| (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.
Cont'd... |
