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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289RADIATION CONTROL
SUBCHAPTER EREGISTRATION REGULATIONS
RULE §289.232Radiation Control Regulations for Dental Radiation Machines

    (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.

        (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:

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      (ii) 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.

      (iii) Failure to comply with any of the procedures that are described in clauses (i) and (ii) of this subparagraph may result in all information in the agency file being disclosed upon an open records request.

    (L) The agency will determine whether information falls within one of the exceptions to the Texas Public Information Act. The agency will determine whether 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 is not an exception.

    (M) Requests for information.

      (i) All requests for open records information shall be in writing and refer to documents currently in possession of the agency.

      (ii) The agency will determine 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 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 copies of documents will be furnished within a reasonable period. A fee will be charged to recover agency costs for copies.

      (iii) Original copies of public records may not be removed from the agency. Under no circumstances shall material be removed from existing records.

  (2) Records requirements.

    (A) Each registrant shall maintain the following records at each site, including authorized records sites for mobile services, at the time intervals specified and make available to the agency for inspection. The records may be maintained in electronic format.

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    (B) For radiation machines authorized for mobile service, copies of the records specified in the table in subparagraph (A)(iii)-(v) of this paragraph shall be maintained with the radiation machine in accordance with subparagraph (A) of this paragraph for inspection by the agency. If on-board processors are utilized, image processing records shall also be made on board in accordance with subsection (j)(12), (13), and (14) of this section and maintained in accordance with subparagraph (A) of this paragraph for inspection by the agency.

    (C) For authorized records sites for mobile services, copies of the records specified in subparagraph (A)(ii) and (vi)-(xii) of this paragraph shall be maintained in accordance with subparagraph (A) of this paragraph for inspection by the agency.

  (3) Reports.

    (A) Reports of stolen, lost, or missing radiation machines.

      (i) 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.

      (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:

        (I) a description of the radiation machine involved, including the manufacturer name, model and serial number;

        (II) a description of the circumstances under which the loss or theft occurred;

        (III) actions that have been taken, or will be taken, to recover the radiation machine; and

        (IV) procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of radiation machines.

      (iii) Subsequent to filing the written report, the registrant shall also report additional information pertaining to the loss or theft within 30 days after the registrant learns of such information.

      (iv) 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.

    (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:

        (I) a total effective dose equivalent of 25 rems (0.25 sievert) or more;

        (II) a lens dose equivalent of 75 rems (0.75 sievert) or more; or

        (III) a shallow dose equivalent to the skin of the whole body or to the skin of any extremities of 250 rads (2.5 grays) or more.

      (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:

        (I) a total effective dose equivalent exceeding 5 rems (0.05 sievert);

        (II) a lens dose equivalent exceeding 15 rems (0.15 sievert); or

        (III) a shallow dose equivalent to the skin of the whole body or to the skin of any extremities exceeding 50 rems (0.5 sievert).

      (iii) Registrants shall make the initial notification reports required by clauses (i) and (ii) of this subparagraph by telephone to the agency and shall confirm the initial notification report within 24 hours by facsimile or other electronic media to the agency.

      (iv) 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 sources of radiation are stated in a separate and detachable portion of the report.

    (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:

        (I) incidents for which notification are required by subparagraph (B) of this paragraph;

        (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:

        (I) estimates of each individual's dose;

        (II) the levels of radiation involved;

Cont'd...

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