Chapter 3701:1-38 License or Registration for Radiation Handlers

3701:1-38-01 Definitions.

(A) As used in this chapter and all other rules promulgated pursuant to Chapter 3748. of the Revised Code:

(1) "A1" means the maximum activity of special form radioactive material permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(2) "A2 " means the maximum activity of radioactive material, other than special form, low specific activity and surface contaminated object material, permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(3) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray, or Gy, and the rad.

(4) "Accelerator or charged particle accelerator" means any of a class of radiation generating equipment designed to electronically accelerate atomic or sub-atomic particles for subsequent bombardment of targets.

(5) "Accelerator-produced radioactive material" means any material made radioactive by a particle accelerator.

(6) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel, or Bq, and the curie, or Ci.

(7) "Address of use" means the building or buildings that are identified on the license or registration and where the source of radiation may be received, used, prepared, or stored, except for temporary job sites.

(8) "Administrative controls" means mechanisms used to protect health and minimize damage to life and property through the use of written policies, procedures, instructions, training, observation of work practices, and related compliance audits.

(9) "Administrative monetary penalty" means a monetary penalty assessed by the director under section 3748.05 of the Revised Code and in compliance with rules adopted thereunder, to emphasize the need for lasting remedial action and to deter future violations.

(10) "Adult" means an individual eighteen or more years of age.

(11) "Agreement state" means any state with which the United States nuclear regulatory commission or the atomic energy commission has entered into an effective agreement under subsection 274B of the Atomic Energy Act. Non-agreement state means any other state.

(12) "Airborne radioactive material" means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

(13) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in appendix C to rule 3701:1-38-12 of the Administrative Code, or

(b) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 per cent of the annual limit on intake or twelve DAC-hours.

(14) "Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

(15) "ALARA" or "as low as is reasonably achievable" means every reasonable effort to maintain exposures to radiation as far below the dose limits as is practical consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials and registered activities in the public interest.

(16) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by off-site response organizations to protect persons off-site.

(17) "Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 sievert (five rem) or a committed dose equivalent of 0.5 sievert (fifty rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(18) "Annually" means either

(a) At intervals not to exceed one year; or

(b) Once per year, at about the same time each year, plus or minus one month.

(19) "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing sources of radiation.

(20) "Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

(21) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied air respirators, or SARs, and self-contained breathing apparatus, or SCBA, units.

(22) "Atomic energy commission" or "AEC" means the federal agency created by the Atomic Energy Act of 1954, as amended, and was the predecessor agency to the current United States nuclear regulatory commission created by the Energy Reorganization Act of 1974.

(23) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include radiation from radioactive materials regulated by the department.

(24) "Becquerel" or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration per second.

(25) "Bioassay" or "radiobioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body.

(26) "Byproduct material" means

(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear materials; or

(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from solution extraction processes. Underground ore bodies depleted by such solution extraction do not constitute byproduct material within the definition.

(27) "Chelating agent" means a chemical compound or mixture that enhances the removal of radioactive material from the body, water or similar applications. Typical chelating agents include amine polycarboxylic acids such as EDTA or DTPA; hydroxy-carboxylic acids; and polycarboxylic acids such as citric acid, carbolic acid, and gluconic acid.

(28) "Chiropractor" means an individual licensed by the state of Ohio to practice chiropractic medicine pursuant to Chapter 4734. of the Revised Code.

(29) "Class" or "lung class" or "inhalation class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for class D, days, of less than ten days, for class W, weeks, from ten to one hundred days, and for class Y, years, of greater than one hundred days.

(30) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(31) "Commencement of construction" means taking any action defined as "construction" or any other activity at the site of a facility subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that has a reasonable nexus to radiological health and safety.

(32) "Committed dose equivalent" or "HT,50 " means the dose equivalent to organs or tissues of reference, T, that will be received from an intake of radioactive material by an individual during the fifty year period following the intake.

(33) "Committed effective dose equivalent" or "HE,50 " means the sum of the products of the weighting factors applicable to each of the body organs or tissues, WT, that are irradiated and the committed dose equivalent to each of these organs or tissues (HE, 50 = WT HT,50).

(34) "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a medical facility.

(35) "Constraint" or "dose constraint" means a value above which specified licensee actions are required.

(36) "Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that are related to radiological safety or security. The term "construction" does not include:

(a) Changes for temporary use of the land for public recreational purposes;

(b) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(c) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(d) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code;

(e) Excavation;

(f) Erection of support buildings (e.g. construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(g) Building of service facilities (e.g. paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(h) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(i) Taking any other action that has no reasonable nexus to radiological health and safety.

(37) "Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.

(38) "Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

(38)

(39) "Curie" or "Ci" means a unit of activity. One curie equals 3.7 x 1010 disintegrations per second equals 3.7 x 1010 becquerels equals 2.22 x 1012 disintegrations per minute.

(40) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of ten megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

(41) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

(42) "Decommission" means to safely remove any licensed operation from service and reduce residual radioactivity to a level that permits release of the licensee's property for unrestricted use and termination of the license. Termination of a license under conditions other than unrestricted use is not permitted by Chapter 3748. of the Revised Code.

(43) "Dedicated check source" means a radioactive source that is used to assure the consistent performance of a radiation detection or measurement device over several months or years.

(44) "Deep dose equivalent" or "Hd " applies to external whole body exposure, and means the dose equivalent at a tissue depth of one centimeter, one thousand milligram per square centimeter.

(45) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

(46) "Dentist" means an individual licensed by the state of Ohio to practice dentistry under Chapter 4715. of the Revised Code.

(47) "Department" means the Ohio department of health.

(48) "Depleted uranium" means the source material uranium in which the isotope uranium-235 is less than 0.711 weight per cent of the total uranium present. Depleted uranium does not include special nuclear material.

(49) "Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. The condition of light work is inhaling 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(50) "Derived air concentration-hour or DAC-hour" means the product of the concentration of radioactive material in air, which is expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (five rem).

(51) "Direct reading dosimeter" means a device that measures radiation dose that does not require another device to read the measured radiation dose. Examples of direct reading dosimeters include pocket dosimeters and electronic dosimeters.

(52) "Director" means the director of health or a designee or authorized representative of the director.

(53) "Discipline" means a branch of knowledge or of teaching.

(54) "Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(55) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus.

(56) "Dose" or "radiation dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed effective dose equivalent, or total effective dose equivalent as defined in other paragraphs of this rule.

(57) "Dose equivalent" or "HT " means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert and rem.

(58) "Dose limits" or "limits" means the permissible upper bounds of radiation doses established in accordance with these regulations but excludes background radiation and medical exposure.

(59) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

(60) "Effective dose equivalent" or "HE " means the sum of the products of the dose equivalent to each organ or tissue, HT, and the weighting factor, WT, applicable to each of the body organs or tissues that are irradiated: (HE = SWT HT).

(61) "Embryo" or "fetus" means the developing human organism from conception until time of birth.

(62) "Engineering controls" means mechanisms used to protect health and minimize damage to life and property through engineering specifications, design, and construction of the product or facility including all of the security and safety features. This includes, but is not limited to, auxiliary security and safety features such as additional external shielding, barriers, and operational interlocks with associated processes.

(63) "Entrance" or "access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials or registered radiation generating equipment. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

(64) "Explosive material" means any chemical compound, mixture or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

(65) "Exposure" means being exposed to sources of ionizing radiation.

(66) "External dose" means that portion of the dose equivalent received from radiation sources outside the body.

(67) "Extremity" means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

(68) "Eye dose equivalent" means the same as lens dose equivalent.

(69) "Facility" means all buildings, equipment, structures and other stationary items that, in addition to the meaning defined in division (H) of section 3748.01 of the Revised Code, are:

(a) Located on a single site or on contiguous or adjacent sites and are operated by the same person and have common corporate or business interests; or

(b) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(70) "Filtering facepiece" or "dust mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

(71) "Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in rule 3701:1-50-13 of the Administrative Code.

(72) "Fit factor" means quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

(73) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

(74) "Generally applicable environmental radiation standards" means standards issued by the United States environmental protection agency under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(75) "Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (one hundred rads).

(76) "Handler" means a facility that handles sources of radiation unless possession is solely for the purpose of transportation.

(77) "Hazardous waste" means those wastes designated as hazardous by rule 3745-51-03 of the Administrative Code.

(78) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

(79) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one millisievert ( 0.1 rem) in one hour at thirty centimeters from the radiation source or thirty centimeters from any surface that the radiation penetrates.

(80) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

(81) "Individual" means any human being.

(82) "Individual monitoring" means

(a) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(b) The assessment of committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e. DAC-hours; or

(c) The assessment of dose equivalent by the use of survey data.

(83) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges; thermoluminescent dosimeters; optically stimulated luminescent dosimeters; pocket ionization chambers; and personal air sampling devices.

(84) "Industrial radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive material or radiation-generating equipment.

(85) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

(86) "Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (five hundred rads) per hour exist at one meter from the sealed radioactive source in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

(87) "Lens dose equivalent" or "eye dose equivalent" means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters; i.e. three hundred milligrams per square centimeter.

(88) "License" means a license issued by the nuclear regulatory commission, the director, or another agreement state in accordance with rules adopted by those organizations.

(89) "Licensee" means a person to whom a license is issued.

(90) "Licensed activity" means an activity authorized by a radioactive material license which is essential to achieving the purpose for which the license was issued or amended.

(91) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license.

(92) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

(93) "Lost or missing licensed source of radiation" means a licensed source of radiation whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

(94) "Low-level radioactive waste" or "LLRW," also "low-level waste," or "LLW" means radioactive waste which is not high-level radioactive waste, spent nuclear fuel, NARM, or byproduct material as defined in section 11 E. (2) of the Atomic Energy Act of 1954, as amended, but is radioactive material that the United States nuclear regulatory commission classifies as low-level radioactive waste.

(95) "Low specific activity material" or "LSA" means radioactive material with limited specific activity which is nonfissile or is excepted under rule 3701:1-50-13 of the Administrative Code, and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA must be in one of three groups:

(a) LSA - I.

(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides which are not intended to be processed for the use of these radionuclides;

(ii) Solid unirradiated natural uranium or depleted uranium or natural thorium or their solid or liquid compounds or mixtures;

(iii) Radioactive material for which the A2 value is unlimited; or

(iv) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed thirty times the value for exempt material activity concentration determined in accordance with rule 3701:1-50-25 of the Administrative Code.

(b) LSA-II.

(i) Water with tritium concentration up to 0.8 terabecquerels per liter (twenty curies per liter); or

(ii) Other material in which the activity is distributed throughout and the average specific activity does not exceed ( 0.0001 x A2 ) per gram for solids and gases, and ( 0.00001 x A2 ) for liquids.

(c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 C.F.R. 71.77 (as published in the January 1, 2006, Code of Federal Regulations), in which:

(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);

(ii) The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed ( 0.1 x A2 ); and

(iii) The estimated average specific activity of the solid does not exceed ( 0.002 x A2 ) per gram.

(96) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

(97) "Medical institution" means an organization in which more than one medical discipline is practiced.

(98) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(99) "Member of the public" means any individual except when that individual is receiving an occupational dose.

(100) "Minor" means an individual less than eighteen years of age.

(101) "Monitoring" or "radiation monitoring" or "radiation protection monitoring" means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

(102) "NARM" or "naturally occurring or accelerator-produced radioactive material" means naturally occurring or accelerator-produced radioactive material, including naturally occurring material that is technologically enhanced, and those nuclides that are generated in a charged particle accelerator, but does not include source material, byproduct material, or special nuclear material.

(103) "NARM licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the conference of radiation control program directors, inc.

(104) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than "Category 1" or "Category 2" levels of any radioactive material listed in the appendix to rule 3701:1-38-25 of the Administrative Code. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. "Category 1" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 1" threshold. "Category 2" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 2" threshold but less than the "Category 1" threshold.

(105) "Negative pressure respirator" or "tight fitting respirator" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

(106) "Nonstochastic effect" or "deterministic effect" means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect.

(107) "NORM" or "naturally occurring radioactive material" means any nuclide that is radioactive in its natural physical state, but does not include source material, byproduct material, or special nuclear material.

(108) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

(109) "Nuclear regulatory commission" means the federal agency established by Title II of the Energy Reorganization Act of 1974, as amended, comprising the members of the commission and all offices, employees, and representatives authorized to act in any case or matter related to licensing and related regulatory function previously assigned to the AEC by the Atomic Energy Act of 1954, as amended.

(110) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, from voluntary participation in medical research programs, or as a member of the public.

(111) "Package" means the packaging together with its radioactive contents as presented for transport.

(a) Fissile material package or type AF package, type BF package, type B(U)F package, or type B(M)F package means a fissile material packaging together with its fissile material contents.

(b) Type A package means a type A packaging together with its radioactive contents. A type A package is defined and must comply with the United States department of transportation regulations in 49 C.F.R. 173 (as published in the October 1, 2005, Code of Federal Regulations).

(c) Type B package means a type B packaging together with its radioactive contents. On approval, a type B package design is designated by the United States nuclear regulatory commission as B(U) unless the package has a maximum normal operating pressure of more than seven hundred kilopascals (one hundred pounds per square inch) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 C.F.R. 71.73 (hypothetical accident conditions) (as published in the January 1, 2006, Code of Federal Regulations), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see United States department of transportation regulations in 49 C.F.R. 173 (as published in the October 1, 2005 Code of Federal Regulations). A type B package approved before September 6, 1983, was designated only as type B. Limitations on its use are specified in 10 C.F.R. 71.19 (as published in the January 1, 2006, Code of Federal Regulations).

(112) "Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of rule 49 C.F.R. 173 Subpart I (as published in the October 1, 2005, Code of Federal Regulations). It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system and auxiliary equipment may be designated as part of the packaging.

(113) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

(114) "Person" means any individual, corporation, association, business enterprise, or other legal entity either public or private and any legal successor, representative, agent, or agency of that individual, corporation, association, business enterprise, or other legal entity. Person also includes the United States, states, political subdivisions of states, and any department, agency, or instrumentality of the United States or a state, except the U.S. department of energy or the U.S. nuclear regulatory commission where the state regulation of radioactive material by either of those agencies is prohibited by federal law.

(115) "Personnel dosimeter", means a device that measures radiation dose that is processed and evaluated by an accredited "National Voluntary Laboratory Accreditation Program" (NVLAP) processor. Examples of personnel dosimeters include film badges, thermo-luminescent dosimeters (TLD), and optically stimulated luminescence (OSL) dosimeters.

(116) "Pharmacist" means a person who is licensed by the state of Ohio to practice pharmacy pursuant to Chapter 4731. of the Revised Code.

(117) "Physician" means a person who is licensed pursuant to Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery.

(118) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

(119) "Podiatrist" means an individual licensed by the state of Ohio to practice podiatry pursuant to Chapter 4731. of the Revised Code.

(120) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

(121) "Positron Emission Tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(122) "Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air purifying elements to the inlet covering.

(123) "Pressure demand respirator" means a positive pressure atmosphere supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

(124) "Public dose" means the dose received by a member of the public from exposure to radiation and/or radioactive material released by the licensee, or to any other source of radiation under the control of a licensee or registrant. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, or from voluntary participation in medical research programs.

(125) "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 54.4 degrees celsius (one hundred thirty degrees fahrenheit). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

(126) "Qualitative fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

(127) "Quality factor" or "Q" means the modifying factor, as listed in paragraphs (A) and (B) of rule 3701:1-38-11 of the Administrative Code, that is used to derive dose equivalent from absorbed dose.

(128) "Quantitative fit test" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

(129) "Quarter" or "quarterly" means a period of time equal to one-fourth of the year observed by the licensee or registrant, approximately thirteen consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(130) "Rad" means the special unit of radiation absorbed dose. One rad is equal to an absorbed dose of one hundred ergs per gram, or 0.01 joule per kilogram, or 0.01 gray.

(131) "Radiation" or "ionizing radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high speed electrons, high speed protons, and other particles capable of producing ions. Radiation does not include nonionizing radiation, such as radio or microwaves, or visible, infrared or ultraviolet light.

(132) "Radiation area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 millisievert ( 0.005 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates.

(133) "Radiation-generating equipment" or "RGE" means any manufactured product or device, or component of such a product or device, or any machine or system that during operation can generate or emit radiation, except those that emit radiation only from radioactive material. "Radiation-generating equipment" does not include either of the following:

(a) Diathermy machines;

(b) Microwave ovens, including food service microwave ovens used for commercial and industrial uses, television receivers, electric lamps, and other household appliances and products that generate very low levels of radiation.

(134) "Radiation Safety Officer" or "RSO" means an individual designated by the licensee 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.

(135) "Radioactive material" means any solid, liquid or gaseous material that emits ionizing radiation spontaneously. "Radioactive material" includes accelerator-produced and naturally occurring radioactive materials and byproduct, source, and special nuclear material.

(136) "Radioactive waste" means waste containing regulated radioactive material.

(137) "Radioactivity" means the transformation of unstable atoms by the emission of radiation.

(138) "Radiography" means the same as industrial radiography.

(139) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.

(140) "Registrant" means a person required by Chapter 3748. of the Revised Code to register radiation-generating equipment with the director.

(141) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rads multiplied by the quality factor (one rem = 0.01 Sv).

(142) "Research and development" means

(a) Theoretical analysis, exploration, or experimentation; or

(b) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. "Research and development" does not include the internal or external administration of sources of radiation to human beings.

(143) "Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 10 C.F.R. 20 (as published in the January 1, 2006, Code of Federal Regulations).

(144) "Respiratory protective equipment or device" means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

(145) "Restricted area" means an area access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(146) "Roentgen" means the amount of gamma or x-rays required to produce ions resulting in a charge of 0.000258 coulombs per kilogram of air under standard conditions.

(147) "Sanitary sewerage" means a system of public sewers for carrying off wastewater and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

(148) "Sealed source" means radioactive material that is encased in a manner designed to prevent leakage or escape of the radioactive material.

(149) "Sealed source and device registry" means the national registry that contains all the registration certificates, generated by both the United States nuclear regulatory commission and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(150) "Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in two hundred fifty years is greater than ten per cent, as designated by the United States geological survey.

(151) "Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

(152) "Shallow dose equivalent" or "HS " means the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter, or seven milligrams per square centimeter.

(153) "Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor. One sievert equals one hundred rem.

(154) "Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by off-site response organizations to protect persons off-site.

(155) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(156) "Site closure and stabilization" means those actions that are taken upon completion of operations that prepare a disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

(157) "Source material" means uranium, thorium, or any combination thereof in any physical or chemical form, or any ores that contain by weight at least one-twentieth of one per cent ( 0.05 per cent) of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.

(158) "Sources of radiation" means radioactive material or radiation generating equipment.

(159) "Special form radioactive material" means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five millimeters ( 0.2 inch); and

(c) It satisfies the test requirements specified by the United States nuclear regulatory commission in 10 C.F.R. 71.75 (as published in the January 1, 2006, Code of Federal Regulations). A special form encapsulation designed in accordance with the United States nuclear regulatory commission requirements identified in 10 C.F.R. 71.4 , in effect on June 30, 1983, and constructed prior to July 1, 1985, and a special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on March 31, 1996, and constructed before April 1, 1998, may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

(160) "Special nuclear material" means either of the following:

(a) Plutonium, uranium-233, uranium enriched in the isotope 233, or in the isotope 235, and any other material that the United States nuclear regulatory commission determines to be special nuclear material, but does not include source material pursuant to section 51 of the "Atomic Energy Act of 1954," 68 Stat 919, 42 USCA 2071 .

(b) Any material artificially enriched by any of the foregoing but does not include source material.

(161) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope uranium-235 in quantities not exceeding three hundred fifty grams of contained uranium-235; uranium-233 in quantities not exceeding two hundred grams; plutonium in quantities not exceeding two hundred grams; or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed unity.

(162) "Stochastic effect" means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

(163) "Supplied-air respirator" or "SAR" or "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

(164) "Surface contaminated object" or "SCO" means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:

(a) SCO-I: a solid object on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed four becquerels per square centimeter (10-4 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerels per square centimeter 10-5 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter ( 0.1 microcurie per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter ( 0.1 microcurie per square centimeter) for all other alpha emitters.

(b) SCO-II: a solid object on which the limits for SCO-I are exceeded and on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeter, does not exceed four hundred becquerels per square centimeter (10-2 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or forty becquerels per square centimeter (10-3 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters.

(165) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material, or the sources of radiation and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

(166) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

(167) "Total effective dose equivalent" or "TEDE" means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

(168) "Transport index" means the dimensionless number, rounded up to the next tenth, placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert per hour at one meter ( 3.3 feet) from the external surface of the package by one hundred, which is equivalent to the maximum radiation level in millirem per hour at one meter ( 3.3 feet).

(169) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A1 for special form radioactive material, or A2 for normal form radioactive material, where A1 and A2 are given in rule 3701:1-50-25 of the Administrative Code.

(170) "Type B quantity" means a quantity of radioactive material greater than a type A quantity.

(171) "Type B package" is defined under "Package."

(172) "United States department of energy" means the department of energy established by the Department of Energy Organization Act, PL 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. 7101 et seq., to the extent that the department of energy or its duly authorized representatives, exercises functions formerly vested in the United States atomic energy commission, its chairman, members, officers and components and transferred to the United States energy research and development administration and to the administrator thereof pursuant to Sections 104(b), (c) and (d) of the Energy Reorganization Act of 1974 ( PL 93-438, 88 Stat. 1233 at 1237, 42 U.S.C. 5814 ) and retransferred to the secretary of energy pursuant to Section 301(a) of the Department of Energy Organization Act ( PL 95-91, 91 Stat. 565 at 577-578, 42 U.S.C. 7151 ).

(173) "Unrestricted area" or "uncontrolled area" means any area, access to which is neither restricted nor controlled by the licensee or registrant.

(174) "User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

(175) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five gray (five hundred rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

(176) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

(177) "Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (A)(26)(b) of this rule, or byproduct material as defined in section 11 E. (3) and (4) of the Atomic Energy Act of 1954, as amended.

(178) "Week" means seven consecutive days starting on Sunday.

(179) "Weighting factor - WT " for an organ or tissue, (T), is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of WT are:

T

Organ dose weighting factors

Organ or tissue

WT

Gonads

0.25

Breast

0.15

Red bone marrow

0.12

Lung

0.12

Thyroid

0.03

Bone surfaces

0.03

Remainder

0.30a

Whole body

1.00b

\a\0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

\b\ for the purpose of weighting the external whole body dose (for adding it to the internal dose) a single weighting factor, WT = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(180) "Whole body" means for purposes of external exposure, head; trunk, including male gonads; arms above the elbow; legs above the knee.

(181) "Worker" means an individual engaged in activities licensed or registered by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.

(182) "Working level" or "WL" means any combination of short-lived radon decay products (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter of air that will result in the ultimate emission of 1.3 x 105 million electron volts alpha particle energy.

(183) "Working level month" or "WLM" means a cumulative exposure to one working level for one hundred seventy hours. (Two thousand working hours per year/twelve months per year equals approximately one hundred seventy hours per month.)

(184) "Year" means the period of time beginning in January used to determine compliance with the provisions of this rule. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

(B) The terms set out in paragraph (A) of this rule may be redefined in other chapters as promulgated pursuant to Chapter 3748. of the Revised Code as used in that chapter only.

Effective: 07/25/2013
R.C. 119.032 review dates: 05/06/2013 and 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.01
Prior Effective Dates: 7/22/2011, 6/20/03, 8/15/05, 10/22/06, 10/27/08, 4/5/09, 10/4/10, 1/1/12

3701:1-38-02 Fees for inspection, application, amendment, and renewal of radioactive material sources of radiation.

(A) As used in this rule, "facility" has the meaning defined in division (H) of section 3748.01 of the Revised Code and the following:

(1) All buildings, equipment, structures, and other stationary items that are located on a single site or on contiguous or adjacent sites and that are operated by the same person and have common corporate or business interests; and

(2) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(B) Notwithstanding the definition of "facility," the director may consider sites that are not contiguous or adjacent as one facility provided that:

(1) The sites are operated by the same person;

(2) The sites are in the same license category or categories;

(3) The applicant for a license provides for one radiation safety officer, and if applicable, one radiation safety committee, as responsible for all sites; and

(4) The director is reasonably satisfied from the information provided in the application that the applicant will adequately control radioactive material at all sites listed in the application.

(a) Unless the director has information of violations of Chapter 3748. of the Revised Code or the rules adopted thereunder at one or more sites, the director shall presume the applicant will adequately control radioactive material at all sites if the sites are located not more than twenty miles driving distance apart as documented by the licensee, and if all sites are within a twenty mile radius from the main site as designated on the license.

(b) The director shall continue to renew a license issued under this paragraph that contains all the sites listed thereon provided the licensee demonstrates continued compliance with this paragraph, Chapter 3748. of the Revised Code, and the rules adopted thereunder.

(C) Every facility that handles radioactive material in any license category as specified in appendix A to this rule for which licensure is required shall apply for a license, license amendment, or license renewal in accordance with this rule. Application for a license, license amendment, or license renewal shall be made on any format prescribed and provided by the director. Licenses shall be issued in accordance with the requirements of Chapter 3748. of the Revised Code, and the rules adopted thereunder. Except as otherwise provided in this rule, a license shall expire five years from the date of issuance.

(1) As used in this paragraph, site means an address of use listed on the license. Temporary job sites are exempted.

(a) Any individual applying for a new license with one or more additional sites or a current licensee amending a license to add one or more additional sites that are located more than twenty miles from the main site shall pay an additional site fee for each such site as follows:

(i) The additional site fee(s) shall be seventy-five percent of the applicable annual fee, as those fees are set forth in paragraphs (D), (F), and (J) of this rule.

(ii) Additional site fees will be invoiced annually with the annual fee.

(b) Broad scope licensees are exempt from paragraph (C)(1)(a) of this rule.

(2) As used in this paragraph, "service" means activities performed by a person, other than a worker as defined in rule 3701:1-38-01 of the Administrative Code, pursuant to an agreement with the facility to perform activities that deal with sources of radiation for the facility.

(a) These activities include, but are not limited to the following:

(i) Conduct leak tests;

(ii) Calibrate survey instruments;

(iii) Provide quality control tests;

(iv) Conduct surveys, characterization, and/or remediation activities;

(v) Manage the disposal of radioactive waste for other persons; or

(vi) Install sources or devices or change sources within a device.

(b) License categories affected are:

(i) 3219 - decontamination services;

(ii) 3220 - leak test service;

(iii) 3221 - instrument calibration service only - source less than 3.7 terabecquerels (one hundred curies);

(iv) 3222 - instrument calibration service only - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(v) 3223 - leak test and instrument calibration - source less than 3.7 terabecquerels (one hundred curies);

(vi) 3224 - leak test and instrument calibration - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(vii) 3225 - other services - including teletherapy, irradiator, and gauge service;

(viii) 3232 - waste disposal service prepackaged only;

(ix) 3233 - waste disposal service - incineration; and

(x) 3234 - waste disposal service processing and/or repackaging.

(D) A radioactive materials license issued by the department may, at the discretion of the director, have more than one license category on any one specific license. A licensee may have more than one radioactive materials license. Except as otherwise provided in paragraph (J) of this rule, the annual fee for a radioactive material license shall be in an amount in accordance with appendix A to this rule.

(1) Upon receipt of an application for a new radioactive material license, the department will issue an invoice for the appropriate fee specified in appendix A to this rule or paragraph (J) of this rule. Annual fees will be invoiced based on the month of the license expiration date and the invoice will state that the fee is due thirty days after the date of the invoice. License fees are not refundable.

(2) An applicant for a new or a renewal or amendment of a radioactive material license must submit a complete application before the director will finalize the review of the application. A complete application is one in which the applicant has provided all the information requested by the director, including any additional information requested after receipt of the application package.

(3) Upon receipt of an application for a license amendment, the department will issue an invoice for the appropriate fee for the proposed amendment as specified in appendix A to this rule. If the amendment is to change the license from operational phase to storage of sealed sources only incident to disposal of the sources, after the amendment the annual fee for the license shall be reduced to fifty per cent of the fee for the operational phase of the license, provided that the sources continue to be in safe storage and leak tested as provided by license condition for the specific sources in storage. The inspection frequency will remain the same as that for the operational phase of the license until after source disposal.

(4) The applicant for a new, or renewal or amendment of a radioactive materials license shall provide to the director all additional information requested within sixty days from the date of the information request. If the director does not receive the requested information within the stated time period, the director may consider the application abandoned. Any further consideration of a new license, or a renewal or amendment of a license shall be pursuant to another application.

(5) The director shall grant a new license, license amendment, or license renewal to any applicant who has submitted a complete application and is in compliance with Chapter 3748. of the Revised Code and the rules adopted thereunder.

(6) When an amendment to a license results in a change to a license category with a higher fee, the licensee will be charged the higher of the two amendment fees for that category. The annual fee for the licensee will escalate to the new category fee on the date of the next annual invoice.

(7) The director shall charge a fee for minor license amendments that do not require review by members of the technical staff at a rate of one hundred dollars per amendment provided that no licensee shall be required to pay more than one thousand dollars for minor amendments in any calendar year. Minor amendments include, but are not limited to, adding a new gauge of the same type already licensed unless that additional gauge increases the license or inspection fee, a corporate name change if the corporate ownership does not change, adding a user name that does not require review of education and experience, and corporate address change if the location of the use of the radioactive material does not change. Amendments to change the radiation safety officer or the chair or members of the radiation safety committee that require review of education or experience are not minor amendments.

(8) License terminations shall be handled as follows:

(a) Except as provided in paragraph (D)(8)(c) of this rule, a termination fee of five hundred dollars or fifty per cent of the annual fee, whichever is less, will be invoiced upon written request from the licensee for termination of the license. This fee is not refundable.

(b) Except as provided in paragraph (D)(8)(c) of this rule, if the termination cost, as determined by paragraph (M) of this rule, exceeds the termination fee in paragraph (D)(8)(a) of this rule, the remainder of the termination expense will be assessed at full cost.

(c) If the license termination would be covered under paragraph (D)(9) of this rule, that paragraph will be used for the termination process.

(d) The license termination process will not be completed until the licensee is in compliance with all rules, including payment of fees.

(9) Licenses, and other approvals related to the licensed activity requiring decommissioning, decontamination, reclamation, site restoration, or long-term care due to the continued presence of radioactive materials shall be charged an annual fee based on the approved decommissioning funding plan as specified in appendix B to this rule.

(a) A decommissioning plan must be approved by the department. Prior to approval of the decommissioning plan the licensee must submit an amendment requesting decommissioning. Until the amendment is approved the licensee's annualized license fee will be reduced by fifty per cent. After approval of the amendment containing the decommissioning plan, the licensee will be invoiced at the annual fee specified in appendix B to this rule.

(b) The annual fee specified in appendix B to this rule is based on the cost of decommissioning. The fee is payable within thirty days of mailing of an invoice by the department.

(c) Routine decommissioning oversight by the department will be charged against the annual amount received and additional invoices will not be issued unless the cost of activities exceeds the annual amount in any given year.

(d) The facility shall receive a monthly statement of items and amounts charged against the annual fee.

(e) If the cost of additional activities arise that require use of additional staff, including any consulting service that exceeds the amount of the annual fee paid by the licensee, these additional costs will be included in any invoice as separate items invoiced for the full cost of the oversight by additional staff or consultants. Oversight activities will be performed at a frequency which adequately monitors health, safety, and the environment.

(f) When the approved decommissioning plan is less than one hundred thousand dollars, the licensee will remain in the current license category and continue to pay the required annual fee specified in appendix A to this rule during decommissioning. Inspections of these licensees will be done as non-routine inspections. Non-routine inspection fees will not be applied until the number of decommissioning inspections performed exceed the inspections that would have been performed if the licensee had not chosen the decommissioning option.

(g) When the licensee has completed the decommissioning, and the director has determined that the licensee cannot terminate the license as provided by the Administrative Code, Chapter 3748. of the Revised Code or the rules adopted thereunder, but the licensee has successfully completed the decommissioning of the operation as required by the approved decommissioning plan, the director will amend the license to a decommissioning/possession only license. The annual fee for a decommissioning/possession only license is provided in appendix B to this rule.

(E) Licenses shall be renewed in accordance with the standard renewal procedure established in Chapter 4745. of the Revised Code, except that a licensee, other than a broad scope licensee, shall apply for renewal of the license ninety days prior to the expiration date of the current license and broad scope licensees shall apply for renewal of their license one hundred eighty days prior to expiration.

(F) The annual fee is listed in appendix A to this rule "column 5" for a new license or "column 6" for a renewal license. To recover the costs of oversight activities where radioactive material is found in the public domain and there is no evident individual that is determined to be responsible, a surcharge of 5.25 per cent has been included in the annual fee listed in "column 5" and "column 6" of appendix A to this rule.

(G) The department shall charge an inspection fee for all non-routine inspections. A non-routine inspection is defined as any inspection that the department conducts in addition to the scheduled routine inspections and one follow-up inspection if necessary. Non-routine inspections include, without limitation:

(1) An inspection performed as a result of an incident;

(2) Any pre-license inspections for a new license applicant when the director determines that an inspection is necessary to assess the adequacy of the information provided in the application;

(3) Inspections prior to license amendment, category change, or termination;

(4) An inspection performed at a facility that results in the issuance of an adjudication order by the director; or

(5) Other enforcement or regulatory inspections, not specified above, that the director determines is necessary to assess compliance with Chapter 3748. of the Revised Code.

(H) The fee for a non-routine inspection shall be based on the actual cost for conducting the inspection which shall include:

(1) An hourly charge of seventy dollars per staff person assigned to the inspection, except staff participating as training will not be included in the charges;

(2) An administrative fee of three hundred thirty dollars;

(3) All necessary laboratory analysis costs for samples collected by department personnel; and

(4) Any staff travel costs which shall be calculated in accordance with rule 126-01-02 of the Administrative Code.

(I) All fees invoiced as provided within this rule, including full cost, routine, and non-routine inspection fees, shall be paid within thirty days of the invoice date specified on the invoice. In accordance with sections 3748.07 and 3748.13 of the Revised Code, any fee that remains unpaid on the ninety-first day after the original invoice date shall be assessed an additional amount equal to ten per cent of the original fee.

(1) The department shall mail invoices by ordinary U.S. mail to the most recent address provided by the licensee.

(2) The department shall maintain a list of the invoices issued and date mailed.

(J) Notwithstanding paragraph (D) of this rule, the department shall charge the following types of licensees reduced license fees in the following specified amounts:

(1) A private entity that provides services, does not engage in manufacturing, and that has three hundred fifty thousand to two million dollars in gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive materials in appendix A to this rule.

(2) A private entity that provides services, does not engage in manufacturing, and that has less than three hundred fifty thousand dollars in gross annual receipts shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(3) A private entity that engages in manufacturing and that has thirty-five to two hundred employees, irrespective of gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(4) A private entity that engages in manufacturing and that has less than thirty-five employees, irrespective of gross annual receipts, shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(5) A nonprofit entity that has gross annual receipts of three hundred fifty thousand dollars to two million dollars shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(6) A nonprofit entity that has gross annual receipts of less than three hundred fifty thousand dollars shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(7) A government jurisdiction or district with a population of twenty thousand to fifty thousand shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material as specified in appendix A to this rule.

(8) A government jurisdiction or district with a population of less than twenty thousand shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive materials as specified in appendix A to this rule.

(9) A health district as defined in section 3709.01 of the Revised Code shall pay a total license fee of twenty-five per cent of the amount specified in appendix A to this rule.

(10) An accredited private or public college or university possessing or using radioactive material in a sealed or unsealed source solely as a part of a college or university course supported by tuition and leading to an accredited degree, but excluding clinical training, shall pay a total license fee as set forth for category "1129" as that amount is specified in appendix A to this rule.

The reduced annual fees specified in this paragraph do not apply to any other fees that a licensee may be required to pay under Chapter 3748. of the Revised Code or rules adopted thereunder. Licensees shall provide certification of their compliance with the provisions of paragraphs (J)(1) to (J)(6) of this rule upon initial application and renewal.

(K) The director may modify the inspection frequency of licensed facilities based upon the performance of the facility.

(L) In accordance with section 3748.22 of the Revised Code, the department shall charge fees sufficient to cover all costs of regulatory, administrative, and enforcement activities conducted pursuant to Chapter 3748. of the Revised Code. The director shall recommend to the radiation advisory council and the public health council changes in the radioactive materials fees if the director finds that fees do not meet the requirements of section 3748.22 of the Revised Code.

(M) Fees for those categories listed as "full cost" such as decommissioning activities, for either partial, building or selected area of a licensed site, or full decommissioning leading to license amendment, category change, or termination and for review of sources and/or devices shall be specified as "full cost" and shall be calculated as the sum of the seventy dollar hourly charge per staff member for the number of hours spent on document review and preparation, licensing, inspection, meetings, teleconferences, in travel, administrative time, the cost of any special contractors as determined necessary by the director, any environmental monitoring for radioactive materials and laboratory analysis, any other associated activities. The administrative fee from paragraph (H)(2) of this rule shall be used for administrative time. Travel expenses shall also be invoiced and shall be calculated at the rate determined by rule 126-1-02 of the Administrative Code. These fees will be invoiced monthly.

(N)

(1) Reciprocity to engage in activities in the state of Ohio which involve radioactive materials may be authorized provided:

(a) The person requesting reciprocity possesses a valid radioactive materials license issued by another agreement state or the United States nuclear regulatory commission which authorizes the same activities proposed to be conducted in Ohio;

(b) The request for reciprocity is made by submission of a completed reciprocity application provided by the director, a copy of the person's radioactive materials license, and payment of the reciprocity fee specified in appendix A to this rule;

(c) The duration of activities to be performed in Ohio under reciprocity does not exceed one hundred eighty days in any one calendar year.

(2) A person who has been granted reciprocity in Ohio shall notify the director at least three business days in advance of each time the person proposes to begin a new use of radioactive materials in the state of Ohio, with the notification made on a form provided by the director.

(3) Activities conducted in Ohio under reciprocity are subject to inspection by the department at any time and the department shall invoice a reciprocity inspection fee of one thousand dollars for each inspection of a person's authorized reciprocity activities.

(4) Reciprocity is authorized for one calendar year, beginning on January first or later date when reciprocity is initially applied for, and ending on December thirty-first.

(5) A person who is authorized reciprocity shall apply for an Ohio radioactive materials license at least thirty days prior to exceeding one hundred eighty days of activities in Ohio.

(O) Requests for safety evaluation of devices, products, or sealed sources used for radioactive materials either for commercial distribution or manufactured in accordance with the unique specifications of, and for use by, a single applicant shall be submitted to the director on a form provided by the director for that review prior to manufacture or commercial distribution.

(1) The application shall specify a license amendment for one of the areas listed below:

(a) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) for commercial distribution.

(b) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) manufactured in accordance with the unique specifications of, and for use by, a single applicant.

(2) The amendment fee for a source or device review shall be "full cost" as outlined in paragraph ((M) of this rule.

(3) The amendment fee in appendix A to this rule for categories under manufacturing and distribution shall be for amendments other than source or device reviews.

(4) Licensees for categories 3211, 3212, 3213, 3214, and 22162 shall pay an annual surcharge of six hundred fifty dollars to cover administrative costs of overall maintenance activities associated with source or device data submitted to the United States nuclear regulatory commission. This surcharge is included in the annual fee for the above listed categories in "column 5" and "column 6" of appendix A to this rule.

(P) When considered necessary by the director, the director may conduct a review of shielding plans or the adequacy of shielding. The director may also conduct such a review upon the request of the licensee or the applicant for a license. The applicant or licensee shall pay a fee for review of shielding plans or adequacy of shielding as specified in paragraph (M) of this rule.

(Q) Individuals with implanted pacemakers that have a radioactive source will not be charged an annual fee as an individual because of the necessity of possessing the device. Unless the director determines other provisions are required, the medical institution that implanted the device shall hold the license for the individual.

(R) If, because of the complexity of a review, such as that for a sealed source or device, decommissioning, license, or incident, it is necessary to obtain the services of a consultant to assist in a final determination, the licensee or applicant will be invoiced for the consulting services.

(S) Licensees with general licenses requiring an annual report to the director shall submit the report with a fee of four hundred twenty dollars within thirty days of mailing an invoice by the department and are subject to late penalties in paragraph (I) of this rule. If a facility has a specific license which is in a category that would include the generally licensed material, the facility may add the generally licensed material to the specific license and will not be charged the additional fee for that generally licensed material. Annual reports are required for devices under a general license containing radionuclides at or above activities listed in paragraph (C)(13) of rule 3701:1-46-05 of the Administrative Code.

Click to view Appendix

Click to view Appendix

Effective: 04/15/2013
R.C. 119.032 review dates: 11/30/2012 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 9/1/97, 9/4/00, 7/22/01, 10/22/06, 7/5/09

3701:1-38-03 Application and renewal of registrations for handlers of radiation-generating equipment.

(A) As used in this rule, "facility" means the state, any political subdivision, person, public or private institution, or group, or any unit of one of those entities, but does not include the federal government agencies, and includes the following:

(1) All buildings, equipment, structures and other stationary items that are located on a single site or on contiguous or adjacent sites and that are operated by the same person and have common corporate or business purposes; and

(2) Portions of a building or structure which are operated by the same person and have common corporate or business purposes.

(B) Notwithstanding the definition of "facility," the director may consider sites that are not contiguous or adjacent as one facility provided that:

(1) The sites are operated by the same person;

(2) The sites are of the same facility type as categorized in paragraph (B) of rule 3701:1-38-04 of the Administrative Code;

(3) The applicant for a registration provides for one individual responsible for radiation protection and implementing quality assurance procedures and policies necessary for effective compliance with Chapter 3748. of the Revised Code and rules adopted thereunder, and if applicable, one quality assurance committee, as responsible for all sites; and

(4) The director is reasonably satisfied from the information provided in the application that the applicant will adequately control the radiation-generating equipment at all sites listed in the application. Unless the director has information of violations of Chapter 3748. of the Revised Code or the rules adopted thereunder at one or more sites, he or she shall presume the applicant will adequately control the radiation-generating equipment at all sites if the sites are located not more than five miles apart.

The director shall continue to renew a registration issued under this paragraph that contains all the sites listed thereon provided the registrant demonstrates continued compliance with this paragraph, Chapter 3748. of the Revised Code, and the rules adopted thereunder.

(C) Every facility that proposes to handle radiation-generating equipment for which registration is required shall apply for a registration at least thirty days prior to handling the equipment. Registration or renewal thereof shall be in accordance with this rule. Radiation-generating equipment for which registration is required includes dental x-ray, diagnostic or medical x-ray, therapeutic x-ray, and industrial or non-medical x-ray. Application for a registration or renewal thereof shall be made on a form prescribed and provided by the director and shall be accompanied by a non-refundable registration fee in accordance with section 3748.07 of the Revised Code. The application shall include the name and qualifications of the individual designated as responsible and readily available for radiation protection and implementing quality assurance policy and procedures necessary for assuring compliance with Chapter 3748. of the Revised Code and rules adopted thereunder. Registrations shall expire two years from the date of issuance.

Registration certificates are not transferrable. If a facility is sold or otherwise transferred to another person after a certificate of registration has been issued, the new handler is required to apply and receive a new registration certificate for the radiation-generating equipment.

(D) Facilities do not need to register the following types of radiation-generating equipment:

(1) Electronic equipment that produces ionizing radiation incidental to its operation for other purposes, if the exposure rate averaged over an area of ten square centimeters does not exceed one-half milliroentgen per hour at a distance of five centimeters from any accessible surface of such equipment if that facility is using the equipment for non-commercial purposes only; or

(2) Radiation-generating equipment that is already registered under Chapter 3748. of the Revised Code by its possessor.

(E) An applicant for a registration shall submit to the director a complete application for registration on a form provided by the director together with the required registration fee. The application shall contain all the information required on the form and accompanying instructions. The applicant for a registration shall provide to the director within thirty days of receipt of the request, all additional requested information. If the director does not receive the requested information within the thirty days, the director may consider the application abandoned. Any further consideration for a new registration shall be pursuant to another application accompanied by another nonrefundable registration fee.

(F) The director shall grant a new registration or renewal to any applicant who has submitted a complete application, paid the registration fee, and is in compliance with applicable rules adopted under Chapter 3748. of the Revised Code . Upon request of the applicant for registration or renewal, the director may grant an exception to the requirements of the applicable rules adopted under Chapter 3748. of the Revised Code if the applicant demonstrates that he or she is in substantial compliance with the requirement and that strict application of the requirement poses undue hardship to the applicant.

(G) Registrations shall be renewed in accordance with the standard renewal procedure established in Chapter 4745. of the Revised Code. The registrant shall apply for renewal at least thirty days prior to the expiration of the registration.

(H) Any handler that assembles, installs, or disposes of radiation-generating equipment within this state shall notify the director, in writing, at least quarterly of such actions.

Each report shall contain the name and address of the facility that received equipment; the manufacturer, model, and serial number of the x-ray tube or x-ray generator transferred, disposed of, or installed; and the date of transfer, disposal, or installation of the radiation-generating equipment.

The state copy of the United States department of health and human services, food and drug administration "Report of Assembly of a Diagnostic X-ray System" form, used for reporting diagnostic x-ray systems which contain certified components, may be used to meet the notification requirements for this rule.

(I) No handler shall transfer, service, or install radiation-generating equipment or the components used in connection with such equipment unless such components and equipment, when properly placed in operation and used, meet the requirements of this chapter and all applicable requirements of Chapter 3701:1-66 or 3701:1-67 of the Administrative Code.

(J) The registrant shall notify the director, in writing, fifteen days prior to making any change which would render the information contained in the application for registration or registration certificate no longer accurate.

(K) Notwithstanding any other requirements of this rule, out-of-state owners of radiation-generating equipment who:

(1) Operate the radiation-generating equipment within Ohio are required to:

(a) Possess a valid Ohio registration;

(b) Provide written notification three days prior to the dates when the radiation-generating equipment will be used in Ohio; and

(c) Assure that the operation of the radiation-generating equipment complies with all applicable rules in Chapters 3701:1-38, 3701:1-66, 3701:1-67, and 3701-72 of the Administrative Code.

(2) Solely transport the radiation-generating equipment to an Ohio facility to be operated by the Ohio facility are not required to register. The Ohio facility using the radiation-generating equipment shall:

(a) Possess a valid Ohio registration;

(b) Provide written notification three days prior to the dates when the radiation-generating equipment will be used in Ohio; and

(c) Verify that the operation of the radiation-generating equipment complies with all applicable rules in Chapters 3701:1-38, 3701:1-66, 3701:1-67, and 3701-72 of the Administrative Code.

(L)

Any facility found as an unregistered handler shall be notified by the director that registration is required pursuant to the requirements of paragraph (C) of this rule. Any such facility that does not apply for registration within ten business days of receiving a notice to register shall be inspected by the department. The unregistered handler shall pay the fee required by section 3748.13 of the Revised Code.

A facility that handles radiation-generating equipment and engages in activities involving the use of radiation-generating equipment that does not obtain an Ohio registration as required by this rule is subject to the fee for the inspection of an unregistered handler specified in section 3748.13 of the Revised Code.

Effective: 04/01/2012
R.C. 119.032 review dates: 12/30/2011 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/1/1998, 12/1/03, 5/12/08

3701:1-38-04 Radiation generating equipment inspection schedule and inspection fee.

(A) Each handler shall afford the director, at all reasonable times, opportunity to inspect radiation-generating equipment and equipment shielding, surroundings, records and other equipment and devices used in connection with handling radiation-generating equipment. Each handler also shall perform, as requested by the director, such tests as the director determines may be necessary for the handler to demonstrate compliance with the requirements of Chapter 3748. of the Revised Code and rules adopted thereunder and to evaluate the extent of radiation hazards that may be present.

(B) The director shall routinely inspect radiation-generating equipment unless that equipment is registered as in storage and rendered inoperable. Routine inspections shall be conducted according to the schedule by facility category listed in appendix A to this rule.

(C) Notwithstanding the inspection frequencies specified in paragraph (B) of this rule, radiation-generating equipment capable of operating at or above two hundred fifty kilovoltage peak may be inspected every twelve months irrespective of facility category.

(D) The director may modify the inspection frequency of a registered facility based upon the performance of the facility.

(E) In addition to any inspections required under this rule, inspections of new or newly installed radiation-generating equipment may be performed within twelve months of installation of the equipment.

(F) Non-routine or special inspections of facilities may be conducted by the director upon receiving complaints or other evidence of violation of the requirements of Chapter 3748. of the Revised Code or rules adopted thereunder, or orders of the director issued pursuant thereto.

(G) Any handler of radiation-generating equipment that is a medical practitioner or a corporation, partnership, or other business entity consisting of medical practitioners, other than a hospital as defined in section 3727.01 of the Revised Code, shall pay to the department of health an inspection fee according to the schedule and categories listed in appendix B to this rule. For purposes of this section "medical practitioner" means a person authorized to practice dentistry pursuant to Chapter 4715. of the Revised Code; medicine and surgery, osteopathic medicine and surgery, or podiatry pursuant to Chapter 4731. of the Revised Code; or chiropracty pursuant to Chapter 4734. of the Revised Code.

(H) Except as otherwise provided in paragraph (G) of this rule, all handlers of radiation-generating equipment shall pay an inspection fee according to the schedule listed in appendix C to this rule.

(I) In accordance with division (B) of section 3748.13 of the Revised Code, the fee for the inspection of a facility that does not possess or that has not applied for registration and for which registration is required, shall pay the amount required in division (B) of section 3748.13 of the Revised Code plus any required amount specified under paragraph (G) or (H) of this rule.

(J) In accordance with section 3748.13 of the Revised Code, the fee for any inspection to determine whether notice of violations cited in a previous inspection have been corrected is fifty per cent of the fee specified in paragraphs (G) and (H) of this rule. Inspections to determine compliance with a notice of violation issued pursuant to paragraph (A) of rule 3701:1-38-06 of the Administrative Code may include, but is not limited to, compliance reviews done off-site.

APPENDIX A

RADIATION-GENERATING EQUIPMENT INSPECTION SCHEDULE

Hospital registered under division (A) of Section 3701.07 of the Revised Code Once every 24 months Additionally, the director will conduct a review of the audit reports in-between inspections.

Podiatry facility Once every 36 months

Chiropractic facility Once every 36 months

Veterinary facility Once every 36 months

Educational facility Once every 36 months

Physician offices, clinics, and other types of health care facilities as defined in Rule 3701-83-43(D) and Rule 3701-83-51(F) of the Administrative Code Once every 36 months

Industrial or non-health care facility Once every 36 months

Dental facility Once every 60 months

APPENDIX B

RADIATION-GENERATING EQUIPMENT INSPECTION FEES FOR ANY HANDLER OF RADIATION-GENERATING EQUIPMENT THAT IS A MEDICAL PRACTITIONER OR A CORPORATION, PARTNERSHIP, OR OTHER BUSINESS ENTITY CONSISTING OF MEDICAL PRACTITIONERS, OTHER THAN A HOSPITAL AS DEFINED IN SECTION 3727.01 OF THE REVISED CODE

First dental x-ray tube The amount required by division (B) of Section 3748.13 of the Revised Code

Each additional dental x-ray tube The amount required by division (B) of Section 3748.13 of the Revised Code

First medical x-ray tube The amount required by division (B) of Section 3748.13 of the Revised Code

Each additional medical x-ray tube The amount required by division (B) of Section 3748.13 of the Revised Code

Each unit of radiation-generating equipment capable of operating at or above 250 kilovoltage peak The amount required by division (B) of Section 3748.13 of the Revised Code

Each facility that is not registered and for which no registration application is pending at the time of inspection. The amount required by division (B) of Section 3748.13 of the Revised Code

A review of shielding plans or the adequacy of shielding for each room where radiation-generating equipment is used. The amount required by division (B) of Section 3748.13 of the Revised Code

APPENDIX C

RADIATION-GENERATING EQUIPMENT INSPECTION FEES

Each hospital having one to ten x-ray tubes $ 960.00

Each hospital having eleven to twenty-five x-ray tubes $1, 800.00

Each hospital having more than twenty-five x-ray tubes $2, 640.00

Each cabinet, gauging, or analytical x-ray tube used in non-health care applications $ 120.00

Each x-ray tube other than cabinet, gauging, or analytical x-ray tubes used in non-health care applications $ 240.00

Each unit of ionizing radiation-generating equipment capable of operating at or above 250 kilovoltage peak $ 610.00

Each assembler-maintainer inspection consisting of an inspection of records and operating procedures of handlers that install or maintain radiation-generating equipment $ 380.00

Each facility that is not registered and for which no registration application is pending at the time of inspection. $ 474.00 plus the fee applicable under this rule.

A review of shielding plans or the adequacy of shielding for each room where radiation-generating equipment is used. $ 762.00

R.C. 119.032 review dates: 11/08/2013 and 11/01/2018
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04 , 3748.13
Prior Effective Dates: 6/1/1998, 2/1/03, 3/21/08, 7/5/09

3701:1-38-05 Administrative penalties.

(A) As used in this rule:

(1) "Repetitive violation" means a same or similar violation that reasonably could have been prevented by a facility's corrective action for the previous violation normally occurring either within the past two years of the inspection at issue or the period within the last two inspections, whichever is longer.

(2) "Event" means a situation involving licensable material and characterized by:

(a) An active adverse impact on equipment or personnel readily obvious by human observation or instrumentation; or

(b) A radiological impact on personnel, the general public, or the environment in excess of regulatory limits, such as an overexposure, a release of radioactive material above the limits set forth in rule 3701:1-38-21 of the Administrative Code or a loss of radioactive material in quantities reportable pursuant to rule 3701:1-38-21 of the Administrative Code.

(B) The director may assess an administrative monetary penalty for failure of any facility required to be licensed under Chapter 3748. of the Revised Code to comply with that chapter or rules adopted thereunder. Any administrative monetary penalty imposed shall be assessed in accordance with this rule. Unless otherwise provided in this rule, the director may issue an order imposing an administrative penalty in addition to and concurrent or subsequent to issuing a written notice of violation as provided in rule 3701:1-38-06 of the Administrative Code. The director may assess an administrative monetary penalty independent of any and all other remedies that may be asserted by the department. Any orders issued or payments or other requirements imposed shall not affect any civil, criminal or administrative enforcement proceedings brought under this chapter or any other provision of state or local law.

(C) Administrative monetary penalties specified in this rule are based upon the level of severity of the violation which includes factors such as the importance or significance of the violation, the length or duration of the violation, whether the violation is repetitive in nature or is similar to previous violations, and the time period between the current violation and any previous violation. The director may issue an administrative monetary penalty as follows:

Severity Level of Violation Penalty

I $5,000

II $4,000

III $2,500

IV up to $500

(D) In addition to the issuance of a notice of violation, in the case of a severity level IV violation the director shall do either of the following:

(1) If within thirty days of the issuance of the notice of violation, or such greater time as the director may determine, the facility remedies the violation and documents to the satisfaction of the director that the facility is in compliance, the director shall withdraw the assessment of an administrative monetary penalty; or

(2) If there remain any items of non-compliance thirty days or such greater time as the director may determine after the issuance of the notice of violation, the director shall maintain the administrative monetary penalty for the items of non-compliance. The director shall reduce the administrative monetary penalty in an amount up to fifty per cent of the penalty assessed for the violation or violations found at severity level IV provided that the facility has corrected at least fifty per cent of the violations.

A group of severity level IV violations may be evaluated in the aggregate and assigned a single severity level III, if the violations have the same or similar underlying cause or program deficiencies, or the violations contributed to or were unavoidable consequences of the underlying problem or program deficiencies.

(E) In addition to the issuance of a notice of violation, in the case of a severity level III violation the director shall assess an administrative monetary penalty in accordance with the following:

(1) If within thirty days of the issuance of the notice of violation or such greater time as the director may determine the facility remedies the violation and documents to the satisfaction of the director that the facility is in compliance, the director may determine to withdraw the assessment of the administrative monetary penalty; or

(2) If there remain any items of non-compliance thirty days after the issuance of the notice of violation or such greater time as the director may determine, the director shall reduce the administrative monetary penalty in an amount up to fifty per cent of the penalty assessed for the violation or violations found at severity level III provided that the facility has corrected at least fifty per cent of the violations.

(F) In the case of a severity level I or II violation, the director shall issue an administrative monetary penalty. The director may reduce the penalty up to fifty per cent of the assessed amount if it is a non-repetitive violation and the facility achieves and documents compliance to the satisfaction of the director within thirty days of receiving the notice of violation.

(G) Notwithstanding paragraphs (C) to (F) of this rule, in the case of a repetitive violation, the director shall not reduce the administrative monetary penalty specified in paragraph (C) of this rule. In the case of a third or subsequent occurrence of the repetitive violation, the director may increase the administrative monetary penalty specified in paragraph (C) of this rule by an additional twenty-five per cent and continue to increase the penalty by an additional twenty-five per cent for each subsequent occurrence.

(H) When a violation occurs and the facility identifies the violation before it results in an event or is cited by the department, the director may reduce the penalty specified in paragraph (C) of this rule as follows:

(1) In the case of a facility that identified the violation as a result of observation, the director may reduce the administrative monetary penalty assessed in accordance with paragraph (C) of this rule in an amount of up to twenty-five per cent.

(2) In the case of a facility that discovered the violation as a result of a self-monitoring effort, such as an audit, test, surveillance, design review, or trouble shooting, the director may reduce the administrative monetary penalty assessed in accordance with paragraph (C) of this rule in an amount up to fifty per cent.

(3) In the case of a facility that self-corrects a severity III or IV violation in a manner and time period approved by director, the director shall not issue an administrative monetary penalty.

(I) Notwithstanding any other provision in this rule, after determination of the severity level of a violation found by the department, the director may increase the amount of the administrative monetary penalty as follows:

(1) In the case of overall past poor facility performance the administrative monetary penalty assessed in accordance with paragraph (C) of this rule may be increased up to one hundred per cent.

(2) In the case of a violation that is flagrant or reckless and that results in a substantial increase in risk to personnel, the general public or the environment, including cases in which the duration of the violation has contributed to the substantial increase in risk, the administrative monetary penalty assessed in accordance with paragraph (C) of this rule may be increased up to one hundred per cent.

(3) In the case of a willful violation within the administrative control of the licensee, the administrative monetary penalty assessed in accordance with paragraph (C) of this rule may be increased up to one hundred per cent.

(J) The facility may appeal the assessment of an administrative monetary penalty in accordance with Chapter 119. of the Revised Code, provided that the facility requests a hearing within thirty days of receiving notice of the administrative penalty assessment. The director may consolidate a hearing on an administrative monetary penalty assessed under this rule with any other complaint or finding of the director where the director determines that there are one or more issues of fact or law in common. No more than one hearing will be conducted with respect to each violation alleged.

R.C. 119.032 review dates: 05/09/2011 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.15 , 3748.17
Prior Effective Dates: 10/22/2006

3701:1-38-06 License or registration adjudication orders; late fees; impoundment; administrative monetary penalty.

(A) The director may suspend or revoke a license or a certificate of registration, or issue adjudication orders for failure by the licensee or registrant to comply with Chapter 3748. of the Revised Code or a rule adopted thereunder. Except as otherwise provided in paragraphs (B), and (D) to (F) of this rule, prior to suspending or revoking a license or certificate of registration, the director shall first give written notice of violation to the licensee or registrant, by certified mail, return-receipt requested, specifying the section of Chapter 3748. of the Revised Code or the rule violated and specifically describing the violation. The notice of violation shall include information concerning the applicable penalties established under sections 3748.19 and 3748.99 of the Revised Code. The director shall provide the licensee or registrant with an informal meeting provided that the licensee or registrant requests the meeting and provided that the meeting is held within thirty days of the date that the licensee or registrant receives the notice of violation or at a later date as determined by the director. If, after thirty days from the date the licensee or registrant received the notice of violation, the facility remains in violation the director may issue an adjudication order. The adjudication order shall specify the section of Chapter 3748. of the Revised Code or the rule violated, specifically describe the violation, specify the action ordered to abate the violation, and order the action to be taken within a specified reasonable time. In the order, the director also may propose to suspend or revoke the license or certificate of registration should the licensee or registrant fail to take the action specified in the order within the specified time.

(B) If the director determines that an emergency exists requiring immediate action to protect the public health or safety, he or she may issue an emergency adjudication order, reciting the existence of an emergency and specifying the necessary action that shall be taken to meet the emergency. The order shall be effective immediately, without notice or hearing, but shall not remain effective for more than ninety days after its issuance. Any facility to which the order is directed shall comply immediately.

(C) In the case of a failure by a licensee or registrant to comply with Chapter 3748. of the Revised Code or the rules adopted thereunder, the director may issue an adjudication order, emergency adjudication order, or may propose the suspension or revocation of the facility's license or registration. The licensee or registrant shall be notified as soon as practicable that the licensee or registrant may appeal any adjudication order, emergency adjudication order, or proposed license or registration suspension or revocation in accordance with Chapter 119. of the Revised Code, provided that the licensee or registrant requests a hearing within thirty days of the time of mailing the order or proposed suspension or revocation. In the case of an emergency adjudication order, the hearing shall be held within thirty days of the request. The director may continue, modify, suspend or revoke an adjudication order at any time, or withdraw a proposed suspension or revocation prior to a final order. In accordance with Chapter 3748. of the Revised Code and this rule, the director may concurrently assert against a licensee or registrant more than one administrative remedy. In the event the licensee or registrant appeals more than one administrative action, the director may consolidate into one hearing any or all issues to be heard.

(D) Registration, license, and inspection fees shall be paid no later than thirty days after the invoice for the fee is mailed. In accordance with sections 3748.07 and 3748.13 of the Revised Code, any fee that remains unpaid on the ninety-first day after the original invoice date shall be assessed an additional amount equal to ten per cent of the original fee. All invoices issued by the department shall include thereon information regarding the assessment for late payment or nonpayment that is specified in division (B) of section 3748.13 of the Revised Code.

(1) The department shall mail invoices by ordinary United States mail to the most recent address provided by the registrant or licensee on his or her application or current registration.

(2) The department shall maintain a list of the invoices issued and date mailed.

(E) The director may impound or order the impounding of sources of radiation that are not stored, used, or disposed of in accordance with Chapter 3748. of the Revised Code or the rules adopted under it if the source of radiation has been abandoned or if the owner cannot be identified or located. If the director determines that an emergency exists requiring immediate impoundment to protect the public health or safety, the director may issue an emergency adjudication order in accordance with paragraph (B) of this rule. The director may make any disposition of the source of radiation consistent with Chapter 3748. of the Revised Code and the rules adopted thereunder.

(F) If the director determines that a licensee has failed to comply with Chapter 3748. of the Revised Code or the rules adopted thereunder, the director may at any time assess and collect an administrative monetary penalty in accordance with rules adopted pursuant to section 3748.05 of the Revised Code. The director may assess the administrative penalty independent of any and all other remedies that may be asserted by the department but may not assess any administrative monetary penalty until specified by rule in accordance with section 3748.05 of the Revised Code. The licensee may appeal the assessment of an administrative monetary penalty in accordance with Chapter 119. of the Revised Code, provided that the licensee requests a hearing within thirty days of the time of mailing the administrative penalty assessment.

Effective: 04/15/2013
R.C. 119.032 review dates: 11/30/2012 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.07 , 3748.17
Prior Effective Dates: 4/30/98, 10/22/2006

3701:1-38-07 General provisions; purpose, scope, and communications.

(A) Chapter 3701:1-38 of the Administrative Code establishes standards for protection against ionizing radiation resulting from activities conducted under licenses and registrations issued by the director. It is the purpose of Chapter 3701:1-38 of the Administrative Code to control the receipt, possession, use, transfer, and disposal of radiation sources by any licensee or registrant in such a manner that the total dose to an individual, including doses resulting from licensed and unlicensed radioactive material and from radiation sources other than background radiation, does not exceed the standards for protection against radiation prescribed in this chapter. The rules in Chapter 3701:1-38 of the Administrative Code apply to facilities that receive, possess, use, transfer, or dispose of radioactive material, and to handlers of radiation-generating equipment. Nothing in this chapter shall be construed as limiting actions of the director that may be necessary to protect health, safety or the environment. The limits in Chapter 3701:1-38 of the Administrative Code do not apply to doses due to background radiation, any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state regulations, or voluntary participation in medical research programs.

(B) Communications and reports, unless otherwise specified in Chapter 3701:1-38 of the Administrative Code, shall be addressed to "Ohio Department of Health, Bureau of Radiation Protection, 246 North High Street, Columbus, Ohio 43215."

Effective: 05/16/2011
R.C. 119.032 review dates: 12/16/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 6/20/03, 2/6/06

3701:1-38-08 Waivers and additional requirements; vacating premises.

(A) The director, upon application of the licensee or registrant, or upon his or her own initiative, may grant a waiver from the requirements of this chapter as he or she determines is authorized by law, provided that the licensee or registrant shows to the satisfaction of the director that there is good cause for the waiver and that the waiver will not result in any undue hazard on public health and safety or detrimental effect on the environment. The terms, conditions and expiration of the waiver shall be set forth in writing by the director. Failure to comply with the terms of the waiver may result in immediate withdrawal of the waiver. The director may issue an order, a license amendment or impose requirements on a license or registration in addition to those established in this chapter, as the director deems appropriate or necessary to protect the public health, safety or the environment.

(B) A licensee or registrant shall notify the department in writing of an intent to vacate at least thirty days prior to vacating or relinquishing possession or control of a premises which may be contaminated with radioactive material as a result of his or her activities.

R.C. 119.032 review dates: 05/09/2011 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.05
Prior Effective Dates: 10/22/2006

3701:1-38-09 Inspection and investigation.

(A) Each licensee or registrant shall afford to the department at all reasonable times, the opportunity to inspect materials, machines, activities, facilities, premises, and records and any other matters relative to the handling of radioactive material or radiation-generating equipment.

(1) During an inspection, department inspectors may consult privately with workers as specified in paragraph (B) of this rule. The licensee or registrant may accompany department inspectors at any other time during the inspection.

(2) If, at the time of inspection, an individual has been authorized by the workers to represent them during department inspections, the licensee or registrant shall notify the inspector of such authorization and shall give the workers' representative an opportunity to accompany the inspector during the inspection of physical working conditions. Each workers' representative shall be routinely engaged in licensed or registered activity under control of the licensee or registrant and shall have received instructions as to the provisions specified in paragraph (B) of rule 3701:1-38-10 of the Administrative Code. Different representatives of licensees or registrants and workers may accompany the inspectors during different phases of an inspection if there is no resulting interference with the conduct of the inspection. However, only one workers' representative at a time may accompany an inspector.

(3) With the approval of the licensee or registrant and the workers' representative, an individual who is not routinely engaged in work under control of the licensee or registrant, for example, a consultant to the licensee or registrant or to the workers' representative, shall be afforded the opportunity to accompany the department inspector during the inspection of physical working conditions.

(4) Notwithstanding any other provision in paragraph (A) of this rule, a department inspector may refuse to permit accompaniment by any individual who deliberately interferes with a fair and orderly inspection. With regard to areas containing information classified by an agency of the United States government in the interest of national security, an individual who accompanies an inspector may have access to such information only if properly authorized. With regard to any area containing proprietary information or trade secrets, the workers' representative for that area shall be an individual previously authorized by the licensee or registrant to enter that area.

(B) Private consultation between a department inspector and a worker during inspections shall be subject to the following:

(1) A department inspector may consult privately with workers concerning matters of occupational radiation protection and other matters related to applicable provisions of a license condition, order, or rules adopted pursuant to Chapter 3748. of the Revised Code.

(2) During the course of an inspection, any worker privately may bring to the attention of a department inspector, either orally or in writing, any past or present condition which the worker has reason to believe may have contributed to or caused any violation of rules adopted pursuant to Chapter 3748. of the Revised Code, license condition, order, or any unnecessary exposure of an individual to sources of radiation under the licensee's or registrant's control. Any such notice in writing shall comply with the requirements specified in paragraph (C) of this rule. The provisions of this paragraph shall not be interpreted as authorization to disregard instructions pursuant to paragraph (B) of rule 3701:1-38-10 of the Administrative Code.

(C) Requests by workers for a department inspection shall be in accordance with the following:

(1) Any worker or representative of workers believing that a violation of Chapter 3748. of the Revised Code or rules adopted thereunder, license condition or order, or any unnecessary exposure of an individual to sources of radioactive material or radiation-generating equipment under the licensee's or registrant's control has occurred in the handling of radioactive material or radiation-generating equipment relative to working conditions may request an inspection by giving notice of the alleged violation to the director. Any such notice shall be in writing, shall set forth the specific grounds for the notice, and shall be signed by the worker or representative of the workers. A copy shall be provided to the licensee or registrant by the department no later than at the time of inspection except that, upon the request of the worker giving such notice, such worker's name and the name of individuals referred to therein shall not appear in such copy or on any record published, released, or made available by the department, except for good cause shown.

(2) If, upon receipt of such notice, the director determines that the written compliant meets the requirements specified in paragraph (C)(1) of this rule and that the director determines that there are reasonable grounds to believe that the alleged violation exists or has occurred or that further investigation is necessary, the department shall inspect the facility as soon as practicable to determine if such alleged violation exists or has occurred. Any such inspection is not limited to matters referred to in the written complaint.

(3) The department shall notify the complainant in writing of the results of the investigation. The complainant may resubmit the written complaint without prejudice.

(D) If the department determines under paragraph (C) of this rule that an inspection is not warranted by a written complaint, such determination shall be in accordance with the following:

(1) If the department determines that an inspection is not warranted because there are no reasonable grounds to believe that a violation exists or has occurred, the department shall notify the complainant in writing of such determination. The complainant may obtain review of such determination by submitting a written statement of position with the department. The department will provide the licensee or registrant with a copy of such statement, excluding, at the request of the complainant, the name of the complainant. The licensee or registrant may submit an opposing written statement of position with the department. The department will provide any opposing statement to the complainant.

(2) Upon the request of the complainant, the director may hold an informal conference in which the complainant and the licensee or registrant may orally present their views. An informal conference may also be held at the request of the licensee or registrant, but disclosure of the identity of the complainant will be made only following receipt of written authorization from the complainant. The director shall consider all written and oral views presented and shall notify the parties in writing of his or her decision on whether an inspection is warranted and the reason therefore.

(E) No licensee or registrant, or contractor or subcontractor of a licensee or registrant shall retaliate or discriminate against any employee or former employee for exercising rights or engaging in activities protected under rules adopted persuant to Chapter 3748. of the Revised Code.

R.C. 119.032 review dates: 05/09/2011 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04 , 3748.13
Prior Effective Dates: 6/26/2006

3701:1-38-10 Notices, instructions, and reports to workers.

(A) Posting of notices to workers.

(1) Each licensee or registrant shall post current copies of the following documents:

(a) All applicable rules promulgated pursuant to Chapters 3748. and 4773. of the Revised Code;

(b) The license or certificate of registration, including, any conditions or documents incorporated by reference into a license and amendments thereto;

(c) The safe operating procedures applicable to activities under the license or registration; and

(d) Any notice of violation involving radiological working conditions, proposed imposition of civil or administrative monetary penalty, or order issued pursuant to rule 3701:1-38-06 of the Administrative Code and any response from the licensee or registrant. Such document shall be posted within five working days after receipt of the document. The licensee's or registrant's response, if any, shall be posted within five working days after dispatch of the document to the director. Such documents shall remain posted for a minimum of five working days or until action correcting the violation has been completed, whichever is later.

(e) The Ohio department of health, bureau of radiation protection issued form titled "Notice to Employees."

(2) If posting of a document specified in paragraphs (A)(1)(a) to (A)(1)(c) of this rule is not practical, the licensee or registrant may post a notice which describes the document and states where it may be readily examined.

(3) Documents, notices, or forms posted pursuant to paragraph (A) of this rule shall appear in a sufficient number of places to permit individuals engaged in licensed or registered activity under the license or registration to observe them on the way to or from any particular work location to which the document applies, shall be conspicuous, and shall be replaced if defaced or altered.

(B) Instruction to workers.

(1) The licensee or registrant shall, with respect to all individuals likely to receive an annual TEDE occupational dose in excess of one millisievert (one hundred millirem):

(a) Keep such individuals informed of the storage, transfer, or use of sources of radiation in the licensee's or registrant's workplace;

(b) Instruct such individuals in the health effects associated with exposure to radiation or radioactive material to the individual and potential offspring, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;

(c) Instruct such individuals in, and instruct such individuals to observe, to the extent within the individual's control, the applicable provisions of rules promulgated under Chapter 3748. of the Revised Code and any license conditions for the protection of personnel from exposures to radiation or radioactive material;

(d) Instruct each such individual of his or her responsibility to report promptly to the licensee or registrant any condition which may constitute, lead to, or cause a violation of Chapter 3748. of the Revised Code, the rules promulgated thereunder, any license condition, or order, and any unnecessary exposure to radiation or radioactive material;

(e) Instruct such individuals in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation or radioactive material; and

(f) Advise such individuals of any radiation exposure reports furnished pursuant to paragraph (C) of this rule.

(2) In determining those individuals subject to the requirements of paragraph (B)(1) of this rule, licensees and registrants shall take into consideration assigned activities during normal and abnormal situations involving exposure to radiation and radioactive materials which can reasonably be expected to occur during the life of the facility. The extent of these instructions shall be commensurate with potential radiological health protection problems present in the workplace.

(C) Notifications and reports to individuals.

(1) Radiation exposure data for an individual and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual shall be reported to the individual as specified in this rule. The information reported shall include data and results obtained pursuant to Chapter 3748. of the Revised Code or rules adopted thereunder, an order, or license condition as shown in records maintained by the licensee or registrant pursuant to paragraph (H) of rule 3701:1-38-20 of the Administrative Code. Each notification and report shall:

(a) Be in writing;

(b) Include appropriate identifying data such as the name of the licensee or registrant, the name of the individual, and the individual's identification number, preferably social security number;

(c) Include the individual's exposure information; and

(d) Contain the statement: "This report is furnished to you under the provisions of rule 3701:1-38-10 of the Administrative Code. You should preserve this report for further reference."

(2) Each licensee or registrant shall make dose information available to workers as shown in records maintained by the licensee under the provisions of paragraph (H) of rule 3701:1-38-20 of the Administrative Code. The licensee or registrant shall provide an annual report to each individual monitored under rule 3701:1-38-14 of the Administrative Code, of the dose received in that monitoring year if:

(a) The individual's occupational dose exceeds one millisievert (one hundred millirem) TEDE or one millisievert (one hundred millirem) to any individual organ or tissue; or

(b) The individual requests his or her annual dose report.

(3) Each licensee or registrant shall furnish reports to workers.

(a) At the request of a worker formerly engaged in activities controlled by the licensee or registrant, each licensee or registrant shall furnish to the worker a report of the worker's exposure to sources of radiation:

(i) As shown in records maintained by the licensee or registrant pursuant to rule 3701:1-38-20 of the Administrative Code for each year the worker was required to be monitored under the provisions of rule 3701:1-38-14 of the Administrative Code; and

(ii) For each year the worker was required to be monitored under the monitoring requirements in effect prior to August 31, 1999.

(b) This report must be furnished within thirty days from the time the request is made or within thirty days after the exposure of the individual has been determined by the licensee or registrant, whichever is later. This report must cover the period of time that the worker's activities involved exposure to sources of radiation licensed or registered by the director and must include the dates and locations of licensed or registered activities in which the worker participated during this period.

(4) When a licensee or registrant is required pursuant to paragraphs (A) to (C) of rule 3701:1-38-21 of the Administrative Code to report to the director any exposure of an individual to sources of radiation, the licensee or the registrant shall also provide the individual a written report on the exposure data included in the report to the director. This report must be transmitted no later than the transmittal to the director.

(5) At the request of a worker who is terminating employment with the licensee or registrant that involved exposure to sources of radiation during the current calendar quarter or the current year, each licensee or registrant shall provide at termination to each worker, or to the worker's designee, a written report regarding the radiation dose received by that worker from operations of the licensee or registrant during the current calendar year or fraction thereof. If the most recent individual monitoring results are not available at that time, a written estimate of the dose must be provided together with a clear indication that this is an estimate.

Effective: 11/14/2013
R.C. 119.032 review dates: 08/29/2013 and 11/01/2018
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/01, 10/22/06, 4/5/09

3701:1-38-11 Radiation protection standards, general provisions.

(A) Quality factors for converting absorbed dose to dose equivalent are as follows:

Type of radiation Quality factor (Q) Absorbed dose equal to a unit dose equivalentA/
X-, gamma, or beta radiation and high-speed electrons .... 1 1
Alpha particles, multiple-charged particles, fission fragments and heavy particles of unknown charge .... 20 0.05
Neutrons of unknown energy .... 10 0.1
High-energy protons .... 10 0.1

A/ Absorbed dose in gray equal to one sievert or the absorbed dose in rad equal to one rem.

(B) If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in sievert per hour or rem per hour, as provided in paragraph (A) of this rule, 0.01 sievert (one rem) of neutron radiation of unknown energies may, for purposes of these regulations, be assumed to result from a total fluence of twenty-five million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee may use the fluence rate per unit dose equivalent or the appropriate Q value as provided in this paragraph to convert a measured tissue dose in gray or rad to dose equivalent in sievert or rem as follows:

  Neutron energy (MeV) Quality factorA/ (Q) Fluence per unit dose equivalentB/ (neutrons cm-2 rem-1) Fluence per unit dose equivalentB/ (neutrons cm-2 Sv-1)
(Thermal)........ 2.5 x10-8 2 980x106 980x108
  1x10-7 2 980x106 980x108
  1x10-6 2 810x106 810x108
  1x10-5 2 810x106 810x108
  1x10-4 2 840x106 840x108
  1x10-3 2 980x106 980x108
  1x10"-2 2.5 1010x106 1010x108
  1x10"-1 7.5 170x106 170x108
  5x10"-1 11 39x106 39x108
  1 11 27x106 27x108
  2.5 9 29x106 29x108
  5 8 23x106 23x108
  7 7 24x106 24x108
  10 6.5 24x106 24x108
  14 7.5 17x106 17x108
  20 8 16x106 16x108
  40 7 14x106 14x108
  60 5.5 16x106 16x108
  1x102 4 20x106 20x108
  2x102 3.5 19x106 19x108
  3x102 3.5 16x106 16x108
  4x102 3.5 14x106 14x108

A/Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-centimeter diameter cylinder tissue-equivalent phantom.

B/Monoenergetic neutrons incident normally on a 30-centimeter diameter cylinder tissue-equivalent phantom.

(C) For the purpose of Chapter 3701:1-38 of the Administrative Code, activity is expressed in the SI unit of becquerel, Bq, or in the special unit of curie, Ci, or their multiples, or disintegrations or transformations per unit of time.

(D) Radiation protection programs.

(1) Each licensee or registrant shall develop, document, and implement a radiation protection program commensurate with the scope and extent of licensed or registered activities to ensure compliance with the provisions of this chapter.Record keeping requirements are provided in paragraph (B) of rule 3701:1-38-20 of the Administrative Code.

(2) The licensee or registrant shall use, to the extent practicable, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and public doses that are as low as is reasonably achievable.

(3) The licensee or registrant shall, at intervals not to exceed twelve months, review the radiation protection program content and implementation.

(4) To implement the ALARA requirements of paragraph (D)(2) of this rule, and notwithstanding the requirements in rule 3701:1-38-13 of the Administrative Code, a constraint on air emissions of radioactive material to the environment, excluding radon-222 and its daughters, shall be established by licensees, such that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of 0.1 millisievert(ten millirem) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the amount exceeding the dose constraint as provided in paragraph (C) of rule 3701:1-38-21 of the Administrative Code and promptly take appropriate corrective action to ensure against recurrence.

Effective: 09/01/2011
R.C. 119.032 review dates: 05/23/2011 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 10/22/2006

3701:1-38-12 Occupational dose limits.

(A) Except in the case of a planned special exposure pursuant to paragraph (F) of this rule, a licensee or registrant shall limit the occupational dose received by an individual adult, as follows:

(1) An annual limit, which is the more limiting of:

(a) The total effective dose equivalent being equal to 0.05 sievert (five rem); or

(b) The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 0.5 sievert (fifty rem).

(2) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, which are:

(a) A lens dose equivalent of 0.15 sievert (fifteen rem), and

(b) A shallow-dose equivalent of 0.5 sievert (fifty rem) to the skin of the whole body or to the skin of any extremity.

(3) Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current calendar year and during the individual's lifetime in accordance with paragraph (F)(5) of this rule.

(4) When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the director. The assigned deep-dose equivalent must be for the part of the body receiving the highest exposure.

(a) The assigned shallow-dose equivalent must be the dose averaged over the contiguous ten square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable; or

(b) When a protective apron is worn while working with radiation-generating equipment and monitoring is conducted as specified in paragraph (C)(1) of rule 3701:1-38-14 of the Administrative Code, the effective dose equivalent for external radiation shall be determined as follows:

(i) When only one individual monitoring device is used and it is located at the neck outside the protective apron, the reported deep dose equivalent value multiplied by 0.3 shall be the effective dose equivalent for external radiation; or

(ii) When two individual monitoring devices are worn, one under the protective apron at the waist and the other outside the protective apron at the neck, the effective dose equivalent for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by 0.04 ; or

(iii) Through the use of computational methods endorsed by the "American National Standards Institute", recommended by the "National Council on Radiation Protection and Measurements", or approved by the director.

(5) Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in appendix C to this rule and may be used by the licensee to determine the individual's dose and to demonstrate compliance with the occupational dose limits. Appendices A and B are explanatory supplements to appendix C to this rule. Notwithstanding the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to ten milligrams in a week in consideration of chemical toxicity.

(6) In accordance with paragraph (E) of this rule, the licensee or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person.

(B) Compliance with requirements for summation of external and internal doses shall be in accordance with the following:

(1) If the licensee is required to monitor under both paragraphs (B)(1) and (B)(2) of rule 3701:1-38-14 of the Administrative Code, the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only under paragraph (B)(1) or only under paragraph (B)(2) of rule 3701:1-38-14 of the Administrative Code, then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses by meeting one of the conditions specified in paragraph (B)(2) of this rule and the conditions in paragraphs (B)(3) and (B)(4) of this rule. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.

(2) If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total effective dose equivalent limit, plus one of the following does not exceed unity:

(a) The sum of the fractions of the inhalation ALI for each radionuclide; or

(b) The total number of derived air concentration-hours, or DAC-hours, for all radionuclides divided by two thousand; or

(c) The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, WT , and the committed dose equivalent, H T,50, per unit intake is greater than ten per cent of the maximum weighted value of HT,50 , that is, WT H T,50, per unit intake for any organ or tissue.

(3) If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than ten percent of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits set forth in paragraph (A) of this rule.

(4) The licensee shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be further evaluated or accounted for pursuant to this paragraph.

(C) Determination of external dose from airborne radioactive material shall be in accordance with the following:

(1) When determining the dose from airborne radioactive material, the licensee shall include the contribution to the deep dose equivalent, lens dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud as specified in appendix C to this rule, footnotes A and B.

(2) The licensee should not use airborne radioactivity measurements or DAC values as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases, or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual should be based upon measurements using instruments or individual monitoring devices.

(D) Determination of internal exposure shall be in accordance with the following:

(1) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required under paragraph (B) of rule 3701:1-38-14 of the Administrative Code, take suitable and timely measurements of:

(a) Concentrations of radioactive materials in air in work areas; or

(b) Quantities of radionuclides in the body; or

(c) Quantities of radionuclides excreted from the body; or

(d) Combinations of these measurements.

(2) Unless respiratory protective equipment is used, as provided in paragraph (C) of rule 3701:1-38-16 of the Administrative Code or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

(3) When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee may:

(a) Use that information to calculate the committed effective dose equivalent, and, if used, the licensee shall document that information in the individual's record; and

(b) Upon prior approval of the department, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and

(c) Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent as specified in appendix A to this rule.

(4) If the licensee chooses to assess intakes of Class Y material using the measurements given in paragraph (D)(1)(b) or (D)(1)(c) of this rule in order to make additional measurements basic to the assessments, the licensee may delay the recording and reporting of the assessments for periods up to seven months, unless otherwise required by paragraph (B)(2) or (C) of rule 3701:1-38-21 of the Administrative Code.

(5) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either:

(a) The sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from appendix C to this rule for each radionuclide in the mixture; or

(b) The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.

(6) If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall by the most restrictive DAC of any radionuclide in the mixture.

(7) When a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if all of the following occur:

(a) The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in paragraph (A) of this rule and in complying with the monitoring requirements in paragraph (B) of rule 3701:1-38-14 of the Administrative Code;

(b) The concentration of any radionuclide disregarded is less than ten percent of its DAC; and

(c) The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed thirty percent.

(8) When determining the committed effective dose equivalent, the licensee may consider the following:

(a) In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one ALI, or an exposure of two thousand DAC-hours, results in a committed effective dose equivalent of 0.05 sievert (five rem), for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent; or

(b) For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 0.5 sievert (fifty rem), the intake of radionuclides that would result in a committed effective dose equivalent of 0.05 sievert (five rem), that is, the stochastic ALI, is listed in parentheses in table I of appendix C to this rule. The licensee may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALI, the licensee shall also demonstrate that the limit in paragraph (A)(1)(b) of this rule is met.

(E) Determination of prior occupational dose shall be made in accordance with the following:

(1) For each individual who is likely to receive an annual occupational dose requiring monitoring pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, the licensee or registrant shall determine the occupational radiation dose received during the current year.

(2) Prior to permitting an individual to participate in a planned special exposure, the licensee shall determine:

(a) The internal and external doses from all previous planned special exposures; and

(b) All doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual.

(3) In complying with the requirements of paragraph (E)(1) or (E)(2) of this rule, a licensee or registrant may:

(a) Accept, as a record of the occupational dose that the individual received during the current year, a written signed statements from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual may have received during the current year;

(b) Accept, as the record of lifetime cumulative radiation dose, a current department form entitled "lifetime occupational exposure history" or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant; and

(c) Obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant, by telephone, telegram, facsimile, e-mail or letter. The licensee or registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.

(4) The licensee or registrant shall record the exposure history, as required by paragraph (A) of this rule, on a form provided by the department or other clear and legible record, of all the information required on that form. The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant shall use the dose shown in the report in preparing the exposure history form. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on the exposure history form indicating the periods of time for which data are not available.

(5) If the licensee or registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee or registrant shall assume:

(a) In establishing administrative controls pursuant to paragraph (A)(6) of this rule for the current year, that the allowable dose limit for the individual is reduced by 12.5 millisievert ( 1.25 rem), for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and

(b) That the individual is not available for planned special exposures.

(6) The licensee or registrant shall retain the records on the exposure history form until the department terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing the exposure history form for three years after the record is made.

(F) A planned special exposure may be authorized by a licensee in accordance with this paragraph. A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in paragraph (A) of this rule provided that each of the following is satisfied:

(1) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the higher exposure are unavailable or impractical;

(2) The licensee and employer, if the employer is not the licensee, specifically authorizes the planned special exposure, in writing, before the exposure occurs;

(3) Before a planned special exposure, the licensee ensures that each individual involved is:

(a) Informed of the purpose of the planned operation; and

(b) Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and

(c) Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present;

(4) Prior to permitting an individual to participate in a planned special exposure, the licensee ascertains prior doses as required by paragraph (E)(2) of this rule during the lifetime of the individual for each individual involved;

(5) The licensee shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:

(a) The numerical values of any of the dose limits in paragraph (A) of this rule in any calendar year; and

(b) Five times the annual dose limits specified in paragraph (A) of this rule during the individual's lifetime;

(6) The licensee maintains records of the conduct of a planned special exposure in accordance with paragraph (E) of rule 3701:1-38-20 of the Administrative Code and submits a written report in accordance with paragraph (D) of rule 3701:1-38-21 of the Administrative Code;

(7) The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within thirty days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual pursuant to paragraph (A)(1) of this rule, but shall be included in evaluations required by paragraphs (F)(4) and (F)(5) of this rule.

(G) Occupational dose limits for minors shall be ten per cent of the annual occupational dose limits specified for adult workers in paragraph (A) of this rule.

(H) Dose equivalent to an embryo or fetus shall be in accordance with the following:

(1) The licensee or registrant shall ensure that the dose equivalent to an embryo or fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed five millisievert ( 0.5 rem). Records shall be maintained in accordance with paragraph (I) of rule 3701:1-38-20 of the Administrative Code.

(2) The licensee or registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (H)(1) of this rule.

(3) The dose equivalent to the embryo or fetus is the sum of:

(a) The deep-dose equivalent to the declared pregnant woman; and

(b) The dose equivalent to the embryo or fetus resulting from radionuclides in the embryo or fetus and from radionuclides in the declared pregnant woman.

(4) If the declared pregnant woman's exposure includes exposure from radiation generating equipment and a protective apron is worn, the dose equivalent to an embryo or fetus shall be taken as the sum of:

(a) The dose equivalent to the embryo or fetus from radionuclides in the embryo or fetus and radionuclides in the declared pregnant woman; and

(b) The dose equivalent that is most representative of the dose to the embryo or fetus from external radiation, that is, in the mother's lower torso region.

(i) If multiple measurements have not been made, assignment of the highest deep dose equivalent for the declared pregnant woman shall be the dose to the embryo or fetus, in accordance with paragraph (A)(4) of this rule; or

(ii) If multiple measurements have been made, assignment of the deep dose equivalent for the declared pregnant woman from the individual monitoring device which is most representative of the dose to the embryo or fetus shall be the dose to the embryo or fetus. Assignment of the highest deep dose equivalent for the declared pregnant woman to the embryo or fetus is not required unless that dose is also the most representative deep dose equivalent for the region of the embryo or fetus.

(5) If by the time the woman declares pregnancy to the licensee or registrant, the dose equivalent to the embryo or fetus has exceeded five millisievert, or 0.5 rem, the licensee or registrant shall be deemed to be in compliance with paragraph (A) of this rule, provided that the additional dose equivalent to the embryo or fetus does not exceed 0.5 millisievert ( 0.05 rem), during the remainder of the pregnancy.

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Effective: 10/04/2010
R.C. 119.032 review dates: 06/24/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2004, 6/20/03, 8/15/05, 4/5/09

3701:1-38-13 Dose limits for individual members of the public.

(A) Each licensee or registrant shall conduct operations so that:

(1) The total effective dose equivalent to individual members of the public from the licensed or registered operation does not exceed one millisievert ( 0.1 rem) in a year, exclusive of the dose contribution from the following:

(a) Background radiation;

(b) Radiation attributable to any medical administration the individual has received;

(c) Exposure to an individual that was administered radioactive materials and has been released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory agency or agreement state regulations;

(d) Voluntary participation in medical research programs;

(e) The licensee's disposal of radioactive material into sanitary sewerage in accordance with paragraph (D) of rule 3701:1-38-19 of the Administrative Code; and

(2) The dose in any unrestricted area from external sources, exclusive of the dose contribution from patients administered radioactive material and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory agency or agreement state regulations, does not exceed 0.02 millisievert ( 0.002 rem) in any one hour.

(B) If the licensee or registrant permits members of the public to have access to controlled or restricted areas, the limits for members of the public continue to apply to those individuals.

(C) A licensee, registrant, or an applicant for a license or registration may apply for prior department authorization to operate up to an annual dose limit for an individual member of the public of five millisievert ( 0.5 rem). This application shall include the following information:

(1) Demonstration of the need for and the expected duration of operation in excess of the limit set forth in paragraph (A) of this rule;

(2) The licensee's or registrant's program to assess and control dose within the five millisievert ( 0.5 rem) annual limit; and

(3) The procedures that the registrant or licensee will follow to maintain the dose ALARA.

(4) Notwithstanding paragraph (A)(1) of this rule, a licensee may permit visitors to an individual who cannot be released, under rule 3701:1-58-30 of the Administrative Code, to receive a radiation dose greater than one millisievert ( 0.1 rem) if:

(a) The radiation dose received does not exceed five millisievert ( 0.5 rem); and

(b) The authorized user, as defined in Chapter 3701:1-58 of the Administrative Code, has determined before the visit that it is appropriate.

(D) In addition to the requirements of paragraphs (A) and (B) of this rule:

(1) A licensee subject to the provisions of the United States environmental protection agency's generally applicable environmental radiation standards in 40 C.F.R. 190, as published in the July 1, 2009 Code of Federal Regulations, shall also comply with those standards.

(2) The department may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose.

(E) The licensee or registrant shall demonstrate compliance with dose limits for individual members of the public.

(1) The licensee or registrant shall make or cause to be made surveys of radiation levels in unrestricted and controlled areas and radioactive materials in effluents released to unrestricted and controlled areas to demonstrate compliance with the dose limits for individual members of the public in paragraph (A) of this rule.

(2) A licensee or registrant shall show compliance with the annual dose limit in paragraph (A) of this rule by:

(a) Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed or registered operation does not exceed the annual dose limit; or

(b) Demonstrating that:

(i) The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in appendix C to rule 3701:1-38-12 of the Administrative Code; and

(ii) If an individual were continuously present in an unrestricted area, the dose from external sources would not exceed 0.02 millisievert ( 0.002 rem) in an hour and 0.5 millisievert ( 0.05 rem) in a year.

(3) Upon approval from the department, the licensee may adjust the effluent concentration values in appendix C to rule 3701:1-38-12 of the Administrative Code for members of the public, to take into account the actual physical and chemical characteristics of the effluents, such as aerosol size distribution, solubility, density, radioactive decay equilibrium, or chemical form.

Effective: 10/04/2010
R.C. 119.032 review dates: 06/24/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/21/2001, 6/20/03, 8/15/05

3701:1-38-14 Survey and monitoring requirements.

(A) Each licensee or registrant shall:

(1) Make, or cause to be made, surveys of areas, including the subsurface, that are:

(a) Necessary to comply with this chapter: and

(b) Reasonable under the circumstances to evaluate:

(i) Radiation levels;

(ii) Concentrations or quantities of residual radioactivity; and

(iii) The potential radiological hazards of the radiation levels and residual radioactivity detected.

(2) Notwithstanding paragraph (C) of rule 3701:1-38-20 of the Administrative Code, records from surveys describing the location and amount of subsurface residual radioactivity identified at the site must be kept with records important for decommissioning, and such records must be retained in accordance with paragraph (I) of rule 3701:1-40-17 , paragraph (F) of rule 3701:1-44-18 , and paragraph (D) of rule 3701:1-56-19 of the Administrative Code, as applicable.

(3) Ensure that instruments and equipment used for quantitative radiation measurements, such as dose rate and effluent monitoring, are calibrated annually for the radiation measured, except as otherwise specified in Chapter 3748. of the Revised Code, rules adopted thereunder, or a license condition.

(4) Ensure that all personnel dosimeters, except for direct and indirect reading dosimeters used to measure the dose to any extremity, that require processing to determine the radiation dose and that are used to comply with paragraph (A) of rule 3701:1-38-12 of the Administrative Code, with other applicable provisions of these regulations, or with conditions specified in a license or registration shall be processed and evaluated by a dosimetry processor that:

(a) Holds a current personnel dosimetry accreditation from the national voluntary laboratory accreditation program of the national institute of standards and technology; and

(b) Is approved in this accreditation process for the type of radiation or radiations included in the national voluntary laboratory accreditation program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored; and

(5) Have procedures in place to minimize the likelihood of a deceptive exposure of an individual monitoring device, and in the event of a suspected deceptive exposure, an investigation should be conducted by the radiation safety officer which will lead to corrective action as necessary.

(B) Conditions requiring individual monitoring of external and internal occupational dose are as follows:

(1) Each licensee or registrant shall monitor exposures from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of rule 3701:1-38-12 of the Administrative Code. Each licensee or registrant shall monitor occupational exposure to radiation from sources of radiation under the control of the licensee or registrant and shall supply and require the use of individual monitoring devices by:

(a) Adults likely to receive, in one year from sources of radiation external to the body, a dose in excess of ten per cent of the limits in paragraph (A) of rule 3701:1-38-12 of the Administrative Code;

(b) Minors likely to receive, in one year, from radiation sources external to the body, a deep dose equivalent in excess of one millisievert ( 0.1 rem), a lens dose equivalent in excess of 1.5 millisievert ( 0.15 rem), or a shallow dose equivalent to the skin or to the extremities in excess of five millisievert ( 0.5 rem);

(c) Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of one millisievert ( 0.1 rem); and

(d) Individuals entering a high or very high radiation area.

(2) To determine compliance with paragraph (D) of rule 3701:1-38-12 of the Administrative Code, each licensee shall monitor the occupational intake of radioactive material by and assess the committed effective dose equivalent to:

(a) Adults likely to receive, in one year, an intake in excess of ten per cent of the applicable ALI in appendix C to rule 3701:1-38-12 of the Administrative Code;

(b) Minors likely to receive, in one year, a committed effective dose equivalent in excess of one millisievert ( 0.1 rem); and

(c) Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of one millisievert ( 0.1 rem).

(C) Each licensee or registrant shall ensure that any individual who is required to monitor occupational doses in accordance with paragraph (B)(1) of this rule wears an individual monitoring device as follows:

(1) An individual monitoring device, used for monitoring the dose to the whole body, shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck.

(2) An individual monitoring device, used for monitoring the dose to an embryo or fetus of a declared pregnant woman pursuant to paragraph (H) of rule 3701:1-38-12 of the Administrative Code, shall be located at the waist under any protective apron being worn by the woman.

(3) An individual monitoring device, used for monitoring the lens dose equivalent, to demonstrate compliance with paragraph (A) of rule 3701:1-38-12 of the Administrative Code, shall be located at the neck outside any protective apron being worn by the monitored individual, or at an unshielded location close to the eye.

(4) An individual monitoring device, used for monitoring the dose to the extremities, to demonstrate compliance with paragraph (A)(2) of rule 3701:1-38-12 of the Administrative Code, shall be worn on the extremity likely to receive the highest exposure. Each individual monitoring device shall be oriented to measure the highest dose to the extremity being monitored.

(5) When only one individual monitoring device is used to determine the effective dose equivalent for external radiation pursuant to paragraph (A)(4)(b) of rule 3701:1-38-12 of the Administrative Code, it shall be located at the neck outside the protective apron. When a second individual monitoring device is used for the same purpose, it shall be located under the protective apron at the waist. The second individual monitoring device is required for a declared pregnant woman.

Effective: 11/14/2013
R.C. 119.032 review dates: 08/29/2013 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.01
Prior Effective Dates: 7/22/2011, 10/22/06

3701:1-38-15 Control of exposure from external sources in high and very high radiation areas.

(A) Control of access to high radiation areas shall be maintained by the licensee or registrant.

(1) Control of access shall be maintained by ensuring that each entrance or access point to a high radiation area has one or more of the following features:

(a) A control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep dose equivalent of one millisievert ( 0.1 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates; or

(b) A control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of the entry; or

(c) Entryways that are locked, except during periods when access to the areas is required, with administrative and/or engineering control over each individual entry.

(2) In place of the controls required by paragraph (A)(1) of this rule, in the case of a high radiation area, the licensee or registrant may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.

(3) The licensee or registrant may apply to the department for approval of alternative methods for controlling access to high radiation areas.

(4) The licensee or registrant shall establish the controls required by paragraphs (A)(1) and (A)(3) of this rule in a way that does not prevent individuals from leaving a high radiation area.

(5) The licensee is not required to control each entrance or access point to a room or other area that is a high radiation area solely because of the presence of radioactive materials prepared for transport and packaged and labeled in accordance with the regulations of the United States department of transportation provided that:

(a) The packages do not remain in the area longer than three days; and

(b) The dose rate at one meter from the external surface of any package does not exceed 0.1 millisievert ( 0.01 rem) per hour.

(6) The licensee is not required to control entrance or access to rooms or other areas in hospitals solely because of the presence of patients containing radioactive material, provided that there are personnel in attendance who are taking the necessary precautions to prevent the exposure of individuals to radiation or radioactive material in excess of the established limits in paragraph (A) of rule 3701:1-38-13 of the Administrative Code and to operate within the ALARA provisions of the licensee's radiation protection program.

(7) The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a high radiation area as described in paragraphs (A)(1) to (A)(4) of this rule if the registrant has met all the specific requirements for access and control specified in other applicable rules, such as, the requirements for industrial radiography, x-rays in the healing arts, and particle accelerators as provided in Chapter 3701:1-66 and 3701:1-67 ofthe Administrative Code.

(B) In the case of access to a very high radiation area, the licensee or registrant shall control access as follows:

(1) In addition to the requirements in paragraph (A) of this rule, and except as provided in paragraph (B)(2) of this rule, the licensee or registrant shall institute measures to ensure that an individual is not able to gain unauthorized or inadvertent access to a very high radiation area. This requirement does not apply to rooms or areas in which diagnostic x-ray systems are the only source of radiation.

(2) The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a very high radiation area as provided in paragraph (B)(1) of this rule if the registrant has met all the specific requirements for access and control specified in other applicable rules, such as, requirements for industrial radiography, x-rays in the healing arts, and particle accelerators as provided in Chapter 3701:1-66 and 3701:1-67 of the Administrative Code.

Effective: 09/01/2011
R.C. 119.032 review dates: 05/23/2011 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 10/22/06

3701:1-38-16 Respiratory protection and controls to restrict internal exposure to radioactive material in a restricted area.

(A) To the extent practical, the licensee shall use process or other engineering controls, such as containment, decontamination or ventilation, to control the concentrations of radioactive material in air. When it is not practical to apply process or other engineering controls to control the concentrations of radioactive material in air to values below those that define an airborne radioactivity area, the licensee shall increase monitoring and limit intakes, consistent with maintaining the total effective dose equivalent ALARA, by one or more of the following means:

(1) Control of access;

(2) Limitation of exposure times;

(3) Use of respiratory protection equipment; or

(4) Other controls as determined by the director.

(B) The licensee may consider safety factors other than radiological factors when determining whether to use respirators. The licensee should also consider the impact of respirator use on workers' industrial health and safety.

(C) If the licensee uses respiratory protection equipment to limit the intake of radioactive material, the licensee shall:

(1) Use only respiratory protection equipment that is tested and certified by the national institute for occupational safety and health (NIOSH) and the mine safety and health administration (MSHA), except that the licensee may use equipment that has not been tested or certified by NIOSH and MSHA, or for which there is no schedule for testing or certification, provided that:

(a) The licensee has submitted and the director has approved an application for authorized use of that equipment; and

(b) The licensee has demonstrated by testing, or demonstrated on the basis of test information, that the material and performance characteristics of the equipment are capable of providing the appropriate proposed degree of protection under anticipated conditions of use;

(2) Implement and maintain a respiratory protection program that includes:

(a) Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate doses;

(b) Surveys and bioassays, as appropriate, to evaluate actual intakes;

(c) Testing whether each respirator is operable immediately prior to each use;

(d) Written procedures regarding the following:

(i) Monitoring, including air sampling and bioassays;

(ii) Supervision and training of respirator users;

(iii) Fit testing;

(iv) Respirator selection;

(v) Breathing air quality;

(vi) Inventory and control;

(vii) Storage, issuance, maintenance, repair, testing, and quality assurance of respiratory protection equipment;

(viii) Recordkeeping; and

(ix) Limitations on periods of respirator use and relief from respirator use.

(e) Determination by a physician that the individual user is medically fit to use the respiratory protection equipment:

(i) Before the initial fitting of a face sealing respirator;

(ii) Before the first field use of non-face sealing respirators; and

(iii) Either every twelve months thereafter, or periodically at a frequency determined by a physician.

(f) Fit testing, with fit factor greater than or equal to ten times the assigned protection factor (APF) for negative pressure devices, and a fit factor greater than or equal to five hundred for any positive pressure, continuous flow, and pressure-demand devices, before the first field use of tight-fitting, face-sealing respirators and periodically thereafter at a frequency not to exceed one year. Fit testing must be performed with the facepiece operating in the negative pressure mode.

(3) Issue a written policy statement or procedure on respirator usage covering:

(a) The use of process or other engineering controls, in lieu of respirators;

(b) The routine, nonroutine, and emergency use of respirators;

(c) The length of periods individuals may use a respirator; and

(d) Conditions for relief from respirator use.

(4) Advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require such relief.

(5) The licensee shall also consider limitations appropriate to the type and mode of use. The licensee shall use respiratory protection equipment within the equipment manufacturer's expressed limitations for type and mode of use and shall provide for adequate vision, communication, low temperature work environments, concurrent use of other safety or radiological protection equipment, and other special capabilities, such as adequate skin protection, when needed. The licensee shall use equipment in such a way as not to interfere with the proper operation of the respirator.

(6) Standby rescue persons are required whenever one-piece atmosphere-supplying suits, or any combination of supplied air respiratory protection device and personnel protective equipment are used from which an unaided individual would have difficulty extricating himself or herself. The standby persons must be equipped with respiratory protection devices or other apparatus appropriate for the potential hazards. The standby rescue persons shall observe or otherwise maintain continuous communication with the workers (visual, voice, signal line, telephone, radio, or other suitable means), and be immediately able to assist them in case of a failure of the air supply or for any other reason that requires relief from distress. A sufficient number of rescue persons must be immediately available to assist all users of this type of equipment and to provide effective emergency rescue if needed.

(7) Atmosphere-supplying respirators must be supplied with respirable air of grade D quality or better as defined by the compressed gas association in publication G- 7.1, "commodity specifications for air," 1997 and included in 29 C.F.R. 1910.134(i)(1)(ii)(A) to (E) (as published in the July 1, 50052009 Code ofFederal Regulations).

(8) The licensee shall ensure that no objects, materials, or substances, such as facial hair, or any conditions that interfere with the seal between the face and facepiece or valve function, and that are under the control of the respiratory wearer, are present between the skin of the wearer's face and the sealing surface of a tight-fitting respirator facepiece.

(D) When estimating exposure of individuals to airborne radioactive materials, the licensee may make allowance for respiratory protection equipment used to limit intakes pursuant to paragraph (A) of this rule, provided that the following requirements, in addition to those in paragraph (C)(1) of this rule, are satisfied:

(1) The licensee selects respiratory protection equipment that provides a protection factor, as specified in appendix A to this rule, greater than the multiple by which peak concentrations of airborne radioactive materials in the working area are expected to exceed the values specified in appendix C to rule 3701:1-38-12 of the Administrative Code. The concentration of radioactive material in the air that is inhaled when respirators are worn may be initially estimated by dividing the ambient concentration in air, without respiratory protection, during each period of uninterrupted use, by the protection factor. If the exposure is later found to be greater than initially estimated, the corrected value shall be used. If the exposure is later found to be less than initially estimated, the corrected value may be used; and

(2) The licensee shall obtain authorization from the department before assigning respiratory protection factors in excess of those specified in appendix A to this rule. The department may authorize a licensee to use higher protection factors on receipt of an application that:

(a) Describes the situation for which a need exists for higher protection factors; and

(b) Demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use.

(E) The department may impose restrictions in addition to the provisions of this rule in order to:

(1) Ensure that the respiratory protection program of the licensee is adequate to limit doses to individuals from intakes of airborne radioactive materials consistent with maintaining total effective dose equivalent ALARA; and

(2) Limit the extent to which a licensee may use respiratory protection equipment instead of process or other engineering controls.

(F) The licensee shall notify the department in writing at least thirty days before the date that respiratory protection equipment is first used pursuant to either paragraph (C) or (D) of this rule, except for emergency use.

Click to view Appendix

Effective: 09/01/2011
R.C. 119.032 review dates: 05/23/2011 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 10/22/06

3701:1-38-17 Storage and control of a licensed or registered source of radiation.

(A) The licensee shall secure licensed radioactive material from unauthorized removal or access.

(B) The licensee shall maintain constant surveillance and shall use devices or administrative procedures to prevent unauthorized use of licensed radioactive material that is in an unrestricted area and that is not in storage.

(C) The registrant shall use devices or administrative procedures to prevent unauthorized use of radiation-generating equipment.

Effective: 09/01/2011
R.C. 119.032 review dates: 05/23/2011 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001

3701:1-38-18 Posting, labeling, and receipt of packages.

(A) Except as provided in paragraph (B) of this rule, caution signs and posting requirements for licensees and registrants are as follows:

(1) The standard radiation symbol, unless otherwise authorized by the department or as provided in paragraph (A)(2) of this rule, shall use the colors magenta, purple, or black on yellow background. The symbol prescribed is the three-bladed design as follows:

image: oh/admin/2014/3701$1-38-18_ph_ff_a_ru_20110819_0828-1.png

(2) Notwithstanding paragraph (A)(1) of this rule, licensees and registrants are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures, with conspicuously cast, etched or stamped radiation caution symbols and without a color requirement.

(3) In addition to the contents of signs and labels prescribed in this chapter, the licensee or registrant may provide, on or near the required signs and labels, additional information, as appropriate, to make individuals aware of potential radiation exposures and to minimize the exposures.

(4) Posting of radiation areas shall be accomplished as follows:

(a) The licensee or registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Radiation Area".

(b) The licensee or registrant shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, High Radiation Area" or "Danger, High Radiation Area".

(c) The licensee or registrant shall post each very high radiation area with conspicuous sign or signs bearing the radiation symbol and words "Grave Danger, Very High Radiation Area".

(d) The licensee shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Airborne Radioactivity Area" or "Danger, Airborne Radioactivity Area".

(e) The licensee shall post each area or room in which there is an amount of licensed material used or stored which exceeds ten times the quantity of such material specified in appendix A of this rule with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Radioactive Material(s)" or "Danger, Radioactive Material(s)".

(f) The licensee shall post access openings to manufacturing or process equipment (such as tanks and vessels) on or in which radiation sources are mounted, if a person could gain access to the radiation beam and receive an annual dose to any part of their body which is greater than the applicable, permissible limits for individuals in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code. The posting must include a conspicuous sign or signs bearing the radiation symbol and warning of the hazard.

(B) The following are exceptions to posting requirements set forth in paragraph (A) of this rule:

(1) A licensee or registrant is not required to post caution signs in an area or room that contains a source of radiation provided that the source is located in the area or room for a period of less than eight hours, and the source of radiation is continuously attended to during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to sources of radiation in excess of the limits established in rule 3701:1-38-13 of the Administrative Code, and the area or room is subject to licensee or registrant control.

(2) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs pursuant to paragraph (A) of this rule provided that the patient could be released from licensee control in accordance with rule 3701:1-58-30 of the Administrative Code.

(3) A room or area is not required to be posted with a caution sign because of the presence of a sealed source provided the radiation level at thirty centimeters from the surface of the sealed source container or housing does not exceed 0.05 millisievert ( 0.005 rem) per hour.

(4) A room or area is not required to be posted with a caution sign because of the presence of radiation-generating equipment used solely for diagnosis in the healing arts.

(5) Rooms in hospitals or clinics that are used for teletherapy are exempt from the requirement to post caution signs if access to the room is controlled pursuant to rule 3701:1-58-59 of the Administrative Code and personnel in attendance take necessary precautions to prevent the inadvertent exposure of workers, other patients, and members of the public to radiation in excess of the limits established in this chapter.

(C) Except as provided in paragraph (E) of this rule, containers shall be labeled as follows:

(1) The licensee shall ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol and the words "Caution, Radioactive Material" or "Danger, Radioactive Material". The label shall also provide information, such as the radionuclides present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment, to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures.

(2) Prior to removal or disposal ofempty uncontaminated containers to unrestricted areas, each licensee shall, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials.

(D) Each registrant shall ensure that each radiation-generating equipment is labeled in a conspicuous manner which cautions individuals that radiation is produced when it is energized.

(E) A licensee is not required to label the following:

(1) Containers holding licensed material in quantities less than the quantities listed in appendix A to this rule;

(2) Containers holding licensed material in concentrations less than those specified in table III of appendix C to rule 3701:1-38-12 of the Administrative Code;

(3) Containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by rule 3701:1-38-13 of the Administrative Code;

(4) Containers when they are in transport and packaged and labeled in accordance with the regulations of the United States department of transportation;

(5) Containers that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, if the contents are identified to these individuals by a readily available written record. Examples of containers of this type are containers in locations such as water-filled canals, storage vaults, or hot cells. The record shall be retained as long as the containers are in use for the purpose indicated on the record; or

(6) Manufacturing or processing equipment such as contaminated piping and tanks, and vessels on or in which radiation sources are installed.

(F) Each licensee shall:

(1) Monitor the external surfaces of a labeled package for radioactive contamination unless the package contains only radioactive material in the form of gas or in special form as defined in rule 3701:1-38-01 of the Administrative Code;

(2) Monitor the external surfaces of a labeled package for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the type A quantity; and

(3) Monitor all packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as a package that is crushed, wet, or damaged.

(4) Perform the monitoring required by this paragraph as soon as practicable after receipt of the package, but not later than three hours after the package is received at the licensee's facility, if it is received during the licensee's normal working hours. If a package is received after working hours, the package shall be monitored no later than three hours from the beginning of the next working day.

(G) Each licensee who expects to receive a package containing quantities of radioactive material in excess of a type A quantity as defined in rule 3701:1-38-01 of the Administrative Code and as provided in rule 3701:1-50-25 of the Administrative Code, shall make arrangements to receive the package when the carrier offers it for delivery or expeditiously upon receiving notification that the package is available for pick-up.

(H) The licensee shall immediately notify the final delivery carrier and the department by telephone and either telegram, mailgram, or facsimile, when:

(1) Removable radioactive surface contamination exceeds the limits as provided in 49 C.F.R. 173.443 (as published in the October 1, 2009 Code of Federal Regulations); or

(2) External radiation levels exceed the limits as provided in 49 C.F.R. 172.403 (as published in the October 1, 2009 Code of Federal Regulations).

(I) Each licensee shall:

(1) Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and

(2) Ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened.

(J) A licensee that transfers a special form source to and from a work site in a vehicle owned or operated by the licensee is exempt from the contamination monitoring requirements of this rule, but is not exempt from the monitoring requirement in this rule for measuring radiation levels that ensures that the source is still properly lodged in its shield.

Click to view Appendix

Effective: 09/01/2011
R.C. 119.032 review dates: 05/23/2011 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 6/20/03, 10/22/06

3701:1-38-19 Waste disposal.

(A) A licensee shall dispose of licensed radioactive material in accordance with this rule. Licensed material shall be disposed of in one of the following manners:

(1) By transfer to an authorized recipient as provided in this chapter, Chapter 3701:1-40 of the Administrative Code, or to the United States department of energy;

(2) By decay in storage provided that the radionuclide has a half-life of one hundred twenty days or less, or as otherwise permitted by the license;

(3) By release in effluents within the limits set forth in rule 3701:1-38-13 of the Administrative Code; or

(4) As authorized pursuant to paragraphs (B) to (F) ofthis rule.

(B) A person shall be specifically licensed to receive waste containing licensed material from another person for:

(1) Treatment prior to disposal;

(2) Treatment or disposal by incineration;

(3) Decay in storage;

(4) Disposal at a land disposal facility licensed pursuant to rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Codeor equivalent United States nuclear regulatory commission or agreement state regulations; or

(5) Storage until transfer to a storage or disposal facility authorized to receive the waste.

(C) A licensee or applicant for a license may apply to the director for approval of proposed disposal procedures that are not otherwise authorized in these rules for the disposal of licensed material generated in the licensee's operations. Each application shall include:

(1) A description of the waste containing licensed material to be disposed of, including the physical and chemical properties that have an impact on risk evaluation, and the proposed manner and conditions of waste disposal;

(2) An analysis and evaluation of pertinent information on the nature of the environment;

(3) The nature and location of other potentially affected facilities; and

(4) An analysis and procedures to ensure that doses are maintained ALARA and within the dose limits in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code.

(D) A licensee may discharge licensed material into sanitary sewerage as follows:

(1) The material is readily soluble in water or is a biological material that is readily dispersible in water;

(2) The quantity of licensed or other radioactive material that the licensee releases into the sewer in one month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in table III of appendix C to rule 3701:1-38-12 of the Administrative Code; and

(3) If more than one radionuclide is to be released, the following conditions must also be satisfied:

(a) The licensee shall determine the fraction of the limit in table III of appendix C to rule 3701:1-38-12 of the Administrative Code represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in table III of appendix C to rule 3701:1-38-12 of the Administrative Code; and

(b) The sum of the fractions for each radionuclide required by paragraph (D)(3)(a) of this rule does not exceed unity.

(4) The total quantity of licensed and other radioactive material that the licensee releases into the sanitary sewerage in a year does not exceed one hundred eighty-five gigabecquerels (five curies) of hydrogen-3, thirty-seven gigabecquerels (one curie) of carbon-14, and thirty-seven gigabecquerels (one curie) of all other radioactive materials combined.

(5) Excreta from an individual undergoing medical diagnosis or therapy with radioactive material is not subject to the limitations contained in paragraph (D) of this rule.

(E) A licensee may dispose of licensed material by decay in storage. A licensee may hold radioactive material with a physical half-life of one hundred twenty days or less for decay-in-storage before disposal as non-radioactive material provided the licensee does the following:

(1) Monitors the material at the container surface prior to disposal and determines that the radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposing shielding;

(2) Removes or obliterates all radiation caution labels and symbols, unless otherwise specified in the license; and

(3) Retains a record of the disposal for three years.

(F) A licensee may treat or dispose of licensed material by incineration only in the form and concentration specified in paragraph (G) of this rule or as specifically approved by the director pursuant to paragraph (C) of this rule.

(G) A licensee may dispose of the following licensed material as if it were not radioactive. The licensee shall maintain records in accordance with paragraph (K) ofrule 3701:1-38-20 of the Administrative Code.

(1) µ 1.85 kilobecquerels ( 0.05 microcurie) or less, of hydrogen-3 or carbon-14 per gram of medium used for liquid scintillation counting; or

(2) 1.85 kilobecquerels ( 0.05 microcurie) ^ or less, of hydrogen-3 or carbon-14 per gram of animal tissue, averaged over the weight of the entire animal. A licensee shall not dispose of tissue pursuant to this paragraph in a manner that would permit its use either as food for humans or as animal feed.

(H) A licensee shall transfer and dispose of licensed material in accordance with the following:

(1) For transfer of radioactive waste intended for disposal at a licensed radioactive waste disposal facility, establish a manifest tracking system, and supplement existing requirements concerning transfers and recordkeeping for those wastes. Each shipment of radioactive waste designated for disposal at a licensed radioactive waste disposal facility shall be accompanied by a shipment manifest as specified in appendix A to this rule.

(2) Each shipment manifest shall include a certification by the waste generator in accordance with appendix A to this rule.

(3) Each person involved in the transfer of waste for disposal or in the disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in appendix A to this rule.

(I) Nothing in this rule relieves a licensee from complying with other applicable federal, state and local regulations governing any other toxic or hazardous properties of materials that may be disposed of under this rule.

Click to view Appendix

Effective: 09/01/2011
R.C. 119.032 review dates: 05/23/2011 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 6/20/03, 10/22/06

3701:1-38-20 Records.

(A) Each licensee or registrant shall use the SI units becquerel, gray, sievert and coulomb per kilogram, or the special units curie, rad, rem and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by this chapter. The licensee or registrant shall make a clear distinction among the quantities entered on the records such as, total effective dose equivalent, total organ dose equivalent, shallow dose equivalent, lens dose equivalent, deep dose equivalent, or committed effective dose equivalent.

(B) Each licensee or registrant shall maintain records of the radiation protection program, including the provisions of the program and audits and other reviews of program content and implementation. The licensee or registrant shall retain the records of the provisions of the program until the department terminates each license or registration pertinent to the record. The licensee or registrant shall retain all the other records required by this paragraph for three years after the record is made.

(C) Records of surveys showing the results of surveys and calibrations required by paragraph (A) ofrule 3701:1-38-14 and paragraph (F) ofrule 3701:1-38-18 of the Administrative Code shall be maintained and retained by the licensee or registrant for three years after the record is made.

(D) The licensee or registrant shall retain each of the following records until the department terminates each license or registration pertinent to the record:

(1) Records of the results ofsurveys to determine the dose from external sources of radiation used, in the absence of or in combination with individual monitoring data, in the assessment ofindividual dose equivalents;

(2) Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose;

(3) Records showing the results of air sampling, surveys, and bioassays required pursuant to paragraphs (C)(2)(a) and (C)(2)(b) of rule 3701:1-38-16 of the Administrative Code; and

(4) Records of the results of measurements and calculations used to evaluate the release ofradioactive effluents to the environment.

(E) Records of tests for leakage or contamination of sealed sources shall be kept in units of becquerel or microcurie, or multiples thereof, and maintained for inspection by the department for at least three years after the records are made.

(F) Records of prior occupational dose and exposure history as required in paragraph (E) of rule 3701:1-38-12 of the Administrative Code shall be recorded by the licensee or registrant on a form provided by the department entitled"lifetime occupational exposure history" in accordance with the instructions for completing this form, or in clear and legible records containing all the information required by the same form. The licensee or registrant shall maintain these records until the department terminates each license or registration pertinent to this record. The licensee or registrant shall retain records used in preparing the form for three years after the record is made.

(G) Records of planned special exposures as required in paragraph (F) of rule 3701:1-38-12 of the Administrative Code shall be maintained by the licensee:

(1) The licensee shall maintain records that describe the following:

(a) The exceptional circumstances requiring the use of a planned special exposure;

(b) The name of the management official who authorized the planned special exposure and a copy of the signed authorization;

(c) What actions were necessary;

(d) Why the actions were necessary;

(e) What precautions were taken to assure that doses were maintained ALARA;

(f) What individual and collective doses were expected to result; and

(g) The doses actually received in the planned special exposure.

(2) The licensee shall retain the records until the department terminates each license pertinent to these records.

(H) Records of individual dose monitoring results shall be maintained by each licensee or registrant for each individual for whom monitoring is required pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, and records of doses received during planned special exposures, accidents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before the effective date of these rules need not be changed.

(1) These records shall include, when applicable:

(a) The deep dose equivalent to the whole body, lens dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities;

(b) The estimated intake or radionuclides as provided in paragraph (B) of rule 3701:1-38-12 of the Administrative Code;

(c) The committed effective dose equivalent assigned to the intake of radionuclides; and

(d) The specific information used to calculate the committed effective dose equivalent pursuant to paragraph (D)(8) of rule 3701:1-38-12 of the Administrative Code; and

(e) The total effective dose equivalent when required by paragraph (B) of rule 3701:1-38-12 of the Administrative Code; and

(f) The total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose.

(2) The licensee or registrant shall make entries of the records specified in paragraph (H) of this rule at least annually.

(I) Each licensee or registrant shall maintain the records specified in paragraph (H) of this rule on department form entitled "occupational exposure record for a monitoring period" in accordance with the instructions for completing this form, or in clear and legible records containing all the information required by the same form. The licensee or registrant shall maintain the records of dose to an embryo or fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy shall also be kept on file, but may be maintained separately from the dose records. The licensee or registrant shall retain each required form or record until the department terminates each license or registration pertinent to the record.

(J) Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limits for individual members of the public specified in paragraph (A) of rule 3701:1-38-13 of the Administrative Code. Each licensee or registrant shall retain the records required by paragraph (H) of this rule until the department terminates each license or registration pertinent to the record.

(K) Records of the disposal of licensed material shall be maintained by each licensee in accordance with paragraphs (C), (D), (F), and (G) of rule 3701:1-38-19 , and Chapter 3701:1-54 of the Administrative Code. The licensee shall retain the records required by this paragraph until the department terminates each pertinent license that requires the record.

(L) Records of tests performed on entry control devices located in a very high radiation area shall be maintained by each licensee in accordance with Chapter 3701:1-52 of the Administrative Code or registrant in accordance with Chapters 3701:1-66 and 3701:1-67 of the Administrative Code. These records must include the date, time, and results of each such test of function. The licensee or registrant shall retain the records required by this paragraph for at least three years after the record is made.

(M) Each record required by this chapter shall be legible throughout the specified retention period. The record shall 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 producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. The licensee or registrant shall maintain adequate safeguards against tampering with and loss of records.

Effective: 09/01/2011
R.C. 119.032 review dates: 05/23/2011 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 6/20/03, 1/29/2007

3701:1-38-21 Reports.

(A) The licensee or registrant shall report stolen, lost, or missing licensed or registered sources of radiation to the director in accordance with the following:

(1) Telephone reports shall be made as follows:

(a) To the bureau of radiation protection point of contact (POC) in accordance with the form "Notice to Employees" issued by the director.

(b) In the case of a licensee, he or she shall make contact:

(i) Immediately after the licensee determines that licensed radioactive material is stolen, lost, or missing in an aggregate quantity equal to or greater than one hundred times the quantity specified in appendix A to rule 3701:1-38-18 of the Administrative Code under such circumstances that it appears to the licensee that an exposure could result to individuals in unrestricted areas;

(ii) Within thirty days after its occurrence becomes known to the licensee, lost, stolen, or missing licensed radioactive material in an aggregate quantity greater than ten times the quantity specified in appendix A to rule 3701:1-38-18 of the Administrative Code that is still missing.

(c) In the case of a registrant, he or she shall make contact immediately after it becomes known that radiation-generating equipment has been stolen, lost, or is missing.

(2) Written reports shall be made as follows:

(a) Each licensee or registrant required to make a report pursuant to paragraph (A)(1) of this rule shall, within thirty days after making the telephone report, make a written report to the director setting forth the following information, where applicable:

(i) A description of the licensed or registered source of radiation involved, including, for radioactive material, the kind, quantity, and chemical and physical form, and in the case of radiation-generating equipment, the manufacturer, model and serial number, type and maximum energy of the radiation emitted;

(ii) A description of the circumstances under which the loss or theft occurred;

(iii) A statement of disposition, or probable disposition, of the licensed or registered source of radiation involved;

(iv) Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas;

(v) Actions that have been taken, or will be taken, to recover the source of radiation; and

(vi) Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed or registered sources of radiation.

(b) Subsequent to filing the written report, the licensee or registrant shall also report additional substantive information on the loss or theft within thirty days after the licensee or registrant learns of such information.

(c) The licensee or registrant shall prepare any report filed with the director pursuant to this rule so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.

(B) Notification of incidents shall be made as follows:

(1) Excluding prescribed medical doses to patients, each licensee or registrant shall immediately report each event involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause any of the following conditions:

(a) An individual receiving:

(i) A total effective dose equivalent of 0.25 sievert (twenty-five rem) or more;

(ii) A lens dose equivalent of 0.75 sievert (seventy-five rem) or more; or

(iii) A shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 2.5 sievert (two hundred fifty rem) or more; or

(b) The release of radioactive material, inside or outside of a restricted area that, had an individual been present for twenty-four hours, the individual could have received an intake five times the occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

(2) Each licensee or registrant shall report to the director, within twenty-four hours of discovery, each event involving loss of control of a licensed or registered source of radiation possessed by the licensee or registrant that may have caused, or threatens to cause, any of the following:

(a) An individual to receive, in a period of twenty-four hours:

(i) A total effective dose equivalent exceeding 0.05 sievert (five rem);

(ii) An lens dose equivalent exceeding 0.15 sievert (fifteen rem); or

(iii) A shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 0.5 sievert (fifty rem); or

(b) The release of radioactive material, inside or outside of a restricted area that, had an individual been present for twenty-four hours, the individual could have received an intake in excess of one occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

(3) Licensees or registrants shall make the reports required by paragraphs (B)(1) and (B)(2) of this rule to the POC by telephone to the department and shall confirm the initial contact by telegram, mailgram, electronic mail, or facsimile to the director.

(4) The licensee or registrant shall prepare each report filed with the director pursuant to this rule so that names of individuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report.

(5) The provisions of paragraph (B) of this rule do not apply to doses that result from planned special exposures, provided such doses are within the limits for planned special exposures and are reported in accordance with this paragraph.

(C) Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the limits shall be made by the licensee or registrant as follows:

(1) Reportable events that are specified in this paragraph shall, in addition to the notification requirements in paragraph (B) of this rule, be reported to the director in writing within thirty days after learning of any of the following occurrences:

(a) Incidents for which notification is required by paragraph (B) of this rule and with doses in excess of any of the following:

(i) The occupational dose limits for adults in paragraphs (A)(1) and (A)(2) of rule 3701:1-38-12 of the Administrative Code;

(ii) The occupational dose limits for a minor in paragraph (G) of rule 3701:1-38-12 of the Administrative Code;

(iii) The limits for an embryo or fetus of a declared pregnant woman in paragraph (H) of rule 3701:1-38-12 of the Administrative Code;

(iv) The limits for an individual member of the public in paragraph (A) of rule 3701:1-38-13 of the Administrative Code;

(v) Any applicable limit in the license or registration; or

(vi) The ALARA constraints for air emissions established under paragraph (D)(4) of rule 3701:1-38-11 of the Administrative Code; or

(b) Levels of radiation or concentrations of radioactive material in:

(i) A restricted area in excess of applicable limits in the license or registration; or

(ii) An unrestricted area in excess of ten times the applicable limit set forth in this chapter or in the license or registration, whether or not involving exposure of any individual in excess of the limits in paragraph (A) of rule 3701:1-38-13 of the Administrative Code; or

(c) For licensees subject to the provisions of the United States environmental protection agency generally applicable environmental radiation standards in 40 C.F.R. 190, levels of radiation or releases of radioactive material in excess of those standards, or of license conditions related to those standards.

(2) Each report required by this rule shall describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:

(a) Estimates of each individual's dose, the level of radiation and concentration of radioactive material involved, and the cause of the elevated exposure, dose rate, or concentration; and

(b) Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints, generally applicable environmental standards, and associated license or registration conditions.

(3) Each report filed pursuant to this rule shall include, for each occupationally overexposed individual, the name, social security account number, and date of birth of the individual. In the case of the limit for an embryo or fetus in paragraph (H) of rule 3701:1-38-12 of the Administrative Code, the identifiers should be those of the declared pregnant woman. The report shall be prepared so that information on each individual is stated in a separate and detachable portion of the report.

(4) All licensees or registrants who make reports pursuant to this rule shall submit the report in writing to the director.

(D) Reports of planned special exposures shall be submitted by the licensee in a written report to the director within thirty days following any planned special exposure conducted in accordance with paragraph (F) of rule 3701:1-38-12 of the Administrative Code, informing the director that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by paragraph (G) of rule 3701:1-38-20 of the Administrative Code.

(E) When a licensee or registrant is required pursuant to paragraph (C) or (D) of this rule to report to the director any exposure of an identified occupationally exposed individual, or an identified member of the public, to radiation or radioactive material, the licensee or registrant shall also provide the individual a report on his or her exposure data included in the report to the director. This report shall be transmitted no later than the transmittal to the director, and shall comply with the provisions of paragraph (C)(1) of rule 3701:1-38-10 of the Administrative Code.

(F) A report of a leaking or contaminated sealed source shall be filed by the licensee with the director within five days of the test results, if the test reveals the presence of one hundred eighty-five becquerels ( 0.005 microcurie) or more of removable contamination. The report shall include the equipment involved, the test results and the corrective action taken.

Effective: 11/14/2013
R.C. 119.032 review dates: 08/29/2013 and 11/01/2018
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 6/20/03, 10/22/06, 4/5/09

3701:1-38-22 Decommissioning.

(A) This rule applies to the decommissioning of facilities licensed under Chapter 3748. of the Revised Code. For low-level waste disposal facilities, this rule applies only to ancillary surface facilities that support radioactive waste disposal activities. This rule does not apply to uranium and thorium recovery facilities already subject to source material licensing requirements in Chapter 3701:1-44 of the Administrative Code or to uranium solution extraction facilities.

(B) Decommissioning with license termination shall be limited to sites considered acceptable for unrestricted release where the residual radioactivity that is distinguishable from background radiation results in a total effective dose equivalent (TEDE) to an average member of the critical group that does not exceed 0.25 millisievert (twenty-five millirem) per year, including that from groundwater sources of drinking water, and the residual radioactivity has been reduced to levels that are as low as reasonably achievable (ALARA). Determination of the levels which are ALARA must take into account consideration of detriments, such as deaths from transportation accidents, expected to potentially result from decontamination and waste disposal.

(C) After a facility has been decommissioned and the license terminated in accordance with the criteria in this rule, the director will require additional cleanup only if, based on new information, it is determined that the criteria of this rule were not met and residual radioactivity remaining at the site could result in a significant threat to public health and safety. When calculating TEDE to the average member of the critical group the licensee shall determine the peak annual TEDE dose expected within the first one thousand years after decommissioning.

(D) A licensee may decommission a facility and maintain a decommissioning possession only license using alternate criteria greater than the dose criterion specified in paragraph (B) of this rule, provided that the licensee:

(1) Provides assurance that public health and safety would continue to be protected, and that it is unlikely that the dose from all man-made sources combined, other than medical, would be more than the one millisievert (one hundred millirem) per year limit set forth in this chapter, by submitting an analysis of possible sources of exposure;

(2) Has employed, to the extent practicable, restrictions on site use in minimizing exposures at the site;

(3) Reduces doses to ALARA levels, taking into consideration any detriments, such as traffic accidents expected to potentially result from decontamination and waste disposal; and

(4) Has submitted a decommissioning plan or license termination plan (LTP) to the director indicating the licensee's intent to decommission in accordance with rule 3701:1-40-18 of the Administrative Code, and specifying that the licensee proposes to decommission by restricting use of the site. The licensee shall document in the decommissioning plan or LTP how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and incorporated, as appropriate, following analysis of that advice. In seeking such advice, the licensee shall provide for:

(a) Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;

(b) An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and

(c) A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues.

(5) Has provided sufficient financial assurance in the form of a trust fund to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilites for any necessary control and maintenance of the site.

(E) When a decommissioning with restrictions is proposed by a licensee, a decommissioning possession only license is required to assure that the provisions of the decommissioning plan as approved by the director remain effective. The license will contain a condition that the director will not require further cleanup unless he or she determines that the criteria of this rule or terms of the license were not met or that residual radioactivity at the site could result in a significant threat to public health and safety.

(F) Any facility that has been decommissioned and has had the United States nuclear regulatory commission license terminated in accordance with a plan approved by the commission on or before August 31, 1999, will not be required to obtain a license or conduct further cleanup unless the director determines that residual radioactivity at the site could result in a significant threat to the public health and safety.

(G) Applicants for licenses, other than renewals, shall describe in the application how facility design and procedures for operation will minimize, to the extent practical, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practical, the generation of radioactive waste.

(H) Licensees shall, to the extent practical, conduct operations to minimize the introduction of residual radioactivity into the site, including the subsurface, in accordance with the existing radiation protection requirements in rule 3701:1-38-11 of the Administrative Code and radiological criteria for license termination in accordance with this rule.

Effective: 11/14/2013
R.C. 119.032 review dates: 08/29/2013 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 10/22/06, 9/1/2011

3701:1-38-23 Reporting of defects and noncompliance.

(A) As used in this rule:

(1) "Basic component" means:

(a) A structure, system, or component, or part thereof that affects their safety function, that is directly procured by the licensee or registrant of facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code and in which a defect or failure to comply with any rule promulgated pursuant to Chapter 3748. of the Revised Code, order issued by the director, or license issued by the department could create a substantial safety hazard; and

(b) Safety-related design, analysis, inspection, testing, fabrication, replacement of parts, or consulting services that are associated with the component hardware whether these services are performed by the component supplier or others.

(2) "Commercial grade item" means an item that is:

(a) Not subject to design or specification requirements that are unique to those facilities or activities;

(b) Used in applications other than those facilities or activities; and

(c) To be ordered from the manufacturer or supplier on the basis of specifications set forth in the manufacturer's published product description, such as a catalog.

(3) "Constructing" or "construction" means the analysis, design, manufacture, fabrication, placement, erection, installation, modification, inspection, or testing of a facility or activity which is subject to this rule and consulting services related to the facility or activity that are safety related.

(4) "Dedication" means an item has been received and designated for use as a basic component.

(5) "Defect" means:

(a) A deviation in a basic component delivered to a purchaser for use in a facility or an activity subject to this rule, if, on the basis of an evaluation, the deviation could create a substantial safety hazard; or

(b) The installation, use, or operation of a basic component containing a defect as defined in this paragraph.

(6) "Deviation" means a departure form the manufacturer's specification's or technical specifications as part of a license or registration issued by the department for a given safety device or safety system associated with that device.

(7) "Discovery" means the completion of the documentation first identifying the existence of a deviation or failure to comply potentially associated with a substantial safety hazard within the evaluation procedures discussed in paragraph (G) of this rule.

(8) "Evaluation" means the process of determining whether a particular deviation could create a substantial hazard or determining whether a failure to comply is associated with a substantial safety hazard.

(9) "Failure to comply" means a failure to meet the requirements of any of the following that could create a substantial safety hazard:

(a) A rule promulgated pursuant to Chapter 3748. of the Revised Code;

(b) An order issued by the director; or

(c) License issued by the department.

(10) "Operating" or "operation" means the operation of a facility or the conduct of a licensed or registered activity which is subject to this rule and consulting services related to operations that are safety related.

(11) "Responsible officer" means:

(a) The president, vice-president or other individual in the organization of a corporation, partnership, or other entity who is vested with executive authority over activities subject to this rule, or

(b) An individual who is appointed or elected according to law, who is authorized to manage and direct the affairs of a corporation, partnership or other entity. In the case of an individual proprietorship, responsible officer means the individual.

(12) "Substantial safety hazard" means a loss of safety function to the extent that there is a major reduction in the degree of protection provided to either public health and safety or the environment, for any facility or activity licensed or registered pursuant to Chapter 3748. of the Revised Code.

(13) "Supplying" or "supplies" means contractually responsible for a basic component used or to be used in a facility or activity which is subject to this rule.

(B) This rule establishes procedures and requirements for implementation of section 3748.04 of the Revised Code, which applies to reporting of defects in equipment used for licensed or registered activities. Any responsible corporate officer ofa firm constructing, owning, operating or supplying the components of any facility or activity which is licensed, registered, or otherwise regulated pursuant to Chapter 3748. of the Revised Code, obtaining information reasonably indicating either of the following, shall notify the director within twenty-four hours:

(1) That the facility, activity or basic component supplied to such facility or activity fails to comply with any applicable rule, regulation, order, registration, or license of the department relating to substantial safety hazards; or

(2) That the facility, activity, or basic component supplied to such facility or activity contains defects, which could create a substantial safety hazard.

(C) This rule applies, except as specifically provided otherwise in Chapter 3748. of the Revised Code, to each individual, partnership, corporation, or other entity licensed or registered pursuant to Chapter 3748. of the Revised Code to possess, use, or transfer within the state of Ohio source material, radioactive material, special nuclear material, or to construct, manufacture, possess, own, operate or transfer within the state of Ohio any radiation-generating equipment and to each responsible officer of such a licensee or registrant. This rule applies also to each individual, corporation, partnership or other entity doing business within the state of Ohio, that supplies basic components for a facility or activity licensed, under Chapter 3748. ofthe Revised Code.

(D) Nothing in this rule should be deemed to preclude either an individual, a manufacturer, or a supplier of a commercial grade item not subject to this rule from reporting to the director, a known or suspected defect or failure to comply and, as authorized by law, the identity of anyone so reporting will be withheld from disclosure. The department will accept collect telephone calls from individuals who wish to speak to department representatives concerning radiation safety-related problems.

(E) Each individual, partnership, corporation, dedicating entity, or other entity subject to this rule shall post current copies of this rule and procedures adopted pursuant to this rule. These documents must be posted in a conspicuous position on any premises within the state of Ohio where the activities subject to this rule are conducted. If posting of this rule or the procedures adopted pursuant to this rule is not practicable, the licensee, registrant, or firm subject to this rule may post a notice which describes the rules and procedures, including the name of the individual to whom reports may be made, and where the rules and procedures may be examined.

(F) The director may, upon application of any interested person or upon the director's own initiative, grant such exemptions from the requirements of this rule as the director determines to be authorized by law and will not endanger public health and safety or the environment, and are otherwise in the public interest. Suppliers of commercial grade items are exempt from the provisions of this rule to the extent that they supply commercial grade items.

(G) Each individual, corporation, partnership, dedicating entity, or other entity subject to this rule shall adopt appropriate procedures to:

(1) Initiate evaluations of deviations and failures to comply that are associated with substantial safety hazards as soon as practicable, but no later than ten days from the date of discovery of the deviation or failure to comply. The director shall be notified of any such deviation or failure to comply in accordance with paragraph (B) of this rule.

(2) Evaluate a reportable defect or failure to comply that could create a substantial safety hazard, were it to remain uncorrected, within thirty days of its discovery, except as provided by paragraph (G)(3) of this rule.

(3) Ensure that if an evaluation of an identified deviation or failure to comply potentially associated with a substantial safety hazard cannot be completed within thirty days from discovery of the deviation or failure to comply, an interim report is prepared and submitted to the director through a responsible corporate officer. The interim report should describe the deviation or failure to comply that is being evaluated and should also state when the evaluation will be completed. This interim report must be submitted in writing within thirty days of discovery of the deviation or failure to comply; and

(4) Ensure that a responsible corporate officer subject to this rule is informed as soon as practicable, and, in all cases, within five working days after completion of the evaluation described in this paragraph if the construction or operation of a facility or activity, or a basic component supplied for such facility or activity either fails to comply with any applicable rule, regulation, order, or license or registration of the department relating to a substantial safety hazard, or contains a defect.

(H) If the deviation or failure to comply is discovered by a supplier of basic components, or services associated with basic components, and the supplier determines that it does not have the capability to perform the evaluation to determine if a defect exists, then the supplier must inform the purchasers or affected licensees or registrants within five working days of this determination so that the purchasers or affected licensees or registrants may evaluate the deviation or failure to comply, pursuant to paragraph (G) of this rule. Nothing in this rule shall be deemed to require manufacturers or suppliers to adopt or maintain procedures for defect identification and evaluation, where the item or service is not dedicated for purposes of licensed or registered activities or equipment. Instead, such is the responsibility of the registrant or licensee, in accordance with paragraph (B) of this rule.

(I) A responsible corporate officer subject to this rule must notify the director within thirty days when he or she obtains information reasonably indicating a failure to comply or a defect affecting:

(1) The construction or operation of a facility or any activity within the state of Ohio that is subject to the licensing or registration requirements under Chapter 3748. of the Revised Code and that is within the facility's responsibility; or

(2) A basic component that is within the facility's responsibility and is supplied for a facility or an activity within the state of Ohio that is subject to the licensing requirements of Chapter 3748. of the Revised Code.

(J) The notification required by paragraphs (B) and (I) of this rule shall include the following information, to the extent known:

(1) Name and address of the individual or individuals informing the director.

(2) Identification of the facility, the activity, or the basic component supplied for such facility or such activity within the state of Ohio which fails to comply or contains a defect.

(3) Identification of the firm constructing the facility or supplying the basic component which fails to comply or contains a defect.

(4) Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to comply.

(5) The date on which the information of such defect or failure to comply was obtained.

(6) In the case of a basic component which contains a defect or fails to comply, the number and location of all such components in use at, supplied for, or being supplied for one or more facilities or activities subject to this rule.

(7) The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action.

(8) Any advice related to the defect or failure to comply about the facility, activity, or basic component that has been, is being, or will be given to purchasers or licensees.

(K) The responsible corporate officer may authorize an individual to provide the notification required by paragraph (J) of this rule, provided that, this shall not relieve the responsible corporate officer of his or her responsibility under this paragraph. Individuals subject to this rule may be required by the director to supply additional information related to a defect or failure to comply. Department action to obtain additional information may be based on reports of defects from other reporting entities.

(L) Each individual, corporation, partnership, or other entity subject to this rule shall prepare and maintain records necessary to accomplish the requirements of this rule, including retaining evaluations of all deviations and failures to comply for a minimum of five years after the date of the evaluation. Each individual, corporation, partnership, dedicating entity, or other entity subject to this rule shall permit the department the opportunity to inspect records pertaining to basic components that relate to the identification and evaluation of deviations, and the reporting of defects and failures to comply, including any advice given to purchasers or licensees on the placement, erection, installation, operation, maintenance, modification, or inspection of a basic component.

(M) Suppliers of basic components must retain any notifications sent to purchasers and affected licenses for a minimum of five years after the date of the notification. Suppliers of basic components must retain a record of the purchasers of basic components for ten years after delivery of the basic component or service associated with a basic component.

Effective: 09/01/2011
R.C. 119.032 review dates: 05/23/2011 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 6/20/03, 10/22/06

3701:1-38-24 Testing for leakage or contamination of sealed sources.

(A) The licensee in possession of any sealed source not subject to the testing requirements of rule 3701:1-46-05 , 3701:1-48-09 , 3701:1-49-07 , 3701:1-52-22 , or 3701:1-58-27 of the Administrative Code, shall assure that:

(1) Each sealed source, except as specified in paragraph (B) of this rule, is tested for leakage or contamination and the test results are received before the sealed source is put into use unless the licensee has a certificate from the transferor indicating that the sealed source was tested within six months before transfer to the licensee;

(2) Each sealed source that is not designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed six months or at alternative intervals as specified in the sealed source and device registry sheet;

(3) Each sealed source that is designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed three months or at alternative intervals as specified in the sealed source and device registry sheet;

(4) For each sealed source that is required to be tested for leakage or contamination, at any other time there is reason to suspect that the sealed source might have been damaged or might be leaking, the licensee shall assure that the sealed source is tested for leakage or contamination before further use;

(5) Tests for leakage for all sealed sources shall be capable of detecting the presence of one hundred eighty-five becquerels ( 0.005 microcurie) of radioactive material on a test sample. Test samples shall be taken from the sealed source or from the surfaces of the container in which the sealed source is stored or mounted on which one might expect contamination to accumulate. For a sealed source contained in a device, test samples are obtained when the source is in the off position;

(B) A licensee need not perform tests for leakage or contamination on the following sealed sources:

(1) Sealed sources containing only radioactive material with a half-life of less than thirty days;

(2) Sealed sources containing only radioactive material as a gas;

(3) Sealed sources containing 3.7 megabecquerels (one hundred microcuries) or less of beta or photon emitting material or three hundred seventy kilobecquerels (ten microcuries) or less of alpha-emitting material;

(4) Sealed sources containing only hydrogen-3;

(5) Seeds of iridium-192 encased in nylon ribbon; and

(6) Sealed sources which are stored, not being used and identified as in storage. The licensee shall, however, test each such sealed source for leakage or contamination and receive the test results before any use or transfer unless it has been tested for leakage or contamination within six months before the date of use or transfer.

(C) Tests for leakage or contamination from sealed sources shall be performed by persons specifically authorized by the director, an agreement state, or the United States nuclear regulatory commission to perform such services.

(D) Test results shall be kept in units of becquerel or microcurie and maintained for inspection by the director. Records of test results for sealed sources shall be made pursuant to paragraph (E) of rule 3701:1-38-20 of the Administrative Code.

(E) A sealed source shall be considered to be leaking if the presence of one hundred eighty-five becquerels ( 0.005 microcurie) or more of removable contamination on any test sample is identified.

(F) The licensee shall immediately withdraw a leaking sealed source from use and shall take action to prevent the spread of contamination. The leaking sealed source shall be repaired or disposed of in accordance with this chapter.

(G) Reports of test results for leaking or contaminated sealed sources shall be made pursuant to paragraph (F) of rule 3701:1-38-21 of the Administrative Code.

R.C. 119.032 review dates: 05/09/2011 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 1/9/2007

3701:1-38-25 Reports of transactions involving nationally tracked sources.

Each licensee who manufactures, transfers, receives, disassembles, or disposes of a nationally tracked source shall complete and submit a national source tracking transaction report as specified in paragraphs (A) to (E) of this rule for each type of transaction.

(A) Each licensee who manufactures a nationally tracked source shall complete and submit a national source tracking transaction report. The report must include the following information:

(1) The name, address, and license number of the reporting licensee;

(2) The name of the individual preparing the report;

(3) The manufacturer, model, and serial number of the source;

(4) The radioactive material in the source;

(5) The initial source strength in becquerels (curies) at the time of manufacture; and

(6) The manufacture date of the source.

(B) Each licensee that transfers a nationally tracked source to another person shall complete and submit a national source tracking transaction report. The report must include the following information:

(1) The name, address, and license number of the reporting licensee;

(2) The name of the individual preparing the report;

(3) The name and license number of the recipient facility and the shipping address;

(4) The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source;

(5) The radioactive material in the source;

(6) The initial or current source strength in becquerels (curies);

(7) The date for which the source strength is reported;

(8) The shipping date;

(9) The estimated arrival date; and

(10) For nationally tracked sources transferred as waste under a uniform low-level radioactive waste manifest, the waste manifest number and the container identification of the container with the nationally tracked source.

(C) Each licensee that receives a nationally tracked source shall complete and submit a national source tracking transaction report. The report must include the following information:

(1) The name, address, and license number of the reporting licensee;

(2) The name of the individual preparing the report;

(3) The name, address, and license number of the person that provided the source;

(4) The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source;

(5) The radioactive material in the source;

(6) The initial or current source strength in becquerels (curies);

(7) The date for which the source strength is reported;

(8) The date of receipt; and

(9) For material received under a uniform low-level radioactive waste manifest, the waste manifest number and the container identification with the nationally tracked source.

(D) Each licensee that disassembles a nationally tracked source shall complete and submit a national source tracking transaction report. The report must include the following information:

(1) The name, address, and license number of the reporting licensee;

(2) The name of the individual preparing the report;

(3) The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source;

(4) The radioactive material in the source;

(5) The initial or current source strength in becquerels (curies);

(6) The date for which the source strength is reported; and

(7) The disassemble date of the source.

(E) Each licensee who disposes of a nationally tracked source shall complete and submit a national source tracking transaction report. The report must include the following information:

(1) The name, address, and license number of the reporting licensee;

(2) The name of the individual preparing the report;

(3) The waste manifest number;

(4) The container identification with the nationally tracked source;

(5) The date of disposal; and

(6) The method of disposal.

(F) The reports discussed in paragraphs (A) to (E) of this rule must be submitted by the close of the next business day after the transaction. A single report may be submitted for multiple sources and transactions. The reports must be submitted to the national source tracking system by using:

(1) The on-line national source tracking system;

(2) Electronically using a computer readable format;

(3) By facsimile;

(4) By mail to the address on the national source tracking transaction report form (NRC form 748); or

(5) By telephone with followup by facsimile or mail.

(G) Each licensee shall correct any error in previously filed reports or file a new report for any missed transaction within five business days of the discovery of the error or missed transaction. Such errors may be detected by a variety of methods such as administrative reviews or by physical inventories required by regulation. In addition, each licensee shall reconcile the inventory of nationally tracked sources possessed by the licensee against that licensee's data in the national source tracking system. The reconciliation must be conducted during the month of January in each year. The reconciliation process must include resolving any discrepancies between the national source tracking system and the actual inventory by filing the reports identified by paragraphs (A) to (E) of this rule. By January thirty-first, of each year, each licensee must submit to the national source tracking system confirmation that the data in the national source tracking system is correct.

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Effective: 11/14/2013
R.C. 119.032 review dates: 08/29/2013 and 11/01/2018
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/27/2008