25 Tex. Admin. Code § 289.232
(a) Purpose. This section establishes the requirements for the use of dental radiation machines.
(2) Requirements of persons using radiation machines are as follows.
(7) Governing of the following in accordance with the Texas Radiation Control Act, Health and Safety Code, Chapter 401; the Texas Administrative Procedure Act, Texas Government Code, Chapter 2001; Title 1, Texas Administrative Code, Chapter 155; and the Formal Hearing Procedures, §§1.21, 1.23, 1.25, and 1.27 of this title:
(b) Scope.
(1) Except as specifically provided in other sections of this chapter, this section applies to persons who receive, possess, use, or transfer dental radiation machines.
(c) Prohibitions.
(2) Individuals shall not be exposed to the useful beam except for healing arts purposes authorized by a dentist. This provision specifically prohibits deliberate exposure for the following purposes:
(d) Definitions. The following words and terms when used in this section shall have the following meaning, unless the context clearly indicates otherwise.
(53) Individual monitoring--The assessment of dose equivalent to an individual by the use of:
(55) Informal conference--A meeting held by the agency with a person to discuss the following:
(78) Party--A person designated as such by the ALJ. A party may consist of the following:
(85) Protective barrier--A barrier of radiation absorbing materials used to reduce radiation exposure. The types of protective barriers are as follows:
(88) Radiation--One or more of the following:
(90) Radiation machine--An x-ray system, subsystem, or component capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation. For purposes of this section, "radiation machine," "x-ray equipment," "x-ray system," and "x-ray unit" are equivalent terms. Types of radiation machines include, but are not limited to:
(97) Research and development--Research and development is defined as:
(115) Technique factors--The conditions of operation that are specified as follows:
(e) Exemptions.
(1) The agency may, upon application or upon its own initiative, exempt a source of radiation or a kind of use or user from the requirements of this section if the agency determines that the law does not prohibit the exemption and it will not result in a significant risk to public health or safety or the environment. In determining such exemptions, the agency will consider:
(9) Individuals who are sole practitioners and sole operators, and the only occupationally exposed individual are exempt from the following requirements:
(f) Communications.
(h) Fees for certificates of registration for dental facilities.
(1) Payment of fees.
(B) A nonrefundable fee specified in §289.204 of this title, as amended, shall be paid for each certificate of registration for radiation machines used in dentistry. The fee shall be paid every two years and shall be paid in full and on or before the due date stated on the invoice.
(2) Failure to pay prescribed fees.
(i) Registration of radiation machine use.
(1) Application for registration of radiation machines.
(E) A radiation safety officer shall be designated on each application form. The qualifications of that individual shall be submitted to the agency with the application. The radiation safety officer shall meet the applicable qualifications of clause (i) of this subparagraph and carry out the responsibilities specified in clause (v) of this subparagraph.
(i) The radiation safety officer shall have the following qualifications:
(ii) In addition to the qualifications in clause (i) of this subparagraph, documentation of the following shall be submitted to the agency:
(III) for non-practitioner radiation safety officers, any one of the following:
(-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 experience or supervised use of radiation machines;
(-b-) evidence of a valid limited general certificate issued under the Medical Radiologic Technologist Certification Act, Texas Occupations Code, Chapter 601, and at least four years of supervised experience or supervised use of radiation machines;
(-c-) evidence of registry by the American Registry of Radiologic Technologists and at least two years of supervised 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 experience or supervised use of radiation machines;
(-e-) evidence of registration with the Texas Board of Nursing as a Registered Nurse and at least two years of supervised experience or supervised use of radiation machines in the respective specialty;
(-f-) evidence of registration with the Texas Physician Assistant Board, and at least two years of supervised use of radiation machines in the respective specialty;
(-g-) evidence of:
(-1-) registration with the Texas State Board of Dental Examiners to perform radiologic procedures under a dentist's instruction and direction or evidence of a valid certificate as a registered dental hygienist; and
(-2-) at least four years of supervised use of radiation machines in the respective dentist's specialty;
(-h-) evidence of bachelor's (or higher) degree in a natural or physical science, health physics, radiological science, nuclear medicine, or nuclear engineering; or
(-i-) evidence of a current Texas license under the Medical Physics Practice Act, Texas Occupations Code, Chapter 602, in medical health physics, diagnostic medical physics, or nuclear medical physics for diagnostic x-ray facilities.
(v) Specific duties of the radiation safety officer include, but are not limited to, the following:
(II) investigating and reporting to the agency each:
(-a-) known or suspected case of radiation exposure to an individual or radiation level detected in excess of limits established by this section; and
(-b-) theft or loss of radiation machines, determining the cause, and taking steps to prevent its recurrence;
(I) Each application shall be accompanied by a completed RC Form 226-1, Business Information Form that shall contain the legal name of the entity or business. The form can be found at http://dshs.texas.gov/radiation/x-ray/medical-faq.aspx. Unless exempt in accordance with the Business and Commerce Code, Chapter 71, the applicant shall:
(2) Application for registration of mobile service operation used in dentistry. In addition to the requirements of paragraph (1) of this subsection, each applicant shall apply for and receive authorization from the agency for mobile service operation before beginning mobile service operation. The following shall be submitted:
(3) Issuance of certificate of registration.
(B) The agency may incorporate in the certificate of registration at the time of issuance, or thereafter by amendment, additional requirements and conditions concerning the registrant's possession, use, and transfer of radiation machines subject to this chapter, as it deems appropriate or necessary in order to:
(4) Terms and conditions of certificates of registration.
(5) Responsibilities of the registrant.
(F) No person shall provide radiation machine services for a person who cannot produce evidence of a completed application for registration or a valid certificate of registration issued by the agency except for:
(G) The registrant shall notify the agency in writing of any changes that would render the information contained in the application for registration or the certificate of registration inaccurate. The notification shall be in writing and signed by an authorized representative.
(i) Notification is required within 30 days after the following changes:
(ii) The registrant shall notify the agency within 30 days after changes in the radiation machines that include:
(H) The registrant, or the parent company, shall notify the agency, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy. This notification shall include:
(I) The registrant shall inventory all radiation machines in the registrant's possession at an interval not to exceed one year.
(i) The inventory shall include:
(J) Receipt, transfer, and disposal of radiation machines.
(i) The registrant shall make and maintain records of receipt, transfer, and disposal of radiation machines. The records shall include the following:
(K) The following criteria applies to loaner radiation machines.
(i) For persons having a valid certificate of registration, loaner radiation machines may be used for up to 30 days. If the loaner radiation machine is used for more than 30 days, the registrant is required, within the next 30 days, to complete the following:
(6) Termination of certificates of registration. When a registrant decides to terminate all activities involving radiation machines authorized under the certificate of registration, the registrant shall notify the agency immediately and:
(7) Modification, suspension, and revocation of certificates of registration.
(8) Reciprocal recognition of out-of-state certificates of registration.
(A) Whenever any radiation machine is to be brought into the State of Texas for any temporary use, the person proposing to bring the radiation machine into the state shall apply for and receive a notice from the agency granting reciprocal recognition before beginning operations. The request for reciprocity shall include the following:
(D) When radiation machines are used as authorized under reciprocity, the out-of-state registrant shall have the following in its possession at all times for inspection by the agency:
(j) Use of radiation machines.
(2) Operating and safety procedures. Each registrant shall have and implement written operating and safety procedures. These procedures shall be read by and accessible to each individual before operating a radiation machine, including any restrictions of the operating technique required for the safe operation of the particular radiation machine.
(A) The registrant shall ensure and document that each individual has read the operating and safety procedures before operating a radiation machine and reviewed the procedures annually not to exceed 12 months. This documentation shall be maintained in accordance with subsection (k)(2) of this section for inspection by the agency. The documentation shall include the following:
(B) The operating and safety procedures shall include, but are not limited to, the following procedures as applicable:
(3) Personnel requirements.
(A) Occupational dose limits.
(i) The registrant shall control the occupational dose to individuals, to the following dose limits.
(II) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of any extremities shall be:
(-a-) a lens dose equivalent of 15 rems (0.15 sievert); and
(-b-) a shallow dose equivalent of 50 rems (0.5 sievert) to the skin of the whole body or to the skin of any extremity.
(B) Dose limits for individual members of the public.
(i) Each registrant shall conduct operations so that:
(D) Instructions to workers. The registrant shall provide instructions to radiation workers before beginning initial work in restricted areas. These instructions shall include the following:
(4) Facility requirements.
(A) Caution signs. Unless otherwise authorized by the agency, the standard radiation symbol prescribed shall use the colors magenta, purple or black on yellow background. The standard radiation symbol prescribed is the three-bladed design as follows:
Attached Graphic
(B) Posting of notices to workers.
(i) Each registrant shall post current copies of the following documents:
(II) a notice that describes the following documents and states where the documents may be examined:
(-a-) a copy of this section;
(-b-) the certificate of registration and conditions or documents incorporated into the certificate of registration by reference and amendments thereto;
(-c-) the operating procedures applicable to work under the certificate of registration; and
(-d-) any notice of violation, if applicable, involving radiological working conditions, or order issued in accordance with subsections (b) and (l)(3) of this section and documentation of the corrections of any violations.
(ii) Documents, notices, or forms posted in accordance with this subsection shall:
(E) Security and control of radiation machines.
(iii) Any person using hand-held dental radiation machines shall ensure proper storage of the unit to include:
(5) Radiation machine requirements.
(A) Technique chart.
(ii) Technique and exposure indicators.
(I) The technique factors to be used during an exposure shall be indicated before the exposure begins except:
(-a-) when automatic exposure controls are used, in which case the technique factors that are set before the exposure shall be indicated; or
(-b-) unless prevented by the design of the certified radiation machine.
(E) Beam quality. The following requirements apply to beam quality.
(i) Half-value layer.
(ii) Filtration controls.
(J) Equipment performance evaluations (EPE).
(i) For all dental radiation machines, the registrant shall perform, or cause to be performed, EPE tests for each item specified in clauses (v) - (xi) of this subparagraph as follows:
(iii) Records of the EPE results shall be available for inspection by the agency and shall include the following:
(v) Timer.
(xi) Measurements of the radiation output for a radiation machine. Measurements of the radiation output for a radiation machine shall be performed with a calibrated dosimetry system in accordance with the following.
(6) Dental research.
(B) Facilities with radiation machines with investigational device exemptions that are involved in clinical studies shall comply with primary regulations that govern the conduct of clinical studies and that apply to the manufacturers, sponsors, clinical investigators, institutional review boards, and the medical device. These regulations include the following:
(9) Additional requirements for dental intraoral radiation machines.
(A) Source-to-skin distance. Radiation machines designed for use with an intraoral image receptor shall be provided with means to limit source-to-skin distance to not less than:
(B) Field limitation. Radiation machines designed for use with an intraoral image receptor shall be provided with means to limit the x-ray beam such that:
(10) Additional requirements for dental extraoral radiation machines.
(A) Dental panoramic radiation machines shall be provided with means to restrict the x-ray beam to the following:
(B) All other dental extraoral radiation machines (e.g., cephalometric) shall be provided with means to restrict the x-ray field to the image receptor. The x-ray field shall not exceed the image receptor by more than:
(11) Additional operational controls.
(B) The registrant's written operating and safety procedures required by paragraph (2) of this subsection shall include the following:
(12) Automatic and manual film processing for dental facilities and mobile dental services.
(14) Digital imaging acquisition systems.
(A) Users of digital imaging acquisition systems shall follow quality assurance/quality control (QA/QC) protocol for digital imaging established by the manufacturer.
(ii) The registrant shall document the frequency at which the quality assurance/quality control protocol is performed. Documentation shall:
(B) If a protocol cannot be established by the manufacturer, it shall be developed and implemented by the registrant.
(i) The QA/QC protocol, as developed and implemented by the registrant, shall include image quality testing for, but not limited to, spatial resolution, noise, artifacts and contrast by using a commercially purchased testing tool or an inanimate object of at least three varying densities.
(iii) The registrant shall document the frequency at which the quality assurance/quality control protocol is performed. Documentation shall:
(k) Records and reports.
(1) General provisions for records and reports.
(K) 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.
(i) 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.
(M) Requests for information.
(ii) The agency will determine whether the information may be released or whether it falls within an exception to the Texas Public Information Act.
(2) Records requirements.
(3) Reports.
(A) Reports of stolen, lost, or missing radiation machines.
(ii) Within 30 days after making the telephone report, each registrant required to make a report according to clause (i) of this subparagraph shall make a written report to the agency that includes the following information:
(B) Reports of incidents.
(i) 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 radiation administered for healing arts purposes, to receive:
(ii) Within 24 hours of discovery of the event, each registrant shall 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:
(C) Reports of exposures and radiation levels exceeding the limits.
(i) In addition to the notification required by subparagraph (B) of this paragraph, each registrant shall submit a written report within 30 days after learning of any of the following occurrences:
(II) doses in excess of any of the following:
(-a-) the occupational dose limits for adults in subsection (j)(3)(A)(i) of this section;
(-b-) the occupational dose limits for a minor in subsection (j)(3)(A)(i)(III) of this section;
(-c-) the limits for an embryo/fetus of a declared pregnant woman in subsection (j)(3)(A)(i)(IV) and (V) of this section;
(-d-) the limits for an individual member of the public in subsection (j)(3)(B) of this section; or
(-e-) any applicable limit in the certificate of registration;
(III) levels of radiation in:
(-a-) a restricted area in excess of applicable limits in the certificate of registration; or
(-b-) an unrestricted area in excess of 10 times the applicable limit set forth in this section or in the certificate of registration conditions, whether or not involving exposure of any individual in excess of the limits in subsection (j)(3)(B) of this section.
(ii) Each report required by clause (i) of this subparagraph shall describe the extent of exposure of individuals to radiation, including, as appropriate:
(D) Reports to individuals of exposures.
(i) If applicable, radiation exposure data for an individual shall be reported to the individual as specified in this paragraph. The information reported shall include data and results obtained in accordance with requirements of this section, orders, certificate of registration conditions, as shown in records made and maintained by the registrant in accordance with this subsection. Each notification and report shall:
(ii) If applicable, each registrant shall provide an annual written report to advise each worker of the worker's estimated dose, received in that monitoring year, as shown in records made and maintained by the registrant in accordance with subparagraph (C) of this paragraph if:
(l) Compliance and hearing procedures.
(1) Inspections. 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 requirements of this section, certificate of registration conditions, and orders issued by the agency.
(A) 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:
(B) The routine inspection interval for dental facilities is four years. On-site inspections and remote inspections may be alternated as determined by the agency. The inspection interval specified is based upon the average number of health-related violations per inspection, as determined from compliance history data. Registrant's having certificates of registration authorizing multiple radiation machine use categories will be inspected on-site at the most frequent interval specified for the radiation machine uses authorized.
(i) Notwithstanding the inspection interval specified in this subparagraph, the agency may inspect registrants more frequently due to:
(C) On-site Inspections.
(D) For remote inspection of dental radiation machines, each registrant shall:
(2) Complaints. Any worker or representative of a worker who believes that a violation of the Act, the requirements of this section, or certificate of registration conditions exists or has occurred in work under a certificate of registration with regard to radiological working conditions in which the worker is engaged, may request an inspection by giving notice of the alleged violation to the agency. Any such notice shall be in writing, shall set forth the specific grounds for the notice, and the worker or representative of the worker shall sign the notice. A copy shall be provided to the registrant by the agency no later than at the time of inspection except that, upon the request of the worker giving such notice, the worker's name and the name of individual referred to therein shall not appear in such copy or on any record published, released, or made available by the agency, except for good cause shown.
(B) No registrant, contractor or subcontractor of a registrant shall discharge or in any manner discriminate against any worker because of the following:
(C) Inspections not warranted.
(3) Hearing and enforcement procedures.
(A) Violations.
(B) Denial of an application for a certificate of registration.
(ii) Any applicant or registrant against whom the agency contemplates denial of an application may request a hearing by submitting a written request to the director within 30 days after service of the notice or date of mailing.
(I) The written request for a hearing shall contain the following:
(-a-) statement requesting a hearing; and
(-b-) name and address of the applicant or registrant.
(C) Compliance procedures for registrants and other persons.
(i) A registrant or other person who commits a violation will be issued a notice of violation. The person receiving the notice shall provide the agency with a written statement and supporting documentation by the date stated in the notice describing the following:
(iii) Any certificate of registration may be modified, suspended, or revoked in whole or in part, for any of the following:
(v) When the agency determines that the action provided for in clause (viii) of this subparagraph or subparagraph (D) of this paragraph is not to be taken immediately, the agency may offer the registrant an opportunity to attend an informal conference to discuss the following with the agency:
(ix) Any applicant or registrant against whom the agency contemplates an action described in clause (viii) of this subparagraph may request a hearing by submitting a written request to the director within 30 days after service of the notice.
(I) The written request for a hearing shall contain the following:
(-a-) statement requesting a hearing;
(-b-) name, address, and identification number of the registrant against whom the action is being taken.
(D) Assessment of administrative penalties.
(ii) Assessment of administrative penalties shall be based on the following criteria:
(iii) Application of administrative penalties. The agency may impose differing levels of penalties for different severity level violations and different classes of users as follows.
(III) Adjustments to the percentages of base amounts in Table B may be made for the presence or absence of the following factors:
(-a-) prompt identification and reporting;
(-b-) corrective action to prevent recurrence;
(-c-) compliance history;
(-d-) prior notice of similar event;
(-e-) multiple occurrences; and
(-f-) negligence that resulted in or increased adverse effects.
(E) Severity levels of violations for registrants or other persons.
(i) Violations for registrants or other persons shall be categorized by one of the following severity levels.
(ii) Criteria to elevate or reduce severity levels.
(I) Severity levels may be elevated to a higher severity level for the following reasons:
(-a-) more than one violation resulted from the same underlying cause;
(-b-) a violation contributed to or was the consequence of the underlying cause, such as a management breakdown or breakdown in the control of registered activities;
(-c-) a violation occurred multiple times between inspections;
(-d-) a violation was willful or grossly negligent;
(-e-) compliance history; or
(-f-) other mitigating factors.
(II) Severity levels may be reduced to a lower level for the following reasons:
(-a-) the registrant identified and corrected the violation before the agency inspection;
(-b-) the registrant's actions corrected the violation and prevented recurrence; or
(-c-) other mitigating factors.
(F) Impoundment of radiation machines. Radiation machines shall be subject to impounding in accordance with Health and Safety Code, §401.068 and this paragraph.
(ii) At the agency's discretion, the impounded radiation machines may be disposed of by:
(G) Emergency orders.
(iv) The person receiving the order shall be afforded the opportunity for a hearing on an emergency order. Notice of the action, along with a complaint, shall be given to the person by personal service or certified mail, addressed to the last known address. A hearing shall be held on an emergency order if the person receiving the order submits a written request to the director within 30 days after the date of the order.
(II) At the conclusion of the hearing and after the proposal for decision is made as provided in the Texas Administrative Procedure Act, Texas Government Code, Chapter 2001, the commissioner shall take one of the following actions:
(-a-) determine that no further action is warranted;
(-b-) amend the certificate of registration;
(-c-) revoke or suspend the certificate of registration;
(-d-) rescind the emergency order; or
(-e-) issue such other order as is appropriate.
(H) Miscellaneous provisions.
(iii) Non-party witness and mileage fees.
Source Note:The provisions of this §289.232 adopted to be effective June 25, 2019, 44 TexReg 3105.