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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289RADIATION CONTROL
SUBCHAPTER EREGISTRATION REGULATIONS
RULE §289.231General Provisions and Standards for Protection Against Machine-Produced Radiation

  (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:

Attached Graphic

  (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).

Attached Graphic

(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.

Cont'd...

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