| (C) operability of the radiation monitor for radioactive contamination in pool water required by subsection (w)(2) of this section using a radiation check source, if applicable; (D) operability of the over-pool radiation monitor at underwater irradiators as required by subsection (l)(2) of this section; (E) operability of the product exit monitor required by subsection (l)(1) of this section; (F) operability of the emergency source return control required by subsection (m)(3) of this section; (G) leak-tightness of systems through which pool water circulates (visual inspection); (H) operability of the heat and smoke detectors and extinguisher system required by subsection (k) of this section (but without turning extinguishers on); (I) operability of the means of pool water replenishment required by subsection (n)(3) of this section; (J) operability of the indicators of high and low pool water levels required by subsection (n)(4) of this section; (K) operability of the intrusion alarm required by subsection (i)(8) of this section, if applicable; (L) functioning and wear of the system, mechanisms, and cables used to raise and lower sources; (M) condition of the barrier to prevent products from hitting the sources or source mechanism as required by subsection (o) of this section; (N) amount of water added to the pool to determine if the pool is leaking; (O) electrical wiring on required safety systems for radiation damage; (P) pool water conductivity measurements and analysis as required by subsection (y)(2) of this section; and (Q) operability of automatic communications systems used to alert individuals to alarms, emergencies, or abnormal event conditions if required by subsection (z)(2)(A) of this section. (2) Malfunctions and defects found during inspection and maintenance checks shall be repaired without undue delay. If repairs are required, the irradiator shall not be operated unless alternative methods are utilized to provide an equivalent level of safety until repairs are completed. (y) Pool water purity. (1) Pool water purification system shall be run sufficiently to maintain the conductivity of the pool water below 20 microsiemens per centimeter under normal circumstances. If pool water conductivity rises above 20 microsiemens per centimeter, the licensee shall take prompt actions to lower the pool water conductivity and shall take corrective actions to prevent future recurrences. (2) The licensee shall measure the pool water conductivity no less than weekly, to assure that the conductivity remains below 20 microsiemens per centimeter. Conductivity meters shall be calibrated at least annually. (z) Attendance during operation. (1) Both an irradiator operator and at least one other individual, who is trained on how to respond to alarms in accordance with subsection (s)(7) of this section and is prepared to promptly render or summon assistance, shall be present onsite whenever it is necessary to enter the radiation room. (2) At least one individual who has received the training on how to respond to alarms described in subsection (s)(7) of this section shall be available and prepared to promptly respond to alarms, emergencies, or abnormal event conditions at any time a panoramic irradiator is operating. If the individual is not onsite, the following requirements shall be met. (A) Automatic means of communications shall be provided from the irradiator control system to alert the individual to alarms, emergencies, or abnormal event conditions. As a minimum, the automatic communication system shall alert the individual to those emergency or abnormal events listed in subsection (t)(2) of this section. (B) The irradiator control system shall be secured from unauthorized access at any time an irradiator operator is not onsite. This security shall include physically securing the key described in subsection (m)(1) of this section to ensure the key is not removed from the control console. (3) At an underwater irradiator, an irradiator operator shall be present at the facility whenever the product is moved into or out of the pool. Individuals who move the product into or out of the pool of an underwater irradiator need not be qualified as irradiator operators; however, they shall have received the training described in subsection (s)(6) and (7) of this section. Static irradiations may be performed without a person present at the facility. (aa) Entering and leaving the radiation room. (1) Upon first entering the radiation room of a panoramic irradiator after an irradiation, the irradiator operator shall use a survey meter to determine that the source has returned to its fully shielded position. The operator shall check the functioning of the survey meter with a radiation check source prior to entry. (2) Before exiting from and locking the door to the radiation room of a panoramic irradiator prior to a planned irradiation, the irradiator operator shall do the following: (A) visually inspect the entire radiation room to verify that no one else is in it; and (B) activate a control in the radiation room that permits the sources to be moved from the shielded position only if the door to the radiation room is locked within a preset time after setting the control. (3) During a power failure, the area around the pool of an underwater irradiator may not be entered without using an operable and calibrated radiation survey meter unless the over-the-pool monitor required by subsection (l)(2) of this section is operating with backup power. (bb) Irradiation of explosive or flammable materials. (1) Irradiation of explosive material is prohibited unless the licensee has received prior written authorization from the agency. Authorization will not be granted unless the licensee can demonstrate that detonation of the explosive would not rupture the sealed sources, injure personnel, damage safety systems, or cause radiation overexposures of personnel. (2) Irradiation of more than small quantities of flammable material (flash point below 140 degrees Fahrenheit) is prohibited in panoramic irradiators unless the licensee has received prior written authorization from the agency. Authorization will not be granted unless the licensee can demonstrate that a fire in the radiation room could be controlled without damage to sealed sources or safety systems and without radiation overexposures of personnel. (cc) Records/documents. The licensee shall maintain the following records/documents at the irradiator for the time intervals indicated for inspection by the agency: (1) a copy of the license, license conditions, documents incorporated into a license by reference, and amendments to the license until superseded by new documents or until the agency terminates the license; (2) records of each individual's training, tests, and safety reviews provided to meet the requirements of subsection (s)(1) - (4), (6), and (7) of this section until three years after the individual terminates work; (3) records of the annual evaluations of the safety performance of irradiator operators required by subsection (s)(5) of this section for three years after the evaluation; (4) a copy of the current operating, safety, and emergency procedures required by subsection (t) of this section until superseded or the agency terminates the license. Records of the RSO review and approval of changes in procedures as required by subsection (t)(3)(C) of this section, retained for three years from the date of the change; (5) film badge, TLD, or OSL results required by subsection (u) of this section until the agency terminates the license; (6) records of radiation surveys required by subsection (v) of this section for three years from the date of the survey; (7) records of radiation survey meter calibrations required by subsection (v) of this section and pool water conductivity meter calibrations required by subsection (y)(2) of this section until three years from the date of calibration; (8) records of the results of leak tests required by subsection (w)(1) of this section and the results of contamination checks required by subsection (w)(2) of this section for three years from the date of each test; (9) records of inspection and maintenance checks required by subsection (x) of this section for three years; (10) records of major malfunctions, significant defects, operating difficulties or irregularities, and major operating problems that involve required radiation safety equipment for three years after repairs are completed; (11) records of the receipt, transfer and disposal, of all licensed sealed sources as required by §289.201(d) and §289.252(x) and (cc) of this title; Cont'd... |
