Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 289 - RADIATION CONTROL
Subchapter D - GENERAL
Section 289.201 - General Provisions for Radioactive Material
Universal Citation: 25 TX Admin Code ยง 289.201
Current through Reg. 49, No. 38; September 20, 2024
(a) Scope. Except as otherwise specifically provided, this section applies to all persons who receive, possess, use, transfer, or acquire any radioactive material, provided, however, that nothing in this section shall apply to any person to the extent such person is subject to regulation by the United States Nuclear Regulatory Commission (NRC) or to radioactive material in the possession of federal agencies. Attention is directed to the fact that regulation by the state 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 state and NRC and to Part 150 of NRC regulations (Title 10, Code of Federal Regulations (CFR), Part 150). A person who receives, possesses, uses, owns, transfers, or acquires radioactive material prior to receiving a license is subject to the requirements of this chapter.
(b) Definitions. The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise.
(1)
Absorbed dose--The energy imparted by ionizing radiation per unit mass of
irradiated material. The units of absorbed dose are the gray (Gy) and the
rad.
(2) Accelerator-produced
material--Any material made radioactive by exposing it to the radiation from a
particle accelerator.
(3) Access
control--Asystem for allowing only approved individuals to have unescorted
access to the security zone and for ensuring that all other individuals are
subject to escorted access.
(4)
Act--Texas Radiation Control Act, Health and Safety Code (HSC), Chapter
401.
(5) Activity--The rate of
disintegration or transformation or decay of radioactive material. The units of
activity are the becquerel (Bq) and the curie (Ci).
(6) Adult--An individual 18 or more years of
age.
(7) Agency--The Department of
State Health Services.
(8)
Aggregated--Accessible by the breach of a single physical barrier that would
allow access to radioactive material in any form, including any devices that
contain the radioactive material, when the total activity equals or exceeds a
category 2 quantity of radioactive material.
(9) Agreement state--Any state with which NRC
has entered into an effective agreement under §274b of the Atomic Energy
Act of 1954, as amended (73 Stat. 689).
(10) Airborne radioactive material--Any
radioactive material dispersed in the air in the form of dusts, fumes,
particulates, mists, vapors, or gases.
(11) Airborne radioactivity area--A room,
enclosure, or area in which airborne radioactive materials exist in
concentrations:
(A) in excess of the derived
air concentrations (DACs) specified in Table I, Column 3 of §
289.202(ggg)(2)(F)
of this title (relating to Standards for Protection Against Radiation from
Radioactive Materials); 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% of the annual limit on intake (ALI) or 12
DAC-hours.
(12) Approved
individual--An individual whom the licensee has determined to be trustworthy
and reliable for unescorted access in accordance with §289.252(ii)(2) -
(8) of this title (relating to Licensing of Radioactive Material) and who has
completed the training required by §
289.252(ii)(10)(C)
of this title.
(13) As low as is
reasonably achievable (ALARA)--Making every reasonable effort to maintain
exposures to radiation as far below the dose limits in these regulations as is
practical, consistent with the purpose for which the licensed activity is
undertaken, taking into account the state of technology, the economics of
improvements in relation to 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
ionizing radiation and licensed sources of radiation in the public
interest.
(14) Background
investigation--The investigation conducted by a licensee or applicant to
support the determination of trustworthiness and reliability.
(15) Background radiation--Radiation from
cosmic sources; non-technologically enhanced naturally occurring radioactive
material, including radon, except as a decay product of source or special
nuclear material, and including global fallout as it exists in the environment
from the testing of nuclear explosive devices or from past nuclear accidents,
such as Chernobyl, that contribute to background radiation and are not under
the control of the licensee. "Background radiation" does not include radiation
from sources of radiation regulated by the agency.
(16) Becquerel (Bq)--The International System
of Units (SI) unit of activity. One becquerel is equal to 1 disintegration or
transformation per second (dps or tps). Commonly used multiples of the
becquerel are the kBq (kilobecquerel, 103 Bq), MBq
(megabecquerel, 106 Bq), GBq (gigabecquerel,
109 Bq), and TBq (terabecquerel,
1012 Bq). 1 Ci = 37 GBq.
(17) Bioassay--The determination of kinds,
quantities, or concentrations, and, in some cases, the locations of radioactive
material in the human body, whether by direct measurement, in vivo counting, or
by analysis and evaluation of materials excreted or removed from the human
body. For purposes of this chapter, "radiobioassay" is an equivalent
term.
(18) Brachytherapy--A method
of radiation therapy in which sealed sources are utilized to deliver a
radiation dose at a distance of up to a few centimeters, by surface,
intracavitary, or interstitial application.
(19) Byproduct material--Byproduct material
is defined as:
(A) any radioactive material
(except special nuclear material) yielded in or made radioactive by exposure to
the radiation incident to the process of producing or utilizing special nuclear
material;
(B) the tailings or
wastes produced by or resulting from the extraction or concentration of uranium
or thorium from any 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;
(C) any discrete source
of radium-226 that is produced, extracted, or converted after extraction,
before, on, or after August 8, 2005, for use for a commercial, medical, or
research activity; or
(D) any
material that has been made radioactive by use of a particle accelerator; and
is produced, extracted, or converted after extraction, before, on, or after
August 8, 2005, for use for a commercial, medical, or research activity;
and
(E) any discrete source of
naturally occurring radioactive material, other than source material, that is
extracted or converted after extraction before, on, or after August 8, 2005,
for use in a commercial, medical, or research activity and that the United
States NRC, in consultation with the Administrator of the United States
Environmental Protection Agency (EPA), the United States Secretary of Energy,
the United States Secretary of Homeland Security, and the head of any other
appropriate Federal agency, determines would pose a threat similar to the
threat posed by a discrete source of radium-226 to the public health and safety
or the common defense and security.
(20) Category 1 quantity of radioactive
material--A quantity of radioactive material meeting or exceeding the category
1 threshold in §
289.252(jj)(9)
of this title. This is determined by calculating the ratio of the total
activity of each radionuclide to the category 1 threshold for that radionuclide
and adding the ratios together. If the sum is equal to or exceeds 1, the
quantity would be considered a category 1 quantity. Category 1 quantities of
radioactive material do not include the radioactive material contained in any
fuel assembly, subassembly, fuel rod, or fuel pellet.
(21) Category 2 quantity of radioactive
material--A quantity of radioactive material meeting or exceeding the category
2 threshold but less than the category 1 threshold in §
289.252(jj)(9)
of this title. This is determined by calculating the ratio of the total
activity of each radionuclide to the category 2 threshold for that radionuclide
and adding the ratios together. If the sum is equal to or exceeds 1, the
quantity would be considered a category 2 quantity. Category 2 quantities of
radioactive material do not include the radioactive material contained in any
fuel assembly, subassembly, fuel rod, or fuel pellet.
(22) Certificate of registration--A form of
permission given by the agency to an applicant who has met the requirements for
registration or mammography system certification set out in the Act and this
chapter.
(23) Certification of
mammography systems (state certification)--A form of permission given by the
agency to an applicant who has met the requirements for mammography system
certification set out in the Act and this chapter.
(24) Collective dose--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.
(25) Commercial--Having financial profit as
the primary aim.
(26) Committed
dose equivalent (HT,50)--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.
(27) Committed effective
dose equivalent (HE,50)--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 each of these organs or tissues
(HE,50 = [SIGMA]WT
HT.50).
(28)
Consortium--An association of medical use licensees and a Positron Emission
Tomography (PET) radionuclide production facility in the same geographical area
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 PET
radionuclide production facility within the consortium shall be located at an
educational institution or a medical facility.
(29) Constraint (dose constraint)--A value
above which specified licensee actions are required.
(30) Critical group--The group of individuals
reasonably expected to receive the greatest exposure to residual radioactivity
for any applicable set of circumstances.
(31) Curie (Ci)--A unit of measurement of
radioactivity. One curie (Ci) is that quantity of radioactive material that
decays at the rate of 3.7 x 1010 disintegrations per
second (dps). Commonly used submultiples of the curie are the millicurie (mCi)
and the microcurie (µCi). One mCi = 1 x 10-3
Ci = 3.7 x 107 dps. One µCi = 1 x
10-6 Ci = 3.7 x 104 dps.
One nanocurie (nCi) = 1 x 10-9 Ci = 3.7 x
101 dps. One picocurie (pCi) = 1 x
10-12 Ci = 3.7 x 10-2
dps.
(32) Decommission--To remove a
facility or site safely from service and reduce residual radioactivity to a
level that permits the following:
(A) release
of the property for unrestricted use and/or termination of license;
or
(B) release of the property
under alternate requirements for license termination.
(33) Deep dose equivalent
(Hd), that applies to external whole body exposure--The
dose equivalent at a tissue depth of 1 centimeter (cm) (1,000 milligrams per
square centimeter (mg/cm 2)).
(34) Depleted uranium--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.
(35) Discrete source--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.
(36)
Distinguishable from background--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 or
equipment, in similar materials using adequate measurement technology, survey,
and statistical techniques.
(37)
Distribution--The physical conveyance and authorized transfer of commodities
from producers to consumers and any intermediate persons involved in that
conveyance.
(38) Diversion--The
unauthorized movement of radioactive material subject to §
289.252(ii)
of this title to a location different from the material's authorized
destination inside or outside of the site at which the material is used or
stored.
(39) Dose--A generic term
that means absorbed dose, dose equivalent, effective dose equivalent, committed
dose equivalent, committed effective dose equivalent, total organ dose
equivalent, or total effective dose equivalent. For purposes of this chapter,
"radiation dose" is an equivalent term.
(40)Dose equivalent
(HT)--The product of the absorbed dose in tissue,
quality factor, and all other necessary modifying factors at the location of
interest. The units of dose equivalent are the sievert (Sv) and rem.
(41) Dose limits--The permissible upper
bounds of radiation doses established in accordance with this chapter. For
purposes of this chapter, "limits" is an equivalent term.
(42)Effective dose equivalent
(HE)--The sum of the products of the dose equivalent to
each organ or tissue (HT) and the weighting factor
(WT) applicable to each of the body organs or tissues
that are irradiated (HE =
[SIGMA]WT HT ).
(43) Embryo/fetus--The developing human
organism from conception until the time of birth.
(44) Entrance or access point--Any opening
through which an individual or extremity of an individual could gain access to
radiation areas or to licensed sources of radiation. This includes portals of
sufficient size to permit human access, irrespective of their intended
use.
(45) Escorted
access--Accompaniment while in a security zone by an approved individual who
maintains continuous direct visual surveillance at all times over an individual
who is not approved for unescorted access.
(46) Exposure--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 SI
unit of exposure is the coulomb per kilogram (C/kg). The roentgen is the
special unit of exposure. For purposes of this chapter, this term is used as a
noun.
(47) Exposure rate--The
exposure per unit of time.
(48)
External dose--That portion of the dose equivalent received from any source of
radiation outside the body.
(49)
Extremity--Hand, elbow, arm below the elbow, foot, knee, and leg below the
knee. The arm above the elbow and the leg above the knee are considered part of
the whole body.
(50) Fingerprint
orders--The orders issued by the NRC or the legally binding requirements issued
by agreement states that require fingerprints and criminal history records
checks for individuals with unescorted access to category 1 and category 2
quantities of radioactive material or safeguards information-modified
handling.
(51) Generally applicable
environmental radiation standards--Standards issued by the EPA under the
authority of the Atomic Energy Act of 1954, as amended, that impose limits on
radiation exposures or levels, or concentrations or quantities of radioactive
material, in the general environment outside the boundaries of locations under
the control of persons possessing or using radioactive material.
(52) Gray (Gy)--The SI unit of absorbed dose.
One gray is equal to an absorbed dose of 1 joule per kilogram (J/kg) or 100
rad.
(53) High radiation area--An
area, accessible to individuals, in which radiation levels from sources of
radiation external to the body could result in an individual receiving a dose
equivalent in excess of 0.1 rem (1 millisievert (mSv)) in one hour at 30 cm
from any source of radiation or from any surface that the radiation
penetrates.
(54) Human use--The
internal or external administration of radiation or radioactive material to
human beings for healing arts purposes or research and/or development
specifically authorized by the agency.
(55) Individual--Any human being.
(56) Individual monitoring--The assessment
of:
(A) dose equivalent to an individual by
the use of individual monitoring devices; or
(B) committed effective dose equivalent to an
individual by bioassay or by determination of the time-weighted air
concentrations to which an individual has been exposed, that is, DAC-hours.
(See the definition for DAC-hours in §
289.202(c)
of this title); or
(C) dose
equivalent to an individual by the use of survey data.
(57) Individual monitoring devices--Devices
designed to be worn by a single individual for the assessment of dose
equivalent. For purposes of this chapter, "personnel dosimeter" and "dosimeter"
are equivalent terms. Examples of individual monitoring devices include, but
are not limited to, film badges, thermoluminescence dosimeters (TLDs),
optically stimulated luminescence dosimeters (OSLs), pocket ionization chambers
(pocket dosimeters), electronic personal dosimeters, and personal air sampling
devices.
(58) Inspection--An
official examination and/or observation including, but not limited to, records,
tests, surveys, and monitoring to determine compliance with the Act and rules,
orders, requirements, and conditions of the agency.
(59) Internal dose--That portion of the dose
equivalent received from radioactive material taken into the body.
(60) Ionizing radiation--Any electromagnetic
or particulate radiation capable of producing ions, directly or indirectly, in
its passage through matter. Ionizing radiation includes gamma rays and x rays,
alpha and beta particles, high-speed electrons, neutrons, and other nuclear
particles.
(61) Land disposal
facility--The land, buildings, and equipment that are intended to be used for
the disposal of low-level radioactive waste (LLRW) into the subsurface of the
land.
(62) Lens dose
equivalent--The external dose equivalent to the lens of the eye at a tissue
depth of 0.3 cm (300 mg/cm2).
(63) License--A form of permission given by the agency
to an applicant who has met the requirements for licensing set out in the Act
and this chapter.
(64) Licensed
material--Radioactive material received, possessed, used, or transferred under
a general or specific license issued by the agency.
(65) Licensee--Any person who is licensed by
the agency in accordance with the Act and this chapter.
(66) Licensing state--Any state with rules
equivalent to the Suggested State Regulations for Control of Radiation relating
to, and having an effective program for, the regulatory control of naturally
occurring or accelerator-produced radioactive material (NARM) and has been
designated as such by the Conference of Radiation Control Program Directors,
Inc. For the purposes of evaluation and/or distribution of sealed sources, this
includes Licensing State Status: Product Review Only.
(67) Local law enforcement agency (LLEA)--A
public or private organization that has been approved by a federal, state, or
local government to carry firearms and make arrests, and is authorized and has
the capability to provide an armed response in the jurisdiction where the
licensed category 1 or category 2 quantity of radioactive material is used,
stored, or transported.
(68) Lost
or missing radioactive material--Radioactive material whose location is
unknown. This definition includes licensed material that has been shipped but
has not reached its planned destination and whose location cannot be readily
traced in the transportation system.
(69) Low-level radioactive waste
(LLRW)--Radioactive material that meets the following criteria:
(A) LLRW is radioactive material that is:
(i) discarded or unwanted and is not exempt
by rule adopted under the Texas Radiation Control Act (Act), HSC,
§401.106;
(ii) waste, as that
term is defined in Title 10, CFR, §61.2; and
(iii) subject to:
(I) concentration limits established in Title
10, CFR, §61.55, or compatible rules adopted by the agency or the Texas
Commission on Environmental Quality (TCEQ), as applicable; and
(II) disposal criteria established in Title
10, CFR, or established by the agency or TCEQ, as applicable.
(B) LLRW does not
include:
(i) high-level radioactive waste as
defined by Title 10, CFR, §60.2;
(ii) spent nuclear fuel as defined by Title
10, CFR, §72.3;
(iii)
byproduct material defined in the Act, HSC, §401.003(3)(B);
(iv) naturally occurring radioactive material
(NORM) waste that is not oil and gas NORM waste;
(v) oil and gas NORM waste; or
(vi) transuranics greater than 100 nanocuries
per gram.
(70) Manufacture--To fabricate or
mechanically produce.
(71) Member
of the public--Any individual, except when that individual is receiving an
occupational dose.
(72) Minor--An
individual less than 18 years of age.
(73) Mobile device--A piece of equipment
containing licensed radioactive material that either is mounted on a permanent
base with wheels and/or casters, or otherwise equipped for moving while
completely assembled and without dismounting; or is a portable device. Mobile
devices do not include stationary equipment installed in a fixed
location.
(74) Monitoring--The
measurement of radiation, radioactive material concentrations, surface area
activities, or quantities of radioactive material and the use of the results of
these measurements to evaluate potential exposures and doses. For purposes of
this chapter, "radiation monitoring" and "radiation protection monitoring" are
equivalent terms.
(75) Movement
control center--An operations center that is remote from transport activity and
that maintains position information on the movement of radioactive material,
receives reports of attempted attacks or thefts, provides a means for reporting
these and other problems to appropriate agencies and can request and coordinate
appropriate aid.
(76) NARM--Any
naturally occurring or accelerator-produced radioactive material except source
material or special nuclear material.
(77) Natural radioactivity--Radioactivity of
naturally occurring nuclides whose location and chemical and physical form have
not been altered by man.
(78)
No-later-than arrival time--The date and time that the shipping licensee and
receiving licensee have established as the time at which an investigation will
be initiated if the shipment has not arrived at the receiving facility. The
no-later-than arrival time may not be more than 6 hours after the estimated
arrival time for shipments of category 2 quantities of radioactive
material.
(79) NRC--The United
States Nuclear Regulatory Commission or its duly authorized
representatives.
(80) Occupational
dose--The dose received by an individual in the course of employment in which
the individual's assigned duties involve exposure to sources of radiation from
licensed/registered and unlicensed/unregistered sources of radiation, whether
in the possession of the licensee/registrant or other person. Occupational dose
does not include dose received from background radiation, from any medical
administration the individual has received, from exposure to individuals
administered radioactive material and released in accordance with this chapter,
from voluntary participation in medical research programs, or as a member of
the public.
(81) Particle
accelerator--Any machine capable of accelerating electrons, protons, deuterons,
or other charged particles in a vacuum and designed to discharge the resultant
particulate or other associated radiation at energies usually in excess of 1
million electron volts (MeV).
(82)
Person--Any individual, corporation, partnership, firm, association, trust,
estate, public or private institution, group, agency, local government, any
other state or political subdivision or agency thereof, or any other legal
entity, and any legal successor, representative, agent, or agency of the
foregoing, other than NRC, and other than federal government agencies licensed
or exempted by NRC.
(83) Personnel
monitoring equipment (See definition for individual monitoring
devices.)
(84) Pharmacist--An
individual licensed by the Texas State Board of Pharmacy to compound and
dispense drugs, prescriptions, and poisons.
(85) Physician--An individual licensed by the
Texas Medical Board.
(86) Portable
device--A piece of equipment containing licensed radioactive material that is
designed by the manufacturer to be hand carried during use.
(87) Positron emission tomography (PET)
radionuclide production facility--A facility operating a cyclotron or
accelerator for the purpose of producing PET radionuclides.
(88) Principal activities--Activities
authorized by the license that are essential to achieving the purpose(s) for
which the license was issued or amended. Storage during which no licensed
material is accessed for use or disposal and activities incidental to
decontamination or decommissioning are not principal activities.
(89) Public dose--The dose received by a
member of the public from exposure to sources of radiation released by a
licensee, or to any other source of radiation under the control of a
licensee/registrant. It does not include occupational dose or doses received
from background radiation, from any medical administration the individual has
received, from exposure to individuals administered radioactive material and
released in accordance with this chapter, or from voluntary participation in
medical research programs.
(90)
Quality factor (Q)--The modifying factor listed in subsection (n)(1) and (2) of
this section that is used to derive dose equivalent from absorbed
dose.
(91) Quarter (calendar
quarter)--A period of time equal to one-fourth of the year observed by the
licensee, approximately 13 consecutive weeks, providing that the beginning of
the first quarter in a year coincides with the starting date of the year and
that no day is omitted or duplicated in consecutive quarters.
(92) Rad--The special unit of absorbed dose.
One rad is equal to an absorbed dose of 100 ergs per gram (erg/g) or 0.01 J/kg
(0.01 Gy).
(93) Radiation--One or
more of the following:
(A) gamma and x rays;
alpha and beta particles and other atomic or nuclear particles or
rays;
(B) emission of radiation
from any electronic device to such energy density levels as to reasonably cause
bodily harm; or
(C) sonic,
ultrasonic, or infrasonic waves from any electronic device or resulting from
the operation of an electronic circuit in an electronic device in the energy
range to reasonably cause detectable bodily harm.
(94) Radiation area--Any 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 cm from
the source of radiation or from any surface that the radiation
penetrates.
(95) Radiation
machine--Any device capable of producing ionizing radiation except those
devices with radioactive material as the only source of radiation.
(96) Radiation safety officer (RSO)--An
individual who has a knowledge of and the authority and responsibility to apply
appropriate radiation protection rules, standards, and practices, who must be
specifically authorized on a radioactive material license, and who is the
primary contact with the agency. Specific training and responsibilities for an
RSO are listed in §
289.252
of this title, §
289.253
of this title (relating to Radiation Safety Requirements for Well Logging
Service Operations and Tracer Studies), §
289.255
of this title (relating to Radiation Safety Requirements and Licensing and
Registration Procedures for Industrial Radiography), and §
289.256
of this title (relating to Medical and Veterinary Use of Radioactive
Material).
(97) Radioactive
material--Any material (solid, liquid, or gas) that emits radiation
spontaneously.
(98) Radioactive
waste--For purposes of this chapter, this term is equivalent to LLRW.
(99) Radioactivity--The disintegration of
unstable atomic nuclei with the emission of radiation.
(100) Radiobioassay (See definition for
bioassay.)
(101) Registrant--Any
person issued a certificate of registration by the agency in accordance with
the Act and this chapter.
(102)
Regulation (See definition for rule.)
(103) Regulations of the United States
Department of Transportation (DOT)--The requirements in Title 49, CFR, Parts
100 - 189.
(104) Rem--The special
unit of any of the quantities expressed as dose equivalent. The dose equivalent
in rem is equal to the absorbed dose in rad multiplied by the quality factor (1
rem = 0.01 sievert (Sv)).
(105)
Research and development--Research and development is defined as:
(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.
(106) Residential location--Any area where a
structure or structures are located in which people lodge or live, and the
grounds on which these structures are located including, but not limited to,
houses, apartments, condominiums, and garages.
(107) Residual radioactivity--The
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 at the site, even if
those burials were made in accordance with the provisions of Title 10, CFR,
Part 20.
(108) Restricted area--An
area, access to which is limited by the licensee for the purpose of protecting
individuals against undue risks from exposure to sources of radiation.
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.
(109) Reviewing official--The
individual who shall make the trustworthiness and reliability determination of
an individual to determine whether the individual may have, or continue to
have, unescorted access to the category 1 or category 2 quantities of
radioactive materials that are possessed by the licensee.
(110) Roentgen (R)--The special unit of
exposure. One roentgen (R) equals 2.58 x 10-4 C/kg
of air. (See definition for exposure.)
(111) Rule (as defined in the Government
Code, Chapters 2001 and 2002, as amended)--Any agency statement of general
applicability that implements, interprets, or prescribes law or policy, or
describes the procedure or practice requirements of an agency. The term
includes the amendment or repeal of a prior section but does not include
statements concerning only the internal management or organization of any
agency and not affecting private rights or procedures. The word "rule" was
formerly referred to as "regulation."
(112) Sabotage--The deliberate damage, with
malevolent intent, to a category 1 or category 2 quantity of radioactive
material, a device that contains a category 1 or category 2 quantity of
radioactive material, or the components of the security system.
(113) Safe haven--A readily recognizable and
readily accessible site at which security is present or from which, in the
event of an emergency, the transport crew can notify and wait for the local law
enforcement authorities.
(114)
Sealed source--Radioactive material that is permanently bonded or fixed in a
capsule or matrix designed to prevent release and dispersal of the radioactive
material.
(115) Security zone--Any
temporary or permanent area determined and established by the licensee for the
physical protection of category 1 or category 2 quantities of radioactive
material.
(116) Shallow dose
equivalent (Hs) (that applies to the external exposure
of the skin of the whole body or the skin of an extremity)--The dose equivalent
at a tissue depth of 0.007 cm (7 mg/cm2).
(117) SI--The abbreviation for the
International System of Units.
(118) Sievert--The SI unit of any of the
quantities expressed as dose equivalent. The dose equivalent in sievert is
equal to the absorbed dose in gray multiplied by the quality factor (1 Sv = 100
rem).
(119) Site boundary--That
line beyond which the land or property is not owned, leased, or otherwise
controlled by the licensee.
(120)
Source material--Source material is defined as:
(A) uranium or thorium, or any combination
thereof, in any physical or chemical form; or
(B) ores that contain by weight 0.05% or more
of uranium, thorium, or any combination thereof; and
(C) does not include special nuclear
material.
(121) Source
of radiation--Any radioactive material, or any device or equipment emitting or
capable of producing radiation.
(122) Special form radioactive
material--Radioactive material that 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 5 millimeters (mm) (0.2 inch);
and
(C) It satisfies the
requirements specified by NRC. A special form encapsulation designed in
accordance with NRC requirements in effect on June 30, 1983, and constructed
prior to July 1, 1985, may continue to be used. A special form encapsulation
designed in accordance with NRC requirements in effect on March 31, 1996, and
constructed prior to April 1, 1998, may continue to be used. A special form
encapsulation either designed or constructed after April 1, 1998, must meet the
requirements of this definition applicable at the time of its design or
construction.
(123)
Special nuclear material--Special nuclear material is defined as:
(A) plutonium (Pu), uranium-233 (U-233),
uranium enriched in the isotope 233 or in the isotope 235, and any other
material that NRC, in accordance with the provisions of the Atomic Energy Act
of 1954, §51 as amended, determines to be special nuclear material, but
does not include source material; or
(B) any material artificially enriched by any
of the foregoing, but does not include source material.
(124) Special nuclear material in quantities
not sufficient to form a critical mass--Uranium enriched in the isotope 235 in
quantities not exceeding 350 grams (g) of contained uranium-235; uranium-233 in
quantities not exceeding 200 g; plutonium in quantities not exceeding 200 g; or
any combination of them in accordance with the following formula.
(A) For each kind of special nuclear
material, determine the ratio between the quantity of that special nuclear
material and the quantity specified above for the same kind of special nuclear
material. The sum of such ratios for all of the kinds of special nuclear
material in combination shall not exceed "1" (i.e., unity).
(B) For example, the following quantities in
combination would not exceed the limitation and are within the formula:
(125) Special
units--The conventional units historically used by licensees, for example,
curie (activity), rad (absorbed dose), and rem (dose equivalent).
(126) Stationary device--A piece of equipment
containing licensed radioactive material that is installed in a fixed location.
(127) Survey--An evaluation of the
radiological conditions and potential hazards incident to the production, use,
transfer, release, disposal, and/or presence of sources of radiation. When
appropriate, such survey includes, but is not limited to, tests, physical
examination of location of materials and equipment, measurements of levels of
radiation or concentration of radioactive material present, and evaluation of
administrative and/or engineered controls.
(128) Telemetric position monitoring
system--A data transfer system that captures information by instrumentation
and/or measuring devices about the location and status of a transport vehicle
or package between the departure and destination locations.
(129) Termination--A release by the agency of
the obligations and authorizations of the licensee under the terms of the
license. It does not relieve a person of duties and responsibilities imposed by
law.
(130) Test--A method of
determining the characteristics or condition of sources of radiation or
components thereof.
(131) Texas
Regulations for Control of Radiation (TRCR)--All sections of Title 25, TAC,
Chapter 289.
(132) Total effective
dose equivalent (TEDE)--The sum of the effective dose equivalent for external
exposures and the committed effective dose equivalent for internal
exposures.
(133) Total organ dose
equivalent (TODE)--The sum of the deep dose equivalent and the committed dose
equivalent to the organ receiving the highest dose as described in §
289.202(rr)(1)(F)
of this title.
(134) Transport
index--The dimensionless number (rounded up to the next tenth) placed on the
label of a package, to designate the degree of control to be exercised by the
carrier during transportation. The transport index is determined as follows:
(A) For non-fissile material packages, the
number determined by multiplying the maximum radiation level in millisievert
per hour (mSv/hr) at 1 meter (m) (3.3 feet) from the external surface of the
package by 100 (equivalent to the maximum radiation level in millirem per hour
(mrem/hr) at 1 m (3.3 feet); or
(B)
For fissile material packages, the number determined by multiplying the maximum
radiation level in mSv/hr at 1 m (3.3 feet) from the external surface of the
package by 100 (equivalent to the maximum radiation level in mrem/hr at 1 m
(3.3 feet), or, for criticality control purposes, the number obtained as
described in Title 10, CFR, §71.59 whichever is larger.
(135) Trustworthiness and
reliability--Characteristics of an individual considered dependable in
judgment, character, and performance, such that unescorted access to category 1
or category 2 quantities of radioactive material by that individual does not
constitute an unreasonable risk to the public health and safety or security. A
determination of trustworthiness and reliability for this purpose is based upon
the results from a background investigation.
(136) Type A quantity--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 §
289.257(ee)
of this title (relating to Packaging and Transportation of Radioactive
Material) or may be determined by procedures described in §
289.257(ee)
of this title.
(137) Type B
quantity--A quantity of radioactive material greater than a type A
quantity.
(138) Unescorted
access--Solitary access to an aggregated category 1 or category 2 quantity of
radioactive material or the devices that contain the material.
(139) Unrefined and unprocessed ore-- Ore in
its natural form prior to any processing, such as grinding, roasting or
beneficiating, or refining. Processing does not include sieving or
encapsulation of ore or preparation of samples for laboratory
analysis.
(140) Unrestricted area
(uncontrolled area)--An area, or access to, which is neither limited nor
controlled by the licensee. For purposes of this chapter, "uncontrolled area"
is an equivalent term.
(141) Very
high radiation area--An area, accessible to individuals, in which radiation
levels from sources of radiation external to the body could result in an
individual receiving an absorbed dose in excess of 500 rads (5 Gy in one hour
at 1 meter (m) from a source of radiation or from any surface that the
radiation penetrates. At very high doses received at high dose rates, units of
absorbed dose, gray and rad, are appropriate, rather than units of dose
equivalent, Sv and rem.
(142)
Veterinarian--An individual licensed by the Texas State Board of Veterinary
Medical Examiners.
(143)
Waste--Low-level radioactive wastes containing source, special nuclear, or
byproduct material that are acceptable for disposal in a land disposal
facility. For the purposes of this definition, low-level radioactive waste
means radioactive waste not classified as high-level radioactive waste,
transuranic waste, spent nuclear fuel, or byproduct material as defined in
paragraph (19)(B) - (E) of this subsection.
(144) Week--Seven consecutive days starting
on Sunday.
(145) Whole body--For
purposes of external exposure, head, trunk including male gonads, arms above
the elbow, or legs above the knee.
(146) Worker--An individual engaged in work
under a license or certificate of registration issued by the agency and
controlled by a licensee or registrant, but does not include the licensee or
registrant.
(147) Working level
(WL)--Any combination of short-lived radon daughters in 1 liter of air that
will result in the ultimate emission of 1.3 x 105
MeV of potential alpha particle energy. The short-lived radon daughters
are--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.
(148) Working level month (WLM)--An exposure
to one working level for 170 hours--2,000 working hours per year divided by 12
months per year is approximately equal to 170 hours per month.
(149) Year--The period of time beginning in
January used to determine compliance with the provisions of this chapter. The
licensee may change the starting date of the year used to determine compliance
by the licensee provided that the change is made at the beginning of the year
and that no day is omitted or duplicated in consecutive years.
(c) Exemptions.
(1) General provision. The agency may, upon
application therefore or upon its own initiative, exempt a source of radiation
or a kind of use or user from the requirements of this chapter if the agency
determines that the exemption is not prohibited by law and will not result in a
significant risk to public health and safety and the environment. In
determining such exemptions, the agency will consider:
(A) state of technology;
(B) economic considerations in relation to
benefits to the public health and safety; and
(C) other societal, socioeconomic, or public
health and safety considerations.
(2) United States Department of Energy (DOE)
contractors and NRC contractors. Any DOE contractor or subcontractor and any
NRC contractor or subcontractor of the following categories operating within
Texas is exempt from this chapter, with the exception of §
289.204
of this title (relating to Fees for Certificates of Registration, Radioactive
Material Licenses, Emergency Planning and Implementation, and Other Regulatory
Services), to the extent that such contractor or subcontractor under that
individual's contract receives, possesses, uses, transfers, or acquires sources
of radiation:
(A) prime contractors
performing work for DOE at United States 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;
(B) prime
contractors of DOE performing research in, or development, manufacture,
storage, testing, or transportation of, atomic weapons or components
thereof;
(C) prime contractors of
DOE using or operating nuclear reactors or other nuclear devices in a United
States government-owned vehicle or vessel; and
(D) any other prime contractor or
subcontractor of DOE or of NRC when the state and NRC jointly determine that:
(i) the exemption of the prime contractor or
subcontractor is authorized by law; and
(ii) in accordance with 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 and the
environment.
(d) Records.
(1) Each licensee shall maintain records
showing the receipt, transfer, and disposal of all non-exempt sources of
radiation.
(A) Records of receipt, transfer,
and disposal of sources of radiation shall include as a minimum, the following
information:
(i) a unique identification of
each source of radiation, including:
(I)
manufacturer's name;
(II)
isotope;
(III) activity;
and
(IV) if available, sealed
source serial number;
(ii) the date of receipt, transfer, or
disposal of each source of radiation;
(iii) for the licensee transferring the
source of radiation, the name of the transferee, the number of the transferee's
radioactive material license authorizing possession of the material, and the
regulatory agency issuing the license to the transferee; and
(iv) for the licensee receiving the source of
radiation, the name of the transferor, the number of the transferor's
radioactive material license authorizing possession of the material, and the
regulatory agency issuing the license to the transferor.
(B) Records of receipt, transfer, and
disposal shall be maintained by the licensee until disposal is authorized by
the agency.
(2)
Additional record requirements and retention periods are specified elsewhere in
this chapter.
(3) All records
required by this chapter shall be accurate and factual.
(4) Records are only valid if stamped,
initialed, or signed and dated by authorized personnel or otherwise
authenticated.
(5) Each record
required by this chapter must be legible throughout the retention period
specified by the agency. The record may be the original or a reproduced copy or
a microform provided that the copy or microform is authenticated by authorized
personnel and that the microform is capable of producing a clear copy
throughout the required retention period. The record may also be stored in
electronic media with the capability for producing legible, accurate, and
complete records during the required retention period. Records, such as
letters, drawings, or specifications, must include all pertinent information
such as stamps, initials, and signatures. The licensee shall maintain adequate
safeguards against tampering with and loss of records.
(e) Inspections.
(1) The agency may enter public or private
property at reasonable times to determine whether, in a matter under the
agency's jurisdiction, there is compliance with the Act, the agency's rules,
license conditions, and orders issued by the agency.
(2) Each licensee shall afford the agency, at
all reasonable times, opportunity to inspect sources of radiation and the
premises and facilities wherein such sources of radiation are used or
stored.
(3) Each licensee shall
make available to the agency for inspection, upon reasonable notice, records
maintained in accordance with this chapter.
(f) Tests.
(1) Each licensee 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:
(A) sources of
radiation;
(B) facilities wherein
sources of radiation are used or stored;
(C) radiation detection and monitoring
instruments; and
(D) other
equipment and devices used in connection with utilization or storage of
licensed sources of radiation.
(2) Each licensee is required to accept from
the agency, samples collected from its facility(ies) or from areas that are
radioactive as a result of its licensed activities.
(g) Tests for leakage and/or contamination of sealed sources.
(1) The licensee in
possession of any sealed source shall assure that:
(A) each sealed source, except as specified
in paragraph (2) of this subsection and §
289.253(i)
of this title, is tested for leakage or contamination and the test results are
received before the sealed source is put into use unless the licensee has a
certificate from the transferor indicating that the sealed source was tested
within 6 months before transfer to the licensee;
(B) each sealed source that is not designed
to emit alpha particles is tested for leakage or contamination at intervals not
to exceed 6 months or at alternative intervals approved by the agency, the NRC,
or any agreement state after evaluation of information specified in §
289.252(v)
of this title or equivalent regulations of the NRC or any agreement
state;
(C) each sealed source that
is designed to emit alpha particles is tested for leakage or contamination at
intervals not to exceed 3 months or at alternative intervals approved by the
agency, the NRC, or any agreement state after evaluation of information
specified in §
289.252(v)
of this title, or equivalent regulations of the NRC, or any agreement
state;
(D) for each sealed source
that is required to be tested for leakage or contamination, at any other time
there is reason to suspect that the sealed source might have been damaged or
might be leaking, the licensee shall assure that the sealed source is tested
for leakage or contamination before further use;
(E) tests for leakage for all sealed sources,
except brachytherapy sources manufactured to contain radium, shall be capable
of detecting the presence of 0.005 µCi (185 Bq) of radioactive material
on a test sample. Test samples shall be taken from the sealed source or from
the surfaces of the container in which the sealed source is stored or mounted
and at the nearest accessible point to the sealed source where contamination
might accumulate. For a sealed source contained in a device, test samples are
obtained when the source is in the "off" position;
(F) the test for leakage for brachytherapy
sources manufactured to contain radium shall be capable of detecting an
absolute leakage rate of 0.001 µCi (37 Bq) of radon-222 in a 24-hour
period when the collection efficiency for radon-222 and its daughters has been
determined with respect to collection method, volume, and time;
(G) tests for contamination from radium
daughters shall be taken on the interior surface of brachytherapy source
storage containers and shall be capable of detecting the presence of 0.005
µCi (185 Bq) of a radium daughter that has a half-life greater than 4
days; and
(H) tests for leakage or
contamination shall be performed using a leak test kit or method approved by
the agency, the NRC, or any agreement state.
(2) A licensee need not perform tests for
leakage or contamination on the following sealed sources:
(A) sealed sources containing only
radioactive material with a half-life of less than 30 days;
(B) sealed sources containing only
radioactive material as a gas;
(C)
sealed sources containing 100 µCi (3.7 MBq) or less of beta or
gamma-emitting material or 10 µCi (370 kBq) or less of alpha or
neutron-emitting material;
(D)
sealed sources containing only hydrogen-3 (tritium);
(E) seeds of iridium-192 encased in nylon
ribbon; and
(F) sealed sources,
except teletherapy and brachytherapy sources, which are stored, not being used,
and identified as in storage. The licensee shall, however, test each such
sealed source for leakage or contamination and receive the test results before
any use or transfer unless it has been tested for leakage or contamination
within six months before the date of use or transfer.
(3) Analysis of tests for leakage or
contamination from sealed sources shall be performed by persons specifically
authorized by the agency, the NRC, or any agreement state, to perform such
services.
(4) Test results shall be
kept in units of microcurie or becquerel and maintained for inspection by the
agency.
(5) The following shall be
considered evidence that a sealed source is leaking:
(A) the presence of 0.005 µCi (185 Bq)
or more of removable contamination on any test sample;
(B) leakage of 0.001 µCi (37 Bq) of
radon-222 per 24 hours for brachytherapy sources manufactured to contain
radium; or
(C) the presence of
removable contamination resulting from the decay of 0.005 µCi (185 Bq) or
more of radium.
(6) The
licensee shall immediately withdraw a leaking sealed source from use and shall
take action to prevent the spread of contamination. Within two years of the
determination that a sealed source is leaking, the leaking sealed source shall
be repaired or transferred for disposal in accordance with §
289.202
of this title. The licensee shall check the equipment associated with the
leaking source for radioactive contamination and, if contaminated, have it
decontaminated or disposed of in accordance with §
289.202
of this title.
(7) Reports of test
results for leaking or contaminated sealed sources shall be made in accordance
with §
289.202(bbb)
of this title.
(h) Additional requirements. The agency may, by rule, order, or condition of license or general license acknowledgment, impose upon any licensee such requirements in addition to those established in this chapter as it deems appropriate or necessary to minimize danger to public health and safety or property or the environment.
(i) Violations. An injunction or other court order may be obtained prohibiting any violation of any provision of the Act or any rule or order issued thereunder. Any person who willfully violates any provision of the Act or any rule or order issued thereunder may be guilty of a misdemeanor and upon conviction, may be punished by fine or imprisonment or both, as provided by law.
(j) Impounding. Sources of radiation shall be subject to impounding in accordance with §401.068 of the Act and § 289.205 of this title (relating to Hearing and Enforcement Procedures).
(k) Communications.
(1) Except where otherwise specified, all
communications and reports concerning this chapter and applications filed under
them should be addressed to Radiation Control, Department of State Health
Services, P.O. Box 149347, Austin, Texas, 78714-9347. Communications, reports,
and applications may be delivered in person to the agency's office located at
8407 Wall Street, Austin, Texas.
(2) Documents transmitted to the agency will
be deemed submitted on the date of the postmark, facsimile, or other electronic
media transmission.
(l) Interpretations. Except as specifically authorized by the agency in writing, no interpretation of the meaning of this chapter by any officer or employee of the agency other than a written interpretation by the Office of General Counsel, Department of State Health Services, will be considered binding upon the agency.
(m) Open records.
(1) Subject to the limitations provided in
the Texas Public Information Act, Government Code, Chapter 552, all information
and data collected, assembled, or maintained by the agency are public records
open to inspection and copying during regular office hours.
(2) Any person who submits written
information or data to the agency and requests that the information be
considered confidential, privileged, or otherwise not available to the public
under the Texas Public Information Act, shall justify such request in writing,
including statutes and cases where applicable, addressed to the agency.
(A) Documents containing information that is
claimed to fall within an exception to the Texas Public Information Act shall
be marked to indicate that fact. Markings shall be placed on the document on
origination or submission.
(i) The words "NOT
AN OPEN RECORD" shall be placed conspicuously at the top and bottom of each
page containing information claimed to fall within one of the
exceptions.
(ii) The following
wording shall be placed at the bottom of the front cover and title page, or
first page of text if there is no front cover or title page:
(B) The agency
requests, whenever possible, that all information submitted under the claim of
an exception to the Texas Public Information Act be extracted from the main
body of the application and submitted as a separate annex or appendix to the
application.
(C) Failure to comply
with any of the procedures described in subparagraphs (A) and (B) of this
paragraph may result in all information in the agency file being disclosed upon
an open records request.
(3) The agency will determine whether
information falls within one of the exceptions to the Texas Public Information
Act. The Office of General Counsel will be queried as to whether or not there
has been a previous determination that the information falls within one of the
exceptions to the Texas Public Information Act. If there has been no previous
determination and the agency believes that the information falls within one of
the exceptions, an opinion of the Attorney General will be requested. If the
agency agrees in writing to the request, the information shall not be open for
public inspection unless the Attorney General's office subsequently determines
that it does not fall within an exception.
(4) Requests for information.
(A) All requests for open records information
must be in writing and refer to documents currently in possession of the
agency.
(B) The agency will
ascertain whether the information may be released or whether it falls within an
exception to the Texas Public Information Act.
(i) The agency may take a reasonable period
of time to determine whether information falls within one of the exceptions to
the Texas Public Information Act.
(ii) If the information is determined to be
public, it will be presented for inspection and/or copies of documents will be
furnished within a reasonable period of time. A fee will be charged to recover
agency costs for copies.
(C) Original copies of public records may not
be removed from the agency. Under no circumstances shall material be removed
from existing records.
(n) Mean quality factors and absorbed dose equivalencies.
(1) As used in this chapter,
the quality factors for converting absorbed dose to dose equivalent are shown
in the following table:
(2) If it is more convenient to
measure the neutron fluence rate than to determine the neutron dose equivalent
rate in sievert per hour or rem per hour, as provided in paragraph (1) of this
subsection, 1 rem (0.01 Sv) of neutron radiation of unknown energies may, for
purposes of this section, 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 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 rad (gray) to dose equivalent in rem (Sv).
(o) Units of activity. For purposes of this chapter, activity is expressed in the special unit of curie (Ci), (Bq), or its multiples, or disintegrations or transformations per second (dps or tps).
(1) 1 Ci = 3.7 x
1010 dps or tps = 3.7 x
1010 Bq= 2.22 x 1012
disintegrations or transformations per minute (dpm or tpm).
(2) 1 Bq = 1 dps or tps.
Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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