Chapter 3701:1-46 Byproduct, Accelerator Produced Material and Radium Licensing

3701:1-46-01 Definitions.

Terms defined in rules 3701:1-38-01 and 3701:1-40-01 and Chapter 3701:1-50 of the Administrative Code shall have the same meaning when used in this chapter except terms redefined within a given rule for use within that rule only and additionally, as used in this chapter:

(A) "Consumer's Risk" means for a given sampling plan, the probability of accepting a lot, when the sampling plan is applied to a submitted lot or process of a given relatively poor quality, whichever is applicable.

(B) "Lot Tolerance Per Cent Defective" means, expressed in per cent defective, the poorest quality in an individual inspection lot that should be accepted.

R.C. 119.032 review dates: 09/18/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08

3701:1-46-02 Purpose and scope.

(A) This chapter establishes general licenses for the possession and use of radioactive material and a general license for ownership of radioactive material. Specific provisions of Chapter 3701:1-40 of the Administrative Code are applicable to general licenses established by this chapter. These provisions are specified in rule 3701:1-46-03 of the Administrative Code or in the particular general license.

(B) This chapter prescribes requirements for the issuance of specific licenses to persons who manufacture or initially transfer items containing radioactive material for sale or distribution to persons generally licensed under Chapter 3701:1-46 or 3701:1-58 of the Administrative Code or equivalent regulations of the United States nuclear regulatory commission or an agreement state .

(C) This chapter also prescribes certain rules governing holders of these licenses. In addition, this chapter prescribes requirements for the issuance of specific licenses to persons who introduce radioactive material into a product or material owned by or in the possession of the licensee or person and rules governing holders of such licenses. Further, this chapter describes procedures and prescribes requirements for the issuance of sealed source and device certificates (covering radiation safety information about a product) to manufacturers or initial transferors of sealed sources or devices containing sealed sources which are to be used by persons specifically licensed under Chapter 3701:1-40 of the Administrative Code or equivalent regulations of the United States nuclear regulatory commission or an agreement state.

(D) The provisions and requirements of this chapter are in addition to, and not in substitution for, other requirements of Chapter 3701:1-40 of the Administrative Code which apply to applications and licenses subject to this chapter.

Effective: 12/01/2012
R.C. 119.032 review dates: 09/10/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08, 10/4/10

3701:1-46-03 Terms and conditions.

The general licenses provided in this chapter are subject to the provisions of paragraph (D) of rule 3701:1-40-08 , paragraphs (A) to (C) of rule 3701:1-40-16, rules 3701:1-40-19 to 3701:1-40-21 , and Chapter 3701:1-38 of the Administrative Code unless indicated otherwise in the specific provision of the general license. Attention is directed particularly to the provisions of the rules in Chapter 3701:1-38 of the Administrative Code which relate to the labeling of containers.

Effective: 04/22/2013
R.C. 119.032 review dates: 11/30/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 01/20/08

3701:1-46-04 Certain devices and equipment.

A general license is hereby issued to transfer, receive, acquire, own, possess and use radioactive material incorporated in the following devices or equipment which have been manufactured, tested and labeled by the manufacturer in accordance with the specifications contained in a specific license issued to the manufacturer by the director.

(A) Static eliminator devices designed for use as static eliminators which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 18.5 megabecquerels (five hundred microcuries) of polonium-210 per device.

(B) Ion generating devices designed for ionization of air which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 18.5 megabecquerels (five hundred microcuries) of polonium- 210 per device or of a total of not more than 1.85 gigabecquerels (fifty millicuries) of hydrogen -3 (tritium) per device.

Effective: 12/01/2012
R.C. 119.032 review dates: 09/10/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08

3701:1-46-05 Certain measuring, gauging or controlling devices.

(A) A general license is hereby issued to commercial and industrial firms; research, educational, and medical institutions; individuals in the conduct of their business; and state or local government agencies to acquire, receive, possess, use or transfer, in accordance with the provisions of paragraphs (B) to (D) of this rule, radioactive material contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.

(B)

(1) The general license in paragraph (A) of this rule applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in:

(a) A specific license issued under rule 3701:1-46-30 of the Administrative Code;

(b) An equivalent specific license issued by an agreement state; or

(c) An equivalent specific license issued by the United States nuclear regulatory commission.

(2) The devices must have been received from one of the specific licensees described in paragraph (B)(1) of this rule or through a transfer made under paragraph (C)(9) of this rule.

(C) Any person who acquires, receives, possesses, uses or transfers radioactive material in a device pursuant to the general license in paragraph (A) of this rule:

(1) Shall assure that all labels affixed to the device at the time of receipt and bearing a statement that removal of the label is prohibited are maintained thereon and shall comply with all instructions and precautions provided by such labels;

(2) Shall assure that the device is tested for leakage of radioactive material and proper operation of the on-off mechanism and indicator, if any, at no longer than six-month intervals or at such other intervals as are specified in the label; however:

(a) Devices containing only krypton need not be tested for leakage of radioactive material, and

(b) Devices containing only tritium or not more than 3.7 megabecquerels (one hundred microcuries) of other beta and/or gamma emitting material or three hundred seventy kilobecquerels (ten microcuries) of alpha emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose;

(3) Shall assure that the tests required by paragraph (C)(2) of this rule and other testing, installation, servicing, and removal from installation involving the radioactive materials, its shielding or containment, are performed:

(a) In accordance with the instructions provided by the labels; or

(b) By a person holding a specific license pursuant to this chapter and Chapter 3701:1-40 of the Administrative Code or from an agreement state or the United States nuclear regulatory commission to perform such activities;

(4) Shall maintain records showing compliance with the requirements of paragraphs (C)(2) and (C)(3) of this rule. The records must show the results of tests. The records also must show the dates of performance of, and the names of persons performing, testing, installing, servicing, and removing from the installation radioactive material and its shielding or containment. The licensee shall retain these records as follows:

(a) Each record of a test for leakage or radioactive material required by paragraph (C)(2) of this rule must be retained for three years after the next required leak test is performed or until the sealed source is transferred or disposed of.

(b) Each record of a test of the on-off mechanism and indicator required by paragraph (C)(2) of this rule must be retained for three years after the next required test of the on-off mechanism and indicator is performed or until the sealed source is transferred or disposed of.

(c) Each record that is required by paragraph (C)(3) of this rule must be retained for three years from the date of the recorded event or until the device is transferred or disposed of.

(5) Shall immediately suspend operation of the device if there is a failure of, or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of one hundred eighty-five becquerels ( 0.005 microcurie) or more removable radioactive material. The device may not be operated until it has been repaired by the manufacturer or other person holding a specific license to repair such devices that was issued under Chapters 3701:1-40 and 3701:1-46 of the Administrative Code or by an agreement state or the United States nuclear regulatory commission. The device and any radioactive material from the device may only be disposed of by transfer to a person authorized by a specific license to receive the radioactive material in the device or as otherwise approved by the director. A report containing a brief description of the event and the remedial action taken; and, in the case of detection of one hundred eighty-five becquerels ( 0.005 microcurie) or more removable radioactive material or failure of or damage to a source likely to result in contamination of the premises or the environs, a plan for ensuring that the premises and environs are acceptable for unrestricted use, must be furnished to the director within thirty days.

(6) Shall not abandon the device containing radioactive material;

(7) Shall not export the device containing radioactive material except in accordance with applicable United States nuclear regulatory commission regulations;

(8)

(a) Shall transfer or dispose of the device containing radioactive material only by export as provided by paragraph (C)(7) of this rule, by transfer to another general licensee as authorized in paragraph (C)(9) of this rule, or to a person authorized to receive the device by a specific license issued under this chapter and Chapter 3701:1-40 of the Administrative Code, utilizing a licensed broker or other authorized waste collector, or equivalent regulations of an agreement state, United States nuclear regulatory commission, or as approved under paragraph (C)(8)(c) of this rule.

(b) Shall within thirty days after the transfer of a device to a specific licensee or export, furnish a report to the director by an appropriate method listed in rule 3701:1-40-04 of the Administrative Code, The report must contain:

(i) The identification of the device by manufacturer's (or initial transferor's) name, model number, and serial number;

(ii) The name, address, and license number of the person receiving the device; and

(iii) The date of the transfer.

(c) Shall obtain written director approval before transferring the device to any other specific licensee not specifically identified in paragraph (C)(8)(a) of this rule; however, a holder of a specific license may transfer a device for possession and use under its own specific license without prior approval, if the holder:

(i) Verifies that the specific license authorizes the possession and use, or applies for and obtains an amendment to the license authorizing the possession and use;

(ii) Removes, alters, covers, or clearly and unambiguously augments the existing label (otherwise required by paragraph (C)(1) of this rule) so that the device is labeled in compliance with rule 3701:1-38-18 of the Administrative Code; however the manufacturer, model number, and serial number must be retained;

(iii) Obtains the manufacturer's or initial transferor's information concerning maintenance that would be applicable under the specific license (such as leak testing procedures); and

(iv) Reports the transfer under paragraph (C)(8)(b) of this rule.

(9) Shall transfer the device to another general licensee only if:

(a) The device remains in use at a particular location. In this case, the transferor shall give the transferee a copy of this rule and any safety documents identified in the label of the device. Within thirty days of the transfer, the transferor shall report to the director:

(i) The manufacturer's (or initial transferor's) name;

(ii) The model number and the serial number of the device transferred;

(iii) The transferee's name and mailing address for the location of use; and

(iv) The name, title, and phone number of the responsible individual identified by the transferee in accordance with paragraph (C)(12) of this rule to have knowledge of and authority to take actions to ensure compliance with the appropriate rules and requirements; or

(b) The device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee.

(10) Shall comply with the provisions of paragraphs (A) and (B) of rule 3701:1-38-21 of the Administrative Code for reporting radiation incidents, theft or loss of licensed material, but shall be exempt from the other requirements of Chapter 3701:1-38 of the Administrative Code.

(11) Shall respond to written requests from the director to provide information relating to the general license within thirty calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the director, by an appropriate method listed in rule 3701:1-40-04 of the Administrative Code, a written justification for the request.

(12) Shall appoint an individual responsible for having knowledge of the appropriate rules and requirements and the authority for taking required actions to comply with appropriate rules and requirements. The general licensee, through this individual, shall ensure the day-to-day compliance with appropriate rules and requirements. This appointment does not relieve the general licensee of responsibility in this regard.

(13)

(a) Shall report, in accordance with paragraphs (C)(13)(b) and (C)(13)(c) of this rule, devices containing at least three hundred seventy megabecquerels (ten millicuries) of cesium-137, 3.7 megabecquerels ( 0.1 millicurie) of strontium-90, thirty-seven megabecquerels (one millicurie) of cobalt-60, 3.7 megabecquerels ( 0.1 millicurie) of radium, or thirty-seven megabecquerels (one millicurie) of americium-241 or any other transuranic, i.e., element with atomic number greater than uranium (92), based on the activity indicated on the label. Each address for a location of use, as described under paragraph (C)(13)(c)(iv) of this rule, represents a separate general license and requires a separate registration and fee.

(b) If in possession of a device meeting the criteria of paragraph (C)(13)(a) of this rule, shall report these devices annually to the director and shall pay the fee required by paragraph (S) of rule 3701:1-38-02 of the Administrative Code. Reporting must be done by verifying, correcting, and/or adding to the information provided in a request received from the director. The information must be submitted to the director within thirty days of the date of the request for information or as otherwise indicated in the request. In addition, a general licensee holding devices meeting the criteria of paragraph (C)(13)(a) of this rule is subject to the bankruptcy notification requirement in Chapter 3701:1-40 of the Administrative Code.

(c) In reporting the devices, the general licensee shall furnish the following information and any other information specifically requested by the director:

(i) Name and mailing address of the general licensee ;

(ii) Information about each device: the manufacturer (or initial transferor), model number, serial number, the radionuclide and activity (as indicated on the label) ;

(iii) Name, title, and telephone number of the responsible person designated as a representative of the general licensee under paragraph (C)(12) of this rule ;

(iv) Address or location at which the device(s) are used and/or stored ;

(v) Certification by the responsible representative of the general licensee that the information concerning the device(s) has been verified through a physical inventory and checking of label information ; and

(vi) Certification by the responsible representative of the general licensee that they are aware of the requirements of the general license.

(14) Shall report changes to the mailing address for the location of use (including change in name of general licensee) to the director within thirty days of the effective date of the change.

(15) May not hold devices that are not in use for longer than two years. If devices with shutters are not being used, the shutter must be locked in the closed position. The testing required by paragraph (C)(2) of this rule need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use are excluded from the two year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.

(D) The director may order the inspection of any facility licensed under this rule if the director determines that an appropriate reason for the inspection exists. These inspections shall be considered as full cost inspections as defined in rule 3701:1-38-02 of the Administrative Code. The reasons the director may conduct for cause inspections include, but are not limited to ;

(1) Failure to respond to official correspondence ;

(2) Release of radioactive material to the environment ;

(3) Investigations of alleged violations of department rules ; or

(4) Failure to comply with the license application process.

(E) The general license in paragraph (A) of this rule does not authorize the manufacture or import of devices containing radioactive material.

Effective: 12/01/2012
R.C. 119.032 review dates: 09/10/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08, 4/5/09, 10/4/10

3701:1-46-06 License to install devices that are generally licensed.

Any person who holds a specific license issued by the United States nuclear regulatory commission or an agreement state authorizing the holder to manufacture, install, or service a device described in rule 3701:1-46-05 of the Administrative Code is hereby granted a general license to install and service such device provided that:

(A) The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued such person by the United States nuclear regulatory commission or an agreement state and requirements of paragraph (C)(2) of rule 3701:1-38-02 of the Administrative Code.

(B) Such person assures that any labels required to be affixed to the device under regulations of the United States nuclear regulatory commission or an agreement state which licensed the manufacturer of the device, bear a statement that removal of the label is prohibited.

R.C. 119.032 review dates: 09/18/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 01/20/08

3701:1-46-07 Luminous safety devices for use in aircraft.

(A) A general license is hereby issued to own, receive, acquire, possess, and use tritium or promethium-147 contained in luminous safety devices for use in aircraft, provided each device contains not more than 0.37 terabecquerels (ten curies) of tritium or 11.1 gigabecquerels (three hundred millicuries) of promethium-147 and that each device has been manufactured, assembled or initially transferred in accordance with a license issued under the provisions of rule 3701:1-46-33 of the Administrative Code or manufactured or assembled in accordance with a specific license issued by the United States nuclear regulatory commission or an agreement state which authorizes manufacture or assembly of the device for distribution to persons generally licensed by the United States nuclear regulatory commission or an agreement state.

(B) Persons who own, receive, acquire, possess or use luminous safety devices pursuant to the general license in this rule are exempt from the requirements of Chapter 3701:1-38 of the Administrative Code except that they shall comply with the provisions of paragraphs (A) and (B) of rule 3701:1-38-21 of the Administrative Code.

(C) This general license does not authorize the manufacture, assembly, repair or import of luminous safety devices containing tritium or promethium-147.

(D) This general license does not authorize the export of luminous safety devices containing tritium or promethium-147.

(E) This general license does not authorize the ownership, receipt, acquisition, possession or use of promethium-147 contained in instrument dials.

R.C. 119.032 review dates: 09/28/2007 and 09/28/2012

Promulgated Under: 119.03

Statutory Authority: 3748.04

Rule Amplifies: 3748.04

Prior Effective Dates: 10/20/2002

R.C. 119.032 review dates: 09/18/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002

3701:1-46-08 Americium-241 or radium-226 in the form of calibration or reference sources.

(A) A general license is hereby issued to those persons listed below to own, receive, acquire, possess, use and transfer, in accordance with the provisions of paragraphs (B) and (C) of this rule, americium-241 or radium-226 in the form of calibration or reference sources.

(1) Any person who holds a specific license issued by the director which authorizes the licensee to receive, possess, use, and transfer radioactive material; and

(2) Any person who holds a specific license issued by the NRC which authorizes the licensee to receive, possess, use, and transfer byproduct material, source material or special nuclear material.

(B) The general license in paragraph (A) of this rule applies only to calibration or reference sources which have been manufactured or initially transferred in accordance with the specifications contained in a specific license issued pursuant to rule 3701:1-46-37 of the Administrative Code or in accordance with the specifications contained in a specific license issued to the manufacturer by the United States nuclear regulatory commission or another agreement state which authorizes manufacture of the sources for distribution to persons with a general license by the United States nuclear regulatory commission or another agreement state.

(C) The general license in paragraph (A) of this rule is subject to the provisions of paragraph (D) of 3701:1-40-08, paragraphs (A) to (C) of 3701:1-40-16, rules 3701:1-40-19 to 3701:1-40-21 , and Chapter 3701:1-38 of the Administrative Code. In addition, persons who own, receive, acquire, possess, use and transfer one or more calibration or reference sources pursuant to this general license:

(1) Shall not possess at any one time, at any one location of storage or use, more than one hundred eighty-five kilobecquerels (five microcuries) of americium-241 or radium-226 in such sources:

(2) Shall not receive, possess, use or transfer such source unless the source, or the storage container, bears a label which includes the following statement or a substantially similar statement which contains the information called for in one of the following statements:

(a) For americium-241:

The receipt, possession, use and transfer of this source, model __, serial no. __, are subject to a general license and the regulations of the United States nuclear regulatory commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

"CAUTION-RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS AMERICIUM-241. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE"

(Name of manufacturer or initial transferor)

(b) For radium-226:

The receipt, possession, use and transfer of this source, model ______ , serial no. _____ , are subject to a general license and the regulations of the United States nuclear regulatory commission or an agreement state. Do not remove this label.

"CAUTION - RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS RADIUM-226. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE."

(Name of manufacturer or initial transferor)

(c) Sources generally licensed under the nuclear regulatory commission or an agreement state prior to January 19, 1975, may bear labels authorized by the United States nuclear regulatory commission regulations in effect on January 1, 1975.

(3) Shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license pursuant to this chapter or from an agreement state, or the United States nuclear regulatory commission to receive the source.

(4) Shall store such source, except when the source is being used, in a closed container adequately designed and constructed to contain either americium-241 or radium-226, as applicable, which might otherwise escape during storage.

(5) Shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.

(D) This general license does not authorize the manufacture or import of calibration or reference sources containing americium-241 or radium-226.

(E) This general license does not authorize the export of calibration or reference sources containing americium-241 or radium-226.

Effective: 12/01/2012
R.C. 119.032 review dates: 09/10/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08, 10/04/10

3701:1-46-09 General license to own radioactive material.

A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provision of this chapter, a general licensee under this paragraph is not authorized to manufacture, produce, transfer, receive, possess, use, import or export , radioactive material except as authorized in a specific license.

Effective: 12/01/2012
R.C. 119.032 review dates: 09/10/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08

3701:1-46-10 General license for strontium-90 in ice detection devices.

(A) A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium-90 contained in ice detection devices, provided each device contains not more than 1.85 megabecquerels (fifty microcuries) of strontium-90 and each device has been manufactured or initially transferred in accordance with the specifications contained in a license issued pursuant to rule 3701:1-46-40 of the Administrative Code or in accordance with the specifications contained in a specific license issued to the manufacturer by the United States nuclear regulatory commission or an agreement state which authorizes manufacture of the ice detection devices for distribution to persons with a general license issued by the United States nuclear regulatory commission or an agreement state.

(B) Persons who own, receive, acquire, possess, use, or transfer strontium-90 contained in ice detection devices pursuant to the general license in paragraph (A) of this rule:

(1) Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating, to the device, discontinue use of the device until it has been inspected, tested for leakage and repaired by a person holding a specific license pursuant to rule 3701:1-38-02 and Chapters 3701:1-40 and 3701:1-46 of the Administrative Code or from the United States nuclear regulatory commission or an agreement state to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of paragraph (A) of rule 3701:1-38-19 of the Administrative Code.

(2) Shall assure that all labels affixed to the device at the time of receipt, and which bear a statement which prohibits removal of the labels, are maintained thereon;

(3) Are exempt from the requirements of Chapter 3701:1-38 of the Administrative Code except that such persons shall comply with the provisions of paragraph (A) of rule 3701:1-38-19 of the Administrative Code and paragraphs (A) and (B) of rule 3701:1-38-21 of the Administrative Code.

(C) The general license does not authorize the manufacture, assembly, disassembly, repair, or import of strontium-90 in ice detection devices.

R.C. 119.032 review dates: 09/18/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002

3701:1-46-11 General license for use of radioactive material for certain in-vitro clinical or laboratory testing.

(A) A general license is hereby issued to any physician, veterinarian in the practice of veterinary medicine, clinical laboratory or hospital to receive, acquire, possess, transfer, or use, for any of the following stated tests, in accordance with the provisions of paragraphs (B) to (F) of this rule, the following radioactive materials in prepackaged units:

(1) Iodine-125, in units not exceeding three hundred seventy kilobecquerels (ten microcuries) each for use in in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(2) Iodine-131, in units not exceeding three hundred seventy kilobecquerels (ten microcuries) each for use in in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(3) Carbon-14, in units not exceeding three hundred seventy kilobecquerels (ten microcuries) each for use in in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(4) Hydrogen-3 (tritium), in units not exceeding 1.85 megabecquerels (fifty microcuries) each for use in in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(5) Iron-59, in units not exceeding seven hundred forty kilobecquerels (twenty microcuries) each for use in in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings, or animals.

(6) Selenium-75, in units not exceeding three hundred seventy kilobecquerels (ten microcuries) each for use in in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(7) Mock iodine-125 reference or calibration sources, in units not exceeding 1.85 kilobecquerels ( 0.05 microcurie) of iodine-129 and one hundred eighty-five becquerels ( 0.005 microcurie) of americium-241 each for use in in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(8) Cobalt-57, in units not exceeding three hundred seventy kilobecquerels (ten microcuries) each for use in in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(B) A person shall not receive, acquire, possess, use, or transfer radioactive material under the general license established by paragraph (A) of this rule unless that person:

(1) Has filed the radioactive materials in-vitro testing form with the director; or

(2) Has a license that authorizes the medical use of radioactive material that was issued under rules for medical uses of radioactive material.

(C) A person who receives, acquires, possesses, or uses radioactive material pursuant to the general license established by paragraph (A) of this rule shall comply with the following:

(1) The general licensee shall not possess at any one time, pursuant to the general license in paragraph (A) of this rule, at any one location of storage or use, a total amount of iodine-125, iodine-131, selenium-75, iron-59, and/or cobalt-57 in excess of 7.4 megabecquerels (two hundred microcuries).

(2) The general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection.

(3) The general licensee shall use the radioactive material only for the uses authorized by paragraph (A) of this rule.

(4) The general licensee shall not transfer the radioactive material except by transfer to a person authorized to receive it by a license pursuant to this chapter, from the United States nuclear regulatory commission, or from an agreement state or transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier.

(5) The general licensee shall dispose of the mock iodine-125 reference or calibration sources described in paragraph (A)(7) of this rule as required by rule 3701:1-38-19 of the Administrative Code.

(D) The general licensee shall not receive, acquire, possess or use radioactive material pursuant to paragraph (A) of this rule:

(1) Except as prepackaged units which are labeled in accordance with the provisions of a specific license issued under the provisions of rule 3701:1-46-42 of the Administrative Code or in accordance with the provisions of a specific license issued by the United States nuclear regulatory commission or an agreement state that authorizes manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), selenium-75, iron-59, mock iodine-125, or cobalt-57 for distribution to persons generally licensed by the United States nuclear regulatory commission or an agreement state.

(2) Unless the following statement, or a substantially similar statement which contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package: This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories or hospitals and only for in- vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the United States nuclear regulatory commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority ________________________ (name of manufacturer)

(E) The licensee possessing or using radioactive materials under the general license of paragraph (A) of this rule shall report in writing to the director any changes in the information furnished by the licensee in department form HEA-5518, "In-Vitro Testing With Radioactive Material Form." The report shall be furnished within thirty days after the effective date of such change.

(F) Any person using radioactive material pursuant to the general license of paragraph (A) of this rule is exempt from the requirements of Chapter 3701:1-38 of the Administrative Code with respect to radioactive materials covered by that general license, except that such persons using the mock iodine-125 described in paragraph (A)(7) of this rule shall comply with the provisions of paragraph (A) of rule 3701:1-38-19 of the Administrative Code and paragraphs (A) and (B) of rule 3701:1-38-21 of the Administrative Code.

R.C. 119.032 review dates: 09/18/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08, 10/04/2010

3701:1-46-12 Maintenance of records.

Each record required by this chapter must be legible throughout the retention period specified by the director. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of 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, specifications, must include all pertinent information such as letters, stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

R.C. 119.032 review dates: 09/18/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002

3701:1-46-13 Introduction of byproduct material, accelerator produced material, or radium in exempt concentrations into products or materials. [Rescinded].

Rescinded eff 4-5-09

3701:1-46-14 Introduction of byproduct material, accelerator produced material, or radium in exempt concentrations into products or materials. [Rescinded].

Rescinded eff 4-5-09

3701:1-46-15 Introduction of radioactive material in exempt concentrations into products or materials, and transfer of ownership or possession of radioactive material in exempt concentrations: prohibition of introduction.

No person may introduce radioactive material in exempt concentration into a product or material knowing or having reason to believe that it will be transferred to persons exempt under rule 3701:1-40-08 of the Administrative Code or equivalent regulations of the United States nuclear regulatory commission or an agreement state, except in accordance with a license issued by the United States nuclear regulatory commission.

Effective: 12/01/2012
R.C. 119.032 review dates: 09/10/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08, 4/05/09

3701:1-46-16 Certain items containing byproduct material, accelerator produced material or radium; requirements for license to apply. [Rescinded].

Rescinded eff 4-5-09

3701:1-46-17 Certain items containing byproduct material, accelerator produced material or radium; quality assurance, prohibition of transfer, and labeling. [Rescinded].

Rescinded eff 4-5-09

3701:1-46-18 Certain items containing byproduct material, accelerator produced material or radium: records and reports of transfer. [Rescinded].

Rescinded eff 4-5-09

3701:1-46-19 Resins containing scandium-46 and designed for sand-consolidation in oil wells: requirements for license to manufacture, or initially transfer for sale or distribution. [Rescinded].

Rescinded eff 4-5-09

3701:1-46-20 Manufacture of exempt quantities of byproduct material, accelerator produced material, or radium: requirements for license. [Rescinded].

Rescinded eff 4-5-09

3701:1-46-21 Manufacture of exempt quantities of byproduct material, accelerator produced material, or radium: conditions of licenses. [Rescinded].

Rescinded eff 4-5-09

3701:1-46-22 Manufacture of exempt quantities of byproduct material, accelerator produced material, or radium: records and material transfer reports. [Rescinded].

Rescinded eff 4-5-09

3701:1-46-23 Radioactive drug: manufacture, preparation of capsules containing carbon-14 urea each for in-vivo diagnostic use for humans to persons exempt from licensing; requirements for a license. [Rescinded].

Rescinded eff 4-5-09

3701:1-46-24 Radioactive drug: manufacture, preparation of capsules containing carbon-14 urea each for in-vivo diagnostic use for humans to persons exempt from licensing: conditions of license. [Rescinded].

Rescinded eff 4-5-09

3701:1-46-25 Self-luminous products containing tritium, krypton-85, or promethium-147: requirements for license to manufacture, process, produce. [Rescinded].

Rescinded eff 4-5-09

3701:1-46-26 Self-luminous products containing tritium, krypton-85, or promethium-147: safety criteria. [Rescinded].

Rescinded eff 4-5-09

3701:1-46-27 Gas and aerosol detectors containing byproduct material, accelerator produced material, or radium: requirements for license to manufacture, process, produce, or initially transfer. [Rescinded].

Rescinded eff 4-5-09

3701:1-46-28 Gas and aerosol detectors containing byproduct material, accelerator produced material, or radium: safety criteria. [Rescinded].

Rescinded eff 4-5-09

3701:1-46-29 Schedule A - prototype tests for automobile lock illuminators. [Rescinded].

Rescinded eff 4-5-09

3701:1-46-30 Radioactive material contained in devices for use under rule 3701:1-46-05 of the Administrative Code; requirements for license to manufacture, or initially transfer.

(A) An application for a specific license to manufacture, or initially transfer devices containing radioactive material to persons generally licensed under rule 3701:1-46-05 of the Administrative Code or equivalent regulations of the United States nuclear regulatory commission or an agreement state will be approved if:

(1) The applicant satisfies the general requirements of rule 3701:1-40-15 of the Administrative Code;

(2) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that:

(a) The device can be safely operated by persons not having training in radiological protection;

(b) Under ordinary conditions of handling, storage, and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in one year a dose in excess of ten per cent of the annual limits specified in paragraph (A) of rule 3701:1-38-12 of the Administrative Code; and

(c) Under accident conditions (such as fire and explosion) associated with handling, storage and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in the appendix A to this rule.

(3) Each device bears a durable, legible, clearly visible label or labels approved by the director which contain in a clearly identified and separate statement:

(a) Instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information);

(b) The requirements, or lack of requirement, for leak testing, or for testing any on-off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by radionuclide, quantity of radioactivity, and date of determination of the quantity; and

(c) The information called for in the following statement in the same or substantially similar form. Devices licensed by the United States nuclear regulatory commission prior to January 19, 1975, may bear labels authorized by the regulations in effect on January 1, 1975. The receipt, possession, use, and transfer of this device model, serial no., are subject to a general license or the equivalent and the regulations of the United States nuclear regulatory commission or a state with which the United States nuclear regulatory commission has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited. The model, serial number, and the name of the manufacturer, or initial transferor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device.

"CAUTION-RADIOACTIVE MATERIAL"

(Name of manufacturer, or initial transferor)

Devices licensed by the United States nuclear regulatory commission prior to January 19, 1975, may bear labels authorized by the regulations in effect on January 1, 1975.

The model, serial number, and the name of the manufacturer, or initial transferor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device.

(4) Each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number, the radionuclide and quantity, the words, "Caution: Radioactive Material," the radiation symbol described in paragraph (A) of rule 3701:1-38-18 of the Administrative Code, and the name of the manufacturer or initial distributor.

(5) Each device meeting the criteria of paragraph (C)(13)(a) of rule 3701:1-46-05 of the Administrative Code, bears a permanent (e.g., embossed, etched, stamped, or engraved) label affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words, "Caution: Radioactive Material," and, if practicable, the radiation symbol described in paragraph (A) of rule 3701:1-38-18 of the Administrative Code.

(B) In the event the applicant desires that the device be required to be tested at intervals longer than six months, either for proper operation of the on-off mechanism and indicator, if any, or for leakage of radioactive material or for both, the applicant shall include in this application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices, and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the on-off mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the director will consider information which includes, but is not limited to:

(1) Primary containment (source capsule);

(2) Protection of primary containment;

(3) Method of sealing containment;

(4) Containment construction materials;

(5) Form of contained radioactive material;

(6) Maximum temperature withstood during prototype tests;

(7) Maximum pressure withstood during prototype tests;

(8) Maximum quantity of contained radioactive material;

(9) Radiotoxicity of contained radioactive material; and

(10) Operating experience with identical devices or similarly designed and constructed devices.

(C) In the event the applicant desires that the general licensee under rule 3701:1-46-05 of the Administrative Code, or under equivalent regulations of the United States nuclear regulatory commission or an agreement state be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the on-off mechanism and indicator, or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and the bases for these estimates. The submitted information must demonstrate that performance of this activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a dose in excess of ten per cent of the annual limits specified in paragraph (A) of rule 3701:1-38-12 of the Administrative Code.

Effective: 12/01/2012
R.C. 119.032 review dates: 09/10/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08, 4/5/09

3701:1-46-31 Radioactive material contained in devices for use under rule 3701:1-46-05 of the Administrative Code: conditions of licenses.

(A) If a device containing radioactive material is to be transferred for use under the general license contained in rule 3701:1-46-05 of the Administrative Code, each person that is licensed under rule 3701:1-46-30 of the Administrative Code shall provide the information specified in this paragraph to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to the initial transfer to the intermediate person. The required information includes:

(1) A copy of rule 3701:1-46-05 of the Administrative Code; if paragraphs (C)(2) to (C)(4), or (C)(13) of rule 3701:1-46-05 of the Administrative Code do not apply to the particular device, those paragraphs may be omitted.

(2) A copy of rule 3701:1-46-03 , paragraphs (A) and (B) of rule 3701:1-38-21 , and rule 3701:1-40-21 of the Administrative Code;

(3) A list of the services that can only be performed by a specific licensee;

(4) Information on acceptable disposal options including estimated costs of disposal at the time of the purchase; and

(5) A copy of rule 3701:1-38-05 of the Administrative Code which provides for penalties for improper disposal.

(B) If radioactive material is to be transferred in a device for use under an equivalent general license of the United States nuclear regulatory commission or an agreement state, each person that is licensed under rule 3701:1-46-30 of the Administrative Code shall provide the information specified in this paragraph to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes:

(1) A copy of paragraphs (A) and (B) of rule 3701:1-38-21 , and rules 3701:1-40-21 , 3701:1-46-03 , and 3701:1-46-05 of the Administrative Code;

(2) A list of the services that can only be performed by a specific licensee;

(3) Information on acceptable disposal options including estimated costs of disposal at the time of the purchase; and

(4) The name, address, and phone number of the contact at the United States nuclear regulatory commission or the agreement state regulatory agency from which additional information may be obtained.

(C) An alternate approach to informing customers may be proposed by the licensee for approval by the director.

(D) If a notification of bankruptcy has been made under paragraph (F) of rule 3701:1-40-16 of the Administrative Code, or the license is to be terminated, each person licensed under rule 3701:1-46-30 of the Administrative Code shall provide, upon request, to the director, and if appropriate, to the United States nuclear regulatory commission and any appropriate agreement state records of final disposition required under paragraph (C) of rule 3701:1-46-32 of the Administrative Code.

Effective: 12/01/2012
R.C. 119.032 review dates: 09/10/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08

3701:1-46-32 Radioactive material contained in devices for use under rule 3701:1-46-05 of the Administrative Code: material transfer reports and records.

Each person licensed under rule 3701:1-46-30 of the Administrative Code to initially transfer devices to generally licensed persons shall:

(A) Report all transfers of devices to persons for use under the general license in rule 3701:1-46-05 of the Administrative Code and all receipts of devices from persons licensed under rule 3701:1-46-05 of the Administrative Code to the director in a clear and legible report containing all of the data required by the form.

(1) The required information includes:

(a) The identity of each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use.

(b) The name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate rules and requirements;

(c) The date of transfer;

(d) The type, model number, and serial number of the device transferred; and

(e) The quantity and type of radioactive material contained in the device.

(2) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).

(3) For devices received from a general licensee under rule 3701:1-46-05 of the Administrative Code, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.

(4) If the licensee makes changes to a device possessed by a general licensee under rule 3701:1-46-05 of the Administrative Code, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.

(5) The report must cover each calendar quarter, must be filed within thirty days of the end of the calendar quarter, and must clearly indicate the period covered by the report.

(6) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

(7) If no transfers have been made to or from persons generally licensed under rule 3701:1-46-05 of the Administrative Code during the reporting period, the report must so indicate.

(B) Report to the responsible regulatory agency, United States nuclear regulatory commission, or agreement state all transfers of devices to persons for use under a general license issued in accordance with the regulations of the United States nuclear regulatory commission, or an agreement state that are equivalent to rule 3701:1-46-05 of the Administrative Code and all receipts of devices from general licensees under the jurisdiction of the United States nuclear regulatory commission, or an agreement state. The report must be in a clear and legible format containing all of the data required by the form.

(1) The required information for transfers to general licensees includes:

(a) The identity of each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use.

(b) The name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate rules and requirements;

(c) The date of transfer;

(d) The type, model number, and serial number of the device transferred; and

(e) The quantity and type of radioactive material contained in the device.

(2) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).

(3) For devices received from a general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.

(4) If the licensee makes changes to a device possessed by a general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.

(5) The report must cover each calendar quarter, must be filed within thirty days of the end of the calendar quarter, and must clearly indicate the period covered by the report.

(6) The report must clearly identify the specific licensee submitting the report and must include the license number of the specific licensee.

(7) If no transfers have been made to or from the United States nuclear regulatory commission or a particular agreement state jurisdiction during the reporting period, this information shall be reported to the United States nuclear regulatory commission or the responsible agreement state agency upon request of the agency.

(C) Maintain all information concerning transfers and receipts of devices that supports the reports required by this rule. Records required by this paragraph must be kept for a period of three years following the date of the recorded event.

Effective: 12/10/2012
R.C. 119.032 review dates: 09/25/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08

3701:1-46-33 Luminous safety devices for use in aircraft: requirements for license to manufacture, assemble, repair or initially transfer.

An application for a specific license to manufacture, assemble, repair or initially transfer luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under rule 3701:1-46-07 of the Administrative Code, will be approved if:

(A) The applicant satisfies the general requirements specified in rule 3701:1-40-15 of the Administrative Code;

(B) The applicant submits sufficient information regarding each device pertinent to evaluation of the potential radiation exposure, including:

(1) Chemical and physical form and maximum quantity of tritium or promethium-147 in each device;

(2) Details of construction and design;

(3) Details of the method of binding or containing the tritium or promethium-147;

(4) Procedures for and results of prototype testing to demonstrate that the tritium or promethium-147 will not be released to the environment under the most severe conditions likely to be encountered in normal use;

(5) Any quality control procedures proposed as alternatives to those prescribed by rule 3701:1-46-35 of the Administrative Code; and

(6) Any additional information, including experimental studies and tests, required by the director to facilitate a determination of the safety of the device.

(C) Each device will contain no more than three hundred seventy gigabecquerels (ten curies) of tritium or 11.1 gigabecquerels (three hundred millicuries) of promethium-147. The levels of radiation from each device containing promethium-147 will not exceed five microgray ( 0.5 millirad) per hour at ten centimeters from any surface when measured through fifty milligrams per square centimeter of absorber.

(D) The director determines that:

(1) The method of incorporation and binding of the tritium or promethium-147 in the device is such that the tritium or promethium-147 will not be released under the most severe conditions which are likely to be encountered in normal use and handling of the device;

(2) The tritium or promethium-147 is incorporated or enclosed so as to preclude direct physical contact by any person with it;

(3) The device is so designed that it cannot easily be disassembled; and

(4) The device has been subjected to and has satisfactorily passed the prototype tests prescribed by rule 3701:1-46-45 of the Administrative Code.

R.C. 119.032 review dates: 09/18/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 01/20/08

3701:1-46-34 Luminous safety devices for use in aircraft: labeling of devices.

(A) A person licensed under rule 3701:1-46-33 of the Administrative Code to manufacture, assemble, or initially transfer devices containing tritium or promethium-147 for distribution to persons generally licensed under rule 3701:1-46-07 of the Administrative Code shall, except as provided in paragraph (B) of this rule, affix to each device a label containing the radiation symbol prescribed by rule 3701:1-38-18 of the Administrative Code, such other information as may be required by the director including disposal instructions when appropriate, and the following or a substantially similar statement which contains the information called for in the following statement:

(1) Devices licensed by the United States nuclear regulatory commission prior to January 19, 1975, may bear labels authorized by the regulations in effect on January 1, 1975.

(2) The receipt, possession, use, and transfer of this device, model _______, serial no. ___, containing ______ (identity and quantity of radioactive material) are subject to a general license or the equivalent and the regulations of the United States nuclear regulatory commission or of a state with which the United States nuclear regulatory commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

"CAUTION-RADIOACTIVE MATERIAL"

(Name of manufacturer, assembler, or initial transferor.) The model, serial number, and name of manufacturer, assembler, or initial transferor may be omitted from this label provided they are elsewhere specified in labeling affixed to the device.

(B) If the director determines that it is not feasible to affix a label to the device containing all the information called for in paragraph (A) of this rule, the director may waive the requirements of that paragraph and require in lieu thereof that:

(1) A label be affixed to the device identifying:

(a) The manufacturer, assembler, or initial transferor; and

(b) The type of radioactive material; and

(2) A leaflet bearing the following information be enclosed in or accompany the container in which the device is shipped:

(a) The name of the manufacturer, assembler, or initial transferor,

(b) The type and quantity of radioactive material,

(c) The model number,

(d) A statement that the receipt, possession, use, and transfer of the device are subject to a general license or the equivalent and the regulations of the United States nuclear regulatory commission or of an agreement state, and

(e) Such other information as may be required by the director, including disposal instructions when appropriate.

R.C. 119.032 review dates: 09/18/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 01/20/08

3701:1-46-35 Luminous safety devices for use in aircraft: quality assurance; prohibition of transfer.

(A) Each person licensed under rule 3701:1-46-33 of the Administrative Code shall visually inspect each device and shall reject any which has an observable physical defect that could affect containment of the tritium or promethium-147.

(B) Each person licensed under rule 3701:1-46-33 of the Administrative Code shall take a random sample of the size required by the table in rule 3701:1-46-48 of the Administrative Code for lot tolerance percent defective of five percent from each inspection lot, and shall subject each unit in the sample to the following tests:

(1) Each device shall be immersed in thirty inches of water for twenty-four hours and shall show no visible evidence of water entry. Absolute pressure of the air above the water shall then be reduced to one inch of mercury. Lowered pressure shall be maintained for one minute or until air bubbles cease to be given off by the water, whichever is the longer. Pressure shall then be increased to normal atmospheric pressure. Any device which leaks as evidenced by bubbles emanating from within the device, or water entering the device, shall be considered as a defective unit.

(2) The immersion test water from the preceding test in paragraph (B)(1) of this rule shall be measured for tritium or promethium-147 content by an apparatus that has been calibrated to measure tritium or promethium-147, as appropriate. If more than 0.1 per cent of the original amount of tritium or promethium-147 in any device is found to have leaked into the immersion test water, the leaking device shall be considered as a defective unit.

(3) The levels of radiation from each device containing promethium-147 shall be measured. Any device which has a radiation level in excess of five microgray ( 0.5 millirad) per hour at ten centimeters from any surface when measured through fifty milligrams per square centimeter of absorber, shall be considered as a defective unit.

(C) An application for a license or for amendment of a license may include a description of procedures proposed as alternatives to those prescribed by paragraph (B) of this rule, and proposed criteria for acceptance under those procedures. The director will approve the proposed alternative procedures if the applicant demonstrates that:

(1) They will consider defective any sampled device which has a leakage rate exceeding 0.1 per cent of the original quantity of tritium or promethium- 147 in any twenty-four hour period; and

(2) The operating characteristic curve or confidence interval estimate for the alternative procedures provides a lot tolerance per cent defective of five per cent at the consumer's risk of 0.10.

(D) No person licensed under rule 3701:1-46-33 of the Administrative Code shall transfer to persons generally licensed under rule 3701:1-46-07 of the Administrative Code:

(1) Any luminous safety device which has been tested and found defective under the criteria and procedures specified in this rule, unless the defective units have been repaired or reworked and have then met the tests set out in paragraph (B) of this rule; or

(2) Any inspection lot which has been rejected as a result of the procedures in rule 3701:1-46-48 of the Administrative Code or alternative procedures in paragraph (C) of this rule, unless the defective units have been sorted and removed or have been repaired or reworked and have then met the tests set out in paragraph (B) of this rule.

Effective: 12/10/2012
R.C. 119.032 review dates: 09/25/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08

3701:1-46-36 Luminous safety devices for use in aircraft: material transfer reports.

Each person licensed under rule 3701:1-46-33 of the Administrative Code shall file an annual report with the director at the following address:

"Ohio Department of Health

Bureau of Radiation Protection

246 North High Street

Columbus, Ohio 43215"

and provide a copy to director of nuclear material safety and safeguards, United States nuclear regulatory commission, Washington, D.C. 20555-0001, which must state the total quantity of tritium or promethium-147 transferred to persons generally licensed under rule 3701:1-46-07 of the Administrative Code. The report must identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. Each report must cover the year ending June thirtieth and must be filed within thirty days thereafter.

Effective: 12/01/2012
R.C. 119.032 review dates: 09/10/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08

3701:1-46-37 Calibration or reference sources containing americium-241 or radium-226: requirements for license to manufacture or initially transfer.

An application for a specific license to manufacture or initially transfer calibration or reference sources containing americium-241 or radium-226, for distribution to persons generally licensed under rule 3701:1-46-08 of the Administrative Code, will be approved if:

(A) The applicant satisfies the general requirements of rule 3701:1-40-15 of the Administrative Code;

(B) The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including:

(1) Chemical and physical form and maximum quantity of americium-241 or radium-226 in the source;

(2) Details of construction and design;

(3) Details of the method of incorporation and binding of the americium-241 or radium-226 in the source;

(4) Procedures for and results of prototype testing of sources, which are designed to contain more than one hundred eighty-five becquerels ( 0.005 microcurie) of americium-241 or radium-226, to demonstrate that the americium-241 or radium-226 contained in each source will not be released or be removed from the source under normal conditions of use;

(5) Details of quality control procedures to be followed in manufacture of the source;

(6) Description of labeling to be affixed to the source or the storage container for the source;

(7) Any additional information, including experimental studies and tests, required by the director to facilitate a determination of the safety of the source.

(C) Each source will contain no more than one hundred eighty-five kilobecquerels (five microcuries) of americium-241 or radium-226.

(D) The director determines, with respect to any type of source containing more than one hundred eighty five-becquerels ( 0.005 microcurie) of americium-241, or radium-226 that:

(1) The method of incorporation and binding of the americium-241 or radium-226 in the source is such that the americium-241 or radium-226 will not be released or be removed from the source under normal conditions of use and handling of the source; and

(2) The source has been subjected to and has satisfactorily passed the prototype tests prescribed by rule 3701:1-46-46 of the Administrative Code.

R.C. 119.032 review dates: 09/18/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08, 10/04/10

3701:1-46-38 Calibration or reference sources containing americium-241 or radium-226: labeling of devices.

(A) Each person licensed under rule 3701:1-46-37 of the Administrative Code shall affix to each source, or storage container for the source, a label which shall contain sufficient information relative to safe use and storage of the source and shall include one of the following statements or a substantially similar statement which contains the information called for in one of the following statements:

(1) For americium-241:

The receipt, possession, use and transfer of this source, model __, serial no. __, are subject to a general license and the regulations of the United States nuclear regulatory commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

"CAUTION-RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS AMERICIUM-241.

DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE."

Name of manufacturer or initial transferor.

(2) For radium-226:

The receipt, possession, use and transfer of this source, model __, serial no. __, are subject to a general license and the regulations of the United States nuclear regulatory commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

"CAUTION-RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS RADIUM-226.

DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE."

Name of manufacturer or initial transferor.

(B) Sources licensed by the United States nuclear regulatory commission prior to January 19, 1975, may bear labels authorized by the regulations in effect on January 1, 1975.

Effective: 12/01/2012
R.C. 119.032 review dates: 09/10/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08, 10/04/10

3701:1-46-39 Calibration or reference sources containing americium-241 or radium-226: leak testing of each source.

Each person licensed under rule 3701:1-46-37 of the Administrative Code shall perform a dry wipe test upon each source containing more than 3.7 kilobecquerels ( 0.1 microcurie) of americium-241 or radium-226 prior to transferring the source to a general licensee under rule 3701:1-46-08 of the Administrative Code. This test shall be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the paper shall be measured by using radiation detection instrumentation capable of detecting one hundred eighty-five becquerels ( 0.005 microcurie) of americium-241 or radium-226. If any such test discloses more than one hundred eighty-five becquerels ( 0.005 microcurie) of radioactive material, the source shall be deemed to be leaking or losing americium-241 or radium-226 and shall not be transferred to a general licensee under rule 3701:1-46-08 of the Administrative Code.

R.C. 119.032 review dates: 09/18/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08, 10/04/10

3701:1-46-40 Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer.

An application for a specific license to manufacture or initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under rule 3701:1-46-10 of the Administrative Code will be approved if:

(A) The applicant satisfies the general requirements specified in rule 3701:1-40-15 of the Administrative Code;

(B) The applicant submits sufficient information regarding each type of device pertinent to evaluation of the potential radiation exposure, including:

(1) Chemical and physical form and maximum quantity of strontium-90 in the device;

(2) Details of construction and design of the source of radiation and its shielding;

(3) Radiation profile of a prototype device;

(4) Procedures for and results of prototype testing of devices to demonstrate that the strontium-90 contained in each device will not be released or be removed from the device under the most severe conditions likely to be encountered in normal handling and use;

(5) Details of quality control procedures to be followed in manufacture of the device;

(6) Description of labeling to be affixed to the device;

(7) Instructions for handling and installation of the device;

(8) Any additional information, including experimental studies and tests, required by the director to facilitate a determination of the safety of the device;

(C) Each device will contain no more than 1.85 megabecquerels (fifty microcuries) of strontium-90 in an insoluble form;

(D) Each device will bear durable, legible labeling which includes the radiation symbol prescribed by paragraph (A) of rule 3701:1-38-18 of the Administrative Code, a statement that the device contains strontium-90 and the quantity thereof, instructions for disposal and statements that the device may be possessed pursuant to a general license, that the manufacturer or civil authorities should be notified if the device is found, that removal of the labeling is prohibited and that disassembly and repair of the device may be performed only by a person holding a specific license to manufacture or service such devices;

(E) The director determines that:

(1) The method of incorporation and binding of the strontium-90 in the device is such that the strontium-90 will not be released from the device under the most severe conditions which are likely to be encountered in normal use and handling of the device;

(2) The strontium-90 is incorporated or enclosed so as to preclude direct physical contact by any individual with it and is shielded so that no individual will receive a radiation exposure to a major portion of his body in excess of five millisieverts ( 0.5 rem) in a year under ordinary circumstances of use;

(3) The device is so designed that it cannot be easily disassembled;

(4) The device has been subjected to and has satisfactorily passed the prototype tests prescribed by rule 3701:1-46-47 of the Administrative Code; and

(5) Quality control procedures have been established to satisfy the requirements of rule 3701:1-46-41 of the Administrative Code.

R.C. 119.032 review dates: 09/18/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08

3701:1-46-41 Ice detection devices containing strontium-90: quality assurance; prohibition of transfer.

(A) Each person licensed under rule 3701:1-46-40 of the Administrative Code shall visually inspect each device and shall reject any which has an observable physical defect that could affect containment of the strontium-90.

(B) Each person licensed under rule 3701:1-46-40 of the Administrative Code shall test each device for possible loss of strontium-90 or for contamination by wiping with filter paper an area of at least one hundred square centimeters on the outside surface of the device, or by wiping the entire surface area if it is less than one hundred square centimeters. The detection on the filter paper of more than two thousand two hundred disintegrations per minute of radioactive material per one hundred square centimeters of surface wiped shall be cause for rejection of the tested device.

(C) Each person licensed under rule 3701:1-46-40 of the Administrative Code shall take a random sample of the size required by the table in rule 3701:1-46-48 of the Administrative Code for lot tolerance per cent defective of five per cent from each inspection lot, and shall subject each unit in the sample to the following tests:

(1) Each device shall be immersed in thirty inches of water for twenty-four hours and shall show no visible evidence of physical contact between the water and the strontium-90. Absolute pressure of the air above the water shall then be reduced to one inch of mercury. Lowered pressure shall be maintained for one minute or until air bubbles cease to be given off by the water, whichever is the longer. Pressure shall then be increased to normal atmospheric pressure. Any device that leaks, as evidenced by physical contact between the water and the strontium-90, shall be considered as a defective unit.

(2) The immersion test water from the preceding test in paragraph (C)(1) of this rule shall be measured for radioactive material. If the amount of radioactive material in the immersion test water is greater than 0.1 per cent of the original amount of strontium-90 in any device, the device shall be considered as a defective unit.

(D) An application for a license or for amendment of a license may include a description of procedures proposed as alternatives to those prescribed by paragraph (C) of this rule, and proposed criteria for acceptance under those procedures. The director will approve the proposed alternative procedures if the applicant demonstrates that:

(1) They will consider defective any sampled device which has a leakage rate exceeding 0.1 per cent of the original quantity of strontium-90 in any twenty-four hour period; and

(2) The operating characteristic curve or confidence interval estimate for the alternative procedures provides a lot tolerance per cent defective of five per cent at the consumer's risk of 0.1.

(E) No person licensed under rule 3701:1-46-40 of the Administrative Code shall transfer to persons generally licensed under rule 3701:1-46-10 of the Administrative Code:

(1) Any device which has been tested and found defective under the criteria and procedures specified in this rule unless the defective units have been repaired or reworked and then met the tests set out in paragraph (C) of this rule; or

(2) Any inspection lot which has been rejected as a result of the procedures in rule 3701:1-46-48 of the Administrative Code or alternative procedures in paragraph (D) of this rule, unless the defective units have been sorted and removed or have been repaired or reworked and have then met the tests set out in paragraph (C) of this rule.

R.C. 119.032 review dates: 09/18/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08

3701:1-46-42 Manufacture and distribution of radioactive material for certain in-vitro clinical or laboratory testing under general license.

An application for a specific license to manufacture or distribute radioactive material for use under the general license in rule 3701:1-46-11 of the Administrative Code will be approved if:

(A) The applicant satisfies the general requirements specified in rule 3701:1-40-15 of the Administrative Code.

(B) The radioactive material is to be prepared for distribution in prepackaged units of:

(1) Iodine-125 in units not exceeding 0.37 megabecquerel (ten microcuries) each.

(2) Iodine-131 in units not exceeding 0.37 megabecquerel (ten microcuries) each.

(3) Carbon-14 in units not exceeding 0.37 megabecquerel (ten microcuries) each.

(4) Hydrogen-3 (tritium) in units not exceeding 1.85 megabecquerels (fifty microcuries) each.

(5) Iron-59 in units not exceeding 0.74 megabecquerel (twenty microcuries) each.

(6) Selenium-75 in units not exceeding 0.37 megabecquerel (ten microcuries) each.

(7) Mock iodine-125 in units not exceeding 1.85 kilobecquerels ( 0.05 microcurie) of iodine-129 and 0.185 kilobecquerel ( 0.005 microcurie) of americium-241 each.

(8) Cobalt-57 in units not exceeding 0.37 megabecquerel (ten microcuries) each.

(C) Each prepackaged unit bears a durable, clearly visible label:

(1) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 0.37 megabecquerel (ten microcuries) of iodine-131, iodine-125, selenium-75, cobalt-57, or carbon-14; 1.85 megabecquerels (fifty microcuries) of hydrogen-3 (tritium); or 0.74 megabecquerel (twenty microcuries) of iron-59; or mock iodine-125 in units not exceeding 1.85 kilobecquerels ( 0.05 microcurie) of iodine-129 and 0.185 kilobecquerel ( 0.005 microcurie) of americium-241 each; and

(2) Displaying the radiation symbol described in paragraph (A) of rule 3701:1-38-18 of the Administrative Code and the words, "Caution, Radioactive Material", and "Not for Internal or External Use in Humans or Animals."

(D) The following statement, or a substantially similar statement which contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

"The radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories or hospitals and only for in-vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the United States Nuclear Regulatory Commission or of a state with which the Commission has entered into an agreement for the exercise of regulatory authority.

(Name of manufacturer)"

(E) The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the mock iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements set out in paragraph (A) of rule 3701:1-38-19 of the Administrative Code.

Effective: 12/10/2012
R.C. 119.032 review dates: 09/25/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 01/20/08, 10/04/10

3701:1-46-43 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing radioactive material for medical use.

(A) An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing radioactive material for use by persons authorized pursuant to Chapter 3701:1-58 of the Administrative Code or equivalent regulations of an agreement state will be approved if:

(1) The applicant satisfies the general requirements specified in rule 3701:1-40-15 of the Administrative Code;

(2) The applicant submits evidence that the applicant is at least one of the following:

(a) Registered with the United States food and drug administration as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 C.F.R. 207.20(a) (as published in the April 1, 2009 Code of Federal Regulations);

(b) Registered or licensed with a state agency as a drug manufacturer;

(c) Licensed as a pharmacy by a state board of pharmacy;

(d) Operating as a nuclear pharmacy within a federal medical institution; or

(e) A positron emission tomography (PET) drug production facility registered with a state agency.

(3) The applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees; and

(4) The applicant satisfies the following labeling requirements:

(a) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half-life greater than one hundred days, the time may be omitted.

(b) A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

(B) A licensee described by paragraph (A)(2)(c) or (A)(2)(d) of this rule:

(1) May prepare radioactive drugs for medical use, as defined in rule 3701:1-38-01 of the Administrative Code, provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, as specified in paragraphs (B)(2) and (B)(3) of this rule, or an individual under the supervision of an authorized nuclear pharmacist as specified in rule 3701:1-58-14 of the Administrative Code.

(2) May allow a pharmacist to work as an authorized nuclear pharmacist if:

(a) This individual qualifies as an authorized nuclear pharmacist as defined in rule 3701:1-58-01 of the Administrative Code,

(b) This individual meets the requirements specified in paragraph (B) of rule 3701:1-58-20 of the Administrative Code and rule 3701:1-58-22 of the Administrative Code and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist, or

(c) This individual is designated as an authorized nuclear pharmacist in accordance with paragraph (B)(4) of this rule.

(3) The actions authorized in paragraphs (B)(1) and (B)(2) of this rule are permitted in spite of more restrictive language in license conditions.

(4) May designate a pharmacist (as defined in rule 3701:1-38-01 of the Administrative Code) as an authorized nuclear pharmacist if:

(a) The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material, and

(b) The individual practiced at a pharmacy at a government agency or federally recognized indian tribe before November 30, 2007 or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the United States nuclear regulatory commission.

(5) Shall provide to the director a copy of:

(a) Each individual's certification by a specialty board whose certification process has been recognized by the United States nuclear regulatory commission or an agreement state as specified in paragraph (A) of rule 3701:1-58-20 of the Administrative Code with the written attestation signed by a preceptor as required by paragraph (B)(2) of rule 3701:1-58-20 of the Administrative Code; or

(b) The United States nuclear regulatory commission or agreement state license; or

(c) The permit issued by a United States nuclear regulatory commission master materials licensee; or

(d) The permit issued by a licensee or United States nuclear regulatory commission master materials permittee of broad scope or; the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist; or

(e) The authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist; or

(f) Documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a government agency or federally recognized indian tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the United States nuclear regulatory commission; and

(g) State pharmacy licensure or registration, no later than thirty days after the date that the licensee allows, under paragraphs (B)(2)(a) and (B)(2)(c) of this rule, the individual to work as an authorized nuclear pharmacist.

(C) A licensee shall possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radioactive drugs prior to transfer for commercial distribution. In addition, the licensee shall:

(1) Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and

(2) Check each instrument for constancy and proper operation at the beginning of each day of use.

(D) Nothing in this rule relieves the licensee from complying with applicable United States food and drug administration, other federal, and state requirements governing radioactive drugs.

Effective: 12/01/2012
R.C. 119.032 review dates: 09/10/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 8/15/05, 1/20/08, 12/22/08, 10/04/10

3701:1-46-44 Manufacture and distribution of sources or devices containing radioactive material for medical use.

(A) An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to Chapter 3701:1-58 of the Administrative Code or equivalent regulations of the United States nuclear regulatory commission or agreement state for use as a calibration, transmission, or reference source or for the uses listed in rules 3701:1-58-43 , 3701:1-58-53 , 3701:1-58-55 , and 3701:1-58-72 of the Administrative Code or equivalent regulations of the United States nuclear regulatory commission or agreement state will be approved if:

(1) The applicant satisfies the general requirements in rule 3701:1-40-15 of the Administrative Code;

(2) The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

(a) The radioactive material contained, its chemical and physical form, and amount;

(b) Details of design and construction of the source or device;

(c) Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents;

(d) For devices containing radioactive material, the radiation profile of a prototype device;

(e) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests;

(f) Procedures and standards for calibrating sources and devices;

(g) Legend and methods for labeling sources and devices as to their radioactive content;

(h) Instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device: provided, that instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label;

(3) The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity and date of assay, and a statement that the director has approved distribution of the (name of source or device) to persons licensed to use radioactive material identified in rules 3701:1-58-26 , 3701:1-58-43 , 3701:1-58-53 , and 3701:1-58-55 of the Administrative Code, as appropriate, and to persons who hold an equivalent license issued by the United States nuclear regulatory commission or an agreement state.

(B) The following is applicable:

(1) In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months, he/she shall include in his/her application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source.

(2) In determining the acceptable interval for test of leakage of radioactive material, the director will consider information that includes, but is not limited to:

(a) Primary containment (source capsule);

(b) Protection of primary containment;

(c) Method of sealing containment;

(d) Containment construction materials;

(e) Form of contained radioactive material;

(f) Maximum temperature withstood during prototype tests;

(g) Maximum pressure withstood during prototype tests;

(h) Maximum quantity of contained radioactive material;

(i) Radiotoxicity of contained radioactive material;

(j) Operating experience with identical sources or devices or similarly designed and constructed sources or devices.

R.C. 119.032 review dates: 09/18/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 8/15/05, 1/20/08, 12/22/08

3701:1-46-45 Prototype tests for luminous safety devices for use in aircraft.

An applicant for a license pursuant to rule 3701:1-46-33 of the Administrative Code shall conduct prototype tests on each of five prototype luminous safety devices for use in aircraft as follows:

(A) Temperature-altitude test. The device shall be placed in a test chamber as it would be used in service. A temperature-altitude condition schedule shall be followed as outlined in table 1:

Table 1 - Temperature-altitude test

Step 1 The internal temperature of the test chamber shall be reduced to - 62° C (- 80° F) and the device shall be maintained for at least one hour at this temperature at atmospheric pressure.

Step 2 The internal temperature of the test chamber shall be raised to - 54° C (- 65° F) and maintained until the temperature of the device has stabilized at - 54° C (- 65° F) at atmospheric pressure.

Step 3 The atmospheric pressure of the chamber shall be reduced to eighty-three millimeters of mercury absolute pressure while the chamber temperature is maintained at - 54° C (- 65° F).

Step 4 The internal temperature of the chamber shall be raised to - 10° C (14° F) and maintained until the temperature of the device has stabilized at - 10° C (14° F), and the internal pressure of the chamber shall then be adjusted to atmospheric pressure. The test chamber door shall then be opened in order that frost will form on the device, and shall remain open until the frost has melted but not long enough to allow the moisture to evaporate. The door shall then be closed.

Step 5 The internal temperature of the chamber shall be raised to 85° C (185° F) at atmospheric pressure. The temperature of the device shall be stabilized at 85° C (185° F) and maintained for two hours. The device shall then be visually inspected to determine the extent of any deterioration.

Step 6 The chamber temperature shall be reduced to 71° C (160° F) at atmospheric pressure. The temperature of the device shall be stabilized at 71° C (160° F) for a period of thirty minutes.

Step 7 The chamber temperature shall be reduced to 55° C (130° F) at atmospheric pressure. The temperature of the device shall be stabilized at this temperature for a period of four hours.

Step 8 The internal temperature of the chamber shall be reduced to 30° C (86° F) and the pressure to one hundred thirty-eight millimeters of mercury absolute pressure and stabilized. The device shall be maintained under these conditions for a period of four hours.

Step 9 The temperature of the test chamber shall be raised to 35° C (95° F) and the pressure reduced to eighty-three millimeters of mercury absolute pressure and stabilized. The device shall be maintained under these conditions for a period of thirty minutes.

Step 10 The internal pressure of the chamber shall be maintained at eighty-three millimeters of mercury absolute pressure and the temperature reduced to 20° C (68° F) and stabilized. The device shall be maintained under these conditions for a period of four hours.

(B) Vibration tests. This procedure applies to items of equipment (including vibration isolating assemblies) intended to be mounted directly on the structure of aircraft powered by reciprocating, turbojet, or turbo-propeller engines or to be mounted directly on gas-turbine engines. The device shall be mounted on an apparatus dynamically similar to the most severe conditions likely to be encountered in normal use. At the end of the test period, the device shall be inspected thoroughly for possible damage. Vibration tests shall be conducted under both resonant and cycling conditions according to the following vibration test schedule (table 2)

Table 2 - Vibration test schedule (times shown refer to one axis of vibration) Type Vibration at room temperature

See Table at

http://www.registerofohio.state.oh.us/pdfs/3701/1/46/3701$1-46-45_PH_FF_A_RU_20080110_1336.pdf

(1) Determination of resonance frequency. Individual resonance frequency surveys shall be conducted by applying vibration to each device along each of any set of three mutually perpendicular axes and varying the frequency of applied vibration slowly through a range of frequencies from five cycles per second to five hundred cycles per second with the double amplitude of the vibration not exceeding that shown in figure 1 for the related frequency.

See Figure at

http://www.registerofohio.state.oh.us/pdfs/3701/1/46/3701$1-46-45_PH_FF_A_RU_20080110_1336.pdf

(2) Resonance tests. The device shall be vibrated at the determined resonance frequency for each axis of vibration for the periods and temperature conditions shown in table 1 and with the applied double amplitude specified in figure 1 for that resonance frequency. When more than one resonant frequency is encountered with vibration applied along any one axis, the test period may be accomplished at the most severe resonance or the period may be divided among the resonant frequencies, whichever is considered most likely to produce failure. When resonant frequencies are not apparent within the specified frequency range, the specimen shall be vibrated for periods twice as long as those shown for resonance in table 2 at a frequency of fifty-five cycles per second and an applied double amplitude of 0.060 inch.

(3) Cycling. Devices to be mounted only on vibration isolators shall be tested by applying vibration along each of three mutually perpendicular axes of the device with an applied double amplitude of 0.060 inch and the frequency cycling between ten and fifty-five cycles per second in one minute cycles for the periods and temperature conditions shown in table 2. Devices to be installed in aircraft without vibration isolators shall be tested by applying vibration along each of three mutually perpendicular axes of the device with an applied double amplitude of 0.036 inch or an applied acceleration of ten G, whichever is the limiting value, and the frequency cycling between ten and five hundred cycles per second in fifteen minute cycles for the periods and temperature conditions shown in table 2.

STRIKE OLD

(C) Accelerated weathering tests. The device shall be subjected to one hundred hours of accelerated weathering in a suitable weathering machine. Panels of Corex D glass shall surround the arc to cut off the ultraviolet radiation below a wave length of two thousand seven hundred angstroms. The light of the carbon arcs shall fall directly on the face of the device. The temperature at the sample shall be maintained at fifty degrees celsius plus or minus three degrees celsius. Temperature measurements shall be made with a black panel thermometer.

(D) Shock test. The device shall be dropped upon a concrete or iron surface in a three foot free gravitational fall, or shall be subjected to equivalent treatment in a test device simulating such a free fall. The drop test shall be repeated one hundred times from random orientations.

(E) Hermetic seal and waterproof test. On completion of all other tests prescribed by this section, the device shall be immersed in thirty inches of water for twenty-four hours and shall show no visible evidence of water entry. Absolute pressure of the air above the water shall then be reduced to one inch of mercury. Lowered pressure shall be maintained for one minute or until air bubbles cease to be given off by the water, whichever is the longer. Pressure shall then be increased to normal atmospheric pressure. Any evidence of bubbles emanating from within the device, or water entering the device, shall be considered leakage.

(F) Observations. After each of the tests prescribed by this rule, each device shall be examined for evidence of physical damage and for loss of tritium or promethium-147. Any evidence of damage to or failure of any device which could affect containment of the tritium or promethium-147 shall be cause for rejection of the design if the damage or failure is attributable to a design defect. Loss of tritium or promethium-147 from each tested device shall be measured by wiping with filter paper an area of at least one hundred square centimeters on the outside surface of the device, or by wiping the entire surface area if it is less than one hundred square centimeters. The amount of tritium or promethium-147 in the water used in the hermetic seal and waterproof test prescribed by paragraph (E) of this rule shall also be measured. Measurements shall be made in an apparatus calibrated to measure tritium or promethium-147, as appropriate. The detection on the filter paper of more than two thousand two hundred disintegrations per minute of tritium or promethium-147 per one hundred square centimeters of surface wiped or in the water of more than 0.1 per cent of the original amount of tritium or promethium-147 in any device shall be cause for rejection of the tested device.

R.C. 119.032 review dates: 09/18/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 6/20/03, 1/20/08

3701:1-46-46 Prototype tests for calibration or reference sources containing americium-241 or radium-226.

An applicant for a license pursuant to rule 3701:1-46-37 of the Administrative Code shall, for any type of source which is designed to contain more than 0.185 kilobecquerel ( 0.005 microcurie) of americium-241 or radium-226, conduct prototype tests, in the order listed, on each of five prototypes of such source, which contains more than 0.185 kilobecquerel ( 0.005 microcurie) of americium-241 or radium-226, as follows:

Prototype tests


              image: oh/admin/2014/3701$1-46-46_ph_ff_a_ru_20100924_1519-1.png

R.C. 119.032 review dates: 09/18/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08, 10/04/2010

3701:1-46-47 Prototype tests for ice detection devices containing strontium-90.

An applicant for a license pursuant to rule 3701:1-46-40 of the Administrative Code shall conduct prototype tests on each of five prototype ice detection devices as follows:

Prototype tests

Temperature-altitude test The device shall be placed in a test chamber as it would be used in service. A temperature-altitude condition schedule shall be followed as outlined in step one through step ten of Table 1 in rule 3701:1-46-45 of the Administrative Code.

Vibration tests The device shall be subjected to vibration tests as set forth in paragraph (B) of rule 3701:1-46-45 of the Administrative Code.

Shock test The device shall be subjected to shock test as set forth in paragraph (D) of rule 3701:1-46-45 of the Administrative Code.

Hermetic seal and waterproof test On completion of all other tests prescribed by this rule, the device shall be immersed in thirty inches of water for twenty-four hours and shall show no visible evidence of physical contact between the water and the strontium-90. Absolute pressure of the air above the water shall then be reduced to one inch of mercury. Lowered pressure shall be maintained for one minute or until air bubbles cease to be given off by the water, whichever is the longer. Pressure shall then be increased to normal atmospheric pressure. Any visible evidence of physical contact between the water and the strontium-90 shall be considered leakage.

Observations After each of the tests prescribed by this rule, each device shall be examined for evidence of physical damage and for loss of strontium-90. Any evidence of leakage or damage to or failure of any device which could affect containment of the strontium-90 shall be cause for rejection of the design if the damage or failure is attributable to a design defect. Loss of strontium-90 from each tested device shall be measured by wiping with filter paper an area of at least one hundred square centimeters on the outside surface of the device, or by wiping the entire surface area if it is less than one hundred square centimeters. The amount of strontium-90 in the water used in the hermetic seal and waterproof test prescribed in this table shall also be measured. The detection on the filter paper of more than two thousand two hundred disintegrations per minute of strontium-90 per one hundred square centimeters of surface wiped or in the water of more than 0.1 per cent of the original amount of strontium-90 in any device, shall be cause for rejection of the tested device.

R.C. 119.032 review dates: 09/18/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08

3701:1-46-48 Acceptance sampling procedures under certain specific licenses.

(A) A random sample shall be taken from each inspection lot of devices licensed under rule 3701:1-46-33 or 3701:1-46-40 of the Administrative Code for which testing is required pursuant to rule 3701:1-46-17 , 3701:1-46-35 , or 3701:1-46-41 of the Administrative Code in accordance with the appropriate sampling table in this rule determined by the designated lot tolerance per cent defective. If the number of defectives in the sample does not exceed the acceptance number in the appropriate sampling table in this rule, the lot shall be accepted. If the number of defectives in the sample exceeds the acceptance number in the appropriate sampling table in this rule, the entire inspection lot shall be rejected.

(B) Single sampling tables for lot tolerance per cent defective:

(1) Lot tolerance per cent defective 0.5 per cent:

Lot size

Sample size

Acceptance number

1 to 180

All

0

181 to 210

180

0

211 to 250

210

0

251 to 300

240

0

301 to 400

275

0

401 to 500

300

0

501 to 600

320

0

601 to 800

350

0

801 to 1,000

365

0

1,001 to 2,000

410

0

2,001 to 3,000

430

0

3,001 to 4,000

440

0

4,001 to 5,000

445

0

5,001 to 7,000

450

0

7,001 to 10,000

455

0

10,001 to 20,000

460

0

20,001 to 50,000

775

1

50,001 to 100,000

780

1

(2) Lot tolerance per cent defective one per cent:

Lot size

Sample size

Acceptance number

1 to 120

All

0

121 to 150

120

0

151 to 200

140

0

201 to 300

165

0

301 to 400

175

0

401 to 500

180

0

501 to 600

190

0

601 to 800

200

0

801 to 1,000

205

0

1,001 to 3,000

220

0

3,001 to 5,000

225

0

5,001 to 10,000

230

0

10,001 to 100,000

390

1

(3) Lot tolerance per cent defective two per cent:

Lot size

Sample size

Acceptance number

1 to 75

All

0

76 to 100

70

0

101 to 200

85

0

201 to 300

95

0

301 to 400

100

0

401 to 600

105

0

601 to 800

110

0

801 to 4,000

115

0

4,001 to 10,000

195

1

10,001 to 100,000

200

1

(4) Lot tolerance per cent defective three per cent:

Lot size

Sample size

Acceptance number

1 to 40

All

0

41 to 55

40

0

56 to 100

55

0

101 to 200

65

0

201 to 500

70

0

501 to 3,000

75

0

3,001 to 100,000

130

1

(5) Lot tolerance per cent defective four per cent:

Lot size

Sample size

Acceptance number

1 to 35

All

0

36 to 50

34

0

51 to 100

44

0

101 to 200

50

0

201 to 2,000

55

0

2,001 to 100,000

95

1

(6) Lot tolerance per cent defective five per cent:

Lot size

Sample size

Acceptance number

1 to 30

All

0

31 to 50

30

0

51 to 100

37

0

101 to 200

40

0

201 to 300

43

0

301 to 400

44

0

401 to 2,000

45

0

2,001 to 100,000

75

1

(7) Lot tolerance per cent defective seven per cent:

Lot size

Sample size

Acceptance number

1 to 25

All

0

26 to 50

24

0

51 to 100

28

0

101 to 200

30

0

201 to 300

31

0

301 to 800

32

0

801 to 1,000

33

0

1,001 to 100,000

55

1

(8) Lot tolerance per cent defective ten per cent:

Lot size

Sample size

Acceptance number

1 to 20

All

0

21 to 50

17

0

51 to 100

20

0

101 to 200

22

0

201 to 800

23

0

801 to 100,000

39

1

Effective: 04/22/2013
R.C. 119.032 review dates: 11/30/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08

3701:1-46-49 Registration of product information.

(A) Any manufacturer or initial distributor of a sealed source or device containing a sealed source whose product is intended for use under a specific license may submit a request to the director for evaluation of radiation safety information about its product and for its registration.

(B) The request for review must be made in duplicate and sent to the director at the following address:

"Ohio Department of Health

Bureau of Radiation Protection

246 North High Street

Columbus, Ohio 43215"

(C) The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.

(D) The director normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the director formulates reasonable standards and criteria with the help of the manufacturer or distributor. The director shall use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property.

(E) After completion of the evaluation, the director issues a certificate of registration to the person making the request. The certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product.

(F) The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with:

(1) The statements and representations, including quality control program, contained in the request; and

(2) The provisions of the registration certificate.

Effective: 12/01/2012
R.C. 119.032 review dates: 09/10/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08

3701:1-46-50 Serialization of nationally tracked sources.

Each licensee who manufactures a nationally tracked source after February 6, 2007, shall assign a unique serial number to each nationally tracked source. Serial numbers must be composed only of alpha-numeric characters.

R.C. 119.032 review dates: 09/18/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/27/2008

3701:1-46-51 General license for certain items and self-luminous products containing radium-226.

(A) A general license is hereby issued to any person to acquire, receive, possess, use, or transfer, in accordance with the provisions of paragraphs (B), (C), and (D) of this rule, radium-226 contained in the following products manufactured prior to November 30, 2007:

(1) Antiquities originally intended for use by the general public. For the purposes of this paragraph, antiquities mean products originally intended for use by the general public and distributed in the late nineteenth and early twentieth centuries, such as radium emanator jars, revigators, radium water jars, radon generators, refrigerator cards, radium bath salts, and healing pads;

(2) Intact timepieces containing greater than 0.037 megabecquerel (one microcurie), nonintact timepieces, and timepiece hands and dials no longer installed in timepieces;

(3) Luminous items installed in air, marine, or land vehicles;

(4) All other luminous products, provided that no more than one hundred items are used or stored at the same location at any one time; and

(5) Small radium sources containing no more than 0.037 megabecquerel (one microcurie) of radium-226. For the purposes of this paragraph, "small radium sources" means discrete survey instrument check sources, sources contained in radiation measuring instruments, sources used in educational demonstrations (such as cloud chambers and spinthariscopes), electron tubes, lightning rods, ionization sources, static eliminators, or as designated by the director or the United States nuclear regulatory commission.

(B) Persons who acquire, receive, possess, use, or transfer radium-226 under the general license issued in paragraph (A) of this rule are exempt from the provisions of rules 3701:1-38-07 , 3701:1-38-09 to 3701:1-38-18 , 3701:1-38-20 to 3701:1-38-25 of the Administrative Code, to the extent that the receipt, possession, use, or transfer of radium-226 is within the terms of the general license; provided, however, that this exemption shall not be deemed to apply to any such person specifically licensed in accordance with rule 3701:1-38-02 of the Administrative Code.

(C) Any person who acquires, receives, possesses, uses, or transfers radium-226 in accordance with the general license in paragraph (A) of this rule:

(1) Shall notify the director should there be any indication of possible damage to the product so that it appears it could result in a loss of the radioactive material. A report containing a brief description of the event, and the remedial action taken, must be furnished to the director in the manner specified in rule 3701:1-40-04 of the Administrative Code within thirty days.

(2) Shall not abandon products containing radium-226. The product, and any radioactive material from the product, may only be disposed of in accordance with rule 3701:1-38-19 of the Administrative Code, or by transfer to a person authorized by a specific license to receive the radium-226 in the product or as otherwise approved by the director.

(3) Shall not export products containing radium-226 except in accordance with United States nuclear regulatory commission regulations.

(4) Shall dispose of products containing radium-226:

(a) At a disposal facility authorized to dispose of radioactive material in accordance with Chapter 3701:1-54 of the Administrative Code or equivalent regulation of an agreement state or the United States nuclear regulatory commission;

(b) By transfer to a person authorized to receive radium-226 by a specific license issued in accordance with rule 3701:1-38-02 of the Administrative Code or equivalent regulations of an agreement state or the United States nuclear regulatory commission; or

(c) As otherwise approved by the director.

(5) Shall respond to written requests from the director to provide information relating to the general license within thirty calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the director, in the manner specified in rule 3701:1-40-04 of the Administrative Code, a written justification for the request.

(D) The general license in paragraph (A) of this rule does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium-226, except that timepieces may be disassembled and repaired.

Effective: 12/01/2012
R.C. 119.032 review dates: 09/10/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/04/2010