sites which:
(A) have been decommissioned prior to the effective date
of this Rule in accordance with criteria approved by the agency; or
(B) have previously submitted and received agency
approval for a license termination plan or for a decommissioning plan.
(3) After a site has been decommissioned and
the license terminated in accordance with the requirements set forth in this
Rule, the agency may require additional cleanup only if, based on new
information, the agency determines that the requirements of this Rule were not
met and residual radioactivity remaining at the site could result in a
significant threat to the public health and safety.
(4) When calculating Total Effective Dose
Equivalent (TEDE) to the average member of the critical group, the licensee
shall determine the peak annual TEDE expected within the first 1,000 years
after decommissioning.
(b) Radiological criteria for unrestricted use of a site
shall be considered acceptable for unrestricted use if the residual
radioactivity that is distinguishable from background radioactivity results in
a TEDE to an average member of the critical group that does not exceed 25
millirem (0.25 millisievert) per year, including that from groundwater sources
of drinking water, and the residual radioactivity has been reduced to levels that
are as low as reasonably achievable (ALARA). Determination of the levels,
which are ALARA, may take into account consideration of detriments, such as
deaths from transportation accidents, expected to potentially result from
decontamination and waste disposal.
(c) A site shall be considered acceptable for license
termination under restricted conditions if:
(1) the licensee can demonstrate that further
reductions in residual radioactivity necessary to comply with the provisions of
Paragraph (b) of this Rule would result in net public or environmental harm or
were not being made because the residual levels associated with restricted
conditions are ALARA. Determination of the levels which are ALARA may take
into account consideration of detriments, such as traffic accidents, expected
to result from decontamination and waste disposal;
(2) the licensee has made provisions for
legally enforceable institutional controls that provide reasonable assurance
that the TEDE from residual radioactivity distinguishable from background
radioactivity, to the average member of the critical group, will not exceed 25
millirem (0.25 millisievert) per year;
(3) the licensee has provided sufficient
financial assurance to enable an independent third party, including a
governmental custodian of a site, to assume and carry out responsibilities for
any necessary control and maintenance of the site. Acceptable financial
assurance mechanisms to meet the requirements of Subparagraph (c)(3) of this
Rule are described in Rule .0354 of this Chapter.
(4) the licensee has submitted to the agency a
decommissioning plan or license termination plan, as described in Rule .0339 of
this Chapter, indicating the licensee's intent to decommission in accordance
with the requirements of this Chapter, and specifying that the licensee intends
to decommission by restricting use of the site;
(5) the licensee has documented in the license
termination plan or decommissioning plan how the advice of individuals and
institutions in the community who may be affected by the decommissioning has
been sought and incorporated, as appropriate, following analysis of that
advice:
(A) licensees proposing to decommission by restricting
use of the site shall have sought advice from such affected parties regarding
the following matters concerning the proposed decommissioning:
(i) whether provisions for institutional controls
proposed by the licensee will provide reasonable assurance that the TEDE from
residual radioactivity distinguishable from background radioactivity to the average
member of the critical group will not exceed 25 millirem (0.25 millisievert)
TEDE per year, will be enforceable and will not impose undue burdens on the
community or other affected parties; and
(ii) whether the licensee has provided sufficient
financial assurance to enable an independent third party, including a
governmental custodian of a site, to assume and carry out responsibilities for
any necessary control and maintenance of the site.
(B) the licensee has provided for:
(i) participation by representatives of a broad
cross-section of community interests who may be affected by the
decommissioning;
(ii) an opportunity for a comprehensive, collective
discussion of the issues by the participants represented; and
(iii) a publicly available summary of the results of
all such discussions, and the extent of agreement and disagreement among the
participants on the issues.
(6) residual radioactivity at the site has been
reduced so that if the institutional controls were no longer in effect, there
is reasonable assurance that the TEDE from residual radioactivity
distinguishable from background radioactivity to the average member of the
critical group is as low as reasonably achievable and would not exceed either:
(A) 100 millirem (1 millisievert) per year; or
(B) 500 millirem (5 millisievert) per year provided the
licensee:
(i) demonstrates that further reductions in
residual radioactivity necessary to comply with the 100 millirem per year (1
millisievert per year) value described in Part (c)(6)(A) of this Rule, are not
technically achievable, would be prohibitively expensive, or would result in
net public or environmental harm;
(ii) makes provisions for durable institutional
controls; or
(iii) provides sufficient financial assurance to
enable a responsible government entity or independent third party, including a
governmental custodian of a site, both to carry out periodic rechecks of the
site no less frequently than every five years to assure that the institutional
controls remain in place as necessary to meet the requirements of Subparagraph
(c)(2) of this Rule and to assume and carry out responsibilities for any
necessary control and maintenance of those controls.
(d) Alternate criteria for license termination:
(1) The agency may terminate a license using alternate
criteria greater than the dose requirements of Paragraph (b), Subparagraph
(c)(2), and Subpart (c)(5)(A)(i) of this Rule, if the licensee:
(A) provides assurance that public health and safety
would continue to be protected, and that it is unlikely that the dose from all
man-made sources combined, other than medical, would be more than 100 millirem
TEDE per year (1 millisievert per year) limit described in Rule .1611 of this
Section, by submitting an analysis of possible sources of exposure;
(B) has employed, to the extent practical, restrictions
on site use according to the provisions of Paragraph (c) of this Rule in
minimizing exposures at the site;
(C) reduces doses to ALARA levels, taking into
consideration detriments such as traffic accidents expected to potentially
result from decontamination and waste disposal;
(D) has submitted a decommissioning plan or license
termination plan to the agency indicating the licensee's intent to decommission
in accordance with the requirements of this Chapter, and specifying that the
licensee proposes to decommission by use of alternate criteria;
(E) has documented in the decommissioning plan or
license termination plan how the advice of individuals and institutions in the
community who may be affected by the decommissioning has been sought and
addressed; and
(F) in seeking such advice, the licensee has provided
for:
(i) participation by representatives of a
broad-cross section of community interests who may be affected by the
decommissioning;
(ii) an opportunity for a comprehensive, collective
discussion of the issues by the participants represented; and
(iii) a publicly available summary of the results of
such discussions, including a description of the extent of agreement and
disagreement among the participants on the issues.
(2) The use of alternate criteria to terminate
a license requires the consideration of any comments provided by any other
interested state agencies and any public comments submitted pursuant to
Paragraph (e) of this Rule.
(e) Upon the receipt of a license termination plan or
decommissioning plan from the licensee, or a proposal by the licensee for
release of a site pursuant to Paragraphs (c) and (d) of this Rule, or whenever
the agency deems such notice to be in the public interest, the agency shall
notify and solicit comments from:
(1) local governments in the vicinity of the
site, appropriate state agencies, the U.S. Environmental Protection Agency, and
any Indian Nation or other indigenous people that have treaty or statutory
rights that could be affected by the decommissioning; and
(2) publish a notice in a forum, such as local
newspapers, letters to state or local organizations or other appropriate forum
that is readily accessible to individuals in the vicinity of the site, and
solicit comments from affected parties.
History Note: Authority G.S. 104E-7(a)(2); 104E-10(b);
Eff. April 1, 1999;
Transferred and Recodified from 15A NCAC 11 .1653 Eff.
February 1, 2015.
