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This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and universities.

Chapter 3701:1-68 | Industrial Radiation Equipment

 
 
 
Rule
Rule 3701:1-68-01 | Definitions.
 

(A) As used in this chapter:

(1) "Access panel" means any barrier or panel which is designed to be removed or opened for maintenance or service purposes, needs tools to open, and permits access to the interior of an enclosed fail-safe system.

(2) "Analytical system" means non-medical radiation-generating equipment used to determine properties of materials being measured or analyzed. Analytical systems include, but are not limited to, gauging, x-ray diffraction, and x-ray fluorescence equipment.

(3) "Aperture" means any opening in the external surface of a cabinet or analytical system, other than a port, which remains open during generation of radiation.

(4) "Cabinet system" means non-medical radiation-generating equipment, which is installed in a shielded enclosure that excludes all personnel, including extremities, from the primary beam during the generation of radiation.

(5) "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.

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

(7) "Control panel" or "control console" means that part of the non-medical radiation-generating equipment used for setting the technique factors.

(8) "Door" means any barrier which is designed to be movable or opened during routine operations, does not generally need tools to open, and permits access to the interior of an enclosed fail-safe system. For the purposes of paragraph (A)(4)(a) of rule 3701:1-68-06 of the Administrative Code, inflexible hardware rigidly affixed to the door will be considered part of the door.

(9) "External surface" means the outside surface of a cabinet system or analytical system, including the high-voltage generator, doors, access panels, latches, control knobs, and other permanently mounted hardware and including the plane across any aperture or port.

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

(11) "Gauging Unit" means non-medical radiation-generating equipment designed and manufactured for the purpose of detecting, measuring or controlling thickness, density, or interface location.

(12) "Ground fault" means an accidental electrical grounding of an electrical conductor.

(13) "Hand-held system" means non-medical radiation-generating equipment that is specifically designed to be held in the hand during operation. Hand-held systems include analytical and radiographic systems.

(14) "Independent certifying organization" means an independent organization that meets all of the criteria of the appendix to rule 3701:1-68-02 of the Administrative Code.

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

(16) "Irradiation system" means non-medical radiation-generating equipment used to alter the chemical, biological, or physical properties of materials or to sterilize materials.

(17) "Local components" means parts of an analytical 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.

(18) "Locked out and tagged" means a process for equipment security and safety in which non-medical radiation-generating equipment is locked to prevent operation and tagged with specific information as to why it is not to be used.

(19) "Miniature radioscopic system" means an imaging system with a fixed source and detector configuration that provides a maximum source to image distance of less than forty-five centimeters (eighteen inches) and is not capable of creating a dose rate to any individual forty-five centimeters (eighteen inches) from the primary beam that exceeds twenty microsievert (two millirem) per hour.

(20) "Non-human security screening system" means a non-human use cabinet x-ray system with accessible openings designed for the detection of weapons, bombs, or contraband concealed in baggage, mail, packages or other commodities.

(21) "Non-medical radiation-generating equipment" means any x-ray equipment other than a security screening system designed to scan individuals, or those used on patients or human research subjects for medical or therapy purposes.

(22) "Open-beam analytical system" means an analytical system configured such that an individual could place any part of his or her body in the primary beam during normal operation.

(23) "Particle accelerator system" means non-medical radiation-generating equipment designed for, or capable of, accelerating charged particles.

(24) "Permanent radiographic installation" means a radiographic system enclosed in a shielded room, cell or vault not located at a temporary job site.

(25) "Port" means any opening in the outside surface of a cabinet system or analytical system which is designed to remain open, during generation of radiation, for the purpose of conveying material to be irradiated into and out of the enclosure, or for partial insertion for irradiation of an object whose dimensions do not permit complete insertion into the enclosure.

(26) "Primary beam" means radiation which passes through the collimator in the radiation source housing by a direct path from the radiation source.

(27) "Radiation Expert" means an individual who meets the qualifications of paragraph (E)(2) of 3701:1-68-02 of the Administrative Code

(28) "Radiographer" means an individual who operates or personally supervises the operation of radiographic systems, related equipment, or radiation survey instruments for radiographic operations.

(29) "Radiographer's assistant" means an individual who, under the personal supervision of a radiographer operates radiographic systems, related equipment, or radiation survey instruments for radiographic operations.

(30) "Radiographic system" means non-medical radiation-generating equipment used to examine the macroscopic structures of material. Radiographic systems include radiographic and radioscopic equipment.

(31) "Shutter" means a device, fixed to any radiation source housing to intercept the primary beam.

(32) "Temporary job site" means a location where radiographic operations are performed and where radiographic systems may be stored other than the locations of use authorized on the registration.

(B) Terms appearing in this chapter, which are not defined in this rule, may be defined in rule 3701:1-38-01 of the Administrative Code.

Last updated June 30, 2023 at 12:42 AM

Supplemental Information

Authorized By: 3748.04
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
Five Year Review Date: 6/9/2028
Prior Effective Dates: 5/1/2012
Rule 3701:1-68-02 | General requirements.
 

(A) Each handler of non-medical radiation-generating equipment will develop, implement and maintain a writtenradiation protection program in the form of a readily available manual or manuals, either in hard copy, printed format or electronic format. For the purpose of this chapter, radiation protection program means written policies and procedures such as testing, auditing and inspection to assure compliance with applicable rules of the Administrative Code. The written radiation protection program will at least address the following:

(1) The evaluation and maintenance of non-medical radiation-generating equipment in accordance with the manufacturer's recommendations;

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

(3) Facility compliance with occupational, pregnant worker and public exposure limits, to include 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) How radiation protection policies and policy changes are made available to the affected workers;

(5) Radiation safety training for ancillary personnel, to include:

(a) Potential hazards of being present in a restricted area;

(b) Location, boundaries, and purpose of restricted areas; and

(c) The identification of all radiation areas, warning signs, and warning lights;

(6) Banning the use of non-medical radiation-generating equipment to intentionally irradiate human beings for any purpose;

(7) Banning the operation of non-medical radiation-generating equipment if the provisions set forth in this rule or any other applicable obligations of Chapter 3701:1-68 of the Administrative Code are not met;

(8) Obligating operators of permanent radiographic installations and cabinet systems that are designed to admit humans to verify no individual is present in the room during radiation exposure;

(9) A current listing of all non-medical radiation-generating equipment, including the location and description of each system;

(10) Data and test results of the evaluation of the shielding and surroundings of all non-medical radiation-generating equipment;

(11) Maintenance logs and incident reports for each non-medical radiation-generating equipment system;

(12) Current copies of valid certification identification cards, issued by the independent program referenced in paragraph (C)(2)(a) of this rule, for each radiographer;

(13) Maintaining records obligated by this chapter, according to the following provisions:

(a) Determination of an individual's radiation exposure following an event where that individual's pocket dosimeter was found off-scale, or that individual's electronic personnel dosimeter read greater than two millisieverts (two hundred millirem) will be maintained until the director terminates the registration;

(b) Calculation of an individual's radiation exposure from the time of issuance to the time of damage or loss of a personnel dosimeter will be maintained until the director terminates the registration;

(c) In accordance with rule 3701:1-38-20 of the Administrative Code, dosimetry reports received from accredited NVLAP personnel dosimeter processors will be kept until the director terminates the registration;

(d) Area radiation surveys conducted at any site other than a temporary job site will be maintained until the director terminates the registration;

(e) Operator training and refresher training will be maintained until the employment of the operator has been terminated or three years, whichever is longer;

(f) All other records generated pursuant to the obligations of this chapter will be maintained for no less than three years;

(g) Check, test or evaluation records will include the date of the check or test, the name of the inspector, the equipment involved, any problems found, and what repair and/or maintenance, if any, was performed; and

(h) Each record will be legible throughout the specified retention period. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of reproducing a clear copy throughout the obligated retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the obligated retention period. Records, such as letters, drawings, and specifications, will include all pertinent information, such as stamps, initials, and signatures. The registrant will maintain adequate safeguards against tampering with and loss of records.

(14) Obligating non-medical radiation-generating equipment to be kept locked at all times, to prevent tampering or removal by unauthorized personnel, except when under the direct surveillance of the operator, or as may be otherwise authorized pursuant to this rule.

(B) Survey instruments and dosimeter obligations:

(1) Radiation survey instruments will be calibrated:

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

(b) Within the preceding six months for radiographic operations conducted at temporary job sites and twelve months for all other operations;

(c) After each instrument servicing other than battery replacement;

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

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

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

(g) At appropriate points for digital instruments.

(2) Direct reading dosimeters will:

(a) Have a range from zero to two millisieverts (two hundred millirem);

(b) Read within plus or minus twenty per cent of the true radiation exposure; and

(c) Be checked for correct response to radiation at periods not to exceed twelve months.

(3) Personnel dosimeters, except for direct and indirect reading dosimeters used to measure the dose to any extremity, that need processing to determine the radiation dose will be processed and evaluated by a dosimetry processor that holds a current personnel dosimetry accreditation from the "National Voluntary Laboratory Accreditation Program" (NVLAP) of the national institute of standards and technology.

(4) The results of all survey instrument and direct reading dosimeter calibration will be recorded.

(C) Radiographic systems will be operated by radiographers and radiographer's assistants who meet the following:

(1) No individual will act as a radiographer or radiographer's assistant unless such individual has been instructed in, and has demonstrated understanding by successful completion of a written examination and competency by successful completion of a practical examination in the subjects identified in this paragraph. Training will be presented on a formal basis and will include the following subjects:

(a) Fundamentals of radiation safety and methods of controlling radiation;

(i) Time;

(ii) Distance;

(iii) Shielding; and

(iv) Collimation;

(b) Characteristics of radiation;

(c) Units of radiation dose;

(i) Significance of radiation dose; and

(ii) Radiation protection standards;

(d) Biological effects of radiation;

(e) Levels of radiation from sources of radiation;

(f) Applicable obligations of state regulations;

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

(h) Operation, inspection, maintenance and control of non-medical radiation-generating equipment to be used;

(i) Use of radiation survey instruments;

(i) Operation;

(ii) Calibration; and

(iii) Limitations;

(j) Survey techniques;

(k) Use of personnel monitoring equipment, to include;

(i) Distribution, wearing and exchange procedures;

(ii) Typically expected exposure levels; and

(iii) Methods to keep exposure levels as low as reasonably achievable; and

(l) Case histories of non-medical radiation-generating equipment accidents.

(2) Certification obligations for radiographers:

(a) Radiographers will 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 obligations in the appendix to this rule; and

(b) Prior to any individual acting as a radiographer, he or she will demonstrate one month of prior on-the-job experience.

(D) The handler will provide refresher training for operators of radiographic systems at intervals not to exceed twelve months.

(1) The training will include, as a minimum:

(a) Any results of internal inspections;

(b) New procedures or equipment;

(c) New or revised regulations;

(d) Any accidents or errors that have been observed; and

(e) Opportunities for attendees to ask safety questions.

(2) The training will be recorded and include, as a minimum:

(a) A list of the topics discussed during the refresher training;

(b) The dates the training was conducted; and

(c) The names of the instructors and attendees.

(E) The individual responsible for radiation protection (IRRP) for radiographic systems will:

(1) Be qualified as an industrial radiographer in accordance with paragraphs (C)(1) and (C)(2) of this rule; or

(2) Hold an associate's degree or higher in health physics, radiologic science, nuclear medicine, nuclear engineering or other ionizing radiation-related discipline.

(F) The specific duties and authorities of the individual responsible for radiation protection (IRRP) include, but are not limited to:

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

(2) Ensuring that operations are conducted safely and to assume control for instituting corrective actions when necessary.

(G) In addition to the obligations of paragraph (F) of this rule, the specific duties and authorities of the individual responsible for radiation protection (IRRP) of radiographic systems addressed in rule 3701:1-68-03 of the Administrative Code include, but are not limited to:

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

(2) Ensuring that obligated radiation surveys are performed and recorded in accordance with the Administrative Code, including any corrective measures when levels of radiation exceed established limits;

(3) 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 obligated by paragraph (C) of rule 3701:1-38-21 of the Administrative Code; and

(4) Auditing each radiographer and radiographer's assistant at intervals not to exceed six months to ensure that the applicable paragraphs of the Ohio Administrative Code and the registrant's operating and emergency procedures are followed.

(a) The audit will:

(i) Include observation of the performance of each radiographer and radiographer's assistant during an actual non-medical radiographic operation, and

(ii) Provide that, if a radiographer or a radiographer's assistant has not participated in a non-medical radiographic operation for more than six months since the last audit, the radiographer or radiographer's assistant will demonstrate knowledge of the training obligations of paragraphs (C)(1)(h), (C)(1)(i) and (C)(1)(j) of this rule by a practical examination before the individual can participate in a radiographic operation.

(b) The director may consider alternatives in those situations where the individual serves as both radiographer and individual responsible for radiation protection.

(c) In those operations where a single individual serves as both radiographer and individual responsible for radiation protection, and performs all radiographic operations, an audit program is not needed.

(d) A record of the audit will include, as a minimum:

(i) The identity of the radiographer or radiographer's assistant audited;

(ii) A list showing the items checked; and

(iii) Any non-compliance observed by the individual responsible for radiation protection.

(H) Operators of analytical, cabinet, hand-held and miniature radioscopic systems are exempt from the obligations of paragraphs (C), (D), and (E) of this rule, and will be obligated to receive training and demonstrated competence in the following:

(1) The safe operation procedures for the equipment;

(2) Precautions and measures to take to minimize radiation exposure;

(3) Significance of the various radiation warning, safety devices, and interlocks incorporated into the systems, or the reasons they have not been installed on certain parts of the systems and the extra precautions needed in such cases;

(4) Recognition of the potential hazards of use, biological effects of radiation, radiation risks, and recognition of signs and symptoms of an acute localized exposure;

(5) Procedures for reporting an actual or suspected accidental exposure or other radiation safety concerns, such as any unusual occurrence or malfunction that may involve exposure to radiation; and

(6) Performing surveys where applicable.

(I) Operators of permanent radiographic installations that meet the design obligations of rule 3701:1-68-06 of the Administrative Code and operators of radiographic particle accelerators, or bomb detection systems are obligated to meet the training topics of paragraph (C)(1) of this rule, but are exempt from the obligations of paragraphs (C)(2) and (E) of this rule.

(J) The director may, upon application thereof or upon his or her own initiative, grant a variance to the obligations of this chapter 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 will 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.

Last updated June 30, 2023 at 12:42 AM

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 6/9/2028
Prior Effective Dates: 5/17/2004, 6/20/2010
Rule 3701:1-68-03 | Non-medical radiographic systems.
 

In addition to the applicable rules in this chapter and Chapter 3701:1-38 of the Administrative Code, handlers of radiographic systems will comply with the following:

(A) Radiographic systems will meet the following equipment standards:

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

(2) A readily visible warning light, labeled with the words "X-RAY ON" or words or symbols having a similar intent, will be located on or near the x-ray source and its controls and will be illuminated when the x-ray source is energized.

(3) All radiographic systems will 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 x-ray source housing; 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.

(4) Permanent radiographic installations will be equipped with the following:

(a) Failsafe interlocks 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.

(5) The exposure switch of hand-held radiographic systems will meet the following:

(a) The switch will be of the "dead-man" type;

(b) The operator will be able to terminate the exposure at any time during an exposure of greater than one-half second; and

(c) It will not be possible to make an exposure when the timer is set to "zero" or "off" position if either position is provided.

(B) Handlers of radiographic systems will comply with the following radiation safety obligations:

(1) Sufficient calibrated and operable radiation survey instruments will be maintained to make physical radiation surveys as obligated by this rule and rule 3701:1-38-14 of the Administrative Code. Radiation survey instruments obligated by this rule will have a range such that 0.2 millisievert (two millirem) per hour through 0.01 sievert (one rem) per hour can be measured.

(2) Radiation area surveys will be performed and the results recorded to confirm compliance with paragraph (A) of rule 3701:1-38-14 of the Administrative Code in accordance with the following:

(a) Upon installation;

(b) After any changes in shielding or the radiographic system that is part of permanent radiographic installation; and

(c) Each time the radiographic system has been moved to an area that has yet to be evaluated for radiation levels at temporary job sites.

(3) A physical radiation survey will be made after each radiographic exposure to verify that the radiation-generating equipment is not still producing radiation unless:

(a) Personnel devices providing an audible signal when activated by radiation and proper operation of the audible detection device is check and recorded daily;

(i) The audible device will be designed so as to clearly indicate entry into a 0.02 mSv (two mrem) per hour or greater radiation field; and

(ii) All personnel working with the radiation-generating equipment will be provided with such a device; or

(b) Stationary area monitors providing an audible signal when activated by radiation will be acceptable and proper operation of the stationary detection device is checked and recorded daily;

(i) The stationary device will be designed so as to clearly indicate entry into a 0.02 mSv (two mrem) per hour or greater radiation field; and

(ii) Stationary area monitors will be evaluated annually to verify that the audible signal activates in a 0.02 mSv (two mrem) per hour radiation field.

(4) A utilization log will be maintained between inspections showing the following information for each radiographic system used:

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

(b) Locations and dates of use;

(c) Operating voltage, tube current, and exposure time for each radiographic exposure; and

(d) Identity of the operator.

(5) Operating and emergency procedures will include instructions in at least the following:

(a) Inspection, maintenance and operability checks of radiographic systems and radiation survey instruments;

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

(c) Notifying proper personnel in the event of an accident; and

(d) Identifying and reporting defects and noncompliance according to the obligations of rule 3701:1-38-23 of the Administrative Code, involving:

(i) The failure of any component, which is critical to safe operation of the device to properly perform its intended function;

(ii) The failure of an indicator on non-medical radiation-generating equipment to show that radiation is being produced;

(iii) The failure of an exposure switch to terminate production of radiation when turned to the off position; or

(iv) The failure of a safety interlock to terminate x-ray production.

(6) At least two qualified individuals will be present at a temporary job site when a radiographic system is being used. At least one of the individuals will be the radiographer to whom the radiographic system is assigned and the other individual will be either a radiographer or a radiographer's assistant.

(7) No individual other than a radiographer or a radiographer's assistant who is under the personal supervision of a radiographer will manipulate controls or operate equipment used in radiographic operations. The personal supervision will include:

(a) The radiographer's physical presence at the site where the radiographic system is being used;

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

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

(8) The handler will not permit any individual to act as a radiographer or as a radiographer's assistant unless, at all times during radiographic operations, each such individual wears, on the trunk of the body, an appropriate direct reading dosimeter and a personnel dosimeter. Analog pocket dosimeters will be recharged at the start of each shift. Electronic dosimeters will be battery-tested at the beginning of each shift. Each personnel dosimeter will be assigned to and worn by only one individual and the handler will assure that:

(a) Direct reading dosimeters are read and exposures are recorded at the beginning and end of each shift.

(b) 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 will be sent for processing within twenty-four hours. In addition, the individual will not resume work associated with the use of x-ray sources until a determination of the individual's radiation exposure has been made. This determination will be made by the individual responsible for radiation protection (IRRP) or the IRRP's designee and the results of this determination will be recorded.

(9) The handler will not permit any individual to perform radiographic operations unless, at all times during radiographic operations, each such individual wears, on the trunk of the body, a personnel monitoring device that will be calibrated for the x-ray energies being utilized.

(a) Personnel dosimeters will be exchanged monthly unless the IRRP has performed an evaluation that indicates a longer frequency is adequate; in this instance the frequency will not exceed three months.

(b) If a personnel dosimeter is lost or damaged, the worker will 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 will 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 will be recorded.

(i) After replacement, each personnel dosimeter will be returned to the supplier for processing within fourteen calendar days of the end of the monitoring period; or

(ii) In circumstances that make it impossible to return each personnel dosimeter in fourteen calendar days, such circumstances will be recorded.

(10) During each radiographic operation, the radiographer, radiographer's assistant or operator will 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 interlocks and signals as described in paragraph (A)(4) of this rule; or

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

(11) When performing radiographic operations at a location other than a permanent radiographic installation having the control devices specified in paragraph (B)(10) of this rule, the industrial radiographer will 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 by using appropriate barriers, such as rope or tape, 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.

(C) In addition to the radiation protection obligations in rule 3701:1-68-02 of the Administrative Code, handlers of radiographic systems will comply with the following:

(1) Radiation survey instrumentation described in paragraph (B)(1) of this rule will be checked and the results recorded at the beginning of each work shift using check sources or other appropriate means to ensure it is operating accurately. If any check conducted reveals the radiation survey instrumentation is not operating accurately, the instrument will not be used to meet the survey obligations of paragraph (B)(2) of this rule.

(2) Radiographic systems will be checked and the results recorded prior to each shift of use to ensure all necessary labeling is present and identify any obvious defects. If any check conducted reveals damage to components critical to radiation safety, the device will be locked out and tagged "DO NOT USE" until repairs have been made.

(3) Entrance interlocks and signals described in paragraph (A)(4) of this rule, will be tested and the results recorded at the beginning of each day of equipment use to ensure proper operation. If an entrance interlock or signal is operating improperly, it will 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 obligations of this rule.

(4) The following documents and records will be available for inspection at each temporary job site:

(a) Appropriate certificate of registration;

(b) Operating and emergency procedures;

(c) Applicable rules promulgated pursuant to Chapter 3748. of the Revised Code;

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

(e) Daily dosimetry for the period of operation at the site;

(f) The latest calibration records for the specific survey instruments and direct reading dosimeters in use at the site. Acceptable records include tags or labels which are affixed to the survey instrument or dosimeter; and

(g) Radiation survey instrumentation checks and radiographic system checks for devices in use at the site.

(D) Handlers of radiographic systems used for bomb detection purposes:

(1) Will be exempt from paragraphs (B)(1) to (B)(3), (B)(6) to (B)(11), (C)(1) to (C)(3) and (C)(4)(d) to (C)(4)(g) of this rule.

(2) May change the interval for calibrating radiation survey instruments as specified in paragraph (B)(1)(b) of rule 3701:1-68-02 of the Administrative Code to annual; and

(3) Will evaluate radiographic systems and record the results of the evaluations, at least annually, 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.

(E) Handlers of hand-held radiographic systems will:

(1) Be exempt from paragraphs (B)(1) to (B)(3), (B)(6) to (B)(11), (C)(1) to (C)(3) and (C)(4)(d) to (C)(4)(g) of this rule.

(2) Evaluate the radiographic systems and record the results of the evaluation, at least annually, 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.

(3) Obligate 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) Requiring the backscatter shield to be in place during all radiographic exposures, if the manufacturer of the hand-held radiation-generating equipment provides a backscatter shield; and

(c) Assuring that the system remains in direct control of the authorized operator and the operator will not aim the primary beam at him/herself or at any individual during exposure;

(d) Establishing and maintaining a restricted area of at least six feet opposite the side of the material being exposed;

(e) Banning individuals from holding material or the image receptor in their hand during exposure;

(f) Operating of software and trigger lock; and

(g) Requiring operators to wear assigned ring badges on the hand closest to the primary beam.

Last updated June 30, 2023 at 12:42 AM

Supplemental Information

Authorized By: 3748.04
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
Five Year Review Date: 6/9/2028
Prior Effective Dates: 10/1/2009
Rule 3701:1-68-04 | Non-medical analytical systems.
 

In addition to the applicable rules in this chapter and Chapter 3701:1-38 of the Administrative Code, handlers of analytical systems will comply with the following:

(A) Analytical systems will meet the following equipment standards:

(1) Open-beam analytical systems will;

(a) Provide an automatic shut-off feature that prevents any part of a person's body from being exposed to the primary x-ray beam path; or

(b) Request a variance from the director to include:

(i) The reason a device or an automatic shut-off feature cannot be used; and

(ii) A description of the alternative methods that will be employed to minimize the possibility of an accidental exposure, including procedures to assure that the operators and others in the area will be informed of the absence of safety devices.

(2) Analytical system installed after February 10, 2006, will 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 analytical system will be provided with a readily discernible indication of:

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

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

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

(4) All analytical systems will 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. Open-beam analytical systems will 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 x-ray source housing installed on or after August 1, 2011 will be equipped with an interlock that shuts off the radiation beamwhen the housing is opened. For each x-ray source housing installed prior to August 1, 2011 and not equipped with an interlock, administrative controls will be instituted to include that the power will be disconnected before any disassembly.

(6) Unused beam ports on x-ray source housings will be secured in the closed position, or mechanically blocked.

(7) All analytical systems other than open-beam analytical systems will be supplied with a protective cabinet which limits leakage radiation measured at a distance of five centimeters from any external 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 analytical systems will comply with the following radiation safety obligations:

(1) The facility's individual responsible for radiation protection (IRRP) will document and implement operating procedures relative to radiation safety. The IRRP will be qualified in accordance with paragraph (H) of rule 3701:1-68-02 of the Administrative Code. The IRRP will assure and document that all operators of analytical systems have received appropriate training. No individual will be permitted to operate analytical systems 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 will be recorded. This record will:

(a) 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) Be approved, and signed in advance for a specified period of time by the individual responsible for radiation protection, and posted near the x-ray 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 x-ray source housings or modifications to shutters, collimators, or beam stops will be performed without ascertaining that the x-ray source is off and will remain off until safe conditions have been restored. The x-ray source power switch, in conjunction with appropriate interlocks, will be used for routine shutdown in preparation for repairs.

(C) In addition to the radiation protection obligations in rule 3701:1-68-02 of the Administrative Code, handlers of analytical systems will comply with the following:

(1) The local components of an analytical system will 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 will be met at any specified radiation source rating.

(2) Radiation area surveys of all analytical systems will be performed and the results recorded to confirm compliance with paragraph (A) of rule 3701:1-38-14 the Administrative Code:

(a) Upon installation;

(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 obligate the presence of a primary 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) Analytical systems will be evaluated and the results recorded at least every six months by individuals qualified according to paragraph (H) of rule 3701:1-68-02 of the Administrative Code, unless the system has been locked out and tagged "DO NOT USE."

(a) The evaluation will verify:

(i) Proper functioning of each interlock and warning light; and

(ii) Each tag and label is legible and properly affixed in the appropriate location.

(b) If an interlock or light is not functioning properly, it will be immediately labeled as defective and repaired or replaced within seven calendar days.

(4) Finger or wrist radiation monitoring devices will be provided to and will be used by:

(a) Operators of open-beam analytical systems without provisions for engineering controls as provided in paragraph (A)(1) of this rule; and

(b) Personnel maintaining analytical systems if the maintenance procedures include the presence of an external radiation beam when any local component in the analytical system is disassembled or removed.

(D) Handlers of gauging units will be exempt from the obligations of paragraphs (C)(2)(c) to (C)(2)(e) of this rule.

(E) Handlers of hand-held analytical systems will:

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

(2) Obligate 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) Banning 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 primary beam.

Last updated June 30, 2023 at 12:42 AM

Supplemental Information

Authorized By: 3748.04
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
Five Year Review Date: 6/9/2028
Prior Effective Dates: 8/1/2011
Rule 3701:1-68-05 | Non-medical particle accelerator systems.
 

In addition to the applicable rules in this chapter and Chapter 3701:1-38 of the Administrative Code, handlers of particle accelerator systems will comply with the following :

(A) Radiation-generating equipment used for particle acceleration will meet the following equipment standards:

(1) All safety instrumentation, readouts, and controls on the particle accelerator control console will be clearly identified and easily discernible.

(2) Each safety interlock will be on a circuit which allows it to operate independently of all other safety interlocks.

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

(4) If a safety interlock system has been tripped, it will 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.

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

(B) Handlers of particle accelerator systems will comply with the following radiation safety obligations:

(1) Each particle accelerator installation will be provided with such shielding as is necessary to assure compliance with the applicable rules adopted pursuant to Chapter 3701:1-38 of the Administrative Code.

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

(3) Each high radiation area will have an audible and visual signal which will be activated for at least fifteen seconds prior to the possible creation of such a high radiation area. Such signals will be clearly discernible in all high radiation areas.

(4) Each location designated as a high radiation area, and each entrance to such location, will be equipped with visible signals that illuminate when, and only when the high-voltage portion of the machine is being energized.

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

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

(7) The handler will not permit any individual to operate a particle accelerator system unless, at all times during operations, each operator is supplied with and wears an appropriate direct reading dosimeter and personnel dosimeter. Analog pocket dosimeters will be recharged at the start of each shift. Electronic dosimeters will be battery-tested at the beginning of each shift. Each personnel dosimeter will be assigned to and worn by only one individual and the handler will assure that:

(a) Direct reading dosimeters are read and exposures are recorded at the beginning and end of each shift.

(b) 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 will be sent for processing within twenty-four hours. In addition, the individual will not resume work associated with the use of a particle accelerator system until a determination of the individual's radiation exposure has been made. This determination will be made by the individual responsible for radiation protection (IRRP) or the IRRP's designee. The results of this determination will be recorded.

(c) Personnel dosimeters will be exchanged monthly unless the IRRP has performed an evaluation that indicates a longer frequency is adequate; in this instance the frequency will not exceed three months.

(d) If a personnel dosimeter is lost or damaged, the worker will 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 will 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 will be recorded:

(i) After replacement, each personnel dosimeter will be returned to the supplier for processing within fourteen calendar days of the end of the monitoring period; or

(ii) In circumstances that make it impossible to return each personnel dosimeter in fourteen calendar days, such circumstances will be recorded.

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

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

(a) Authorized by the IRRP;

(b) Recorded in a permanent log;

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

(d) Terminated as soon as possible.

(10) The particle accelerator will be secured when not in operation to prevent unauthorized use.

(C) In addition to the radiation protection obligations in rule 3701:1-68-02 of the Administrative Code, handlers of particle accelerator systems will comply with the following:

(1) A radiation expert, with education and experience acceptable to the director, will 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) A radiation shielding survey will be performed and recorded by aradiation expert, with education and experience acceptable to the director, when changes have been made in shielding, operation, equipment, or occupancy of adjacent areas.

(3) All surveys will be made in accordance with the written procedures established by a radiation expert, with education and experience acceptable to the director.

(4) Portable monitoring equipment will be tested for proper operation and the results recorded daily.

(5) Particle accelerator systems will be evaluated and the results recorded at least every three months not to exceed fourteen weeks, by individuals qualified according to paragraph (I) of rule 3701:1-68-02 of the Administrative Code, unless the system has been locked out and tagged "DO NOT USE" and is under administrative control of the IRRP:

(a) The evaluation will verify:

(i) Proper functioning of interlocks and warning devices; and

(ii) Each label is legible and properly affixed in the appropriate location.

(b) In the event the safety equipment is operating improperly, it will be immediately reported to the IRRP and will be repaired or replaced and never bypassed so as to enable radiation production.

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

(7) A copy of the current operating and the emergency procedures will be maintained at the particle accelerator system control panel.

(D) The IRRP will be qualified in accordance with paragraph (I) of rule 3701:1-68-02 of the Administrative Code. In addition to the obligations of paragraph (F) of rule 3701:1-68-02 of the Administrative Code, the specific duties and authority of the IRRP for particle accelerator systems include, but are not limited to:

(1) Termination of the operations if such action is deemed necessary to minimize danger to public health and safety.

(2) The development and maintenance of a particle accelerator handbook that describes the electrical circuits and the associated interlock systems. This handbook will be kept current as to any changes in the system.

(3) Documenting that individuals have 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.

Last updated June 30, 2023 at 12:42 AM

Supplemental Information

Authorized By: 3748.04
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
Five Year Review Date: 6/9/2028
Prior Effective Dates: 2/15/2001
Rule 3701:1-68-06 | Non-medical cabinet systems.
 

In addition to the applicable rules in this chapter and Chapter 3701:1-38 of the Administrative Code, handlers of cabinet systems will comply with the following:

(A) All cabinet system will meet the following equipment standards:

(1) Radiation emitted from a cabinet system will not exceed an exposure of 4.4 microgray (0.5 milliroentgen) in one hour at any point five centimeters outside the external surface.

(2) Cabinet systems provided with at least one port will be designed such that the insertion of any part of the human body through any port into the primary beam will not be possible.

(3) Cabinet systems provided with at least one aperture will be designed such that the insertion of any part of the human body through any aperture will not be possible.

(4) Safety Interlocks:

(a) Each door will have a minimum of two safety interlocks. One, but not both of theobligated interlocks will be such that door opening results in physical disconnection of the energy supply circuit to the high-voltage generator, and such disconnection will not be dependent upon any moving part other than the door;

(b) Each access panel will have at least one safety interlock;

(c) Following interruption of x-ray generation by the functioning of any safety interlock, use of a control provided in accordance with paragraph (A)(6)(b) of this rule will be necessary for resumption of x-ray generation; and

(d) Failure of any single part of the enclosed fail-safe system will not cause failure of more than one obligated safety interlock.

(5) A ground fault will not result in the generation of x-rays.

(6) Controls and indicators will provide:

(a) A key-actuated control to ensure that x-ray generation is not possible with the key removed;

(b) A control or controls to initiate and terminate the generation of x-rays other than by functioning of a safety interlock or the main power control;

(c) Two independent means which indicate when and only when x-rays are being generated, unless the x-ray generation period is less than one-half second, in which case the indicators will be activated for one-half second, and which are discernible from any point at which initiation of x-ray generation is possible. Failure of a single part of the cabinet system will not cause failure of both indicators to perform their intended function. One, but not both, of the indicators obligated by this paragraph may be a milliammeter labeled to indicate x-ray tube current. All other indicators will be legibly labeled "X-RAY ON";

(d) Additional means other than milliammeters which indicate when and only when x-rays are being generated, unless the x-ray generation period is less than one-half second in which case the indicators will be activated for one-half second, as needed to insure that at least one indicator is visible from each door, access panel, and port, and is legibly labeled "X-RAY ON"; and

(e) Warning labels:

(i) There will be permanently affixed or inscribed on the cabinet x-ray system at the location of any controls which can be used to initiate x-ray generation, a clearly legible and visible label bearing the statement: "CAUTION: X-RAYS PRODUCED WHEN ENERGIZED."

(ii) There will be permanently affixed or inscribed on the cabinet x-ray system adjacent to each port a clearly legible and visible label bearing the statement: "CAUTION: DO NOT INSERT ANY PART OF THE BODY WHEN SYSTEM IS ENERGIZED - X-RAY HAZARD."

(B) In addition to the obligations specified in paragraph (A) of this rule, cabinet systems that are designed to admit humans will provide:

(1) A control within the enclosure for preventing and terminating x-ray generation, which is electrically and/or mechanically separated from the interlock system and cannot be reset, overridden or bypassed from the outside of the enclosure.

(2) No means by which x-ray generation can be initiated from within the enclosure.

(3) Audible and visible warning signals within the enclosure that are actuated for at least ten seconds immediately prior to the first initiation of x-ray generation after closing any door designed to admit humans. Failure of any single part of the cabinet system will not cause failure of both the audible and visible warning signals.

(4) A visible warning signal within the enclosure which remains actuated when and only when x-rays are being generated, unless the x-ray generation period is less than one-half second in which case the indicators will be activated for one-half second.

(5) All entrances into the enclosure will be provided with a conspicuously visible warning device, which operates only when radiation is being produced.

(6) Signs indicating the meaning of the warning signals provided pursuant to paragraphs (B)(3) and (B)(4) of this rule and containing instructions for the use of the control provided pursuant to paragraph (B)(1) of this rule. These signs will be legible, accessible to view, and illuminated when the main power control is in the "on" position.

(7) A means for a person within the enclosure to be able to egress at all times.

(C) In addition to the obligations specified in paragraph (A) of this rule, non-human security screening systems and cabinet x-ray systems with accessible openings will:

(1) Have means to ensure operator presence at the control area in a position which permits surveillance of the openings and doors during generation of x-radiation.

(2) During an exposure or preset succession of exposures of one-half second or greater duration, provide the means to enable the operator to terminate the exposure or preset succession of exposures at any time.

(3) During an exposure or preset succession of exposures of less than one-half second duration, may provide the means to allow completion of the exposure in progress but will enable the operator to prevent additional exposures.

(D) Cabinet systems will be evaluated and the results recorded every three months not to exceed fourteen weeks, by individuals qualified according to paragraph (H) of rule 3701:1-68-02 of the Administrative Code, unless the system has been locked out and tagged "DO NOT USE" and is under the administrative control of the IRRP:

(1) The evaluation will verify:

(a) Proper functioning of each interlock, control, indicator and warning signal; and

(b) Each label is legible and properly affixed in the appropriate location.

(2) If an interlock, control, indicator or warning signal fails, it will be immediately labeled as defective and repaired or replaced within seven calendar days.

(E) Radiation area surveys will be performed and the results recorded to confirm compliance with paragraph (A)(1) of this rule and paragraph (A) of rule 3701:1-38-14 of the Administrative Code in accordance with the following:

(1) Upon installation of the equipment;

(2) During the performance of maintenance, calibration and other procedures if the procedures obligate the presence of a primary beam; and

(3) Any time a visual inspection of the cabinet system reveals an abnormal condition.

(F) A physical radiation survey will be made after each radiographic exposure and before entry of personnel into a cabinet system designed to admit humans to verify that the radiation-generating equipment is not still producing radiation.

(1) Personnel devices providing an audible signal when activated by radiation will be acceptable for the survey, provided:

(a) Proper operation of the audible detection device is checked and recorded daily;

(b) The audible device is designed so as to clearly indicate entry into a 0.02 mSv (two mrem) per hour or greater radiation field; and

(c) All personnel working with the cabinet system are equipped with such a device; or

(2) Stationary area monitors providing an audible signal when activated by radiation will be acceptable for the survey, provided:

(a) Proper operation of the stationary detection device is checked and recorded daily;

(b) The stationary device is designed so as to clearly indicate entry into a 0.02 mSv (two mrem) per hour or greater radiation field; and

(c) Stationary area monitors are evaluated annually to determine that the audible signal operates at a 0.02 mSv (two mrem) per hour radiation field.

(G) The "Individual Responsible for Radiation Protection" (IRRP) will be qualified in accordance with paragraph (H) of rule 3701:1-68-02 of the Administrative Code.

Last updated June 30, 2023 at 12:42 AM

Supplemental Information

Authorized By: 3748.04
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
Five Year Review Date: 6/9/2028
Prior Effective Dates: 10/1/2009