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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289RADIATION CONTROL
SUBCHAPTER FLICENSE REGULATIONS
RULE §289.258Licensing and Radiation Safety Requirements for Irradiators

    (E) leak testing of sources;

    (F) inspection and maintenance checks required by subsection (x) of this section;

    (G) loading, unloading, and repositioning sources, if the operations will be performed by the licensee; and

    (H) inspection of movable shielding required by subsection (i)(8) of this section, if applicable.

  (2) The licensee shall have and follow emergency or abnormal event procedures, appropriate for the irradiator type, for:

    (A) sources stuck in the unshielded position;

    (B) personnel overexposures;

    (C) a radiation alarm from the product exit portal monitor or pool monitor;

    (D) detection of leaking source, pool contamination, or alarm caused by contamination of pool water;

    (E) a low or high water level indicator, an abnormal water loss, or leakage from the source storage pool;

    (F) a prolonged loss of electrical power;

    (G) a fire alarm or explosion in the radiation room;

    (H) an alarm indicating unauthorized entry into the radiation room, area around pool, or another alarmed area;

    (I) natural phenomena, including an earthquake, a tornado, flooding, or other phenomena as appropriate for the geographical location of the facility; and

    (J) the jamming of automatic conveyor systems.

  (3) The licensee may revise operating, safety, and emergency procedures without agency approval only if all of the following conditions are met:

    (A) the revisions do not reduce the safety of the facility;

    (B) the revisions are consistent with the outline or summary of procedures including procedures for changes to operating, safety, and emergency procedures submitted with the license application;

    (C) the revisions have been reviewed and approved by the radiation safety officer; and

    (D) the users or operators are instructed and tested on the revised procedures before they are put into use.

  (4) Changes to operating, safety, and emergency procedures shall be submitted to the agency after the provisions of paragraph (3) of this subsection are completed.

(u) Personnel monitoring.

  (1) Irradiator operators shall wear an individual monitoring device that is processed and evaluated by an accredited National Voluntary Laboratory Accreditation Program (NVLAP) processor while operating a panoramic irradiator or while in the area around the pool of an underwater irradiator. The personnel dosimeter processor must be accredited for high-energy photons in the normal and accident dose ranges (see §289.202(p)(3) of this title). Each personnel dosimeter must be assigned to and worn by only one individual. Film badges must be processed at least monthly, and other personnel dosimeters must be processed at least quarterly. After replacement, each film badge, a thermoluminescent dosimeter (TLD), or optically stimulated luminescence device (OSL) shall be returned to the supplier for processing within 14 calendar days of the exchange date specified by the personnel monitoring supplier or as soon as practicable. In circumstances that make it impossible to return each film badge, TLD, or OSL within 14 calendar days, such circumstances shall be documented and available for review by the agency.

  (2) Other individuals who enter the radiation room of a panoramic irradiator shall wear a dosimeter, which may be a pocket dosimeter. For groups of visitors, only two people who enter the radiation room are required to wear dosimeters. If pocket dosimeters are used to meet the requirements of the paragraph, a check of their response to radiation shall be done at least annually. Acceptable dosimeters shall read within plus or minus 30% of the true radiation dose.

(v) Radiation surveys.

  (1) A radiation survey of the area outside the shielding of the radiation room of a panoramic irradiator shall be conducted with the sources in the exposed position before the facility starts to operate. A radiation survey of the area above the pool of pool irradiators shall be conducted after the sources are loaded but before the facility starts to operate. Additional radiation surveys of the shielding shall be performed at intervals not to exceed three years and before resuming operation after addition of new sources or any modification to the radiation room shielding or structure that might increase dose rates.

  (2) If the radiation levels specified in subsection (j) of this section are exceeded, the facility shall be modified to comply with the requirements in subsection (j) of this section.

  (3) Portable radiation survey meters shall be calibrated at least annually to an accuracy of plus or minus 20% for the gamma energy of the sources in use. The calibration shall be done at two points on each scale or, for digital instruments, at one point per decade over the range that will be used. Portable radiation survey meters shall be of a type that does not saturate and read zero at high radiation dose rates.

  (4) Water from the irradiator pool, other potentially contaminated liquids, and sediments from pool vacuuming shall be monitored for radioactive contamination before release to unrestricted areas. Radioactive concentrations shall not exceed those specified in Table 2, Column 2 or Table 3 of §289.202(ggg)(2) of this title.

  (5) Before releasing resins for unrestricted use, they shall be monitored in an area with a background level less than 0.05 mrem (0.5 µSv) per hour. The resins may be released only if the survey does not detect radiation levels above background radiation levels. The survey meter used shall be capable of detecting radiation levels of 0.05 mrem (0.5 µSv) per hour.

(w) Detection of leaking sources.

  (1) Each dry-source-storage sealed source shall be tested for leakage at intervals not to exceed six months using a leak test kit or method approved by the agency, the commission, an agreement state, or a licensing state. In the absence of a certificate from a transferor that a test has been made within the six months before the transfer, the sealed source may not be used until tested. The test shall be capable of detecting the presence of 0.005 microcurie (200 becquerels) of radioactive material and shall be performed by a person approved by the agency, the NRC, an agreement state, or a licensing state to perform the test.

  (2) For pool irradiators, sources may not be put into the pool unless the licensee tests the sources for leaks or has a certificate from a transferor that a leak test has been done within the six months before the transfer. Water from the pool shall be checked for contamination each day the irradiator operates. The check may be done either by using a radiation monitor on a pool water circulating system or by analysis of a sample of pool water. If a check for contamination is done by analysis of a sample of pool water, the results of the analysis shall be available within 24 hours. If the licensee uses a radiation monitor on a pool water circulating system, the detection of above normal radiation levels shall activate an alarm. The alarm set-point shall be set as low as practical, but high enough to avoid false alarms. The licensee may reset the alarm set-point to a higher level if necessary to operate the pool water purification system to clear up contamination in the pool if specifically provided for in written emergency procedures.

  (3) If a leaking source is detected, the licensee shall arrange to remove the leaking source from service and have it decontaminated, repaired, or disposed of by an agency, NRC, agreement state, or licensing state licensee who is authorized to perform these functions. The licensee shall promptly check its personnel, equipment, facilities, and irradiated product for radioactive contamination. No product may be shipped until the product has been checked and found free of contamination. If a product has been shipped that may have been inadvertently contaminated, the licensee shall arrange to locate and survey that product for contamination. If any personnel are found to be contaminated, decontamination shall be performed promptly. If contaminated equipment, facilities, or products are found, the licensee shall arrange to have them decontaminated or disposed of by an agency, NRC, agreement state, or licensing state licensee who is authorized to perform these functions. If a pool is contaminated, the licensee shall arrange to clean the pool until the contamination levels do not exceed the appropriate concentration in Table 2, Column 2 of §289.202(ggg)(2) of this title. (See §289.202(xx) and (yy) of this title for reporting requirements.)

(x) Inspection and maintenance.

  (1) The licensee shall perform inspection and maintenance checks that include, as a minimum, each of the following at the frequency specified in the license or license application:

    (A) operability of each aspect of the access control system required by subsection (i) of this section;

    (B) functioning of the source position indicator required by subsection (m) (2) of this section;

Cont'd...

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