| (a) Purpose.
(1) This section provides for the registration of persons
using radiation machines and persons who are in the business of providing
radiation machine services.
(2) Requirements for the registration of persons using
radiation machines.
(A) No person shall use radiation machines except as
authorized in a certificate of registration issued by the Department
of State Health Services (department) per the requirements of this
section.
(B) A person who receives, possesses, uses, owns, or
acquires radiation machines before receiving a certificate of registration
is subject to the requirements of this chapter.
(b) Scope.
(1) In addition to the requirements of this section,
all registrants are subject to the requirements of:
(A) §289.203 of this title (relating to Notices,
Instructions, and Reports to Workers; Inspections);
(B) §289.204 of this title (relating to Fees for
Certificates of Registration, Radioactive Material Licenses, Emergency
Planning and Implementation, and Other Regulatory Services);
(C) §289.205 of this title (relating to Hearing
and Enforcement Procedures); and
(D) §289.231 of this title (relating to General
Provisions and Standards for Protection Against Machine-Produced Radiation).
(2) Registrants using radiation machines in the healing
arts are also subject to the requirements of §289.227 of this
title (relating to Use of Radiation Machines in the Healing Arts).
Morgues, educational facilities, and forensic medicine or investigations
utilizing radiation machines for non-human use are subject to the
specific requirements of §289.227 of this title.
(3) Registrants using analytical and other industrial
radiation machines, such as x-ray equipment used for cathodoluminescence,
ion implantation, gauging, or electron beam welding, are subject to
the requirements of §289.228 of this title (relating to Radiation
Safety Requirements for Industrial Radiation Machines).
(4) Registrants using accelerators, therapeutic radiation
machines, simulators, and electronic brachytherapy devices are also
subject to the requirements of §289.229 of this title (relating
to Radiation Safety Requirements for Accelerators, Therapeutic Radiation
Machines, Simulators, and Electronic Brachytherapy Devices).
(5) Registrants using mammography radiation machines
are also subject to the requirements of §289.230 of this title
(relating to Certification of Mammography Systems and Mammography
Machines Used for Interventional Breast Radiography) and §289.234
of this title (relating to Mammography Accreditation).
(6) Registrants using radiation machines in industrial
radiographic operations are also subject to the requirements of §289.255
of this title (relating to Radiation Safety Requirements and Licensing
and Registration Procedures for Industrial Radiography).
(7) Registrants using radiation machines in dental
medicine are subject to the requirements of §289.232 of this
title (relating to Radiation Control Regulations for Dental Radiation
Machines).
(8) Registrants using radiation machines in veterinary
medicine are subject to the requirements of §289.233 of this
title (relating to Radiation Control Regulations for Radiation Machines
Used in Veterinary Medicine).
(9) Registrants using laser radiation machines are
subject to the requirements of §289.301 of this title (relating
to Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed
Light Devices).
(10) To determine compliance with the requirements
in this chapter for radiation machines, all radiation air kerma rate
or dose measurements for fluoroscopy or computed tomography radiation
machines shall be performed by a licensed medical physicist with a
specialty in diagnostic medical physics.
(11) For purposes of this section, radiation services
include:
(A) measurement of air kerma rate or dose measurements
on radiation machines that are not for human use;
(B) measurement of air kerma for human-use, general
radiographic and special purpose radiation machines, as defined in §289.227
and §289.229 of this title, by or under the supervision of a
licensed medical physicist;
(C) performance of services specified in paragraph
(10) of this subsection or services requiring a licensed medical physicist
as specified in §289.227(e) and §289.229 of this title on
radiation machines for human use;
(D) demonstration and sale of radiation machines or
imaging acquisition systems that require the individual to operate
a radiation machine or cause a radiation machine to be energized;
(E) assembly, installation or repair of a radiation
machine to ensure it is operating according to manufacturer's specifications;
(F) completion of equipment performance evaluations
(EPE) on dental radiation machines and machines used in veterinary
medicine; and
(G) provision of radiation machines to a facility for
limited periods.
(12) For purposes of this section, a person providing
the services described in paragraph (11)(G) of this subsection is
a provider of equipment.
(13) For purposes of this section, a practitioner of
the healing arts is a person licensed to practice healing arts by
either the Texas Medical Board as a physician, the Texas Board of
Chiropractic Examiners, or the Texas State Board of Podiatric Medical
Examiners.
(14) For purposes of this section, a physician is an
individual licensed by the Texas Medical Board.
(15) For purposes of this section, a certified physician
is a physician licensed by the Texas Medical Board and certified in
radiation oncology or therapeutic radiology.
(16) For purposes of this section, veterinary-use is
the use of a radiation machine for the practice of veterinary medicine
as defined by Texas Occupations Code Chapter 801. Animal research
is not considered veterinary-use.
(17) This section does not apply to an entity under
the jurisdiction of the federal government.
(c) Prohibitions.
(1) No person shall cause the operation of a radiation
machine that results in exposure of an individual to the useful beam
for training, demonstration, or other non-healing arts purposes.
(2) No person shall use radiation machines or perform
radiation machine services except as authorized in a certificate of
registration issued by the department per the requirements of this
section.
(3) Radiation machines shall be designated for human-use
or veterinary-use but shall not be designated for both unless one
of the following conditions are met:
(A) the machine use is for human research conducted
per subsection (u) of this section; or
(B) the facility has applied for and received written
authorization from the department.
(d) Exemptions.
(1) Electronic equipment that produces radiation incidental
to its operation for other purposes is exempt from the registration
and notification requirements of this section, provided that the dose
equivalent rate averaged over an area of 10 square centimeters (cm2 ) does not exceed 0.5 millirem per hour (mrem/hr)(0.005
mSv per hour (mSv/hr)) at 5 centimeters (cm) from any accessible surface
of such equipment. The production, testing, or factory servicing of
such equipment shall not be exempt.
(2) Radiation machines in transit or storage incident
to transit are exempt from the requirements of this section. This
exemption does not apply to the providers of radiation machines for
mobile services.
(3) Facilities that have placed all radiation machines
in storage, including on-site storage secured from unauthorized use
or removal, and have notified the department in writing, are exempt
from the requirements of this section. This exemption is void if any
radiation machine is energized resulting in the production of radiation.
Before resuming use of the machine(s) for human use, the machine shall
meet all requirements of this section.
(4) Inoperable radiation machines are exempt from the
requirements of this section. For this section, an inoperable radiation
machine means a radiation machine that cannot be energized when connected
to a power supply without repair or modification.
(5) Domestic television receivers, video display terminals,
transmission microscopes, and electron microscopes, including the
servicing of such devices, are exempt from the requirements of this
section.
(6) A person that takes possession of a radiation machine
as the result of foreclosure, bankruptcy, or other default of payment
may possess the machine without registering it. If the machine is
energized, it shall be under the supervision of a person registered
per this section and shall be energized only to demonstrate that the
machine is operable for sale, lease, or transfer purposes.
(7) Facilities, including academic institutions and
research or development facilities, registered for the use of radiation
machines are exempt from the registration requirements of subsection
(j) of this section, regarding radiation services, to the extent that
their personnel perform radiation services only for the registrant
by whom they are employed.
(8) Bone densitometry machines used by, or under the
supervision of, a licensed physician, are exempt from equipment performance
evaluations.
(e) General requirements for application for registration.
(1) Application for registration shall be completed
on forms prescribed by the department and shall contain all the information
required by the form and accompanying instructions. For initial registrations
with multiple use locations, a separate application RC Form 226-2
shall be completed for each use location under the registration.
(2) A radiation safety officer (RSO) shall be designated
on each application form. The qualifications of that individual shall
be submitted to the department with the application. The RSO shall
meet the applicable qualifications specified in paragraph (3) of this
subsection and carry out the responsibilities of subsection (n) of
this section.
(3) Qualifications for RSOs for registrants.
(A) All RSOs shall meet the following general qualifications
in addition to qualifications in specific categories:
(i) knowledge of potential radiation hazards and emergency
precautions; and
(ii) completed educational courses related to ionizing
radiation safety or a radiation safety officer course; or
(iii) experience in the use and familiarity of the
type of equipment used.
(B) Specific qualifications for RSOs by the facility
type are as follows.
(i) RSOs for healing arts facilities shall meet the
following qualifications:
(I) practitioner RSOs shall submit documentation of
their licensing board number;
(II) qualifications for a non-practitioner RSO with
radiation machine-related credentials, and the following credentials
will be accepted for an RSO who is not a practitioner:
(-a-) evidence of a valid general certificate issued
under the Medical Radiologic Technologist Certification Act, Texas
Occupations Code, Chapter 601, and at least two years of supervised
radiation safety experience or supervised use of radiation machines;
(-b-) evidence of a valid limited certificate issued
under the Medical Radiologic Technologist Certification Act, Texas
Occupations Code, Chapter 601, and at least four years of supervised
radiation safety experience or supervised use of radiation machines;
(-c-) evidence of registry by the American Registry
of Radiologic Technologists (ARRT) or the American Registry of Clinical
Radiologic Technologists (ARCRT) and at least two years of supervised
radiation safety experience or supervised use of radiation machines;
(-d-) evidence of associate degree in radiologic technology,
health physics, or nuclear technology, and at least two years of supervised
radiation safety experience or supervised use of radiation machines;
(-e-) for radiation therapy facilities, evidence of
registry by the ARRT or ARCRT and at least four years of supervised
radiation-related experience or supervised use of radiation therapy
machines; or
(-f-) evidence of a current Texas license under the
Medical Physics Practice Act, Texas Occupations Code, Chapter 602,
in one or more of the following appropriate specialties:
(-1-) medical health physics, diagnostic medical physics,
or nuclear medical physics for diagnostic x-ray facilities; or
(-2-) medical health physics or therapeutic medical
physics for radiation therapy facilities; or
(III) qualification for a non-practitioner RSO without
radiation machine-related credentials, and an RSO who is not a practitioner
and who does not have radiation machine-related credentials must meet
the following criteria:
(-a-) credentials:
(-1-) evidence of registration with the Texas Board
of Nursing as a registered nurse and at least two years of supervised
experience in the use of radiation machines in their respective specialty;
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