Arkansas Administrative Code
Agency 007 - Arkansas Department of Health
Division 14 - Radiation Control and Emergency Management
Rule 007.14.15-001 - Control of Sources of Ionizing Radiation

a. Each person (registrant) having physical possession or control of a radiation machine capable of producing radiation in the state of Arkansas shall apply for registration of such machine with the Department within thirty (30) days of the date of acquisition.

b. Notwithstanding RH-21 a., each applicant for the following uses shall apply for and receive authorization from the Department prior to operation of the machine: healing arts screening; therapeutic radiation machine use pursuant to RH-10301., RH-10307., orRH-10308.; and use of radiation therapy simulation systems.

c. A Radiation Safety Officer shall be designated on each application form. The qualifications of this individual shall be submitted for Department approval with the application.

d. Each application shall be signed by the applicant or registrant or other individual duly authorized to act for and on his behalf.

e. A prospective Authorized User physician responsible for directing the operation of therapeutic radiation machines subject to RH-10301., RH-10307., or RH- 10308., as applicable, shall be designated on each therapeutic radiation machine application.

a. Installation or servicing of radiation machines and associated radiation machine components.

b. Installation or servicing of devices containing radioactive material.

c. Consulting services including surveys, and evaluation of Naturally Occurring Radioactive Material (NORM) sites or material.

d. Calibration of radiation machines or radiation measurement instruments or devices.

e. Leak tests and leak test analysis. Procedures must be submitted to this Department on how the test is performed and how the analysis is performed at the time of application.

f. Providing training to licensee or registrant personnel. Training outline must be submitted to the Department at the time of application. Training includes but is not limited to:

g. Personnel Dosimetry Services.

a. Any person who sells, leases, transfers, lends, disposes, assembles or installs radiation machines in this state shall notify the Department within fifteen (15) days of:

b. In the case of diagnostic x-ray systems which contain certified components, a copy of the assembler's report prepared in compliance with requirements of the Federal diagnostic x-ray standard (21 CFR 1020.30(d)) shall be submitted to the Department within fifteen (15) days following completion of the assembly. Such report shall suffice in lieu of any other report by the assembler.

c. No person shall make, sell, lease, transfer, lend, assemble or install radiation machines or the supplies used in connection with such machines unless such supplies and equipment when properly placed in operation and used shall meet the requirements of these Regulations.

a. Domestic television receivers, providing the dose rate at 5 cm from any outer surface of 10 cm area is less than 0.5 mrem per hour.

b. Other electrical equipment that produces radiation incidental to its operation from other purposes, providing the dose rate to the whole body at the point of nearest approach to such equipment when any external shielding is removed does not exceed 0.5 rem per year. The production testing or factory servicing of such equipment shall not be exempt.

c. Radiation machines while in transit or storage incident thereto.

a. Sources of radiation.

b. Facilities wherein sources of radiation are used or stored.

c. Radiation detection and monitoring instruments.

d. Other equipment and devices used in connection with utilization or storage of registered sources of radiation.

a. The Department may, upon application therefore, or upon its own initiative, grant such exemptions or exceptions from the requirements of these Regulations as it determines are authorized by law and will not result in undue hazard to public health and safety or property.

b. U.S. Department of Energy Contractors and U. S. Nuclear Regulatory Commission Contractors. Any U.S. Department of Energy contractor or subcontractor and any U.S. Nuclear Regulatory Commission contractor or subcontractor of the following categories operating within this state is exempt from these Regulations to the extent that such contractor or subcontractor under his contract receives, possesses, uses, transfers or acquires sources of radiation:

a. Comply with all applicable regulations of the Department; and

b. Supply the Department with such other information as the Department may reasonably request.

a. All x-ray units - $65.00 per tube, up to a maximum of $260.00.

b. Vendor services providing radiation equipment services or radiation safety services, or both - $65.00.

a. X-ray shoe-fitting equipment prohibited.

No shoe-fitting device or shoe-fitting machine which uses fluoroscopic, x-ray or radiation principles shall be operated or maintained in this state.

b. Penalty for use of x-ray shoe-fitting machine.

Any person violating the provisions of these Regulations shall be guilty of a misdemeanor and upon conviction shall be punished by a fine of not less than fifty dollars ($50.00) and not more than five hundred dollars ($500.00), and each day that such violation shall continue shall constitute a separate offense.

a. Any person who violates any of the provisions of the Act or rules, regulations or orders in effect pursuant thereto of the Department shall, upon conviction thereof, be punished by a fine of not less than one hundred dollars ($100.00) nor more than two thousand dollars ($2,000.00), or by imprisonment for not more than six (6) months or be both fined and imprisoned.

b. Impounding.

Sources of radiation shall be subject to impounding pursuant to Section 5 of these Regulations.

a. Section 2, Part I to Section 3, Part J to Section 3, and Sections 7 through 9 provide for the licensing of radioactive material. Except for persons exempt as provided in Part C to Section 2 and RH-750., no person shall manufacture, produce, transfer, receive, acquire, own, possess, or use radioactive material except as authorized in a specific or general license issued in accordance with these Regulations.1

b. In addition to the requirements of this Section, all licensees, except as otherwise noted in these Regulations, are subject to the requirements of Section 3 and Section 4 of these Regulations as well as any regulations specific to the type of radioactive material or particle accelerator use. Licensees engaged in industrial radiographic operations are subject to the requirements in Part I to Section 3; licensees engaged in well logging and subsurface tracer studies are subject to the requirements in Part J to Section 3; licensees using Naturally Occurring Radioactive Material (NORM) are subject to the requirements in Section 7; licensees using irradiators are subject to the requirements in Section 8; and licensees using radionuclides in the healing arts are subject to the requirements in Section 9. Particle accelerators are licensed pursuant to Section 6, with use requirements found in Sections 6 and 11.

a. The Radioactive Material Fees are as follows:

b. Deleted. SeeRH-5003.

c. The Generally Licensed Device Fees are as follows:

d. Other fees are as follows:

e. Reciprocity fees are as follows:

1. Meets the requirements in RH-8317.; or

2. Is identified as an authorized nuclear pharmacist on a specific license or equivalent permit that authorizes medical use, the practice of nuclear pharmacy, commercial nuclear pharmacy or the manufacture and distribution of radiopharmaceuticals issued by the Department, Nuclear Regulatory Commission or Agreement State; or

3. Is identified as an authorized nuclear pharmacist on a permit issued by a Department, Nuclear Regulatory Commission, or Agreement State specific license of broad scope that is authorized to permit the use of radioactive material.

1. Meets the requirements in RH-8318. and RH-8510., RH-8540., RH-8560., RH-8570., RH-8580., RH-8610., RH-8615., RH-8621., or RH-8660.; or

2. Is identified as an authorized user on a license or equivalent permit issued by the Department, Nuclear Regulatory Commission or Agreement State; or

3. Is identified as an authorized user on a permit issued by a Department, Nuclear Regulatory Commission or Agreement State specific license of broad scope that is authorized to permit the medical use of radioactive material.

Becquerel (Bq)- One becquerel is equal to one disintegration per second (dps).

Buffer zone- A portion of the disposal site that is controlled by the licensee and that lies under the disposal units and between the disposal units and the boundary of the site.

Byproduct material-

1. Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or using special nuclear material;

2. The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute "byproduct material" within this definition;

3.

4. Any discrete source of naturally occurring radioactive material, other than source material, that:

1. Changes for temporary use of the land for public recreational purposes;

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

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

4. Erection offences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to this part;

5. Excavation;

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

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

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

9. Taking any other action that has no reasonable nexus to radiological health and safety.

Curie (Ci)- One curie is that amount of radioactive material which disintegrates at the rate of 37 billion atoms per second.

Custodial Agency- An agency of the government designated to act on behalf of the government owner of the disposal site.

Cyclotron- A particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of 10 megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

Department- Arkansas Department of Health.

Depleted uranium- The source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material.

Discrete source- A radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

Disposal- The isolation of radioactive wastes from the biosphere inhabited by man and containing his food chains by emplacement in a land disposal facility.

Disposal site- That portion of a land disposal facility which is used for disposal of waste. It consists of disposal units and a buffer zone.

Disposal unit- A discrete portion of the disposal site into which waste is placed for disposal. For near surface disposal, the unit is usually a trench.

Dose commitment- The total radiation dose to a part of the body that will result from retention in the body of radioactive material. For purposes of estimating the dose commitment, it is assumed that from the time of intake the period of exposure to retained material will not exceed 50 years.

Effective Dose Equivalent- The sum of the products of the dose equivalent to the organ or tissue and the weighting factors applicable to each of the body organs or tissues that are irradiated. Weighting factors are: 0.25 for gonads, 0.15 for breast, 0.12 for red bone marrow, 0.12 for lungs, 0.03 for thyroid, 0.03 for bone surface, and 0.06 for each of the other five organs receiving the highest dose equivalent.

Engineered barrier- A man-made structure or device that is intended to improve the land disposal facility's ability to meet the performance objectives in RH-407.C.

Explosive material- Any chemical compound, mixture, or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

Government agency- Any executive department, commission, independent establishment, corporation, wholly or partly owned by the United States of America, which is an instrumentality of the United States, or any board, bureau, division, service, office, officer, authority, administration, or other establishment in the executive branch of the Government.

Hazardous waste- Those wastes designated as hazardous by Environmental Protection Agency regulations in 40 CFR Part 261.

Human use- The internal or external administration of radiation or radioactive materials to human beings.

Hydrogeologic unit- Any soil or rock unit or zone which by virtue of its porosity or permeability or lack thereof, has a distinct influence on the storage or movement of ground water.

Inadvertent intruder- 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.

Individual- Any human being.

Inspection- An official examination or observation including but not limited to, tests, surveys and monitoring to determine compliance with rules, regulations, orders, requirements and conditions of the Department.

Intruder barrier- A sufficient depth of cover over the waste that inhibits contact with waste and helps to ensure that radiation exposures to an inadvertent intruder will meet the performance objectives set forth in this Section or engineered structures that provide equivalent protection to the inadvertent intruder.

Land disposal facility- The land, buildings and equipment which are intended to be used for the disposal of the radioactive wastes into the subsurface of the land. For purposes of this Section, a geologic repository is not considered a land disposal facility.

License- Except where otherwise specified, a license issued pursuant to these Regulations.

Licensee- Any person who is licensed by the Department in accordance with these Regulations and the Act.

Licensing State- Any state with regulations equivalent to the Suggested State Regulations for Control of Radiation relating to, and an effective program for, the regulatory control of Naturally-Occurring and Accelerator-Produced Radioactive Material (NARM).

Lot Tolerance Percent Defective- Expressed in percent defective, the poorest quality in an individual inspection lot that should be accepted.

Monitoring- Observing and making measurements to provide data to evaluate the performance and characteristics of the disposal site.

Near-surface disposal facility- A land disposal facility in which radioactive waste is disposed of in or within the upper 30 meters of the earth's surface.

Particle accelerator- Any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

Person-

1. Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, Government agency other than the U.S. Nuclear Regulatory Commission or the U.S. Department of Energy (except that the DOE shall be considered a person within the meaning of the regulations in 10 CFR chapter I to the extent that its facilities and activities are subject to the licensing and related regulatory authority of the NRC under section 202 of the Energy Reorganization Act of 1974 (88 Stat. 1244), the Uranium Mill Tailings Radiation Control Act of 1978 (92 Stat. 3021), the Nuclear Waste Policy Act of 1982 (96 Stat. 2201), and section 3(b)(2) of the Low-Level Radioactive Waste Policy Amendments Act of 1985 (99 Stat. 1842)), any State or any political subdivision of or any political entity within a State, any foreign government or nation or any political subdivision of any such government or nation, or other entity; and

2. Any legal successor, representative, agent, or agency of the foregoing.

Pharmacist- An individual registered by this State to compound and dispense drugs, prescriptions and poisons.

Physician- Any individual possessing a valid physician's and surgeon's certificate issued by this state.

Principal activities- Activities authorized by the license which are essential to achieving the purpose(s) for which the license was issued or amended. Storage during which no licensed material is accessed for use or disposal and activities incidental to decontamination or decommissioning are not principal activities.

Pyrophoric liquid- Any liquid that ignites spontaneously in dry or moist air at or below 130° F (54.5° C). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing or which can be ignited readily and when ignited, burns so vigorously and persistently as to create a serious transportation, handling or disposal hazard. Included are spontaneously combustible and water-reactive materials.

Radiation- Ionizing radiation, i.e., gamma rays and x-rays, alpha and beta particles, high speed electrons, neutrons and other nuclear particles; but not sound, radio waves, visible, infrared or ultraviolet light.

Radioactive material- Any material, solid, liquid or gas which emits radiation spontaneously, including any natural radioactive material such as radium.

Radiographer- Any individual who performs or who, in attendance at the site where sources of radiation are being used, personally supervises industrial radiographic operations and who is responsible to the licensee or registrant for assuring compliance with the requirements of these Regulations and the conditions of registration or of a license.

Radiographer's assistant- Any individual who, under the personal supervision of a radiographer, uses sources of radiation, related handling tools or survey instruments in industrial radiography.

Radiographic exposure device- Any instrument containing a sealed source fastened or contained therein, in which the sealed source or shielding thereof may be moved or otherwise changed, from a shielded to unshielded position for purposes of making a radiographic exposure.

Radiography- The examination of the macroscopic structure of materials by nondestructive methods utilizing sources of radiation.

Registrant- Any person who is registered with Department and is legally obligated to register with the Department pursuant to these Regulations and the Act.

Registration- Registration with the Department in accordance with these Regulations adopted by the Department.

Research and Development-

1. Theoretical analysis, exploration or experimentation; or

2. The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, material and processes.

Research and Development used in these Regulations does not include the internal or external administration of radiation or radioactive material to human beings.

Sealed source- Radioactive material that is permanently bonded or fixed in a capsule or matrix designed to prevent release and dispersal of the radioactive material under the most severe conditions which are likely to be encountered in normal use and handling.

Sealed Source and Device Registry- The national registry that contains all the registration certificates, generated by both the Nuclear Regulatory Commission and the Agreement States, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

Site Area Emergency- Events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by offsite response organizations to protect persons offsite.

Site closure and stabilization- Those actions that are taken upon completion of operations that prepare the disposal site for custodial care and assure that the disposal site will remain stable and will not need ongoing active maintenance.

Source material-

1. Uranium or thorium or any combination thereof in any physical or chemical form, or

2. Ores which contain by weight one-twentieth of one percent (0.05%) or more of uranium, thorium or any combination thereof. Source material does not include special nuclear material.

Source of radiation- Any radioactive material, device or equipment emitting or capable of producing radiation.

Special nuclear material-

1. Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material that the U.S. Nuclear Regulatory Commission, pursuant to the provisions of Section 51 of the Atomic Energy Act of 1954, as amended, determines to be special nuclear material, but does not include source material, or

2. Any material artificially enriched by any of the foregoing but does not include source material.

Special nuclear material in quantities not sufficient to form a critical mass-

Uranium enriched in the isotope 235 in quantities not exceeding 350 grams of contained uranium-235; uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams or any combination of them in accordance with the following formula:

For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed "1" (i.e., unity). For example, the following quantities in combination would not exceed the limitation and are within the formula, as follows:

Click here to view image

Stability- Structural stability.

Surveillance- Observation of the disposal site for purposes of visual detection of need for maintenance, custodial care, evidence of intrusion and compliance with other license and regulatory requirements.

Unrefined and unprocessed ore- Ore in its natural form prior to any processing, such as grinding, roasting, beneficiating or refining. Processing does not include sieving or encapsulation of ore or preparation of samples for laboratory analysis.

U.S. Department of Energy- The Department of Energy established by Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. 7101 et seq., to the extent that the Department exercises functions formerly vested in the U.S. Atomic Energy Commission, its Chairman, members, officers and components and transferred to the U.S. Energy Research and Development Administration and to the Administrator thereof pursuant to Sections 104(b), (c) and (d) of the Energy Reorganization Act of 1974 ( Public Law 93-438, October 11, 1974, 88 Stat. 1233 at 1237, effective January 19, 1975) and retransferred to the Secretary of Energy pursuant to Section 301(a) of the Department of Energy Organization Act ( Public Law 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 U.S.C. 7151, effective October 1, 1977.)

Waste- Those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraphs 2., 3., and 4. of the definition of byproduct material set forth in this section.

Waste handling licensees- Persons licensed to receive and store radioactive wastes prior to disposal and/or persons licensed to dispose of radioactive waste.

a. Any person is exempt from this Section to the extent that such person receives, possesses, uses, owns, transfers, or delivers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than one-twentieth of one percent (0.05%) of the mixture, compound, solution, or alloy.

b. Any person is exempt from this Section to the extent that such person receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material; provided that, except as authorized in a specific license, such person shall not refine or process such ore.

c.

a. Exempt concentrations.

b. Certain items containing radioactive material.

c. Deleted.

d. Gas and aerosol detectors containing radioactive material.

e. Self-luminous products containing radioactive material.

f. Radioactive drug: capsules containing carbon-14 urea for "in vivo" diagnostic use for humans.

g. Certain industrial devices.

a. Prime contractors performing work for the DOE at U.S. Government-owned or controlled sites, including the transportation of sources of radiation to or from such sites and the performance of contract services during temporary interruptions of such transportation;

b. Prime contractors of the DOE performing research in or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof;

c. Prime contractors of the DOE using or operating nuclear reactors or other nuclear devices in a U.S. Government owned vehicle or vessel; and d. Any other prime contractor or subcontractor of the DOE or of the NRC when the State and the NRC jointly determine:

a. Except as provided in paragraphs c. through e. of this section, any person is exempt from these Regulations to the extent that such person receives, possesses, uses, transfers, owns or acquires radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in RH-901., Schedule B to Section 2.

b. Any person who possesses radioactive material received or acquired under the general license formerly provided in RH-402.a. or similar general license of the Nuclear Regulatory Commission or an Agreement State, is exempt from the requirements for a license set forth in this Section to the extent that such person possesses, uses, transfers or owns such radioactive material.

c. This RH-305. does not authorize the production, packaging or repackaging of radioactive material for purposes of commercial distribution or the incorporation of radioactive material into products intended for commercial distribution.

d. No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in Schedule B to Section 2, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under this section or equivalent regulations of the U.S. Nuclear Regulatory Commission or any Agreement State, except in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to section 32.18 of 10 CFR Part 32, which license states that the radioactive material may be transferred by the licensee to persons exempt under this section or the equivalent regulations of the U.S. Nuclear Regulatory Commission or any Agreement State.

e. No person may, for purposes of producing an increased radiation level, combine quantities of radioactive material covered by this exemption so that the aggregate quantity exceeds the limits set forth in RH-901. (Schedule B to Section 2), except for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise permitted by the regulations in this Section.

a. Small quantities of source material.

b. Receipt of title to source material.

A general license is hereby issued authorizing the receipt of title to source material without regard to quantity. This general license does not authorize any person to receive, possess, deliver, use, or transfer source material.

c. Certain industrial products or devices.

a. Certain detecting, measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere.

NOTE: Persons possessing radioactive material in devices under a general license in RH-402.a. before January 15,1975, may continue to possess, use, or transfer that material in accordance with the labeling requirements of RH-402.a. devices in effect on January 14,1975.

A general license is hereby issued to commercial and industrial firms and research, educational and medical institutions, individuals in the conduct of their business, and Federal, State or local government agencies to acquire, receive, possess, use or transfer, in accordance with the provisions of RH-402.b., c. and d., radioactive material contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.

b.

c. Any person who owns, receives, acquires, possesses, uses or transfers radioactive material in a device pursuant to the general license in RH-402.a.:

d. The general license in RH-402.a. does not authorize the manufacture or import of devices containing radioactive material.

e. The general license provided in RH-402.a. is subject to the provisions of RH-60., RH-409., RH-416., RH-500., RH-501., RH-600., RH-601., RH-602., RH-751., RH-4012., Section 3- and Section 4.

f.

g.

h. Ownership of radioactive material.

A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of these Regulations, this general license does not authorize the manufacture, production, transfer, receipt, possession or use of radioactive material.

i. Ice detection devices.

j. Products containing radium-226.

k. Use of radioactive material for certain in vitro clinical or laboratory testing-

m. A general license is hereby issued to receive title to and own special nuclear material without regard to quantity. Notwithstanding any other provision of this Section, a general licensee under RH-402. is not authorized to acquire, deliver, receive, possess, use, transfer, import, or export special nuclear material, except as authorized in a specific license.

n. Incidentally produced radioactive material generated by the operation of a particle accelerator.

A general license is hereby issued to possess radioactive material produced incidentally to the operation of a particle accelerator. The general license is subject to the applicable provisions of this Section and Section 3. A licensee shall transfer this radioactive material in accordance with Part E of this Section and Section 4. A licensee shall dispose of this radioactive material only by way of Department approved procedures.

a. Application for specific licenses shall be filed on forms supplied by the Arkansas Department of Health, Radiation Control Section, 4815 West Markham Street, Slot 30, Little Rock, Arkansas 72205-3867. The application shall set forth all applicable information called for by the form. An application for a license may request a license for one or more activities.

b. The Department may at any time after the filing of the original application and before the expiration of the license, require further statements in order to enable the Department to determine whether the application should be granted or denied or whether a license should be modified or revoked.

c. Each application shall be signed by the applicant or licensee or an individual duly authorized to act for and on his behalf.

d. In the application, the applicant may incorporate, by reference, information contained in previous applications, statements or reports filed with the Department, provided that such references are clear and specific.

e. Applications and documents submitted to the Department in connection with the applications may be made available for public inspection except that the Department may withhold any document or part thereof from public inspection if disclosure of its contents is not required in the public interest and would adversely affect the interest of a person concern

f The Department may verify information contained in applications and secure additional information deemed necessary to make a reasonable determination as to whether to issue a license and whether special conditions should be attached thereto by visiting the facility or location where radioactive materials would be possessed or used and by discussing details of proposed possession or use of the radioactive materials with the applicant or his designated representative.

g. Requirements for emergency response plans for certain licensees.

h.

i. In accordance with RH-409.h., certain licensees must furnish a proposed decommissioning funding plan or a certification of financial assurance for decommissioning.

j. An application from a medical facility, educational institution, or Federal facility to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under Section 9 of these regulations or equivalent Agreement State requirements shall include:

a. The applicant is qualified by reason of training and experience to use the material in question for the purpose requested in accordance with Section 3 of these Regulations in such a manner as to minimize danger to public health and safety or property;

b. The applicant's proposed equipment, facilities and procedures are adequate to protect health and minimize danger to public health and safety or property;

c. The issuance of the license will not be inimical to the health and safety of the public;

d. The applicant satisfies any applicable special requirements contained in Section 2, Section 3, Sections 7 through 9, and Section 12 of these Regulations; and e. In the case of an application for a license to receive and possess radioactive material for the conduct of any activity which the Department determines will significantly affect the quality of the environment, the Director of the Arkansas Department of Health, or his/her designee, before commencement of construction of the plant or facility in which the activity will be conducted, on the basis of information filed and evaluations made pursuant to Subpart A, "National Environmental Policy Act - Regulations Implementing Section 102(2)," of 10 CFR Part 51, has concluded, after weighing the environmental, economic, technical, and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion shall be grounds for denial of a license to receive and possess radioactive material in such plant or facility. Commencement of construction as defined in RH-200. may include non-construction activities if the activity has a reasonable nexus to radiological safety and security.

a. Licensing of the manufacture and initial transfer of industrial products and devices containing depleted uranium.

b. Licensing of the initial transfer of source material for use under the "small quantities of source material" general license.

c.- d. Reserved.

e. Licensing of the manufacture or initial transfer of devices to persons generally licensed under RH-402.a.

f. Deleted. SeeRH-1800.b.2.

g. Licensing of the introduction of radioactive material into products in exempt concentrations.

No person may introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under RH-301.a., or equivalent regulations of an Agreement State, except in accordance with a license issued pursuant to 10 CFR 32.11.

h. Licensing of the manufacture, assembly, repair, or initial transfer of luminous safety devices for use in aircraft.

i. Licensing of the manufacture or initial transfer of calibration or reference sources containing americium-241, plutonium, or radium-226.

j. Licensing of the manufacture and distribution of radioactive material for certain in vitroclinical or laboratory testing under general license.

An application for a specific license to manufacture or distribute radioactive material for use under the general license of RH-402.k. will be approved if:

k. Licensing of the manufacture or initial transfer of ice detection devices containing strontium-90.

m. Deleted.

n. Manufacture and distribution of sources or devices containing radioactive material for medical use.

a. The different types of broad licenses are set forth below:

b. An application for a Type A specific license of broad scope will be approved if:

c. An application for a Type B specific license of broad scope will be approved if:

d. An application for a Type C specific license of broad scope will be approved if:

e. Specific license of broad scope are subject to the following conditions:

a. Each person shall file an application with the Department and obtain a license as provided in this section before commencing construction of a land disposal facility. Failure to comply with this requirement may be grounds for denial of a license.

b. Content of application.

An application to receive from others, possess and dispose of wastes containing or contaminated with radioactive material by land disposal must consist of general information, specific technical information, institutional information and financial information as set forth in this paragraph. An environmental report prepared in accordance with Subpart A of 10 CFR Part 51 must accompany the application.

c. Performance objectives.

d. Technical requirements for land disposal facilities.

e. Funding for disposal site closure and stabilization.

a. Upon a determination that an application meets the requirements of the Act and these Regulations of the Department, the Department will issue a specific license authorizing the proposed activity in such form and containing such conditions and limitations as it deems appropriate and necessary to effectuate the purposes of the Act.

b. The Department may incorporate in any license at the time of issuance or thereafter by appropriate rule, regulation or order, such additional requirements and conditions with respect to the licensee's receipt, possession, use and transfer of licensed material as it deems appropriate or necessary in order to:

a. Each license issued pursuant to these Regulations shall be subject to all the provisions of the Act now or hereafter in effect and to all rules, regulations and orders of the Department.

b.

c. Each person licensed by the Department pursuant to these Regulations shall confine their use and possession of the material licensed to the locations and purposes authorized in the license. Except as otherwise provided in the license, a license issued pursuant to these Regulations shall carry with it the right to receive, acquire, own and possess radioactive material. Preparation for shipment and transport of radioactive material shall be in accordance with the provisions of Section 4 of these Regulations.

d. The Department may incorporate, in any license issued pursuant to these Regulations, at the time of issuance, or thereafter by appropriate rule, regulation or order, such additional requirements and conditions with respect to the licensee's receipt, possession, use and transfer of radioactive material as it deems appropriate or necessary in order to:

e. Each licensee shall notify the Department in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license. This notification requirement applies to all specific licenses issued under these Regulations.

f Licensees required to submit emergency plans by RH-403.g .shall follow the emergency plan approved by the Department. Proposed changes to the plan may not be implemented without prior application to and prior approval by the Department.

g. Bankruptcy notification.

h. Financial assurance and record keeping for decommissioning.

i. Each portable gauge licensee shall use a minimum of two (2) independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee.

j. Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, in accordance with RH-8531. The licensee shall record the results of each test and retain each record for 3 years after the record is made.

k.

a. Except as provided in RH-411 .b., each specific license shall expire at the end of the day, in the month and year stated therein.

b. Each specific license revoked by the Department expires with the Department's final determination to revoke the license, or on the expiration date stated in the determination, or as otherwise provided by Department Order.

c. Each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of radioactive material until the Department notifies the licensee in writing that the license is terminated. During this time, the licensee shall:

d. Within sixty (60) days of the occurrence of any of the following, each licensee shall provide notification to the Department in writing of such occurrence, and either begin decommissioning its site, or any separate building or outdoor area that contains residual radioactivity so that the building or outdoor area is suitable for release in accordance with Department requirements, or submit within twelve (12) months of notification a decommissioning plan, if required by RH-410.g., and begin decommissioning upon approval of that plan if:

e. Coincident with the notification required by RH-410.d., the licensee shall maintain in effect all decommissioning financial assurances established by the licensee pursuant to RH-409.h. in conjunction with a license issuance or renewal or as required by RH-410. The amount of the financial assurance must be increased, or may be decreased, as appropriate, to cover the detailed cost estimate for decommissioning established pursuant to RH-410.g.4.E.

f. The Department may grant a request to extend the time periods established in RH-410.d. if the Department determines that this relief is not detrimental to the public health and safety and is otherwise in the public interest. The request must be submitted no later than thirty (30) days before notification pursuant to RH-410.d. The schedule for decommissioning set forth in RH-410.d. may not commence until the Department has made a determination on the request.

g.

h.

i. The Department may approve a request for an alternative schedule for completion of decommissioning of the site separate building or outdoor area, and license termination if appropriate, if the Department determines that the alternative is warranted by consideration of the following:

j. As the final step in decommissioning, the licensee shall:

k. Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the Department determines that:

a. Application for renewal of specific licenses shall be filed in accordance with Part D, RH-403.

b. In any case in which a licensee, not less than thirty (30) days prior to expiration of this existing license, has filed an application in proper form for renewal or for a new license authorizing the same activities, such existing license shall not expire until the application has been finally approved or disapproved by the Department.

a. The terms and conditions of each license and sealed source and device registration certificate issued under these Regulations shall be subject to amendment, revision, or modification or the license may be suspended or revoked by reason of amendments to the Act or by reason of rules, regulations, and orders issued by the Department.

b. Any license or sealed source and device registration certificate may be revoked, suspended, or modified, in whole or in part, for any material false statement in the application or in any statement of fact required under provisions of the Act or of these Regulations or because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means that would warrant the Department to refuse to grant a license or sealed source and device registration certificate on an original application, or for violation of, or failure to observe any of the terms and conditions of the Act or the license or of any rule, regulation, or order of the Department.

c. Except in cases of willful violation or those in which the public health, interest, or safety requires otherwise, no license or sealed source and device registration certificate shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefor, facts or conduct that may warrant such action shall have been called to the attention of the licensee or certificate holder in writing, and the licensee or certificate holder shall have been accorded opportunity to demonstrate or achieve compliance with all lawful requirements.

d. The Department may terminate a specific license upon request submitted by the licensee to the Department in writing.

a. Except as otherwise provided in the license and subject to the provisions of paragraphs b. and c. of this section, any licensee may transfer radioactive material, subject to acceptance by the transferee, to:

b. Before transferring radioactive material to a specific licensee of the Department, the NRC, or an Agreement State, or to a general licensee who is required to register with the Department, the NRC, or an Agreement State prior to receipt of the radioactive material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred.

c. The following methods for the verification required by RH-501 .b. are acceptable:

a. Each person who receives radioactive material pursuant to a license issued pursuant to the regulations in this Section, Part I to Section 3, Part J to Section 3, and Sections 7, 8, and 9 of these Regulations shall keep records showing the receipt, transfer, and disposal of the radioactive material as follows:

b. The licensee shall retain each record that is required by the regulations in this Section, Part I to Section 3, Part J to Section 3, and Sections 7, 8, and 9 of these Regulations or by license condition for the period specified by the appropriate regulation or license condition. If a retention period is not otherwise specified by regulation or license condition, the record must be retained until the Department terminates each license that authorizes the activity that is subject to the recordkeeping requirement.

c.

d. Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than 120 days, in an unsealed form, shall forward the following records to the Department:

e. If licensed activities are transferred or assigned in accordance with RH-409.b., each licensee authorized to possess radioactive material, with a half-life greater than 120 days, in an unsealed form, shall transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated:

f Prior to license termination, each licensee shall forward the records required by RH-409.h.7. to the Department.

a. Each licensee shall afford to the Department at all reasonable times opportunity to inspect radioactive material and the premises and facilities wherein such radioactive material is used or stored.

b. Each licensee shall make available to the Department for inspection, upon reasonable notice, records kept by the licensee pursuant to these Regulations.

a. Sources of radiation;

b. Facilities wherein radioactive materials are used or stored;

c. Radiation detection and monitoring instruments; and d. Other equipment and devices used in connection with utilization or storage of licensed material.

a. Violations.

An injunction or other court order may be obtained prohibiting any violation of any provision of the Act or any regulation or order issued thereunder. Any person who willfully violates any provision of the Act or any regulation or order issued thereunder may be guilty of a felony, misdemeanor, or crime and, upon conviction, may be punished by fine or imprisonment or both, as provided by law. Arkansas Code Annotated § 20-21-204 describes criminal and civil penalties which may be assessed.

b. Impounding.

Sources of radiation shall be subject to impounding pursuant to Section 5 of these Regulations.

a. Licenses of Byproduct, Source, and Special Nuclear Material in Quantities Not Sufficient to Form a Critical Mass.

b. Licenses of Naturally Occurring and Accelerator-Produced Radioactive Material.

c. Recognition of Agreement State Licenses.

1. Many radioisotopes disintegrate into isotopes which are also radioactive. In expressing the concentrations in Schedule C, the activity stated is that of the parent isotope and takes into account the daughters.

2. For purposes of RH-301 .a. where there is involved a combination of isotopes, the limit for the combination should be derived as follows:

Determine for each isotope in the product the ratio between the concentration present in the product and the exempt concentration established in Schedule C for the specific isotope when not in combination. The sum of such ratios may not exceed "1" (i.e., unity).

Example:

Click here to view image

Footnotes for Schedule C to Section 2:

- Values are given in Column 1 only for those materials normally used as gases.

-' uCi/gm for solids.

I. Introduction

An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on obtaining a parent company guarantee that funds will be available for decommissioning costs and on a demonstration that the parent company passes a financial test. This appendix establishes criteria for passing the financial test and for obtaining the parent company guarantee.

II. Financial Test

III. Parent Company Guarantee

The terms of a parent company guarantee which an applicant or licensee obtains must provide that:

I. Introduction

An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the company passes the financial test of Section II of this Appendix. The terms of the self-guarantee are in Section III of this Appendix. This Appendix establishes criteria for passing the financial test for the self-guarantee and establishes the terms for a self-guarantee.

II. Financial Test

III. Company Self-Guarantee

The terms of a self-guarantee which an applicant or licensee furnishes must provide that: