Arkansas Administrative Code
Agency 007 - Arkansas Department of Health
Division 35 - Center for Health Protection
Rule 007.35.21-001 - Rules for Control of Sources of Ionizing Radiation

1. Protect health or to minimize danger to life or property;

2. Require such reports and the keeping of such records as may be necessary or appropriate to effectuate the purposes of the Act; and

3. Prevent loss or theft of radiation machines subject to this Section.

1. Safe use and handling of x-ray equipment.

2. Safe use and handling of radioactive material.

3. Safe use and handling of Naturally Occurring Radioactive Material (NORM).

4. Training provided to Radiation Safety/Protection Officer.

1. Any individual offering or furnishing personnel dosimetry services to a Department licensee or registrant shall report each year to the Department all radiation exposure levels greater than limits set forth in RH-1200.a., within ten (10) days after the start of the next reporting period. This report shall include but is not limited to:

2. Any individual offering or furnishing personnel dosimetry services shall not lower or amend radiation exposure reports except by authorization from the Department.

3. Any individual offering or furnishing personnel dosimetry services shall comply with all additional requirements of quality assurance and control of personnel dosimetry, as deemed appropriate and necessary by the Department.

1. The name and address of persons who have received these machines;

2. The manufacturer, model and serial number of each radiation machine transferred; and

3. The date of transfer of each radiation machine.

1. Prime contractors performing work for the U.S. Department of Energy 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;

2. Any other prime contractor or subcontractor of the U.S. Department of Energy or of the U.S. Nuclear Regulatory Commission when the Department and the U.S. Nuclear Regulatory Commission jointly determine:

1. Engage in deliberate misconduct that causes or would have caused, if not detected, a licensee, certificate of registration holder, or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation of any license issued by the Department; or

2. Deliberately submit to the Department, a licensee, certificate of registration holder, an applicant, or a licensee's, certificate holder's or applicant's, contractor or subcontractor, information that the person submitting the information knows to be incomplete or inaccurate in some respect material to the Department.

1. Would cause a licensee, certificate of registration holder, or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation, of any license issued by the Department; or

2. Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a licensee, certificate of registration holder, applicant, contractor, or subcontractor.

A. Any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or

B. Any material that:

A. The U.S. Nuclear Regulatory Commission, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and

B. Before, on, or after August 8, 2005, is extracted or converted after extraction for use in a commercial, medical, or research activity.

CFR - Code of Federal Regulations.

Chelating agent - Amine polycarboxylic acids (e.g., EDTA, DTPA), hydroxycarboxylic acids and polycarboxylic acids (e.g., citric acid, carbolic acid and glucinic acid).

Commencement of construction - Any action defined as "construction" or any other activity at the site of a facility subject to the regulations in this Section that has a reasonable nexus to radiological health and safety.

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

Construction - The installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the regulations in this Section that are related to radiological safety or security. The term "construction" does not include:

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.

Decommission - to remove a facility or site safely from service and reduce residual radioactivity to a level that permits:

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.

Licensed material - Source material, special nuclear material, or byproduct material received, possessed, used, transferred or disposed of under a general license provided by regulation or a specific license issued by the Department.

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 -

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

Physician - A doctor of medicine or doctor of osteopathy licensed by the Arkansas State Medical Board to prescribe drugs in the practice of medicine.

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 130º F (54.5º 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 -

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 encased in a capsule designed to prevent leakage or escape of the radioactive material.

Sealed Source and Device Registry - The national registry that contains all the registration certificates, generated by both the U.S. 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 -

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

Special nuclear 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:

175 (grams contained U-235) / 350 + 50 (grams U-233) / 200 + 50 (grams Pu) / 200 = 1

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.

1. Any person is exempt from this Section and Section 3 to the extent that such person receives, possesses, uses, or transfers:

2. The exemptions contained in RH-300.c.1. do not authorize the manufacture, of any of the products described.

3. No person may initially transfer for sale or distribution a product containing source material to persons exempt under RH-300.c.1., or equivalent regulations of the U.S. Nuclear Regulatory Commission or of an Agreement State, unless authorized by a license issued under 10 CFR 40.52 to initially transfer such products for sale or distribution.

1. Except as provided in RH-301.a.3. and RH-301.a.4., any person is exempt from this Section to the extent that such person receives, possesses, uses, transfers, owns or acquires products or materials containing radioactive material in concentrations not in excess of those listed in Schedule C to Section 3, RH-902.

2. This section shall not be deemed to authorize the import of radioactive material or products containing radioactive material.

3. A manufacturer, processor, or producer of a product or material in an Agreement State is exempt from the requirements for a license and from these Regulations to the extent that this person transfers radioactive material contained in a product or material in concentrations not in excess of those specified in RH-902. (Schedule C to Section 2) and introduced into the product or material by a licensee holding a specific license issued by the U.S. Nuclear Regulatory Commission expressly authorizing such introduction. This exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

4. 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 the U.S. Nuclear Regulatory Commission or an Agreement State, except in accordance with a license issued by the NRC pursuant to 10 CFR 32.11.

1. Except for persons who apply radioactive material to, or persons who incorporate radioactive material into, the following products, any person is exempt from these Regulations to the extent that such person receives, possesses, uses, transfers, owns or acquires the following products:

2. Any person who desires to apply radioactive material to, or to incorporate radioactive material into, the products exempted in RH-301.b.1. above, or who desires to initially transfer for sale or distribution such products containing radioactive material, should apply for a specific license pursuant to 10 CFR 32.14, which license states that the product may be distributed by the licensee to persons exempt from RH-301.b.1.

1. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution gas and aerosol detectors containing radioactive material, any person is exempt from the requirements for a license set forth in the Act and from these Regulations to the extent that such person receives, possesses, uses, transfers, owns or acquires radioactive material in gas and aerosol detectors designed to protect health, safety, or property, and manufactured, processed, produced, or initially transferred in accordance with a specific license issued under 10 CFR 32.26, which license authorizes the initial transfer of the product for use under RH-301.d. This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007, in accordance with a specific license issued by an Agreement State under comparable provisions to 10 CFR 32.26 authorizing distribution to persons exempt from regulatory requirements.

2. Any person who desires to manufacture, process, or produce gas and aerosol detectors containing radioactive material, or to initially transfer such products for use under RH-301.d.1., should apply for a license under 10 CFR 32.26 and for a certificate of registration in accordance with 10 CFR 32.210 or equivalent Agreement State regulations.

1. Tritium, krypton-85, or promethium-147.

Except for persons who manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85 or promethium-147, any person is exempt from these Regulations to the extent that such person receives, possesses, uses, transfers, owns, or acquires tritium, krypton-85 or promethium-147 in self-luminous products manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to 10 CFR 32.22, which license authorizes the transfer of the product to persons who are exempt from regulatory requirements or equivalent regulations of an Agreement State. The exemption in RH-301.e. does not apply to tritium, krypton-85 or promethium-147 used in products primarily for frivolous purposes or in toys or adornments.

2. Radium-226.

Any person is exempt from these Regulations to the extent that such person receives, possesses, uses, transfers, or owns articles containing less than 0.1 µCi (3.7 kBq) of radium-226 which were manufactured prior to November 30, 2007.

3. Any person who desires to manufacture, process, or produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147 for use under RH-301.e.1., should apply for a license under 10 CFR 32.22 and for a certificate of registration in accordance with 10 CFR 32.210 or equivalent Agreement State regulations.

1. Except as provided in paragraphs RH-301.f.2. and RH-301.f.3., any person is exempt from the requirements for a license and from the regulations in this Section and Section 9 provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing one (1) microcurie (37 kBq) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for "in vivo" diagnostic use for humans.

2. Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to Section 9.

3. Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive specific license pursuant to 10 CFR 32.21.

4. Nothing in RH-301.f. relieves persons from complying with applicable Food & Drug Administration (FDA), other Federal, and State requirements governing receipt, administration, and use of drugs.

1. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing radioactive material 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 an ionized atmosphere, any person is exempt from the requirements for a license set forth in the Act and from these Regulations to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material, in these certain detecting, measuring, gauging, or controlling devices and certain devices for producing an ionized atmosphere, and manufactured, processed, produced, or initially transferred in accordance with a specific license issued under 10 CFR 32.30, which license authorizes the initial transfer of the device for use under RH-301.g. This exemption does not cover sources not incorporated into a device, such as calibration and reference sources.

2. Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing radioactive material for use under RH-301.g.1., should apply for a license under 10 CFR 32.30 and for a certificate of registration in accordance with 10 CFR 32.210 or equivalent Agreement State regulations.

1. that the exemption of the prime contractor or subcontractor is authorized by law; and

2. that, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.

1. A general license is hereby issued authorizing commercial and industrial firms; research, educational, and medical institutions; and Federal, State, and local government agencies to receive, possess, use, and transfer uranium and thorium, in their natural isotopic concentrations and in the form of depleted uranium, for research, development, educational, commercial, or operational purposes in the following forms and quantities:

2. Any person who receives, possesses, uses, or transfers source material in accordance with the general license in paragraph a. of this section:

3. Any person who receives, possesses, uses, or transfers source material in accordance with paragraph a. of this section shall conduct activities so as to minimize contamination of the facility and the environment. When activities involving such source material are permanently ceased at any site, if evidence of significant contamination is identified, the general licensee shall notify the Department in writing about such contamination and may consult with the Department as to the appropriateness of sampling and restoration activities to ensure that any contamination or residual source material remaining at the site where source material was used under this general license is not likely to result in exposures that exceed the limits in RH-1216.

4. Any person who receives, possesses, uses or transfers source material in accordance with the general license granted in paragraph a. of this section is exempt from the provisions of Section 3 of these Regulations to the extent that such receipt, possession, use, and transfer are within the terms of this general license, except that such person shall comply with the provisions of RH-1216. and RH-1400. to the extent necessary to meet the provisions of paragraphs a.2.B. and a.3. of this section. However, this exemption does not apply to any person who also holds a specific license issued pursuant to these Regulations.

5. No person may initially transfer or distribute source material to persons generally licensed under paragraph a.1.A. or a.1.B. of this section, or equivalent regulations of the U.S. Nuclear Regulatory Commission or of an Agreement State, unless authorized by a specific license issued in accordance with RH-405.b.1. or equivalent provisions of the NRC or of an Agreement State. This prohibition does not apply to analytical laboratories returning processed samples to the client who initially provided the sample. Initial distribution of source material to persons generally licensed by paragraph a.1. of this section before March 1, 2016, without specific authorization may continue for one year beyond this date. Distribution may also be continued until the Department takes final action on a pending application for license or license amendment to specifically authorize distribution submitted on or before March 1, 2017.

1. A general license is hereby issued to receive, acquire, possess, use, or transfer, in accordance with the provisions of paragraphs c.2. through c.5. of this section, depleted uranium contained in industrial products or devices for the purpose of providing a concentrated mass in a small volume of the product or device.

2. The general license in paragraph c.1. of this section applies only to industrial products or devices which have been manufactured or initially transferred either in accordance with a specific license issued to the manufacturer of the products or devices pursuant to RH-405.a.1. or in accordance with a specific license issued to the manufacturer by the U.S. Nuclear Regulatory Commission or an Agreement State which authorizes manufacture of the products or devices for distribution to persons generally licensed by the NRC or an Agreement State.

3.

4. A person who receives, acquires, possesses, or uses depleted uranium pursuant to the general license established by paragraph c.1. of this section:

5. Any person receiving, acquiring, possessing, using, or transferring depleted uranium pursuant to the general license established by paragraph c.1. of this section is exempt from the requirements of Section 3 of these Regulations with respect to the depleted uranium covered by that general license.

1.

The general license in RH-402.a. applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in:

2. The devices must have been received from one of the specific licensees described above in RH-402.b.1. or through a transfer made under RH-402.c.9.

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

2. Shall assure that the device is tested for leakage of radioactive material and proper operations of the on-off mechanism and indicator, if any, at no longer than six (6) month intervals or at such other intervals as are specified in the label; however:

3. Shall assure that the tests required by RH-402.c.2. and other testing, installation, servicing and removal from installation involving the radioactive materials, its shielding or containment, are performed:

4. Shall maintain records showing compliance with the requirements of RH-402.c.2. and c.3. The records must show the results of tests. The records also must show the dates of performance of, and the names of persons performing, testing, installing, servicing, and removing from the installation radioactive material and its shielding or containment. The licensee shall retain these records as follows:

5. Shall immediately suspend operation of the device if there is a failure of, or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of 185 bequerel (0.005 microcurie) or more removable radioactive material. The device may not be operated until it has been repaired by the manufacturer or other person holding a specific license to repair such devices that was issued under RH-405.e. or the U.S. Nuclear Regulatory Commission or by an Agreement State.

The device and any radioactive material from the device may only be disposed of by transfer to a person authorized by a specific license to receive the radioactive material in the device or as otherwise approved by the Department. A report containing a brief description of the event and the remedial action taken; and, in the case of detection of 0.005 microcurie or more removable radioactive material or failure of or damage to a source likely to result in contamination of the premises or the environs, a plan for ensuring that the premises and environs are acceptable for unrestricted use, must be furnished within thirty (30) days to:

Arkansas Department of Health

Radiation Control Section

ATTN: General License Registration Program

4815 West Markham Street, Slot 30

Little Rock, Arkansas 72205-3867

Under these circumstances, the criteria set out in RH-1216., "Radiological Criteria for Unrestricted Use,'' may be applicable, as determined by the Department on a case-by-case basis;

6. Shall not abandon the device containing radioactive material;

7. Shall not export the device containing radioactive material except in accordance with U.S. Nuclear Regulatory Commission Regulations outlined in Part 110, "Export and Import of Nuclear Equipment and Material";

8.

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

10. Shall comply with the provisions of RH-1501. and RH-1502. for reporting radiation incidents, theft, or loss of licensed material, but shall be exempt from the other requirements of Section 3 of these Regulations.

11. Shall respond to written requests from the Department to provide information relating to the general license within thirty (30) calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the General License Registration Program a written justification for the request.

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

13.

14. Shall report changes to the mailing address for the location of use (including change in name of general licensee) to the:

Arkansas Department of Health

Radiation Control Section

Attention: General License Registration Program

4815 West Markham Street, Slot 30

Little Rock, Arkansas 72205-3867

within thirty (30) days of the effective date of the change. For a portable device, a report of address change is only required for a change in the device's primary place of storage.

15. May not hold devices that are not in use for longer than twenty-four (24) months following the last principal activity use.

1. A general license is hereby issued to own, receive, acquire, possess and use tritium or promethium-147 contained in luminous safety devices for use in aircraft, provided each device contains not more than ten (10) curies (370 GBq) of tritium or 300 millicuries (11.1 GBq) of promethium-147 and that each device has been manufactured, assembled, or initially transferred in accordance with the specifications contained in a specific license issued to the manufacturer, assembler, or initial transferor by the Department pursuant to RH-405.h.,or by the U.S. Nuclear Regulatory Commission or an Agreement State pursuant to equivalent requirements.

2. Persons who own, receive, acquire, possess or use luminous safety devices pursuant to the general license in RH-402.f.1. are exempt from the requirements of Section 3, except that they shall comply with the provisions of RH-1501. and RH-1502.

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

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

5. The general license in paragraph f.1. of this section is subject to the provisions of RH-409., RH-416., Part E of Section 2, RH-600., RH-602., RH-603., RH-700., RH-751., and Section 4.

1. A general license is hereby issued to those persons listed below to own, receive, acquire, possess, use, and transfer, in accordance with the provisions of paragraphs g.4. and g.5. of this section, americium-241 in the form of calibration or reference sources:

2. A general license is hereby issued to own, receive, possess, use, and transfer plutonium in the form of calibration or reference sources in accordance with the provisions of paragraphs g.4. and g.5. of this section to any person who holds a specific license issued by the Department which authorizes receipt, possession, use, and transfer of radioactive material.

3. A general license is hereby issued to own, receive, possess, use, and transfer radium-226 in the form of calibration or reference sources in accordance with the provisions of paragraphs g.4. and g.5. of this section to any person who holds a specific license issued by the Department which authorizes receipt, possession, use, and transfer of radioactive material.

4. The general licenses in paragraphs g.1. through g.3. of this section apply only to calibration or reference sources which have been manufactured or initially transferred in accordance with the specifications contained in a specific license issued to the manufacturer or initial transferor of the sources by the Department pursuant to RH-405.i., or by the U.S. Nuclear Regulatory Commission or an Agreement State pursuant to equivalent requirements.

5. The general licenses in paragraphs g.1. through g.3. of this section are subject to the provisions of RH-301.a.4., RH-409., RH-416., Part E of Section 2, RH-600. through RH-603., RH-700., RH-751., Section 3, and Section 4. In addition, persons who own, receive, acquire, possess, use, or transfer one (1) or more calibration or reference sources pursuant to these general licenses:

6. These general licenses do not authorize the manufacture, import, or export of calibration or reference sources containing americium-241, plutonium, or radium-226.

1. A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium-90 contained in ice detection devices, provided each device contains not more than 50 microcuries (1.85 MBq) of strontium-90 and that each device has been manufactured or initially transferred in accordance with the specifications contained in a specific license issued to the manufacturer or initial transferor by the Department pursuant to RH-405.k., or by the U.S. Nuclear Regulatory Commission or an Agreement State pursuant to equivalent requirements.

2. Persons who own, receive, acquire, possess, use, or transfer strontium-90 contained in ice detection devices pursuant to the general license in paragraph i.1. of this section:

3. This general license does not authorize the manufacture, assembly, disassembly, repair, import, or export of strontium-90 in ice detection devices.

4. The general license in paragraph i.1. of this section is subject to the provisions of RH-409., RH-416., Part E of Section 2, RH-600., RH-602., RH-603., RH-700., RH-751., and Section 4.

1. A general license is hereby issued to any person to acquire, receive, possess, use, or transfer, in accordance with the provisions of RH-402.j.2. through 4., radium-226 contained in the following products manufactured prior to November 30, 2007.

2. Persons who acquire, receive, possess, use, or transfer radioactive material under the general license issued in RH-402.j.1. are exempt from the provisions of Section 3, and RH-600. and RH-601., to the extent that the receipt, possession, use, or transfer of radioactive material is within the terms of the general license; provided, however, that this exemption shall not be deemed to apply to any such person specifically licensed under this Section.

3. Any person who acquires, receives, possesses, uses, or transfers radioactive material in accordance with the general license in RH-402.j.1. shall:

4. The general license in RH-402.j.1. does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium-226, except that timepieces may be disassembled and repaired.

1. A general license is hereby issued to any physician, veterinarian, clinical laboratory, or hospital to receive, acquire, possess, transfer, or use, for any of the following stated tests, in accordance with the provisions of RH-402.k.2., 3., 4., 5. and 6. of this paragraph k., the following radioactive materials in prepackaged units:

2. No person shall receive, acquire, possess, use, or transfer radioactive material pursuant to the general license established by RH-402.k.1. until the individual has filed RC FORM 512, "Registration Certificate - In Vitro Testing with Radioactive Material under General License," with the General License Registration Program, Radiation Control Section, Arkansas Department of Health and received from the Department a validated copy of this form with registration number assigned or until he has been authorized pursuant to RH-8013. to use radioactive material under the general license in RH-402.k. The registrant shall furnish on the above form the following information and such other information as may be required by that form:

3. A person who receives, acquires, possesses, or uses radioactive material pursuant to the general license established by RH-402.k.1. shall comply with the following:

4. The general licensee shall not receive, acquire, possess, or use radioactive material pursuant to RH-402.k.1.:

5. The registrant possessing or using radioactive material under the general license of RH-402.k.1. shall report in writing to the Radiation Control Section, any changes in the information furnished by him in the RC FORM 512, "Registration Certificate -In Vitro Testing with Radioactive Material under General License." The report shall be furnished within thirty (30) days after the effective date of such change.

6. Any person using radioactive material pursuant to the general license of RH-402.k.1. is exempt from the requirements of Section 3, "Standards for Protection Against Radiation," with respect to radioactive material covered by that general license, except that such persons using the Mock Iodine-125 described in RH-402.k.1.G. shall comply with the provisions of RH-1400., RH-1501., and RH-1502.

1. Each application to possess radioactive materials in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities in RH-905., Schedule F to Section 2 - "Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release," must contain either:

2. One or more of the following factors may be used to support an evaluation submitted under RH-403.g.1.A.:

3. An emergency plan for responding to a release of radioactive material submitted under RH-403.g.1.B. must include the following information:

4. The licensee shall allow the Department and the offsite response organizations expected to respond in case of an accident sixty (60) days to comment on the licensee's emergency plan before submitting it in final form to the Department. The licensee shall provide any comments received within the sixty (60) days to the Department with the emergency plan.

1.

Except as provided in paragraphs h.2., h.3., and h.4. of this section, an application for a specific license to use radioactive material in the form of a sealed source or in a device that contains the sealed source must either:

2. For sources or devices manufactured before October 23, 2012 that are not registered with the NRC under 10 CFR 32.210 or with an Agreement State, and for which the applicant is unable to provide all categories of information specified in 10 CFR 32.210(c), the application must include:

3. For sealed sources and devices allowed to be distributed without registration of safety information in accordance with 10 CFR 32.210(g)(1), the applicant may supply only the manufacturer, model number, and radionuclide and quantity.

4. If it is not feasible to identify each sealed source and device individually, the applicant may propose constraints on the number and type of sealed sources and devices to be used and the conditions under which they will be used, in lieu of identifying each sealed source and device.

1. A request for authorization for the production of PET radionuclides or evidence of an existing license issued under this Section or Agreement State requirements for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.

2. Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in RH-405.l.1.B.

3. Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in RH-405.l.2.B.

4. Information identified in RH-405.l.1.C. on the PET drugs to be noncommercially transferred to members of its consortium.

1. Special requirements for issuance of specific licenses under RH-405.a.1.

2. Conditions of specific licenses issued pursuant to RH-405.a.1.

Each person licensed pursuant to RH-405.a.1. shall:

1. Special requirements for issuance of specific licenses under RH-405.b.1.

An application for a specific license to initially transfer source material for use under RH-401.a., or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State, will be approved if:

2. Conditions of specific licenses issued pursuant to RH-405.b.1.

1. An application for a specific license to manufacture or initially transfer devices containing radioactive material, excluding special nuclear material, to persons generally licensed under RH-402.a. or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State will be approved if:

2. In the event the applicant desires that the device be required to be tested at intervals longer than six (6) months, either for proper operation of the on-off mechanism and indicator, if any, or for leakage of radioactive material or for both, he shall include in his application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the on-off mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the Department will consider information which includes, but is not limited to:

3. In the event the applicant desires that the general licensee under RH-402.a., or under equivalent regulations of the NRC or an Agreement State, be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the on-off mechanism and indicator or remove the device from installation, he shall include in his application written instructions to be followed by the general licensee, estimated calendar year doses associated with such activity or activities and bases for such estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage and use of devices under the general license, is unlikely to cause that individual to receive a calendar year dose in excess of ten percent (10%) of the limits specified in RH-1200.a.

4.

5. Material transfer reports and records.

Each person licensed under RH-405.e. to initially transfer devices to generally licensed persons shall comply with the requirements of this subparagraph.

1. An application for a specific license to manufacture, assemble, repair, or initially transfer luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under RH-402.f., will be approved if:

2. Labeling of devices.

3. Quality assurance; prohibition of transfer.

4. Material transfer reports.

1. An application for a specific license to manufacture or initially transfer calibration or reference sources containing americium-241, plutonium, or radium-226 for distribution to persons generally licensed under RH-402.g. will be approved if:

2. Labeling of devices.

Each person licensed under RH-405.i.. shall affix to each source, or storage container for the source, a label which shall contain sufficient information relative to safe use and storage of the source and shall include the following statement or a substantially similar statement which contains the information called for in the following statement: 9/

"The receipt, possession, use, and transfer of this source, Model __, Serial No. __, are subject to a general license and the regulations of the United States Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

CAUTION--RADIOACTIVE MATERIAL

THIS SOURCE CONTAINS AMERICIUM-241

[PLUTONIUM OR RADIUM-226].

DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

____________________________________________

Name of manufacturer or initial transferor"

3. Leak testing of each source.

Each person licensed under RH-405.i. shall perform a dry wipe test upon each source containing more than 0.1 microcuries (3.7 kBq) of americium-241, plutonium, or radium-226 before transferring the source to a general licensee under RH-402.g. or under equivalent regulations of the NRC or of an Agreement State. This test shall be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the filter paper shall be measured using methods capable of detecting 0.005 microcuries (185 Bq) of americium-241, plutonium, or radium-226. If a source has been shown to be leaking or losing more than 0.005 microcuries (185 Bq) of americium-241, plutonium, or radium-226 by the methods described in RH-405.i.3., the source must be rejected and must not be transferred to a general licensee under RH-402.g., or equivalent regulations of the NRC or an Agreement State.

1. The applicant satisfies the general requirements specified RH-404.; and

2. The radioactive material is to be prepared for distribution in prepackaged units of:

3. Each prepackaged unit bears a durable, clearly visible label:

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

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

____________________________________

(name of manufacturer)"

5. The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements set out in RH-1400.

1. An application for a specific license to manufacture or initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under RH-402.i. will be approved if:

2. Quality assurance; prohibition of transfer.

1. An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing radioactive material for use by persons authorized pursuant to Section 9, "Use of Radionuclides in the Healing Arts," will be approved if:

2. A licensee described by RH-405.l.1.B.iii. or RH-405.l.1.B.iv. of this paragraph l.:

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

4. Nothing in this paragraph l. relieves the licensee from complying with applicable U.S. Food and Drug Administration, other Federal, and State requirements governing radioactive drugs.

1. An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed under Section 9, "Use of Radionuclides in the Healing Arts," for use as a calibration, transmission, or reference source or for the uses listed in RH-8600., RH-8620., RH-8630., and RH-8670. will be approved if:

2.

1. A "Type A specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license, for any authorized purpose. The quantities specified are usually in the multicurie range.

2. A "Type B specific license of broad scope" is specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in RH-904., Schedule E to Section 2, for any authorized purpose. The possession limit for a Type B broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Schedule E to Section 2, Column I. If two or more radionuclides are possessed thereunder, the possession limit for each is determined as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in Schedule E to Section 2, Column I, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

3. A "Type C specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in RH-904., Schedule E to Section 2, for any authorized purpose. The possession limit for a Type C broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Schedule E to Section 2, Column II. If two or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in Schedule E to Section 2, Column II, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

1. The applicant satisfies the general requirements specified in RH-404.;

2. The applicant has engaged in a reasonable number of activities involving the use of radioactive material; and

3. The applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting and management review that are necessary to assure safe operations, including:

1. The applicant satisfies the general requirements specified in RH-404.; and

2. The applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to assure safe operations, including:

1. The applicant satisfied the general requirements specified in RH-404.; and

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

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

1. Persons licensed pursuant to RH-406. shall not:

2. Each Type A specific license of broad scope issued under this section shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety committee.

3. Each Type B specific license of broad scope issued under this section shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiological safety officer.

4. Each Type C specific license of broad scope issued under this section shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals who satisfy the requirements of paragraph d. of this RH-406.

1. The general information must include each of the following:

2. The specific technical information must include the following information needed for demonstration that the performance objectives of RH-407.c. and the applicable technical requirements of RH-407.d. will be met:

3. The institutional information must include:

4. The financial information must 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 as specified in RH-407.e.

5. Any expiration date on a license applies only to the above ground activities and to the authority to dispose of waste. Failure to renew the license shall not relieve the licensee of responsibility for carrying out site closure, post-closure observation and transfer of the license to the site owner. An application for renewal or an application for closure must be filed at least thirty (30) days prior to license expiration.

6. Contents of an application for closure.

7. Transfer of license.

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. General requirement.

Land disposal facilities must be sited, designed, operated, closed and controlled after closure so that reasonable assurance exists that exposures to humans are within the limits established in the performance objectives in RH-407.c.2. through 5.

2. Protection of the general population from releases of radioactivity.

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 an equivalent of 25 millirems to the whole body, 75 millirems to the thyroid and 25 millirems to any other organ of 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.

3. Protection of individuals from inadvertent intrusion.

Design, operation and closure of the land disposal facility must ensure protection of any individual inadvertently intruding into the disposal site and occupying the site or contacting the waste at any time after active institutional controls over the disposal site are removed.

4. Protection of individuals during operations.

Operations at the land disposal facility must be conducted in compliance with the standards for radiation protection set out in Section 3 of these Regulations, except for releases of radioactivity in effluents from the land disposal facility which shall be governed by RH-407.c.2. Every reasonable effort shall be made to maintain radiation exposures as low as is reasonably achievable.

5. Stability of the disposal site after closure.

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

1. Disposal site suitability for near-surface disposal.

2. Disposal site design for near-surface disposal.

3. Near-surface disposal facility operation and disposal site closure.

4. Environmental monitoring.

5. The Department may, upon request or on its own initiative, authorize provisions other than those set forth in RH-407.d.2. through 4. for the segregation and disposal of waste and for the design and operation of a land disposal facility on a specific basis, if it finds reasonable assurance of compliance with the performance objectives in RH-407.c.

6. Classification of waste for near-surface disposal.

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, improved waste form and deeper disposal 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.

7. Waste characteristics.

8. Each package must be clearly labeled to identify whether it is Class A waste, Class B waste, or Class C waste in accordance with RH-407.d.6.

9. The Department may, upon request or on its 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, it finds reasonable assurance of compliance with the performance objectives in RH-407.c.

10. Institutional requirements.

1. The applicant shall provide assurance that sufficient funds will be available to carry out disposal site closure and stabilization, including decontamination or dismantlement of land disposal facility structures; and 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. 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 capital costs that would be incurred if an independent contractor were hired to perform the closure and stabilization work.

2. In order to avoid unnecessary duplication and expense, the Department will accept financial sureties that have been consolidated with earmarked financial or surety arrangements established to meet requirements of other Federal or State agencies and/or local governing bodies for such decontamination, closure and stabilization. The Department will accept this arrangement only if they are considered adequate to satisfy these requirements and that the portion of the surety which covers the closure of the disposal site is clearly identified and committed for use in accomplishing these activities.

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 surety liability should change in accordance with the predicted cost of future 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. This will yield a surety that is at least sufficient at all times to cover the costs of closure of the disposal units that are expected to be used before the next license renewal.

5. The term of the surety mechanism must be open-ended unless it can be demonstrated that another arrangement would provide an equivalent level of assurance. This assurance could be provided with a surety mechanism which is written for a specified period of time (e.g., five (5) years) yet which must be automatically renewed unless the party who issues the surety notifies the Department and the beneficiary (the licensee) not less than ninety (90) 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 (30) days after notification of cancellation. If the licensee fails to provide a replacement surety acceptable to the Department, the site owner may collect on the original surety.

6. Proof of forfeiture must 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 would have to be clearly stated on any surety instrument which is not open-ended and must be agreed to by all parties. Liability under the surety mechanism must 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.

7. Financial surety arrangements generally acceptable to the Department include surety bonds, cash deposits, certificates of deposits, deposits of government securities, escrow accounts, irrevocable letters or lines of credit, trust funds and combinations of the above or such other types of arrangements as may be approved by the Department. However, self-insurance or any arrangement which essentially constitutes pledging the assets of the licensee will not satisfy the surety requirement for private sector applicants since this provides no additional assurance other than that which already exists through license requirements.

1. No license issued or granted pursuant to these Rules nor any right under a license shall be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person, unless the Department shall, after securing full information, find that the transfer is in accordance with the provisions of the Act and shall give its consent in writing.

2. An application for transfer of license must include:

1. Protect health or to minimize danger to life or property;

2. Require such reports and the keeping of such records and to provide for such inspections of activities under the license as may be necessary or appropriate to effectuate the purposes of the Act and rules thereunder; and

3. Prevent loss or theft of licensed material.

1. Each general licensee that is required to register by RH-402.c.13. and each specific licensee shall notify the Department in writing immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of Title 11 (Bankruptcy) of the United States Code by or against:

2. This notification must indicate:

1.

2. Each applicant for a specific license authorizing possession and use of radioactive material of half-life greater than 120 days and/or source material, in quantities specified in RH-409.h.4., shall either:

3.

4. Table of required amounts of financial assurance for decommissioning by quantity of material.

Licensees required to submit the $1,125,000 amount must do so by December 2, 2006. Licensees required to submit the $113,000 or $225,000 amount must do so by June 2, 2007. Licensees having possession limits exceeding the upper bounds of this table must base financial assurance on a decommissioning funding plan.

Greater than 104 but less than or equal to 105 times the applicable quantities in Appendix E to Section 2 in unsealed form.

(For a combination of isotopes, if R, as defined in RH-409.h.1.A., divided by 104 is greater than 1 but R divided by 105 is less than or equal to 1). $1,125,000

Greater than 103 but less than or equal to 104 times the applicable quantities in Appendix E to Section 2 in unsealed form.

(For a combination of isotopes, if R, as defined in RH-409.h.1.A., divided by 103 is greater than 1 but R divided by 104 is less than or equal to 1). $225,000

Greater than 1010 but less than or equal to 1012 times the applicable quantities in Appendix E to Section 2 in sealed sources or plated foils.

(For a combination of isotopes, if R, as defined in RH-409.h.1.A., divided by 1010 is greater than 1, but R divided by 1012 is less than or equal to 1). $113,000

Greater than 10 mCi but less than or equal to 100 mCi of source material in a readily dispersible form.. $225,000

5.

6. The financial instrument must include the licensee's name, license number, and the name, address, and other contact information of the issuer, and, if a trust is used, the trustee. When any of the foregoing information changes, the licensee must, within 30 days, submit financial instruments reflecting such changes. The financial instrument submitted must be a signed original or signed original duplicate, except where a copy of the signed original is specifically permitted. Financial assurance for decommissioning must be provided by one or more of the following methods:

7. Each person licensed under these Regulations shall keep records of information important to decommissioning of the facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned in accordance with RH-409.b., licensees shall transfer all records described in this paragraph to the new licensee. In this case, the new licensee will be responsible for maintaining these records until the license is terminated.

If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. Information the Department considers important to decommissioning consists of:

8. In providing financial assurance under RH-409.h., each licensee must use the financial assurance funds only for decommissioning activities and each licensee must monitor the balance of funds held to account for market variations. The licensee must replenish the funds, and report such actions to the Department, as follows:

1. Authorization under RH-403.j. to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs.

2. Each licensee authorized under RH-403.j. to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall:

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

2. Continue to control entry to restricted areas until they are suitable for release in accordance with Department requirements.

1. The license has expired pursuant to RH-410.a. or RH-410.b.; or

2. The licensee has decided to permanently cease principal activities, as defined in this Section, at the entire site or in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with Department requirements; or

3. No principal activities under the license have been conducted for a period of twenty-four (24) months; or

4. No principal activities have been conducted for a period of twenty-four (24) months in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with Department requirements.

1. Any licensee who has not provided financial assurance to cover the detailed cost estimate submitted with the decommissioning plan shall do so when this regulation becomes effective July 1, 2002.

2. Following approval of the decommissioning plan, a licensee may reduce the amount of the financial assurance as decommissioning proceeds and radiological contamination is reduced at the site with the approval of the Department.

1.

A decommissioning plan must be submitted if required by license conditions or if the procedures and activities necessary to carry out decommissioning of the site or separate building or outdoor area have not been previously approved by the Department and these procedures could increase potential health and safety impacts to workers or to the public, such as in any of the following cases:

2. The Department may approve an alternate schedule for submittal of a decommissioning plan required in RH-410.d. if the Department determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and presents no undue risk from radiation to the public health and safety and is otherwise in the public interest.

3. Procedures such as those listed in RH-410.g.1. with potential health and safety impacts may not be carried out prior to approval of the decommissioning plan.

4. The proposed decommissioning plan for the site or separate building or outdoor area must include:

5. The proposed decommissioning plan will be approved by the Department if the information therein demonstrates that the decommissioning will be completed as soon as practicable and that the health and safety of workers and the public will be adequately protected.

1. Except as provided in RH-410.i., licensees shall complete decommissioning of the site or separate building or outdoor area as soon as practicable but no later than twenty-four (24) months following the initiation of decommissioning.

2. Except as provided in RH-410.i., when decommissioning involves the entire site, the licensee shall request license termination as soon as practicable but no later than twenty-four (24) months following the initiation of decommissioning.

1. Whether it is technically feasible to complete decommissioning within the allotted twenty-four (24) month period;

2. Whether sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted twenty-four (24) month period;

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

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

5. Other site-specific factors which the Department may consider appropriate on a case-by-case basis, such as the regulatory requirements of other government agencies, lawsuits, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.

1. Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed, up-to-date RC FORM 530, "Certificate of Disposition of Materials," or equivalent information; and

2. Conduct a radiation survey of the premises where the licensed activities were carried out, and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning in RH-1216., RH-1217., and/or RH-1218. The licensee shall, as appropriate:

1. Radioactive material has been properly disposed;

2. Reasonable effort has been made to eliminate residual radioactive contamination, if present; and

3.

4. Records required by RH-600. have been received.

1. The Department;

2. The U.S. Department of Energy;

3. Any person exempt from these Regulations to the extent permitted under such exemption;

4. Any person in an Agreement State, subject to the jurisdiction of that State, who has been exempted from the licensing requirements and regulations of that State, to the extent permitted under such exemption;

5. Any person in U.S. Nuclear Regulatory Commission (NRC) jurisdiction, subject to the jurisdiction of the NRC, who has been exempted from the licensing requirements and regulations of the NRC, to the extent permitted under such exemption;

6. Any person authorized to receive such material under terms of a general license or a specific license or their equivalents issued by the Department, the NRC, or an Agreement State; or

7. As otherwise authorized by the Department in writing.

1. The transferor may have in his possession, and read, a current copy of the transferee's specific license or registration certificate.

2. The transferor may have in his possession a written certification by the transferee that he is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date;

3. For emergency shipments the transferor may accept oral certification by the transferee that he is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date; provided, that the oral certification is confirmed in writing within ten (10) days;

4. The transferor may obtain other sources of information compiled by a reporting service from official records of the Department, the NRC, or the licensing agency of an Agreement State as to the identity of licensees and the scope and expiration dates of licenses and registrations; or

5. When none of the methods of verification in RH-501.c.1. through 4. are readily available or when a transferor desires to verify that information received by one of such methods is correct or up-to-date, the transferor may obtain and record confirmation from the Department, the NRC, or the licensing agency of an Agreement State that the transferee is licensed to receive the radioactive material.

1. The licensee shall retain each record of receipt of radioactive material as long as the material is possessed and for three (3) years following transfer or disposal of the material.

2. The licensee who transferred the material shall maintain each record of transfer for three (3) years after each transfer unless a specific requirement in another part of these Regulations dictates otherwise.

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

4. If radioactive material is combined or mixed with other licensed material and subsequently treated in a manner that makes direct correlation of a receipt record with a transfer, export, or disposition record impossible, the licensee may use evaluative techniques (such as first-in-first-out) to make the records that are required by this Section account for 100 percent (100%) of the material received.

1. The licensee shall retain each record that is required by the regulations in this Section, Part I of Section 3, Part J of 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.

2. If there is a conflict between the Department's regulations in this Section, Part I of Section 3, Part J of Section 3, and Sections 7, 8, and 9 of these Regulations, license condition, or other written Department approval or authorization pertaining to the retention period for the same type of record, the retention period specified in the regulations in this Section, Part I of Section 3, Part J of Section 3, and Sections 7, 8, and 9 of these Regulations for such records shall apply unless the Department, pursuant to RH-304., has granted a specific exemption from the record retention requirements specified in the regulations in this Section, Part I of Section 3, Part J of Section 3, and Sections 7, 8, and 9 of these Regulations.

1. Records of disposal of licensed material made under RH-1401., RH-1402., a previous RH-1403. that authorized certain burials 11/, RH-1404., RH-1405., RH-1408.; and

2. Records required by RH-1500.c.2.D.

1. Records of disposal of licensed material made under RH-1401., RH-1402., a previous RH-1403. that authorized certain burials 11/, RH-1404., RH-1405., RH-1408.; and

2. Records required by RH-1500.c.2.D.

1. An unplanned contamination event that:

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

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

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

1. Licensees shall make reports required by paragraphs a. and b. of this section by telephone to the Department at 1-800-633 -1735. To the extent that the information is available at the time of notification, the information provided in these reports must include:

2. Written report.

Each licensee that makes a report required by paragraph a. or b. of this section shall submit a written follow-up report within thirty (30) days of the initial report. Written reports prepared pursuant to other regulations may be submitted to fulfill this requirement if the reports contain all of the necessary information and the appropriate distribution is made. These written reports must be sent to the Arkansas Department of Health, Radiation Control Section Chief, 4815 West Markham Street, Slot 30, Little Rock, Arkansas, 722053867. The reports must include the following:

1. Subject to these regulations, any person who holds a specific license from the NRC or an Agreement State, and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within this State for a period not in excess of 180 days in any calendar year provided that:

2. Notwithstanding the provisions of RH-750.a.1., any person who holds a specific license issued by the NRC or an Agreement State authorizing the holder to manufacture, transfer, install, or service a device described in RH-401., RH-402.a., and RH-402.h. within areas subject to the jurisdiction of the licensing body is hereby granted a general license to install, transfer, demonstrate, or service such a device in this State provided that:

3. The Department may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by the NRC or an Agreement State, or any product distributed pursuant to such licensing document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property.

1. Subject to these regulations and Section 7 of these regulations, any person who holds a specific license from a Licensing State, and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within this State for a period not in excess of 180 days in any calendar year provided that:

2. Notwithstanding the provisions of RH-750.b.1., any person who holds a specific license issued by a Licensing State authorizing the holder to manufacture, transfer, install, or service a device described in RH-401., RH-402.a., and RH-402.h. within areas subject to the jurisdiction of the licensing body is hereby granted a general license to install, transfer, demonstrate, or service such a device in this State provided that:

3. The Department may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by a Licensing State, or any product distributed pursuant to such licensing document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property.

1. Before radioactive materials can be used at a temporary job site within the State at any Federal facility, the jurisdictional status of the job site shall be determined. If the jurisdictional status is unknown, the Federal agency should be contacted to determine if the job site is under exclusive Federal jurisdiction.

2. Before radioactive material can be used at a temporary job site in another State, authorization shall be obtained for the State if it is an Agreement State, or from the NRC for any non-Agreement State, either by filing for reciprocity or applying for a specific license.