Chapter 3701:1-68 Industrial Radiation Equipment

3701:1-68-01 Definitions.

(A) Terms defined in this rule are intended to be used within this chapter of the Administrative Code.

(B) As used in this chapter:

(1) "Analytical radiation-generating equipment" means a group or system of components which produce ionizing radiation as either a primary or a secondary result and is used to determine properties of materials being measured or analyzed. Analytical radiation-generating equipment includes, but is not limited to, gauging units, electron microscopes, x-ray diffraction, and spectrometer devices.

(2) "Annual" means at least once a year, not to exceed fourteen months.

(3) "Cabinet irradiation" means irradiation conducted using a cabinet x-ray system.

(4) "Cabinet radiography" means radiography conducted using a cabinet x-ray system.

(5) "Cabinet x-ray system" means an x-ray system with the x-ray tube installed in a shielded enclosure termed a cabinet, such that every location on the exterior of the cabinet meets the dose limits for individual members of the public as specified in rule 3701:1-38-13 of the Administrative Code. A cabinet x-ray system is independent of existing architectural structures except the floor on which it may be placed; is intended to contain at least that portion of a material being irradiated; and must exclude all personnel, including extremities, from its interior during the generation of radiation.

(6) "Calibration" means the determination of the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or the radiation output of a source of radiation relative to a standard.

(7) "Collimator" means a device or mechanism by which the x-ray beam is restricted in size.

(8) "Control panel" means that part of the radiation-generating equipment used for setting the technique factors.

(9) "Enclosed system" means industrial radiation-generating equipment operated in an enclosure or cabinet and may include, but is not limited to, cabinet radiography, irradiation devices, and other equipment.

(10) "Fail-safe characteristics" means a design feature which causes beam port shutters to close, or otherwise prevents emergence of the primary beam, upon failure of a safety or warning device.

(11) "Hand-held" means radiation-generating equipment that is specifically designed to be held in the hand during operation.

(12) "Independent certifying organization" means an independent organization that meets all of the criteria of appendix A to rule 3701:1-68-03 of the Adminsitrative Code.

(13) "Individual responsible for radiation protection (IRRP)" means an individual designated by the registrant who has the knowledge and responsibility for the overall radiation safety program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(14) "Industrial radiation-generating equipment" means any x-ray device other than those used on patients for medical diagnosis or therapy purposes, including, but not limited to, industrial radiography equipment, irradiators, analytical devices, and particle accelerators.

(15) "Industrial radiographer" means any individual who performs or personally supervises industrial radiographic operations and who is responsible to the registrant for assuring compliance with the requirements of these regulations and certification of registration conditions.

(16) "Industrial radiographer assistant" means any individual who, under the personal supervision of an industrial radiographer, uses radiation-generating equipment, related equipment, or radiation survey instruments in industrial radiography.

(17) "Industrial radiography equipment" means radiation-generating equipment which produces ionizing radiation to examine the macroscopic structures of material by nondestructive testing methods.

(18) "Ionizing radiation" means gamma rays and x-rays, alpha and beta particles, high-speed electrons, neutrons, protons, or other atomic or nuclear particles or rays with sufficient energy to form ions during an interaction with matter, but does not include sound or radiowaves or visible, infrared, or ultraviolet light.

(19) "Irradiation devices" means radiation-generating equipment used to alter the chemical, biological, or physical properties of materials or to sterilize materials.

(20) "Kilovoltage peak (kVp)" means the maximum value of the electrical potential difference between the cathode and the anode of the x-ray tube during an exposure.

(21) "Leakage radiation" means all radiation coming from within the x-ray tube housing except the useful beam.

(22) "Local components" means parts of an analytical radiation-generating system and includes areas that are struck by x-rays such as radiation source housings, port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors, and shielding, but does not include power supplies, transformers, amplifiers, readout devices, and control panels.

(23) "Locked out and tagged" means a system of equipment security and safety in which radiation-generating equipment, rendered inoperable for storage or because of faulty operation is locked to prevent operation and tagged with specific information as to why it is not to be used. Suggested tag warning, "DO NOT USE - EQUIPMENT NEEDS REPAIR OR CALIBRATION -CONTACT INDIVIDUAL RESPONSIBLE FOR RADIATION PROTECTION PRIOR TO USE."

(24) "Nondestructive testing (NDT)" means the development and application of technical methods to examine materials or components in ways that do not impair future usefulness and serviceability in order to detect, locate, measure and evaluate flaws; to assess integrity, properties and composition; and to measure geometrical characteristics.

(25) "Open-beam" means analytical radiation-generating equipment in which an individual could place any part of his or her body in the primary beam during normal operation.

(26) "Particle accelerator" means a system of components which produce particles that are used to determine or alter properties of materials being measured, modified or analyzed.

(27) "Permanent radiographic installation" means an enclosed shielded room, cell, or vault, not located at a temporary jobsite, in which industrial radiography is performed. Permanent radiographic installation includes a cabinet x-ray system used for industrial radiography that is large enough to walk into.

(28) "Quality assurance program" means a program providing for verification by written procedures such as testing, auditing, and inspection to ensure that deficiencies, deviations, defective equipment, or unsafe practices, or a combination thereof, relating to the use, disposal, management, or manufacture of radiation devices are identified, promptly corrected, and reported to the appropriate regulatory authorities.

(29) "Radiation worker" means an individual engaged in activities registered by the department and controlled by the registrant, but does not include the registrant.

(30) "Shutter" means a device, fixed to any industrial radiation-generating equipment housing to intercept the useful beam.

(31) "Temporary jobsite" means a location where radiographic operations are performed and where sources of radiation may be stored other than the locations of use authorized on the registration.

Effective: 05/01/2012
R.C. 119.032 review dates: 05/01/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.01 , 3748.02 , 3748.04 , 3748.05 , 3748.06 , 3748.07 , 3748.12 , 3748.13 , 3748.15 , 3748.17 , 3748.18 , 3748.19 , 3748.20 , 3748.22 , 3748.99

3701:1-68-02 Quality assurance.

(A) Each handler of industrial radiation-generating equipment shall develop and maintain a written quality assurance program. The quality assurance program shall address and document, at least, the following:

(1) The intervals of, and procedures for, the evaluation of all each type of industrial radiation-generating equipment to ensure compliance with all applicable rules of Chapter 3701:1-38 and Chapter 37021:1-68 of the Administrative Code;

(2) Radiation monitoring requirements such as, surveys, occupational exposure limits, maintenance of records, and procedures regarding the use of area and personnel monitoring;

(3) Procedures for notifying the director when individuals are occupationally over-exposed to radiation, pursuant to rule 3701:1-38-12 and rule 3701:1-38-21 of the Administrative Code;

(4) Radiation safety procedures for each type of industrial radiation-generating equipment to be handled;

(5) Training of operators of each type of industrial radiation-generating equipment to be handled in order to assure competency in the operating procedures;

(6) In addition to the requirements of paragraph (B)(1) of rule 3701:1-38-10 of the Administrative Code, individuals likely to be working in a restricted area or to receive an annual occupational dose in excess of one millisievert (one hundred millirem) shall be instructed in the potential hazards of being present in such an area, to include the following:

(a) The location, boundaries, and purpose of restricted areas; and

(b) A description of the industrial radiation-generating equipment and its location;

(7) The quality control tests to be performed and the frequency of the quality control tests to be performed as applicable to the type of industrial radiation-generating equipment and its use;

(8) Quality assurance policies and a method to educate the workers on any policy changes;

(9) Radiation workers' role and responsibility for following and supporting the facility's quality assurance program;

(10) ALARA policies regarding personnel protection, including time, distance, and shielding;

(11) Policies regarding prenatal exposure;

(12) Policies regarding radiation safety training for ancillary personnel;

(13) Policies regarding training for personnel with quality assurance responsibilities;

(14) Policies regarding protection of public to include identification of all radiation areas, warning signs, warning lights, and interlocks.

(B) The following items shall be readily available for review by the department during inspections:

(1) A complete listing of all industrial radiation-generating equipment, including the current location and description of each unit;

(2) All quality assurance documents as required under this rule;

(3) Data and test results of the evaluation of each industrial radiation-generating equipment unit, its shielding, and surroundings;

(4) Maintenance logs and incident reports for each industrial radiation-generating equipment system;

(5) Current copies of each industrial radiographer's and industrial radiographer assistant's records as required by paragraph (H)(4) of rule 3701:1-68-03 of the Administrative Code; and

(6) Records of quality control tests for each industrial radiation-generating equipment unit which indicates the following:

(a) The personnel responsible for monitoring and performing the quality control tests;

(b) A brief description of the procedures to be used to perform the quality control tests;

(c) A list of the equipment to be used in performing each quality control test;

(d) The manner in which the performance of quality control tests will be documented; and

(e) The instrumentation used to perform area radiation surveys, calibrations, and evaluations, as appropriate, of each type of industrial radiation-generating equipment, including at least biennial calibration certificates or cross-calibration documentation done within the biennium.

Replaces: part of 37701:1-66-04

Effective: 05/01/2012
R.C. 119.032 review dates: 05/01/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 6/1/1998, 12/1/03, 12/22/08

3701:1-68-03 Industrial radiography and irradiation devices.

In addition to the applicable rules in Chapter 3701:1-38 and Chapter 3701:1-68 of the Administrative Code, handlers of industrial radiography and irradiation devices shall comply with the following:

(A) Radiation-generating equipment used for industrial radiography or irradiation shall meet the following equipment standards:

(1) A lock designed to prevent unauthorized or accidental production of ionizing radiation shall be provided.

(2) Permanent installations having a high radiation area shall be equipped with the following:

(a) Failsafe interlock at each entrance used for personnel access to the high radiation area;

(b) A visible signal that is activated when radiation is produced; and

(c) An audible signal that is activated when an attempt is made to enter the high radiation area while radiation is being produced.

(3) A readily visible warning light, labeled with the words "X-RAY ON" or words or symbols having a similar intent, shall be located on or near the source of radiation and its controls and shall be illuminated when the radiation source is energized;

(4) All industrial radiography and irradiation devices shall be labeled with a readily discernible sign or signs bearing the radiation symbol and the words:

(a) "CAUTION - HIGH INTENSITY X-RAY BEAM", or appropriate words having a similar intent, on or near the housing of the source of radiation; and

(b) "CAUTION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED", or appropriate words having a similar intent, near any switch or control that directly energizes the unit.

(B) In addition to paragraph (A) of this rule, handlers shall comply with the following radiation safety requirements:

(1) A physical inventory of all industrial radiography and irradiation devices shall be conducted each calendar quarter. Records of the inventories shall be maintained between inspections and shall include:

(a) The number and type;

(b) The location;

(c) The date of the inventory;

(d) The name of the individual making the inventory; and

(e) The manufacturer, model number, and the serial number.

(2) Industrial radiography equipment and irradiation devices shall be kept locked at all times, to prevent tampering or removal by unauthorized personnel, except when under the direct surveillance of a industrial radiographer or industrial radiographer assistant, or as may be otherwise authorized pursuant to this rule.

(3) Sufficient calibrated and operable radiation survey instruments shall be maintained to make physical radiation surveys as required by this rule and rule 3701:1-38-14 of the Administrative Code.

(a) Instrumentation required by this rule shall have a range such that 0.02 millisievert (two millirem) per hour through 0.01 sievert (one rem) per hour can be measured.

(b) Radiation survey instruments shall be calibrated:

(i) For the type of radiation to be monitored;

(ii) At intervals not to exceed six months and after each instrument servicing other than battery replacement;

(iii) Such that accuracy within plus or minus twenty per cent can be demonstrated;

(iv) At two points located approximately one third and two thirds of full-scale on each scale for linear scale instruments;

(v) At midrange of each decade, and at two points of at least one decade for logarithmic scale instruments; and

(vi) At appropriate points for digital instruments.

(4) The following items shall be supplied to each location where industrial radiography or irradiation operations are performed:

(a) At least one operable, calibrated survey instrument;

(b) A current whole body personnel dosimeter assigned to each radiation worker;

(c) An operable, calibrated direct reading dosimeter with a range of zero to two millisieverts (two hundred millirem), or an appropriate electronic dosimeter, for each radiation worker; and

(d) Appropriate barriers, such as ropes, tapes, and signs.

(5) A utilization log shall be maintained between inspections showing the following information for each piece of industrial radiography equipment used:

(a) At temporary job sites:

(i) Manufacturer, model number, and serial number;

(ii) Locations and dates of use;

(iii) Results of radiation surveys as required by this rule and rule 3701:1-38-14 of the Administrative Code;

(iv) Dates that each piece of industrial radiography equipment is removed from storage and returned to storage;

(v) Operating kilovoltage, tube current, and exposure time for each radiographic exposure; and

(vi) Identity and signature of the industrial radiographer to whom the equipment was assigned.

(b) At permanent radiographic installations:

(i) Manufacturer, model number, and serial number;

(ii) Dates each industrial radiography device is energized;

(iii) Results of radiation surveys as required by this rule and rule 3701:1-38-14 of the Administrative Code;

(iv) Dates that each piece of industrial radiography equipment is removed from storage and returned to storage;

(v) Operating kilovoltage, tube current, and exposure time for each radiographic exposure; and

(vi) Identity and signature of the industrial radiographer.

(6) Operating and emergency procedures shall include instructions in at least the following:

(a) Handling and use of industrial radiography or irradiation equipment to be employed such that no individual is likely to be exposed to radiation doses in excess of the limits established in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code;

(b) Methods and occasions for conducting radiation surveys;

(c) Methods for controlling access to radiation areas;

(d) Methods and occasions for locking and securing industrial radiography and irradiation devices;

(e) Personnel monitoring and the use of personnel monitoring equipment, including all steps that must be taken immediately by monitored personnel in the event a dosimeter is found to be off scale or beyond its range.

(f) If appropriate, security and control of industrial radiography equipment during transportation to field locations;

(g) Minimizing additional exposure of individuals in the event of an accident;

(h) The procedure for notifying proper personnel in the event of an accident;

(i) Maintenance of records; and

(j) The inspection and maintenance of industrial radiography and irradiation devices.

(7) If the provisions set forth in this rule or any other applicable equipment requirements of Chapter 3701:1-68 of the Administrative Code are not met, the industrial radiography and irradiation devices shall not be operated.

(8) Industrial radiography and irradiation devices shall not be used to intentionally irradiate human beings for any purpose.

(9) At least two qualified individuals shall be present at temporary job sites when industrial radiography equipment is being used. At least one of the individuals shall be the industrial radiographer to whom the industrial radiography equipment is assigned and the other individual shall be either an industrial radiographer or an industrial radiographer assistant.

(10) No individual other than an industrial radiographer or an industrial radiographer assistant who is under the personal supervision of an industrial radiographer shall manipulate controls or operate equipment used in radiographic operations. The personal supervision must include:

(a) The industrial radiographer's physical presence at the site where the industrial radiography equipment is being used;

(b) The availability of the industrial radiographer to give immediate assistance if required; and

(c) The industrial radiographer's direct observation of the industrial radiographer assistant's performance of the operations referred to in this rule.

(11) The handler shall not permit any individual to act as an industrial radiographer or as an industrial radiographer assistant unless, at all times during radiographic operations, each such individual wears an appropriate direct reading dosimeter and a personnel dosimeter. Pocket dosimeters shall have a range from zero to two millisieverts (two hundred millirem) and analog dosimeters shall be recharged at the start of each shift. Electronic dosimeters shall be battery-tested at the beginning of each shift. Each personnel dosimeter shall be assigned to and worn by only one individual and the handler shall assure that:

(a) Direct reading dosimeters are read and exposures are recorded at the beginning and end of each shift. These records shall be maintained between inspections;

(b) Direct reading dosimeters are checked for correct response to radiation at periods not to exceed twelve months. Acceptable dosimeters shall read within plus or minus twenty per cent of the true radiation exposure. Records of this check shall be maintained between inspections;

(c) If an individual's pocket dosimeter is found to be off-scale, or the electronic personnel dosimeter reads greater than two millisieverts (two hundred mrem), the individual's personnel dosimeter must be sent for processing within twenty-four hours. In addition, the individual may not resume work associated with the use of sources of radiation until a determination of the individual's radiation exposure has been made. This determination must be made by the individual responsible for radiation protection (IRRP) or the IRRP's designee. The results of this determination must be documented and maintained until the department terminates the registration.

(d) Dosimetry reports received from the accredited "National Voluntary Laboratory Accreditation Program" (NVLAP) personnel dosimeter processor are kept for review during inspection in accordance with rule 3701:1-38-20 of the Administrative Code;

(e) If a personnel dosimeter is lost or damaged, the worker shall cease work immediately until a replacement personnel dosimeter is provided and the exposure is calculated for the time period from issuance to loss or damage of the personnel dosimeter. This calculation must be made by the IRRP or the IRRP's designee. The results of the calculated exposure and the time period for which the personnel dosimeter was lost or damaged must be included in the records maintained until the department terminates the registration;

(f) Personnel dosimeters shall be exchanged monthly unless the IRRP has performed an evaluation that indicates a longer frequency is adequate. Under no circumstances shall the frequency exceed three months. Documentation of the evaluation shall be maintained for inspection.

(g) After replacement, each personnel dosimeter must be returned to the supplier for processing within fourteen calendar days of the end of the monitoring period, or as soon as practicable. In circumstances that make it impossible to return each personnel dosimeter in fourteen calendar days, such circumstances must be documented and available for review by the department.

(12) No radiographic operation shall be conducted unless calibrated and operable radiation survey instrumentation is available and used at each site where radiographic exposures are made.

(13) A physical radiation survey shall be made after each radiographic exposure to verify that the radiation-generating device is not still producing radiation.

(14) Records shall be kept of the surveys in accordance with paragraph (C) of rule 3701:1-38-20 of the Administrative Code.

(15) During each radiographic operation, the industrial radiographer or industrial radiographer assistant shall maintain surveillance of the operation to protect against unauthorized entry into a high radiation area, except:

(a) When the high radiation area is equipped with a control device or alarm system as described in paragraph (A)(2) of this rule; or

(b) When the high radiation area is locked to protect against unauthorized or accidental entry.

(16) When performing radiographic operations at a location other than a permanent radiographic installation having the control devices specified in paragraph (B)(15) of this rule, the industrial radiographer shall be responsible for:

(a) Posting signs bearing the radiation symbol and the words "CAUTION HIGH RADIATION AREA" at the perimeter of the calculated high radiation area;

(b) Restricting access and posting signs bearing the radiation symbol and the words "CAUTION RADIATION AREA" at the perimeter of the restricted area; and

(c) Maintaining constant visual surveillance of the restricted area boundary to prevent access by unauthorized personnel.

(17) Radiographic operations shall not be performed if any of the items in paragraph (B)(4) of this rule are not available at the jobsite or are inoperable.

(C) In addition to the requirements listed in rule 3701:1-68-02 of the Administrative Code, handlers shall comply with the following quality assurance requirements:

(1) Radiation survey instrumentation described in paragraph (B)(3) of this rule shall be checked at the beginning of each day of use and at the beginning of each work shift using check sources or other appropriate means to ensure it is operating accurately.

(2) Industrial radiography and irradiation devices shall be checked prior to each day or shift of use to identify any obvious defects. If any check conducted reveals damage to components critical to radiation safety, the device shall be locked out and tagged until repairs have been made.

(3) Entrance control devices and alarm systems described in paragraph (A)(2) of this rule, shall be tested at the beginning of each day of equipment use for proper operation. If an entrance control device or an alarm system is operating improperly, it shall be immediately labeled as defective and repaired or replaced within seven calendar days. The facility may continue operations during this seven-day period, provided the handler implements the continuous surveillance requirements of this rule. Records of these tests shall be maintained between inspections from the date of the event.

(4) Industrial radiography and irradiation devices shall be evaluated every three months, not to exceed fourteen weeks, to assure proper functioning of components important to safety unless the radiation-generating equipment has been locked out and tagged "DO NOT USE" and is under the administrative control of the IRRP. All appropriate parts shall be maintained in accordance with the manufacturer's specifications. Records of evaluations shall be maintained between inspections.

(5) The following documents and records shall be available for inspection at each temporary jobsite where industrial radiography is being performed:

(a) Appropriate certificate of registration;

(b) Operating and emergency procedures;

(c) Copies of applicable rules adopted pursuant to Chapter 3748. of the Revised Code;

(d) Records of surveys required pursuant to this rule and rule 3701:1-38-14 of the Administrative Code for the period of operation at the site;

(e) Daily dosimeter records for the period of operation at the site; and

(f) The latest instrument calibration records for specific devices in use at the site. Acceptable records include tags or labels which are affixed to the device or survey meter.

(D) The IRRP for industrial radiography shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the registrant's program.

(1) The minimum qualifications, training, and experience for IRRPs for industrial radiography are as follows:

(a) Completion of the training and testing requirements of paragraph (E) of this rule;

(b) Two thousand hours of hands-on experience as a qualified radiographer in industrial radiographic operations; and

(c) Formal training in the establishment and maintenance of a radiation protection program.

(2) The department will consider alternatives to paragraph (D)(1) of this rule when the IRRP for industrial radiography has appropriate training and/or experience in the field of ionizing radiation, and in addition, has adequate formal training with respect to the establishment and maintenance of a radiation safety protection program.

(3) The specific duties and authorities of the IRRP for industrial radiography include, but are not limited to:

(a) Establishing and overseeing all operating, emergency, and ALARA procedures as required by Chapter 3701:1-38 of the Administrative Code, and reviewing them regularly to ensure that the procedures in use conform to current regulatory requirements, and to the registration conditions.

(b) Overseeing and approving all phases of the training program for radiographic personnel, ensuring that appropriate and effective radiation protection practices are taught;

(c) Ensuring that required radiation surveys are performed and documented in accordance with the regulations, including any corrective measures when levels of radiation exceed established limits;

(d) Ensuring that personnel monitoring devices are calibrated and used properly by occupationally-exposed personnel, that records are kept of the monitoring results, and that timely notifications are made as required by paragraph (C) of rule 3701:1-38-21 of the Administrative Code; and

(e) Ensuring that operations are conducted safely and to assume control for instituting corrective actions including stopping of operations when necessary.

(E) No individual shall act as an industrial radiographer or industrial radiographer assistant unless such individual has received copies of, been instructed in, and has demonstrated understanding and competency in the subjects identified in this paragraph. Training provided to qualify as industrial radiographers and industrial radiographer assistants shall be presented on a formal basis. This training shall include following subjects:

(1) Fundamentals of radiation safety;

(a) Characteristics of radiation;

(b) Units of radiation dose;

(c) Significance of radiation dose;

(i) Radiation protection standards;

(ii) Biological effects of radiation; and

(iii) Case histories of radiography accidents;

(d) Levels of radiation from sources of radiation; and

(e) Methods of controlling radiation dose;

(i) Working time;

(ii) Working distance; and

(iii) Shielding.

(2) Radiation detection instrumentation to be used;

(a) Use of radiation survey instruments;

(i) Operation;

(ii) Calibration; and

(iii) Limitations;

(b) Survey techniques; and

(c) Use of personnel monitoring equipment;

(3) Applicable requirements of federal and state regulations;

(4) Registrant's written operating and emergency procedures; and

(5) Radiographic equipment to be used;

(a) Operation and control of x-ray equipment;

(b) Handling equipment; and

(c) Collimators.

(F) Handlers shall assure that personnel performing industrial radiography meet the following requirements.

(1) Industrial radiographers shall be certified through an independent program approved by the United States nuclear regulatory commission, the "Conference of Radiation Control Program Directors Inc.," or equivalent certification approved by the director in accordance with the requirements in the appendix to this rule.

(2) Each industrial radiographer at a job site shall have on his or her person a valid certification identification card issued by the independent program reference in paragraph (F)(1) of this rule.

(3) Prior to any individual acting as an industrial radiographer, he or she shall demonstrate two months of prior on-the-job experience.

(4) Prior to an individual acting as an industrial radiographer assistant, he or she shall demonstrate competence in the training subjects identified in paragraph (E) of this rule.

(G) Handlers shall assure that the following requirements are met regarding the individuals operating the industrial radiography equipment:

(1) Each industrial radiographer and industrial radiographer assistant shall be audited at intervals not to exceed six months by the registrant's IRRP to ensure that the registrant's operating procedures are followed;

(2) The handler shall provide refresher safety training for each industrial radiographer and industrial radiographer assistant at intervals not to exceed twelve months. The training shall include, as a minimum, any results of internal inspections, new procedures or equipment, new or revised regulations, and accidents or errors that have been observed. The review shall also provide opportunities for employees to ask safety questions.

(3) Records of internal audits shall be maintained between inspections from the date of the audit; and

(4) Records of each industrial radiographer and industrial radiographer assistant training, including certificates of successful completion, oral, written, and practical examinations, and refresher training shall be maintained until termination of an individual's employment or the next inspection, which ever period is longer.

(H) Handlers utilizing a cabinet x-ray system shall ensure the following:

(1) A cabinet x-ray system that is large enough to walk into, shall:

(a) Comply with all applicable requirements of this rule; and

(b) Be evaluated with at least one operable calibrated survey instrument at intervals not to exceed twelve months. Records of these evaluations shall be maintained between inspections.

(2) A cabinet x-ray system that is not large enough to walk into and designed to exclude all personnel, including extremities, from the interior of the cabinet during the generation of radiation, is exempt from the requirements of paragraphs (A) to (H)(1) of this rule, except that:

(a) No handler shall permit any individual to operate a cabinet x-ray system until such individual has received a copy of, and instruction in, the operating procedures for the equipment and has demonstrated competence in its use. Records which demonstrate compliance with this paragraph shall be maintained between inspections; and

(b) Tests for proper operation of high radiation area control devices, interlocks, warning lights, and labels specified in paragraphs (A)(2) to (A)(4) of this rule, where applicable, shall be conducted, recorded, and maintained in accordance with paragraph (C)(4) of this rule.

(3) The handler shall perform an evaluation, at intervals not to exceed twelve months, to determine compliance with rules adopted pursuant to Chapter 3748. of the Revised Code. Records of these evaluations shall be maintained between inspections.

(4) A certified enclosed system shall be maintained in compliance with requirement in 21 C.F.R. 1020.40 (as published in the April 1, 2007 Code of Federal Regulations) and the handler shall maintain documentation of compliance between inspections.

(5) Radiation emitted from the cabinet x-ray system shall not exceed a dose equivalent of five microsieverts ( 0.5 millirem) in one hour at any point five centimeters outside the external surface.

(I) The director may, upon application thereof or upon his or her own initiative, grant a variance to the requirements of this rule as he or she determines is authorized by law, provided that the registrant shows to the satisfaction of the director that there is good cause for the variance, and that the variance will not result in any undue hazard or effect on the public health and safety or environment. The terms, conditions, and expiration of the variance shall be set forth in writing by the director. Failure to comply with the terms of the variance may result in immediate revocation of the variance.

(J) Handlers of industrial radiation-generating equipment used for bomb detection purposes shall be exempt from paragraphs (B)(1), (B)(3), (B)(4)(b), (B)(4)(c), (B)(6)(e), (B)(9) to (B)(13), (B)(15), (B)(16), (C)(1) to (C)(3), (C)(5)(e), (D)(1)(b), (D)(1)(c), and (F) of this rule. In addition to these exemptions, the interval for calibrating radiation survey instruments as listed in paragraph (B)(3)(b)(ii) of this rule, and the frequency for the evaluation of operable radiation-generating equipment as listed in paragraph (C)(4) of this rule may be changed to annually.

Replaces: 3701:1-66-12

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Effective: 05/01/2012
R.C. 119.032 review dates: 05/01/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 2/15/2001, 5/17/04, 10/1/09, 6/20/10

3701:1-68-04 Industrial analytical radiation-generating equipment.

In addition to the applicable rules in Chapter 3701:1-38 and Chapter 3701:1-68 of the Administrative Code, handlers of industrial analytical radiation-generating equipment shall comply with the following:

(A) Industrial analytical radiation-generating equipment shall meet the following equipment standards:

(1) Open beam configurations shall have a device or an automatic shut-off feature that prevents any part of a person's body from being exposed to the primary x-ray beam path.

(2) Open-beam configurations and all other equipment installed after February 10, 2006, shall be provided with a readily visible warning light labeled with the words "X-RAY ON" or symbols having a similar intent, and be located near the x-ray source and its controls and be illuminated when the x-ray source is energized. In addition, open beam configurations shall be provided with a readily discernible indication of:

(a) X-ray source power "on-off" status located near the radiation source housing, if the primary beam is controlled in this manner; or

(b) Shutter "open-closed" status located near each radiation port on the source housing, if the primary beam is controlled in this manner.

(3) Except for gauging units, open-beam systems installed after February 10, 2006, shall have warning devices, or a system of warning devices, such as redundant lights with fail-safe characteristics.

(4) All analytical radiation-generating equipment shall conspicuously display a clearly legible label or labels bearing the radiation symbol and the words "CAUTION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED" or appropriate words having a similar intent, near any switch or control that directly energizes the unit. Analytical radiation-generating equipment with open-beam configurations shall have an additional warning label on or near the x-ray housing with the radiation symbol with the words "CAUTION - HIGH INTENSITY X-RAY BEAM" or appropriate words having a similar intent.

(5) Each radiation source housing shall be equipped with an interlock that shuts off the radiation beam before the source is removed from the radiation source housing or before the housing is disassembled. For each radiation source installed prior to the effective date of this rule and not equipped with an interlock, administrative controls shall be instituted to include that the power shall be disconnected before any disassembly.

(6) Unused radiation ports on radiation source housings shall be secured in the closed position, or mechanically blocked.

(7) All industrial analytical radiation-generating equipment other than open beam shall be supplied with a protective cabinet which limits leakage radiation measured at a distance of five centimeters from its surface such that it is not capable of producing a dose in excess of 2.5 microsievert ( 0.25 millirem) in one hour.

(B) Handlers of industrial analytical radiation-generating equipment shall comply with the following radiation safety requirements:

(1) The facility's individual responsible for radiation protection (IRRP) shall document and implement operating procedures relative to radiation safety. The IRRP shall be qualified in accordance with paragraph (B)(13) of rule 3701:1-68-01 of the Administrative Code and paragraph (C)(4) of this rule. The IRRP shall assure and document that all operators of industrial analytical radiation-generating equipment have received appropriate training. No individual shall be permitted to operate industrial analytical radiation-generating equipment in any manner other than that specified in the procedures unless such individual has obtained written approval of the IRRP.

(2) Any temporary alteration to safety devices, such as by-passing interlocks or removing shielding shall be:

(a) Documented and maintained for inspection for a minimum of three years. This record shall contain such information as date the alteration was made, type of alteration, length of time alteration remained in place, and signature of the individual who made the alteration and the individual who restored the safety device to the original condition; and

(b) Approved, and signed in advance for a specified period of time by the individual responsible for radiation protection, and posted near the radiation-generating source housing with the signatures of approval.

(3) Except as specified in paragraph (B)(2) of this rule, no operation involving removal of covers, shielding materials or radiation source housings or modifications to shutters, collimators, or beam stops shall be performed without ascertaining that the radiation source is off and will remain off until safe conditions have been restored. The radiation source power switch, in conjunction with appropriate interlocks, shall be used for routine shutdown in preparation for repairs.

(4) Industrial analytical radiation-generating equipment shall not be used to intentionally irradiate human beings.

(C) In addition to the requirements in rule 3701:1-68-02 of the Administrative Code, handlers of industrial analytical radiation-generating equipment shall comply with the following quality assurance requirements:

(1) The local components of an industrial analytical radiation-generating system shall be located, arranged, and include sufficient shielding or access control such that no radiation levels exist in any area surrounding the local component group which could result in a dose to an individual present therein in excess of the dose limits given in Chapter 3701:1-38 of the Administrative Code. These levels shall be met at any specified radiation source rating.

(2) Radiation surveys of all industrial analytical radiation-generating systems shall be performed in compliance with the rules of Chapter 3701:1-38 of the Administrative Code:

(a) Upon installation of the radiation-generating equipment;

(b) Following any change in the initial arrangement, number, or type of local components in the system;

(c) Following any maintenance requiring the disassembly or removal of a local component in the system;

(d) During the performance of maintenance and alignment procedures if the procedures require the presence of a primary x-ray beam when any local component in the system is disassembled or removed;

(e) Any time a visual inspection of the local components in the system reveals an abnormal condition; and

(f) Whenever personnel monitoring reports show an unexplained increase over the previous monitoring period or the readings are approaching the limits specified in rules adopted pursuant to Chapter 3701:1-38 of the Administrative Code.

(3) Proper operation of all radiation safety devises, such as interlocks, lights and labels, shall be checked at least every six months by individuals qualified according to paragraph (C)(4) of this rule. Documentation shall be maintained and available for inspection for a minimum of three years and shall include any corrective actions taken.

(4) No individual shall be permitted to operate or maintain industrial analytical radiation-generating equipment unless that individual has received training and demonstrated competence regarding the following:

(a) Identification of radiation hazards associated with the use of the equipment;

(b) Significance of the various radiation warning, safety devices, and interlocks incorporated into the equipment, or the reasons they have not been installed on certain pieces of equipment and the extra precautions required in such cases;

(c) Standard operating procedures for the equipment;

(d) Recognition of symptoms of an acute localized exposure;

(e) Proper procedures for reporting an actual or suspected exposure in accordance with in rule 3701:1-38-21 of the Administrative Code.

The individual responsible for radiation protection shall verify and document compliance with this paragraph and maintain and make the documentation available for inspection for a minimum of three years.

(5) Finger or wrist radiation monitoring devices shall be provided to and shall be used by:

(a) Industrial analytical radiation-generating equipment workers using systems having an open-beam configuration without provisions for engineering controls as provided in paragraph (A)(1) of this rule; and

(b) Personnel maintaining industrial analytical radiation-generating equipment if the maintenance procedures require the presence of an external radiation beam when any local component in the industrial analytical radiation-generating system is disassembled or removed.

(D) Handlers of electron microscopes and photoelectron spectrometers shall be exempt from the requirements of paragraphs (C)(2)(b) to (C)(2)(f), paragraph (C)(3), paragraphs (C)(4)(a) to (C)(4)(b), and paragraphs (C)(4)(d) to (C)(4)(e) of this rule.

(E) Handlers of gauging units shall be exempt from the requirements of paragraphs (C)(2)(c) to (C)(2)(e) of this rule.

(F) Handlers of hand-held open beam analyzer systems shall:

(1) Be exempt from the requirements of paragraphs (A)(1) and (A)(3) of this rule;

(2) Require the IRRP to document and implement safe operating procedures to include, but not be limited to:

(a) Using specific administrative controls to prevent unauthorized access or use of the system;

(b) Assuring that the system remains in direct control of the authorized operator;

(c) Prohibiting individuals from holding a sample in their hand during irradiation;

(d) Operating of software, trigger locks and proximity sensors;

(e) Using analyzer stands when the sample fits or when the part does not completely cover the beam port;

(f) Taking precautions during irradiation to prevent exposure of the operator or other individuals;

(g) Establishing and maintaining a restricted area of at least three feet opposite the side of the sample being exposed;

(h) Having alternative engineering and administrative safety controls that effectively prevent personnel exposure to the primary beam; and

(i) Requiring operators to wear assigned ring badges on the hand closest to the beam port; and

(3) Assure that the IRRP documents and implements radiation safety training to each operator before operating the equipment, and annually thereafter, audits the operators to assure competency in all safety procedures and standard operating procedures.

(G) The director may, upon application thereof or upon his or her own initiative, grant a variance to the requirements of this rule as he or she determines is authorized by law, provided that the registrant shows to the satisfaction of the director that there is good cause for the variance, and that the variance will not result in any undue hazard or effect on the public health and safety or environment. The terms, conditions, and expiration of the variance shall be set forth in writing by the director. Failure to comply with the terms of the variance may result in immediate revocation of the variance.

Replaces: 3701:1-66-13

Effective: 05/01/2012
R.C. 119.032 review dates: 05/01/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.01 , 3748.02 , 3748.04 , 3748.05 , 3748.06 , 3748.07 , 3748.12 , 3748.121 , 3748.13 , 3748.14 , 3748.15 , 3748.17 , 3748.18 , 3748.19 , 3748.20 , 3748.22 , 3748.99
Prior Effective Dates: 2/15/2001, 2/10/06, 8/1/11

3701:1-68-05 Industrial particle accelerators.

In addition to the applicable rules in Chapter 3701:1-38 and Chapter 3701:1-68 of the Administrative Code, handlers of particle accelerators shall comply with the following requirements:

(A) Handlers shall not use a particle accelerator until the department has verified that:

(1) The handler and the operators are qualified by reason of training and experience to use the particle accelerator for its intended uses, in accordance with the requirements of this rule;

(2) The proposed or existing particle accelerator, facility, and operating procedures are adequate to protect health and minimize danger to public health and safety;

(3) The individual responsible for radiation protection (IRRP) has been appointed;

(4) There is an established radiation safety committee to approve, in advance, proposals for uses of the particle accelerator whenever deemed necessary by the department;

(5) There is an adequate training program for operators of particle accelerators; and

(6) Any special requirements are met, as determined by the department, and that a certificate of registration has been issued.

(B) Handlers of particle accelerators shall meet the following controls, warnings and interlock systems requirements:

(1) Each entrance into a target room or other high radiation area shall be provided with a safety interlock that shuts down the machine in the event of any barrier penetration;

(2) All safety instrumentation, readouts, and controls on the particle accelerator control console shall be clearly identified and easily discernible;

(3) Each safety interlock shall be on a circuit which allows it to operate independently of all other safety interlocks;

(4) All safety systems or interlocks shall be designed so that any defect or component failure in the safety interlock system prevents production of radiation by the accelerator;

(5) If a safety interlock system has been tripped, it shall only be possible to resume operation of the particle accelerator by manually resetting controls at the position where the safety interlock has been tripped, and at the control console;

(6) Each high radiation area shall have an audible and visual warning device which shall be activated for at least fifteen seconds prior to the possible creation of such a high radiation area. Such warning devices shall be clearly discernible in all high radiation areas;

(7) Each particle accelerator shall bear a warning label on the control console which cautions individuals that radiation is produced when it is energized, and any other warning label required by rules adopted pursuant to Chapter 3701:1-38 of the Administrative Code;

(8) Each location designated as a high radiation area, and each entrance to such location, shall be equipped with easily observable warning lights that operate when, and only when the high-voltage portion of the machine is being energized;

(9) Barriers, temporary or otherwise, and pathways leading to high radiation areas shall be posted in accordance with rule 3701:1-38-18 of the Administrative Code; and

(10) An emergency power cutoff switch shall be located and easily identifiable in all high radiation areas and shall include a manual reset so that the accelerator cannot be restarted from the accelerator control console without resetting the cutoff switch.

(C) Handlers shall comply with the following structural shielding and safety requirements:

(1) A health physicist or a radiation expert, with education and experience acceptable to the department, shall be consulted in the design of a particle accelerator installation and called upon to perform a radiation survey when the accelerator is first capable of producing radiation;

(2) Provide each industrial particle accelerator installation with such shielding as is necessary to assure compliance with the applicable rules adopted pursuant to Chapter 3701:1-38 of the Administrative Code;

(3) The IRRP shall have the responsibility and authority to terminate the operations at a particle accelerator facility if such action is deemed necessary to minimize danger to public health and safety;

(4) Ventilation systems shall be provided to ensure that personnel entering any area where airborne radioactivity may be produced will not be exposed to airborne radioactive material in excess of those limits specified in table I of appendix C to rule 3701:1-38-12 of the Administrative Code;

(5) A registrant, as required by Chapter 3701:1-38 of the Administrative Code, shall not vent, release, or otherwise discharge airborne radioactive material to an unrestricted are which exceeds the limits specified in table II of appendix C of rule 3701:1-38-12 of the Administrative Code. Concentrations may be averaged over a period not greater than one year. Every effort should be made to maintain releases of radioactive material to unrestricted areas as far below these limits as is reasonably achievable.

(D) Handlers of particle accelerators shall comply with the following safe operating requirements:

(1) The particle accelerator shall be secured when not in operation to prevent unauthorized use;

(2) The safety interlock system shall not be used to turn off the particle accelerator beam, except in an emergency or when testing of the safety interlock system;

(3) All safety and warning devices, including interlocks, shall be checked for proper operation at intervals not to exceed three months. Results of such tests shall be maintained at the accelerator facility for inspection by the department. In the event the safety equipment is operating improperly, it shall be immediately reported to the IRRP and shall be repaired or replaced and never bypassed so as to enable radiation production;

(4) The handler's IRRP shall develop and maintain a particle accelerator handbook that describes the electrical circuits and the associated interlock systems, and this handbook shall be kept current as to any changes in the system;

(5) A copy of the current operating and the emergency procedures shall be maintained at the particle accelerator control console;

(6) If, for any reason, it is necessary to intentionally bypass a safety interlock or interlocks, such action shall be:

(a) Authorized by the IRRP;

(b) Recorded in a permanent log;

(c) Posted as a written notice at the accelerator control console; and

(d) Terminated as soon as possible; and

(7) The handler shall assure that each particle accelerator operator is supplied with, and uses, the following:

(a) Direct reading dosimeter; and

(b) Personnel dosimeter.

(E) Handlers of particle accelerators shall comply with the following radiation monitoring requirements:

(1) Appropriate portable monitoring equipment, which is operable and has been appropriately calibrated for the types of radiation being produced, shall be available at each particle accelerator facility. Such equipment shall be tested for proper operation daily and calibrated at intervals not to exceed one year and after each servicing and repair;

(2) A radiation shielding survey shall be performed and documented by a health physicist or qualified expert, with education and experience acceptable to the department, when changes have been made in shielding, operation, equipment, or occupancy of adjacent areas.

(3) Whenever applicable, periodic surveys shall be made to determine the amount of airborne particulate radioactivity present.

(4) Radiation levels in all high radiation areas shall be continuously monitored. The monitoring devices shall be electrically independent of the accelerator control and safety interlock systems and capable of providing a readout at the control panel;

(5) All surveys shall be made in accordance with the written procedures established by a health physicist or radiation expert, with education and experience acceptable to the department;

(6) Records of all radiation surveys, calibrations, and instrumentation tests shall be maintained at the particle accelerator facility for inspection by the department;

(7) Whenever applicable, surveys for removable contamination shall be made to determine the degree of contamination.

(F) No individual shall act as a particle accelerator operator:

(1) Unless that individual has received instruction in, and has demonstrated an understanding of:

(a) The subjects outlined in appendix A to this rule;

(b) The requirements of this rule and the applicable requirements of Chapter 3701:1-38 of the Administrative Code;

(c) The registrant's operating and emergency procedures for each particle accelerator; and

(2) Until the IRRP has documented that the individual has demonstrated competency in the use of the particle accelerator, related equipment, and radiation survey instruments that will be used to monitor the particle accelerator at that facility. The particle accelerator operator shall have immediate access to copies of the documents required by paragraph (F)(1) of this rule.

(G) The director may, upon application thereof or upon his or her own initiative, grant a variance to the requirements of this rule as he or she determines is authorized by law, provided that the registrant shows to the satisfaction of the director that there is good cause for the variance, and that the variance will not result in any undue hazard or effect on the public health, safety, or environment. The terms, conditions, and expiration of the variance shall be set forth in writing by the director. Failure to comply with the terms of the variance may result in immediate revocation of the variance.

Replaces: 3701:1-66-17

Click to view Appendix

Effective: 05/01/2012
R.C. 119.032 review dates: 05/01/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.01 , 3748.02 , 3748.04 , 3748.05 , 3748.06 , 3748.07 , 3748.12 , 3748.12 , 3748.121 , 3748.13 , 3748.14 , 3748.15 , 3748.17 , 3748.18 , 3748.19 , 3748.20 , 3748.22 , 3748.99
Prior Effective Dates: 2/15/2001, 6/1/06, 9/1/11