Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 289 - RADIATION CONTROL
Subchapter E - REGISTRATION REGULATIONS
Section 289.231 - General Provisions and Standards for Protection Against Machine-Produced Radiation
Universal Citation: 25 TX Admin Code ยง 289.231
Current through Reg. 49, No. 38; September 20, 2024
(a) Purpose.
(1) This section establishes standards for
protection against ionizing radiation resulting from the use of radiation
machines.
(2) The requirements in
this section are designed to control the receipt, possession, use, and transfer
of radiation machines by any person so 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 this section. However, nothing in this section shall be construed
as limiting actions that may be necessary to protect health and safety in an
emergency. A person who receives, possesses, uses, owns, or acquires radiation
machines prior to receiving a certificate of registration is subject to the
requirements of this chapter.
(b) Scope.
(1) Except as specifically provided in other
sections of this chapter, this section applies to persons who receive, possess,
use, or transfer radiation machines. The dose 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 exposure from
individuals administered radioactive material and released in accordance with
this chapter, or to voluntary participation in medical research programs.
However, no radiation may be deliberately applied to human beings except by or
under the supervision of an individual authorized by and licensed in accordance
with Texas' statutes to engage in the healing arts.
(2) Registrants who are also licensed by the
agency to receive, possess, use, and transfer radioactive materials must also
comply with the requirements of §
289.201
of this title (relating to General Provisions for Radioactive Material) and
§
289.202
of this title (relating to Standards for Protection Against Radiation from
Radioactive Material).
(c) Definitions. The following words and terms when used in this section shall have the following meaning, 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) Act--Texas Radiation
Control Act, Health and Safety Code, Chapter 401.
(3) Adult--An individual 18 or more years of
age.
(4) Agency--The Department of
State Health Services.
(5)
Agreement State--Any state with which the United States Nuclear Regulatory
Commission (NRC) has entered into an effective agreement under §274b. of
the Atomic Energy Act of 1954, as amended (73 Stat.689).
(6) As low as is reasonably achievable
(ALARA)--Making every reasonable effort to maintain exposures to radiation as
far below the dose limits in this chapter as is practical, consistent with the
purpose for which the registered 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 radiation machines in
the public interest.
(7) 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 registrant. "Background
radiation" does not include radiation from sources of radiation regulated by
the agency.
(8) 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 Texas Radiation Control Act (Act) and this chapter.
(9) 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.
(10)
Chiropractor--An individual licensed by the Texas Board of Chiropractic
Examiners.
(11) 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.
(12) Declared pregnant
woman--A woman who has voluntarily informed the registrant, in writing, of her
pregnancy and the estimated date of conception. The declaration remains in
effect until the declared pregnant woman voluntarily withdraws the declaration
in writing or is no longer pregnant.
(13) Deep dose equivalent (DDE), that applies
to external whole body exposure--The dose equivalent (DE) at a tissue depth of
1 centimeter (cm) (1,000 milligrams per square centimeter (mg/cm
2)).
(14) Dentist--An individual licensed by the
Texas State Board of Dental Examiners.
(15) Dose--For external exposure to x-ray
radiation from radiation machines, a generic term that means absorbed dose, DE,
or total effective dose equivalent. For purposes of this chapter, "radiation
dose" is an equivalent term.
(16)
Dose equivalent (DE)--The product of the absorbed dose in tissue, quality
factor, and all other necessary modifying factors at the location of interest.
The units of DE are the sievert (Sv) and rem.
(17) 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.
(18) Dosimetry processor--A person that
processes and evaluates personnel monitoring devices in order to determine the
radiation dose delivered to the monitoring devices.
(19) Embryo/fetus--The developing human
organism from conception until the time of birth.
(20) Entrance or access point--Any opening
through which an individual or extremity of an individual could gain access to
radiation areas or to radiation machines. This includes portals of sufficient
size to permit human access, irrespective of their intended use.
(21) 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
International System of Units (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.
(22) Exposure rate (air kerma rate)--The
exposure per unit of time.
(23)
External dose--That portion of the DE received from any source of radiation
outside the body.
(24)
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.
(25) 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.
(26)
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 DE 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.
(27) Human
use--For exposure to x-ray radiation from radiation machines, the external
administration of radiation to human beings for healing arts purposes or
research and/or development specifically authorized by the agency.
(28) Individual--Any human being.
(29) Individual monitoring--The assessment of
DE to an individual by the use of:
(A)
individual monitoring devices; or
(B) survey data.
(30) Individual monitoring devices--Devices
designed to be worn by a single individual for the assessment of DE. 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),
and electronic personal dosimeters.
(31) 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.
(32) 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.
(33) Lens dose
equivalent (LDE)--The external DE to the lens of the eye at a tissue depth of
0.3 cm (300 mg/cm2).
(34) 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.
(35)
Licensed material--Radioactive material received, possessed, used, or
transferred under a general or specific license issued by the agency.
(36) Licensee--Any person who is licensed by
the agency in accordance with the Act and this chapter.
(37) 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.
(38) Lost or missing radiation machine(s)--A
radiation machine(s) whose location is unknown.
(39) Machine-produced radiation--A stimulated
emission of radiation from a manufactured product or device or component part
of a manufactured product or device that has an electronic circuit that during
operation can generate or emit a physical field of radiation.
(40) Manufacture--To fabricate or
mechanically produce.
(41) Member
of the public--Any individual, except when that individual is receiving an
occupational dose.
(42) Minimal
threat radiation machines--Those radiation machines capable of generating or
emitting fields of radiation that, during the operation of which:
(A) no deliberate exposure of an individual
occurs;
(B) the radiation is not
emitted in an open beam configuration; and
(C) no physical injury to an individual has
occurred and is known by the agency.
(43) Minor--An individual less than 18 years
of age.
(44) Monitoring--The
measurement of radiation 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.
(45) 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.
(46) 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
MeV.
(47) 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 the
NRC, and other than federal government agencies licensed or exempted by the
NRC.
(48) Personnel monitoring
equipment--(See definition for individual monitoring devices.)
(49) Physician--An individual licensed by the
Texas Medical Board.
(50)
Podiatrist--An individual licensed by the Texas State Board of Podiatric
Medical Examiners.
(51) 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.
(52) Quarter--A period of time equal to
one-fourth of the year observed by the 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.
(53) 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 gray).
(54) Radiation--One or more of the following:
(A) gamma and x-ray; alpha and beta particles
and other atomic or nuclear particles or rays;
(B) radiation emitted to energy density
levels that could reasonably cause bodily harm from an electronic device;
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.
(55) Radiation area--Any area, accessible to
individuals, in which radiation levels could result in an individual receiving
a DE in excess of 0.005 rem (0.05 mSv) in 1 hour at 30 cm from the radiation
machine or from any surface that the radiation penetrates.
(56) Radiation machine--Any device capable of
producing ionizing radiation except those devices with radioactive material as
the only source of radiation.
(57)
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 certificate
of registration, and who is the primary contact with the agency.
(58) Registrant--Any person issued a
certificate of registration by the agency in accordance with the Act and this
chapter.
(59) Regulation (See
definition for rule.)
(60) Rem--The
special unit of any of the quantities expressed as DE. The DE in rem is equal
to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01
sievert (Sv)).
(61) Remote
inspection--An examination by the agency of information submitted by the
registrant on a form provided by the agency.
(62) 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.
(63) Restricted area--An area,
access to which is limited by the registrant for the purpose of protecting
individuals against undue risks from exposure to 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.
(64) Roentgen (R)--The special unit of
exposure. One roentgen (R) equals 2.58 x 10-4 C/kg
of air. (See definition for exposure.)
(65) 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."
(66) 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). For purposes of this
chapter, the acronym SDE has the same meaning as the term shallow dose
equivalent.
(67) SI--The
abbreviation for the International System of Units.
(68) Sievert (Sv)--The SI unit of any of the
quantities expressed as DE. The DE in sievert is equal to the absorbed dose in
gray multiplied by the quality factor (1 Sv = 100 rem).
(69) Site boundary--That line beyond which
the land or property is not owned, leased, or otherwise controlled by the
registrant.
(70) Source of
radiation--Any radioactive material, or any device or equipment emitting or
capable of producing radiation.
(71) Special units--The conventional units
historically used by registrants, for example, rad (absorbed dose), and rem
(DE).
(72) Survey--An evaluation of
the radiological conditions and potential hazards incident to the production,
use, transfer, disposal, and/or presence of sources of radiation. When
appropriate, such survey includes, but is not limited to, tests, physical
examination of location of equipment, measurements of levels of radiation
present, and evaluation of administrative and/or engineered controls.
(73) Termination--A release by the agency of
the obligations and authorizations of the registrant under the terms of the
certificate of registration. It does not relieve a person of duties and
responsibilities imposed by law.
(74) Texas Regulations for Control of
Radiation (TRCR)--All sections of Title 25 Texas Administrative Code (TAC),
Chapter 289.
(75) Total effective
dose equivalent (TEDE)--For external exposures only to x-ray radiation from
radiation machines, the TEDE is equal to the DDE. If an individual receives an
occupational dose from both radiation machines and radioactive materials, the
TEDE is the sum of the DDE for external exposures and the committed effective
dose equivalent for internal exposures as defined in §
289.201(b)
of this title.
(76) Unrestricted
area (uncontrolled area)--An area, access to which is neither limited nor
controlled by the registrant. For purposes of this chapter, "uncontrolled area"
is an equivalent term.
(77) 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 grays) in 1 hour
at 1 meter (m) from a radiation machine 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 DE, Sv and
rem.
(78) Veterinarian--An
individual licensed by the Texas Board of Veterinary Medical
Examiners.
(79) Week--Seven
consecutive days starting on Sunday.
(80) Whole body--For purposes of external
exposure, head, trunk including male gonads, arms above the elbow, or legs
above the knee.
(81) Worker--An
individual engaged in work under a certificate of registration issued by the
agency and controlled by a registrant, but does not include the
registrant.
(82) Year--The period
of time beginning in January used to determine compliance with the provisions
of this chapter. The registrant may change the starting date of the year used
to determine compliance by the registrant provided that the change is made at
the beginning of the year and that no day is omitted or duplicated in
consecutive years.
(d) Exemptions. 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:
(1) state of technology;
(2) economic considerations in relation to
benefits to the public health and safety; and
(3) other societal, socioeconomic, or public
health and safety considerations.
(e) Prohibited uses.
(1) A hand-held fluoroscopic screen shall not
be used unless accepted for certification by the United States Food and Drug
Administration (FDA), Center for Devices and Radiological Health.
(2) A shoe-fitting fluoroscopic device shall
not be used.
(f) Additional requirements. The agency may, by rule, order, or condition of certificate of registration, impose upon any registrant 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.
(g) Violations. A court injunction or agency order may be issued 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 subject to civil and/or administrative penalties. Such person may also be guilty of a misdemeanor and upon conviction, may be punished by fine or imprisonment or both, as provided by law.
(h) Impounding. Radiation machines 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).
(i) Communications.
(1) Except where otherwise specified, all
communications and reports concerning this chapter and applications filed under
them should be addressed to the Radiation Control Program, Department of State
Health Services, P.O. Box 149347, Mail Code 1987, 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, telegram, telefacsimile, or
electronic media transmission.
(j) 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 legal interpretation by the agency, will be considered binding upon the agency.
(k) Mean quality factors and absorbed dose equivalencies.
(1) As used
in this chapter, the quality factors for converting absorbed dose to DE 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 or registrant may use the fluence
rate per unit DE or the appropriate Q value from the following table to convert
a measured tissue dose in rad (gray) to DE in rem (Sv).
(l) As low as reasonably achievable (ALARA). The registrant shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and public doses that are ALARA.
(m) Occupational dose limits.
(1) The registrant shall control the
occupational dose to individuals to the following dose limits.
(A) An annual limit shall be the TEDE being
equal to 5 rems (0.05 Sv).
(B) The
annual limits to the lens of the eye, to the skin of the whole body, and to the
skin of the extremities shall be:
(i) an LDE
of 15 rems (0.15 Sv); and
(ii) an
SDE of 50 rems (0.5 Sv) to the skin of the whole body, or to the skin of any
extremity.
(C) The
annual limits for a minor shall be 10% of the annual occupational dose limits
specified in subparagraphs (A) and (B) of this paragraph.
(D) If a woman declares her pregnancy, the
registrant shall ensure that the DE 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). If a woman chooses not to declare pregnancy, the
occupational dose limits specified in paragraph (1)(A) and (B) of this
subsection are applicable to the woman.
(i)
The registrant shall make efforts to avoid substantial variation above a
uniform monthly exposure rate (air kerma rate) to a declared pregnant woman so
as to satisfy the limit in paragraph (1) of this subsection. The National
Council on Radiation Protection and Measurements recommended in NCRP Report No.
91 "Recommendations on Limits for Exposure to Ionizing Radiation" (June 1,
1987) that no more than 0.05 rem (0.5 mSv) to the embryo/fetus be received in
any 1 month.
(ii) If by the time
the woman declares pregnancy to the registrant, the DE to the embryo/fetus has
exceeded 0.45 rem (4.5 mSv), the registrant shall be deemed to be in compliance
with paragraph (1) of this subsection, if the additional DE to the embryo/fetus
does not exceed 0.05 rem (0.5 mSv) during the remainder of the
pregnancy.
(iii) The DE to an
embryo/fetus shall be taken as the DE that is most representative of the DE to
the embryo/fetus from external radiation, that is, in the mother's lower torso
region.
(iv) If multiple
measurements have been made, assignment of the DDE for the declared pregnant
woman from the individual monitoring device that is most representative of the
DE to the embryo/fetus shall be the DE to the embryo/fetus. Assignment of the
highest DDE for the declared pregnant woman to the embryo/fetus is not required
unless that dose is also the most representative DDE for the region of the
embryo/fetus.
(v) If multiple
measurements have not been made, assignment of the highest DDE for the declared
pregnant woman shall be the DE to the embryo/fetus.
(2) The assigned DDE shall be for
the portion of the body receiving the highest exposure. The assigned SDE shall
be the dose averaged over the contiguous 10 square centimeters of skin
receiving the highest exposure.
(3)
When a protective apron is worn while working with fluoroscopic equipment used
for clinical diagnostic or research purposes, the effective dose equivalent
(EDE) for external radiation shall be determined as follows.
(A) When only 1 individual monitoring device
is used and it is located at the neck (collar) outside the protective apron,
the reported DDE shall be the EDE for external radiation; or
(B) When only 1 individual monitoring device
is used and it is located at the neck (collar) outside the protective apron,
and the reported dose exceeds 25% of the limit specified in paragraph (1) of
this subsection, the reported DDE value multiplied by 0.3 shall be the EDE for
external radiation; or
(C) When
individual monitoring devices are worn, both under the protective apron at the
waist and outside the protective apron at the neck (collar), the EDE for
external radiation shall be assigned the value of the sum of the DDE reported
for the individual monitoring device located at the waist under the protective
apron multiplied by 1.5 and the DDE reported for the individual monitoring
device located at the neck (collar) outside the protective apron multiplied by
0.04.
(4) The EDE
determined by paragraph (3) of this subsection shall be recorded as part of an
individual's dose record and will contribute to that individual's annual
TEDE.
(5) The DDE, LDE, and SDE may
be assessed from surveys or 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.
(6) The registrant shall reduce the dose that
an individual may be allowed to receive in the current year by the amount of
occupational dose received from radiation machines or radioactive materials
while employed by any other person. See subsection (r)(4) of this
section.
(n) Conditions requiring individual monitoring of occupational dose.
(1) Each registrant shall monitor exposures
from radiation machines at levels sufficient to demonstrate compliance with the
occupational dose limits of this section. As a minimum, each registrant shall
monitor occupational exposure to radiation from radiation machines and shall
supply and require the use of individual monitoring devices by:
(A) adults likely to receive, in 1 year from
sources external to the body, a dose in excess of 10% of the limits in
subsection (m)(1) of this section;
(B) minors likely to receive, in 1 year from
sources of radiation external to the body, a DDE in excess of 0.1 rem (1 mSv),
an LDE in excess of 0.15 rem (1.5 mSv), or an SDE to the skin or to the
extremities 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
DDE in excess of 0.1 rem (1 mSv); and
(D) individuals entering a high or very high
radiation area.
(2)
Notwithstanding the requirements of paragraph (1)(A) of this subsection, no
personnel monitoring shall be required for personnel operating only minimal
threat radiation machines as specified in subsection (ll)(3) of this
section.
(o) Dose limits for individual members of the public.
(1)
Each registrant shall conduct operations so that:
(A) the TEDE to individual members of the
public from exposure to radiation from radiation machines does not exceed 0.5
rem (5 mSv) in a year, exclusive of the dose contribution from background
radiation, exposure of patients to radiation for the purpose of medical
diagnosis or therapy, or to voluntary participation in medical research
programs; and
(B) the dose in any
unrestricted area from registered external sources does not exceed 0.002 rem
(0.02 mSv) in any 1 hour.
(2) If the registrant permits members of the
public to have access to restricted areas, the limits for members of the public
continue to apply to those individuals.
(3) The agency may impose additional
restrictions on radiation levels in unrestricted areas in order to restrict the
collective dose.
(4) The registrant
shall ensure that in facilities utilizing both radiation producing machines and
radioactive materials, the TEDE to an individual member of the public shall not
exceed 0.1 rem (1 mSv) in 1 year.
(p) Compliance with dose limits for individual members of the public.
(1) The
registrant shall make or cause to be made surveys of radiation levels in
unrestricted areas to demonstrate compliance with the dose limits for
individual members of the public as required in subsection (o) of this
section.
(2) A registrant shall
show compliance with the annual dose limit in subsection (o) of this section by
demonstrating by measurement or calculation that the TEDE to the individual
likely to receive the highest dose from the registered operation does not
exceed the annual dose limit.
(3)
Registrants exempt from individual monitoring requirements in accordance with
subsection (n)(2) of this section are exempt from the requirements of
paragraphs (1) and (2) of this subsection.
(q) Location and use of individual monitoring devices.
(1) Each registrant shall ensure that
individuals who are required to monitor occupational doses in accordance with
subsection (n)(l) of this section wear and use individual monitoring devices as
follows.
(A) An individual monitoring device
shall be assigned to and worn by only one individual.
(B) An individual monitoring device used for
monitoring the dose to the whole body shall be worn at the unshielded location
of the whole body likely to receive the highest exposure. When a protective
apron is worn, the location of the individual monitoring device is typically at
the neck (collar).
(C) If an
additional individual monitoring device is used for monitoring the dose to an
embryo/fetus of a declared pregnant woman, in accordance with subsection
(n)(1)(C) of this section, it shall be located at the waist under any
protective apron being worn by the woman.
(D) An individual monitoring device used for
monitoring the LDE, to demonstrate compliance with subsection (m)(1)(B)(i) of
this section, shall be located at the neck (collar) or at a location closer to
the eye, outside any protective apron being worn by the monitored
individual.
(E) An individual
monitoring device used for monitoring the dose to the extremities, to
demonstrate compliance with subsection (m)(1)(B)(ii) of this section, shall be
worn on the extremity likely to receive the highest exposure. Each individual
monitoring device, to the extent practicable, shall be oriented to measure the
highest dose to the extremity being monitored.
(2) Each registrant shall ensure that
individual monitoring devices are returned to the dosimetry processor for
proper processing.
(3) Each
registrant shall ensure that adequate precautions are taken to prevent a
deceptive exposure of an individual monitoring device.
(r) Determination of occupational dose for the current year.
(1) For each individual who
is likely to receive, in a year, an occupational dose requiring monitoring in
accordance with subsection (n) of this section, the registrant shall determine
the occupational radiation dose received during the current year. Occupational
dose includes doses received from exposure to registered/licensed or
unregistered/unlicensed sources of radiation as defined in subsection (c) of
this section.
(2) In complying with
the requirements of paragraph (1) of this subsection, a registrant may:
(A) accept, as a record of the occupational
dose that the individual received during the current year, RC Form 231-3 from
prior or other current employers, or other clear and legible record, of all
information required on that form and indicating any periods of time for which
data are not available; or
(B)
accept, as a record of the occupational dose that the individual received
during the current year, a written signed statement from the individual, or
from the individual's prior or other current employer(s) for work involving
radiation exposure, that discloses the nature and the amount of any
occupational dose that the individual received during the current year;
or
(C) obtain reports of the
individual's DE from prior or other current employer(s) for work involving
radiation exposure, or the individual's current employer, if the individual is
not employed by the registrant, by telephone, telegram, facsimile, or letter.
The registrant shall request a written verification of the dose data if the
authenticity of the transmitted report cannot be established.
(3) The registrant shall record
the exposure data for the current year, as required by paragraph (1) of this
subsection, on RC Form 231-3, or other clear and legible record, of all the
information required on RC Form 231-3.
(4) If the registrant is unable to obtain a
complete record of an individual's current occupational dose while employed by
any other registrant or licensee, the registrant shall assume in establishing
administrative controls in accordance with subsection (m)(6) of this section
for the current year, that the allowable dose limit for the individual is
reduced by 1.25 rems (12.5 millisieverts (mSv)) for each quarter; or 416
millirems (mrem) (4.16 mSv) for each month for which records were unavailable
and the individual was engaged in activities that could have resulted in
occupational radiation exposure.
(5) If an individual has incomplete (for
example, a lost or damaged personnel monitoring device) current occupational
dose data for the current year and that individual is employed solely by the
registrant during the current year, the registrant shall:
(A) assume that the allowable dose limit for
the individual is reduced by 1.25 rems (12.5 mSv) for each quarter;
(B) assume that the allowable dose limit for
the individual is reduced by 416 mrem (4.16 mSv) for each month; or
(C) assess an occupational dose for the
individual during the period of missing data using surveys, radiation
measurements, or other comparable data for the purpose of demonstrating
compliance with the occupational dose limits.
(6) Administrative controls established in
accordance with paragraph (4) of this subsection shall be documented and
maintained for inspection by the agency. Occupational dose assessments made in
accordance with paragraph (5) of this subsection and records of data used to
make the assessment shall be maintained for inspection by the agency. The
registrant shall retain the records in accordance with subsection (ll)(6) of
this section.
(s) General surveys and monitoring.
(1) Each
registrant shall make, or cause to be made, surveys that:
(A) are necessary for the registrant to
comply with this section; and
(B)
are necessary under the circumstances to evaluate:
(i) the magnitude and extent of radiation
levels; and
(ii) the potential
radiological hazards.
(2) The registrant shall ensure that
instruments and equipment used for qualitative and quantitative radiation
measurements, for example, dose rate, are operable and calibrated:
(A) by a person licensed or registered by the
agency, another agreement state, a licensing state, or the NRC to perform such
service;
(B) at intervals not to
exceed 12 months unless a different time interval is specified in another
section of this chapter;
(C) after
each instrument or equipment repair;
(D) for the types of radiation used and at
energies appropriate for use; and
(E) at an accuracy within 20% of the true
radiation level.
(3) All
individual monitoring devices, except for direct and indirect reading pocket
dosimeters, electronic personal dosimeters, and those individual monitoring
devices used to measure the dose to any extremity, that require processing to
determine the radiation dose and that are used by registrants to comply with
subsection (m) of this section, with other applicable provisions of this
chapter, shall be processed and evaluated by a dosimetry processor:
(A) holding current personnel dosimetry
accreditation from the National Voluntary Laboratory Accreditation Program
(NVLAP) of the National Institute of Standards and Technology; and
(B) 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.
(t) Control of access to high radiation areas.
(1) The registrant shall ensure that
each entrance or access point to a high radiation area has one or more of the
following features:
(A) 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 DDE of 0.1 rem (1 mSv)
in one hour at 30 cm from the source of radiation from any surface that the
radiation penetrates;
(B) 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
(C)
entryways that are locked, except during periods when access to the areas is
required, with positive control over each individual entry.
(2) In place of the controls
required by paragraph (1) of this subsection for a high radiation area, the
registrant may substitute continuous direct or electronic surveillance that is
capable of preventing unauthorized entry.
(3) The registrant may apply to the agency
for approval of alternative methods for controlling access to high radiation
areas.
(4) The registrant shall
establish the controls required by paragraphs (1) and (3) of this subsection in
a way that does not prevent individuals from leaving a high radiation
area.
(5) The registrant is not
required to control entrance or access to rooms or other areas containing
radiation machines capable of producing a high radiation area as described in
this subsection if the registrant has met all the specific requirements for
access and control specified in other applicable sections of this chapter, such
as §
289.227
of this title (relating to Use of Radiation Machines in the Healing Arts),
§
289.229
of this title (relating to Radiation Safety for Accelerators, Therapeutic
Radiation Machines, Simulators, and Electronic Brachytherapy Devices), and
§
289.255
of this title (relating to Radiation Safety Requirements and Licensing and
Registration Procedures for Industrial Radiography).
(u) Control of access to very high radiation areas.
(1) In addition to the requirements in
subsection (t) of this section, the registrant shall institute measures to
ensure that an individual is not able to gain unauthorized or inadvertent
access to areas in which radiation levels could be encountered at 500 rads (5
grays) or more in 1 hour at 1 m from a radiation machine or any surface through
which the radiation penetrates at this level.
(2) The registrant is not required to control
entrance or access to rooms or other areas containing radiation machines
capable of producing a very high radiation area as described in paragraph (1)
of this subsection if the registrant has met all the specific requirements for
access and control specified in other applicable sections of this chapter, such
as §
289.227
of this title, §
289.229
of this title, and §
289.255
of this title.
(3) The entry
control devices required by paragraphs (1) and (2) of this subsection shall be
established in such a way that no individual will be prevented from leaving the
area.
(v) Security and control of radiation machines.
(1) The
registrant shall secure radiation machines from unauthorized removal.
(2) The registrant shall use devices and/or
administrative procedures to prevent unauthorized use of radiation
machines.
(w) Caution signs. Unless otherwise authorized by the agency, the standard radiation symbol prescribed shall use the colors magenta, or purple, or black on yellow background. The standard radiation symbol prescribed is the three-bladed design as follows:
(1) the
cross-hatched area of the symbol is to be magenta, purple, or black;
and
(2) the background of the
symbol is to be yellow.
(x) Posting requirements.
(1) The registrant shall post each radiation
area with a conspicuous sign or signs bearing the radiation symbol and the
words "CAUTION, RADIATION AREA."
(2) The registrant shall post each high
radiation area with a conspicuous sign or signs bearing the radiation symbol
and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION
AREA."
(3) The registrant shall
post each very high radiation area with a conspicuous sign or signs bearing the
radiation symbol and words "GRAVE DANGER, VERY HIGH RADIATION AREA." If the
very high radiation area involves medical treatment of patients, the registrant
may omit the word "GRAVE" from the sign or signs.
(y) Exceptions to posting requirements. A registrant is not required to post caution signs in areas or rooms containing radiation machines for periods of less than 8 hours, if each of the following conditions is met:
(1) the radiation machines
are constantly attended during these periods by an individual who takes the
precautions necessary to prevent the exposure of individuals to radiation in
excess of the limits established in this section; and
(2) the area or room is subject to the
registrant's control.
(z) Labeling radiation machines. Each registrant shall ensure that each radiation machine is labeled in a conspicuous manner that cautions individuals that radiation is produced when it is energized. This label shall be affixed in a clearly visible location on the face of the control unit.
(aa) 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 agency will determine 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.
(bb) General provisions for records.
(1) All records required by this chapter
shall be accurate and factual. These records shall be maintained by the
registrant in accordance with subsection (ll)(6) of this section. Additional
record requirements are specified elsewhere in this chapter.
(2) Records are only valid if stamped,
initialed, or signed and dated by authorized personnel or otherwise
authenticated.
(3) Each registrant
shall use the SI units gray, sievert, and coulomb per kilogram, or the special
units rad, rem, and roentgen, including multiples and subdivisions, and shall
clearly indicate the units of all quantities on records required by this
chapter.
(4) The registrant shall
make a clear distinction among the quantities entered on the records required
by this section, such as TEDE, SDE, LDE, or DDE.
(5) Records required in accordance with
subsections (cc) - (ee) of this section shall include the date and the
identification of individual(s) making the record, and, as applicable, a unique
identification of survey instrument(s) used, and an exact description of the
location of the survey.
(6) Copies
of records required in accordance with subsections (cc) - (ee) of this section,
and by certificate of registration conditions that are relevant to operations
at an additional authorized use/storage site shall be maintained at that site
in addition to the main site specified on a certificate of registration in
accordance with subsection (ll)(6) of this section.
(cc) Records of surveys.
(1) Each registrant shall make and maintain
records showing the results of surveys and calibrations required by subsection
(s) of this section. The registrant shall retain these records in accordance
with subsection (ll)(6) of this section.
(2) The registrant shall retain the results
of surveys to determine the dose from external sources of radiation used, in
the absence of or in combination with individual monitoring data, in the
assessment of individual DEs in accordance with subsection (ll)(6) of this
section.
(dd) Records of individual monitoring results.
(1) Each
registrant shall make and maintain records in accordance with subsection (r) of
this section of the doses received by all individuals for whom monitoring was
required in accordance with subsection (n) of this section, and records of
doses received during accidents, and emergency conditions. Assessments of DE
and records made using units in effect before January 1, 1994, need not be
changed. These records shall include, when applicable:
(A) the DDE to the whole body, LDE, SDE to
the skin of the whole body, and SDE to the skin of any extremities;
and
(B) the data used to make
occupational dose assessments in accordance with subsection (r)(5) of this
section.
(2) The
registrant shall make entries of the records specified in paragraph (1) of this
subsection at intervals not to exceed 1 year and within 90 days of the end of
the year.
(3) The registrant shall
maintain the records specified in paragraph (1) of this subsection on RC Form
231-3, in accordance with the instructions for RC Form 231-3, or in clear and
legible records containing all the information required by RC Form
231-3.
(4) The registrant shall
maintain the records of dose to an embryo/fetus with the records of dose to the
declared pregnant woman. The declaration of pregnancy, including the estimated
date of conception, shall also be kept on file, but may be maintained
separately from the dose records.
(5) The registrant shall retain each required
form or record required by this subsection and records used in preparing RC
Form 231-3 or equivalent in accordance with subsection (ll)(6) of this
section.
(ee) Records of dose to individual members of the public.
(1)
Each registrant shall maintain records sufficient to demonstrate compliance
with the dose limit for individual members of the public. See subsections (o)
and (p) of this section.
(2) The
registrant shall retain the records required by paragraph (1) of this
subsection in accordance with subsection (ll)(6) of this section.
(ff) Form of records.
(1) Each record required by this chapter
shall be legible throughout the specified retention period.
(2) The record shall 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.
(3) The record may also be stored in
electronic media with the capability for producing legible, accurate, and
complete records during the required retention period.
(4) Records, such as letters, drawings, and
specifications, shall include all pertinent information, such as stamps,
initials, and signatures.
(5) The
registrant shall maintain adequate safeguards against tampering with and loss
of records.
(gg) Reports of stolen, lost, or missing radiation machines.
(1) Each registrant shall report to the
agency by telephone a stolen, lost, or missing radiation machine immediately
after its occurrence becomes known to the registrant.
(2) Each registrant required to make a report
in accordance with paragraph (1) of this subsection shall, within 30 days after
making the telephone report, make a written report to the agency that includes
the following information:
(A) a description
of the radiation machine involved, including, the manufacturer, model and
serial number;
(B) a description of
the circumstances under which the loss or theft occurred;
(C) exposures of individuals to radiation,
circumstances under which the exposures occurred, and the possible TEDE to
persons in unrestricted areas;
(D)
actions that have been taken, or will be taken, to recover the radiation
machine; and
(E) procedures or
measures that have been, or will be, adopted to ensure against a recurrence of
the loss or theft of radiation machines.
(3) Subsequent to filing the written report,
the registrant shall also report additional substantive information on the loss
or theft within 30 days after the registrant learns of such
information.
(4) The registrant
shall prepare any report filed with the agency in accordance with this
subsection so that names of individuals who may have received exposure to
radiation are stated in a separate and detachable portion of the
report.
(hh) Notification of incidents.
(1)
Notwithstanding other requirements for notification, each registrant shall
immediately report each event involving a radiation machine possessed by the
registrant that may have caused or threatens to cause an individual, except a
patient administered radiation for the purpose of medical diagnosis or therapy,
to receive:
(A) a TEDE of 25 rems (0.25 Sv)
or more;
(B) an LDE of 75 rems
(0.75 Sv) or more; or
(C) an SDE to
the skin of the whole body or to the skin of the extremities of 250 rads (2.5
grays) or more.
(2) Each
registrant shall, within 24 hours of discovery of the event, report to the
agency each event involving loss of control of a radiation machine possessed by
the registrant that may have caused, or threatens to cause an individual to
receive, in a period of 24 hours:
(A) a TEDE
exceeding 5 rems (0.05 Sv);
(B) an
LDE exceeding 15 rems (0.15 Sv); or
(C) an SDE to the skin of the whole body or
to the skin of the extremities exceeding 50 rems (0.5 Sv).
(3) Registrants shall make the initial
notification reports required by paragraphs (1) and (2) of this subsection by
telephone to the agency and shall confirm the initial notification report
within 24 hours by telegram, mailgram, or facsimile to the agency.
(4) The registrant shall prepare each report
filed with the agency in accordance with this section so that names of
individuals who have received exposure to radiation are stated in a separate
and detachable portion of the report.
(ii) Reports of exposures and radiation levels exceeding the limits.
(1) In addition
to the notification required by subsection (hh) of this section, each
registrant shall submit a written report within 30 days after learning of any
of the following occurrences:
(A) incidents
for which notification is required by subsection (hh) of this
section;
(B) doses in excess of any
of the following:
(i) the occupational dose
limits for adults in subsection (m)(1)(A) and (B) of this section;
(ii) the occupational dose limits for a minor
in subsection (m)(1)(C) of this section;
(iii) the limits for an embryo/fetus of a
declared pregnant woman in subsection (m)(1)(D) of this section;
(iv) the limits for an individual member of
the public in subsection (o) of this section; or
(v) any applicable limit in the
registration;
(C) levels
of radiation in:
(i) a restricted area in
excess of applicable limits in the certificate of registration; or
(ii) an unrestricted area in excess of 10
times the applicable limit set forth in this section or in the registration,
whether or not involving exposure of any individual in excess of the limits in
subsection (o) of this section.
(2) Each report required by paragraph (1) of
this subsection shall describe the extent of exposure of individuals to
radiation, including, as appropriate:
(A)
estimates of each individual's dose;
(B) the levels of radiation
involved;
(C) the cause of the
elevated exposures, dose rates; and
(D) corrective steps taken or planned to
ensure against a recurrence, including the schedule for achieving conformance
with applicable limits, and associated registration conditions.
(3) Each report filed in
accordance with paragraph (1) of this subsection shall include for each
individual exposed: the name, social security number, and date of birth. With
respect to the limit for the embryo/fetus in subsection (m)(1)(D) of this
section, the identifiers should be those of the declared pregnant woman. The
report shall be prepared so that this information is stated in a separate and
detachable portion of the report.
(4) All registrants who make reports in
accordance with paragraph (1) of this subsection shall submit the report in
writing to the agency.
(jj) Notifications and reports to individuals.
(1) Requirements for
notification and reports to individuals of exposure to radiation are specified
in §
289.203
of this title (relating to Notices, Instructions and Reports to Workers;
Inspections).
(2) When a registrant
is required in accordance with subsection (ii) of this section to report to the
agency any exposure of an identified occupationally exposed individual, or an
identified member of the public, to radiation, the registrant shall also notify
the individual and provide a copy of the report submitted to the agency, to the
individual. Such notice shall be transmitted at a time not later than the
transmittal to the agency, and shall comply with the provisions of §
289.203
of this title.
(kk) 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, certificate of registration conditions, and orders issued by the
agency.
(2) Each registrant 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 registrant
shall make available to the agency for inspection, upon reasonable notice,
records made and maintained in accordance with this chapter.
(4) Inspection of radiation machines and
services.
(A) Routine inspections by agency
personnel will be made no more frequently than the intervals specified in
subsection (ll)(2) of this section. Registrants having certificates of
registration authorizing multiple uses will be inspected at the most frequent
interval specified for the uses authorized.
(B) Notwithstanding the inspection intervals
specified in this section, the agency may inspect registrants more frequently
due to:
(i) the persistence or severity of
violations found during an inspection;
(ii) investigation of an incident or
complaint concerning the facility;
(iii) a request for an inspection by a
worker(s) in accordance with §
289.203
of this title;
(iv) any change in a
facility or equipment that might cause a significant increase in radiation
output or hazard; or
(v) a mutual
agreement between the agency and registrant.
(C) On-site routine inspections and remote
inspections may be alternated as determined by the agency.
(D) For remote inspection of radiation
machines, each registrant shall respond to a request from the agency for a
remote inspection by performing the following:
(i) completing the remote inspection forms in
accordance with the instructions included with the forms; and
(ii) returning to the agency the completed
remote inspection forms with documentation of the most recent equipment
performance evaluation performed in accordance with §
289.227(o)
of this title and an inventory in accordance with §
289.226(m)(1)(B)
of this title, by the deadline indicated on the form.
(E) The agency will conduct inspections of
radiation machines or lasers in a manner designed to cause as little disruption
of a healing arts practice as is practicable.
(5) A person who inspects medical radiation
machines or lasers will have training in the design and uses of the machines
and will receive training specified in subsection (ll)(4) and/or (5) of this
section.
(6) Each registrant shall
perform, upon instructions from the agency, or shall permit the agency to
perform such reasonable surveys as the agency deems appropriate or necessary
including, but not limited to, surveys of:
(A) radiation machines;
(B) facilities where radiation machines are
used or stored;
(C) radiation
detection and monitoring instruments; and
(D) other equipment and devices used in
connection with utilization or storage of radiation machines.
(ll) Appendices.
(1) Definitions of machine types and types of
use. For the purposes of this section, the listed machine types and types of
use have the following meanings:
(A)
CT--computerized tomography machines used for medical purposes;
(B) fluoroscopy--fluoroscopic machines used
for medical purposes;
(C)
accelerators, simulators other therapeutic machines, and electronic
brachytherapy devices, used for medical purposes;
(D) radiographic only--facilities possessing
and using only radiographic machines for medical purposes, including but not
limited to, tomography, chiropractic machines, and bone
densitometers;
(E) podiatric
radiographic only--facilities possessing and using only radiographic machines
for podiatry. This category may also include bone densitometers;
(F) minimal threat only--facilities
possessing and using only machines defined as minimal threat
machines;
(G) industrial
radiography only--facilities possessing and using radiographic machines for
industrial radiography, including accelerators. This category includes machines
used at permanent and temporary job sites;
(H) other industrial--facilities possessing
and using radiation machines for other industrial purposes (non-human use),
including diffraction, hand-held light intensifying imaging devices, flash
radiography, accelerators, CT, and fluoroscopy;
(I) services--persons providing the services
listed in §
289.226(b)(10)
of this title;
(J) laser (human
use/research/academic)--lasers used for medical and/or research or academic
purposes, including veterinary use; and
(K) laser other
(industrial/entertainment/services)--lasers used for industrial purposes, for
demonstration/sales, and for stationary/mobile entertainment light shows. This
category also includes facilities that provide calibration/repair services for
lasers and that provide lasers to facilities for short periods of
time.
(2) Inspection
intervals for registrants.
(3)
Minimal threat radiation machines. Minimal threat radiation machines include,
but are not limited to, the following:
(A)
x-ray fluorescence (machine);
(B)
x-ray gauges;
(C) particle size
analyzer (x-ray);
(D) electron beam
welding;
(E) ion implantation
devices;
(F) cathodoluminescence
devices;
(G) package x-ray;
and
(H) certified cabinet
x-ray.
(4) Training for
agency inspectors of radiation machines for human use.
(A) Objectives. Training of agency
individuals performing inspections of radiation machines for human use will be
conducted by the agency. Upon completion of training, the inspector will be
able to:
(i) select and operate the necessary
testing equipment used to perform an inspection of radiation
machines;
(ii) utilize radiation
protection principles;
(iii)
operate radiation detection instruments;
(iv) define basic regulatory
terminology;
(v) apply this section
regarding radiation machines;
(vi)
perform routine agency inspections of radiation machines;
(vii) complete agency inspection
documentation;
(viii) demonstrate
knowledge of agency ethics, professional, and technical policies; and
(ix) successfully achieve the objectives in
this subparagraph.
(B)
Initial training program.
(i) Initial training
will be conducted during a six-month period.
(ii) All training evaluation instruments will
be developed by the agency.
(iii)
Instruments to be used in determining a proficiency level are as follows:
(I) evaluation of each inspector's training
needs prior to initial training;
(II) evaluation of knowledge obtained and
verification of tasks performed by each inspector subsequent to training
received by the agency; and
(III)
evaluation of each inspector's task performance by the agency.
(C) Continuing
education.
(i) The agency inspector of
radiation machines for human use will accumulate 24 hours of continuing
education regarding radiation machines for human use, at intervals not to
exceed 24 months. These hours of continuing education may be acquired as
follows:
(I) documented continuing education
earned in an agency-accepted training format; and
(II) agency staff meetings.
(ii) Failure to obtain 24 hours of
continuing education within each 24-month interval may result in a reassessment
by the agency of an agency inspector's proficiency level.
(iii) After the initial training period, each
inspector of radiation machines for human use will be evaluated by the agency,
at intervals not to exceed 12 months.
(D) Agency proficiency standards. The agency
proficiency standards for agency inspectors of radiation machines for human use
are as follows.
(i) Level I. The agency
inspector has not successfully achieved the objectives in subparagraph (A) of
this paragraph after the initial training period. Additional training is
required. Unsupervised inspections will not be performed.
(ii) Level II. The agency inspector has
partially achieved the objectives in subparagraph (A) of this paragraph, but
has not achieved the objective in subparagraph (A)(ix) of this paragraph after
the initial training period. Additional training is required. Unsupervised
inspections are not permitted for the type of radiation machines for human use
for which the objectives of subparagraph (A)(ix) of this paragraph have not
been achieved. Unsupervised inspections may be performed for the type of
radiation machines for human use for which the objectives in subparagraph
(A)(ix) of this paragraph have been successfully achieved.
(iii) Level III. The agency inspector has
successfully achieved the objectives in subparagraph (A) of this paragraph.
Supervision is not required for routine inspections.
(5) Training for agency inspectors
of lasers. Initial training will include an introduction to the requirements in
this chapter and inspection forms. Inspections of 2 medical and 2 entertainment
lasers, conducted by an inspector having completed the requirements of this
paragraph, shall be observed before unsupervised inspection of lasers is
permitted.
(6) Time requirements
for record keeping. The following are time requirements for record keeping.
(7)
Occupational exposure form. The following, RC Form 231-3 is to be used to
document occupational exposure record for a monitoring period.
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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