10 C.F.R. Subpart D—Operation of Irradiators
Title 10 - Energy
(a) Before an individual is permitted to operate an irradiator without a supervisor present, the individual must be instructed in: (1) The fundamentals of radiation protection applied to irradiators (including the differences between external radiation and radioactive contamination, units of radiation dose, NRC dose limits, why large radiation doses must be avoided, how shielding and access controls prevent large doses, how an irradiator is designed to prevent contamination, the proper use of survey meters and personnel dosimeters, other radiation safety features of an irradiator, and the basic function of the irradiator); (2) The requirements of parts 19 and 36 of NRC regulations that are relevant to the irradiator; (3) The operation of the irradiator; (4) Those operating and emergency procedures listed in §36.53 that the individual is responsible for performing; and (5) Case histories of accidents or problems involving irradiators. (b) Before an individual is permitted to operate an irradiator without a supervisor present, the individual shall pass a written test on the instruction received consisting primarily of questions based on the licensee's operating and emergency procedures that the individual is responsible for performing and other operations necessary to safely operate the irradiator without supervision. (c) Before an individual is permitted to operate an irradiator without a supervisor present, the individual must have received on-the-job training or simulator training in the use of the irradiator as described in the license application. The individual shall also demonstrate the ability to perform those portions of the operating and emergency procedures that he or she is to perform. (d) The licensee shall conduct safety reviews for irradiator operators at least annually. The licensee shall give each operator a brief written test on the information. Each safety review must include, to the extent appropriate, each of the following— (1) Changes in operating and emergency procedures since the last review, if any; (2) Changes in regulations and license conditions since the last review, if any; (3) Reports on recent accidents, mistakes, or problems that have occurred at irradiators, if any; (4) Relevant results of inspections of operator safety performance; (5) Relevant results of the facility's inspection and maintenance checks; and (6) A drill to practice an emergency or abnormal event procedure. (e) The licensee shall evaluate the safety performance of each irradiator operator at least annually to ensure that regulations, license conditions, and operating and emergency procedures are followed. The licensee shall discuss the results of the evaluation with the operator and shall instruct the operator on how to correct any mistakes or deficiencies observed. (f) Individuals who will be permitted unescorted access to the radiation room of the irradiator or the area around the pool of an underwater irradiator, but who have not received the training required for operators and the radiation safety officer, shall be instructed and tested in any precautions they should take to avoid radiation exposure, any procedures or parts of procedures listed in §36.53 that they are expected to perform or comply with, and their proper response to alarms required in this part. Tests may be oral. (g) Individuals who must be prepared to respond to alarms required by §§36.23(b), 36.23(i), 36.27(a), 36.29(a), 36.29(b), and 36.59(b) shall be trained and tested on how to respond. Each individual shall be retested at least once a year. Tests may be oral. (a) The licensee shall have and follow written operating procedures for— (1) Operation of the irradiator, including entering and leaving the radiation room; (2) Use of personnel dosimeters; (3) Surveying the shielding of panoramic irradiators; (4) Monitoring pool water for contamination while the water is in the pool and before release of pool water to unrestricted areas; (5) Leak testing of sources; (6) Inspection and maintenance checks required by §36.61; (7) Loading, unloading, and repositioning sources, if the operations will be performed by the licensee; and (8) Inspection of movable shielding required by §36.23(h), if applicable. (b) The licensee shall have and follow emergency or abnormal event procedures, appropriate for the irradiator type, for— (1) Sources stuck in the unshielded position; (2) Personnel overexposures; (3) A radiation alarm from the product exit portal monitor or pool monitor; (4) Detection of leaking sources, pool contamination, or alarm caused by contamination of pool water; (5) A low or high water level indicator, an abnormal water loss, or leakage from the source storage pool; (6) A prolonged loss of electrical power; (7) A fire alarm or explosion in the radiation room; (8) An alarm indicating unauthorized entry into the radiation room, area around pool, or another alarmed area; (9) Natural phenomena, including an earthquake, a tornado, flooding, or other phenomena as appropriate for the geographical location of the facility; and (10) The jamming of automatic conveyor systems. (c) The licensee may revise operating and emergency procedures without Commission approval only if all of the following conditions are met: (1) The revisions do not reduce the safety of the facility, (2) The revisions are consistent with the outline or summary of procedures submitted with the license application, (3) The revisions have been reviewed and approved by the radiation safety officer, and (4) The users or operators are instructed and tested on the revised procedures before they are put into use. (a) Irradiator operators shall wear a personnel dosimeter 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 10 CFR 20.1501(c)). 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. (b) 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 this paragraph, a check of their response to radiation must be done at least annually. Acceptable dosimeters must read within plus or minus 30 percent of the true radiation dose. [58 FR 7728, Feb. 9, 1993, as amended at 65 FR 63752, Oct. 24, 2000] (a) A radiation survey of the area outside the shielding of the radiation room of a panoramic irradiator must 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 must be conducted after the sources are loaded but before the facility starts to operate. Additional radiation surveys of the shielding must be performed at intervals not to exceed 3 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. (b) If the radiation levels specified in §36.25 are exceeded, the facility must be modified to comply with the requirements in §36.25. (c) Portable radiation survey meters must be calibrated at least annually to an accuracy of ±20 percent for the gamma energy of the sources in use. The calibration must 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 must be of a type that does not saturate and read zero at high radiation dose rates. (d) Water from the irradiator pool, other potentially contaminated liquids, and sediments from pool vacuuming must be monitored for radioactive contamination before release to unrestricted areas. Radioactive concentrations must not exceed those specified in 10 CFR part 20, table 2, column 2 or table 3 of appendix B, “Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage.” (e) Before releasing resins for unrestricted use, they must be monitored before release in an area with a background level less than 0.5 microsievert (0.05 millirem) per hour. The resins may be released only if the survey does not detect radiation levels above background radiation levels. The survey meter used must be capable of detecting radiation levels of 0.5 microsievert (0.05 millirem) per hour. (a) Each dry-source-storage sealed source must be tested for leakage at intervals not to exceed 6 months using a leak test kit or method approved by the Commission or an Agreement State. In the absence of a certificate from a transferor that a test has been made within the 6 months before the transfer, the sealed source may not be used until tested. The test must be capable of detecting the presence of 200 becquerels (0.005 microcurie) of radioactive material and must be performed by a person approved by the Commission or an Agreement State to perform the test. (b) 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 leak test has been done within the 6 months before the transfer. Water from the pool must 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 must 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 must activate an alarm. The alarm set-point must 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 clean up contamination in the pool if specifically provided for in written emergency procedures. (c) 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 NRC or Agreement State licensee that 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 must be performed promptly. If contaminated equipment, facilities, or products are found, the licensee shall arrange to have them decontaminated or disposed of by an NRC or Agreement State licensee that 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, appendix B to part 20. (See 10 CFR 30.50 for reporting requirements.) [58 FR 7728, Feb. 9, 1993, as amended at 58 FR 67660, Dec. 22, 1993] (a) 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: (1) Operability of each aspect of the access control system required by §36.23. (2) Functioning of the source position indicator required by §36.31(b). (3) Operability of the radiation monitor for radioactive contamination in pool water required by §36.59(b) using a radiation check source, if applicable. (4) Operability of the over-pool radiation monitor at underwater irradiators as required by §36.29(b). (5) Operability of the product exit monitor required by §36.29(a). (6) Operability of the emergency source return control required by §36.31(c). (7) Leak-tightness of systems through which pool water circulates (visual inspection). (8) Operability of the heat and smoke detectors and extinguisher system required by §36.27 (but without turning extinguishers on). (9) Operability of the means of pool water replenishment required by §36.33(c). (10) Operability of the indicators of high and low pool water levels required by §36.33(d). (11) Operability of the intrusion alarm required by §36.23(i), if applicable. (12) Functioning and wear of the system, mechanisms, and cables used to raise and lower sources. (13) Condition of the barrier to prevent products from hitting the sources or source mechanism as required by §36.35. (14) Amount of water added to the pool to determine if the pool is leaking. (15) Electrical wiring on required safety systems for radiation damage. (16) Pool water conductivity measurements and analysis as required by §36.63(b). (b) Malfunctions and defects found during inspection and maintenance checks must be repaired without undue delay. (a) Pool water purification system must 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. (b) The licensee shall measure the pool water conductivity frequently enough, but no less than weekly, to assure that the conductivity remains below 20 microsiemens per centimeter. Conductivity meters must be calibrated at least annually. (a) Both an irradiator operator and at least one other individual, who is trained on how to respond and prepared to promptly render or summon assistance if the access control alarm sounds, shall be present onsite: (1) Whenever the irradiator is operated using an automatic product conveyor system; and (2) Whenever the product is moved into or out of the radiation room when the irradiator is operated in a batch mode. (b) At a panoramic irradiator at which static irradiations (no movement of the product) are occurring, a person who has received the training on how to respond to alarms described in §36.51(g) must be onsite. (c) At an underwater irradiator, an irradiator operator must 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 must have received the training described in §36.51 (f) and (g). Static irradiations may be performed without a person present at the facility. (a) 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. (b) Before exiting from and locking the door to the radiation room of a panoramic irradiator prior to a planned irradiation, the irradiator operator shall: (1) Visually inspect the entire radiation room to verify that no one else is in it; and (2) 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. (c) 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 §36.29(b) is operating with backup power. (a) Irradiation of explosive material is prohibited unless the licensee has received prior written authorization from the Commission. 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. (b) Irradiation of more than small quantities of flammable material (flash point below 140 °F) is prohibited in panoramic irradiators unless the licensee has received prior written authorization from the Commission. 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.
Title 10: Energy
PART 36—LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS
Subpart D—Operation of Irradiators
§ 36.51 Training.
§ 36.53 Operating and emergency procedures.
§ 36.55 Personnel monitoring.
§ 36.57 Radiation surveys.
§ 36.59 Detection of leaking sources.
§ 36.61 Inspection and maintenance.
§ 36.63 Pool water purity.
§ 36.65 Attendance during operation.
§ 36.67 Entering and leaving the radiation room.
§ 36.69 Irradiation of explosive or flammable materials.
