Section .0100 – General Provisions

Link to law: http://reports.oah.state.nc.us/ncac/title 10a - health and human services/chapter 15 - radiation protection/chapter 15 rules.html
Published: 2015

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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 ra