Chapter 3701:1-54 Radiation Generator and Broker Reporting Requirements

3701:1-54-01 Definitions.

As used in Chapter 3701:1-54 of the Administrative Code:

(A) "Above grade construction" for the purposes of a disposal cell for radioactive waste, means the structural design such that the bottom of the waste is at or above the elevation of the native surface topography.

(B) "Active maintenance" as used in reference to an AIF, means any improvements or repairs to the physical features of an AIF that are intended to preserve the ability of the facility to perform its function of isolating radioactive waste.

"Active maintenance" as used in reference to land disposal of radioactive waste, means any significant remedial activity needed during the period of institutional control to maintain a reasonable assurance that the performance objectives are met. Such active maintenance includes, but is not limited to, ongoing activities such as the pumping and treatment of water from a disposal unit or one-time measures such as replacement of a disposal unit cover. Active maintenance does not include custodial activities such as repair of fencing, repair or replacement of monitoring equipment, revegetation, minor additions to soil cover, minor repair of disposal unit covers, and general disposal site upkeep such as mowing grass.

(C) "Assured isolation" means an integrated management system for isolating licensable radioactive waste for a period not to exceed one hundred years, while preserving options for its long term management through robust, accessible facilities, and planned preventative maintenance. The time limit starts from the date that the radioactive waste is received by the AIF.

(D) "Assured isolation facility (AIF)" means the structures and land containing the operational components of a site for the assured isolation of licensable radioactive waste. This includes, but is not limited to, support and administrative facilities, roads and staging areas.

(E) "Assured isolation site" means the entire plot of land on which an AIF is located, including that portion of the earth underlying the facility which is of significance to its structural stability, or is related to the environmental monitoring of the facility.

(F) "Broker" means any person who takes possession of radioactive waste solely for purposes of consolidation and shipment.

(G) "Buffer Zone" means a portion of a site that is controlled by the licensee and that lies under the storage or disposal units and between the structure containing the radioactive waste and the site boundary.

(H) "Carrier" means a person who is engaged in the transportation of radioactive waste by air, rail, road, highway, or water.

(I) "Disposal" or "dispose" means the permanent isolation of radioactive waste in accordance with Chapter 3748. of the Revised Code and the rules promulgated thereunder.

(J) "Disposal site" means that portion of a facility that is used for the disposal of low level radioactive waste and that consists of disposal units and a buffer zone.

(K) "Disposal unit" means a discrete portion of the facility into which low level radioactive waste is placed for disposal.

(L) "Engineered Barrier" means a man made structure or device that us intended to improve a facility's ability to meet the performance objectives.

(M) "Frequent earthquake activity" means more than three earthquakes of greater than Richter magnitude of 4.5, within an epicentral distance of less than 24.2 kilometers (fifteen miles), over a projected interval of one hundred years, based on currently available scientific analyses of the past one hundred years seismicity.

(N) "Generator" means a person who first produces radioactive waste, including, without limitation, any person who does so in the course of or incident to manufacturing, power generation, processing, waste treatment, waste storage, medical diagnosis or treatment, research, or other industrial or commercial activity. "Generator" does not include a patient who may discharge radioactive material in body wastes or fluids as the result of a medical procedure; however, the waste or fluids generated by such a patient are low-level radioactive waste. If the person who first produced an item or quantity of waste cannot be identified, "generator" means the person first possessing the waste who can be identified.

(O) "Inadvertent intruder" means a person who might occupy the disposal site after closure and engage in normal activities, such as agriculture, dwelling, construction, or other pursuits in which the person might be unknowingly exposed to radiation from the waste.

(P) "Inadvertent intrusion" means any activity performed by a person that would unknowingly expose or release radiation from the waste, or compromise barriers designed to meet the performance objectives of the disposal site.

(Q) "Isolation" means the segregation and impoundment of radioactive waste in a manner that protects the environment inhabited by humans, including, but not limited to, the human food chain.

(R) "Karst" means a terrain with an assemblage of landforms such as sinkholes and caves that are due to weathering of predominantly carbonate bedrock.

(S) "Land disposal" means disposal of radioactive waste in a land disposal facility.

(T) "Land disposal facility" means the land, buildings, and equipment that is intended to be used for the disposal of radioactive waste.

(U) "Mixed waste" is radioactive waste that contains a listed hazardous waste or exhibits a hazardous waste characteristic identified in 40 C.F.R. 261, Subpart C, as published in the July 1, 2009 Code of Federal Regulations.

(V) "Monitoring" means activities undertaken by the licensee in evaluating the characteristics or performance of a facility or a site through systematic measurement and analysis of specific parameters.

(W) "Processor" means a person who treats or repackages radioactive material received from another person.

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

(Y) "Recoverable" means the ability to physically collect and remove the waste from its present location.

(Z) "Retrievable" means the ability to remove a container and its contents as a single entity when used in reference to waste storage.

(AA) "Stability" means structural stability.

(BB) "Storage" or "store" means the retention of radioactive waste, prior to disposal in a manner that allows for surveillance, control, and subsequent retrieval.

(CC) "Surveillance" means activities undertaken by the licensee in monitoring and observation of a site for purposes of visual detection of a need for maintenance, custodial care, evidence of intrusion, and compliance with other license and regulatory requirements.

(DD) "Treatment" means any method, technique, or process, including storage for radioactive decay, that changes the physical, chemical, or biological characteristics or composition of any radioactive waste in order to render the waste safer for transport or management, amenable to recovery, convertible to another usable material, or reduced in volume.

(EE) "Waste management" means the storage, treatment, or disposal of radioactive waste.

(FF) "Waste processing" is the act or process of treating radioactive waste.

Effective: 11/28/2010
R.C. 119.032 review dates: 08/20/2010 and 08/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 2/13/1999, 9/15/03, 2/6/06

3701:1-54-02 Generator reporting and fee requirements.

(A) Except as otherwise provided in paragraph (D) of this rule, on or before the thirtieth day of April each year, each generator shall submit to the director, on forms provided by the director at least ninety days prior, an annual report containing the following information for the previous calendar year:

(1) The name, address, and telephone number of the generator, including the name of the person responsible for low-level radioactive waste management;

(2) The types and amounts of low-level radioactive waste generated during the previous calendar year;

(3) The types and amounts of low-level radioactive waste first placed in storage during the previous calendar year, and the types and amounts of wastes remaining in storage from previous calendar years;

(4) The types and amounts of low-level radioactive waste shipped during the previous calendar year, including carrier or broker, and the means of shipment;

(5) A statement indicating whether or not additional low-level radioactive waste was stored or shipped or both and not reported to the director during the previous report period;

(6) A description of the methods used to treat, store, and dispose of low-level radioactive waste;

(7) A description of any actions taken or planned to be taken to reduce the low-level radioactive waste volume or production; and

(8) The types and amounts of low-level radioactive waste expected to be generated or placed in storage during the next calendar year.

(B) Except as otherwise provided in paragraphs (C) and (D) of this rule, within thirty days after the director issues an invoice, all generators shall pay a fee as follows:

(1) At least fifty dollars if any low-level radioactive waste was generated, or three dollars and fifty cents per cubic foot of low-level radioactive waste that was generated during the previous calendar year, whichever is greater, except that for waste generated by a uranium enrichment facility, the generator shall pay seventy-five cents per cubic foot rather than three dollars and fifty cents per cubic foot for such wastes; and

(2) Three dollars and fifty cents per cubic foot of low-level radioactive waste that was stored or held in storage for more than forty-two months, except that for such waste held in storage by a uranium enrichment facility, the generator shall pay seventy-five cents rather than three dollars and fifty cents per cubic foot for such wastes; and

(3) In addition to the minimum charge and the per cubic foot charge provided in paragraphs (B)(1) and (B)(2) of this rule, a generator shall pay a per cubic foot surcharge based on the activity of the waste as classified in rule 3701:1-54-10 of the Administrative Code. There is no surcharge for class A waste. The surcharge for class B waste is an additional fifty per cent of the amount charged under paragraph (B)(1) or (B)(2) of this rule. The per cubic foot surcharge for class C waste is an additional one hundred per cent of the amount charged under paragraph (B)(1) or (B)(2) of this rule.

(C) Notwithstanding paragraph (B) of this rule, if the low-level radioactive waste is high-volume radioactive waste which contains soil, building debris, or rubble typically resulting from decommissioning or decontamination efforts, in an amount containing at least fifty cubic feet, the fee shall be one dollar per cubic yard for such wastes generated during the previous calendar year or for such wastes that have been stored for more than twelve months.

(D) Notwithstanding paragraph (B) of this rule, radioactive waste generated and disposed of in accordance with paragraphs (D) to (G) of rule 3701:1-38-19 of the Administrative Code shall be exempt from the requirements of this rule.

(E) If the low-level radioactive waste is treated by the generator, the fees specified in paragraphs (B) and (C) of this rule shall be determined based on the volume of waste that remains after treatment. The generator shall certify on a form provided by the director the amount of waste that was sent to a processor and the amount of waste sent back to the generator or disposed of on behalf of the generator.

(F) Paragraphs (B) and (C) of this rule shall be applicable to low-level radioactive waste generated or first placed in storage on or after January 1, 1998. The director shall include a notice on each invoice that the generator may appeal the determination of the fees, provided the generator requests a hearing within thirty days of the date of the invoice.

(G) In accordance with division (H) of section 3748.04 of the Revised Code, any fee that remains unpaid on the ninety-first day after the original invoice date shall be assessed an additional amount equal to ten per cent of the original fee.

(H) The director may annually review, at the generator's location, documentation and information that the generator used to prepare the report and the certification required by paragraphs (A) and (E) of this rule. If the director determines that the documentation and information that the generator used to prepare the report is inadequate to determine the accuracy of the report, the director may issue an order pursuant to division (B)(4) of section 3748.05 of the Revised Code to require the generator to amend the report so that the report is accurate.

(I) Any generator shall, upon the request of the director, provide additional information as required.

(J) Reports generated in accordance with this rule must be maintained by the licensee for a period of five years after being submitted to the director.

Effective: 05/20/2013
R.C. 119.032 review dates: 03/05/2013 and 08/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 2/13/1999, 1/24/03, 3/21/08

3701:1-54-03 Assured isolation facility.

(A) This rule covers the licensing of the storage and safe isolation of licensable radioactive waste, and not disposal of such waste as delineated in rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code, over the term of a license prior to disposal in accordance with Chapter 3701:1-38 of the Administrative Code, and other rules promulgated under Chapter 3748. of the Revised Code. The requirements of this rule are in addition to those in Chapters 3701:1-40, 3701:1-44 and 3701:1-56 of the Administrative Code, and other rules pursuant to Chapter 3748. of the Revised Code. The requirements of this rule apply to all generators of radioactive waste, and those that store radioactive waste, as follows:

(1) All of the requirements of this rule apply to an assured isolation facility (AIF) used by more than one licensee to hold radioactive waste for storage or any radioactive waste generator who proposes to store radioactive waste at a location other than their currently licensed facility.

(2) Licensees that continue to hold only their own radioactive waste beyond a five year period at their currently licensed facility shall apply for a license to operate an AIF and must comply with paragraphs (B), (C)(1), (C)(2), (C)(4), (C)(5), (C)(7), (C)(9), (D)(3), (D)(4), and (E) to (N) of this rule. Licensees undergoing license termination in accordance with rules 3701:1-38-22 and 3701:1-40-18 of the Administrative Code, or are undergoing decommissioning under an approved decommissioning plan in place as of the date of this rule, are exempt from the licensing requirements of this rule.

(3) Notwithstanding the requirements of paragraph (A)(2) of this rule, licensees that demonstrate a need to hold their own radioactive waste beyond a five year period at their currently licensed facility may apply for an amendment to the license under which the waste is currently stored. The license amendment will be based on the licensee's needs, but will not permit storage beyond a total of ten years from the date that the waste was generated. The amendment may be approved if the director finds that the licensee (a) provides good cause for the need for the extension, (b) demonstrates that the waste will continue to be safely stored during the extension, and (c) submits a planned schedule for the disposition of the waste.

(B) The performance objectives of an AIF are to:

(1) Protect the environment, the general public, and workers from unnecessary exposures to ionizing radiation.

(2) Keep radioactive material secure from unauthorized access or removal.

(3) Protect the waste and containers from the adverse effects of environmental conditions, including, but not limited to, temperature, humidity, and water.

(4) Use sound engineering designs and prudent procedural practices to maintain doses to workers and the general public, and radionuclide releases to the environment as low as reasonably achievable.

(5) The individual storage containers shall be individually inspectable and readily retrievable.

(C) The contents of a license application shall provide sufficient information on the AIF, its operators, and the types of waste held, to provide reasonable assurance that the performance objectives will be met. As a minimum, the applicant shall do the following:

(1) Submit a license application pursuant to Chapter 3701:1-40 of the Administrative Code.

(2) Provide a description of the licensed operating activities requested, including, but not limited to:

(a) The location of the proposed site;

(b) The licensed activities involving the transportation, storage, and handling of radioactive waste;

(c) The types, chemical and/or physical forms and quantities of radioactive waste to be received, possessed, and stored;

(d) The proposed time schedules for construction and receipt of radioactive waste at the proposed AIF; and

(e) The estimated maximum amount of radioactive waste to be stored, both in terms of volume and activity, by radionuclide.

(3) Describe the site suitability for storage of licensed radioactive materials for each of the following categories.

(a) Describe and justify the location of the AIF in terms of land use. Include in the description the nearby structures present, local land usage, local populations, public facilities, local roads and traffic.

(b) Define the characteristics of the site by identifying and describing applicable portions of paragraph (D)(1) of this rule.

(c) Provide a description of the site radiological environmental monitoring program to meet the criteria in paragraph (I) of this rule. Include baseline information for the data to be collected.

(d) Provide an environmental assessment report required by Chapter 3701:1-40 of the Administrative Code.

(4) Provide a complete description of the AIF, including drawings, to meet the applicable criteria of paragraphs (D) and (E) of this rule.

(5) Submit details on the operation of the AIF covering the topics listed in paragraph (F) of this rule.

(6) Provide a description of the community awareness and communication program to be used.

(a) Identify the means of communication, types of information to be provided, and when the information will be provided to:

(i) Notify the community of the proposed operation and licensing; and

(ii) Maintain community input on operational status, operational changes, and off-site emergency response capacity.

(b) Identify how the effectiveness of the communications will be monitored and ensured.

(7) Submit any applicable decommissioning funding plan and financial assurance in accordance with Chapter 3701:1-40, Chapter 3701:1-44 or Chapter 3701:1-56 of the Administrative Code.

(8) Submit an emergency response plan in accordance with Chapter 3701:1-40 of the Administrative Code.

(9) Submit the quality assurance program used in accordance with rule 3701:1-54-04 of the Administrative Code to ensure that the maintenance and operation of the AIF meets the performance objectives, is consistent with the contents of the license application, and satisfies the requirements for the receipt, handling, emplacement and retrieval of waste in this rule.

(D) The design of an AIF shall provide reasonable assurance that the radioactive waste will maintain its integrity and remain isolated from the environment as intended.

(1) The overall hydrogeologic environment of the site, in combination with engineering design, shall act to minimize and control potential radioactive waste migration into surface water and ground water in the event of an accidental release. Identification and consideration of the hydrogeologic environment shall include, but is not limited to:

(a) Upstream drainage features such as the potential for frequent ponding and slope stability;

(b) Characteristics of nearby rivers, streams, wetlands, or other bodies of water;

(c) Distance to, and nature of, the water table and aquifer;

(d) Analysis of earthquake potential or other land movement and its consequences;

(e) The proximity to creeks or culverts; and

(f) Soil types under the AIF with respect to compatibility with the foundation and structural design.

(2) No new AIF shall be located:

(a) In a one-hundred year flood plain or a wetland; or

(b) In the recharge area of a sole source aquifer unless it can be demonstrated with reasonable assurance the new AIF will be designed, constructed, operated, and decommissioned without an unreasonable risk to the aquifer.

(3) The AIF shall be constructed as designed to:

(a) Safely handle and store the waste commensurate with the characteristics of the waste;

(b) Aid in fire suppression, provide filtered air ventilation, maintain environmental controls, and to the extent possible be constructed of nonflammable building materials;

(c) Store waste such that each individual waste container is readily retrievable and inspectable; and

(d) Be made of materials, and use methods, considered to ease future decontamination and decommissioning efforts.

(4) The AIF shall include design features to aid in keeping the radioactive waste isolated. The design features must:

(a) Minimize water infiltration and prevent any waste container from contact with water.

(b) Preserve the structural integrity of each waste container.

(c) Ensure that the site drainage and slope stability preserves the integrity of the AIF's foundation.

(d) Ensure that the AIF shall meet the standards prescribed in ASCE/SEI 7- 10 "Minimum Design Loads for Buildings and Other Structures" for a Category II facility as defined in the standard. This publication may be purchased from the "American Society of Civil Engineers, 1801 Alexander Bell Drive, Reston, Virginia 20191-4400, telephone (800) 548-2723," or this publication can be viewed at "the Bureau of Radiation Protection library, 246 N. High Street Columbus, Ohio 43215." Facilities that will have containers exceeding a Type A Quantity of radioactive material in normal form, as defined in Chapter 3701:1-50 of the Administrative Code, must meet the criteria for a category III facility as defined in the standard.

(e) Minimize occupational and non-occupational exposures.

(f) Provide for site and effluent monitoring as appropriate for the AIF.

(g) Ensure that buildings and areas used for the storage of radioactive wastes shall have appropriate ventilation and fire protection systems to minimize the release of radioactive materials into the soil, water, or atmosphere.

(h) Provide facilities and equipment for repackaging leaking or damaged containers.

(i) Ensure that the design and operation of the radioactive waste storage area shall be such that radiation levels, concentrations, and potential exposures due to airborne releases during operations are within the limits specified in Chapter 3701:1-38 of the Administrative Code and are maintained as low as reasonably achievable ( ALARA).

(j) Ensure that the design and operation of the AIF shall be compatible with the objectives of the decommissioning funding plan for the AIF.

(k) Ensure that the AIF shall be designed to confine spills. Independent and diverse engineering barriers shall be provided as necessary to minimize potential releases from the AIF.

(E) The applicant shall provide a description of the site and accurate drawings of the AIF. The descriptions shall address the following features, and any design features used in support of the performance objectives:

(1) Describe the ventilation system and how it will ensure adequate environmental controls of the storage area, including, but not limited to, heating, cooling, and humidity. Describe any applicable exhaust air filtration used.

(2) Describe the fire protection and suppression system to minimize the likelihood and extent of fire.

(3) Describe any plumbing, pipes, and/or wiring that goes through the storage or handling areas.

(4) Describe the physical security of the radioactive waste areas and the AIF. Include how acts of sabotage or deliberate attacks, and the consequences thereof, will be minimized.

(5) Identify radioactive waste storage areas, demonstrating where radioactive waste will be stored and how radioactive waste containers will be accessible for routine inspections.

(6) Describe the locations of radioactive waste handling areas, air sampling stations, effluent filters and any sources of flammable or explosive material.

(7) Provide a description and accurate drawing of any required special handling equipment to be employed.

(8) Describe the equipment installed to maintain control over the maximum concentrations of radioactive materials in gaseous and liquid effluents produced during normal operation and the means employed to keep levels of radioactive material in effluents to unrestricted areas ALARA.

(9) Describe the building codes and standards applied to the design and construction of the AIF.

(10) Describe the AIF construction, including, but not limited to, the building materials and method of construction. Submit copies of required building and zoning permits.

(11) Describe the activity, volume, classification and specifications of the radioactive material to be received, possessed, and stored at the AIF.

(F) The applicant shall describe the operations of the AIF in accordance with the radioactive waste procedures to meet the performance objectives.

(1) Describe the procedures to secure radioactive materials from unauthorized access and removal, including the control of access to the AIF. Include how acts of sabotage or deliberate attacks, and the consequences thereof, will be minimized.

(2) The commingling of radioactive wastes from different generators into a single waste container is prohibited. Describe the procedures used to verify this requirement is met.

(3) Describe the radiation safety program for control and monitoring of radioactive effluents to ensure compliance with the occupational radiation exposure limits, and to control contamination of personnel, vehicles, equipment, buildings, and the AIF. Routine operations, inadvertent releases, and accidents must be addressed. The program description must include procedures, instrumentation, facilities, and equipment.

(4) Submit the procedures for receipt and acceptance of waste packages. The procedures shall include examination of shipping documents, visual check of waste package, survey for removable contamination and external radiation level, identification of packages requiring remediation, corrective actions, and disposition of unacceptable packages.

(5) Describe the program for safe placement and inspection of waste in storage and maintaining occupational exposures ALARA. The program should include periodic radiation and contamination surveys of individual packages and the storage area in general, as well as posting the storage area.

(6) Describe the system for maintaining accurate records of radioactive materials and a current inventory of radioactive waste.

(7) Characterize the radioactive waste to be stored in terms of:

(a) Volume of waste by class A, B, or C as defined in rule 3701:1-54-10 of the Administrative Code; and

(b) Physical form of the waste: solid, liquid, or gas.

(8) The AIF operator shall describe:

(a) The packages or containers to be used for storage of radioactive waste, any hazards the waste may pose to the packaging integrity, and the projected storage life of the packaging or containers;

(b) The program for periodic inspections of radioactive waste packages to ensure that they retain their integrity and containment of radioactive waste; and

(c) The procedures and equipment used for remote handling and repackaging damaged or leaking waste containers.

(9) Provide the following descriptions of the equipment and procedures:

(a) Provide a flow diagram of radioactive waste receipt and storage operations.

(b) Describe the equipment and procedures used to maintain control over on-site exposures to and releases of radioactive material. Include monitoring methods, containment mechanisms, accident mitigation methods and procedures, and the corrective action process used when deviations are discovered.

(c) Describe the spill detection equipment and cleanup plans for the site and associated transportation of radioactive material.

(10) Provide a description of the site radiological environmental monitoring program to meet the criteria in paragraph (I) of this rule. Include baseline information for the data to be collected.

(11) Provide a description of the personnel training and retraining program.

(12) Each licensee shall have emergency response procedures for radionuclide incidents.

(a) If an emergency response plan is required in paragraph (C)(8) of this rule, the applicant shall provide all offsite emergency response organizations that would respond in the event of an accident a copy of the plan and allow sixty days to comment on the applicant's emergency response plan prior to submitting the plan to the director.

(b) The applicant shall submit copies of any comments received during the comment period to the director with the emergency response plan.

(13) Describe the system for maintaining inventory of receipt, storage, and transfer of radioactive waste.

(14) Describe the disposition of radioactive material and the AIF upon termination of the license.

(G) To meet the radiation safety requirements the following must be met:

(1) The safety manual shall include a description of personnel monitoring methods, training and procedures to be followed to prevent employees from ingesting or inhaling radioactive materials, and methods to keep radiation exposures ALARA;

(2) The operating manual shall include procedures to protect the integrity of the waste and waste containers during normal handling and storage conditions, and shipping radioactive materials;

(3) An emergency response manual shall include procedures to address likely minor and major accident conditions, incident response command structures, and a description of procedures for responding to emergencies, including notification of and coordination with local fire, police and medical departments;

(4) The radiation safety program shall incorporate the requirements of Chapters 3701:1-38 and 3701:1-40 of the Administrative Code, and include topics on the ALARA policy, radiation safety procedures, training, ventilation systems, air sampling, contamination control, internal exposure control and assessments, external exposure control, and instrumentation used; and

(5) The applicant shall describe the program for training personnel in procedures for packaging, handling, placement, inspection, surveying and emergency response for radioactive waste storage and transportation.

(H) Radioactive waste and materials are to be transported, handled, and stored in a safe manner to meet the performance objectives in paragraph (B) of this rule.

(1) Radioactive waste shall contain only class A, B, or C waste, determined by radionuclide activity and concentration, as provided in rule 3701:1-54-10 of the Administrative Code.

(2) Radioactive waste shall meet the waste characteristics of rule 3701:1-54-10 of the Administrative Code.

(3) No individual waste container dose rate shall exceed one-tenth mSv/hr (ten mrem/hr) at one meter or two mSv/hr (two hundred mrem/hr) on the surface.

(4) The radioactive waste shall be secured from unauthorized access and removal by individuals, and maintained to prevent unintentional releases to the environment.

(I) A radiological environmental monitoring program shall be developed and used to measure and monitor radionuclides in all pathways to individuals and the general public from licensed radiological operations. All applicants shall:

(1) Describe the environmental monitoring program to provide data to evaluate potential health and environmental impacts in support of the performance objectives.

(2) Describe the action levels of radionuclides in the environment that will initiate an investigation or corrective action.

(3) Describe the plan for additional monitoring in the event of an unintentional release of radionuclides.

(J) Records and reports shall be developed and maintained in accordance with Chapters 3701:1-38, 3701:1-40, and other chapters of the Administrative Code promulgated pursuant to Chapter 3748. of the Revised Code, and the following:

(1) The licensee shall prepare and send statements to each generator of their own waste status, including but not limited to volume, radionuclides, activity, waste container condition, regarding prior year inventory balances, additions and withdrawals of waste from the AIF, and final inventory balance. Both the licensee and the generator shall retain copies of these reports for three years.

(2) The licensee shall prepare and send an annual summary report to the director and publish a local notice of the report's availability to the public. The report shall include, at a minimum, a summary of waste in the AIF (prior year inventory balances, additions, withdrawals, and final balances), capacity utilization (volume and radionuclide license limits), incidents, environmental monitoring results, radionuclide releases to the environment, and a fiscal annual report. The licensee shall retain copies of these reports until the license has been terminated.

(3) The annual report to the generators and the annual summary report shall be completed and submitted to the director within sixty days after the end of the calendar year.

(K) The institutional requirements include:

(1) The radioactive materials will remain under active licensee control throughout the term of the license so that the licensee performs an environmental monitoring program, maintains surveillance and custodial care of the radioactive materials and the facility, and satisfies other requirements as determined by the director.

(2) The generator of the radioactive waste shall retain title to the waste.

(3) The generator is responsible for the radioactive waste as shipped, including but not limited to the original containers and contents delivered, waste form, and radionuclide identification and quantification. The AIF operator is responsible for the waste handling and storage conditions after acceptance of the waste until its ultimate disposition.

(4) Each generator shall issue an irrevocable trust to the AIF operator to cover the cost of disposal in the event that the generator becomes bankrupt. The AIF operator must submit a copy of each trust agreement to the director. Each trust shall be reviewed and updated every five years.

(L) Financial assurance, decommissioning, and license termination requirements include:

(1) The licensee shall meet the applicable financial assurance and decommissioning requirements for unrestricted release in rules 3701:1-38-22 and 3701:1-40-17 of the Administrative Code.

(2) The AIF shall return radioactive materials to the generator or generator's designee upon the AIF's failure to renew a license or prior to license termination.

(3) In the event that the AIF cannot meet the financial assurance requirements as determined by the director, the waste held must be returned to the generators or their designees within ninety days after determination that the licensee financial assurance cannot be met.

(M) The limitations placed on an AIF include:

(1) Each license will place limitations on the aggregate radioactive waste volume as well as radionuclide quantities.

(2) An AIF license shall be renewed in accordance with Chapter 3701:1-40 of the Administrative Code. During the license renewal process, an existing licensed AIF shall verify compliance with the originally licensed structural design for the originally licensed usage. Any changes from the originally licensed usage or structural design will require a reevaluation of the entire AIF based on current standards.

(3) All users of the AIF shall contractually agree to the return of the radioactive waste to the generator, or transfer to the generator's designee licensed to receive such waste, at the end of the radioactive material storage, which may not exceed one hundred years from the time of the receipt of the waste.

(N) Commencement of construction prior to the director issuing a license or renewal for the AIF is at the economic risk of the applicant.

Effective: 04/15/2013
R.C. 119.032 review dates: 11/30/2012 and 08/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 9/15/2003, 3/21/08

3701:1-54-04 Quality assurance.

(A) The purpose of this rule is to set quality assurance requirements for facilities licensed under Chapter 3701:1-54 of the Administrative Code. The quality assurance requirements of a licensee apply to the design, operation, and decommissioning, of a facility for items and activities that are important to safety. The quality assurance program must include the following elements: the design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, modification of structures, systems, and components, that are important to safety. The quality assurance requirements also apply to the operational procedures for ensuring compliance with safety requirements.

(B) The quality assurance functions are to:

(1) Ensure that an appropriate quality assurance program is established and effectively executed;

(2) Verify, by procedures such as checking, auditing, and inspection, that activities affecting the functions that are important to safety have been correctly performed; and

(3) Ensure that the persons and organizations performing quality assurance functions have sufficient authority and organizational freedom to identify quality problems; to initiate, recommend, or provide solutions; and to verify implementation of solutions.

(C) The licensee, or applicant for a license, shall be responsible for the establishment and execution of the quality assurance program. The licensee may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, but the licensee shall retain responsibility for the program. The licensee, or applicant for a license, shall clearly establish and delineate in writing the authority and duties of persons and organizations performing activities affecting the functions and structures, systems, and components, which are important to safety. These activities include performing the functions associated with attaining quality objectives and the quality assurance functions.

(D) A quality assurance program shall meet the following:

(1) The licensee, or applicant for a license, shall document the quality assurance program by written procedures or instructions and shall carry out the program in accordance with these procedures throughout the period during which the facility is licensed. The licensee, or applicant for a license, shall identify the structures, systems, and components to be covered by the quality assurance program, the major organizations participating in the program, and the designated functions of these organizations.

(2) The licensee, or applicant for a license, through their quality assurance programs, shall provide control over activities affecting the quality of the identified structures, systems, and components to an extent commensurate with the importance to safety and, as necessary, to ensure conformance with the approved design of each facility.

(3) The licensee, or applicant for a license, shall base the requirements and procedures of their quality assurance program(s) on the following considerations concerning the complexity and proposed use of the structures, systems, or components:

(a) The impact of malfunction or failure of the item on safety;

(b) The design and fabrication complexity or uniqueness of the item;

(c) The need for special controls and surveillance over processes and equipment;

(d) The degree to which functional compliance can be demonstrated by inspection or test; and

(e) The quality history and degree of standardization of the item.

(4) The licensee, or applicant for a license, shall provide for indoctrination and training of personnel performing activities affecting quality as necessary to ensure that suitable proficiency is achieved and maintained.

(5) The licensee, or applicant for a license, shall review the status and adequacy of the quality assurance program at established intervals. Management of other organizations participating in the quality assurance program must regularly review the status and adequacy of that part of the quality assurance program that they are executing.

(6) The persons and organizations performing quality assurance functions shall report to a management level that ensures that the required authority and organizational freedom, including sufficient independence from cost and schedule considerations when these considerations are opposed to safety considerations, are provided. The individual(s) assigned the responsibility for assuring effective execution of any portion of the quality assurance program, at any location where activities subject to this section are being performed, must have direct authority, freedom, and access to the levels of management necessary to perform this function.

(E) A quality assurance program shall establish measures to ensure that applicable regulatory requirements and the design basis, as specified in the license application for those structures, systems, and components to which this chapter applies, are correctly translated into specifications, drawings, procedures, and instructions. These measures must include provisions to ensure that appropriate quality standards are specified and included in design documents and that deviations from standards are controlled. Measures must be established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the functions of the structures, systems, and components which are important to safety.

(F) A quality assurance program shall establish requirements for:

(1) Procurement document control by establishing measures to assure that applicable regulatory requirements, design bases, and other requirements which are necessary to assure adequate quality or safety are included or referenced in the documents for procurement of material, equipment, and services, whether purchased by the licensee, or by the licensee's contractors or subcontractors. To the extent necessary, the licensee, or applicant for a license, shall require contractors or subcontractors to provide a quality assurance program consistent with the applicable provisions of this rule.

(2) Instructions, procedures and drawings prescribing activities affecting quality or safety by documented instructions, procedures, or drawings of a type appropriate to the circumstances and shall require that these instructions, procedures, and drawings be followed. The instructions, procedures, and drawings must include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished.

(3) Document control by establishing measures to control the issuance of documents such as instructions, procedures, and drawings, including changes, which prescribe all activities affecting quality or safety. These measures must assure that documents, including changes, are reviewed for adequacy, approved for release by authorized personnel, and distributed and used at the location where the prescribed activity is performed. These measures must ensure that changes to documents are reviewed and approved.

(4) Control of purchased material, equipment, and services requirements:

(a) Establishing measures to ensure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents. These measures must include provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery;

(b) The licensee, or applicant for a license, shall have available documentary evidence that material and equipment conform to the procurement specifications prior to installation or use of the material and equipment. The licensee shall retain or have available this documentary evidence for the life of the facility. The licensee shall ensure that the evidence is sufficient to identify the specific requirements met by the purchased material and equipment; and

(c) The licensee, or applicant for a license, or a designee of either, shall assess the effectiveness of the control of quality by contractors and subcontractors at intervals consistent with the importance, complexity, and quantity of the product or services.

(5) Identification and control of materials, parts, and components by establishing measures for the identification and control of materials, parts, and components. These measures must ensure that identification of the item is maintained either on the item or on records traceable to the item as required, throughout fabrication, installation, and use of the item. These identification and control measures must be designed to prevent the use of incorrect or defective materials, parts, and components.

(6) Control of special processes by establishing measures to ensure that special processes are controlled and accomplished by qualified personnel using qualified procedures in accordance with applicable codes, standards, specifications, criteria, and other special requirements.

(7) Licensee inspection by establishing and executing a program for inspection of quality or safety related activities by or for the organization performing the activity to verify conformance with the documented instructions, procedures, and drawings for accomplishing the activity. Individuals other than those who performed the activity being inspected must perform the inspection. Examinations, measurements, or tests of material or products processed must be performed for each work operation where necessary to assure quality. If direct inspection of processed material or products cannot be carried out, indirect control by monitoring processing methods, equipment, and personnel must be provided. Both inspection and process monitoring must be provided when quality control is inadequate without both.

(8) Test control by establishing a test program to ensure that all testing, required to demonstrate that the structures, systems, and components will perform satisfactorily in service, is identified and performed in accordance with written test procedures that incorporate the requirements of this chapter and the requirements and acceptance limits contained in the facility. The test procedures must include provisions to ensure that all prerequisites for the given test are met, that adequate test instrumentation is available and used, and that the test is performed under suitable environmental conditions. The licensee, or applicant for a license, shall document and evaluate the test results to ensure that test requirements have been satisfied.

(9) Control of measuring and test equipment requirements, the licensee, or applicant for a license, shall establish measures to ensure that tools, gauges, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified periods to maintain accuracy within necessary limits.

(10) Handling, storage and shipping control by establishing measures to control, in accordance with work and inspection instructions, the handling, storage, shipping, cleaning, and preservation of materials and equipment to prevent damage or deterioration.

(11) Inspection, test and operating status:

(a) Establish measures to indicate, by the use of markings such as stamps, tags, labels, routing cards, or other suitable means, the status of inspections and tests performed upon individual items of the facility. These measures must provide for the identification of items that have satisfactorily passed required inspections and tests where necessary to preclude inadvertent bypassing of the inspections and tests.

(b) Establish measures to identify the operating status of structures, systems, and components of the facility, such as tagging valves and switches, to prevent inadvertent operation.

(12) Nonconforming materials, parts and components by establishing measures to control materials, parts, or components that do not conform to their requirements in order to prevent their inadvertent use or installation. These measures must include, as appropriate, procedures for identification, documentation, segregation, disposition, and notification to affected organizations. Nonconforming items must be reviewed and accepted, rejected, repaired, or reworked in accordance with documented procedures.

(13) Corrective action by establishing measures to ensure that conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations, defective material and equipment, and nonconformances, are promptly identified and corrected. In the case of a significant condition identified as adverse to quality, the measures must ensure that the cause of the condition is determined and corrective action is taken to preclude repetition. The identification of the significant condition adverse to quality, the cause of the condition, and the corrective action taken must be documented and reported to appropriate levels of management.

(14) Record keeping requirements, the licensee, or applicant for a license, shall maintain sufficient records to furnish evidence of activities affecting quality. The records must include the following: design records, records of use, and the results of reviews, inspections, tests, audits, monitoring of work performance, and materials analyses. The records must include closely related data such as qualifications of personnel, procedures, and equipment. Inspection and test records must, at a minimum, identify the inspector or data recorder, the type of observation, the results, the acceptability, and the action taken in connection with any noted deficiencies. Records must be identifiable and retrievable. Records pertaining to the design, fabrication, erection, facility as built diagrams, testing, maintenance, and use of structures, systems, and components important to safety must be maintained by or under the control of the licensee until the director terminates the license.

(15) Auditing requirements by conducting a comprehensive system of planned and periodic audits to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program. The audits must be performed in accordance with written procedures or checklists by appropriately trained personnel not having direct responsibilities in the areas being audited. Audited results must be documented and reviewed by management having responsibility in the area audited. Follow-up action, including reaudit of deficient areas, must be taken where indicated.

(16) Measures for the identification and control of design interfaces and for coordination among participating design organizations. These measures must include the establishment of written procedures among participating design organizations for the review, approval, release, distribution, and revision of documents involving design interfaces. The design control measures must provide for verifying or checking the adequacy of the design.

(a) For verifying or checking processes, the licensee shall designate individuals or groups other than those who were responsible for the original design, but who may be from the same organization.

(b) Where a test program is used to verify the adequacy of a specific design feature in lieu of other verifying or checking the processes, the licensee shall include suitable qualification testing of a prototype or sample unit under the most adverse testing condition.

(c) The licensee, or applicant for a license, shall subject design changes, including field changes, to design control measures commensurate with those applied to the original design. Changes in the conditions specified in the license requires prior approval by the director.

Effective: 04/15/2013
R.C. 119.032 review dates: 11/30/2012 and 08/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 9/15/2003, 3/21/08

3701:1-54-05 Radioactive waste processing.

(A) This rule covers the licensing of radioactive waste processors. The requirements of this rule are in addition to those in Chapters 3701:1-40, 3701:1-44 and 3701:1-56 of the Administrative Code, and other rules pursuant to Chapter 3748. of the Revised Code.

(B) The performance objectives for a radioactive waste processing facility are to:

(1) Protect the environment, the general public, and workers from unnecessary exposures to ionizing radiation and radionuclide releases exceeding the limits and constraints delineated in Chapter 3701:1-38 of the Administrative Code;

(2) Keep radioactive material secure from unauthorized access or removal; and

(3) Use sound engineering designs and prudent procedural practices to maintain doses to workers and the general public and radionuclide releases to the environment as low as reasonably achievable ( ALARA).

(C) A facility is exempt from the licensing requirements of this rule to process radioactive waste if:

(1) The facility, in accordance with a specific license, processes only its own radioactive waste;

(2) Site decommissioning activities are conducted on-site in accordance with a specific license; or

(3) The facility is not required to have a decommissioning funding plan pursuant to rule 3701:1-40-17 of the Administrative Code.

(D) The application for a radioactive waste processing facility shall provide sufficient information on the facility and its operators, and the types of waste processed, to provide reasonable assurance that the performance objectives in paragraph (B) of this rule will be met. As a minimum, the applicant shall do the following:

(1) Submit a license application pursuant to Chapter 3701:1-40 of the Administrative Code;

(2) Provide a description of the site suitability for processing radioactive waste for each of the following categories:

(a) The location of the facility in terms of land use. Include in the description the nearby structures present, local land usage, local populations, public facilities, local roads and traffic;

(b) The characteristics of the site in accordance with criteria contained in paragraph (E)(1) of this rule; and

(c) The site radiological environmental monitoring program to meet the criteria in paragraph (I) of this rule. Include baseline information for the data to be collected.

(3) Provide a complete description of the facility, including but not limited to drawings, to meet the criteria of paragraphs (E) and (F) of this rule.

(4) Submit details on the operation of the facility covering the topics listed in paragraph (G) of this rule.

(5) Submit the quality assurance program used in accordance with rule 3701:1-54-04 of the Administrative Code to ensure that the construction, maintenance and operation of the facility meets the performance objectives, is consistent with the contents of the license application, and satisfies the requirements for the receipt, handling, processing and shipping of waste in this rule.

(6) In addition to the requirements of rule 3701:1-40-38 of the Administrative Code, provide a description of the community awareness and communication program to be used. Identify the means of communication, types of information to be provided, and when the information will be provided to notify the community of the proposed operation and licensing, and identify how the effectiveness of the communication will be monitored and ensured.

(7) Describe the program for training personnel in procedures for packaging, handling, placement, inspection, surveying and emergency response for radioactive waste processing, storage and transportation.

(E) The facility design, location, and site geology shall provide reasonable assurance that radioactive materials will remain isolated from the environment as intended.

(1) The overall hydrogeologic environment of the site, in combination with engineering design, shall act to minimize and control potential radioactive material migration into surface water and ground water in the event of an accidental release. Identification and consideration of the hydrogeologic environment shall include, but is not limited to:

(a) Upstream drainage features including the potential for frequent ponding and slope stability;

(b) Characteristics of nearby rivers, streams, wetlands, or other bodies of water;

(c) Distance to the water table and aquifer;

(d) Analysis of earthquake potential or other land movement and its consequences; and

(e) Soil types under the facility with respect to compatibility with the foundation and structural design.

(2) Ensure that the licensee's structures shall meet the standards prescribed in ASCE/SEI 7- 10 "Minimum Design Loads for Buildings and Other Structures" for a Category II facility as defined in the standard. This publication may be purchased from the "American Society of Civil Engineers, 1801 Alexander Bell Drive, Reston, Virginia 20191-4400, telephone (800) 548-2723," or this publication can be viewed at "the Bureau of Radiation Protection library, 246 N. High Street Columbus, Ohio 43215." Facilities that will have containers exceeding type A quantities of radioactive material in normal form, as defined in Chapter 3701:1-50 of the Administrative Code, must meet the criteria for a category III facility as defined in the standard.

(3) No facility shall be:

(a) Located in a one hundred year flood plain;

(b) Located in a wetland; or

(c) Operated where an emergency response plan would be required as identified in paragraph (G) of rule 3701:1-40-14 of the Administrative Code.

(4) The facility shall be constructed to:

(a) Safely handle and process the waste commensurate with the characteristics of the waste;

(b) Aid in fire suppression, provide filtered air ventilation, maintain environmental controls, and to the extent possible, be constructed of nonflammable building materials; and

(c) Use materials considered to ease future decontamination and decommissioning efforts.

(5) The facility shall incorporate the following design features to aid in keeping the radioactive waste isolated.

(a) Buildings and areas used for processing radioactive waste shall have appropriate ventilation and fire protection systems to minimize the release of radioactive materials into the soil, water, or atmosphere.

(b) Provide facilities and equipment for repackaging leaking or damaged containers.

(c) The facility shall be designed to confine spills. Independent and diverse engineering barriers shall be provided as necessary to minimize potential releases from the facility.

(d) Any person's radioactive waste may not be held on site for more than one year from the time of receipt.

(F) Using both general descriptions and detailed drawings of the facility, identify the following features, and any design features used in support of the performance objectives.

(1) Describe the ventilation system and how it will assure adequate environmental controls of the processing and holding areas. Describe any applicable exhaust air filtration used.

(2) Describe the fire protection and suppression system to minimize the likelihood and extent of fire.

(3) Describe the physical security of the radioactive waste areas and the facility.

(4) Identify radioactive waste processing areas and where radioactive waste will be held. Identify how the processing areas and radioactive waste containers will be accessible for routine inspections.

(5) Describe the locations of radioactive waste handling areas, air sampling stations, effluent filters and any sources of flammable or explosive material.

(6) Provide a description and accurate drawing of any required special handling equipment to be employed.

(7) Describe the equipment installed to maintain control over the maximum concentrations of radioactive materials in gaseous and liquid effluents produced during normal operation and the means employed to keep levels of radioactive material in effluents to unrestricted areas ALARA.

(8) Identify the building codes and standards applied to the design and construction of the facility, and verify that the facility has been certified as complying with these codes.

(G) Pursuant to the requirements of paragraph (B) of this rule, describe the following.

(1) Procedures to secure radioactive materials from unauthorized access and removal, including control of access to the facility;

(2) Procedures used to ensure that all radioactive waste subject to transportation will meet transportation requirements;

(3) Radiation safety program for control and monitoring of radioactive effluents to ensure compliance with the occupational radiation exposure limits, and to control contamination of personnel, vehicles, equipment, buildings, and the facility. Both routine operations and accidents must be addressed. The program description must include procedures, instrumentation, facilities, and equipment;

(4) Procedures for receipt and acceptance of waste packages. The procedures shall include examination of shipping documents, visual check of waste package, survey for removable contamination and external radiation level, identification of packages requiring remediation, corrective actions, and disposition of unacceptable packages;

(5) A program for safe placement and inspection of waste and maintaining occupational exposures ALARA when it is not being processed. The program shall include periodic radiation and contamination surveys of individual packages;

(6) A program for periodic inspections of radioactive waste packages to ensure that they retain their integrity and containment of radioactive waste;

(7) The procedures and equipment used for remote handling and/or repackaging damaged or leaking waste containers;

(8) General flow diagram and detailed procedures of radioactive waste receipt, handling, processing, and storage operations;

(9) Spill detection equipment and cleanup plans for the site and associated transportation of radioactive material; and

(10) A system for maintaining inventory of receipt, processing, storage, and transfer of radioactive waste.

(H) The radiation safety requirements shall include the following documents and content:

(1) The radiation safety manual shall include a description of personnel monitoring methods, training and procedures to be followed to limit employees' exposure to radioactive materials, and methods to keep radiation exposures ALARA;

(2) The operating manual shall include procedures to protect the integrity of the equipment and radioactive material containment during normal handling, processing, and storage conditions, and when shipping radioactive materials; and

(3) An emergency response manual shall include procedures to address likely accident conditions.

(I) The facility shall maintain a radiological environmental monitoring program , to measure and monitor radionuclides in all pathways to individuals, the environment, and the general public from radiological operations. In establishing such a program, the facility must do the following:

(1) Identify all the possible onsite and offsite environmental radiological exposure pathways. The exposure pathways shall include but are not limited to applicable air, soil, groundwater, surface water, and vegetation. The offsite pathway exposure locations shall take into consideration meteorological, terrestrial, and emission source parameters;

(2) Describe the environmental monitoring program to provide data to evaluate radionuclide releases and accumulations in the environment;

(3) Describe the action levels of radionuclides in the environment that will initiate an investigation or corrective action; and

(4) Describe the plan for taking corrective measures if an unintentional release of radionuclides material is indicated.

(J) The licensee shall:

(1) Keep records showing the receipt, inventory, processing, transfer, and disposal of all radioactive waste; and

(2) Prepare and send an annual summary report to the director and publish a local notice of the report's availability to the public. The report shall include, at a minimum, a summary of radioactive waste received, processed, disposed, transferred, incidents, and environmental monitoring results. The annual summary report shall be completed and submitted within ninety days after the end of the licensee's fiscal year.

(K) The processor shall contractually agree with the generator to the return of radioactive waste to the generator. The waste processor may dispose of the radioactive waste on behalf of the generator at a licensed disposal facility in a timely manner.

Effective: 04/15/2013
R.C. 119.032 review dates: 11/30/2012 and 08/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 9/15/2003, 3/21/08

3701:1-54-06 Land disposal - purpose and scope.

(A) The purpose of rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code is to establish procedures, criteria, and terms and conditions upon which the department issues licenses for the land disposal of radioactive waste received from another licensee and radioactive waste disposed of in accordance with paragraph (C) of rule 3701:1-38-19 of the Administrative Code.

(B) The requirements of rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code are in addition to those in Chapter 3701:1-40 of the Administrative Code, and other rules adopted pursuant to Chapter 3748. of the Revised Code.

(C) The requirements of rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code apply to a radioactive waste land disposal facility used by more than one licensee to dispose of radioactive waste or to a licensee that disposes of any radioactive waste at a location other than its currently licensed facility.

(1) Rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code establish performance objectives and technical requirements for the land disposal of radioactive waste received from another licensee.

(2) The objectives are to protect the public health and safety, to minimize exposures to ionizing radiation, and not to adversely affect the environment from the land disposal of radioactive wastes received from another licensee.

(3) The land disposal requirements in rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code are in addition to, and not a substitution for, other applicable rules.

(4) Rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code do not apply to byproduct material as defined in section 11e(2) of the Atomic Energy Act and codified in 42 U.S.C. 2014e(2).

(5) As used in rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code,"waste" means the same as "radioactive waste" as defined in rule 3701:1-38-01 of the Administrative Code.

(D) The requirements of rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code apply to radioactive waste disposal facilities utilizing an above grade engineered structure.

R.C. 119.032 review dates: 08/06/2010 and 08/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 2/13/1999, 9/15/03, 2/6/06

3701:1-54-07 Land disposal - license.

(A) No person shall receive, possess or dispose of radioactive waste received from another licensee at a land disposal facility unless authorized by a license issued by the department pursuant to this rule. Each person shall file an application with the department in accordance with the procedural requirements of Chapter 3701:1-40 of the Administrative Code as if those rules also included source, and special nuclear material, and obtain a license as provided in this rule before commencement of construction of a land disposal facility. Failure to comply with this requirement may be grounds for denial of a license.

(B) In addition to the requirements set forth in paragraph (A) of this rule, an application to receive, possess, and dispose of wastes received from other licensees at a land disposal facility shall consist of the following general information, specific technical information, institutional information, and financial information.

(1) The general information shall include:

(a) Identity of the applicant;

(b) Qualifications of the applicant:

(i) The organizational structure of the applicant, both offsite and onsite, including a description of the lines of authority and assignments of responsibilities, whether in the form of administrative directives, contract provisions, or otherwise;

(ii) Technical qualifications, including minimum training and experience for the applicant and each member of the applicant's organization engaging in the proposed activities;

(iii) A description of the applicant's personnel training program; and

(iv) The plan to maintain an adequate complement of trained personnel to conduct waste receipt, handling, and disposal operations in a safe manner;

(c) A description of:

(i) The location of the proposed disposal site;

(ii) The general scope of the proposed activities;

(iii) The type and quantities of waste to be received, possessed and disposed;

(iv) Plans for the use of the land disposal facility for purposes other than disposal of wastes; and

(v) The proposed facility and equipment; and

(d) Proposed schedules of construction, receipt of the waste, and first emplacement of waste at the proposed disposal facility.

(2) Specific technical information shall include, but is not limited to, the following information needed to demonstrate that the performance objectives and the applicable technical requirements of rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code will be met:

(a) Include a description of the natural and demographic disposal site characteristics as determined by disposal site selection and characterization activities. The description shall include geologic, geochemical, geotechnical, hydrologic, ecologic, archaelogic, meteorologic, climatologic, and biotic features, as well as projected population growth, population distribution, political subdivision, and land use of the disposal site and vicinity.

(b) Include a description of the design features of the land disposal facility and the disposal units. The description shall include those design features related to infiltration of water; integrity of covers for disposal units; structural stability of backfill, wastes, and covers; contact of wastes with standing water; disposal site drainage; disposal site closure and stabilization; elimination to the extent practicable of long-term disposal site maintenance; inadvertent intrusion; occupational exposures; disposal site monitoring; and adequacy of the size of the buffer zone for monitoring and potential mitigative measures.

(c) Include a description of the principal design criteria and their relationship to the performance objectives.

(d) Include a description of the design basis natural events or phenomena and their relationship to the principal design criteria.

(e) Include a description of codes and standards that the applicant has applied to the design, and will apply to construction of the land disposal facilities.

(f) Include a description of the construction and operation of the land disposal facility. The description shall include as a minimum the methods of construction of disposal units; waste emplacement; the procedures for and areas of waste segregation; types of intruder barriers; onsite traffic and drainage systems; survey control program; methods and areas of waste storage; and methods to control surface water and groundwater access to the wastes. The description shall also include a description of the methods to be employed in the handling and disposal of wastes containing chelating agents or other nonradiological substances that might affect meeting the performance objectives of rule 3701:1-54-08 of the Administrative Code.

(g) Include a description of the disposal site closure plan, including those design features which are intended to facilitate disposal site closure and to eliminate the need for ongoing active maintenance.

(h) Include an identification of the known natural resources at the disposal site, the exploitation of which could result in inadvertent intrusion into the wastes after removal of active institutional control.

(i) Include a description of the kind, amount, classification and specifications of the radioactive material proposed to be received, possessed, and disposed of at the land disposal facility.

(j) Submit a quality assurance program meeting the requirements in rule 3701:1-54-04 of the Administrative Code. Include a description of the quality assurance program for the determination of natural disposal site characteristics and for quality assurance during the design, construction, operation, and closure of the land disposal facility and the receipt, handling, and emplacement of waste. Audits and managerial controls must be included.

(k) Include a description of the radiation safety program for control and monitoring of (i) radioactive effluents to ensure compliance with the performance objectives in paragraph (B)(1) of rule 3701:1-54-08 of the Administrative Code,(ii) occupational radiation exposures to ensure compliance with the requirements of Chapter 3701:1-38 of the Administrative Code, and (iii) contamination of personnel, vehicles, equipment, buildings, and the disposal site. Both routine operations and accidents shall be addressed. The program description must include procedures, instrumentation, facilities, and equipment.

(l) Include a description of the environmental monitoring program to provide data to evaluate potential health and environmental impacts and the plan for taking corrective measures if migration is indicated.

(m) Include a description of the administrative procedures that the applicant will apply to control activities at the land disposal facility.

(n) Include a description of the facility's record keeping system as required in rule 3701:1-54-12 of the Administrative Code.

(o) Include a description of the security and safeguards for radioactive material as required in paragraph (B)(5) of rule 3701:1-54-08 of the Administrative Code.

(3) The specific technical information shall also include the following analyses needed to demonstrate that the performance objectives of rule 3701:1-54-08 of the Administrative Code will be met.

(a) Pathways analyzed in demonstrating protection of the general population from releases of radioactivity shall include air, soil, groundwater, surface water, plant uptake, and exhumation by burrowing animals. The analyses shall clearly identify and differentiate between the roles performed by the natural disposal site characteristics and design features in isolating and segregating the wastes. The analyses shall clearly demonstrate that there is reasonable assurance that the exposures to humans from the release of radioactivity will not exceed the limits set forth in paragraph (B)(1) of rule 3701:1-54-08 of the Administrative Code.

(b) Analyses of the protection of individuals from inadvertent intrusion shall include demonstration that there is reasonable assurance the waste classification and segregation requirements will be met and that adequate barriers to inadvertent intrusion will be provided.

(c) Analyses of the protection of individuals during operations shall include assessments of expected exposures due to routine operations and likely accidents during handling, storage, and disposal of waste. The analyses shall provide reasonable assurance that exposures will be controlled to meet the requirements of Chapter 3701:1-38 of the Administrative Code.

(d) Analyses of the long-term stability of the disposal site and the need for ongoing active maintenance after closure shall be based upon analyses of active natural processes such as erosion, mass wasting, slope failure, settlement of wastes and backfill, infiltration through covers over disposal areas and adjacent soils, and surface drainage of the disposal site. The analyses shall provide reasonable assurance that there will not be a need for ongoing active maintenance of the disposal site following closure.

(4) The financial information shall be sufficient to demonstrate that the financial qualifications of the applicant are adequate to carry out the activities for which the license is sought and meet other financial assurance requirements of rule 3701:1-54-11 of the Administrative Code.

(C) A license for the receipt, possession, and disposal of waste containing or contaminated with radioactive material will be issued by the department upon finding that:

(1) The issuance of a license will not constitute an unreasonable risk to the health and safety of the public;

(2) The applicant is qualified by reason of training and experience to carry out the disposal operations requested in a manner that protects health and minimizes danger to life or property;

(3) The applicant's proposed disposal site, disposal design, land disposal facility operations, including equipment, facilities and procedures, disposal site closure, and post-closure institutional control are adequate to protect the public health and safety in that they provide reasonable assurance that the general population will be protected from releases of radioactivity as specified in the performance objectives in paragraph (B)(1) of rule 3701:1-54-08 of the Administrative Code;

(4) The applicant's proposed disposal site, disposal site design, land disposal facility operations, including equipment, facilities, and procedures, disposal site closure, and post-closure institutional control are adequate to protect the public health and safety in that they will provide reasonable assurance that individual inadvertent intruders are protected in accordance with the performance objectives in paragraph (B)(2) of rule 3701:1-54-08 of the Administrative Code;

(5) The applicant's proposed land disposal facility operations, including equipment, facilities, and procedures, are adequate to protect the public health and safety in that they will provide reasonable assurance that the standards for radiation protection set out in Chapter 3701:1-38 of the Administrative Code will be met;

(6) The applicant's proposed disposal site, disposal site design, land disposal facility operations, disposal site closure, post-closure institutional control are adequate to protect the public health and safety in that they will provide reasonable assurance that the long-term stability of the disposed waste and the disposal site will be achieved and will eliminate to the extent practicable the need for ongoing maintenance of the disposal site post-closure;

(7) The applicant's demonstration provides reasonable assurance that the applicable technical requirements of rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code have been met;

(8) The applicant's proposal for institutional control provides reasonable assurance that such control will be provided for the length of time found necessary to ensure the findings in paragraphs (C)(3) to (C)(6) of this rule and that the institutional control meets the requirements in paragraph (A) of rule 3701:1-54-08 of the Administrative Code;

(9) The financial or surety arrangements meet the requirements of rule 3701:1-54-11 of the Administrative Code; and

(10) Adequate security and safeguards exist to provide a reasonable assurance precluding theft or sabotage of the radioactive materials.

(D) A license issued under this rule is subject to the requirements in Chapters 3701:1-40, 3701:1-44, and 3701:1-56 of the Administrative Code in addition to individual license conditions.

(E) An application for renewal or for closure under paragraph (F) of this rule must be filed at least one hundred-eighty days prior to license expiration.

(1) Applications for renewal of a license must be filed in accordance with paragraph (B) of this rule. Applications for closure must be filed in accordance with paragraph (F) of this rule. Information contained in previous applications, statements, or reports filed with the department under the license may be incorporated by reference if the references are clear and specific.

(2) If a licensee has properly filed an application for renewal of a license, the license will not expire until the department has taken final action on the application for renewal.

(3) The department will apply the criteria set forth in paragraph (C) of this rule to descriptions and changes not previously approved on a license amendment in order to determine if a license will be renewed.

(F) Prior to final closure of the disposal site, or as otherwise directed by the department, the licensee shall submit an application to amend the license for closure.

(1) The closure application shall include a final revision and specific details of the disposal site closure plan included as part of the license application submitted under paragraph (B)(2)(g) of this rule that includes each of the following:

(a) Additional geologic, hydrologic, or other data pertinent to the long-term containment of emplaced wastes obtained during the operational period.

(b) The results of tests, experiments, or any other analyses relating to backfill of excavated areas, closure and sealing, waste migration and interaction with emplacement media, or any other tests, experiments, or analyses pertinent to the long-term containment of emplaced waste within the disposal site.

(c) Any proposed revision of plans for:

(i) Decontamination and/or dismantlement of surface facilities;

(ii) Backfilling of excavated areas; or

(iii) Stabilization of the disposal site for post-closure care.

(d) Any significant new information regarding the environmental impact of closure activities and long-term performance of the disposal site.

(2) Upon review and consideration of an application to amend the license for closure submitted in accordance with paragraph (F)(1) of this rule, the department shall issue an amendment authorizing closure if there is reasonable assurance that the long-term performance objectives will be met.

(G) The licensee shall observe, monitor, and carry out necessary maintenance and repairs at the disposal site until the site closure is complete and the license is transferred by the department in accordance with paragraph (H) of this rule. Responsibility for the disposal site must be maintained by the licensee for five years. A shorter or longer time period for post-closure observation and maintenance may be established and approved as part of the site closure plan, based on site-specific conditions.

(H) Following closure and the period of post-closure observation and maintenance, the licensee may apply for an amendment to transfer the license to the disposal site owner. The license shall be transferred when the department finds:

(1) That the closure of the disposal site has been made in conformance with the licensee's disposal site closure plan, as amended and approved as part of the license;

(2) That reasonable assurance has been provided by the licensee that the performance objectives of rule 3701:1-54-08 of the Administrative Code are met;

(3) That any funds and necessary records for care will be transferred to the disposal site owner;

(4) That the post-closure monitoring program is operational for implementation by the disposal site owner.

(I) Following any period of institutional control needed to meet the requirements found necessary under paragraph (C) of this rule, the licensee may apply for an amendment to terminate the license.

(1) The application shall be filed in accordance with the provisions of Chapter 3701:1-40 of the Administrative Code.

(2) A license shall be terminated only when the department finds:

(a) That the institutional control requirements found necessary under paragraph (C)(8) of this rule have been met;

(b) That any additional requirements resulting from new information developed during the institutional control period have been met;

(c) Permanent monuments or markers warning against intrusion have been installed; and

(d) All records are transferred to the department.

Effective: 11/28/2010
R.C. 119.032 review dates: 08/20/2010 and 08/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 2/6/2006

3701:1-54-08 Land disposal - facility requirements.

(A) The land owner or custodial agency shall conduct an institutional control program to physically control access to the disposal site following transfer of control of the disposal site from the disposal site operator. The institutional control program shall also include, but not be limited to, conducting an environmental monitoring program at the disposal site, periodic surveillance, minor custodial care, and other requirements as determined by the department; and administration of funds to cover the costs for these activities. The period of institutional controls will be determined by the department, but institutional controls may not be relied upon for more than one hundred years following transfer of control of the disposal site to the owner.

(B) The performance objectives for the general requirements of a land disposal facility are to ensure public health and safety. Land disposal facilities shall be sited, designed, operated, closed, and controlled after closure to provide reasonable assurance that the following performance objectives will be met.

(1) Concentrations of radioactive material which may be released to the general environment in ground water, surface water, air, soil, plants, or animals must not result in an annual dose exceeding the equivalent of 0.25 millisievert (twenty-five millirem) to the whole body, 0.75 millisievert (seventy-five millirem) to the thyroid, or 0.25 millisievert (twenty-five millirem) to any other organ to any member of the public. Reasonable effort should be made to maintain releases of radioactivity in effluents to the general environment as low as is reasonably achievable.

(2) The design, operation and closure of the land disposal facility shall ensure protection of any individual inadvertently intruding into the disposal site and occupying the site or contacting the waste at any time after institutional controls over the disposal site are removed.

(3) Operations at the land disposal facility shall be conducted in compliance with the standards for radiation protection as set out in Chapter 3701:1-38 of the Administrative Code, except for those releases of radioactivity in effluents from the land disposal facility, which shall be governed by paragraph (B)(1) of this rule. Every reasonable effort should be made to maintain radiation exposures as low as is reasonably achievable.

(4) The disposal facility shall be sited, designed, used, operated, and closed to achieve long-term stability of the disposal site and to eliminate, to the extent practical, the need for ongoing active maintenance of the disposal site after closure so that only surveillance, monitoring, or minor custodial care are required.

(5) The licensee shall develop and implement security measures to protect against and to detect unauthorized access to radioactive material or safety and security systems from external as well as internal threats. The licensee shall perform periodic inspections to ensure that all radioactive material is accounted for and that safety and security systems are operating as designed. The licensee shall report any deficiency involving the radioactive material inventory or a safety and security system to the department.

(6) The radioactive waste and its containers shall be protected from adverse environmental conditions including, but not limited to, temperature changes that could compromise the isolation of the waste from the biosphere.

(7) The licensee shall use standard engineering designs and procedural practices to maintain doses to people, and radionuclide releases to the environment, as low as reasonably achievable.

(C) The operation of the disposal facility shall incorporate the following items.

(1) Wastes designated as Class A pursuant to paragraph (A) of rule 3701:1-54-10 of the Administrative Code shall be segregated from other wastes by placing in disposal units which are sufficiently separated from disposal units for the other waste classes so that any interaction between Class A wastes and other wastes will not result in the failure to meet the performance objectives of this rule. This segregation is not necessary for Class A wastes if they meet the stability requirements of in paragraph (B) of rule 3701:1-54-10 of the Administrative Code.

(2) Wastes designated as Class C pursuant to paragraph (A) of rule 3701:1-54-10 of the Administrative Code, shall be disposed of with intruder barriers that are designed to protect against an inadvertent intrusion for at least five hundred years.

(3) Only waste classified as Class A, B, or C pursuant to rule 3701:1-54-10 of the Administrative Code, shall be acceptable for land disposal. All waste shall be disposed of in accordance with requirements of paragraphs (C)(4) to (C)(11) of this rule.

(4) Waste shall be packaged in appropriate containers for disposal when applicable. Wastes shall be emplaced in a manner that maintains the package integrity during emplacement, minimizes void spaces between packages, and permits the void spaces to be filled.

(5) Void spaces between packages shall be filled as needed to reduce future subsidence within the fill.

(6) Waste shall be placed and covered in a manner that limits the radiation dose rate at the surface of the cover to levels that at a minimum will permit the licensee to comply with all provisions of rule 3701:1-38-13 of the Administrative Code at the time the license is transferred pursuant to paragraph (H) of rule 3701:1-54-07 of the Administrative Code.

(7) The boundaries and locations of each disposal unit shall be accurately located and mapped by means of a land survey. Disposal units shall be marked in such a way that the boundaries of each unit can be easily defined. Three permanent survey marker control points shall be established on the site to facilitate surveys.

(8) A buffer zone of land shall be maintained between any disposed waste and the disposal site boundary and beneath the disposed waste. The buffer zone shall be of adequate dimensions to carry out environmental monitoring activities specified in paragraph (E) of rule 3701:1-54-09 of the Administrative Code and to take mitigative measures if needed.

(9) Closure and stabilization measures as set forth in the approved site closure plan shall be carried out as each disposal unit is filled and covered.

(10) Active waste disposal operations shall not have an adverse effect on completed closure and stabilization measures.

(11) Only wastes containing or contaminated with radioactive material shall be disposed of at the disposal site.

(12) Proposals for disposal of waste that is not acceptable for land disposal because the waste form and disposal methods must be different and, in general, more stringent than those specified for Class C waste, may be submitted to the department for approval.

(D) Each licensee shall perform, or permit the department to perform, any tests the department deems appropriate or necessary for the administration of the regulations in rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code, including, but not limited to, tests of:

(1) Wastes, including physical form;

(2) Facilities used for the receipt, storage, treatment, handling or disposal of wastes;

(3) Radiation detection and monitoring instruments;

(4) Other equipment and devices used in connection with the receipt, possession, handling, treatment, storage, or disposal of waste; or

(5) Environmental sampling or testing.

(E) The licensee shall comply with the quality assurance requirements identified in rule 3701:1-54-04 of the Administrative Code.

(F) The licensee shall make land disposal facilities available for inspections as follows:

(1) Each licensee shall afford to the department at all reasonable times opportunity to inspect waste not yet disposed of, and the premises, equipment, operations, and facilities in which wastes are received, possessed, handled, treated, stored, or disposed.

(2) Each licensee shall make available to the department for inspection, upon reasonable notice, records kept by it pursuant to these regulations. Authorized representatives of the department may copy and take away copies of, for the department's use, any record required to be kept pursuant to this chapter.

R.C. 119.032 review dates: 08/06/2010 and 08/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 2/6/2006

3701:1-54-09 Land disposal - site selection, design, and environmental assessment.

(A) The primary emphasis in disposal site suitability is given to isolation of wastes, a matter having long-term impacts, and to disposal site features that ensure that the long-term performance objectives are met, as opposed to short-term convenience or benefits.

(1) Suitable disposal site features shall include the following items.

(a) The disposal site shall be capable of being characterized, modeled, analyzed and monitored.

(b) Within the region where the facility will be located, a disposal site should be selected so that projected population growth and future developments are not likely to affect the ability of the disposal facility to meet the performance objectives of this rule.

(c) Areas shall be avoided having known natural resources that, if exploited, could result in failure to meet the performance objectives of this rule.

(d) The disposal site shall be generally well drained and free of areas of flooding or frequent ponding. The disposal site shall not be located in a one hundred year flood plain, coastal high-hazard area, or wetland, as defined in Federal Executive Order 11988, "Floodplain Management Guidelines." The disposal units shall be designed and constructed to be outside the five hundred year floodplain.

(e) Upstream drainage areas shall be minimized to decrease the amount of runoff that could erode or inundate waste disposal units.

(f) The disposal site shall provide sufficient depth to the water table that ground water intrusion, perennial or otherwise, into the waste will not occur.

(g) The hydrogeologic unit used for disposal shall not discharge groundwater to the surface within the disposal site. The soil or rock layers immediately beneath the facility, but above the water table shall have good vertical drainage or be engineered to have good drainage to prevent water from ponding around the base of the facility. The shallowest hydrogeologic unit beneath the facility shall not discharge perennially to the site.

(h) Areas shall be avoided where tectonic processes such as faulting, folding, seismic activity, or vulcanization may occur with such frequency and extent that it may significantly affect the ability of the disposal site to meet the performance objectives of this rule or may preclude defensible modeling and prediction of long-term impacts.

(i) Areas should be avoided where surface geologic processes such as mass wasting, erosion, slumping, landsliding, or weathering occur with such frequency and extent that it may significantly affect the ability of the disposal site to meet the performance objectives of this rule, or may preclude defensible modeling and prediction of long-term impacts.

(j) The disposal site must not be located where nearby facilities or activities could affect the ability of the site to meet the performance objectives of this rule or mask the environmental monitoring program.

(2) Additional exclusionary criteria include prohibiting a site from having any of the following features listed below.

(a) The disposal units shall not be located within one kilometer ( 0.62 miles) of any of the following:

(i) Any area designated by the United States department of the interior as a national park or recreation area or national monument;

(ii) Any area designated by the United States department of the interior as a national wildlife refuge or a national wild and scenic river;

(iii) Any area designated by the forest service in the United States department of agriculture as a special interest area or a research natural area in the Wayne national forest;

(iv) Any area designated by the department of natural resources as a state park or state park purchase area under Chapter 1541. of the Revised Code;

(v) The Shawnee wilderness area as designated under section 1503.43 of the Revised Code, any area dedicated by the department of natural resources as a state nature preserve under Chapter 1517. of the Revised Code, any area established as a wildlife area under Chapter 1531. of the Revised Code and rules adopted under it, or a wild, scenic, or recreational river area established by the department under section 1517.14 of the Revised Code;

(vi) An area designated as an archeological or historic site in the national register of historic places under the "National Historic Preservation Act" 80 Stat. 915 to 919 (1966), 16 U.S.C. 470 .

(vii) This section applies to land dedicated for any use specified in it on or before the effective date of section 3747.12 of the Revised Code (September 8, 1995).

(b) The disposal site shall not be located within the Lake Erie coastal area, as "coastal area" is defined in section 1506.01 of the Revised Code.

(c) The disposal site shall not be located where activities related to the development, construction, operation, closure, institutional control, or long-term care of the facility would result in the elimination at the site of endangered or threatened plant or animal species identified under federal law or in rules adopted under section 1518.01 or section 1531.25 of the Revised Code.

(d) The disposal site shall not contain any wetlands, as defined in 40 C.F.R. 230.3 , as published in the July, 1, 2009 Code of Federal Regulations, or lakes unless they can be declassified.

(e) The disposal site shall not be located in any of the following:

(i) An area likely to experience ground motions with a horizontal acceleration greater than twenty per cent of gravity in rock with a ninety per cent probability of not being exceeded in two hundred fifty years, as defined by currently available seismic risk evaluation procedures; or

(ii) An area with frequent earthquake activity.

(f) The disposal site shall not be located in an area of known or probable subsidence caused by an operating underground mine in existence at the time the disposal site is being characterized or by an abandoned underground mine.

(g) The disposal site shall not contain areas of steeply sloping topography or areas underlain by unconsolidated or bedrock geological units known to be susceptible to mass movement or land failure, such as landsliding or liquefaction, and where "steeply sloping topography" means a slope greater than twenty degrees.

(h) The disposal site shall not be located in areas of known or probable karst.

(i) The disposal site shall not be located over a sole source aquifer or within an endorsed wellhead protection area as defined by the state wellhead protection program established pursuant to Chapter 6109. and Chapter 6111. of the Revised Code.

(j) The disposal site shall not be located above an aquifer capable of sustaining a yield of one hundred gallons per minute of potable water for a twenty-four hour period to a water supply well located within one thousand feet of the disposal site.

(k) The use of shallow land burial, caverns, mines, or wells shall not be used as disposal techniques at the facility.

(B) Provide an environmental assessment report required by Chapter 3701:1-40 of the Administrative Code as if that chapter also included source, and special nuclear material.

(C) Provide a description of the public participation process as required by rule 3701:1-40-38 of the Administrative Code.

(D) The licensee shall perform environmental monitoring as recorded below.

(1) At the time a license application is submitted, the applicant shall have conducted a preoperational monitoring program to provide basic environmental data on the disposal site characteristics. The applicant shall obtain information about the ecology, meteorology, climate, hydrology, hydrogeology, geology including geophysics and geotechnical engineering, geochemistry, and seismology of the disposal site. For those characteristics that are subject to seasonal variation, data must cover at least a twelve month period.

(2) During the land disposal facility site construction and operation, the licensee shall maintain an environmental monitoring program. Measurements and observations must be made and recorded to provide data to evaluate the potential health and environmental impacts during both the construction and the operation of the facility and to enable the evaluation of long-term effects and the need for mitigative measures. The monitoring system must be capable of providing early warning of releases of radionuclides from the disposal site before they leave the site boundary.

(3) After the disposal site is closed, the licensee responsible for post-operational surveillance of the disposal site shall maintain a monitoring system based on the operating history and the closure and stabilization of the disposal site. The monitoring system must be capable of providing early warning of releases of radionuclides from the disposal site before they leave the site boundary.

(4) The licensee will provide continuous monitoring to be able to detect a breech of the disposal unit boundary.

(5) The licensee shall have a plan for taking corrective measures if the environmental monitoring program detects migration of radionuclides which would indicate that the performance objectives may not be met.

(E) The director may, upon request or on his or her own initiative, authorize provisions other than those set forth in paragraphs (D) and (E) of this rule and paragraph (C) of rule 3701:1-54-08 of the Administrative Code for the segregation and disposal of waste and for the design and operation of a land disposal facility on a specific basis, if he or she finds reasonable assurance of compliance with the performance objectives of this chapter.

Effective: 11/28/2010
R.C. 119.032 review dates: 08/20/2010 and 08/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 2/6/2006

3701:1-54-10 Land disposal - waste classifications and characteristics.

(A) The criteria to use for classifying waste for disposal are recorded below.

(1) Determination of the classification of radioactive waste involves two considerations. First, consideration must be given to the concentration of long-lived radionuclides (and their shorter-lived precursors) whose potential hazard will persist long after such precautions as institutional controls and improved waste form have ceased to be effective. These precautions delay the time when long-lived radionuclides could cause exposures. In addition, the magnitude of the potential dose is limited by the concentration and availability of the radionuclide at the time of exposure. Second, consideration must be given to the concentration of shorter-lived radionuclides for which requirements on institutional controls, waste form, and disposal methods are effective.

(2) Determination of waste classes shall be performed using the following criteria.

(a) Class A waste is waste that is usually segregated from other waste classes at the disposal site. The physical form and characteristics of class A waste must meet the minimum requirements set forth in paragraph (B) of this rule. If class A waste also meets the stability requirements set forth in paragraph (B) of this rule, it is not necessary to segregate the waste for disposal.

(b) Class B waste is waste that must meet more rigorous requirements on waste form to ensure stability after disposal. The physical form and characteristics of class B waste must meet both the minimum and stability requirements set forth in paragraph (B) of this rule.

(c) Class C waste is waste that not only must meet more rigorous requirements on waste form to ensure stability but also requires additional measures at the disposal facility to protect against inadvertent intrusion. The physical form and characteristics of class C waste must meet both the minimum and stability requirements set forth in paragraph (B) of this rule.

(d) Waste that exceeds class C is not acceptable for disposal under rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code.

(3) If radioactive waste contains only radionuclides listed in table 1, classification shall be determined as follows:

(a) If the concentration does not exceed 0.1 times the value in table 1, the waste is class A.

(b) If the concentration exceeds 0.1 times the value in table 1 but does not exceed the value in table 1, the waste is class C.

(c) If the concentration exceeds the value in table 1, the waste is not acceptable for disposal under rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code.

(d) For wastes containing mixtures of radionuclides listed in table 1, the total concentration shall be determined by the sum of fractions rule described in paragraph (A)(7) of this rule.

image: oh/admin/2014/3701$1-54-10_ph_ff_a_ru_20101118_1330-1.png

\1\ Units are megabecquerels per gram.

\2\ Units are nanocuries per gram.

(4) If radioactive waste does not contain any of the radionuclides listed in table 1, classification shall be determined based on the concentrations shown in table 2. However, as specified in paragraph (A)(6) of this rule, if radioactive waste does not contain any radionuclides listed in either table 1 or table 2, it is class A.

(a) If the concentration does not exceed the value in column 1, the waste is class A.

(b) If the concentration exceeds the value in column 1, but does not exceed the value in column 2, the waste is class B.

(c) If the concentration exceeds the value in column 2, but does not exceed the value in column 3, the waste is class C.

(d) If the concentration exceeds the value in column 3, the waste is not acceptable for disposal under rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code.

(e) For wastes containing mixtures of the radionuclides listed in table 2, the total concentration shall be determined by the sum of fractions rule described in paragraph (A)(7) of this rule.

image: oh/admin/2014/3701$1-54-10_ph_ff_a_ru_20101118_1330-2.png

image: oh/admin/2014/3701$1-54-10_ph_ff_a_ru_20101118_1330-3.png

\1\There are no limits established for these radionuclides in class B or C wastes. Practical considerations such as the effects of external radiation and internal heat generation on transportation, handling, and disposal will limit the concentrations for these wastes. These -wastes shall be class B unless the concentrations of other nuclides in table 2 determine the waste to be class C independent of these radionuclides.

(5) If radioactive waste contains a mixture of radionuclides, some of which are listed in table 1, and some of which are listed in table 2, classification shall be determined as follows:

(a) If the concentration of a radionuclide listed in table 1 does not exceed 0.1 times the value listed in table 1, the class shall be that determined by the concentration of radionuclides listed in table 2.

(b) If the concentration of a radionuclide listed in table 1 exceeds 0.1 times the value listed in table 1 but does not exceed the value in table 1, the waste shall be class C, provided the concentration of radionuclides listed in table 2 does not exceed the value shown in column 3 of table 2.

(6) If radioactive waste does not contain any radionuclides listed in either table 1 or table 2, it is class A.

(7) This is the sum of the fractions rule for mixtures of radionuclides. For determining classification for waste that contains a mixture of radionuclides, it is necessary to determine the sum of fractions by dividing each radionuclide's concentration by the appropriate limit and adding the resulting values. The appropriate limits must all be taken from the same column of the same table. The sum of the fractions for the column must be less than one if the waste class is to be determined by that column.

(8) The concentration of a radionuclide may be determined by indirect methods such as use of scaling factors which relate the inferred concentration of one radionuclide to another that is measured, or radionuclide material accountability, if there is reasonable assurance that the indirect methods can be correlated with actual measurements. The concentration of a radionuclide may be averaged over the volume of the waste, or weight of the waste if the units are expressed as megabecquerels or nanocuries per gram.

(9) Each package of waste must be clearly labeled to identify whether it is class A waste, class B waste, or class C waste, in accordance with paragraphs (A)(1) to (A)(8) of this rule.

(B) The following waste characteristics are minimum requirements for all classes of waste and are intended to facilitate handling at the disposal site and provide protection of health and safety of personnel at the disposal site.

(1) Waste must not be packaged for disposal in cardboard or fiberboard boxes.

(2) Liquid waste must be solidified or packaged in sufficient absorbent material to absorb twice the volume of the liquid.

(3) Solid waste containing liquid shall contain as little free standing and noncorrosive liquid as is reasonably achievable, but in no case shall the liquid exceed one per cent of the volume.

(4) Waste must not be readily capable of detonation or of explosive decomposition or reaction at normal pressures and temperatures, or of explosive reaction with water.

(5) Waste must not contain, or be capable of generating, quantities of toxic gases, vapors, or fumes harmful to persons transporting, handling, or disposing of the waste. This does not apply to radioactive gaseous waste packaged in accordance with paragraph (B)(7) of this rule.

(6) Waste must not be pyrophoric. Pyrophoric materials contained in waste shall be treated, prepared, and packaged to be nonflammable.

(7) Waste in a gaseous form must be packaged at a pressure that does not exceed 1.5 atmospheres at twenty degrees celsius. Total activity must not exceed one hundred curies per container.

(8) Waste containing biological, pathogenic, or infectious material must be treated to reduce to the maximum extent practicable the potential hazard from the non-radiological materials.

(9) The requirements in this rule are intended to provide stability of the waste. Stability is intended to ensure that the waste does not structurally degrade and affect overall stability of the site through slumping, collapse, or other failure of the disposal unit and thereby lead to water infiltration. Stability is also a factor in limiting exposure to an inadvertent intruder, since it provides a recognizable and nondispersible waste.

(a) Waste must have structural stability. A structurally stable waste form will generally maintain its physical dimensions and its form, under the expected disposal conditions such as weight of overburden and compaction equipment, the presence of moisture, and microbial activity, and internal factors such as radiation effects and chemical changes. Structural stability can be provided by the waste form itself, processing the waste to a stable form, or placing the waste in a disposal container or structure that provides stability after disposal.

(b) Notwithstanding the provisions in paragraphs (B)(2) and (B)(3) of this rule, liquid wastes, or wastes containing liquid, must be converted into a form that contains as little free standing and noncorrosive liquid as is reasonably achievable, but in no case shall the liquid exceed one per cent of the volume of the waste when the waste is in a disposal container designed to ensure stability, or 0.5 per cent of the volume of the waste for waste processed to a stable form.

(c) Void spaces within the waste and between the waste and its package must be reduced to the extent practicable.

(C) The director may, upon request or on his or her own initiative, authorize other provisions for the classification and characteristics of waste on a specific basis, if, after evaluation of the specific characteristics of the waste, disposal site, and method of disposal, he or she finds reasonable assurance of compliance with the performance objectives specified in Chapter 3701:1-54 of the Administrative Code.

Effective: 11/28/2010
R.C. 119.032 review dates: 08/20/2010 and 08/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 2/6/2006

3701:1-54-11 Land disposal - financial assurance.

(A) Each applicant shall show that it either possesses the necessary funds or has reasonable assurance of obtaining the necessary funds, or by a combination of the two, to cover the estimated costs of conducting all licensed activities over the planned operating life of the project, including costs of construction and operation.

(B) The licensee shall satisfy the disposal site closure and stabilization funding requirements identified below.

(1) The applicant shall provide assurances prior to the commencement of operations that sufficient funds will be available to carry out disposal site closure and stabilization, including:

(a) Decontamination or dismantlement of land disposal facility structures; and

(b) Closure and stabilization of the disposal site so that following transfer of the disposal site to the site owner, the need for ongoing active maintenance is eliminated to the extent practicable and only minor custodial care, surveillance, and monitoring are required.

(2) These assurances shall be based on department-approved cost estimates reflecting the department-approved plan for disposal site closure and stabilization. The applicant's cost estimates must take into account total costs that would be incurred if an independent contractor were hired to perform the closure and stabilization work.

(3) The licensee's surety mechanism will be annually reviewed by the department to assure that sufficient funds are available for completion of the closure plan, assuming that the work has to be performed by an independent contractor.

(4) The amount of the licensee's financial or surety arrangement shall change in accordance with changes in the predicted costs of closure and stabilization. Factors affecting closure and stabilization cost estimates include inflation, increases in the amount of disturbed land, changes in engineering plans, closure and stabilization that has already been accomplished, and any other conditions affecting costs. The financial or surety arrangement shall be sufficient at all times to cover the costs of closure and stabilization of the disposal units that are expected to be used before the next license renewal.

(5) The financial or surety arrangement shall be either open-ended or be written for a specified period of time and shall be automatically renewed unless the person who issues the surety notifies the department, the beneficiary (the site owner), and the principal (the licensee) not less than ninety days prior to the renewal date of its intention not to renew. In such a situation, the licensee must submit a replacement surety within thirty days after notification of cancellation. If the licensee fails to provide a replacement surety acceptable to the department, the beneficiary may collect on the original surety.

(6) Proof of forfeiture shall not be necessary to collect the surety so that, in the event that the licensee could not provide an acceptable replacement surety within the required time, the surety shall be automatically collected prior to its expiration. The conditions described above shall be clearly stated on any surety instrument.

(7) Financial or surety arrangements shall satisfy the requirements identified in rule 3701:1-40-17 of the Administrative Code.

(8) The licensee's financial or surety arrangement shall remain in effect until the closure and stabilization program has been completed and approved by the department, and the license has been transferred to the site owner.

(C) The licensee shall provide financial assurances for institutional controls as recorded below.

(1) Prior to the issuance of the license, the applicant shall provide for department approval a decommissioning funding plan that ensures that sufficient funds will be available to cover the costs of monitoring and any required maintenance during the institutional control period. The decommissioning funding plan shall be reviewed every five years by the department to ensure that changes in inflation, technology, and disposal facility operations are reflected in the arrangements.

(2) Subsequent changes to the decommissioning funding plan specified in paragraph (C)(1) of this rule relevant to institutional control shall be submitted to the department for prior approval.

(3) For the purposes of the decommissioning funding plan required in paragraph (C)(1) of this rule the types of acceptable financial guaranties shall include bonds issued by fidelity or surety companies authorized to do business in the state, certificates of deposit, deposits of government securities, irrevocable letters or lines of credit, trust funds, escrow accounts, or similar types of arrangements, but shall not include any arrangements that constitute self-insurance.

(4) Financial or surety arrangements shall satisfy the requirements identified in rule 3701:1-40-17 of the Administrative Code.

R.C. 119.032 review dates: 08/06/2010 and 08/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 2/6/2006

3701:1-54-12 Land disposal - records and reports.

The licensee shall maintain records, reports, and transfers as recorded below.

(A) Each licensee shall maintain any records and make any reports in connection with the licensed activities as may be required by the conditions of the license or by the rules, regulations, and orders of the department.

(B) Records which are required by the regulations in this chapter or by license conditions must be maintained for a period specified by the appropriate regulations in this chapter or by license condition. If a retention period is not otherwise specified, these records must be maintained and transferred to the officials specified in paragraph (E) of this rule as a condition of license termination unless the department otherwise authorizes their disposition.

(C) Records which must be maintained pursuant to this chapter may be the original or a reproduced copy or a microform if this reproduced copy or microform is capable of producing copy that is clear and legible at the end of the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, or specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

(D) If there is a conflict between the department's regulations in this chapter, license condition, or other written department approval or authorization pertaining to the retention period for the same type of record, the longest retention period specified takes precedence.

(E) Notwithstanding paragraphs (A) to (D) of this rule, the licensee shall record the location and the quantity of radioactive wastes contained in the disposal site and transfer these records upon license termination to the department and other agencies as designated by the department.

(F) Following receipt and acceptance of a shipment of radioactive waste, the licensee shall record the following information and retain these records until the department transfers or terminates the license that authorizes the activities described in this paragraph.

(1) The date that the shipment is received at the disposal facility;

(2) The date of disposal of the waste;

(3) A traceable shipment manifest number;

(4) A description of any engineered barrier or structural overpack provided for disposal of the waste;

(5) The location of disposal at the disposal site;

(6) The containment integrity of the waste disposal containers as received;

(7) Any discrepancies between materials listed on the manifest and those received;

(8) The volume of any pallets, bracing, or other shipping or onsite generated materials that are contaminated, and are disposed of as contaminated or suspect materials;

(9) Any evidence of leaking or damaged disposal containers or radiation or contamination levels in excess of limits specified in rule 3701:1-50-17 of the Administrative Code and United States department of transportation regulations of 49 C.F.R. 173.443 , as published in the October 1, 2008, Code of Federal Regulations;

(10) A description of any repackaging operations of any of the disposal containers included in the shipment; and

(11) Any other information required by the department as a license condition.

(G) Each licensee shall comply with the safeguards reporting requirements of 10 C.F.R. 30.55 , 10 C.F.R. 40.64 , 10 C.F.R. 70.53 and 10 C.F.R. 70.54, as published in the January 1, 2009 Code of Federal Regulations, if the quantities or activities of materials received or transferred exceed the limits of these sections. Inventory reports required by these sections are not required for materials after disposal.

(H) Each licensee authorized to dispose of radioactive waste received from other persons shall file a copy of its financial report or a certified financial statement annually with the department in order to update the information base for determining financial qualifications.

(I) Each licensee authorized to dispose of waste materials received from other persons, pursuant to this chapter, shall submit annual reports to the department. Reports must be submitted by the end of the first calendar quarter of each year for the preceding year. The reports shall include:

(1) Specification of the quantity of each of the principal radionuclides released to unrestricted areas in liquid and in airborne effluents during the preceding year;

(2) The results of the environmental monitoring program;

(3) A summary of licensee disposal unit survey and maintenance activities;

(4) A summary, by waste class, of activities and quantities of radionuclides disposed of;

(5) Any instances in which observed site characteristics were significantly different from those described in the application for a license; and

(6) Any other information the department may require. If the quantities of radioactive materials released during the reporting period, monitoring results, or maintenance performed are significantly different from those expected in the materials previously reviewed as part of the licensing action, the report must cover this specifically.

(J) Each licensee shall report in accordance with the requirements of 10 C.F.R. 70.52 , as published in the January 1, 2009 Code of Federal Regulations, to the department and the United States nuclear regulatory commission.

(K) Any transfer of radioactive material by the licensee is subject to the requirements in rules 3701:1-40-19 , 3701:1-44-21, and 3701:1-56-08 of the Administrative Code.

(L) In addition to the other requirements of this rule, the licensee shall store, or have stored, manifest and other information pertaining to receipt and disposal of radioactive waste in an electronic recordkeeping system.

(1) The manifest information that must be electronically stored is:

(a) That information required in appendix G to rule 3701:1-38-19 of the Administrative Code with the exception of shipper and carrier telephone numbers and shipper and consignee certifications; and

(b) That information required in paragraph (F) of this rule.

(2) As specified in facility license conditions, the licensee shall report the stored information, or subsets of this information, on a computer-readable medium.

Effective: 11/28/2010
R.C. 119.032 review dates: 08/20/2010 and 08/01/2015
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 2/6/2006