Chapter 3701:1-40 Byproduct and Accelerator Produced Materials

3701:1-40-01 Definitions.

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

(A) "Bureau assessment report" means a document prepared by the department that briefly provides evidence and analysis of whether there is an adverse radiological impact on human health or the human environment or whether there is no significant impact.

(B) "Categorical exclusion" means a category of actions which do not individually or cumulatively have a significant effect on human health or the human environment.

(C) "Environmental report" means a document submitted to the department by an applicant for a license, renewal, or amendment thereof, that aids the department in completing the bureau assessment report.

Effective: 10/04/2010
R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 2/6/06

3701:1-40-02 Scope.

(A) This chapter prescribes specific radiation protection requirements applicable to all persons in Ohio handling radioactive material for which licensure is required. The requirements of this chapter are in addition to, and not in substitution for, other requirements of the Administrative Code. In any conflict between the requirements in this chapter and a specific requirement in another chapter of the Administrative Code adopted pursuant to Chapter 3748. of the Revised Code, the more specific requirement governs.

(B) The director may issue licenses for radioactive material as outlined in this chapter. Handlers of source material and special nuclear material less than critical mass shall comply with the requirements of Chapters 3701:1-44 and 3701:1-56 of the Administrative Code, respectively. The director shall issue a specific license to a named person upon application filed in accordance with paragraph (C) of rule 3701:1-38-02 of the Administrative Code. A general license may be effective without application to the director based on criteria in rules covering manufacture and distribution of radioactive material and rule 3701:1-38-02 of the Administrative Code.

Effective: 10/04/2010
R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/01, 8/15/05

3701:1-40-03 Activities requiring license.

Unless otherwise exempt as provided in rule 3701:1-43-07 of the Administrative Code, or unless possession is solely for the purpose of transportation, no person shall handle or possess (including manufacture, produce, acquire, or own) or dispose of (including closure, decommissioning, reclamation, or long-term surveillance or care) radioactive material except as authorized in a specific or general license issued in accordance with this chapter, or other chapters of the Administrative Code adopted pursuant to Chapter 3748. of the Revised Code and rule 3701:1-38-02 of the Administrative Code.

Effective: 05/23/2013
R.C. 119.032 review dates: 03/06/2013 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05, 10/4/10

3701:1-40-04 Communications.

Except as otherwise provided, any communication or report required by this chapter shall be filed in accordance with Chapter 3748. of the Revised Code and rules promulgated thereunder. Documents pertaining to license application or any license matter, unless otherwise directed in writing, shall be submitted to the department at the following address or electronic submission in a manner approved by the director.

"Ohio Department of Health

Bureau of Radiation Protection

246 North High Street

Columbus, Ohio 43215."

Effective: 10/04/2010
R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05

3701:1-40-05 Completeness and accuracy of information.

All information provided to the director by an applicant for a license, or by a licensee, and all information required to be maintained by the applicant or the licensee in accordance with license conditions or by Chapter 3748. of the Revised Code or Rules adopted thereunder, shall be complete and accurate in all material respects.

R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05

3701:1-40-06 Department of energy contractors.

(A) Except to the extent that United States department of energy facilities or activities of the types subject to licensing pursuant to section 202 of the "Energy Reorganization Act of 1974" are involved, any prime contractor of the United States department of energy is exempt from the license requirements set forth in sections 81 and 82 of the "Atomic Energy Act" and from the regulations in this chapter to the extent that such contractor, under his prime contract with the United States department of energy, manufactures, produces, transfers, receives, acquires, owns, possesses, or uses byproduct material for:

(1) The performance of work for the United States department of energy at a United States government-owned or controlled site, including the transportation of byproduct material to or from such site and the performance of contract services during temporary interruptions of such transportation;

(2) Research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof; or

(3) The use or operation of nuclear reactors or other nuclear devices in a United States government-owned vehicle or vessel.

(B) In addition to the exemptions specified in paragraph (A) of this rule and subject to the requirement for licensing of the United States department of energy facilities and activities pursuant to section 202 of the "Energy Reorganization Act of 1974", any prime contractor or subcontractor of the United States department of energy or the United States nuclear regulatory commission is exempt from the requirements for a license set forth in sections 81 and 82 of the "Atomic Energy Act" and from the regulations in this chapter to the extent that such prime contractor or subcontractor manufactures, produces, transfers, receives, acquires, owns, possesses, or uses byproduct material under his prime contract or subcontract when the United States nuclear regulatory commission determines that the exemption of the prime contractor or subcontractor is authorized by law; and that, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.

Effective: 10/04/2010
R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05

3701:1-40-07 Carriers.

Common and contract carriers, freight forwarders, warehousemen, and the U. S. postal service are exempt from the regulations in this chapter and Chapters 3701:1-37, 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code, to the extent that they are not required to be licensed as set forth in Chapter 3748. of the Revised Code and rule 3701:1-38-02 of the Administrative Code, and to the extent that they only transport or store radioactive material in the regular course of carriage for another or storage incident thereto.

Effective: 05/15/2014
R.C. 119.032 review dates: 02/28/2014 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05, 10/4/10

3701:1-40-08 Exempt concentrations.

(A) Except as may be required in paragraphs (C) and (D) of this rule, any person is exempt from the requirements for a license set forth in this chapter and Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code to the extent that such person receives, possesses, uses, transfers, owns, or acquires products or materials containing radioactive material in concentrations that do not exceed those listed in the appendix to this rule.

(B) This rule shall not be deemed to authorize the import of radioactive material or products containing radioactive material.

(C) A manufacturer, processor, or producer of a product or material from the rules in this chapter and Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code to the extent that the person transfers radioactive material contained in a product or material in concentrations not in excess of those specified in the appendix to this rule and introduced into the product or material by a licensee holding a specific license issued by an agreement state, the United States nuclear regulatory commission, or the director, expressly authorizing such introduction. This exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

(D) No person may introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under this rule, except in accordance with a license issued by the United States nuclear regulatory commission.

Appendix

Exempt Concentrations

See Appendix at

http://www.registerofohio.state.oh.us/pdfs/3701/1/40/3701$1-40-08_PH_FF_A_APP1_20090501_1249.pdf

R.C. 119.032 review dates: 11/01/2013 and 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04 , 3748.07
Prior Effective Dates: 7/22/2001, 8/15/05, 5/11/09

3701:1-40-09 Certain items containing radioactive material.

(A) Except for persons who apply radioactive material to, or persons who incorporate radioactive material into, the following products, or persons who initially transfer for sale or distribution the following products containing radioactive material, any person is exempt from the requirements for a license set forth in this chapter and Chapters 3701:1-38, 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code to the extent that such person receives, possesses, uses, transfers, owns, or acquires the following products:

(1) Timepieces or hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified levels of radiation:

(a) Nine hundred twenty-five megabecquerels (twenty-five millicuries) of tritium per timepiece,

(b) One hundred eighty-five megabecquerels (five millicuries) of tritium per hand,

(c) Five hundred fifty-five megabecquerels (fifteen millicuries) of tritium per dial (bezels when used shall be considered as part of the dial),

(d) 3.7 megabecquerels (one hundred microcuries) of promethium-147 per watch or 7.4 megabecquerels (two hundred microcuries) of promethium-147 per any other timepiece,

(e) Seven hundred forty kilobecquerels (twenty microcuries) of promethium-147 per watch hand or 1.48 megabecquerels (forty microcuries) of promethium-147 per other timepiece hand,

(f) 2.22 megabecquerels (sixty microcuries) of promethium-147 per watch dial or 4.44 megabecquerels (one hundred twenty microcuries) of promethium-147 per other timepiece dial (bezels when used shall be considered as part of the dial), and

(g) The levels of radiation from hands and dials containing promethium-147 will not exceed, when measured through fifty milligrams per square centimeter of absorber:

(i) For wrist watches, one nanogray ( 0.1 millirad) per hour at ten centimeters from any surface,

(ii) For pocket watches, one nanogray ( 0.1 millirad) per hour at one centimeter from any surface, and

(iii) For any other timepiece, two nanogray ( 0.2 millirad) per hour at ten centimeters from any surface.

(h) Thirty-seven kilobecquerels (one microcurie) of radium-226 per timepiece in intact timepieces manufactured prior to November 30, 2007.

(2)

(a) Static elimination devices which contain, as a sealed source or sources, byproduct material consisting of a total of not more than 18.5 megabecquerels (five hundred microcuries) of polonium-210 per device.

(b) Ion generating tubes designed for ionization of air that contain, as a sealed source or sources, byproduct 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.

(c) Such devices authorized before October 23, 2012 for use under the general license then provided in rule 3701:1-46-04 of the Administrative Code and equivalent regulations of "Agreement States" and manufactured, tested, and labeled by the manufacturer in accordance with the specifications contained in a specific license issued by the director.

(3) Balances of precision containing not more than thirty-seven megabecquerels (one millicurie) of tritium per balance or not more than 18.5 megabecquerels ( 0.5 millicurie) of tritium per balance part manufactured before December 17, 2007.

(4) Marine compasses containing not more than 27.75 gigabecquerels (seven hundred fifty millicuries) of tritium gas and other marine navigational instruments containing not more than 9.25 gigabecquerels (two hundred fifty millicuries) of tritium gas manufactured before December 17, 2007.

(5) Ionization chamber smoke detectors containing not more than thirty-seven kilobecquerels (one microcurie) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.

(6) Electron tubes: provided, that each tube does not contain more than one of the following specified quantities of byproduct material:

(a) 5.55 gigabecquerels (one hundred fifty millicuries) of tritium per microwave receiver protector tube or three hundred seventy megabecquerels (ten millicuries) of tritium per any other electron tube;

(b) Thirty-seven kilobecquerels (one microcurie) of cobalt-60;

(c) One hundred eighty-five kilobecquerels (five microcuries) of nickel-63;

(d) 1.11 megabecquerels (thirty microcuries) of krypton-85;

(e) One hundred eighty-five kilobecquerels (five microcuries) of cesium-137; or

(f) 1.11 megabecquerels (thirty microcuries) of promethium-147;

And provided further, that the levels of radiation from each electron tube containing radioactive material do not exceed ten nanogray (one millirad) per hour at one centimeter from any surface when measured through seven milligrams per square centimeter of absorber. For purposes of this paragraph, electron tubes include spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pickup tubes, radiation detection tubes, and any other completely sealed tube that is designed to conduct or control electrical currents.

(7) Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided that:

(a) Each source contains no more than one exempt quantity as set forth in the appendix to rule 3701:1-40-11 of the Administrative Code; and

(b) Each instrument contains no more than ten exempt quantities. For the purposes of this paragraph, an instrument's source may contain either one type or different types of radionuclides, and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in the appendix to rule 3701:1-40-11 of the Administrative Code, provided that the sum of such fractions shall not exceed unity.

(c) For purposes of this paragraph, 1.85 kilobecquerels ( 0.05 microcurie) of americium-241 is considered an exempt quantity under the appendix to rule 3701:1-40-11 of the Administrative Code.

(B) Any person who desires to apply radioactive material to, or to incorporate radioactive material into, the products exempted in paragraph (A) of this rule, or who desires to initially transfer for sale or distribution such products containing radioactive material, shall apply for a specific license issued by the United States nuclear regulatory commission.

Effective: 01/16/2014
R.C. 119.032 review dates: 11/01/2013 and 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04 , 3748.06 , 3748.07
Prior Effective Dates: 7/22/2001, 8/15/05, 4/5/09

3701:1-40-10 Resins containing scandium-46 and designed for sand-consolidation in oil wells. [Rescinded].

Rescinded eff 4-5-09

3701:1-40-11 Exempt quantities.

(A) Except as provided in paragraphs (C) to (E) of this rule, any person is exempt from requirements set forth in this chapter and from the rules in Chapters 3701:1-46, 3701:1-48, 3701:1-49, and 3701:1-52 of the Administrative Code, to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in the appendix to this rule.

(B) Any person who possesses radioactive material received or acquired before September 25, 1971, under the general license then provided in 10 C.F.R. section 31.4 or similar general license of a state, is exempt from the requirements for a license set forth in this chapter and from the rules in Chapters 3701:1-46, 3701:1-48, 3701:1-49, and 3701:1-52 of the Administrative Code, to the extent that this person possesses, uses, transfers, or owns radioactive material.

(C) This rule does not authorize for purposes of commercial distribution the production, packaging, repackaging, or transfer of radioactive material or the incorporation of radioactive material into products intended for commercial distribution.

(D) No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in the appendix to this rule, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under this chapter or equivalent regulations of an agreement state or the United States nuclear regulatory commission, except in accordance with a license, issued by the United States nuclear regulatory commission, which states that the radioactive material may be transferred by the licensee to persons exempt under this rule or the equivalent regulations of an agreement state or the United States nuclear regulatory commission.

(E) No person may, for purposes of producing an increased radiation level, combine quantities of radioactive material covered by this exemption so that the aggregate quantity exceeds the limits set forth in the appendix to this rule, except for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise permitted by the rules in this chapter.

Click to view Appendix

Effective: 01/01/2012
R.C. 119.032 review dates: 08/30/2011 and 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04 , 3748.06 , 3748.07
Prior Effective Dates: 7/22/2001, 8/15/05, 5/11/09, 10/4/10

3701:1-40-12 Self-luminous products containing tritium, krypton-85, or promethium-147.

(A) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147, and except as provided in paragraph (C) of this rule, a person is exempt from the license requirements set forth in Chapters 3701:1-38, 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code to the extent that such person receives, possesses, uses, transfers, owns, or acquires tritium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, produced, or initially transferred in accordance with a specific license issued pursuant to 10 C.F.R. 32.22 , as published in the January 1, 2009, Code of Federal Regulations, which license authorizes the initial transfer of the product for use.

(B) Any person who desires to manufacture, process, or produce self-luminous products containing tritium, krypton-85, or promethium-147, or to transfer such products for use pursuant to paragraph (A) of this rule, shall apply for a license pursuant to 10 C.F.R. 32.22 , as published in the January 1, 2009, Code of Federal Regulations, which license states that the product may be transferred by the licensee to persons exempt from the regulations pursuant to paragraph (A) of this rule or equivalent regulations of an agreement state, or the United States nuclear regulatory commission.

(C) The exemption in paragraph (A) of this rule does not apply to tritium, krypton-85, or promethium-147 used in products primarily for frivolous purposes or in toys or adornments.

Effective: 10/04/2010
R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04 , 3748.06 , 3748.07
Prior Effective Dates: 7/22/2001, 8/15/05

3701:1-40-13 Gas and aerosol detectors containing radioactive material.

(A) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution gas and aerosol detectors containing radioactive material, a person is exempt from license requirements set forth in this chapter or Chapters 3701:1-38, 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material, in gas and aerosol detectors designed to protect life or property from fires and airborne hazards, and manufactured, processed, produced, or initially transferred in accordance with a specific license for manufacture and distribution issued pursuant to 10 C.F.R. 32.26 , as published in the January 1, 2010, Code of Federal Regulations. This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007, in accordance with a specific license issued by a state under comparable provisions to 10 C.F.R. 32.26 , as published in the January 1, 2007, Code of Federal Regulations, authorizing distribution to persons exempt from regulatory requirements.

(B) A person who desires to manufacture, process, or produce gas and aerosol detectors containing radioactive material, or to initially transfer such products for use pursuant to paragraph (A) of this rule, shall apply for a license for manufacture and distribution pursuant to 10 C.F.R. 32.26 , as published in the January 1, 2010, Code of Federal Regulations.

Effective: 01/01/2012
R.C. 119.032 review dates: 08/30/2011 and 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04 , 3748.06 , 3748.07
Prior Effective Dates: 7/22/2001, 8/15/05, 10/4/2010

3701:1-40-14 Application for specific licenses.

(A) An applicant for a license to receive and possess radioactive material shall apply in accordance with rule 3701:1-38-02 of the Administrative Code and this chapter on a form prescribed by the director. The original application shall be filed with the director. Information contained in previous applications, statements or reports filed with the director may be incorporated by reference, provided that the reference is clear, specific, and has been on file with the department for not more than two licensing periods, and provided that the item being referenced in the document is being referenced without change.

(B) The director may at any time after the filing of the original application require additional information from the applicant in order to determine whether a license should be issued or whether a current license should be modified or revoked.

(C) Each application shall be signed by the applicant or a person duly authorized to act for the applicant.

(D) An application for a license to receive and possess radioactive material for the conduct of any activity which the director has determined pursuant to rule 3701:1-40-36 of the Administrative Code could potentially affect the quality of the environment shall be filed at least nine months prior to commencement of construction of the plant or facility in which the activity will be conducted and shall be accompanied by any environmental report required pursuant to rule 3701:1-40-36 of the Administrative Code. The applicant is prohibited from the commencement of construction activities in areas covered by the environmental reporting requirements identified in rules 3701:1-40-30 to 3701:1-40-38 of the Administrative Code before the conclusion of these reviews. The terms "construction" and "commencement of construction" shall have the same meaning as identified in rule 3701:1-38-01 of the Administrative Code.

(E) An application for a specific license other than broad scope as defined in rule 3701:1-40-23 of the Administrative Code to use radioactive material in the form of a sealed source or in a device that contains the sealed source must either:

(1) Identify the source or device by manufacturer and model number as registered in the sealed source and device registry of the United States nuclear regulatory commission in accordance with sealed source and device registry requirements contained in rule 3701:1-46-49 of the Administrative Code, or with equivalent requirements from an agreement state or the United States nuclear regulatory commission; or

(2) Contain the information specified in sealed source and device registry requirements contained in paragraph (C) of rule 3701:1-46-49 of the Administrative Code so that the department is able to perform the review; or

(3) For sources or devices containing naturally occurring or accelerator-produced radioactive material manufactured prior to November 30, 2007, that are not registered with the director in accordance with rule 3701:1-46-49 of the Administrative Code or equivalent requirements from an agreement state or the United States nuclear regulatory commission, and for which the applicant is unable to provide all categories of information specified in rule 3701:1-46-49 of the Administrative Code, the applicant must provide:

(a) All available information identified in rule 3701:1-46-49 of the Administrative Code concerning the source, and, if applicable, the device; and

(b) Sufficient additional information to demonstrate that there is reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Such information must include a description of the source or device, a description of radiation safety features, the intended use and associated operating experience, and the results of a recent leak test.

(F) In the case of an application for a license specified in rule 3701:1-40-16 of the Administrative Code, or an application for a specific license specified in Chapter 3701:1-46, 3701:1-48, or 3701:1-58 of the Administrative Code, the applicant shall provide a proposed decommissioning funding plan or a certification of financial assurance for decommissioning.

(G) Requirement for an emergency response plan:

(1) Each application to possess radioactive materials in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities specified in the appendix to this rule shall contain either:

(a) An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed 0.01 sievert (one rem) TEDE or 0.05 sievert (five rem) to the thyroid; or

(b) An emergency plan for responding to a release of radioactive material.

(2) One or more of the following factors may be used to support an evaluation of the need to submit an emergency plan under this paragraph:

(a) The radioactive material is physically separated so that only a portion of the material could be involved in an accident;

(b) All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;

(c) The release fraction in the respirable size range would be lower than the release fraction specified in the appendix to this rule due to the chemical or physical form of the material;

(d) The solubility of the radioactive material would reduce the dose received;

(e) Facility design or engineered safety features in the facility would cause the release fraction to be lower than the limit specified in the appendix to this rule;

(f) Operating restrictions or procedures would prevent a release fraction as large as that shown in the appendix to this rule; or

(g) Other factors appropriate for the specific facility as determined by the director.

(3) An emergency plan for responding to a release of radioactive material submitted under paragraph (G)(1)(b) of this rule shall include the following information:

(a) A brief description of the licensee's facility and the area near the site.

(b) An identification of each type of possible radioactive material accident which may require protective action.

(c) A classification system for classifying an accident as either an alert or a site area emergency.

(d) Identification of the means of detecting each type of accident in a timely manner.

(e) A brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers onsite, and a description of the program for maintaining the equipment.

(f) A brief description of the methods and equipment to assess releases of byproduct and accelerator produced materials.

(g) A brief description of the responsibilities of the licensee's personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and the department, and identification of personnel responsible for developing, maintaining, and updating the plan.

(h) A commitment to, and a brief description of, the means to promptly notify offsite response organizations and request offsite assistance, including medical assistance for the treatment of contaminated injured onsite workers when appropriate. A control point shall be established. The notification and coordination shall be planned so that in the event that some personnel, parts of the facility, or some equipment is not available, that unavailability will not prevent such notification and coordination. The licensee shall also commit to notifying the department immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency. These reporting requirements do not supersede or release licensees from complying with the requirements of the "Emergency Planning and Community Right-to-Know Act of 1986," Title III, Pub. L. 99-499 or other state or federal reporting requirements.

(i) A brief description of the types of information on facility status, radioactive releases, and recommended protective actions, if necessary, to be given to offsite response organizations and to the department.

(j) A brief description of the frequency, performance objectives and plans for the training that the licensee will provide workers on how to respond to an emergency including any special instructions and orientation tours the licensee would offer to fire, police, medical and other emergency personnel. The training shall familiarize personnel with site-specific emergency procedures. The training also shall thoroughly prepare site personnel for their responsibilities in the event of an accident, including training on the emergency scenarios postulated as most probable for the specific site, and the use of team training for such scenarios.

(k) A brief description of the means of restoring the facility to a safe condition after an accident.

(l) Provisions for conducting quarterly communication checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. Quarterly communication checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee shall invite offsite response organizations to participate in the biennial exercises. Participation of offsite response organizations in biennial exercises, although recommended, is not required. Exercises must use accident scenarios postulated as most probable for the specific site and the scenarios shall not be known to most exercise participants. The licensee shall critique each exercise using individuals not having direct implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and overall effectiveness of the response. Deficiencies found by the critiques must be corrected.

(m) A certification that the applicant has met all responsibilities under the "Emergency Planning and Community Right-to-Know Act of 1986," Title III, Pub. L. 99-499, if applicable to the applicant's activities at the proposed place of use of the byproduct or accelerator produced material.

(n) The licensee must have and maintain liability coverage for incidents which would activate the plan to cover bodily injury and property damage to third parties caused by incidents which would activate the plan in the amount of at least one million dollars per occurrence with an annual aggregate of at least two million dollars, exclusive of legal defense costs.

(4) The licensee shall allow the offsite response organizations expected to respond in case of an accident sixty days to comment on the licensee's emergency plan before submitting it to the department. The licensee shall provide any comments received within the sixty days to the department with the emergency plan.

(H) Information provided by a licensee or applicant for a license or license renewal that constitutes a "trade secret" as defined in section 1333.61 of the Revised Code is not subject to public disclosure in accordance with sections 1333.61 to 1333.69 of the Revised Code.

(I) An application from a medical facility, or educational institution to produce positron emission tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use in accordance with rules in Chapter 3701:1-58 of the Administrative Code shall include:

(1) A request for authorization for the production of PET radionuclides or evidence of an existing license issued in accordance with rule 3701:1-38-02 of the Administrative Code for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.

(2) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in paragraph (A)(2) of rule 3701:1-46-43 of the Administrative Code.

(3) Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in paragraph (B)(2) of rule 3701:1-46-43 of the Administrative Code.

(4) Information identified in paragraph (A)(3) of rule 3701:1-46-43 of the Administrative Code, on the PET drugs to be non-commercially transferred to members of its consortium.

Click to view Appendix

Effective: 07/25/2013
R.C. 119.032 review dates: 05/06/2013 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05, 10/4/10

3701:1-40-15 General requirements for issuance of specific licenses.

(A) An application for a specific license will be approved if:

(1) The application is for a purpose authorized by Chapter 3748. of the Revised Code and the rules adopted thereunder;

(2) The applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property or the environment;

(3) The applicant is qualified by training and experience to use the radioactive material for the purpose requested in such manner as to protect health and minimize danger to life or property or the environment;

(4) The applicant satisfies any special requirements contained in rule 3701:1-38-02 of the Administrative Code, and Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code; and

(5) In the case of an application for a license to receive and possess radioactive material for the conduct of any activity which the director determines could potentially affect the quality of the environment, the department, before commencement of construction of the plant or facility in which the activity will be conducted, on the basis of information filed and evaluations made pursuant to rule 3701:1-40-30 of the Administrative Code, has concluded, after weighing the environmental, economic, technical, and other benefits against environmental costs and considering available alternatives, shall conclude that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion shall be grounds for denial of a license to receive and possess radioactive material in such plant or facility. As used in this paragraph the term "commencement of construction" is as defined in rule 3701:1-38-01 of the Administrative Code.

(B) Upon a determination that an application meets the requirements of Chapter 3748. of the Revised Code and the rules adopted thereunder, the director will issue a specific license authorizing the possession and use of radioactive material.

Effective: 07/25/2013
R.C. 119.032 review dates: 05/06/2013 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05, 10/4/10

3701:1-40-16 Terms and conditions of licenses.

(A)

(1) A license, or any right under a license, shall not be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person, unless the director finds that the transfer is in accordance with this rule and Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code. A license or any right contained therein may not be transferred or conveyed without the written authorization of the director. If the director approves the transfer and receives payment of the appropriate licensing fee, a new license will be issued to the transferee.

(2) An application for transfer of license must include:

(a) The identity, technical and financial qualifications of the proposed transferee; and

(b) Financial assurance for decommissioning information required by rule 3701:1-40-17 of the Administrative Code.

(B) Each licensee shall confine possession and use of radioactive material to the locations and purposes authorized in the license. Preparation for shipment and transport of radioactive material shall be in accordance with Chapter 3701:1-50 of the Administrative Code.

(C) The director may incorporate at the time of issuance, or thereafter by appropriate rule, regulation, or order, such additional requirements or conditions with respect to the licensee's receipt, possession, use and transfer of radioactive material as the director deems appropriate or necessary in order to protect the environment, protect health, or minimize danger to life or property. The director may require such reports and the keeping of such records, and provide for such inspections of activities under the license as may be necessary to effectuate the purposes of Chapter 3748. of the Revised Code or rules adopted thereunder.

(D) A licensee that is required to submit an emergency plan pursuant to rule 3701:1-40-14 of the Administrative Code shall follow the emergency plan approved by the director. The licensee may amend the approved plan without approval of the director provided that the amendment does not decrease the effectiveness of the plan. Within six months after amending the emergency plan, the licensee shall furnish the amended plan to both the director and to affected offsite response organizations. Any proposed amendment to the emergency plan that decreases, or potentially decreases, the effectiveness of the approved emergency plan may not be implemented without prior approval by the director.

(E) Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, in accordance with rule 3701:1-58-35 of the Administrative Code. The licensee shall record the results of each test and retain each record for three years after the record is made.

(F) Each licensee must notify the director by certified mail within ten business days of the commencement of a voluntary or involuntary bankruptcy petition that has been filed by or against:

(1) The licensee;

(2) An entity, defined in this rule as person, estate, trust, governmental unit, and United States trustee, controlling the licensee or listing the license or licensee as property of the estate; or

(3) An affiliate of the licensee defined in this rule as an entity that directly or indirectly owns, controls, or holds with power to vote, twenty per cent or more of the outstanding voting securities of the debtor, other than an entity that holds such securities:

(a) In a fiduciary or agency capacity without sole discretionary power to vote such securities; or

(b) Solely to secure a debt, if such entity has not in fact exercised such power to vote.

The notification shall specify the bankruptcy court in which the petition for bankruptcy was filed and the date of the filing petition.

(G) The director may, upon application including adequate documentation by a person or by his own initiative, grant such exemptions from the requirements of this chapter or other chapters of the Administrative Code involving radioactive materials promulgated under Chapter 3748. of the Revised Code that are authorized by law and will not result in undue hazard to life or property and are otherwise in the public interest.

(H) Each portable gauge licensee shall use a minimum of two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee.

(I)

(1) Authorization under paragraph (I) of rule 3701:1-40-14 of the Administrative Code to produce positron emission tomography (PET) radioactive drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable United States federal drug administration, other federal, and state requirements governing radioactive drugs.

(2) Each licensee authorized under paragraph (I) of rule 3701:1-40-14 of the Administrative Code to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall:

(a) Satisfy the labeling requirements in paragraph (A)(4) of rule 3701:1-46-43 of the Administrative Code for each PET radioactive drug transport radiation shield and each syringe, vial, or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of its consortium.

(b) Possess and use instrumentation to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of its consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in paragraph (C) of rule 3701:1-46-43 of the Administrative Code.

(3) A licensee that is a pharmacy authorized under paragraph (I) of rule 3701:1-40-14 of the Administrative Code to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall require that any individual that prepares PET radioactive drugs shall be:

(a) An authorized nuclear pharmacist that meets the requirements in paragraph (B)(2) of rule 3701:1-46-43 of the Administrative Code, or

(b) An individual under the supervision of an authorized nuclear pharmacist as specified in rule 3701:1-58-14 of the Administrative Code.

(4) A pharmacy, authorized under paragraph (I) of rule 3701:1-40-14 of the Administrative Code to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium that allows an individual to work as an authorized nuclear pharmacist, shall meet the requirements of paragraph (B)(5) of rule 3701:1-46-43 of the Administrative Code.

Effective: 11/14/2013
R.C. 119.032 review dates: 08/29/2013 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05, 3/22/07, 10/4/10

3701:1-40-17 Financial assurance and record keeping for decommissioning.

(A) Prior to the director issuing a radioactive materials license:

(1) Each applicant for a specific license or license renewal authorizing the possession and use of unsealed radioactive material of half-life greater than one hundred twenty days and in quantities exceeding ten thousand times the applicable quantities set forth in appendix A to this rule shall submit a decommissioning funding plan as described in paragraph (D) of this rule. The decommissioning funding plan must also be submitted when a combination of radionuclides is involved if R divided by ten thousand is greater than one, where R is defined here as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to this rule.

(2) Each applicant for a specific license or license renewal authorizing the possession and use of sealed sources or plated foils of half-life greater than one hundred twenty days and in quantities exceeding one trillion times the applicable quantities of appendix A to this rule, shall submit a decommissioning funding plan as described in paragraph (D) of this rule. The decommissioning funding plan must also be submitted when a combination of radionuclides is involved if R divided by one trillion is greater than one, where R is defined here as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to this rule.

(B) Prior to the director issuing a radioactive materials license, each applicant for a specific license or license renewal authorizing possession and use of radioactive material of half-life greater than one hundred twenty days and in quantities specified in paragraph (C) of this rule shall either:

(1) Submit a decommissioning funding plan as described in paragraph (D) of this rule; or

(2) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by paragraph (C) of this rule using one of the methods described in paragraph (E) of this rule. The applicant shall submit to the director, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule.

(C) Prior to the director issuing a radioactive materials license, an applicant providing certification of financial assurance for decommissioning as specified in paragraph (B)(2) of this rule shall provide the certification in a monetary amount based upon the quantity of licensed material specified as follows:

(1) Greater than one thousand but less than or equal to ten thousand times the applicable quantities of appendix A to this rule in unsealed form. For a combination of radionuclides, if R, as defined in paragraph (A) of this rule, divided by one thousand is greater than one but R divided by ten thousand is less than or equal to one, the sum of three hundred thousand dollars.

(2) Greater than ten billion but less than one trillion times the applicable quantities of appendix A to this rule in sealed sources or plated foils. For a combination of radionuclides, if R, as defined in paragraph (A) of this rule, divided by ten billion is greater than one but R divided by one trillion is less than or equal to one, the sum of one hundred fifty thousand dollars.

(D) .

(1) Each decommissioning funding plan must be submitted for review and approval and must contain:

(a) A detailed cost estimate for decommissioning, in an amount reflecting:

(i) The cost of an independent contractor to perform all decommissioning activities;

(ii) The cost of meeting the criteria specified in paragraph (B) of rule 3701:1-38-22 of the Administrative Code for unrestricted use, provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of paragraph (D) of rule 3701:1-38-22 of the Administrative Code, the cost estimate may be based on meeting this criteria;

(iii) The volume of onsite subsurface material containing residual radioactivity that will require remediation to meet the criteria for license termination; and

(iv) An adequate contingency factor.

(b) Identification of and justification for using the key assumptions contained in the decommissioning cost estimate;

(c) A description of the method of assuring funds for decommissioning from paragraph (E) of this rule, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;

(d) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and

(e) A signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).

(2) At the time of license renewal and at intervals not to exceed three years, the decommissioning funding plan must be resubmitted with adjustments as necessary to account for the changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:

(a) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;

(b) Waste inventory increasing above the amount previously estimated;

(c) Waste disposal costs increasing above the amount previously estimated;

(d) Facility modifications;

(e) Changes in authorized possession limits;

(f) Actual remediation costs that exceed the previous cost estimate;

(g) Onsite disposal; and

(h) Use of a settling pond.

(E) Financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, shall be provided by the licensee and approved by the director prior to the issuance of the license and shall be provided by one or more of the following methods:

(1) Prepayment by depositing into an account segregated from licensee assets and outside the licensee's administrative control, cash or liquid assets such that the amount of funds will be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.

(2) Surety, insurance, or other method in accordance with paragraph (F) of this rule, that guarantees that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A guarantee by the applicant or licensee may not be used in combination with any other financial methods used to satisfy the requirements of this paragraph or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company.

(3) A parent company guarantee of funds for decommissioning costs based on a financial test may be used provided that the parent company meets the requirements specified in appendix B of this rule. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this rule.

(4) For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used provided that the guarantee meets the requirements of appendix C to this rule.

(5) For commercial companies that do not issue bonds, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix D to this rule.

(6) For nonprofit colleges, universities, hospitals, or research and development entities, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix E to this rule. The director may require proof of nonprofit status.

(7) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provisions must be as stated in paragraph (E)(2) of this rule.

(8) In the case of state or local government licensee, a statement of intent containing a cost estimate for decommissioning or an amount specified in paragraphs (C)(1) to (C)(3) of this rule, and indicating that funds for decommissioning will be obtained when necessary. As used in this rule, "state or local government licensee" does not include government owned or assisted colleges, universities or hospitals.

(F) Any surety method or insurance used to provide financial assurance for decommissioning shall be in the form of instruments that contain language as provided in appendix F to this rule, and shall contain the following conditions:

(1) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically unless ninety days or more prior to the renewal date, the issuer notifies the director, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the director within thirty days after receipt of notification of cancellation.

(2) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the director. An acceptable trustee includes an appropriate state or federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a federal or state agency.

(3) The surety method or insurance must remain in effect until the director has terminated the license.

(4) The surety company issuing the bond must, at a minimum, be among those listed as acceptable in the most recent version of "Circular 570" of the United States department of the treasury.

(G) A licensee must notify the director by certified mail within ten business days of the commencement of a voluntary or involuntary bankruptcy proceeding under Title 11 of the United States Code. A licensee who fulfills the financial assurance requirements by obtaining a trust fund, surety bond, or other acceptable financial assurance will be deemed to be without the required financial assurance or liability coverage in the event of bankruptcy of the trustee or issuing institution, or a suspension or revocation of the authority of the trustee institution issuing the instrument. The licensee shall establish other financial assurance within sixty days after such an event.

(H) Financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, that is provided by a contract of insurance shall not include any arrangement that constitutes self-insurance. As used in this rule:

(1) "Insurance" means a contract issued or underwritten by an insurance company, insurance service, or insurance organization which is licensed to engage in the business of insurance in Ohio, that binds the insurer to indemnify another against a specified loss in return for premiums paid.

(2) "Self insurance" means a contract of insurance issued either by the licensee or by an insurer affiliated with or an affiliate of the licensee.

(3) "Affiliate of" or "affiliated with" means that the licensee, either directly or indirectly, through one or more intermediaries or subsidiaries, controls, is controlled by, or is under common control with the insurer.

(4) "Control", including "controlled by", and "under common control with" means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting securities, by contract, proxy, membership on the board, or otherwise.

(I) Each person licensed under this chapter, and rule 3701:1-38-02 of the Administrative Code as well as chapters containing rules regarding manufacturing and distribution (Chapter 3701:1-46 of the Administrative Code), industrial radiography (Chapter 3701:1-48 of the Administrative Code), well logging Chapter 3701:1-49 of the Administrative Code), irradiators (Chapter 3701:1-52 of the Administrative Code), and medical use (Chapter 3701:1-58 of the Administrative Code) promulgated pursuant to Chapter 3748. of the Revised Code shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned in accordance with paragraph (B) of rule 3701:1-40-20 of the Administrative Code, a licensee shall transfer all records described in this paragraph to the new licensee, which will be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. As used in this rule, "information important to the decommissioning of a facility" includes the following:

(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved radionuclides, quantities, forms, and concentrations.

(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

(3) Except in the case of an area that contains only a sealed source, provided the source has not leaked or no contamination remains after any leak, or in the case of a byproduct or accelerator produced material having only a half-life of less than sixty-five days, a list contained in a single document and updated every two years, of the following:

(a) All areas designated and formerly designated restricted areas as defined in rule 3701:1-38-01 of the Administrative Code.

(b) All areas outside of restricted areas that require documentation under paragraph (I)(1) of this rule.

(c) All areas outside of restricted areas where current and previous wastes have been buried as documented under rule 3701:1-38-20 of the Administrative Code; and

(d) All areas outside of restricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code, or apply for approval for disposal under rule 3701:1-38-19 of the Administrative Code.

(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.

Click to view Appendix

Click to view Appendix

Click to view Appendix

Effective: 11/14/2013
R.C. 119.032 review dates: 08/29/2013 and 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04 , 3748.11
Prior Effective Dates: 7/22/2001, 8/15/05, 7/7/08, 12/22/08

3701:1-40-18 Expiration or termination of license; decommissioning of sites and separate buildings or outdoor areas.

(A) Each specific license expires at the end of the day on the expiration date stated in the license unless the licensee has filed an application for renewal under rule 3701:1-38-02 of the Administrative Code and this rule not less than ninety days before the expiration date stated in the existing license. Except that a licensee holding a broad scope license shall apply for renewal not less than one hundred eighty days prior to expiration in accordance with paragraph (E) of rule 3701:1-38-02 of the Administrative Code. If an application for renewal has been filed at least ninety days, or in the case of a broad scope license, at least one hundred eighty days prior to the expiration date stated in the existing license, the existing license expires at the later of the end of the day on which the director makes a final determination to deny the renewal application or, if the determination states an expiration date, the expiration date stated in the determination.

(B) Each specific license for the possession of radioactive material that requires a decommissioning plan shall continue in effect and shall be renewed during the decommissioning period, until the director notifies the licensee in writing after decommissioning that the license is terminated. During this time, the licensee shall:

(1) Limit actions involving radioactive material to those related to decommissioning; and

(2) Continue to control entry to any restricted area until that area is suitable for release in accordance with department requirements as may be imposed by rule 3701:1-38-22 of the Administrative Code.

(C) A licensee shall provide written notice to the director within sixty days of the occurrence of any of the following, in accordance with rule 3701:1-40-04 of the Administrative Code:

(1) The license has expired;

(2) The licensee has decided to permanently cease licensed activities at the entire site or in any separate building, room or outdoor area that contains residual radioactivity such that the building, room or outdoor area is unsuitable for release in accordance with the definition of "decommissioning" in Chapter 3748. of the Revised Code and the regulations for decommissioning in rule 3701:1-38-22 of the Administrative Code.

(3) No licensed activities have been conducted for a period of twenty-four months; or

(2) If the procedures and activities necessary to carry out decommissioning of the

(4) No licensed activities have been conducted for a period of twenty-four months in any separate building, room or outdoor area that contains residual radioactivity such that the building, room or outdoor area is unsuitable for release in accordance with rule 3701:1-38-22 of the Administrative Code.

(D) In the event of an occurrence as set forth in paragraph (C) of this rule, the licensee shall either:

(1) Begin decommissioning the site, and any separate building, room or outdoor area that contains residual radioactivity so that the site, building, room and outdoor area are suitable for release in accordance with rule 3701:1-38-22 of the Administrative Code; or

(2) If required by paragraph (G)(1) of this rule, submit within twelve months of notification, a decommissioning plan and begin decommissioning upon the director's approval of that plan.

(E) In addition to written notification of an occurrence, the licensee shall maintain all decommissioning financial assurances established by the licensee pursuant to rule 3701:1-40-17 of the Administrative Code in conjunction with a license issuance or renewal or as required by this rule.

(F) The director may grant a request to extend the twelve-month time period to submit a decommissioning plan established in paragraph (D)(2) of this rule provided that the director determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and that the extension is not detrimental to the public health and safety or the environment and is otherwise in the public interest. The extension request must be submitted no later than thirty days after the occurrence for which notification is required. Decommissioning set forth in paragraph (D)(2) of this rule may not commence until the director has made a determination on the extension request.

(G) The licensee shall submit a decommissioning plan to the director prior to commencing any decommissioning in the following cases:

(1) If required by license condition; or

(2) If the procedures and activities necessary to carry out decommissioning of the site or separate building, room or outdoor area have not been previously approved by the director and these procedures could increase potential health and safety risk to workers or to the public, such as in any of the following cases:

(a) Decommissioning procedures would involve techniques not applied routinely during cleanup or maintenance operations;

(b) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation;

(c) Decommissioning procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or

(d) Decommissioning procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.

(H) A proposed decommissioning plan for a site or separate building, room or outdoor area shall include the following:

(1) A description of the conditions of the site or separate building, room or outdoor area sufficient to evaluate the acceptability of the plan;

(2) A description of planned decommissioning activities;

(3) A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning;

(4) A description of the planned final radiation survey;

(5) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning; and

(6) In the case of a decommissioning plan that results in the licensee completing decommissioning later than twenty-four months after plan approval, the plan shall include a justification for the delay based on the criteria in paragraph (J) of this rule.

The proposed decommissioning plan will be approved by the director if the information therein demonstrates compliance with rule 3701:1-38-22 of the Administrative Code, that the decommissioning will be completed as soon as practicable, and that the health and safety of workers and the public will be adequately protected.

(I) Except as provided in paragraph (J) of this rule, a licensee shall:

(1) Complete decommissioning of the site or separate building or outdoor area as soon as practicable but no later than twenty-four months following the initiation of decommissioning; and

(2) When decommissioning involves the entire site, request license termination as soon as practicable but no later than twenty-four months following the initiation of decommissioning, unless the decommissioning is still actively in progress.

(J) The director may approve a request for an alternative schedule for completion of decommissioning and license termination. In considering whether an alternative schedule is warranted, the director shall consider the following:

(1) Whether it is technically feasible to complete decommissioning within twenty-four months;

(2) Whether sufficient waste disposal capacity is available to allow completion of decommissioning within twenty-four months;

(3) Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay;

(4) Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and

(5) Any other factor that the director finds is unique to the site, such as the regulatory requirements of other government agencies, lawsuits, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.

(K) After decommissioning the site, the licensee shall:

(1) Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed disposition of radioactive materials form provided by the director; and

(2) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning set forth in rule 3701:1-38-22 of the Administrative Code. The licensee shall survey and report as follows:

(a) Levels of gamma radiation in units of millisieverts (microroentgen) per hour at one meter from surfaces and radioactivity, including alpha and beta, in units of megabecquerels (disintegrations per minute or microcuries) per one hundred square centimeters, removable and fixed, for surfaces, megabecquerels (microcuries) per milliliter for water, and becquerels (picocuries) per gram for solids such as soils or concrete; and

(b) Identification of any survey instrument used and a certification that each instrument was properly calibrated and tested prior to being used to measure radioactivity at the site.

(L) Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the director determines that:

(1) Radioactive material has been properly disposed;

(2) Reasonable effort has been made to eliminate residual radioactive contamination, if present;

(3) A radiation survey has been performed which demonstrates that the premises are suitable for release in accordance with the criteria for decommissioning, or other information is submitted by the licensee that is sufficient to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning in this chapter and rule 3701:1-38-22 of the Administrative Code; and

(4) All applicable fees have been paid.

Effective: 09/01/2011
R.C. 119.032 review dates: 05/23/2011 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04 , 3748.11
Prior Effective Dates: 7/22/2001, 8/15/05, 1/29/07

3701:1-40-19 Transfer of radioactive material.

(A) No licensee shall transfer radioactive material except as authorized by this rule.

(B) Except as otherwise provided in the license and subject to the provisions of paragraph (C) of this rule, any licensee may transfer radioactive material:

(1) To the United States department of energy;

(2) To the agency in any agreement state which regulates radioactive material pursuant to an agreement under section 274 of the "Atomic Energy Act", as amended;

(3) To any person exempt from the licensing requirements of the act and regulations in this chapter, to the extent permitted under such exemption;

(4) To any person in an agreement state, subject to the jurisdiction of that state, who has been exempted from the licensing requirements and regulations of that state, to the extent permitted under such exemption;

(5) To any person authorized to receive such radioactive material under terms of a specific license or a general license or their equivalents issued by the United States atomic energy commission, the United States nuclear regulatory commission, or an agreement state; or

(6) As otherwise authorized by the director in writing.

(C) Before transferring radioactive material to an entity specified in paragraph (B) of this rule, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred. The licensee may verify the transferee's authorization to accept the material by possessing one of the following:

(1) A current copy of the transferee's specific license or registration certificate specifying the type, form, and quantity of radioactive material to be transferred;

(2) A written certification by the receiving licensee certifying that the licensee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, and further specifying the license or registration certificate number, issuing agency, and expiration date;

(3) In the case of an emergency shipment, the transferring licensee may accept oral certification by the receiving licensee that the licensee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, and further, specifying the license or registration certificate number, issuing agency and expiration date. The transferring licensee shall obtain written confirmation detailing the oral certification within ten days of the emergency transfer; or

(4) The transferor may obtain other sources of information compiled by a reporting service from official records of the department, United States nuclear regulatory commission, or the licensing agency of an agreement state as to the identity of the receiving licensee, whether the licensee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, and the expiration date of the receiving licensee's license or registration.

Effective: 10/04/2010
R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05

3701:1-40-20 Reporting requirements.

(A) Except as provided in paragraph (D) of this rule, each licensee shall notify the department as soon as possible, but not later than four hours after the discovery of an event that prevents immediate protective action necessary to avoid exposure to radiation or radioactive material that could exceed regulatory limits, or a release of licensed material that could exceed regulatory limits. An event that requires such an immediate report may include a fire, explosion, or toxic gas release.

(B) Each licensee shall notify the department within twenty-four hours after the discovery of any of the following events involving licensed material:

(1) An unplanned contamination event that involves:

(a) Access to the contaminated area, by workers or the public, to be restricted for more than twenty-four hours by imposing additional radiological controls or by prohibiting entry into the area;

(b) A quantity of material greater than five times the lowest annual limit on intake specified in the appendices to rule 3701:1-38-12 of the Administrative Code ; and

(c) Access to the area restricted for a reason other than to allow radionuclides with a half-life of less than twenty-four hours to decay prior to decontamination.

(2) An event in which equipment is disabled or fails to function as designed when:

(a) The equipment is required by regulation or license condition to prevent a release exceeding regulatory limits, to prevent exposure to radiation or radioactive material exceeding regulatory limits, or to mitigate the consequences of an accident;

(b) The equipment is required to be available and operable when it is disabled or fails to function; and

(c) No redundant equipment is available and operable to perform the required safety function.

(3) An event that requires unplanned medical treatment of an individual with spreadable radioactive contamination on the individual's clothing or body.

(4) An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:

(a) The quantity of material involved is greater than five times the lowest annual limit on intake specified in the appendices to rule 3701:1-38-12 of the Administrative Code ; and

(b) The damage affects the integrity of the licensed material or its container.

(C) The licensee shall prepare and submit a report in response to the requirements of this rule as follows:

(1) Licensees shall make reports required by paragraphs (A) and (B) of this rule by telephone, to the department at the telephone number listed in the notice to employees required by paragraph (A)(1)(e) of rule 3701:1-38-10 of the Administrative Code. To the extent that the information is available at the time of notification, the information provided in these reports must include:

(a) The caller's name and call back telephone number;

(b) A description of the event, including date and time;

(c) The exact location of the event;

(d) The radionuclides, quantities, and chemical and physical form of the licensed material involved; and

(e) Any personnel radiation exposure data available.

(2) Each licensee who makes a report required by paragraph (A) or (B) of this rule shall submit a written follow-up report within thirty days of the initial report. Written reports prepared pursuant to other regulations may be submitted to fulfill this requirement if the report contains all of the necessary information and the appropriate distribution is made. These written reports shall be sent to the department in the manner specified in rule 3701:1-40-04 of the Administrative Code. The report must include the following:

(a) A description of the event, including the probable cause and the manufacturer and model number, if applicable, of any equipment that failed or malfunctioned;

(b) The exact location of the event;

(c) The radionuclides, quantities, and chemical and physical form of the licensed material involved;

(d) Date and time of the event;

(e) Corrective actions taken or planned and the results of any evaluations or assessments; and

(f) The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.

(D) This rule applies to all licensees possessing material licensed under rule 3701:1-38-02 of the Administrative Code. This rule does not apply to material under a license subject to the notification requirements in 10 C.F.R. 50.72 , as published in the January 1, 2009, Code of Federal Regulations.

(E) An applicant for a license or a licensee shall notify the department within two working days of information identified by the applicant or licensee as having for the regulated activity, an active adverse impact on equipment or personnel readily obvious by human observation or instrumentation, or a radiological impact on personnel or the environment in excess of regulatory limits. An applicant or licensee violates this paragraph only if the applicant or licensee fails to notify the director of information that the applicant or licensee has or should have identified.

Effective: 10/04/2010
R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05

3701:1-40-21 Records.

(A) Each person who receives radioactive material under a license issued pursuant to the rules in this chapter, and other chapters of the Administrative Code adopted pursuant to Chapter 3748. of the Revised Code, and rule 3701:1-38-02 of the Administrative Code, shall keep records showing the receipt, transfer, and disposal of the radioactive material as follows:

(1) The licensee shall retain each record of receipt of radioactive material as long as the material is possessed and for three years following transfer or disposal of the material.

(2) The licensee who transferred the material shall retain each record of transfer for three years after each transfer unless otherwise specified by rule for that particular licensed activity.

(3) The licensee who disposed of the material shall retain each record of disposal of radioactive material until the director terminates each license that authorizes disposal of the material.

(B) Except as provided in paragraph (C) of this rule, the licensee shall retain each record that is required by this chapter, Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 ofthe Administrative Code, and rule 3701:1-38-02 of the Administrative Code, or by license condition for the period specified by the appropriate regulation or license condition. If a retention period is not otherwise specified by rule or license condition, the record must be retained until the director terminates each license that authorizes the activity that is subject to the record-keeping requirement. Such records may be either the original record or a reproduced copy or microform, provided that such copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by the director. The record also may be stored in electronic media provided that the licensee is capable of producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against record tampering and loss.

(C) In the case of a conflict between a record requirement specified in rule and that requirement specified as a license condition, the licensee shall comply with the license condition.

(D) Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than one hundred twenty days, in an unsealed form, shall forward to the department, records of disposal of radioactive material buried without specific state authority or buried without authorization from the United States nuclear regulatory commission prior to January 28, 1981, pursuant to 10 C.F.R. 20.304.

(E) If licensed activities are transferred or assigned in accordance with paragraph (B) of rule 3701:1-40-19 of the Administrative Code, each licensee authorized to possess radioactive material, with a half-life greater than one hundred twenty days, in an unsealed form, shall transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated:

(1) Records of disposal of licensed material made under rule 3701:1-38-19 of the Administrative Code, including any burial authorized under a United States nuclear regulatory commission license on or before January 28, 1981, or a previous"section 20.304 " permitted burial of a small quantity of licensed material in soil by a United States nuclear regulatory commission licensee on or before January 28, 1981, without specific authorization, in accordance with 10 C.F.R. 20.304 as that section existed on January 1, 1981.

(2) Records required by rule 3701:1-38-20 of the Administrative Code.

(F) Prior to license termination, each licensee shall forward to the department all the records required by paragraph (I) of rule 3701:1-40-17 of the Administrative Code.

Effective: 09/01/2011
R.C. 119.032 review dates: 05/23/2011 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05, 1/29/07

3701:1-40-22 Specific licenses of broad scope.

(A) An application for specific license of broad scope shall be made in accordance with rules 3701:1-38-02 and 3701:1-40-14 of the Administrative Code.

(1) If a current licensee wants to obtain a broad scope license, the application will be considered by the director if the application addresses and meets requirements of this chapter and rule 3701:1-38-02 of the Administrative Code.

(2) Broad scope licensees are not exempt from the notification requirements in paragraph (C) of rule 3701:1-40-18 of the Administrative Code.

(B) A "type A specific license of broad scope", or "type A broad license" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license, for authorized purposes, with quantities usually greater than one curie.

(C) A "type B specific license of broad scope" or "type B broad license" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in column I of the appendix to this rule for authorized purposes. The possession limit for a type B broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in column I of the appendix to this rule. If two or more radionuclides are possessed under a type B broad license, the possession limit for each is calculated as follows:

(1) For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified for that radionuclide in column I of the appendix to this rule.

(2) Add the ratios for all radionuclides possessed under the license. The possession limit is reached when the sum of all ratios exceeds unity.

(D) A "type C specific license of broad scope" or "type C broad license" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in column II of the appendix to this rule, for authorized purposes. The possession limit for a type C broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in column II of the appendix to this rule. If two or more radionuclides are possessed under a type C broad license, the possession limit for each is calculated as follows:

(1) For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified for that radionuclide in column II of the appendix to this rule.

(2) Add the ratios for all radionuclides possessed under the license. The possession limit is reached when the sum of all ratios exceeds unity.

Click to view Appendix

Effective: 10/04/2010
R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04 , 3748.06 , 3748.07
Prior Effective Dates: 7/22/2001, 8/15/05

3701:1-40-23 Requirements for the issuance of a type A specific license of broad scope.

The director shall approve an application for a type A specific license of broad scope provided that the applicant:

(A) Satisfies the general requirements specified in rules 3701:1-38-02 and 3701:1-40-15 of the Administrative Code;

(B) Has engaged in a reasonable number of activities involving the use of radioactive material; and

(C) Has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control, and accounting and management review that are necessary to assure safe operations, including:

(1) The establishment of a radiation safety committee composed of such persons as a radiation safety officer, a representative of management, and persons trained and experienced in the safe use of radioactive materials;

(2) The appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiological safety matters; and

(3) The establishment of appropriate administrative procedures to assure:

(a) Control of procurement and use of radioactive material;

(b) Completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

(c) Review, approval, and recording by the radiation safety committee of safety evaluations of proposed uses prepared in accordance with paragraph (C)(3)(b) of this rule prior to use of the radioactive material.

Effective: 10/04/2010
R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04 , 3748.06 , 3748.07
Prior Effective Dates: 7/22/2001, 8/15/05

3701:1-40-24 Requirements for the issuance of a type B specific license of broad scope.

The director shall approve an application for a type B specific license of broad scope provided that the applicant:

(A) Satisfies the general requirements specified in rules 3701:1-38-02 and 3701:1-40-15 of the Administrative Code; and

(B) Has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to assure safe operations, including:

(1) The appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiological safety matters; and

(2) The establishment of appropriate administrative procedures to assure:

(a) Control of procurement and use of radioactive material;

(b) Completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

(c) Review, approval, and recording by the radiation safety officer of safety evaluations of proposed uses prepared in accordance with paragraph (B)(2)(b) of this rule prior to use of the radioactive material.

Effective: 10/04/2010
R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04 , 3748.06 , 3748.07
Prior Effective Dates: 7/22/2001, 8/15/05

3701:1-40-25 Requirements for the issuance of a type C specific license of broad scope.

The director shall approve an application for a type C specific license of broad scope provided that the applicant:

(A) Satisfies the general requirements specified in rules 3701:1-38-02 and 3701:1-40-15 of the Administrative Code;

(B) The applicant submits a statement that radioactive material will be used only by, or under the direct supervision of, individuals who have received:

(1) A college degree from an accredited institution at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering; and

(2) At least forty hours of training and experience in the safe handling of radioactive materials, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used; and

(C) The applicant has established administrative controls and provisions relating to procurement of radioactive material, procedures, record keeping, material control and accounting, and management review necessary to assure safe operations.

Effective: 10/04/2010
R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04 , 3748.06 , 3748.07
Prior Effective Dates: 7/22/2001, 8/15/05

3701:1-40-26 Conditions of specific licenses of broad scope.

(A) Unless specifically authorized pursuant to other rules of this chapter, persons licensed under rules 3701:1-40-22 to 3701:1-40-25 of the Administrative Code shall not:

(1) Conduct tracer studies in the environment involving direct release of radioactive material;

(2) Receive, acquire, own, possess, use, transfer, or import devices containing three thousand seven hundred terabecquerels (one hundred thousand curies) or more of radioactive material in sealed sources used for irradiation of materials;

(3) Conduct activities for which a specific license issued by the director under this chapter or Chapter 3701:1-46, 3701:1-48, or 3701:1-58 of the Administrative Code is required; or

(4) Add or cause the addition of radioactive material to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being.

(B) Each type A specific license of broad scope issued under this chapter and rule 3701:1-38-02 of the Administrative Code shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety committee.

(C) Each type B specific license of broad scope issued under this chapter and rule 3701:1-38-02 of the Administrative Code shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety officer.

(D) Each type C specific license of broad scope issued under this chapter and rule 3701:1-38-02 of the Administrative Code shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals who satisfy the requirements of rule 3701:1-40-25 of the Administrative Code.

Effective: 10/04/2010
R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04 , 3748.06 , 3748.07
Prior Effective Dates: 7/22/2001, 8/15/05

3701:1-40-27 Exemptions and continued regulatory authority in agreement states and in offshore waters under section 274 of the Atomic Energy Act.

(A) Except as provided in paragraph (B) of this rule, a person who receives, possesses, uses or transfers byproduct material, source, or special nuclear material in Ohio, in quantities not sufficient to form a critical mass is required to obtain a license from Ohio in accordance with Chapter 3748. of the Revised Code, and rule 3701:1-38-02 of the Administrative Code.

(B) The following activities are exempt based on section 3748.21 of the Revised Code since these activities are under United States nuclear regulatory commission jurisdiction:

(1) Activities set forth in 10 C.F.R. 150.15 , as published in the January 1, 2009, Code of Federal Regulations, and any person in offshore waters with respect to byproduct, source, and special nuclear material.

(2) All persons who knowingly provide to any licensee, contractor, or subcontractor, components, equipment, materials, or other goods or services that relate to a licensee's activities, and as such, may be individually subject to enforcement action by the United States nuclear regulatory commission for violation of 10 C.F.R. 30.10, 40.10, and 70.10, as published in the January 1, 2009, Code of Federal Regulations, if applicable, for radioactive material taken or used in a non-agreement state outside of the state of Ohio or within Ohio under exclusive federal jurisdiction.

(3) Any federal government agency as that term is defined in 10 C.F.R. 150.3 , as published in the January 1, 2009, Code of Federal Regulations.

Effective: 10/04/2010
R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04 , 3748.21
Prior Effective Dates: 7/22/2001, 8/15/05

3701:1-40-28 Recognition of agreement state licenses - reciprocity.

(A) Any person who holds a specific license from another agreement state or the United States nuclear regulatory commission and who maintains an office from which the licensee directs the licensed activity and retains radiation safety records, will be granted reciprocity in the state of Ohio to conduct the same licensed activity provided that:

(1) The reciprocity form is current;

(2) The person has not violated Chapter 3748. of the Revised Code or the rules adopted thereunder;

(3) The person applies for reciprocity as outlined in this rule;

(4) The person notifies the department at least three days in advance of each entry into the state after the reciprocity agreement has been granted unless all dates and locations are specified within the agreement document; and

(5) There is no permanent location in Ohio requiring a specific license for radioactive materials.

(B) The United States nuclear regulatory commission retains authority to issue a general license to conduct the same activity in non-agreement states, areas of exclusive federal jurisdiction within agreement states, and offshore waters. The provisions of this paragraph do not apply if the agreement state, or the United States nuclear regulatory commission limits the authorized activity to a specific installation or location not within Ohio.

(C) A person applying for reciprocity in the state of Ohio as specified in paragraph (A) of this rule shall do the following:

(1) At least three days prior to engaging in each activity for the first time in a calendar year, the person shall submit on a form provided by the director, an application for reciprocity to conduct the activity in the state of Ohio, a copy of his or her United States nuclear regulatory commission or agreement state specific license, and the appropriate fee as prescribed in rule 3701:1-38-02 of the Administrative Code. If the person, due to an emergency, is unable to file the submittal three days before engaging in activities under reciprocity, the department may waive the three-day time requirement provided that the licensee:

(a) Informs the department by telephone or facsimile of the information provided on the reciprocity application;

(b) Receives oral or written authorization for the activity from the department; and

(c) Within three days after the notification, files the reciprocity application form, a copy of the United States nuclear regulatory commission or agreement state license, and the appropriate fee.

(2) The person shall file an amended reciprocity form with the appropriate fee with the department to request approval for changes in work locations, radioactive material, or work activities different from the information contained on the initial reciprocity application.

(D) An Ohio reciprocity agreement shall expire on the last day of December of the same year that the reciprocity agreement was issued.

(E) A licensee that is engaging in activities authorized by an Ohio reciprocity agreement shall comply with all terms and conditions of the specific license for which Ohio reciprocity was issued, except for such terms or conditions as are contrary to the requirements of this rule.

(F) No person shall engage in the activities authorized by an Ohio reciprocity agreement for more than one hundred eighty days in any calendar year.

Effective: 10/04/2010
R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05

3701:1-40-29 Funds for reclamation of radioactive material.

(A) The total amount of funds the department collects, pursuant to a license for radioactive material or for any activity that results in the production of such material, for reclamation or long term maintenance and monitoring of such material, shall after November 8, 1981, be transferred to the United States if title and custody of such material and its disposal site is transferred to the United States upon termination of such license. Such funds include, but are not limited to, sums collected for long term surveillance which includes continued site observation, monitoring and, where necessary, maintenance. Such funds do not, however, include monies held as surety where no default has occurred and the reclamation or other bonded activity has been performed.

(B) The payments the department receives for reclamation or long term surveillance must, after November 8, 1981, be sufficient to ensure compliance with those standards established by the United States nuclear regulatory commission pertaining to bonds, sureties, and financial arrangements to ensure adequate reclamation and long term management of such radioactive material and its disposal site.

Effective: 09/01/2011
R.C. 119.032 review dates: 05/23/2011 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04 , 3748.11
Prior Effective Dates: 7/22/2001

3701:1-40-30 Preliminary procedures for environmental review.

(A) The department shall require an environmental report to be submitted with the license application and a bureau assessment report following the department review of the environmental report in the case of any of the following:

(1) The applicant proposes a major action that could potentially affect the environment as it relates to human health;

(2) Any other action which the director determines is a major action which could potentially affect the environment as it relates to human health;

(3) The applicant applies for a license to possess and use source material for uranium milling or production of uranium hexafluoride pursuant to Chapter 3701:1-44 of the Administrative Code;

(4) The applicant applies for a license or renewal authorizing receipt and disposal of radioactive waste from other persons pursuant to Chapter 3701:1-54 of the Administrative Code.

(5) The applicant applies for a license amendment pursuant to Chapter 3701:1-54 of the Administrative Code authorizing either of the following:

(a) Closure of a land disposal site; or

(b) Transfer of the license to the disposal site owner for the purpose of institutional control; or

(6) Notwithstanding paragraph (C) of this rule, and in accordance with paragraph (B) of this rule, the department may, in special circumstances, require the preparation of an environmental report and bureau assessment report on an action that is listed as a categorical exclusion.

(B) Except in special circumstances as determined by the director at his or her discretion, an environmental report and bureau assessment report is not required in the case of an action included in the list of categorical exclusions set forth in paragraph (C) of this rule. Notwithstanding paragraph (C) of this rule, the director, at his or her discretion, may require an environmental report and bureau assessment report if he or she determines that special circumstances exist because the proposed action involves an unreasonable or unnecessary individual or cumulative risk to the human environment.

(C) The following categories of actions are considered categorical exclusions:

(1) Issuance of an amendment to a license for a radioactive material waste disposal site or an amendment to a radioactive materials license if required by Chapter 3701:1-54 of the Administrative Code which are administrative, organizational, or procedural in nature, or which result in a change in process operations or equipment, provided that:

(a) There is no significant change in the type or significant increase in the amount of any effluent that may be released offsite;

(b) There is no significant increase in individual or cumulative occupational radiation exposure;

(c) There is no significant construction impact; and

(d) There is no significant increase in the potential for or consequences from radiological accidents.

(2) Issuance, amendment or renewal of radioactive materials licenses issued pursuant to this chapter and Chapters 3701:1-44, 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, 3701:1-56 and 3701:1-58 ofthe Administrative Code affecting general licenses, manufacture and distribution, industrial radiography, well logging, irradiators, medical use, source material, special nuclear material of less than critical mass authorizing the following:

(a) Distribution of radioactive materials and devices or products containing radioactive material to general licensees and to persons exempt from licensing;

(b) Distribution of radio-pharmaceuticals, generators, reagent kits, or sealed sources to persons licensed in accordance with Chapter 3701:1-58 of the Administrative Code;

(c) Nuclear pharmacies;

(d) Medical and veterinary facilities;

(e) Use of radioactive materials for research and development and for educational purposes;

(f) Industrial radiography;

(g) Irradiators;

(h) Use of sealed sources or gauging devices, analytical instruments or other devices containing sealed sources;

(i) Use of uranium as shielding material in containers or devices;

(j) Possession of radioactive material incident to performing services such as installation, maintenance, leak tests and calibration;

(k) Use of sealed sources or radioactive tracers in well-logging procedures;

(l) Acceptance of packaged radioactive wastes from others for transfer to a licensed disposal facility, provided that the interim storage period for any package does not exceed one hundred eighty days and the total possession limit for all packages held in interim storage at the same time does not exceed 1.85 terabecquerels (fifty curies);

(m) Manufacturing or processing of source, radioactive, special nuclear materials or NARM for distribution to other licensees, except processing of source material for extraction of rare earth and other metals and processing of NARM for extraction of metals;

(n) Nuclear laundries;

(o) Possession, manufacturing, processing, shipment, testing, or other use of depleted uranium military munitions; or

(p) Any use of NARM, source, radioactive, or special nuclear material not listed in paragraphs (C)(2)(a) to (C)(2)(o) of this rule which involves quantities and forms of source, radioactive, or special nuclear material of quantities less than a critical mass, similar to those listed in paragraphs (C)(2)(a) to (C)(2)(o) of this rule.

Effective: 09/01/2011
R.C. 119.032 review dates: 05/23/2011 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05, 10/22/06

3701:1-40-31 Determination to prepare bureau assessment report; eligibility for categorical exclusion.

(A) Before taking a proposed action subject to the provisions of this rule, the department will determine whether the proposed action is of the type listed in paragraph (C) of rule 3701:1-40-30 of this chapter as a categorical exclusion, or whether an environmental report is required and a bureau assessment report will be prepared. A bureau assessment report may be a finding of either no significant impact, or a report that assesses the adverse radiological impact of a proposed facility or action.

(B) Whenever the director determines that a bureau assessment report will be prepared by the department in connection with a proposed action, the department shall develop an action plan and proposed time line. The department shall also do the following:

(1) Publish notice of a public meeting on the proposed license and content of the applicant's environmental report as provided in rule 3701:1-40-37 of thhis chapter.

(2) Provide that the public meeting includes discussion on the proposed environmental report, action plan and time line for the bureau assessment report and provide the outline and deadlines for public comment.

(3) Provide the locations where a copy of the environmental report may be viewed.

(C) In preparing the bureau assessment report, the department shall, to the extent necessary:

(1) Involve any state agency which has jurisdiction or relevant, substantial expertise with respect to any environmental impact involved or which is authorized to develop and enforce relevant environmental standards;

(2) Involve affected federal and local agencies, including those authorized to develop and enforce relevant environmental standards;

(3) Identify other environmental review and consultation requirements related to the proposed action so that other required analyses and studies may be prepared concurrently and integrated with the bureau assessment report;

(4) Indicate the relationship between the timing of the preparation of environmental analyses and the department's tentative planning and decision-making schedule;

(5) Identify any cooperating agencies, and as appropriate, allocate assignments for preparation and schedules for completion of the assessment report to the director and any cooperating agencies;

(6) Describe the means by which the bureau assessment report will be prepared, including any contractor assistance to be used;

(7) Prepare the report, which shall include at least the following:

(a) A discussion of the proposed action;

(b) The need for the proposed action;

(c) Alternatives;

(d) The environmental impact of the proposed action and the alternatives as appropriate; and

(e) A list of agencies and persons consulted, and identification of sources used; and

(8) Provide a concise summary of the determinations and conclusions reached, including the significant issues identified.

(D) At any time prior to issuance of the bureau assessment report, the director may revise the determinations made under paragraphs (B) and (C) of this rule, as appropriate, if substantial changes are made in the proposed action, or if significant new circumstances or information arise which bear on the proposed action or its impacts.

R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05

3701:1-40-32 Finding of no significant impact.

(A) In accordance with paragraph (A) of rule 3701:1-40-31 of the Administrative Code, the department may prepare a bureau assessment report that makes a finding that the proposed action presents no significant radiological impact to the environment as it affects human health. A finding of no significant impact shall:

(1) Identify the proposed action;

(2) State that the department has determined not to prepare a formal bureau assessment report for the proposed action;

(3) Briefly present the reasons why the proposed action will not have a significant adverse radiological impact on the quality of human health or the environment;

(4) Note any other related environmental documents; and

(5) State that the finding and any related environmental documents are available for public inspection and where the documents may be inspected.

(B) As provided in paragraph (C) of this rule, the department may make a determination to prepare and issue a draft finding of no significant impact for public review and comment before making a final determination whether to prepare a bureau assessment report or a final finding of no significant impact on the proposed action. The department may use consultants to prepare a draft or final finding of no significant impact. The cost of any such finding is a part of the licensing or renewal of a facility and shall be paid by the applicant upon receipt of an invoice from the department.

(C) Circumstances in which a draft finding of no significant impact may be prepared may include the following:

(1) A finding of no significant impact appears warranted for the proposed action but the proposed action is closely similar to one which normally requires the preparation of bureau assessment report, or

(2) The proposed action is without precedent.

(D) A draft finding of no significant impact will:

(1) Be marked "draft";

(2) Contain the information specified in paragraph (A) of this rule;

(3) Be accompanied by or include a request for comments on the proposed action and on the draft finding within thirty days, or such longer period as may be specified in the notice of the draft finding; and

(4) Be published in the appropriate newspapers within the state of Ohio as required by paragraph (I) of this rule and rule 3701:1-40-37 of the Administrative Code.

(E) A draft finding of no significant impact shall be distributed as provided for a bureau assessment report in rule 3701:1-40-34 of the Administrative Code.

(F) When a draft finding of no significant impact is issued for a proposed action, a final determination to prepare a bureau assessment report or a final finding of no significant impact for that action shall not be made until the last day of the public comment period has expired.

(G) Except as provided in paragraph (B) of this rule, the finding of no significant impact will be prepared by the department.

(H) The department will conduct a public meeting prior to issuing a final finding of no significant impact. The meeting shall be noticed in accordance with the requirements of rule 3701:1-40-37 of the Administrative Code and shall be held in the county where the proposed facility is located. Whenever the department makes a draft or final finding of no significant impact on a proposed action, the finding will be published as provided for a bureau assessment report in rule 3701:1-40-34 of the Administrative Code.

(I) The department shall not take the proposed action until after the final finding has been published in accordance with the requirements of rule 3701:1-40-37 of the Administrative Code.

Effective: 10/04/2010
R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748-02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05

3701:1-40-33 Environmental report.

(A) Each applicant for a license or license amendment or a renewal of a license that is listed in paragraphs (F)(1) to (F)(5) of this rule, shall submit to the department the application with a separate document entitled "applicant's environmental report" or "supplement to applicant's environmental report" with copies in an amount specified in the appendix to this rule. The applicant's environmental report shall contain the information specified in this rule. If the application is for an amendment to or a renewal of a license for which the applicant has previously submitted an environmental report, the supplement to applicant's environmental report may be limited to incorporating by reference, updating or supplementing the information previously submitted to reflect any significant environmental change, including a change resulting from operational experience or a change in operations or proposed decommissioning activities. If the applicant is a contractor of the United States department of energy that is licensed by the state of Ohio for the possession and use of radioactive materials, the environmental report may be in the form of either an environmental impact statement or an environmental assessment, as appropriate. An applicant may submit a supplement to an environmental report at any time.

(B) The environmental report shall contain a description of the proposed action, a statement of its purposes, a description of the environment affected, and discuss all of the following:

(1) The radiological impact of the proposed action on the environment;

(2) Any adverse radiological environmental effects which cannot be avoided should the proposal be implemented; and

(3) A complete discussion of alternatives in order to aid the department in developing and exploring appropriate alternatives to recommended courses of action. To the extent practicable, the environmental impacts of the proposal and the alternatives should be presented in comparative form.

(C) The environmental report shall include an analysis that considers and balances the environmental effects of the proposed action, the environmental impacts of alternatives to the proposed action, and alternatives available for reducing or avoiding adverse environmental effects as they relate to human health. The analyses for environmental reports shall, to the fullest extent practicable, quantify the various factors considered. To the extent that there are important qualitative considerations or factors that cannot be quantified, those considerations or factors shall be discussed in qualitative terms. The environmental report should contain sufficient data to aid the department in development of an independent analysis.

(D) The environmental report shall list all state of Ohio permits, licenses, approvals and other entitlements which must be obtained in connection with the proposed action and all federal permits, licenses, approvals and other entitlements which must be obtained in connection with the proposed action and shall describe the status of compliance with these requirements. The environmental report shall also include a discussion of the status of compliance with applicable environmental quality standards and requirements including, but not limited to, applicable zoning and land-use regulations, and water pollution limitations or requirements which have been imposed by federal or state agencies having responsibility for environmental protection. The discussion of alternatives in the report shall include a discussion of whether the alternatives will comply with such applicable environmental quality standards and requirements.

(E) The information submitted pursuant to paragraphs (B) to (D) of this rule should not be confined to information supporting the proposed action but shall also include any adverse information.

(F) In accordance with paragraph (A) of this rule, each applicant shall prepare an environmental report for the following types of actions:

(1) Issuance or renewal of a license for:

(a) Possession and use of special nuclear material for processing, scrap recovery, or conversion of uranium hexafluoride pursuant to rules Chapter 3701:1-56 of the Administrative Code.

(b) Possession and use of source material for uranium milling or production of uranium hexafluoride pursuant to Chapter 3701:1-44 ofthe Administrative Code.

(c) Receipt, processing, or disposal of radioactive waste from other persons pursuant to Chapter 3701:1-54 ofthe Administrative Code.

(d) Processing of source material for extraction of rare earth and other metals.

(e) Use of radioactive tracers in field flood studies involving secondary and tertiary oil and gas recovery.

(f) Processing or recycling of NARM that would result in concentration of radioactivity in waste materials in amounts that exceed concentrations provided in Chapter 3701:1-40 of the Administrative Code for the processing or recycling of NARM.

(g) Processing or recycling of soils or materials containing concentrations of source or radioactive material or NARM that exceed concentrations provided in Chapter 3701:1-40 of the Administrative Code relative to disposal.

(2) Issuance of an amendment that would authorize or result in:

(a) A significant expansion of a site;

(b) A significant change in the types of effluents;

(c) A significant increase in the amounts of effluents;

(d) A significant increase in individual or cumulative occupational radiation exposure; or

(e) A significant increase in the potential for or consequences from radiological accidents.

(3) Termination of a license for the possession and use of source material for uranium milling.

(4) Issuance of a license amendment pursuant to Chapter 3701:1-54 ofthe Administrative Code authorizing:

(a) Closure ofa land disposal site;

(b) Transfer of the license to the disposal site owner for the purpose of institutional control; or

(5) Any other licensing action for which the director determines an environmental report is necessary.

(G) Each applicant for issuance of a license for disposal of radioactive waste pursuant to Chapter 3701:1-54 of the Administrative Code shall submit to the department with the application a separate document, entitled "applicant's environmental report - license for disposal of radioactive waste" with copies as specified in the appendix to this rule. The environmental report and any supplement to the environmental report may incorporate by reference information contained in the application or in any previous application, statement or report filed with the director, provided that such references are clear and specific and that copies of the information so incorporated are available at the department and in any public document room established by the director near the proposed disposal site.

(H) The environmental report shall contain the information specified in this rule, shall address the applicant's environmental monitoring program required by Chapter 3701:1-54 of the Administrative Code, and shall be as complete as possible in the light of information that is available at the time the environmental report is submitted.

(I) The applicant shall supplement the environmental report in a timely manner as necessary to permit the department to review, prior to issuance, amendment or renewal of a license, new information regarding the environmental impact of previously proposed activities, information regarding the environmental impact of any changes in previously proposed activities, or any significant new information regarding the environmental impact of closure activities and long-term performance of the disposal site.

(J) Each applicant for a license, or an amendment to, or renewal of a license that pursuant to these rules requires an environmental report shall submit such report or any supplement to an environmental report with the number of copies specified in the appendix to this rule. The applicant shall retain additional copies of the environmental report or any supplement to the environmental report in the number of copies specified for distribution to federal, state, and local officials in accordance with written instructions issued by the director.

Click to view Appendix

Effective: 09/01/2011
R.C. 119.032 review dates: 05/23/2011 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 10/22/06

3701:1-40-34 Bureau assessment report.

(A) The department shall prepare either a draft or final bureau assessment report as soon as practicable after receipt of the applicant's environmental report and after a determination that a finding of no significant impact is not appropriate. The action plan and time line shall address whether a draft assessment report shall be prepared prior to preparation of the final bureau assessment report. To the fullest extent practicable, the bureau assessment report shall be prepared concurrently or integrated with environmental impact analyses and related surveys and studies if required by state or federal law.

(B) The bureau assessment report, and any draft report thereof, shall be concise, clear and analytic, and written in plain language with appropriate graphics. The report shall state how alternatives considered in it and decisions based on it will or will not achieve the requirements of any relevant and applicable environmental laws and policies. The report also shall identify any methodologies used and sources relied upon, and shall be supported by evidence that the necessary environmental analyses have been made.

(C) The director shall cooperate with other relevant state and local agencies and the United States nuclear regulatory commission to the fullest extent possible to reduce duplication between federal, state and local requirements.

(D) To the extent sufficient information is available, the bureau assessment report, and any draft report thereof, shall include consideration of major points of view concerning the environmental impacts of the proposed action and the alternatives, and contain an analysis of significant problems and objections raised by other federal, state, and local agencies and by any comments received from the public.

The bureau assessment report and any draft report thereof, shall include a preliminary analysis that considers and weighs the environmental effects of the proposed action; the environmental impacts of alternatives to the proposed action; and alternatives available for reducing or avoiding adverse environmental effects. The analysis for all bureau assessment reports shall, to the fullest extent practicable, quantify the various factors considered. To the extent that there are important qualitative considerations or factors that cannot be quantified, these considerations or factors shall be discussed in qualitative terms. Due consideration shall be given to compliance with environmental quality standards and requirements that have been imposed by federal or state agencies having responsibility for environmental protection. Satisfaction of department of health standards and criteria pertaining to radiological effects shall be necessary to meet the licensing requirements of Chapter 3748. of the Revised Code. The analysis shall consider the radiological effects of the proposed action and alternatives.

(E) The bureau assessment report, and any draft report thereof, shall list all state and federal permits, licenses, approvals, and other entitlements which must be obtained in implementing the proposed action and shall describe the status of compliance with those requirements. If it is uncertain whether a state or federal permit, license, approval, or other entitlement is necessary, the bureau assessment report shall so indicate.

(F) The bureau assessment report normally shall include a recommendation by the director respecting the proposed action. This recommendation shall be based on the information and analysis described in paragraphs (A) to (E) of this rule and shall be reached after considering the environmental effects of the proposed action and reasonable alternatives.

(G) The department shall prepare a supplement to a bureau assessment report for which a notice of availability has been published if there are substantial changes in the proposed action that are relevant to adverse radiological concerns that bear on the proposed action or its impacts.

(H) The department may prepare a supplement to a bureau assessment report when preparation of a supplement will provide additional information necessary to address concerns related to adverse radiological impact.

(I) The supplement to a bureau assessment report shall be prepared and noticed in the same manner as the bureau assessment report except that additional action plans and time lines need not be used.

(J) Each bureau assessment report, and each supplement to a bureau assessment report distributed in accordance with this rule, and each news release provided pursuant to this rule, shall be accompanied by or include a request for comments on the proposed action and on the bureau assessment report or any supplement to the bureau assessment report and shall state where comments should be submitted and the date on which the comment period closes. A minimum comment period of forty-five days shall be provided. The comment period shall be calculated from the publication date for the notice in the applicable area newspapers. If no comments are provided within the time specified, it will be presumed, unless the applicant requests an extension of time, that the applicant has no comment. To the extent practicable, the department will grant reasonable requests for extensions of time of up to fifteen days. The comment period for any agency is concurrent with the public comment period.

(K) A copy of the bureau assessment report shall be distributed to:

(1) The Ohio environmental protection agency;

(2) Any other state or federal agency which has special expertise or jurisdiction by law with respect to any environmental impact involved or which is authorized to develop and enforce relevant environmental standards;

(3) The applicant;

(4) Appropriate federal, state, and local agencies authorized to develop and enforce relevant environmental standards, land use, and zoning;

(5) Appropriate state, regional and metropolitan clearinghouses; and

(6) Upon request, any other person to the extent available.

(L) A supplement to a bureau assessment report shall be distributed in the same manner as the bureau assessment report to which it relates.

(M) News releases stating the availability for comment and place for obtaining or inspecting a bureau assessment report or supplement will be provided to at least one local newspaper of general circulation in the county where the action is proposed to occur.

(N) A notice of availability shall be published in appropriate area newspapers in accordance with rule 3701:1-40-37 of the Administrative Code.

(O) The director shall not render a decision on a proposed action, including the issuance of a license, or amendment to, or renewal of a license, for which a bureau assessment report is required, until the later of the following dates:

(1) Forty-five days after the department publishes in an appropriate area newspaper, a notice stating that the draft bureau assessment report is available at the department for review.

(2) Thirty days after the department publishes in an appropriate area newspaper, a notice stating that the final bureau assessment report has been completed and is available at the department for review.

If a notice of filing of a final bureau assessment report is published by the department within forty-five days after a notice of a draft bureau assessment report has been published by the department, the minimum thirty-day period and the minimum forty-five-day period may run concurrently to the extent they overlap.

(P) The cost of preparing a bureau assessment report shall be paid by the applicant for the action being requested. The amount shall include the cost of any contractors employed by the department, and staff time involved in the preparation and analysis of the environmental report and the subsequent bureau assessment report.

(Q) The format of the report shall be in accordance with department guidelines for the preparation of a bureau assessment report.

R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22 2001, 8/15/05

3701:1-40-35 Final publishing of bureau assessment report.

(A) The department shall consider comments received pursuant to rules 3701:1-40-34 and 3701:1-40-37 of this chapter and prepare a final bureau assessment report that contains the elements specified in rule 3701:1-40-34 of the Administrative Code.

(B) The final bureau assessment report shall contain all of the following:

(1) A summary of responses to any relevant comments received on the draft bureau assessment report or on any supplement to the draft bureau assessment report;

(2) A discussion of any relevant opposing view not adequately discussed in the draft bureau assessment report or in any supplement to the draft bureau assessment report, and a response to the issues raised;

(3) A statement on how the alternatives considered in it and decisions based on it will or will not achieve the requirements of any relevant and applicable environmental laws and policies; and

(4) A final analysis and a final recommendation on the action to be taken.

(C) If the proposed action has not been taken, the department will prepare a supplement to a final bureau assessment report for which a notice of availability has been published as provided in rule 3701:1-40-37 of the Administrative Code, if:

(1) There are substantial changes in the proposed action that are relevant to environmental concerns; or

(2) There are significant new circumstances or information relevant to environmental concerns and bearing on the proposed action or its impacts.

The supplement shall contain a request for comments as provided in rule 3701:1-40-34 of the Administrative Code, and a notice of availability shall be published in applicable local newspapers as provided in rule 3701:1-40-37 of the Administrative Code. If comments are not requested, a notice of availability of a supplement to a final bureau assessment report shall be published as provided in rule 3701:1-40-37 of the Administrative Code.

(D) The supplement to a final bureau assessment report will be prepared in the same manner as the final bureau assessment report.

(E) A copy of the final bureau assessment report will be distributed to the following:

(1) The Ohio environmental protection agency;

(2) The applicant;

(3) Appropriate federal, state, regional and metropolitan clearinghouses; and

(4) Each person providing comment.

Additional copies will be made available by request to the department.

(F) If the final bureau assessment report is unusually long, or there are so many comments on a draft bureau assessment report or any supplement to a draft bureau assessment report that distribution of the entire final report to all persons providing comments is impracticable, a summary of the final statement and the substantive comments may be distributed.

(G) A supplement to a final bureau assessment report shall be distributed in the same manner as the final bureau assessment report to which it relates.

(H) News releases stating the availability and place for obtaining or inspecting a final bureau assessment report or supplement shall be provided to area newspapers where the proposed action is to occur and other appropriate media.

(I) A notice of availability will be published in accordance with rule 3701:1-40-37 of the Administrative Code.

(J) The final bureau assessment report, together with any comments and any supplement, will accompany the application and be considered in the director's decision-making process. The final bureau assessment report, together with any comments and any supplement, will be made a part of the record of any adjudicatory proceeding resulting from the director's decision.

R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05

3701:1-40-36 Requirement to provide a decision.

(A) If a final bureau assessment report is required, the report shall become part of the director's decision. The decision shall be clearly identified and shall include the following:

(1) A statement of the decision.

(2) Identification of all alternatives considered by the department, a statement that these alternatives were included in the range of alternatives discussed in the bureau assessment report, and a statement specifying any alternative that is considered to be environmentally preferable.

(3) A discussion of preferences among alternatives based on relevant factors including statutory requirements in Chapter 3748. of the Revised Code.

(4) A statement indicating whether the department has taken all practicable measures to avoid or minimize environmental harm from the alternative selected, and if not, to explain why those measures were not adopted. The statement also shall summarize any license conditions and monitoring programs adopted in connection with mitigation measures.

(B) The decision may be integrated into any other record prepared by the department in connection with the action.

(C) The decision may incorporate by reference material contained in a final bureau assessment report. The applicant may appeal a final decision as provided in rule 3701:1-38-06 of the Administrative Code.

R.C. 119.032 review dates: 05/16/2011 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04 , 3748.11
Prior Effective Dates: 7/22/2001

3701:1-40-37 Bureau assessment report; public notice.

(A) As used in this rule, the term "publish" shall mean a printed notice in a newspaper of general circulation in the county where a proposed action or a facility is or is to be located. The department shall invoice the applicant and the applicant shall pay for all costs of publishing notices required by this rule.

(B) In accordance with rule 3701:1-40-31 of this chapter, the department shall publish a notice of intent stating that a bureau assessment report will be prepared. The notice will contain the information specified in paragraph (B) of rule 3701:1-40-31 of this chapter. Copies of the notice will be sent to appropriate federal, state, and local agencies, and appropriate state, regional, and metropolitan clearinghouses.

(C) Upon completion of a draft bureau assessment report or any supplement to a draft bureau assessment report, the department shall publish a notice of availability of the draft report. The notice of availability will request comments on the proposed action and on the draft report or any supplement to the draft report and will specify where comments should be submitted and when the comment period expires. The notice further shall state that copies of the draft report or any supplement to the draft report are available for public inspection at the department along with any comments received from interested persons. Copies of the notice will be sent to appropriate state, regional, and metropolitan clearinghouses, the involved licensee or applicant, and to interested persons upon request.

(D) Upon completion of a final bureau assessment report or any supplement to a final bureau assessment report, the department shall publish a notice of availability of the final report. The notice will state that copies of the final report or any supplement to the final report are available for public inspection and that inspection may be made at the department. Copies of the notice will be sent to appropriate federal, state and local agencies and appropriate state regional, and metropolitan clearinghouses, the involved licensee or applicant, and to interested persons upon request.

(E) In accordance with rule 3701:1-40-32 of this chapter, the department shall publish the finding of no significant impact. The finding of no significant impact will be identified as a draft or final finding, and shall contain the information specified in rule 3701:1-40-32 of this chapter, as appropriate. A draft finding of no significant impact will include a request for comments which specifies where comments should be submitted and when the comment period expires. The finding will state that copies of the finding, the environmental report setting forth the basis for the finding and any related environmental documents are available for public inspection at the department.

(F) A copy of a draft or final finding of no significant impact will be sent to the applicant and to appropriate federal, state, and local agencies and appropriate state, regional, and metropolitan clearinghouses. A copy of the draft finding also shall be sent to each person making comment.

(G) Copies of environmental reports, draft and final bureau assessment reports, bureau assessment report and findings of no significant impact, together with any related comments and environmental documents, will be placed in the department of health, bureau of radiation protection library at 246 North High Street, Columbus, Ohio.

R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05

3701:1-40-38 Public participation process.

(A) The scope of this process applies to the initial licensing, decommissioning, and any major amendment for the following types of facilities: waste disposal, assured isolation storage, waste processing, facilities required to have an emergency response plan pursuant to paragraph (G) of rule 3701:1-40-14 of the Administrative Code . A major amendment consists of proposed changes to a facility or operations within a facility that would impact radiological operations to the extent that an enhancement of radiation dose to the general public may potentially exist.

(B) Notice of complete license application will be given to the public. A public notice of the pending action will be issued in the local newspaper of general circulation in the county where the applicant is located. The contiguous local governments in proximity to the facility in question will be likewise notified. A copy of the public notice will be placed in the depository library closest to the proposed facility. A notice that the bureau has received a complete license application for any facility referenced in paragraph (A) of this rule will be provided to everyone on the mailing list of interested parties and the listserv of the bureau of radiation protection at the conclusion of the completeness review of an application for such a facility. The notice will also be posted on the department's web page for a period of forty-five days. The public may submit comments on the application to the department for consideration during the forty-five day comment period.

(C) A public participation program will be part of this process. The applicant for a facility listed in paragraph (A) of this rule shall be required to include, in any application for a license or major amendment to a license, the information provided to the public and the mechanism for such provision. This information shall be adequate to portray the types of radiological operations on site, the potential dose to the general population in proximity to the site, precautions to be taken to maintain such exposure ALARA, and how any member of the public can obtain additional information.

(D) The director may establish a public meeting process for the types of actions identified in paragraph (A) of this rule, if the director believes that such is needed in order to adequately address issues associated with the application.

(1) The scope of the meeting shall be limited to whether the application complies with applicable provisions of Chapter 3748. of the Revised Code and all applicable rules adopted thereunder.

(a) The department may hold one or more public meetings on the application at the discretion of the bureau of radiation protection.

(b) The department shall provide public notice of the meeting to one newspaper having general circulation in the county of the facility and to the individuals specified in paragraph (B) of this rule, including the availability of guidance.

(c) The department shall develop and provide guidance on the process for participation. Individuals may contact the department to obtain a copy of the guidance in advance of the meeting.

(2) The bureau of radiation protection is responsible for maintaining all records, exhibits, and correspondence submitted or issued in any public meeting. The bureau will maintain these documents on file for the duration of the license.

(3) The director shall designate a facilitator for any public meeting that is held.

(4) In any public meeting the applicant shall be a participant. Any other person may present information, orally or in writing, at the public meeting.

(5) After publication of a notice of public meeting, participants are afforded the opportunity to submit written presentations. If a participant provides a written presentation, the presentation shall describe in detail any deficiency resulting in a regulatory noncompliance in the license application, why such is deficient, and the relief sought.

(6) The facilitator shall allow oral presentations. Oral presentations shall focus on the content requirements specified in paragraph (D)(5) of this rule. Time limits may also be imposed by the facilitator.

(7) The processing of information received by the bureau shall be as follows:

(a) All information received concerning the application shall be considered by the bureau of radiation protection in deliberations for approval or denial of the license application under consideration.

(b) No later than forty-five days after the meeting, the bureau of radiation protection shall issued a written summary of the information presented pursuant to this rule. The report will be available on the department's web page.

(c) Written comments may be submitted to the bureau of radiation protection within two weeks following issuance of a summary report by the bureau of radiation protection on the public meeting.

(8) The applicant for a facility license shall pay all costs associated with the conduct of any public meeting(s) conducted pursuant to this rule. The costs associated with the meeting shall be invoiced at full cost in accordance with paragraph (M) of rule 3701:1-38-02 of the Administrative Code.

Effective: 10/04/2010
R.C. 119.032 review dates: 06/25/2010 and 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.05
Prior Effective Dates: 7/22/2001, 8/15/05

3701:1-40-39 Radioactive drug: capsules containing carbon-14 urea for "in vivo" diagnostic use for humans.

(A) Except as provided in paragraphs (B) and (C) of this rule, any person is exempt from the requirements for a license set forth in this chapter and Chapter 3701:1-58 of the Administrative Code, provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing thirty-seven kilobecquerels (one microcurie) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for "in vivo" diagnostic use for humans.

(B) Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license under Chapter 3701:1-58 of the Administrative Code.

(C) Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license under Chapter 3701:1-46 of the Administrative Code.

(D) Nothing in this rule relieves persons from complying with applicable United States food and drug administration, other federal, and state requirements governing receipt, administration, and use of drugs.

Replaces: 3701:1-40-03

Effective: 10/04/2010
R.C. 119.032 review dates: 06/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02 , 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05