Arkansas Administrative Code
Agency 007 - Arkansas Department of Health
Division 14 - Radiation Control and Emergency Management
Rule 007.14.17-001 - Rules and Regulations for Control of Sources of Ionizing Radiation
Current through Register Vol. 49, No. 9, September, 2024
SECTION 1. REGISTRATION OF SOURCES OF RADIATION
Act 96 of 1913, Act 8 of Second Extraordinary Special Session of 1961, as Amended.
Every person possessing a reportable source of radiation shall register in accordance with the provisions of these Regulations.
All communications concerning these Regulations shall be addressed to the Arkansas Department of Health, Radiation Control Section, 4815 West Markham Street, Slot 30, Little Rock, Arkansas, 72205-3867.
In addition to the requirements of this Section, all registrants are subject to the applicable provisions of other Sections of these Regulations.
Act - Act 8 of Second Extraordinary Special Session of 1961, as amended.
Decommission- To remove (as a facility) safely from service and reduce residual radioactivity to a level that permits release of the property for unrestricted use and termination of license.
Department- The Arkansas Department of Health.
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.
Installation- The location where one or more reportable sources of radiation are used, operated or stored.
Person - Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this state or any other state or political subdivision or agency thereof and any legal successor, representative, agent or agency of the foregoing, other than the United States Nuclear Regulatory Commission and other federal government agencies.
Possessing a source of radiation- Using, operating, storing, manufacturing or otherwise having control of a source of radiation in the State of Arkansas.
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 or radio waves or visible, infrared or ultraviolet light.
Radiation machine- Any device capable of producing radiation, but excluding particle accelerators and devices which produce radiation only by the use of radioactive material.
Radioactive material- Any material, solid, liquid, or gas which emits radiation spontaneously, including any natural radioactive material such as radium.
Registrant - Any person who is registering or who has registered with the Department pursuant to these Regulations.
Reportable source of radiation- Any source of radiation as specified under RH-20 of these Regulations.
Source of radiation- Any radioactive material or device or equipment emitting or capable of producing any radiation.
The following constitute reportable sources of radiation: radiation machines, except when not installed in such manner as to be capable of producing radiation.
Every person possessing a registered source of radiation shall renew such registration with the Department during December of each year for the following year, as long as the activity requiring such registration continues and at such other times as the Department shall deem necessary.
Registration and renewal shall be made on forms furnished by the Department. The registration or renewal of registration shall set forth all applicable information called for by the form. The Department may request additional information as part of the registration process.
Every person who registers shall complete a separate registration form for each installation.
If the reporting of each installation or other information called for is impractical, the Department, upon the request of a registrant, may approve registration in such special form as the Department may prescribe.
The registrant shall notify the Department in writing of any changes that would render the information contained in the application for registration no longer accurate, including, but not limited to, the following changes: name or mailing address of the registrant; location of the installation or an additional use location; designation of the Radiation Safety Officer; and the receipt, sale, or disposal of any reportable source of radiation. Notification of the Department is required within ten (10) days of a change, unless the change involves a machine use listed in RH-21.b. Changes regarding RH-21.b. uses must be reported in writing to the Department prior to the change being made.
Every registrant who permanently discontinues the use of, or permanently disposes of, all his reportable sources of radiation at an installation shall notify the Department within ten (10) days of such action.
This Part provides for the registration of persons providing radiation machine installation, servicing and/or vendor services to licensees or registrants.
Each individual who is engaged in the business of installing or offering to install radiation machines, or is engaged in the business of furnishing or offering to furnish radiation machine servicing or services in this state to a Department registrant, shall apply for registration of such services with the Department on July 1, 1983 or thereafter, prior to furnishing or offering to furnish any such services.
Registration and renewal shall be completed on forms furnished by the Department and shall contain all information required by the Department as indicated on the forms and accompanying instructions.
Each person applying for registration under this Part shall specify the training and experience that qualify the individual to discharge the services for which the individual is applying for registration.
Each registrant described in this Part shall not provide the services until such persons provide evidence that they have been registered with the Department. For the purpose of this Part, services may include but shall not be limited to:
The following materials and devices do not require registration:
Common and contract carriers are exempt from the requirement to register to the extent that they transport or store reportable sources of radiation in the regular course of their carriage for another or storage incident thereto.
Any person possessing a radiation machine that is a reportable source of radiation or who provides radiation machine installations and/or services shall be subject to the requirements of Section 3 of these Regulations, "Standards for Protection Against Radiation."
Each person who possesses a reportable source of radiation shall keep records showing the receipt (for any source received after January 1, 1963), transfer or disposal of such source of radiation. Additional record requirements are specified elsewhere in these Regulations.
The Department or its duly authorized representatives shall for reasonable cause have the power to enter at all reasonable times upon any private or public property for the purpose of determining whether or not there is compliance with or violation of the provisions of these rules and regulations, except that entry into areas under the jurisdiction of the federal government shall be effected only with the concurrence of the federal government or its duly designated representative.
Each registrant shall, upon reasonable notice, make available for inspection by the Department records kept by the registrant pertaining to his receipt, possession, use, transfer or disposal of sources of radiation.
Upon instruction from the Department, each registrant shall perform or cause to have performed and shall permit the Department to perform, such reasonable tests as the Department deems appropriate or necessary in the administration of the regulation, including, but not limited to, tests of:
The Department may, by rule, regulation or order, impose upon any registrant such requirements in addition to those established in this Regulation as it deems appropriate or necessary to minimize danger to public health and safety or property.
Whenever any radiation machine is brought into the state for any temporary use, the persons proposing to bring such a machine into the state shall give written notice to the Department at least two (2) days before such a machine enters the state. The notice shall include the type of radiation machine; the nature, duration and scope of use; and the exact location where the radiation machine is to be used and state(s) in which this machine is registered.
If for a specific case, the two (2) day period would impose an undue hardship on the person, upon application to the Department, permission to proceed sooner may be granted. In addition, the out-of-state person must:
In accordance with Arkansas Code Annotated § 20-21-217, annual fees for registration shall be paid. Nonpayment of fees shall result in escalated enforcement action and/or revocation of registration.
In accordance with Arkansas Code Annotated § 20-21-217, X-ray Registration Fees are as follows:
No hand-held fluoroscopic screen shall be used.
No shoe-fitting device or shoe-fitting machine which uses fluoroscopic, x-ray or radiation principles shall be operated or maintained in this state.
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.
Sources of radiation shall be subject to impounding pursuant to Section 5 of these Regulations.
SECTION 2. LICENSING OF RADIOACTIVE MATERIALS (FOOTNOTES APPEAR AT THE END OF THIS SECTION)
The provisions of these Regulations shall become operative on the effective date of an agreement executed by the State of Arkansas and the Federal Government under the provisions of Section 274 of the Atomic Energy Act of 1954, as amended (73 Stat. 689).
In accordance with Act 596 of 2011, codified at Arkansas Code Annotated § 20-21-217, annual fees for licensing shall be paid. Nonpayment of fees shall result in escalated enforcement action and/or revocation of license.
The following Radioactive Material Fees are based upon 15% of the U. S. Nuclear Regulatory Commission's Federal Fiscal Year 2012 annual fees found in 10 CFR 171.16.
|
CATEGORY |
CODE |
FEE |
|
Academic Broad Scope |
01120 |
$2,115.00 |
|
Academic R&D |
03620 |
$1,215.00 |
|
Accelerator Produced Radionuclides |
03210 |
$2,280.00 |
|
Consultant Services |
03225 |
$2,145.00 |
|
Eye Applicator (Sr-90) |
02210 |
$1,260.00 |
|
Gamma Knife |
02310 |
$2,625.00 |
|
Gas Chromatographs |
03123 |
$720.00 |
|
High Dose Rate Remote Afterloader |
02230 |
$1,260.00 |
|
Industrial Radiography |
03310 |
$3,855.00 |
|
Instrument Calibration |
03221; 03222 |
$720.00 |
|
In-vitro Testing |
02410 |
$720.00 |
|
Irradiators - Activity < 10,000 Curies |
03511 |
$2,280.00 |
|
Irradiators - Activity [GRATER THAN OR EQUAL TO] 10,000 Curies |
03521 |
$20,625.00 |
|
Irradiators - Self-shielded |
03510 |
$1,305.00 |
|
Manufacturing & Distributing |
03214 |
$1,770.00 |
|
Measuring Systems - Analytical Devices |
03122 |
$720.00 |
|
Measuring Systems - Fixed Gauge |
03120 |
$720.00 |
|
Measuring Systems - Portable Gauge |
03121 |
$720.00 |
|
Medical Broad Scope |
02110 |
$6,810.00 |
|
Medical Facility - No Written Directive Required |
02121 |
$1,260.00 |
|
Medical Facility - Written Directive Required |
02120 |
$1,260.00 |
|
Medical Private Practice |
02200; 02201 |
$1,260.00 |
|
Medical Therapy |
02240 |
$1,260.00 |
|
Mobile Medical Services |
02231 |
$1,260.00 |
|
Nuclear Pharmacy |
02500 |
$2,430.00 |
|
Veterinary |
02400 |
$720.00 |
|
Well Logging - Including Tracers |
03110; 03111; 03112 |
$1,500.00 |
|
Other Radioactive Material (non-NORM) Decommissioning |
$5,000.00 |
|
CATEGORY |
FEE |
|
Certain measuring, gauging, and controlling devices |
$720.00 |
|
Generally licensed gas chromatographs |
$720.00 |
|
Static elimination devices |
$125.00 |
|
Source material devices |
$500.00 |
|
Devices containing depleted uranium |
$500.00 |
|
Public safety devices containing radioactive material |
$25.00 |
|
All other general license registrations other than those specified above |
$300.00 |
|
Portable and fixed gauges |
$1,125.00 |
|
CATEGORY |
FEE |
|
Naturally Occurring Radioactive Material (NORM) License |
$2,500.00 |
|
Naturally Occurring Radioactive Material (NORM) Site - General License |
$500.00 |
|
Arkansas State Board of Health Rules and Regulations for Control of Sources of Ionizing |
$0.00 for first copy $30.00 for each additional copy |
|
Radiation |
|
|
Amendment to existing license |
$50.00 per amendment |
|
CATEGORY |
FEE |
|
Naturally Occurring Radioactive Material (NORM) Decommissioning |
$2,500.00 |
|
Other Radioactive Material (non-NORM) Decommissioning |
$5,000.00 |
|
Radiography, Field |
$3,855.00 |
|
Well Logging with Sealed Sources Only |
$1,500.00 |
|
Well Logging with Tracer Studies |
$1,500.00 |
|
Nuclear Gauge |
$720.00 |
|
Consultant |
$2,145.00 |
|
Gas Chromatograph, Lead Paint Analyzer |
$720.00 |
Except where otherwise specified, all communications concerning these Regulations may be addressed to the Arkansas Department of Health, Radiation Control Section, 4815 West Markham Street, Slot 30, Little Rock, Arkansas, 72205-3867.
Except as specifically authorized by the Department in writing, no interpretations of the meaning of the regulations in this Section by an officer or employee of the Department other than a written interpretation by the Department Director or designee will be recognized as binding upon the Department.
Accelerator-produced material - Any material made radioactive by a particle accelerator.
Act - Act 8 of Second Extraordinary Session of 1961, as amended.
Active maintenance - Any significant remedial activity needed during the period of institutional control to maintain a reasonable assurance that the performance objectives in RH-407.c.2. and 3. are met. Such active maintenance includes ongoing activities such as the pumping and treatment of water from a disposal unit or one-time measures such as replacement of a disposal unit cover. Active maintenance does not include custodial activities such as repair of fencing, repair or replacement of monitoring equipment, revegetation, minor additions to soil cover, minor repair of disposal unit covers and general disposal site upkeep such as mowing grass.
Agreement State - Any state with which the Atomic Energy Commission or the U.S. Nuclear Regulatory Commission has entered into an effective agreement under subsection 274 b. of the Atomic Energy Act of 1954 (68 Stat. 919), including any amendments thereto. Non-agreement State means any other State.
Alert - Events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by offsite response organizations to protect persons offsite.
Authorized nuclear pharmacist - A pharmacist who:
Authorized user - A physician, dentist, or podiatrist who:
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 -
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 - 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 1300 F (54.50 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) + 50 (grams U-233) + 50 (grams Pu) = 1 350 200 200
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.
Any person is exempt from this Section and Section 3 to the extent
that such person receives, possesses, uses, or transfers:
or industrial lighting, provided that each lamp does not contain more than two (2) grams of thorium;
August 27, 2013, provided that the glaze contains not more than twenty percent (20%) by weight source material;
percent (2%) by weight source material;
impressed with the legend "CAUTION -RADIOACTIVE SHIELDING - URANIUM"; and
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:
Static elimination devices which contain, as a sealed
source or sources, radioactive material consisting of a total of not more than 500 µCi (18.5 MBq) of polonium-210 per device.
that contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 µCi (18.5 MBq) of polonium-210 per device or of a total of not more than 50 mCi (1.85 GBq) of hydrogen-3 (tritium) per device.
protector tube or ten (10) millicuries of tritium per any electron tube;
And provided further, that the level of radiation due to radioactive material contained in each electron tube does not exceed one (1) millirad per hour at one (1) centimeter from any surface when measured through seven (7) milligrams per square centimeter of absorber.4/
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.
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 µ Ci (3.7 kBq) of radium-226 which were manufactured prior to November 30, 2007.
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.
Common and contract carriers, freight forwarders, warehousemen, and the U.S. Postal Service are exempt from the regulations in this Section and Part I of Section 3, Part J of Section 3, Sections 6 through 9, and Section 12 of these Regulations and the requirements for a license set forth in the Act to the extent that they transport or store radioactive material in the regular course of carriage for another or storage incident thereto.
Any U.S. Department of Energy (DOE) contractor or subcontractor and any U.S. Nuclear of Regulatory Commission (NRC) 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:
The Department may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this Section as it determines are authorized by law and will not result in undue hazard to public health and safety or property, and are otherwise in the public interest.
Licenses for radioactive materials are of two (2) types: general and specific.
General License - provided by regulation, grants authority to a person for certain activities involving radioactive material, and is effective without the filing of an application with the Department or the issuance of a licensing document to a particular person. However, registration with the Department may be required by the particular general license.
Specific License - issued to a named person who has filed an application with the Department for the license under the provisions of these Regulations.
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:
dispersible forms (e.g., gaseous, liquid, powder, etc.) at any one time. Any material processed by the general licensee that alters the chemical or physical form of the material containing source material must be accounted for as a dispersible form. A person authorized to possess, use, and transfer source material under this paragraph may not receive more than a total of 7 kg (15.4 lb) of uranium and thorium in any one calendar year. Persons possessing source material in excess of these limits as of March 1, 2016, may continue to possess up to 7 kg (15.4 lb) of uranium and thorium at any one time for one year beyond this date, or until the Department takes final action on a pending license amendment or application for a specific license submitted on or before March 1, 2017, for such
material; and receive up to 70 kg (154 lb) of uranium or thorium in any one calendar year until December 31, 2017, or until the Department takes final action on a pending license amendment or application for a specific license submitted on or before March 1, 2017, for such material; and
material in accordance with the general license in paragraph a. of this section:
material in a solid, non-dispersible form may be transferred each calendar year, by a person authorized to receive, possess, use, and transfer source material under this general license to persons receiving the material for permanent disposal. The recipient of source material transferred under the provisions of this paragraph is exempt from the requirements to obtain a license under this Section to the extent the source material is permanently disposed. This provision does not apply to any person who is in possession of source material under a specific license issued pursuant to these Regulations; or
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.
uranium pursuant to the general license established by paragraph c.1. of this section shall file RC FORM 513, "Registration Certificate - Use of Depleted Uranium Under General License," with the General License Registration Program, Radiation Control Section, Arkansas Department of Health. The form shall be submitted within 30 days after the first receipt or acquisition of such depleted uranium. Persons possessing depleted uranium pursuant to the general license in paragraph c.1. of this section as of March 1, 2016, shall register the depleted uranium with the Department on or before March 1, 2017. The general licensee shall furnish on the form the following information and such other information as may be required by the form:
and will maintain procedures designed to establish physical control over the depleted uranium described in paragraph c.1. of this section and designed to prevent transfer of such depleted uranium in any form, including metal scrap, to persons not authorized to receive the depleted uranium; and
uranium pursuant to the general license established by paragraph c.1. of this section:
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.
NOTE:Different general licenses are issued in this section, each of which has its own specific conditions and requirements.
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.
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:
licensees described above in RH-402.b.1. or through a transfer made under RH-402.c.9.
radioactive material in a device pursuant to the general license in RH-402.a.:
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;
radioactive material only by export as provided by U.S. Nuclear Regulatory Commission Regulations outlined in Part 110, "Export and Import of Nuclear Equipment and Material," by transfer to another general licensee as authorized by RH-402.c.9., or to a person authorized to receive the device by a specific license issued under Section 2, or Section 2 that authorizes waste collection, or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State, or as otherwise approved under RH-402.c.8.C.
Arkansas Department of Health
Radiation Control Section
ATTN: General License Registration Program
4815 West Markham Street, Slot 30
Little Rock, Arkansas 72205-3867
The report must contain:
(or initial transferor's) name, model number, and serial number;
person receiving the device (license number not applicable if exported); and
transferring the device to any other specific licensee not specifically identified in RH-402.c.8.A.; however, a holder of a specific license may transfer a device for possession and use under its own specific license without prior approval, if, the holder:
possession and use, or applies for and obtains an amendment to the license authorizing the possession and use;
unambiguously augments the existing label (otherwise required by RH-402.c.1.) so that the device is labeled in compliance with RH-1309.; however, the manufacturer, model number, and serial number must be retained;
information concerning maintenance that would be applicable under the specific license (such as leak testing procedures); and
Arkansas Department of Health
Radiation Control Section
ATTN: General License Registration Program
4815 West Markham Street, Slot 30
Little Rock, Arkansas 72205-3867
device transferred;
responsible individual identified by the transferee in accordance with RH-402.c.12. to have knowledge of and authority to take actions to ensure compliance with the appropriate regulations and requirements; or
devices containing at least ten (10) mCi (370 MBq) of cesium-137, 0.1 mCi (3.7 MBq) of strontium-90, one (1) mCi (37 MBq) of cobalt-60, 0.1 mCi (3.7 MBq) of radium-226, one (1) mCi (37 MBq) of nickel-63, or one (1) mCi (37 MBq) of americium-241 or any other transuranic (i.e., element with atomic number greater than uranium (92)), based on the activity indicated on the label. Each address for a location of use, as described under RH-402.c.13.C., represents a separate general licensee and requires a separate registration and fee.
initial transferor), model number, serial number, the radioisotope and activity as indicated on label.
responsible person designated as a representative of the general licensee under RH-402.c.12.
general licensee that the information concerning the device(s) has been verified through a physical inventory and checking of label information.
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.
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:
Department which authorizes receipt, possession, use, and transfer of radioactive material; and
storage or use, more than five (5) microcuries (185 kBq) of americium-241, five (5) microcuries (185 kBq) of plutonium, or five (5) microcuries (185 kBq) of radium-226 in such sources;
"The receipt, possession, use and transfer of this source, Model ______, Serial No. ______, are subject to a general license and the regulations 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. 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)"
A general license is hereby issued to own byproduct material without regard to quantity. Notwithstanding any other provision of these Regulations, a general licensee under this paragraph is not authorized to manufacture, produce, transfer, receive, possess, use, import, or export byproduct material, except as authorized in a specific license.
provisions of RH-409., RH-416., Part E to Section 2, RH-600., RH-602., RH-603., RH-700., RH-751., and Section 4.
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.
Arkansas Department of Health Radiation Control Section Attention: Radioactive Materials Program 4815 West Markham Street, Slot 30 Little Rock, Arkansas 72205
manufacture, assembly, disassembly, repair, or import of products containing radium-226, except that timepieces may be disassembled and repaired.
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:
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:
material pursuant to the general license established by RH-402.k.1. shall comply with the following:
reference or calibration sources described in RH-402.k.1.G. as required by RH-1400.
"This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories, or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the 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)"
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.
A general license is hereby issued to receive title to and own special nuclear material without regard to quantity. Notwithstanding any other provision of these Regulations, a general licensee under this paragraph is not authorized to acquire, deliver, receive, possess, use, transfer, import, or export special nuclear material, except as authorized in a specific license.
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.
material submitted under RH-403.g.1.B. must include the following information:
A brief description of the licensee's facility and area near the site.
An identification of each type of radioactive materials accident for which protective actions may be needed.
A system for classifying each accident as "alert" or "site area emergency."
Identification of the means of detecting each type of accident in a timely manner.
A brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers onsite, and a description of the program for maintaining the equipment.
A brief description of the methods and equipment to assess releases of radioactive materials.
A brief description of the responsibilities of licensee personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and the Department; also responsibilities for developing, maintaining, and updating the plan.
A commitment to and a brief description of the means to promptly notify offsite response organizations and request offsite assistance, including medical assistance for the treatment of contaminated injured onsite workers when appropriate. A control point must be established. The notification and coordination must be planned so that unavailability of some personnel, parts of the facility, and some equipment will not prevent the notification and coordination. The licensee shall also commit to notify the Department immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency.
A brief description of the types of information regarding facility status, radioactive releases and, if necessary, recommended protective actions.
A brief description of the frequency, performance objectives and plans for the training that the licensee will provide workers on how to respond to an emergency including any special instructions and orientation tours the licensee would offer to fire, police, medical and other emergency personnel. The training shall familiarize personnel with site-specific emergency procedures.
Also, the training shall thoroughly prepare site personnel for their responsibilities in the event of accident scenarios postulated as most probable for the specific site, including the use of team training for such scenarios.
A brief description of the means of restoring the facility to a safe condition after an accident.
Provisions for conducting quarterly communications checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. Quarterly communications checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee shall invite offsite response organizations to participate in the biennial exercises. Participation of offsite response organizations in biennial exercises, although recommended, is not required. Exercises must use accident scenarios postulated as most probable for the specific site; the scenarios shall not be known to most exercise participants.
The licensee shall critique each exercise using individuals not having direct implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and overall effectiveness of the response. Deficiencies found by the critiques must be corrected.
A certification that the applicant has met its responsibilities under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Public Law 99-499, if applicable to the applicant's activities at the proposed place of use of the radioactive material.
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.
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:
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:
decommissioning funding plan or a certification of financial assurance for decommissioning.
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:
noncommercially transferred to members of its consortium.
A license application will be approved if the Department determines that:
specified in RH-404.;
relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards of the industrial product or device to provide reasonable assurance that possession, use, or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in one (1) year a radiation dose in excess of ten percent (10%) of the annual limits specified in RH-1200.a.; and
regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.
license under this paragraph if the end uses of the industrial product or device cannot be reasonably foreseen.
Each person licensed pursuant to RH-405.a.1. shall:
product or device and the number of the license under which the product or device was manufactured or initially transferred, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and
of the product or device are subject to a general license or the equivalent and the regulations of the NRC or of an Agreement State;
Furnish a copy of the general license contained in RH-401.c. and a copy of RC FORM 513, "Registration Certificate - Use of Depleted Uranium Under General License," to each person to whom the licensee transfers depleted uranium in a product or device for use pursuant to the general license contained in RH-401.c.; or
Report to the Department all transfers of industrial
products or devices to persons for use under the general license in RH-401.c. Such report shall identify each general licensee by name and address, an individual by name and title who may constitute a point of contact between the Department and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such a product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under RH-401.c. during the reporting period, the report shall so indicate;
will be in use, the NRC or an Agreement State, all transfers of industrial products or devices to persons for use under the general license in the NRC's or an Agreement State's regulations equivalent to RH-401.c. Such report shall identify each general licensee by name and address, an individual by name and title who may constitute a point of contact between the agency and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person. If no transfers have been made to NRC general licensees or to general licensees within a particular Agreement State during the reporting period, this information shall be reported to the NRC or to the responsible Agreement State agency upon request of the appropriate governing agency; and
contact for each general licensee to whom the licensee transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in RH-401.c. or equivalent regulations of the NRC or an Agreement State. The records shall be maintained for three (3) years from the date of transfer and shall show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the report requirements of this paragraph.
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:
relevant equivalent regulations of the NRC or an Agreement State; and
instructions relating to handling, use, storage, and disposal of the material.
include the following information:
Agreement State agency that identifies all persons, operating under provisions equivalent to RH-401.a., to whom greater than 50 grams (0.11 lb) of source material has been transferred within a single calendar quarter. The report shall include the following information specific to those transfers made to NRC jurisdiction or to the Agreement State being reported to:
covering all transfers for the previous calendar year. If no transfers were made to persons generally licensed under RH-401.a. or equivalent NRC or Agreement State provisions during the current period, a report shall be submitted to the Department indicating so. If no transfers have been made to NRC general licensees or to general licensees within a particular Agreement State during the reporting period, this information shall be reported to the NRC or to the responsible Agreement State agency upon request of the appropriate governing agency.
information that supports the reports required by this paragraph concerning each transfer to a general licensee for a period of three (3) years after the event is included in a report to the Department, the NRC, or to an Agreement State agency.
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:
having training in radiological protection;
use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in any period of one (1) calendar year a dose in excess of 10% of the limits specified in RH-1200.a.; and
explosion) associated with handling, storage, and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the following organ doses:
|
Part of body Dose in rem |
|
|
Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye |
15 |
|
Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than one (1) square centimeter |
200 |
|
Other organs |
50 |
safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information);
testing, or for testing any on-off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and
"Thereceipt,possession,useandtransferofthis
device, Model ______, 10/ Serial No. _____ ,10/ are
subject to a general license or the equivalent and the regulations of the U.S. NRC or of a State with which the NRC has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.
CAUTION - RADIOACTIVE MATERIAL
(name of manufacturer or initial transferor)"
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:
designed and constructed devices.
transferred for use under the general license contained in RH-402.a., each person that is licensed under RH-405.e. shall provide the information specified in paragraph e.4.A. of this section to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes:
regulations equivalent to RH-402.a.-e., RH-600., RH-1501., and RH-1502. or a copy of RH-402.a.-e., RH-600., RH-1501., and RH-1502. If a copy of a non-governing agency's regulations is provided to a prospective general licensee in lieu of the governing agency's regulations, it shall be accompanied by a note explaining that use of the device is regulated by the governing agency, the agency who has jurisdiction where the device will be in use. If certain paragraphs of the regulations do not apply to the particular device, those paragraphs may be omitted.
a specific licensee;
Each person licensed under RH-405.e. to initially transfer devices to generally licensed persons shall comply with the requirements of this subparagraph.
licensees includes:
name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use.
temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).
licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.
be filed within thirty (30) days of the end of the calendar quarter, and must clearly indicate the period covered by the report.
licensees includes:
name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use.
temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).
be filed within thirty (30) days of the end of the calendar quarter, and must clearly indicate the period covered by the report.
licensee submitting the report and must include the license number of the specific licensee.
transfers and receipts of devices that supports the reports required by this subparagraph. Records required by this subparagraph must be maintained for a period of three (3) years following the date of the recorded event.
Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing radioactive material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements under RH-305., or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State, may be obtained only from the NRC pursuant to 10 CFR 32.18.
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.
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:
of tritium or promethium-147 in each device;
demonstrate that the tritium or promethium-147 will not be released to the environment under the most severe conditions likely to be encountered in normal use;
are sufficient to ensure compliance with RH-405.h.3.;
tritium or promethium-147 in the device is such that the tritium or promethium-147 will not be released under the most severe conditions which are likely to be encountered in normal use and handling of the device;
enclosed so as to preclude direct physical contact by any person with it;
take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of tritium or promethium-147, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering.
damage and for loss of tritium or promethium-147, after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in 405.h.1.E.iii.
promethium-147 on the device of more than 2,200 disintegrations per minute per 100 square centimeters of surface area; or
assemble, or initially transfer devices containing tritium or promethium-147 for distribution to persons generally licensed under RH-402.f. shall, except as provided in RH-405.h.2.B., affix to each device a label containing the radiation symbol prescribed by RH-1303., such other information as may be required by the Department
including disposal instructions when appropriate, and the
following or a substantially similar statement which contains the information called for in the following statement9/:
"Thereceipt,possession,useandtransferofthis
device, Model ______, 10/ Serial No. _____ ,10/
containing __________ (identity and quantity of
radioactive material) are subject to a general license or the equivalent and the regulations of the U.S. NRC or of a State with which the NRC has entered into an agreement for the exercise of regulatory authority. Do not remove this label.
CAUTION - RADIOACTIVE MATERIAL
(name of manufacturer, assembler, or initial transferor)"
enclosed in or accompany the container in which the device is shipped:
manufacture of the luminous safety device in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed devices are capable of performing their intended functions; and
procedures, by procedures specified in RH-405.h.3.C. and in the license issued under RH-405.h., to provide at least ninety-five percent (95%) confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded.
individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of tritium or promethium-147, such as absolute pressure and water immersion.
containment failure, or for loss of tritium or promethium-147 after each stage of testing, using methods of inspection adequate for applying the following criteria for defective:
persons generally licensed under RH-402.f., or under an equivalent general license of the NRC or an Agreement State:
defective under any condition of a license issued under RH-405.h., or RH-405.h.3.B., unless the defective luminous safety device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or
lot that has been sampled and rejected as a result of the procedures in RH-405.h.3.B.ii., unless:
in manufacture of the source;
deposited on each source is measured by direct counting of the source.
take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment or binding of americium-241, plutonium, or radium-226, such as physical handling, moisture, and water immersion.
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"
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.
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:
"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)"
of strontium-90 in the device;
radiation and its shielding;
in manufacture of the device;
strontium-90 in the device is such that the strontium-90 will not be released from the device under the most severe conditions which are likely to be encountered in normal use and handling of the device;
to preclude direct physical contact by any individual with it and is shielded so that no individual will receive a radiation exposure to a major portion of his body in excess of 0.5 rem (5 mSv) in a year under ordinary circumstances of use;
satisfy the requirements of RH-405.k.2.
take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of strontium-90, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering.
damage and for loss of strontium-90 after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in RH-405.k.1.F.iii.
more of the original amount of strontium-90 from the device; or
manufacture of the ice detection device containing strontium-90 in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed devices are capable of performing their intended functions; and
procedures, by procedures specified in RH-405.k.2.D. and in the license issued under RH-405.k., to provide at least ninety-five percent (95%) confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded.
individual, aggregate, and cumulative effects of environmental conditions expected in service that could possibly affect the effective containment of strontium-90, such as absolute pressure and water immersion.
containment failure, or for loss of strontium-90 after each stage of testing, using methods of inspection adequate to determine compliance with the following criteria for defective: A leak resulting in a loss of 0.1 percent or more of the original amount of strontium-90 from the device and any other criteria specified in the license issued under RH-405.k.
tested and found defective under the criteria specified in a license issued under RH-405.k., unless the defective ice detection device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or
contained within any lot that has been sampled and rejected as a result of the procedures in RH-405.k.2.C.ii., unless:
whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words
"CAUTION, RADIOACTIVE MATERIAL"
or "DANGER, RADIOACTIVE MATERIAL";
the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half life greater than 100 (one hundred) days, the time may be omitted.
container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words
"CAUTION, RADIOACTIVE MATERIAL"
or "DANGER, RADIOACTIVE MATERIAL"
and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.
be required to be tested for leakage of radioactive material at intervals longer than six (6) months, he shall include in his application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source.
This section prescribes requirements for the issuance of specific licenses of broad scope for radioactive material ("broad licenses") and certain regulations governing holders of such licenses.
approved if:
material;
of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and
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.
description of the business or occupation of the applicant;
address of each partner and the principal location where the partnership does business;
unincorporated association, the state where it is incorporated or organized and the principal location where it does business and the names and addresses of its directors and principal officers; and
representative of another person in filing the application, all information required under this paragraph must be supplied with respect to the other person.
offsite and onsite, including a description of lines of authority and assignments of responsibilities, whether in the form of administrative directives, contract provisions, or otherwise;
experience, of the applicant and members of the applicant's staff to engage in the proposed activities. Minimum training and experience requirements for personnel filling key positions described in RH-407.b.1.B.i. must be provided;
purposes other than disposal of radioactive wastes; and
information needed for demonstration that the performance objectives of RH-407.c. and the applicable technical requirements of RH-407.d. will be met:
The description must also include a description of the methods to be employed in the handling and disposal of wastes containing chelating agents or other non-radiological substances that might affect meeting the performance objectives in RH-407.c.
specifications of the radioactive material proposed to be received, possessed and disposed of at the land disposal facility.
LLW disposal, developed and applied by the applicant for the determination of natural disposal site characteristics and for quality assurance during the design, construction, operation and closure of the land disposal facility and the receipt, handling and emplacement of waste.
provide data to evaluate potential health and environmental impacts and the plan for taking corrective measures if migration of radionuclides is indicated.
applicant will apply to control activities at the land disposal facility.
The specific technical information must also include the following analyses needed to demonstrate that the performance objectives of RH-407.c. will be met:
the general population from releases of radioactivity must include air, soil, groundwater, surface water, plant uptake and exhumation by burrowing animals.
The analyses must clearly identify and differentiate between the roles performed by the natural disposal site characteristics and design features in isolating and segregating the wastes.
The analyses must clearly demonstrate that there is reasonable assurance that the exposure to humans from the release of radioactivity will not exceed the limits set forth in RH-407.c.2.
inadvertent intrusion must include demonstration that there is reasonable assurance the waste classification and segregation requirements will be met and that adequate barriers to inadvertent intrusion will be provided.
disposal site data pertinent to the long-term containment of emplaced radioactive wastes obtained during the operational period.
relating to backfill of excavated areas, closure and sealing, waste migration and interaction with emplacement media, or any other tests, experiments or analysis pertinent to the long-term containment of emplaced waste within the disposal site.
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:
assume responsibility for institutional control of the disposal site is prepared to assume responsibility and ensure that the institutional requirements found necessary under RH-407.d.10.B. will be met.
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.
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.
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.
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.
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.
discharge ground water to the surface within the disposal site.
faulting, folding, seismic activity or vulcanism may occur with such frequency and extent to significantly affect the ability of the disposal site to meet the performance objectives in RH-407.c. or may preclude defensible modeling and prediction of long-term impacts.
such as mass wasting, erosion, slumping, land-sliding or weathering occur with such frequency and extent to significantly affect the ability of the disposal site to meet the performance objectives in RH-407.c. or may preclude defensible modeling and prediction of long-term impacts.
approved site closure plan must be carried out as each disposal unit (e.g., each trench) is filled and covered.
adverse effect on completed closure and stabilization measures.
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.
from other waste classes at the disposal site. The physical form and characteristics of Class A waste must meet the minimum requirements set forth in RH-407.d.7.A. If Class A waste also meets the stability requirements set forth in RH-407.d.7.B., it is not necessary to segregate the waste for disposal.
rigorous requirements on waste form to ensure stability after disposal. The physical form and characteristics of Class B waste must meet both the minimum and stability requirements set forth in RH-407.d.7.
more rigorous requirements on waste form to ensure stability but also requires additional measures at the disposal facility to protect against inadvertent intrusion. The physical form and characteristics of Class C waste must meet both the minimum and stability requirements set forth in RH-407.d.7.
If radioactive waste contains only radionuclides listed in Table 1 to RH-407., classification shall be determined as follows:
value in Table 1, the waste is Class A.
ii If the concentration exceeds 0.1 times the value in
Table 1 but does not exceed the value in Table 1, the waste is Class C.
TABLE 1 TO RH-407.
|
Radionuclide |
Concentration (Curies per cubic meter) |
|
C-14 |
8 |
|
C-14 in activated metal |
80 |
|
Ni-59 in activated metal |
220 |
|
Nb-94 in activated metal |
0.2 |
|
Tc-99 |
3 |
|
I-129 |
0.08 |
|
Alpha emitting transuranic nuclides with half-life greater than five years |
100a |
|
Pu-241 |
3500 a |
|
Cm-242 |
20000 a |
a Units are nanocuries per gram.
If radioactive waste does not contain any of the radionuclides listed in Table 1, classification shall be determined based on the concentrations shown in Table 2 to RH-407. However, as specified in RH-407.d.6.E. of this section, if radioactive waste does not contain any nuclides listed in either Table 1 or 2, it is Class A.
the waste is Class A.
but does not exceed the value in Column 2, the waste is Class B.
TABLE 2 TO RH-407.
|
Radionuclide |
Concentration (Curies per cubic meter) |
||
|
Col. 1 |
Col. 2 |
Col. 3 |
|
|
Total of all nuclides less than 5 year half-life |
700 |
(a) |
(a) |
|
H-3 |
40 |
(a) |
(a) |
|
Co-60 |
700 |
(a) |
(a) |
|
Ni-63 |
3.5 |
70 |
700 |
|
Ni-63 in activated metal |
35 |
700 |
7000 |
|
Sr-90 |
0.04 |
150 |
7000 |
|
Cs-137 |
1 |
44 |
4600 |
a There are no limits established for these radionuclides in Class B or C wastes. Practical consideration such as the effects of external radiation and internal heat generation on transportation, handling, and disposal will limit the concentrations for these wastes. These wastes shall be Class B unless the concentrations of other nuclides in Table 2 determine the waste to be Class C independent of these nuclides.
If radioactive waste contains a mixture of radionuclides, some of which are listed in Table 1 and some of which are listed in Table 2, classification shall be determined as follows:
does not exceed 0.1 times the value listed in Table 1, the class shall be that determined by the concentration of nuclides listed in Table 2.
exceeds 0.1 times the value listed in Table 1 but does not exceed the value in Table 1, the waste shall be Class C, provided the concentration of nuclides listed in Table 2 does not exceed the value shown in Column 3 of Table 2.
If radioactive waste does not contain any nuclides listed in either Table 1 or 2, it is Class A.
For determining classification for waste that contains a mixture of radionuclides, it is necessary to determine the sum of fractions by dividing each nuclide's concentration by the appropriate limit and adding the resulting values. The appropriate limits must all be taken from the same column of the same table. The sum of the fractions for the column must be less than 1.0 if the waste class is to be determined by that column.
Example: A waste contains Sr-90 in a concentration of 50 Ci/m3 and Cs-137 in a concentration of 22 Ci/m3. Since the concentrations both exceed the values in Column1, Table 2, they must be compared to Column 2 values. For Sr-90 fraction, 50/150 = 0.33; for Cs-137 fraction, 22/44 = 0.5; the sum of the fractions = 0.83. Since the sum is less than 1.0, the waste is Class B.
The concentration of a radionuclide may be determined by indirect methods such as use of scaling factors which relate the inferred concentration of one radionuclide to another that is measured, or radionuclide material accountability, if there is reasonable assurance that the indirect methods can be correlated with actual measurements. The concentration of a radionuclide may be averaged over the volume of the waste or weight of the waste if the units are expressed as nanocuries per gram.
cardboard or fiberboard boxes.
sufficient absorbent material to absorb twice the volume of the liquid.
quantities of toxic gases, vapors or fumes harmful to persons transporting, handling, or disposing of the waste. This does not apply to radioactive gaseous waste packaged in accordance with RH-407.d.7.A.vii.
stable waste form will generally maintain its physical dimensions and its form, under the expected disposal conditions such as weight of overburden and compaction equipment, the presence of moisture and microbial activity, and internal factors such as radiation effects and chemical changes. Structural stability can be provided by the waste form itself, processing the waste to a stable form, or placing the waste in a disposal container or structure that provides stability after disposal.
and iii., liquid wastes or wastes containing liquid, must be converted into a form that contains as little freestanding and noncorrosive liquid as is reasonably achievable, but in no case shall the liquid exceed one percent (1%) of the volume of the waste when the waste is in a disposal container designed to ensure stability, or 0.5% of the volume of the waste for waste processed to a stable form.
Class A waste, Class B waste, or Class C waste in accordance with RH-407.d.6.
Disposal of radioactive waste received from other persons may be permitted only on land owned in fee by the Federal or a State government.
The land owner or custodial agency shall carry out an institutional control program to physically control access to the disposal site following transfer of control of the disposal site from the disposal site operator. The institutional control program must also include, but not be limited to, carrying out an environmental monitoring program at the disposal site, periodic surveillance, minor custodial care and other requirements as determined by the Department, and administration of funds to cover the costs for these activities. The period of institutional controls will be determined by the Department, but institutional controls may not be relied upon for more than 100 years following transfer of control of the disposal site to the owner.
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.
No license issued or granted pursuant to these Regulations 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.
possession and use of unsealed radioactive material of half-life greater than 120 days and in quantities exceeding 105 times the applicable quantities set forth in Appendix E to Section 2 shall submit a decommissioning funding plan as described in RH-409.h.5. The decommissioning funding plan must also be submitted when a combination of isotopes is involved if R divided by 105 is greater than 1 (unity rule), where R is defined here as the sum of the ratios of the quantity of each isotope to the applicable value in Appendix E to Section 2.
1993, which is of a type described in RH-409.h.1. or h.2., shall provide financial assurance for decommissioning in accordance with the criteria set forth in RH-409.h.
radioactivity in the facility and environment, including the subsurface, is detected at levels that would, if left uncorrected, prevent the site from meeting the RH-1216. criteria for unrestricted use, the licensee must submit a decommissioning funding plan within one year of when the survey is completed.
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
review and approval and must contain:
amount reflecting:
assumptions contained in the DCE;
assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and
obtained to satisfy the requirements of RH-409.h.6. (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).
residual radioactivity in onsite subsurface material;
previously estimated;
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:
Prepayment is the deposit prior to the start of operation into an account segregated from licensee assets and outside the licensee's administrative control of cash or liquid assets such that the amount of funds would be sufficient to pay decommissioning costs. Prepayment must be made into a trust account, and the trustee and the trust must be acceptable to the Department.
These methods guarantee that decommissioning costs will be paid. A surety method may be in the form of a surety bond, or letter of credit. A parent company guarantee of funds for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in Appendix A to Section 2.
For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in Appendix B to Section 2. For commercial corporations that do not issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs may be used if the guarantee and test are as contained in Appendix C to Section 2. For nonprofit entities, such as colleges, universities, and nonprofit hospitals, a guarantee of funds by the applicant or licensee may be used if the guarantee and test are as contained in Appendix D to Section 2.
Except for an external sinking fund, a parent company guarantee or a guarantee by the applicant or licensee may not be used in combination with any other financial methods to satisfy the requirements of RH-409.h. A guarantee by the applicant or licensee may not be used in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company. Any surety method or insurance used to provide financial assurance for decommissioning must contain the following conditions:
or, if written for a specified term, such as five (5) years, must be renewed automatically unless ninety (90) days or more prior to the renewal date, the issuer notifies the Department, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the Department within thirty (30) days after receipt of notification of cancellation.
a trust established for decommissioning costs. The trustee and trust must be acceptable to the Department. An acceptable trustee includes an appropriate State or Federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a Federal or State agency.
An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected.
An external sinking fund must be in the form of a trust. If the other guarantee method is used, no surety or insurance may be combined with the external sinking fund. The
surety, insurance, or other guarantee provisions must be as stated in RH-409.h.6.B.
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:
individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.
restricted areas as defined in RH-1100.;
documentation under RH-409.h.7.A.;
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:
(75%) of the cost, the licensee must increase the balance to cover the cost, and must do so within 30 days after the end of the calendar quarter.
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.
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.
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.
radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall:
requirements in RH-405.l.2.B., or
authorized nuclear pharmacist as specified in RH-8306.
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:
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.
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.
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.
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:
written notice to the licensee when the Department determines that:
that the premises are suitable for release in accordance with the criteria for decommissioning in RH-1216., RH-1217., and/or RH-1218.; or
Applications for amendment of a license shall be filed in accordance with RH-403. and shall specify the respects in which the licensee desires his license to be amended and the grounds for the amendment. Applications for amendment of sealed source and device registration certificates shall be filed in accordance with 10 CFR 32.210 and any other applicable provisions and shall specify the respects in which the certificate holder desires his certificate to be amended and the grounds for the amendment.
In considering an application to renew or amend a license or to amend a sealed source and device registration certificate, the Department will apply the applicable criteria set forth in RH-404., RH-405., and RH-406. and in Sections 2, 3, 4, 5, 6, 7, 8, and 9 of these Regulations.
No licensee shall transfer radioactive material except as authorized pursuant to this Part.
Preparation for shipment and transport of radioactive material shall be in accordance with the provisions of Section 4 of these Regulations.
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:
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.
Each record required by this Section, Part I to Section 3, Part J to Section
3, and Sections 7, 8, and 9 of these Regulations must be legible throughout the specified retention period. The record may be the original or a reproduced copy or microform if such reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by Department regulations. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
Each licensee shall notify the Department as soon as possible but not later than four (4) hours after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits or releases of licensed material that could exceed regulatory limits. (Events may include fires, explosions, toxic gas releases, et cetera.)
Each licensee shall notify the Department within twenty-four (24) hours after the discovery of any of the following events involving licensed material:
Reports made by licensees in response to the requirements of this section must be made as follows:
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:
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, 72205-3867. The reports must include the following:
Upon instruction from the Department, each licensee shall perform or cause to have performed and shall permit the Department to perform, such reasonable tests as the Department deems appropriate or necessary, including, but not limited to, tests of:
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.
Sources of radiation shall be subject to impounding pursuant to Section 5 of these Regulations.
radioactive material possessed or used under the general license provided in RH-750.a.1. except by transfer to a person:
NRC to receive such material, or
material under RH-301.a.
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:
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.
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:
radioactive material possessed or used under the general license provided in RH-750.b.1. except by transfer to a person:
another Licensing State to receive such material, or
material under these Regulations.
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:
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.
The Department may, by rule, regulation, or order, impose upon any licensee such requirements in addition to those established in the regulations in this Section as it deems appropriate or necessary to minimize danger to public health and safety or property.
SCHEDULE B TO SECTION 2 EXEMPT QUANTITIES
|
Radioactive Material |
Micro-curies |
|
Antimony-122 (Sb-122) |
100 |
|
Antimony-124 (Sb-124) |
10 |
|
Antimony-125 (Sb-125) |
10 |
|
Arsenic-73 (As-73) |
100 |
|
Arsenic-74 (As-74) |
10 |
|
Arsenic-76 (As-76) |
10 |
|
Arsenic-77 (As-77) |
100 |
|
Barium-131 (Ba-131) |
10 |
|
Barium-133 (Ba-133) |
10 |
|
Barium-140 (Ba-140) |
10 |
|
Bismuth-210 (Bi-210) |
1 |
|
Bromine-82 (Br-82) |
10 |
|
Cadmium-109 (Cd-109) |
10 |
|
Cadmium-115m (Cd-115m) |
10 |
|
Cadmium-115 (Cd-115) |
100 |
|
Calcium-45 (Ca-45) |
10 |
|
Calcium-47 (Ca-47) |
10 |
|
Carbon-14 (C-14) |
100 |
|
Cerium-141 (Ce-141) |
100 |
|
Cerium-143 (Ce-143) |
100 |
|
Cerium-144 (Ce-144) |
1 |
|
Cesium-129 (Cs-129) |
100 |
|
Cesium-131 (Cs-131) |
1,000 |
|
Cesium-134m (Cs-134m) |
100 |
|
Cesium-134 (Cs-134) |
1 |
|
Cesium-135 (Cs-135) |
10 |
|
Cesium-136 (Cs-136) |
10 |
|
Cesium-137 (Cs-137) |
10 |
|
Chlorine-36 (Cl-36) |
10 |
|
Chlorine-38 (Cl-38) |
10 |
|
Chromium-51 (Cr-51) |
1,000 |
|
Cobalt-57 (Co-57) |
100 |
|
Cobalt-58m (Co-58m) |
10 |
|
Cobalt-58 (Co-58) |
10 |
|
Cobalt-60 (Co-60) |
1 |
|
Copper-64 (Cu-64) |
100 |
|
Dysprosium-165 (Dy-165) |
10 |
|
Dysprosium-166 (Dy-166) |
100 |
|
Erbium-169 (Er-169) |
100 |
|
Erbium-171 (Er-171) |
100 |
|
Europium-152 (Eu-152) 9.2 h |
100 |
|
Europium-152 (Eu-152) 13 yr |
1 |
|
Europium-154 (Eu-154) |
1 |
|
Europium-155 (Eu-155) |
10 |
|
Fluorine-18 (F-18) |
1,000 |
|
Gadolinium-153 (Gd-153) |
10 |
|
Gadolinium-159 (Gd-159) |
100 |
|
Gallium-67 (Ga-67) |
100 |
|
Gallium-72 (Ga-72) |
10 |
|
Germanium-68 (Ge-68) |
10 |
|
Germanium-71 (Ge-71) |
100 |
|
Gold-195 (Au-195) |
10 |
|
Gold-198 (Au-198) |
100 |
|
Gold-199 (Au-199) |
100 |
|
Hafnium-181 (Hf-181) |
10 |
|
Holmium-166 (Ho-166) |
100 |
|
Hydrogen-3 (H-3) |
1,000 |
|
Indium-111 (In-111) |
100 |
|
Indium-113m (In-113m) |
100 |
|
Indium-114m (In-114m) |
10 |
|
Indium-115m (In-115m) |
100 |
|
Indium-115 (In-115) |
10 |
|
Iodine-123 (I-123) |
100 |
|
Iodine-125 (I-125) |
1 |
|
Iodine-126 (I-126) |
1 |
|
Iodine-129 (I-129) |
0.1 |
|
Iodine-131 (I-131) |
1 |
|
Iodine-132 (I-132) |
10 |
|
Iodine-133 (I-133) |
1 |
|
Iodine-134 (I-134) |
10 |
|
Iodine-135 (I-135) |
10 |
|
Iridium-192 (Ir-192) |
10 |
|
Iridium-194 (Ir-194) |
100 |
|
Iron-52 (Fe-52) |
10 |
|
Iron-55 (Fe-55) |
100 |
|
Iron-59 (Fe-59) |
10 |
|
Krypton-85 (Kr-85) |
100 |
|
Krypton-87 (Kr-87) |
10 |
|
Lanthanum-140 (La-140) |
10 |
|
Lutetium-177 (Lu-177) |
100 |
|
Manganese-52 (Mn-52) |
10 |
|
Manganese-54 (Mn-54) |
10 |
|
Manganese-56 (Mn-56) |
10 |
|
Mercury-197m (Hg-197m) |
100 |
|
Mercury-197 (Hg-197) |
100 |
|
Mercury-203 (Hg-203) |
10 |
|
Molybdenum-99 (Mo-99) |
100 |
|
Neodymium-147 (Nd-147) |
100 |
|
Neodymium-149 (Nd-149) |
100 |
|
Nickel-59 (Ni-59) |
100 |
|
Nickel-63 (Ni-63) |
10 |
|
Nickel-65 (Ni-65) |
100 |
|
Niobium-93m (Nb-93m) |
10 |
|
Niobium-95 (Nb-95) |
10 |
|
Niobium-97 (Nb-97) |
10 |
|
Osmium-185 (Os-185) |
10 |
|
Osmium-191m (Os-191m) |
100 |
|
Osmium-191 (Os-191) |
100 |
|
Osmium-193 (Os-193) |
100 |
|
Palladium-103 (Pd-103) |
100 |
|
Palladium-109 (Pd-109) |
100 |
|
Phosphorus-32 (P-32) |
10 |
|
Platinum-191 (Pt-191) |
100 |
|
Platinum-193m (Pt-193m) |
100 |
|
Platinum-193 (Pt-193) |
100 |
|
Platinum-197m (Pt-197m) |
100 |
|
Platinum-197 (Pt-197) |
100 |
|
Polonium-210 (Po-210) |
0.1 |
|
Potassium-42 (K-42) |
10 |
|
Potassium-43 (K-43) |
10 |
|
Praseodymium-142 (Pr-142) |
100 |
|
Praseodymium-143 (Pr-143) |
100 |
|
Promethium-147 (Pm-147) |
10 |
|
Promethium-149 (Pm-149) |
10 |
|
Rhenium-186 (Re-186) |
100 |
|
Rhenium-188 (Re-188) |
100 |
|
Rhodium-103m (Rh-103m) |
100 |
|
Rhodium-105 (Rh-105) |
100 |
|
Rubidium-81 (Rh-81) |
10 |
|
Rubidium-86 (Rb-86) |
10 |
|
Rubidium-87 (Rb-87) |
10 |
|
Ruthenium-97 (Ru-97) |
100 |
|
Ruthenium-103 (Ru-103) |
10 |
|
Ruthenium-105 (Ru-105) |
10 |
|
Ruthenium-106 (Ru-106) |
1 |
|
Samarium-151 (Sm-151) |
10 |
|
Samarium-153 (Sm-153) |
100 |
|
Scandium-46 (Sc-46) |
10 |
|
Scandium-47 (Sc-47) |
100 |
|
Scandium-48 (Sc-48) |
10 |
|
Selenium-75 (Se-75) |
10 |
|
Silicon-31 (Si-31) |
100 |
|
Silver-105 (Ag-105) |
10 |
|
Silver-110m (Ag-110m) |
1 |
|
Silver-111 (Ag-111) |
100 |
|
Sodium-22 (Na-22) |
10 |
|
Sodium-24 (Na-24) |
10 |
|
Strontium-85 (Sr-85) |
10 |
|
Strontium-89 (Sr-89) |
1 |
|
Strontium-90 (Sr-90) |
0.1 |
|
Strontium-91 (Sr-91) |
10 |
|
Strontium-92 (Sr-92) |
10 |
|
Sulphur-35 (S-35) |
100 |
|
Tantalum-182 (Ta-182) |
10 |
|
Technetium-96 (Tc-96) |
10 |
|
Technetium-97m (Tc-97m) |
100 |
|
Technetium-97 (Tc-97) |
100 |
|
Technetium-99m (Tc-99m) |
100 |
|
Technetium-99 (Tc-99) |
10 |
|
Tellurium-125m (Te-125m) |
10 |
|
Tellurium-127m (Te-127m) |
10 |
|
Tellurium-127 (Te-127) |
100 |
|
Tellurium-129m (Te-129m) |
10 |
|
Tellurium-129 (Te-129) |
100 |
|
Tellurium-131m (Te-131m) |
10 |
|
Tellurium-132 (Te-132) |
10 |
|
Terbium-160 (Tb-160) |
10 |
|
Thallium-200 (Tl-200) |
100 |
|
Thallium-201 (Tl-201) |
100 |
|
Thallium-202 (Tl-202) |
100 |
|
Thallium-204 (Tl-204) |
10 |
|
Thulium-170 (Tm-170) |
10 |
|
Thulium-171 (Tm-171) |
10 |
|
Tin-113 (Sn-113) |
10 |
|
Tin-125 (Sn-125) |
10 |
|
Tungsten-181 (W-181) |
10 |
|
Tungsten-185 (W-185) |
10 |
|
Tungsten-187 (W-187) |
100 |
|
Vanadium-48 (V-48) |
10 |
|
Xenon-131m (Xe-131m) |
1,000 |
|
Xenon-133 (Xe-133) |
100 |
|
Xenon-135 (Xe-135) |
100 |
|
Ytterbium-175 (Yb-175) |
100 |
|
Yttrium-87 (Y-87) |
10 |
|
Yttrium-88 (Y-88) |
10 |
|
Yttrium-90 (Y-90) |
10 |
|
Yttrium-91 (Y-91) |
10 |
|
Yttrium-92 (Y-92) |
100 |
|
Yttrium-93 (Y-93) |
100 |
|
Zinc-65 (Zn-65) |
10 |
|
Zinc-69m (Zn-69m) |
100 |
|
Zinc-69 (Zn-69) |
1,000 |
|
Zirconium-93 (Zr-93) |
10 |
|
Zirconium-95 (Zr-95) |
10 |
|
Zirconium-97 (Zr-97) |
10 |
|
Any radioactive material not listed above, other than alpha emitting radioactive material |
0.1 |
EXEMPT CONCENTRATIONS
|
Element (atomic number) |
Isotope |
Column I Gas concentration µCi/mla/ |
Column II Liquid and solid concentration µCi/mlb/ |
|
Antimony (51) |
Sb-122 |
------- |
3 X 10-4 |
|
Sb-124 |
------- |
2 X 10-4 |
|
|
Sb-125 |
1 X 10-3 |
||
|
Argon (18) |
A-37 |
1 X 10-3 |
------- |
|
A-41 |
4 X 10-7 |
||
|
Arsenic (33) |
As-73 |
------- |
5 X 10-3 |
|
As-74 |
------- |
5 X 10-4 |
|
|
As-76 |
------- |
2 X 10-4 |
|
|
As-77 |
------- |
8 X 10-4 |
|
|
Barium (56) |
Ba-131 |
------- |
2 X 10-3 |
|
Ba-140 |
------- |
3 X 10-4 |
|
|
Beryllium (4) |
Be-7 |
------- |
2 X 10-2 |
|
Bismuth (83) |
Bi-206 |
4 X 10-4 |
|
|
Bromine (35) |
Br-82 |
4 X 10-7 |
3 X 10-3 |
|
Cadmium (48) |
Cd-109 |
------- |
2 X 10-3 |
|
Cd-115m |
------- |
3 X 10-4 |
|
|
Cd-115 |
------- |
3 X 10-4 |
|
|
Calcium (20) |
Ca-45 |
------- |
9 X 10-5 |
|
Ca-47 |
5 X 10-4 |
||
|
Carbon (6) |
C-14 |
1 X 10-6 |
8 X 10-3 |
|
Cerium (58) |
Ce-141 |
------- |
9 X 10-4 |
|
Ce-143 |
------- |
4 X 10-4 |
|
|
Ce-144 |
------- |
1 X 10-4 |
|
|
Cesium (55) |
Cs-131 |
------- |
2 X 10-2 |
|
Cs-134m |
------- |
6 X 10-2 |
|
|
Cs-134 |
9 X 10-5 |
||
|
Chlorine (17) |
Cl-38 |
9 X 10-7 |
4 X 10-3 |
|
Chromium (24) |
Cr-51 |
------- |
2 X 10-2 |
|
Cobalt (27) |
Co-57 |
------- |
5 X 10-3 |
|
Co-58 |
------- |
1 X 10-3 |
|
|
Co-60 |
------- |
5 X 10-4 |
|
|
Copper (29) |
Cu-64 |
------- |
3 X 10-3 |
|
Dysprosium (66) |
Dy-165 |
------- |
4 X 10-3 |
|
Dy-166 |
------- |
4 X 10-4 |
|
|
Erbium (68) |
Er-169 |
------- |
9 X 10-4 |
|
Er-171 |
------- |
1 X 10-3 |
|
|
Europium (63) |
Eu-152 - |
------- |
6 X 10-4 |
|
(T/2=9.2 hrs) |
------- |
||
|
Eu-155 |
2 X 10-3 |
||
|
Fluorine (9) |
F-18 |
2 X 10-6 |
8 X 10-3 |
|
Gadolinium (64) |
Gd-153 |
------- |
2 X 10-3 |
|
Gd-159 |
------- |
8 X 10-4 |
|
|
Gallium (31) |
Ga-72 |
------- |
4 X 10-4 |
|
Germanium (32) |
Ge-71 |
------- |
2 X 10-2 |
|
Gold (79) |
Au-196 |
------- |
2 X 10-3 |
|
Au-198 |
------- |
5 X 10-4 |
|
|
Au-199 |
------- |
2 X 10-3 |
|
|
Hafnium (72) |
Hf-181 |
7 X 10-4 |
|
|
Hydrogen (1) |
H-3 |
5 X 10-6 |
3 X 10-2 |
|
Indium (49) |
In-113m |
------- |
1 X 10-2 |
|
In-114m |
2 X 10-4 |
||
|
Iodine (53) |
I-126 |
3 X 10-9 |
2 X 10-5 |
|
I-131 |
3 X 10-9 |
2 X 10-5 |
|
|
I-132 |
8 X 10-8 |
6 X 10-4 |
|
|
I-133 |
1 X 10-8 |
7 X 10-5 |
|
|
I-134 |
2 X 10-7 |
1 X 10-3 |
|
|
Iridium (77) |
Ir-190 |
------- |
2 X 10-3 |
|
Ir-192 |
------- |
4 X 10-4 |
|
|
Ir-194 |
------- |
3 X 10-4 |
|
|
Iron (26) |
Fe-55 |
------- |
8 X 10-3 |
|
Fe-59 |
6 X 10-4 |
||
|
Krypton (36) |
Kr-85m |
1 X 10-6 |
------- |
|
Kr-85 |
3 X 10-6 |
||
|
Lanthanum (57) |
La-140 |
------- |
2 X 10-4 |
|
Lead (82) |
Pb-203 |
------- |
4 X 10-3 |
|
Lutetium (71) |
Lu-177 |
------- |
1 X 10-3 |
|
Manganese (25) |
Mn-52 |
------- |
3 X 10-4 |
|
Mn-54 |
------- |
1 X 10-3 |
|
|
Mn-56 |
------- |
1 X 10-3 |
|
|
Mercury (80) |
Hg-197m |
------- |
2 X 10-3 |
|
Hg-197 |
------- |
3 X 10-3 |
|
|
Hg-203 |
------- |
2 X 10-4 |
|
|
Molybdenum (42) |
Mo-99 |
------- |
2 X 10-3 |
|
Neodymium (60) |
Nd-147 |
------- |
6 X 10-4 |
|
Nd-149 |
------- |
3 X 10-3 |
|
|
Nickel (28) |
Ni-65 |
------- |
1 X 10-3 |
|
Niobium |
|||
|
(Columbium)(41) |
Nb-95 |
------- |
1 X 10-3 |
|
Nb-97 |
------- |
9 X 10-3 |
|
|
Osmium (76) |
Os-185 |
------- |
7 X 10-4 |
|
Os-191m |
------- |
3 X 10-2 |
|
|
Os-191 |
------- |
2 X 10-3 |
|
|
Os-193 |
------- |
6 X 10-4 |
|
|
Palladium (46) |
Pd-103 |
------- |
3 X 10-3 |
|
Pd-109 |
------- |
9 X 10-4 |
|
|
Phosphorus (15) |
P-32 |
------- |
2 X 10-4 |
|
Platinum (78) |
Pt-191 |
------- |
1 X 10-3 |
|
Pt-193m |
------- |
1 X 10-2 |
|
|
Pt-197m |
------- |
1 X 10-2 |
|
|
Pt-197 |
------- |
1 X 10-3 |
|
|
Potassium (19) |
K-42 |
------- |
3 X 10-3 |
|
Praseodymium (50) |
Pr-142 |
------- |
3 X 10-4 |
|
Pr-143 |
------- |
5 X 10-4 |
|
|
Promethium (61) |
Pm-147 |
------- |
2 X 10-3 |
|
Pm-149 |
------- |
4 X 10-4 |
|
|
Rhenium (75) |
Re-183 |
------- |
6 X 10-3 |
|
Re-186 |
------- |
9 X 10-4 |
|
|
Re-188 |
------- |
6 X 10-4 |
|
|
Rhodium (45) |
Rh-103m |
------- |
1 X 10-1 |
|
Rh-105 |
------- |
1 X 10-3 |
|
|
Rubidium (37) |
Rb-86 |
------- |
7 X 10-4 |
|
Ruthenium (44) |
Ru-97 |
------- |
4 X 10-4 |
|
Ru-103 |
------- |
8 X 10-4 |
|
|
Ru-105 |
------- |
1 X 10-3 |
|
|
Ru-106 |
------- |
1 X 10-4 |
|
|
Samarium (62) |
Sm-153 |
------- |
8 X 10-4 |
|
Scandium (21) |
Sc-46 |
------- |
4 X 10-4 |
|
Sc-47 |
------- |
9 X 10-4 |
|
|
Sc-48 |
------- |
3 X 10-4 |
|
|
Selenium (34) |
Se-75 |
------- |
3 X 10-3 |
|
Silicon (14) |
Si-31 |
------- |
9 X 10-3 |
|
Silver (47) |
Ag-105 |
------- |
1 X 10-3 |
|
Ag-110m |
------- |
3 X 10-4 |
|
|
Ag-111 |
------- |
4 X 10-4 |
|
|
Sodium (11) |
Na-24 |
------- |
2 X 10-3 |
|
Strontium (38) |
Sr-85 |
------- |
1 X 10-4 |
|
Sr-89 |
------- |
1 X 10-4 |
|
|
Sr-91 |
------- |
7 X 10-4 |
|
|
Sr-92 |
7 X 10-4 |
||
|
Sulfur (16) |
S-35 |
9 X 10-8 |
6 X 10-4 |
|
Tantalum (73) |
Ta-182 |
------- |
4 X 10-4 |
|
Technetium (43) |
Tc-96m |
------- |
1 X 10-1 |
|
Tc-96 |
------- |
1 X 10-3 |
|
|
Tellurium (52) |
Te-125m |
------- |
2 X 10-3 |
|
Te-127m |
------- |
6 X 10-4 |
|
|
Te-127 |
------- |
3 X 10-3 |
|
|
Te-129m |
------- |
3 X 10-4 |
|
|
Te-131m |
------- |
6 X 10-4 |
|
|
Te-132 |
------- |
3 X 10-4 |
|
Terbium (65) |
Tb-160 |
------- |
4 X 10-4 |
|
Thallium (81) |
Tl-200 |
------- |
4 X 10-3 |
|
Tl-201 |
------- |
3 X 10-3 |
|
|
Tl-202 |
------- |
1 X 10-3 |
|
|
Tl-204 |
------- |
1 X 10-3 |
|
|
Thulium (69) |
Tm-170 |
------- |
5 X 10-4 |
|
Tm-171 |
------- |
5 X 10-3 |
|
|
Tin (50) |
Sn-113 |
------- |
9 X 10-4 |
|
Sn-125 |
------- |
2 X 10-4 |
|
|
Tungsten |
|||
|
(Wolfram)(74) |
W-181 |
------- |
4 X 10-3 |
|
W-187 |
------- |
7 X 10-4 |
|
|
Vanadium (23) |
V-48 |
3 X 10-4 |
|
|
Xenon (54) |
Xe-131m |
4 X 10-6 |
------- |
|
Xe-133 |
3 X 10-6 |
------- |
|
|
Xe-135 |
1 X 10-6 |
||
|
Ytterbium (70) |
Yb-175 |
------- |
1 X 10-3 |
|
Yttrium (39) |
Y-90 |
------- |
2 X 10-4 |
|
Y-91m |
------- |
3 X 10-2 |
|
|
Y-91 |
------- |
3 X 10-4 |
|
|
Y-92 |
------- |
6 X 10-4 |
|
|
Y-93 |
------- |
3 X 10-4 |
|
|
Zinc (30) |
Zn-65 |
------- |
1 X 10-3 |
|
Zn-69m |
------- |
7 X 10-4 |
|
|
Zn-69 |
------- |
2 X 10-2 |
|
|
Zirconium (40) |
Zr-95 |
------- |
6 X 10-4 |
|
Zr-97 |
------- |
2 X 10-4 |
|
|
Beta and/or gamma e radioactive material n listed above with half-life less than 3 years |
mitting ot ---- |
1 X 10-10 |
1 X 10-6 |
Notes :
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:
Concentration of Isotope A in Product + Concentration of Isotope B in Product [LESS THAN OR EQUAL TO] 1 Exempt concentration of Isotope A Exempt concentration of Isotope B
Footnotes for Schedule C to Section 2:
a/ Values are given in Column 1 only for those materials normally used as gases.
b/ µCi/gm for solids.
LIMITS FOR BROAD LICENSES
|
Radioactive Material |
Column I (Curies) |
Column II (Curies) |
|
Antimony-122 |
1 |
0.01 |
|
Antimony-124 |
1 |
0.01 |
|
Antimony-125 |
1 |
0.01 |
|
Arsenic-73 |
10 |
0.1 |
|
Arsenic-74 |
1 |
0.01 |
|
Arsenic-76 |
1 |
0.01 |
|
Arsenic-77 |
10 |
0.1 |
|
Barium-131 |
10 |
0.1 |
|
Barium-140 |
1 |
0.01 |
|
Beryllium-7 |
10 |
0.1 |
|
Bismuth-210 |
0.1 |
0.001 |
|
Bromine-82 |
10 |
0.1 |
|
Cadmium-109 |
1 |
0.01 |
|
Cadmium-115m |
1 |
0.01 |
|
Cadmium-115 |
10 |
0.1 |
|
Calcium-45 |
1 |
0.01 |
|
Calcium-47 |
10 |
0.1 |
|
Carbon-14 |
100 |
1 |
|
Cerium-141 |
10 |
0.1 |
|
Cerium-143 |
10 |
0.1 |
|
Cerium-144 |
0.1 |
0.001 |
|
Cesium-131 |
100 |
1 |
|
Cesium-134m |
100 |
1 |
|
Cesium-134 |
0.1 |
0.001 |
|
Cesium-135 |
1 |
0.01 |
|
Cesium-136 |
10 |
0.1 |
|
Cesium-137 |
0.1 |
0.001 |
|
Chlorine-36 |
1 |
0.01 |
|
Chlorine-38 |
100 |
1 |
|
Chronmium-51 |
100 |
1 |
|
Cobalt-57 |
10 |
0.1 |
|
Cobalt-58m |
100 |
1 |
|
Cobalt-58 |
1 |
0.01 |
|
Cobalt-60 |
0.1 |
0.001 |
|
Copper-64 |
10 |
0.1 |
|
Dysprosium-165 |
100 |
1 |
|
Dysprosium-166 |
10 |
0.1 |
|
Erbium-169 |
10 |
0.1 |
|
Erbium-171 |
10 |
0.1 |
|
Europium-152 9.2 h |
10 |
0.1 |
|
Europium-152 13 y |
0.1 |
0.001 |
|
Europium-154 |
0.1 |
0.001 |
|
Europium-155 |
1 |
0.01 |
|
Fluorine-18 |
100 |
1 |
|
Gadolinium-153 |
1 |
0.01 |
|
Gadolinium-159 |
10 |
0.1 |
|
Gallium-72 |
10 |
0.1 |
|
Germanium-71 |
100 |
1 |
|
Gold-198 |
10 |
0.1 |
|
Gold-199 |
10 |
0.1 |
|
Hafnium-181 |
1 |
0.01 |
|
Holmium-166 |
10 |
0.1 |
|
Hydrogen-3 |
100 |
1 |
|
Indium-113m |
100 |
1 |
|
Indium-114m |
1 |
0.01 |
|
Indium-115m |
100 |
1 |
|
Indium-115 |
1 |
0.01 |
|
Iodine-125 |
0.1 |
0.001 |
|
Iodine-126 |
0.1 |
0.001 |
|
Iodine-129 |
0.1 |
0.001 |
|
Iodine-131 |
0.1 |
0.001 |
|
Iodine-132 |
10 |
0.1 |
|
Iodine-133 |
1 |
0.01 |
|
Iodine-134 |
10 |
0.1 |
|
Iodine-135 |
1 |
0.01 |
|
Iridium-192 |
1 |
0.01 |
|
Iridium-194 |
10 |
0.1 |
|
Iron-55 |
10 |
0.1 |
|
Iron-59 |
1 |
0.01 |
|
Krypton-85 |
100 |
1 |
|
Krypton-87 |
10 |
0.1 |
|
Lanthanum-140 |
1 |
0.01 |
|
Lutetium-177 |
10 |
0.1 |
|
Manganese-52 |
1 |
0.01 |
|
Manganese-54 |
1 |
0.01 |
|
Manganese-56 |
10 |
0.1 |
|
Mercury-197m |
10 |
0.1 |
|
Mercuty-197 |
10 |
0.1 |
|
Mercury-203 |
1 |
0.01 |
|
Molybdenum-99 |
10 |
0.1 |
|
Neodymium-147 |
10 |
0.1 |
|
Neodymium-149 |
10 |
0.1 |
|
Nickel-59 |
10 |
0.1 |
|
Nickel-63 |
1 |
0.01 |
|
Nickel-65 |
10 |
0.1 |
|
Niobium-93m |
1 |
0.01 |
|
Niobium-95 |
1 |
0.01 |
|
Niobium-97 |
100 |
1 |
|
Osmium-185 |
1 |
0.01 |
|
Osmium-191m |
100 |
1 |
|
Osmium-191 |
10 |
0.1 |
|
Osmium-193 |
10 |
0.1 |
|
Palladium-103 |
10 |
0.1 |
|
Palladium-109 |
10 |
0.1 |
|
Phosphorus-32 |
1 |
0.01 |
|
Platinum-191 |
10 |
0.1 |
|
Platinum-193m |
100 |
1 |
|
Platinum-193 |
10 |
0.1 |
|
Platinum-197m |
100 |
1 |
|
Platinum-197 |
10 |
0.1 |
|
Polonium-210 |
0.01 |
0.0001 |
|
Potassium-42 |
1 |
0.01 |
|
Praseodymium-142 |
10 |
0.1 |
|
Praseodymium-143 |
10 |
0.1 |
|
Promethium-147 |
1 |
0.01 |
|
Promethium-149 |
10 |
0.1 |
|
Radium-226 |
0.01 |
0.0001 |
|
Rhenium-186 |
10 |
0.1 |
|
Rhenium-188 |
10 |
0.1 |
|
Rhodium-103m |
1,000 |
10 |
|
Rhodium-105 |
10 |
0.1 |
|
Rubidium-86 |
1 |
0.01 |
|
Rubidium-87 |
1 |
0.01 |
|
Ruthenium-97 |
100 |
1 |
|
Ruthenium-103 |
1 |
0.01 |
|
Ruthenium-105 |
10 |
0.1 |
|
Ruthenium-106 |
0.1 |
0.001 |
|
Samarium-151 |
1 |
0.01 |
|
Samarium-153 |
10 |
0.1 |
|
Scandium-46 |
1 |
0.01 |
|
Scandium-47 |
10 |
0.1 |
|
Scandium-48 |
1 |
0.01 |
|
Selenium-75 |
1 |
0.01 |
|
Silicon-31 |
10 |
0.1 |
|
Silver-105 |
1 |
0.01 |
|
Silver-110m |
0.1 |
0.001 |
|
Silver-111 |
10 |
0.1 |
|
Sodium-22 |
0.1 |
0.001 |
|
Sodium-24 |
1 |
0.01 |
|
Strontium-85m |
1,000 |
10 |
|
Strontium-85 |
1 |
0.01 |
|
Strontium-89 |
1 |
0.01 |
|
Strontium-90 |
0.01 |
0.0001 |
|
Strontium-91 |
10 |
0.1 |
|
Strontium-92 |
10 |
0.1 |
|
Sulfur-35 |
10 |
0.1 |
|
Tantalum-182 |
1 |
0.01 |
|
Technetium-96 |
10 |
0.1 |
|
Technetium-97m |
10 |
0.1 |
|
Technetium-97 |
10 |
0.1 |
|
Technetium-99m |
100 |
1 |
|
Technetium-99 |
1 |
0.01 |
|
Tellurium-125m |
1 |
0.01 |
|
Tellurium-127m |
1 |
0.01 |
|
Tellurium-127 |
10 |
0.1 |
|
Tellurium-129m |
1 |
0.01 |
|
Tellurium-129 |
100 |
1 |
|
Tellurium-131m |
10 |
0.1 |
|
Tellurium-132 |
1 |
0.01 |
|
Terbium-160 |
1 |
0.01 |
|
Thallium-200 |
10 |
0.1 |
|
Thallium-201 |
10 |
0.1 |
|
Thallium-202 |
10 |
0.1 |
|
Tallium-204 |
1 |
0.01 |
|
Thulium-170 |
1 |
0.01 |
|
Thulium-171 |
1 |
0.01 |
|
Tin-113 |
1 |
0.01 |
|
Tin-125 |
1 |
0.01 |
|
Tungsten-181 |
1 |
0.01 |
|
Tungsten-185 |
1 |
0.01 |
|
Tungsten-187 |
10 |
0.1 |
|
Vanadium-48 |
1 |
0.01 |
|
Xenon-131m |
1,000 |
10 |
|
Xenon-133 |
100 |
1 |
|
Xenon-135 |
100 |
1 |
|
Ytterbium-175 |
10 |
0.1 |
|
Yttrium-90 |
1 |
0.01 |
|
Yttrium-91 |
1 |
0.01 |
|
Yttrium-92 |
10 |
0.1 |
|
Yttrium-93 |
1 |
0.01 |
|
Zinc-65 |
1 |
0.01 |
|
Zinc-69m |
10 |
0.1 |
|
Zinc-69 |
100 |
1 |
|
Zirconium-93 |
1 |
0.01 |
|
Zirconium-95 |
1 |
0.01 |
|
Zirconium-97 |
1 |
0.01 |
|
Any radioactive material other than alpha emitting radioactive material, source material, or special nuclear material not listed above |
0.1 |
0.001 |
QUANTITIES OF RADIOACTIVE MATERIALS REQUIRING CONSIDERATION OF THE NEED FOR AN EMERGENCY PLAN FOR RESPONDING TO A RELEASE
|
Radioactive material a/ b/ |
Release Fraction |
Quantity (Curies) |
|
Actinium-228 |
0.001 |
4,000 |
|
Americium-241 |
.001 |
2 |
|
Americium-242 |
.001 |
2 |
|
Americium-243 |
.001 |
2 |
|
Antimony-124 |
.01 |
4,000 |
|
Antimony-126 |
.01 |
6,000 |
|
Barium-133 |
.01 |
10,000 |
|
Barium-140 |
.01 |
30,000 |
|
Bismuth-207 |
.01 |
5,000 |
|
Bismuth-210 |
.01 |
600 |
|
Cadmium-109 |
.01 |
1,000 |
|
Cadmium-113 |
.01 |
80 |
|
Calcium-45 |
.01 |
20,000 |
|
Californium-252 |
.001 |
9 (20 mg) |
|
Carbon-14 (Non CO) |
.01 |
50,000 |
|
Cerium-141 |
.01 |
10,000 |
|
Cerium-144 |
.01 |
300 |
|
Cesium-134 |
.01 |
2,000 |
|
Cesium-137 |
.01 |
3,000 |
|
Chlorine-36 |
.5 |
100 |
|
Chromium-51 |
.01 |
300,000 |
|
Cobalt-60 |
.001 |
5,000 |
|
Copper-64 |
.01 |
200,000 |
|
Curium-242 |
.001 |
60 |
|
Curium-243 |
.001 |
3 |
|
Curium-244 |
.001 |
4 |
|
Curium-245 |
.001 |
2 |
|
Europium-152 |
.01 |
500 |
|
Europium-154 |
.01 |
400 |
|
Europium-155 |
.01 |
3,000 |
|
Gadolinium-153 |
.01 |
5,000 |
|
Germanium-68 |
.01 |
2,000 |
|
Gold-198 |
.01 |
30,000 |
|
Hafnium-172 |
.01 |
400 |
|
Hafnium-181 |
.01 |
7,000 |
|
Holmium-166m |
.01 |
100 |
|
Hydrogen-3 |
.5 |
20,000 |
|
Iodine-125 |
.5 |
10 |
|
Iodine-131 |
.5 |
10 |
|
Indium-114m |
.01 |
1,000 |
|
Iridium-192 |
.001 |
40,000 |
|
Iron-55 |
.01 |
40,000 |
|
Iron-59 |
.01 |
7,000 |
|
Krypton-85 |
1.0 |
6,000,000 |
|
Lead-210 |
.01 |
8 |
|
Maganese-56 |
.01 |
60,000 |
|
Mercury-203 |
.01 |
10,000 |
|
Molybdenum-99 |
.01 |
30,000 |
|
Neptunium-237 |
.001 |
2 |
|
Nickel-63 |
.01 |
20,000 |
|
Niobium-94 |
.01 |
300 |
|
Phosphorus-32 |
.5 |
100 |
|
Phosphorus-33 |
.5 |
1,000 |
|
Polonium-210 |
.01 |
10 |
|
Potassium-42 |
.01 |
9,000 |
|
Promethium-145 |
.01 |
4,000 |
|
Promethium-147 |
.01 |
4,000 |
|
Radium-226 |
.001 |
100 |
|
Ruthenium-106 |
.01 |
200 |
|
Samarium-151 |
.01 |
4,000 |
|
Scandium-46 |
.01 |
3,000 |
|
Selenium-75 |
.01 |
10,000 |
|
Silver-110m |
.01 |
1,000 |
|
Sodium-22 |
.01 |
9,000 |
|
Sodium-24 |
.01 |
10,000 |
|
Strontium-89 |
.01 |
3,000 |
|
Strontium-90 |
.01 |
90 |
|
Sulfur-35 |
.5 |
900 |
|
Technetium-99 |
.01 |
10,000 |
|
Technetium-99m |
.01 |
400,000 |
|
Tellurium-127m |
.01 |
5,000 |
|
Tellurium-129m |
.01 |
5,000 |
|
Terbium-160 |
.01 |
4,000 |
|
Thulium-170 |
.01 |
4,000 |
|
Tin-113 |
.01 |
10,000 |
|
Tin-123 |
.01 |
3,000 |
|
Tin-126 |
.01 |
1,000 |
|
Titanium-44 |
.01 |
100 |
|
Vanadium-48 |
.01 |
7,000 |
|
Xenon-133 |
1.0 |
900,000 |
|
Yttrium-91 |
.01 |
2,000 |
|
Zinc-65 |
.01 |
5,000 |
|
Zirconium-93 |
.01 |
400 |
|
Zirconium-95 |
.01 |
5,000 |
|
Any other beta-gamma emitter |
.01 |
10,000 |
|
Mixed fission products |
.01 |
1,000 |
|
Mixed corrosion products |
.01 |
10,000 |
|
Contaminated equipment, beta-gamma |
.001 |
10,000 |
|
Irradiated material, any form other than solid noncombustible |
.01 |
1,000 |
|
Irradiated material, solid noncombustible |
.001 |
10,000 |
|
Mixed radioactive waste, beta-gamma |
.01 |
1,000 |
|
Packaged mixed waste, beta-gamma b/ |
.001 |
10,000 |
|
Any other alpha emitter |
.001 |
2 |
|
Contaminated equipment, alpha |
.0001 |
20 |
|
Packaged waste, alpha b/ |
.0001 |
20 |
|
Combinations of radioactive materials listed above a/ |
-- |
-- |
Footnotes for Schedule F to Section 2:
a/ For combinations of radioactive materials, consideration of the need for an emergency plan is required if the sum of the ratios of the quantity of each radioactive material authorized to the quantity listed for that material in Schedule F to Section 2 exceeds one.
b/ Waste packaged in Type B containers does not require an emergency plan.
APPENDIX A TO SECTION 2
CRITERIA RELATING TO USE OF FINANCIAL TESTS AND PARENT COMPANY GUARANTEE FOR PROVIDING REASONABLE ASSURANCE OF FUNDS FOR DECOMMISSIONING
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.
either paragraph A.1. or A.2. of this section. For purposes of applying the Appendix A criteria, tangible net worth must be calculated to exclude all intangible assets and the net book value of the nuclear facility and site, and total net worth, which may include intangible assets, must be calculated to exclude the net book value and goodwill of the nuclear facility and site.
pass the test and provide documentation of its continued eligibility to use the parent company guarantee to the Department within ninety (90) days after the close of each succeeding fiscal year.
paragraph A. of this Appendix, the licensee must send notice to the Department of intent to establish alternate financial assurance as specified in the Department's regulations. The notice must be sent by certified mail within ninety (90) days after the end of the fiscal year for which the yearend financial data show that the parent company no longer meets the financial test requirements. The licensee must provide alternate financial assurance within 120 days after the end of such fiscal year.
The terms of a parent company guarantee which an applicant or licensee obtains must provide that:
immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of title 11 (Bankruptcy) of the United States Code, or the occurrence of any other event listed in paragraph F of this section, by or against:
APPENDIX B TO SECTION 2
CRITERIA RELATING TO USE OF FINANCIAL TESTS AND SELF GUARANTEE FOR PROVIDING REASONABLE ASSURANCE OF FUNDS FOR DECOMMISSIONING
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.
The terms of a self-guarantee which an applicant or licensee furnishes must provide that:
be rated in any category of "A" or above by either Standard and Poor's or in any category of "A3" and above by Moody's, the licensee will notify the Department in writing within twenty (20) days after publication of the change by the rating service.
any category of A or above by both Standard and Poor and Moody's, the licensee no longer meets the requirements of Section II.A of this Appendix.
environment must be established for decommissioning costs before the self-guarantee agreement is submitted.
acceptable trustee includes an appropriate State or Federal Government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a Federal or State agency. The Department has the right to change the trustee. An acceptable trust will meet the regulatory criteria established in these Regulations that govern the issuance of the license for which the guarantor has accepted the obligation to pay for decommissioning costs.
inability to pay its debts generally, or makes a general assignment for the benefit of creditors, or any proceeding is instituted by or against the guarantor seeking to adjudicate it as bankrupt or insolvent, or seeking dissolution, liquidation, winding-up, reorganization, arrangement, adjustment, protection, relief or composition of it or its debts under any law relating to bankruptcy, insolvency, or reorganization or relief of debtors, or seeking the entry of an order for relief or the appointment of a receiver, trustee, custodian, or other similar official for the guarantor or for any substantial part of its property, or the guarantor takes any action to authorize or effect any of the actions stated in this paragraph, then the Department may:
following the occurrence of any event listed in paragraph H. of this section, and must include a description of the event, including major creditors, the amounts involved, and the actions taken to assure that the amount of funds guaranteed by the self-guarantee agreement for decommissioning will be transferred to the standby trust as soon as possible.
APPENDIX C TO SECTION 2
CRITERIA RELATING TO USE OF FINANCIAL TESTS AND SELF GUARANTEE FOR PROVIDING REASONABLE ASSURANCE OF FUNDS FOR DECOMMISSIONING BY COMMERCIAL COMPANIES THAT HAVE NO OUTSTANDING RATED BONDS
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.
The terms of a self-guarantee which an applicant or licensee furnishes must provide that:
cancellation by certified mail, return receipt requested, to the Department. Cancellation may not occur until an alternative financial assurance mechanism is in place.
following the occurrence of any event listed in paragraph F of this section, and must include a description of the event, including major creditors, the amounts involved, and the actions taken to assure that the amount of funds guaranteed by the self-guarantee agreement for decommissioning will be transferred to the standby trust as soon as possible.
APPENDIX D TO SECTION 2
CRITERIA RELATING TO USE OF FINANCIAL TESTS AND SELF GUARANTEE FOR PROVIDING REASONABLE ASSURANCE OF FUNDS FOR DECOMMISSIONING BY NONPROFIT COLLEGES, UNIVERSITIES, AND HOSPITALS
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 applicant or licensee 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.
The terms of a self-guarantee which an applicant or licensee furnishes must provide that:
acceptable trustee includes an appropriate State or Federal Government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a Federal or State agency. The Department has the right to change the trustee. An acceptable trust will meet the regulatory criteria established in these Regulations that govern the issuance of the license for which the guarantor has accepted the obligation to pay for decommissioning costs.
following the occurrence of any event listed in paragraph G of this section, and must include a description of the event, including major creditors, the amounts involved, and the actions taken to assure that the amount of funds guaranteed by the self-guarantee agreement for decommissioning will be transferred to the standby trust as soon as possible.
APPENDIX E TO SECTION 2
QUANTITIES FOR USE WITH RH-409.h.
|
Material |
Microcurie |
|
Americium-241 |
0.01 |
|
Antimony-122 |
100 |
|
Antimony-124 |
10 |
|
Antimony-125 |
10 |
|
Arsenic-73 |
100 |
|
Arsenic-74 |
10 |
|
Arsenic-76 |
10 |
|
Arsenic-77 |
100 |
|
Barium-131 |
10 |
|
Barium-133 |
10 |
|
Barium-140 |
10 |
|
Bismuth-210 |
1 |
|
Bromine-82 |
10 |
|
Cadmium-109 |
10 |
|
Cadmium-115m |
10 |
|
Cadmium-115 |
100 |
|
Calcium-45 |
10 |
|
Calcium-47 |
10 |
|
Carbon-14 |
100 |
|
Cerium-141 |
100 |
|
Cerium-143 |
100 |
|
Cerium-144 |
1 |
|
Cesium-131 |
1,000 |
|
Cesium-134m |
100 |
|
Cesium-134 |
1 |
|
Cesium-135 |
10 |
|
Cesium-136 |
10 |
|
Cesium-137 |
10 |
|
Chlorine-36 |
10 |
|
Chlorine-38 |
10 |
|
Chromium-51 |
1,000 |
|
Cobalt-58m |
10 |
|
Cobalt-58 |
10 |
|
Cobalt-60 |
1 |
|
Copper-64 |
100 |
|
Dysprosium-165 |
10 |
|
Dysprosium-166 |
100 |
|
Erbium-169 |
100 |
|
Erbium-171 |
100 |
|
Europium-152 9.2h |
100 |
|
Europium-152 13yr |
1 |
|
Europium-154 |
1 |
|
Europium-155 |
10 |
|
Fluorine-18 |
1,000 |
|
Gadolinium-153 |
10 |
|
Gadolinium-159 |
100 |
|
Gallium-72 |
10 |
|
Germanium-71 |
100 |
|
Gold-198 |
100 |
|
Gold-199 |
100 |
|
Hafnium-181 |
10 |
|
Holmium-166 |
100 |
|
Hydrogen-3 |
1,000 |
|
Indium-113m |
100 |
|
Indium-114m |
10 |
|
Indium-115m |
100 |
|
Indium-115 |
10 |
|
Iodine-125 |
1 |
|
Iodine-126 |
1 |
|
Iodine-129 |
0.1 |
|
Iodine-131 |
1 |
|
Iodine-132 |
10 |
|
Iodine-133 |
1 |
|
Iodine-134 |
10 |
|
Iodine-135 |
10 |
|
Iridium-192 |
10 |
|
Iridium-194 |
100 |
|
Iron-55 |
100 |
|
Iron-59 |
10 |
|
Krypton-85 |
100 |
|
Krypton-87 |
10 |
|
Lanthanum-140 |
10 |
|
Lutetium-177 |
100 |
|
Manganese-52 |
10 |
|
Manganese-54 |
10 |
|
Manganese-56 |
10 |
|
Mercury-197m |
100 |
|
Mercury-197 |
100 |
|
Mercury-203 |
10 |
|
Molybdenum-99 |
100 |
|
Neodymium-147 |
100 |
|
Neodymium-149 |
100 |
|
Nickel-59 |
100 |
|
Nickel-63 |
10 |
|
Nickel-65 |
100 |
|
Niobium-93m |
10 |
|
Niobium-95 |
10 |
|
Niobium-97 |
10 |
|
Osmium-185 |
10 |
|
Osmium-191m |
100 |
|
Osmium-191 |
100 |
|
Osmium-193 |
100 |
|
Palladium-103 |
100 |
|
Palladium-109 |
100 |
|
Phosphorus-32 |
10 |
|
Platinum-191 |
100 |
|
Platinum-193m |
100 |
|
Platinum-193 |
100 |
|
Platinum-197m |
100 |
|
Platinum-197 |
100 |
|
Plutonium-239 |
0.01 |
|
Polonium-210 |
0.1 |
|
Potassium-42 |
10 |
|
Praseodymium-142 |
100 |
|
Praseodymium-143 |
100 |
|
Promethium-147 |
10 |
|
Promethium-149 |
10 |
|
Radium-226 |
0.01 |
|
Rhenium-186 |
100 |
|
Rhenium-188 |
100 |
|
Rhodium-103m |
100 |
|
Rhodium-105 |
100 |
|
Rubidium-86 |
10 |
|
Rubidium-87 |
10 |
|
Ruthenium-97 |
100 |
|
Ruthenium-103 |
10 |
|
Ruthenium-105 |
10 |
|
Ruthenium-106 |
1 |
|
Samarium-151 |
10 |
|
Samarium-153 |
100 |
|
Scandium-46 |
10 |
|
Scandium-47 |
100 |
|
Scandium-48 |
10 |
|
Selenium-75 |
10 |
|
Silicon-31 |
100 |
|
Silver-105 |
10 |
|
Silver-110m |
1 |
|
Silver-111 |
100 |
|
Sodium-24 |
10 |
|
Strontium-85 |
10 |
|
Strontium-89 |
1 |
|
Strontium-90 |
0.1 |
|
Strontium-91 |
10 |
|
Strontium-92 |
10 |
|
Sulfur-35 |
100 |
|
Tantalum-182 |
10 |
|
Technetium-96 |
10 |
|
Technetium-97m |
100 |
|
Technetium-97 |
100 |
|
Technetium-99m |
100 |
|
Technetium-99 |
10 |
|
Tellurium-125m |
10 |
|
Tellurium-127m |
10 |
|
Tellurium-127 |
100 |
|
Tellurium-129m |
10 |
|
Tellurium-129 |
100 |
|
Tellurium-131m |
10 |
|
Tellurium-132 |
10 |
|
Terbium-160 |
10 |
|
Thallium-200 |
100 |
|
Thallium-201 |
100 |
|
Thallium-202 |
100 |
|
Thallium-204 |
10 |
|
Thorium (natural)a/ |
100 |
|
Thulium-170 |
10 |
|
Thulium-171 |
10 |
|
Tin-113 |
10 |
|
Tin-125 |
10 |
|
Tungsten-181 |
10 |
|
Tungsten-185 |
10 |
|
Tungsten-187 |
100 |
|
Uranium (natural)b/ |
100 |
|
Uranium-233 |
0.01 |
|
U-234 - U-235 |
0.01 |
|
Vanadium-48 |
10 |
|
Xenon-131m |
1,000 |
|
Xenon-133 |
100 |
|
Xenon-135 |
100 |
|
Ytterbium-175 |
100 |
|
Yttrium-90 |
10 |
|
Yttrium-91 |
10 |
|
Yttrium-92 |
100 |
|
Yttrium-93 |
100 |
|
Zinc-65 |
10 |
|
Zinc-69m |
100 |
|
Zinc-69 |
1,000 |
|
Zirconium-93 |
10 |
|
Zirconium-95 |
10 |
|
Zirconium-97 |
10 |
|
Any alpha emitting radionuclide not listed above or mixtures of alpha emitters of unknown composition |
0.01 |
|
Any radionuclide other than alpha emitting radionuclides, not listed above or mixtures of beta emitters of unknown composition |
0.1 |
Note:
Where there is involved a combination of radionuclides in known amounts, the limit for the combination should be derived as follows: Determine, for each radionuclide in the combination, the ratio between the quantity present in the combination and the limit otherwise established for the specific radionuclide when not in combination. The sum of such ratios for all radionuclides in the combination may not exceed "1" (i.e., "unity").
Footnotes for Appendix E to Section 2:
a/ Based on alpha disintegration rate of Th-232, Th-230, and their daughter products.
b/ Based on alpha disintegration rate of U-238, U-234, and U-235.
FOOTNOTES TO SECTION 2
1/ Attention is directed to the fact that regulation by the State of source material,
byproduct material, and special nuclear material in quantities not sufficient to form a critical mass is subject to the provisions of the agreement between the State and the U.S. Nuclear Regulatory Commission and to 10 CFR Part 150 of the Commission's regulations.
2/ The requirements specified in RH-300.c.1.E.i. and ii. need not be met by
counterweights manufactured prior to December 31, 1969, provided that such counterweights are impressed with the legend, "CAUTION - RADIOACTIVE MATERIAL - URANIUM," as previously required by these Regulations.
3/ Deleted.
4/ For purposes of this subparagraph, "electron tubes" include spark gap tubes,
power tubes, gas tubes including glow lamps, receiving tubes, microwaves tubes, indicator tubes, pick-up tubes, radiation detection tubes and any other completely sealed tube that is designed to conduct or control electrical currents.
5/ Deleted.
6/ Deleted.
7/ Deleted.
8/ The New Drug provisions of the Federal Food, Drug and Cosmetic Act also govern the availability and use of any specific diagnostic drugs in interstate commerce.
9/ Sources licensed under RH-405.e., RH-105.h. or RH-405.i. prior to January 19, 1975 may bear labels authorized by the regulations in effect on January 1, 1975.
10/ The model, serial number, and the name of the manufacturer or initial transferor may be omitted from this label provided they are elsewhere specified in labeling affixed to the device.
11/ A previous RH-1403. permitted certain burials of small quantities of licensed
materials in soil before January 1, 1983, without specific Department authorization. As of January 1, 1983, these burials had to receive specific approval by the Department, in accordance with the revised RH-1403. Disposal by burial in soil came to be regulated under RH-1401.
SECTION 3. STANDARDS FOR PROTECTION AGAINST RADIATION
(FOOTNOTES APPEAR AT THE END OF THIS SECTION)
The provisions of these Regulations shall become effective on January 1, 1963, except where another effective date is specifically noted.
Except where otherwise specified, all communications concerning these Regulations may be addressed to the Arkansas Department of Health, Radiation Control Section, 4815 West Markham Street, Slot 30, Little Rock, Arkansas, 72205-3867.
Absorbed dose - The energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the rad and the gray (Gy).
Accelerator-produced material - Any material made radioactive by a particle accelerator.
Act - Act 8 of Second Extraordinary Session of 1961, as amended.
Activity - The rate of disintegration (transformation or decay of radioactive material). The units of activity are the curie (Ci) and the becquerel (Bq).
Adult - An individual 18 or more years of age.
Agreement State - Any state with which the Atomic Energy Commission or the U.S. Nuclear Regulatory Commission has entered into an effective agreement under subsection 274 b. of the Atomic Energy Act of 1954 (68 Stat. 919), including any amendments thereto. Non-agreement State means any other State.
Airborne radioactive material - Radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.
Airborne radioactivity area - A room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:
Air-purifying respirator - A respirator with an air purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.
ALARA (acronym for "as low as is reasonably achievable") - Making every reasonable effort to maintain exposures to radiation as far below the dose limits in this Section as is practical consistent with the purpose for which the licensed activity or x-ray equipment use is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of x-ray equipment, nuclear energy and licensed materials in the public interest.
Annual limit on intake (ALI) - The derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 5 rems (0.05 Sv) or a committed dose equivalent of 50 rems (0.5 Sv) to any individual organ or tissue. (ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Table I, Columns 1 and 2, of Appendix G to Section 3).
Assigned protection factor (APF) - The expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.
Atmosphere-supplying respirator - A respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SARs) and self-contained breathing apparatus (SCBA) units.
Background radiation - Radiation from cosmic sources, naturally occurring radioactive materials, including radon (except as a decay product of source or special nuclear material) and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee or registrant.
Becquerel (Bq) - One becquerel is equal to one disintegration per second (dps).
Bioassay (radiobioassay) - The determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement (in vivo counting) or by analysis and evaluation of materials excreted or removed from the human body.
Byproduct material -
converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or
and
before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; and
Class (or lung class or inhalation class) - A classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for Class D (Days) of less than 10 days, for Class W (Weeks) from 10 to 100 days, and for Class Y (Years) of greater than 100 days.
Collective dose - The sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.
Committed dose equivalent (HT,50) - The dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake.
Committed effective dose equivalent (HE,50) - The sum of the products of the weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to these organs or tissues (HE,50 = wTHT,50).
Constraint (dose constraint) - a value above which specified licensee or registrant actions are required.
Controlled area - An area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason.
Critical Group - the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.
Curie (Ci) - One curie is that amount of radioactive material which disintegrates at the rate of 37 billion atoms per second.
Declared pregnant woman - A woman who has voluntarily informed her employer, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared woman withdraws the declaration in writing or is no longer pregnant.
Decommission - to remove a facility or site safely from service and reduce residual radioactivity to a level that permits:
Deep-dose equivalent (Hd) - (which applies to external whole-body exposure) The dose equivalent at a tissue depth of one (1) cm (1000 mg/cm2).
Demand respirator - An atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.
Department - The Arkansas Department of Health or its duly authorized representatives.
Department of Energy (DOE) - The Department of Energy established by the Department of Energy Organization Act ( Public Law 95-91, 91 Stat. 565, 42 U.S.C. 7101 et seq.) to the extent that the DOE, or its duly authorized representatives, 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, 88 Stat. 1233 at 1237, 42 U.S.C. 5814) and retransferred to the Secretary of Energy pursuant to Section 301(a) of the Department of Energy Organization Act ( Public Law 95-91, 91 Stat. 565 at 577-578, 42 U.S.C. 7151).
Derived air concentration (DAC) - The concentration of a given radionuclide in air which, if breathed by the reference man for a working year of 2,000 hours under conditions of light work (inhalation rate 1.2 cubic meters of air per hour), results in an intake of one ALI. DAC values are given in Table I, Column 3, of Appendix G to Section 3.
Derived air concentration-hour (DAC-hour) - The product of the concentration of radioactive material in air (expressed as a fraction or multiple of the derived air concentration for each radionuclide) and the time of exposure to that radionuclide, in hours. A licensee may take 2,000 DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 5 rems (0.05 Sv).
Director - Director of the Arkansas Department of Health.
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.
Disposable respirator - A respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).
Distinguishable from background - the detectable concentration of a radionuclide is statistically different from the background concentration of that radionuclide in the vicinity of the site or, in the case of structures, in similar materials using adequate measurement technology, survey, and statistical techniques.
Dose or radiation dose - A generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, or total effective dose equivalent, as defined in other Paragraphs of this Section.
Dose equivalent (HT) - The product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the rem and sievert (Sv).
Dosimetry processor - An individual or an organization that processes and evaluates individual monitoring equipment in order to determine the radiation dose delivered to the equipment.
Effective dose equivalent (HE) - The sum of the products of the dose equivalent to the organ or tissue (HT) and the weighting factors (wT) applicable to each of the body organs or tissues that are irradiated (HE = wTHT).
Embryo/fetus - The developing human organism from conception until the time of birth.
Entrance or access point - Any location through which an individual could gain access to radiation areas or to radioactive materials. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.
Exposure - Being exposed to ionizing radiation or to radioactive material.
External dose - That portion of the dose equivalent received from radiation sources outside the body.
Extremity - Hand, elbow, arm below the elbow, foot, knee, and leg below the knee.
Eye dose equivalent - The external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2).
Filtering facepiece (dust mask) - A negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable strap.
Fit factor - A quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.
Fit test - The use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.
Generally applicable environmental radiation standards - Standards issued by the Environmental Protection Agency (EPA) under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.
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.
Gray - See RH-1102., "Units of Radiation Dose."
Helmet - A rigid respirator inlet covering that also provides head protection against impact and penetration.
High radiation area - An area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 0.1 rem (1 mSv) in one (1) hour at thirty (30) centimeters from the radiation source or thirty (30) centimeters from any surface that the radiation penetrates.
Hood - A respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.
Individual - Any human being.
Individual monitoring:
Individual Monitoring Devices (individual monitoring equipment) - Devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges, thermoluminescent dosimeters (TLDs), pocket ionization chambers, and personal ("lapel") air sampling devices.
Internal dose - That portion of the dose equivalent received from radioactive material taken into the body.
Lens dose equivalent (LDE) - applies to the external exposure of the lens of the
eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2).
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 - The holder of a license.
Limits (dose limits) - The permissible upper bounds of radiation doses.
Loose-fitting facepiece- A respiratory inlet covering that is designed to form a partial seal with the face.
Lost or missing licensed material - Licensed material whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.
Member of the public - Any individual except when that individual is receiving an occupational dose.
Minor- An individual less than 18 years of age.
Monitoring (radiation monitoring, radiation protection monitoring) - The measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.
Nationally tracked source - A sealed source containing a quantity equal to or greater than Category 1 or Category 2 levels of any radioactive material listed in Appendix D of this Section. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 1 threshold. Category 2 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold.
Negative pressure respirator (tight fitting) - A respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.
Nonstochastic effect - Health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect (also called a deterministic effect).
Occupational dose - The dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or to radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include dose received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with RH-8420., from voluntary participation in medical research programs, or as a member of the general public.
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.
Planned special exposure - An infrequent exposure to radiation, separate from and in addition to the annual dose limits.
Positive pressure respirator - a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.
Powered air-purifying respirator (PADR) - an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.
Pressure demand respirator - a positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.
Public dose - The dose received by a member of the public from exposure to radiation or radioactive material released by a licensee, or to any other source of radiation under the control of a licensee or registrant. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with RH-8420, or from voluntary participation in medical research programs.
Qualitative fit test (QLFT) - A pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.
Quality Factor (Q) - The modifying factor (listed in Tables 1 and 2 of RH-1102.) that is used to derive dose equivalent from absorbed dose.
Quantitative fit test (QNFT) - An assessment of the adequacy of respirator fit by numerically measuring the leakage into the respirator.
Quarter - A period of time equal to one-fourth of the year observed by the licensee (approximately 13 consecutive weeks), providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.
Rad - See RH-1102., "Units of Radiation Dose."
Radiation (ionizing radiation) - Alpha particles, beta particles, gamma rays, x-rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. Radiation, as used in this Part, does not include non-ionizing radiation, such as radio- or microwaves, or visible, infrared, or ultraviolet light.
Radiation area - An area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.005 rem (0.05 mSv) in one (1) hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates.
Radiation machine - Any device capable of producing radiation, but excluding devices which produce radiation only by the use of radioactive material.
Radioactive material - Any material (solid, liquid or gas) which emits radiation spontaneously including any natural radioactive material such as radium.
Radioactivity - The transformation of unstable atomic nuclei by the emission of radiation.
Reference man - A hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.
Rem - See RH-1102., "Units of Radiation Dose."
Residual radioactivity - Radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of Part E, "Waste Disposal."
Respiratory protective device - An apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.
Restricted area - An area, access to which is limited by the licensee for the purpose of protecting individuals against undue risks from exposure to radiation and radioactive materials. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.
Sanitary sewerage - A system of public sewers for carrying off waste water and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.
Self-contained breathing apparatus(SCBA) - An atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.
Shallow-dose equivalent (Hs) - (which applies to the external exposure of the skin of the whole body or the skin of an extremity) - The dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2).
Sievert - See RH-1102., "Units of Radiation Dose."
Site boundary - That line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee.
Source material -
Source of radiation - Any radioactive material or any radiation machine.
Special nuclear material -
Storage container - A device in which sealed sources are transported or stored.
Stochastic effects - Health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.
Supplied-air respirator (SAR) or airline respirator - an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.
Survey - An evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.
Temporary jobsite - A location to which radioactive materials or x-ray equipment have been dispatched to perform one (1) or more of the following service operations:
Tight-fitting facepiece- A respiratory inlet covering that forms a complete seal with the face.
Total Effective Dose Equivalent (TEDE) - The sum of the effective-dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).
Uncontrolled area or unrestricted area - Any area to which access is not controlled by the licensee or registrant for the purposes of protection of individuals from exposure to radiation and radioactive materials and any area used for residential quarters.
Uranium fuel cycle - The operations of milling of uranium ore, chemical conversion of uranium, isotopic enrichment of uranium, fabrication of uranium fuel, generation of electricity by a light-water-cooled nuclear power plant using uranium fuel, and reprocessing of spent uranium fuel to the extent that these activities directly support the production of electrical power for public use. Uranium fuel cycle does not include mining operations, operations at waste disposal sites, transportation of radioactive material in support of these operations, and the reuse of recovered non-uranium special nuclear and byproduct materials from the cycle.
User seal check (fit check) - An action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure, irritant smoke check, or isoamyl acetate check.
Very high radiation area - An area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of 500 rads (5 grays) in one (1) hour at one (1) meter from a radiation source or from any surface that the radiation penetrates.
Note: At very high doses received at high dose rates, units of absorbed dose (e.g., rads and grays) are appropriate, rather than units of dose equivalent (e.g., rems and sieverts).
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.
Week - Seven (7) consecutive days starting on Sunday.
Weighting factor (wT) - For an organ or tissue (T) is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective equivalent, the values of wT are:
ORGAN DOSE WEIGHTING FACTORS
|
Organ or Tissue |
wT |
|
Gonads |
0.25 |
|
Breast |
0.15 |
|
Red bone marrow |
0.12 |
|
Lung |
0.12 |
|
Thyroid |
0.03 |
|
Bone surfaces |
0.03 |
|
Remainder |
0.30a |
|
Whole Body |
1.00b |
a 0.30 results from 0.06 for each of 5 "remainder" organs (excluding the skin and the lens of the eye) that receive the highest doses.
b For the purpose of weighting the external whole body dose (for adding it to the internal dose), a single weighting factor, wT = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.
Whole body - For purposes of external exposure, head, trunk (including male gonads), arms above the elbow, or legs above the knee.
Worker - An individual engaged in work under a license or registration issued by the Department and controlled by a licensee or registrant.
Working level (WL) - Any combination of short-lived radon daughters (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter of air that will result in the ultimate emission of 1.3 x 105 MeV of potential alpha particle energy.
Working level month (WLM) - An exposure to one working level for 170 hours (2,000 working hours per year/12 months per year = approximately 170 hours per month).
Year - The period of time beginning in January used to determine compliance with the provisions of this Section. The licensee may change the starting date of the year used to determine compliance by the licensee provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.
As used in this Section, the units of radiation dose are:
dose equivalent are shown in Table I to RH-1102.
TABLE I TO RH-1102. QUALITY FACTORS AND ABSORBED DOSE EQUIVALENCIES
|
Type of Radiation |
Quality Factor (Q) |
Absorbed Dose Equal to a Unit Dose Equivalenta |
|
X-, gamma, or beta radiation |
1 |
1 |
|
Alpha particles, multiple-charged particles, fission fragments, and heavy particles of unknown charge |
20 |
0.05 |
|
Neutrons of unknown energy |
10 |
0.1 |
|
High-energy protons |
10 |
0.1 |
a Absorbed dose in rad equal to 1 rem or the absorbed dose in gray equal to 1 sievert.
TABLE II TO RH-1102.
MEAN QUALITY FACTORS, Q, AND FLUENCE PER UNIT DOSE EQUIVALENT FOR MONOENERGETIC NEUTRONS
|
Neutron Energy (MeV) |
Quality Factora (Q) |
Fluence per Unit Dose Equivalentb (neutrons cm-2 rem -1) |
|
|
(thermal)...... |
2.5 x 10-8 |
2 |
980 x 106 |
|
1 x 10-7 |
2 |
980 x 106 |
|
|
1 x 10-6 |
2 |
810 x 106 |
|
|
1 x 10-5 |
2 |
810 x 106 |
|
|
1 x 10-4 |
2 |
840 x 106 |
|
|
1 x 10-3 |
2 |
980 x 106 |
|
|
1 x 10-2 |
2.5 |
1010 x 106 |
|
|
1 x 10-1 |
7.5 |
170 x 106 |
|
|
5 x 10-1 |
11 |
39 x 106 |
|
|
1 |
11 |
27 x 106 |
|
|
2.5 |
9 |
29 x 106 |
|
|
5 |
8 |
23 x 106 |
|
|
7 |
7 |
24 x 106 |
|
|
10 |
6.5 |
24 x 106 |
|
|
14 |
7.5 |
17 x 106 |
|
|
20 |
8 |
16 x 106 |
|
|
40 |
7 |
14 x 106 |
|
|
60 |
5.5 |
16 x 106 |
|
|
1 x 102 |
4 |
20 x 106 |
|
|
2 x 102 |
3.5 |
19 x 106 |
|
|
3 x 102 |
3.5 |
16 x 106 |
|
|
4 x 102 |
3.5 |
14 x 106 |
a Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30 cm diameter cylinder tissue-equivalent phantom.
b Monoenergetic neutrons incident normally on a 30 cm diameter cylinder tissue-equivalent phantom.
For the purposes of this Part, activity is expressed in the special unit of curies (Ci) or in the SI unit of becquerels (Bq), or their multiples, or disintegrations (transformations) per unit of time.
Except as specifically authorized by the Department in writing, no interpretations of the meaning of the regulations in this Section by an officer or employee of the Department other than a written interpretation by the Department Director or designee will be recognized as binding upon the Department.
(currently Appendices A, B, E-H, and J of Section 3 and Appendix A of Section 4) and there are no corresponding provisions in RH-1000. through RH-2110., then the license condition remains in force until there is a license amendment or license renewal that modifies or removes this condition.
licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only under RH-1302.a. or only under RH-1302.b., then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses by meeting one of the conditions specified in RH-1201.b. and the conditions in RH-1201.c. and RH-1201.d.
NOTE:The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.
NOTE:The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be further evaluated.
Licensees shall, when determining the dose from airborne radioactive material, include the contribution to the deep-dose equivalent, eye dose equivalent, and shallow-dose equivalent from external exposure to the radioactive cloud. (See Appendix G to Section 3, footnotes a and b.)
NOTE:Airborne radioactivity measurements and DAC values should not be used as the primary means to assess the deep-dose equivalent when the airborne radioactive material includes radionuclides other than noble gases or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep-dose equivalent to an individual should be based upon measurements using instruments or individual monitoring devices.
In order to calculate the committed effective dose equivalent, the
licensee may assume that the inhalation of one ALI, or an exposure of 2,000 DAC-hours, results in a committed effective dose equivalent of 5 rems (0.05 Sv) for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent.
nonstochastic organ dose limit of 50 rems (0.5 Sv), the intake of radionuclides that would result in a committed effective dose equivalent of 5 rems (0.05 Sv) (the stochastic ALI) is listed in parentheses in Table I of Appendix G to Section 3.
In this case, the licensee may, as a simplifying assumption, use the stochastic ALIs to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALIs, the licensee must also demonstrate that the limit in RH-1200.a.1.B. is met.
A licensee or registrant may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in RH-1200. provided that each of the following conditions is satisfied:
The annual occupational dose limits for minors are ten percent (10%) of the annual dose limits specified for adult workers in RH-1200.
embryo/fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv). (For recordkeeping requirements, see RH-1500.f.)
Where necessary or desirable in order to aid in determining the extent of an individual's exposure to concentrations of radioactive material, the Department may require a licensee to make available to the individual appropriate bioassay services and to furnish a copy of the reports of such services to the Department.
being used and are identified as being in storage. The licensee shall, however, test each such sealed source for leakage and/or contamination and receive the test results before any use or transfer unless it has been tested for leakage and/or contamination within the required leak test interval before the date of use or transfer. No sealed source shall be stored for a period of more than 3 years without being tested for leakage and/or contamination.
transfer, or dispose of radioactive material is subject to RH-1215. through RH-1220.
A site will be considered acceptable for unrestricted use if the residual radioactivity that is distinguishable from background radiation results in a TEDE to an average member of the critical group that does not exceed 25 mrem (0.25 mSv) per year, including that from groundwater sources of drinking water, and the residual radioactivity has been reduced to levels that are as low as reasonably achievable (ALARA). Determination of the levels which are ALARA must take into account consideration of any detriments, such as deaths from transportation accidents, expected to potentially result from decontamination and waste disposal.
A site will be considered acceptable for license termination under restricted conditions if:
shall seek advice from such affected parties regarding the following matters concerning the proposed decommissioning:
from residual radioactivity distinguishable from background to the average member of the critical group will not exceed 25 mrem (0.25 mSv) TEDE per year;
assurance to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site.
licensee shall provide for:
institutional controls were no longer in effect, there is reasonable assurance that the TEDE from residual radioactivity distinguishable from background to the average member of the critical group is as low as reasonably achievable and would not exceed either:
responsible government entity or independent third party, including a governmental custodian of a site, both to carry out periodic rechecks of the site no less frequently than every five (5) years to assure that the institutional controls remain in place as necessary to meet the criteria of RH-1217.b. and to assume and carry out responsibilities for any necessary control and maintenance of those controls. Acceptable financial assurance mechanisms are those in RH-1217.c.
than the dose criterion of RH-1216., RH-1217.b., and RH-1217.d.1.A.i., if the licensee:
fund to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site.
the Department after consideration of the Department's staff recommendations that will address any comments provided by the U.S. Environmental Protection Agency, any other State Governmental organization, and any public comments submitted pursuant to RH-1219.
Upon the receipt of an LTP or decommissioning plan from the licensee, or a proposal by the licensee for release of a site pursuant to RH-1217. or RH-1218., or whenever the Department deems such notice to be in the public interest, the Department shall:
local organizations, or other appropriate forum, that is readily accessible to individuals in the vicinity of the site, and solicit comments from affected parties.
National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology [formerly called National Bureau of Standards], and
Each licensee or registrant shall monitor exposures to radiation and radioactive material at levels sufficient to demonstrate compliance with the occupational dose limits of this Section. As a minimum:
radiation from licensed and unlicensed radiation sources under the control of the licensee and shall supply and require the use of individual monitoring devices by:
NOTE:All of the occupational doses in RH-1200. continue to be applicable to the declared pregnant worker as long as the embryo/fetus dose limit is not exceeded.
The licensee or registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA."
The licensee or registrant shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA."
The licensee or registrant shall post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "GRAVE DANGER, VERY HIGH RADIATION AREA."
The licensee shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, AIRBORNE RADIOACTIVITY AREA" or "DANGER, AIRBORNE RADIOACTIVITY AREA."
The licensee shall post each area or room in which there is used or stored an amount of licensed material exceeding ten (10) times the quantity of such material specified in Appendix H to Section 3 with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)."
not required solely because of the presence of patients containing radioactive material, provided that there are personnel in attendance who will take the necessary precautions to prevent the exposure of individuals to radiation or radioactive material in excess of the limits established in this Section and to operate within the ALARA provisions of the licensee's radiation protection program.
Very high radiation areas.
In addition to the requirements in RH-1303.c., the licensee or registrant shall institute additional measures to ensure that an individual is not able to gain unauthorized or inadvertent access to areas in which radiation levels could be encountered at 500 rads (5 grays) or more in one (1) hour at one (1) meter from a radiation source or any surface through which the radiation penetrates.
from inadvertently entering the area when very high radiation levels exist;
control device is actuated that causes the radiation level within the area, from the sealed source, to be reduced below that at which it would be possible for an individual to receive a deep-dose equivalent in excess of 0.1 rem (1 mSv) in one (1) hour; and
source, is reduced below that at which it would be possible for an individual to receive a deep-dose equivalent in excess of 0.1 rem (1 mSv) in one (1) hour; and
generated to make an individual attempting to enter the area aware of the hazard and at least one other authorized individual, who is physically present, familiar with the activity and prepared to render or summon assistance, aware of the failure of the entry control devices.
below that at which it would be possible for an individual to receive a deep-dose equivalent in excess of 0.1 rem (1 mSv) in one (1) hour; and
generated to make potentially affected individuals aware of the hazard and the licensee or at least one other individual, who is familiar with the activity and prepared to render or summon assistance, aware of the failure or removal of the physical barrier.
be tested for proper functioning. (See RH-1500.i. for recordkeeping requirements.)
with the source of radiation on any day (unless operations were continued uninterrupted from the previous day);
operation of the source of radiation after any unintended interruption; and
necessary to place the source in safe condition or to effect repairs on controls, unless control devices are functioning properly.
The licensee shall use, to the extent practical, process or other engineering controls (e.g., containment, decontamination, or ventilation) to control the concentration of radioactive material in air.
equipment that is tested and certified or had certification extended by the National Institute for Occupational Safety and Health (NIOSH) except as otherwise noted in this Section.
been tested or certified by NIOSH, or for which there is no schedule for testing or certification, the licensee shall submit an application for authorized use of this equipment, except as provided in this Section. The application must include evidence that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use. This must be demonstrated either by licensee testing or on the basis of reliable test information.
potential hazard, permit proper equipment selection, and estimate doses;
repair, testing, and quality assurance of respiratory protection equipment;
appropriate to the type and mode of use. When selecting respiratory devices, the licensee shall provide for vision correction, adequate communication, low temperature work environments, and the concurrent use of other safety or radiological protection equipment. The licensee shall use equipment in such a way as not to interfere with the proper operation of the respirator.
The Department may impose restrictions in addition to those in RH-1303.f.4. and RH-1303.f.5. and Appendix E to Section 3 to:
The licensee shall obtain authorization from the Department before using assigned protection factors in excess of those specified in Appendix E to Section 3. The Department may authorize a licensee to use higher assigned protection factors on receipt of an application that:
container to unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive material.
operated shall be appropriately labeled so as to caution individuals that such devices or equipment produce radiation when operated.
machines used solely in the healing arts, which is capable of producing, in any area accessible to individuals, a dose rate in excess of ten (10) millirems per hour shall be provided with a warning signal or light. Such a signal or light shall be so connected as to be activated automatically when the machine is "on" in order to provide adequate warning against entering the area.
Notwithstanding the provisions of RH-1303.:
Instructions required for individuals working in or frequenting any portion of a restricted area are specified in Part N of this Section.
radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as packages that are crushed, wet, or damaged.
The licensee shall control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage.
CAUTIONDANGER
or RADIOACTIVE MATERIALRADIOACTIVE MATERIAL
The label must also provide sufficient information (such as the radionuclide(s) present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment) to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures.
Each licensee or registrant shall ensure that individuals who are required to monitor occupational doses in accordance with RH-1302.a. wear individual monitoring devices as follows:
whole body shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck (collar);
A licensee shall dispose of licensed material only:
A licensee or applicant for a license may apply to the Department for approval of proposed procedures, not otherwise authorized in these Regulations, to dispose of licensed material generated in the licensee's activities. Each application shall include:
A licensee may treat or dispose of licensed material by incineration only in the amounts and forms specified in RH-1405. or as specifically approved by the Department pursuant to RH-1401.
designed to:
Nothing in this Part relieves the licensee from complying with other applicable Federal, State, and local regulations governing any other toxic or hazardous properties of materials that may be disposed of under this Part.
byproduct material set forth in RH-1100. may be disposed of in accordance with RH-407. of this chapter, even though it is not defined as low level radioactive waste. Therefore, any licensed byproduct material being disposed of at a facility, or transferred for ultimate disposal at a facility licensed under RH-407., must meet the requirements of RH-1406.
and 4. of the definition of byproduct material set forth in RH-1100., at a disposal facility authorized to dispose of such material in accordance with any Federal or State solid or hazardous waste law, including the Solid Waste Disposal Act, as authorized under the Energy Policy Act of 2005.
exposures, the licensee or registrant shall maintain records that describe:
Department terminates each pertinent license or registration requiring these records.
Each licensee or registrant shall maintain records of doses received by all individuals for whom monitoring was required pursuant to RH-1302., and records of doses received during planned special exposures, accidents, and emergency conditions. These records7/ must include, when applicable:
The licensee or registrant shall make entries of the records specified in paragraph f.1. of this section at least annually.
The licensee or registrant shall maintain the records specified in paragraph f.1. of this section on an up-to-date RC FORM 110, "Occupational Dose Record for a Monitoring Period," in accordance with the instructions for RC FORM 110, or in clear and legible records containing all the information required by that form.
The records required under this section should be protected from public disclosure because of their personal privacy nature.
Each licensee or registrant conducting activities as described in the definition for temporary jobsite in RH-1100. shall have the following records available at the temporary jobsite for inspection by the Department:
Record retention periods.
Each record required by this Section must be legible throughout the specified retention period. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, must include all pertinent information, such as stamps, initials, and signatures. The licensee or registrant shall maintain adequate safeguards against tampering with and loss of records.
All licensees or registrants shall make reports to the Department at 1-800-633 -1735.
All licensees or registrants shall make reports to the Arkansas Department of Health, Radiation Control Section Chief, 4815 West Markham Street, Slot 30, Little Rock, Arkansas, 72205-3867.
Notwithstanding any other requirements for notification, each licensee or registrant shall immediately report to the Department any event involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause any of the following conditions:
Each licensee or registrant shall, within twenty-four (24) hours of discovery of the event, report to the Department any event involving loss of control of a licensed or registered source of radiation possessed by the licensee or registrant that may have caused, or threatens to cause, any of the following conditions:
area, so that, had an individual been present for twenty-four (24) hours, the individual could have received an intake in excess of one occupational annual limit on intake. (The provisions of this paragraph do not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.)
The licensee or registrant shall submit a written report to the Department within thirty (30) days following any planned special exposure conducted in accordance with RH-1205., informing the Department that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by RH-1500.e.
In addition to the notification required by RH-1502., each licensee or registrant shall submit a written report within thirty (30) days after learning of any of the following occurrences:
the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:
section shall submit the report in writing to the Arkansas Department of Health, Radiation Control Section Chief, 4815 West Markham Street, Slot 30, Little Rock, Arkansas, 72205-3867.
radiation or radioactive material are specified in Part N of this Section (RH-2804).
When a licensee or registrant is required pursuant to RH-1503. or RH-1504. to report to the Department any exposure of an identified occupationally exposed individual, or an identified member of the public, to radiation or radioactive material, the licensee or registrant shall also provide the individual a report on his or her exposure data included in the report to the Department. The report must be transmitted no later than the transmittal to the Department.
Each specific licensee shall, no less than thirty (30) days before vacating or relinquishing possession or control of premises which may have been contaminated with radioactive material as a result of the activities, notify the Department in writing of intent to vacate. When deemed necessary by the Department, the licensee shall decontaminate the premises in such a manner as the Department may specify.
A licensee shall file a report with the Department within five (5) days if a test for leakage and/or contamination required by RH-1212. reveals the presence of 0.005 microcuries (185 Bq) or more of removable contamination. The written report must include the results of the test; the date the test results were received; identification of the source such as manufacturer, model number, and serial number; the radionuclide and its estimated activity; any equipment involved; any contamination which resulted from the leaking source; and the corrective actions taken.
pursuant to Part I of Section 3; or
TABLE TO RH-1509.a.2.
|
Radionuclide |
Activitya |
|
|
Ci |
GBq |
|
|
Cesium-137 |
1 |
37 |
|
Cobalt-60 |
1 |
37 |
|
Gold-198 |
100 |
3,700 |
|
Iodine-131 |
1 |
37 |
|
Iridium-192 |
10 |
370 |
|
Krypton-85 |
1,000 |
37,000 |
|
Promethium-147 |
10 |
370 |
|
Technetium-99m |
1,000 |
37,000 |
a The Department may require as a license condition, or by rule, Regulation, or order pursuant to RH-2001., reports from licensees who are licensed to use radionuclides not on this list, in quantities sufficient to cause comparable radiation levels.
Each licensee who manufactures, transfers, receives, disassembles, or disposes of a nationally tracked source shall complete and submit a National Source Tracking Transaction Report as specified in paragraphs a. through e. of this section for each type of transaction. See Appendix D to Section 3, "Nationally Tracked Source Thresholds."
if not available, other information to uniquely identify the source;
if not available, other information to uniquely identify the source;
if not available, other information to uniquely identify the source;
new report for any missed transaction within five (5) business days of the discovery of the error or missed transaction. Such errors may be detected by a variety of methods such as administrative reviews or by physical inventories required by regulation. In addition, each licensee shall reconcile the inventory of nationally tracked sources possessed by the licensee against that licensee's data in the National Source Tracking System. The reconciliation must be conducted during the month of January in each year. The reconciliation process must include resolving any discrepancies between the National Source Tracking System and the actual inventory by filing the reports identified by paragraphs a. through e. of this section. By January 31 of each year, each licensee must submit to the National Source Tracking System confirmation that the data in the National Source Tracking System is correct.
shall report its initial inventory of Category 1 nationally tracked sources to the National Source Tracking System by January 31, 2009. Each licensee that possesses Category 2 nationally tracked sources shall report its initial inventory of Category 2 nationally tracked sources to the National Source Tracking System by January 31, 2009. The information may be submitted by using any of the methods identified by paragraph f.1. through f.4. of this section. The initial inventory report must include the following information:
Upon instruction from the Department, each licensee and registrant shall perform or cause to have performed, and shall permit the Department to perform, such reasonable tests as the Department deems appropriate or necessary, including, but not limited to, tests of:
SPECIAL REQUIREMENTS FOR THE USE OF X-RAYS IN THE HEALING ARTS
This Part establishes requirements, for which a registrant (or licensee) is responsible, for use of x-ray equipment by or under the supervision of an individual authorized by and licensed in accordance with state statutes to engage in the healing arts or veterinary medicine. The provisions of this Part are in addition to and not in substitution for, other applicable provisions of these Regulations.
Accessible surface - The external surface of the enclosure or housing provided by the manufacturer.
Added filtration - Any filtration which is in addition to the inherent filtration
Aluminum equivalent - The thickness of type 1100 aluminum alloy11/ affording the same attenuation, under specified conditions, as the material in question.
Assembler - Any person engaged in the business of assembling, replacing or installing one or more components into an x-ray system or subsystem.
Attenuation block - A block or stack, having dimensions 20 centimeters by 20 centimeters by 3.8 centimeters, of type 1100 aluminum alloy11/ or other materials having equivalent attenuation.
Automatic exposure control - A device which automatically controls one or more technique factors in order to obtain at a pre-selected location(s) a required quantity of radiation. (See also "Phototimer.")
Barrier - See "Protective barrier."
Beam axis - A line from the source through the centers of the x-ray fields.
Beam-limiting device - A device which provides a means to restrict the dimensions of the x-ray field.
Beam monitoring system - A system designed to detect and measure the radiation present in the useful beam.
Calibration - The determination of (1) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument or (2) the strength of a source of radiation relative to a standard.
Cephalometric device - A device intended for the radiographic visualization and measurement of the dimensions of the human head.
Certified components - Components of x-ray systems which are subject to regulations promulgated under Public Law 90-602, the Radiation Control for Health and Safety Act of 1968.
Certified system - Any x-ray system which has one or more certified component(s).
Changeable filters - Any filter, exclusive of inherent filtration, which can be removed from the useful beam through any electronic, mechanical or physical process.
Coefficient of variation or "C" - The ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:
where:
s = Estimated standard deviation of the population;
x = Mean value of observations in sample;
xi = ith observation in sample; and
n = Number of observations in sample.
Contact therapy system - An x-ray system used for therapy with the x-ray tube port placed in contact with or within five (5) centimeters of the surface being treated.
Control panel - That part of the x-ray control upon which are mounted the switches, knobs, push buttons, and other hardware necessary for manually setting the technique factors.
Cooling curve - The graphical relationship between heat units stored and cooling time.
Dead-man switch - A switch constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator.
Detector - See "Radiation detector."
Diagnostic source assembly - The tube housing assembly with a beam-limiting device attached.
Diagnostic x-ray system - An x-ray system designed for irradiation of any part of the human body for the purpose of diagnosis or visualization.
Direct scattered radiation - The scattered radiation which has been deviated in direction only by materials irradiated by the useful beam. (See "Scattered radiation.")
Entrance exposure - The roentgens per unit time at the point where the center of the useful beam enters the patient.
Equipment - See "X-ray equipment."
Exposure - The quotient of dQ by dm where dQ is the absolute value of the total charge of the ions of one sign produced in air when all the electrons (negatrons and positrons) liberated by photons in a volume element of air having mass dm are completely stopped in air. (The special unit of exposure is the roentgen [R]).
Field emission equipment - Equipment which uses an x-ray tube in which electron emission from the cathode is due solely to the action of an electric field.
Filter - Material placed in the useful beam to absorb preferentially selected radiations.
Fluoroscopic imaging assembly - A subsystem in which x-ray photons produce a fluoroscopic image. It includes the image receptor(s) such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.
Focal spot - The area projected on the anode of the x-ray tube by the electrons accelerated from the cathode and from which the useful beam originates.
Full beam detector - A radiation detector of such size that the total cross section of the maximum size useful beam is intercepted.
General purpose radiographic x-ray system - Any radiographic x-ray system which, by design, is not limited to radiographic examination of specific anatomical regions.
Gonad shield - A protective barrier for the testes or ovaries.
Half-value layer- The thickness of specified material which attenuates the beam of radiation to an extent such that the exposure rate is reduced to one-half of its original value. In this definition, the contribution of all scattered radiation, other than any which might be present initially in the beam concerned, is deemed to be excluded.
Healing arts screening- The testing of human beings using x-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such x-ray tests for the purpose of diagnosis or treatment.
Heat unit- A unit of energy equal to the product of the peak kilovoltage, milliamperes and seconds, i.e., kVp x mA x second.
HVL- See "Half-value layer."
Image intensifier- A device, installed in its housing, which instantaneously converts an x-ray pattern into a corresponding light image of higher energy density.
Image receptor- Any device, such as a fluorescent screen or radiographic film, which transforms incident x-ray photons either into a visible image or into another form which can be made into a visible image by further transformations.
Image receptor support- For mammographic systems, that part of the system designed to support the image receptor in a horizontal plane during a mammographic examination.
Inherent filtration- The filtration of the useful beam provided by the permanently installed components of the tube housing assembly.
Interlock- A device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.
Irradiation- The exposure of matter to ionizing radiation.
Kilovolts peak- See "Peak tube potential."
kV- Kilovolts.
kVp- See "Peak tube potential."
kWs- Kilowatt second. It is equivalent to 103 kV·mA·sec, i.e.,
(A) kWs = (X)kV · (Y)mA · (Z)sec · kWs = XYZ kWs 103kV · mA · sec 103 Lead equivalent - The thickness of lead affording the same attenuation, under specified conditions, as the material in question.Leakage radiation - Radiation emanating from the diagnostic or therapeutic source assembly except for:
Leakage technique factors - The technique factors associated with the tube housing assembly which are used in measuring leakage radiation. They are defined as follows:
Light field - That area of the intersection of the light beam from the beam-limiting device and one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the focus of points at which the illumination is one-fourth of the maximum in the intersection.
Line-voltage regulation - The difference between the no-load and the load line potentials expressed as a percentage of the load line potential. It is calculated using the following equation:
where:
Vn = No-load line potential; and V1 = Load line potential.
mA - Milliampere.
mAs - Milliampere second.
Maximum line current - The root-mean-square current in the supply line of an x-ray machine operating at its maximum rating.
Mobile equipment - See "X-ray equipment."
Patient - An individual subjected to healing arts examination, diagnosis or treatment.
Peak tube potential - The maximum value of the potential difference across the x-ray tube during an exposure.
Phantom - A volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation.
Phototimer - A method for controlling radiation exposures to image receptors by the amount of radiation which reaches a radiation monitoring device(s). The radiation monitoring device(s) is part of an electronic circuit which controls the duration of time the tube is activated. (See "Automatic exposure control.")
PID - See "Position indicating device."
Position indicating device - A device on dental x-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.
Primary dose monitoring system - A system which will monitor the useful beam during irradiation and which will terminate irradiation when the pre-selected number of dose monitor units have been acquired.
Primary protective barrier - See "Protective barrier."
Protective apron - An apron made of radiation attenuating materials used to reduce radiation exposure.
Protective barrier - A barrier of radiation attenuating material(s) used to reduce radiation exposure. The types of protective barriers are as follows:
Protective glove - A glove made of radiation attenuating materials used to reduce radiation exposure.
Qualified expert - An individual who has demonstrated to the satisfaction of the Department that such individual possesses the knowledge and training to measure ionizing radiation, to evaluate safety techniques and to advise regarding radiation protection needs.
Radiation detector - A device which in the presence of radiation provides by either direct or indirect means, a signal or other indication suitable for use in measuring one or more quantities of incident radiation.
Radiation therapy simulation system - A radiographic or fluoroscopic x-ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.
Radiograph - An image receptor on which the image is created directly or indirectly by an x-ray pattern and results in a permanent record.
Radiograph imaging system - Any system whereby a permanent or semipermanent image is recorded on an image receptor by the action of ionizing radiation.
Rating - The operating limits as specified by the component manufacturer.
Recording - Producing a permanent form of an image resulting from x-ray photons (e.g., film, video tape).
Response time - The time required for an instrument system to reach 90 percent (90%) of its final reading when the radiation-sensitive volume of the instrument system is exposed to a step change in radiation flux from zero sufficient to provide a steady state mid scale reading.
Scattered radiation - Radiation that, during passage through matter, has been deviated in direction. (See "Direct scattered radiation.")
Secondary dose monitoring system - A system which will terminate irradiation in the event of failure of the primary system.
Secondary protective barrier - See "Protective barrier."
Shutter - A device attached to the tube housing assembly which can totally intercept the useful beam and which as a lead equivalency not less than that of the tube housing assembly.
SID - See "Source-image receptor distance."
Source - The focal spot of the x-ray tube.
Source-image receptor distance - The distance from the source to the center of the input surface of the image receptor.
Spot check - A procedure which is performed to assure that a previous calibration continues to be valid.
Spot film - A radiograph which is made during a fluoroscopic examination to permanently record conditions which exist during that fluoroscopic procedure.
Spot-film device - A device intended to transport and/or position a radiographic image receptor between the x-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette over the input end of an image intensifier for the purpose of making a radiograph.
SSD - The distance between the source and the skin of the patient.
Stationary equipment - See "X-ray equipment."
Stray radiation - The sum of leakage and scattered radiation.
Technique factors - The conditions of operation. They are specified as follows:
Termination of irradiation - The stopping of irradiation in a fashion which will not permit continuance of irradiation without the resetting of operating conditions at the control panel.
Traceable to a national standard - A quantity or a measurement that has been compared to a NIST* (National Institute of Standards and Technology) standard directly or indirectly through one or more intermediate steps and that all comparisons have been documented.
Therapeutic-type housing -
Therapeutic x-ray and/or electron system - A system designed for irradiation of any part of the human body for the purpose of treatment or alleviation of symptoms of disease.
Tube - An x-ray tube, unless otherwise specified. *formerly NBS (National Bureau of Standards)
Tube housing assembly - The tube housing with tube installed. It includes high-voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing.
Tube rating chart - The set of curves which specify the rated limits of operation of the tube in terms of the technique factors.
Useful beam - The radiation which passes through the tube housing port and the aperture of the beam-limiting device when the exposure switch or timer is activated.
Variable-aperture beam-limiting device - A beam-limiting device which has capacity for stepless adjustment of the x-ray field size at a given SID.
Visible area - That portion of the input surface of the image receptor over which incident x-ray photons are producing a visible image.
Wedge filter- An added filter effecting continuous progressive attenuation on all or part of the useful beam.
X-ray control- A device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers and similar devices, which control the technique factors of an x-ray exposure.
X-ray equipment- An x-ray system, subsystem or component thereof. Types of x-ray equipment are as follows:
1. Mobile x-ray equipment: X-ray equipment mounted on a permanent base with wheels and/or casters for moving while completely assembled.
2. Portable x-ray equipment: X-ray equipment designed to be hand-carried.
3. Stationary x-ray equipment: X-ray equipment which is installed in a fixed location.
X-ray field- The area of the intersection of the useful beam and any one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the exposure rate is one-fourth of the maximum in the intersection.
X-ray high-voltage generator- A device which transforms electrical energy from the potential supplied by the x-ray control to the tube operating potential. The device may also include means for transforming alternating current to direct current, filament transformers for the x-ray tube(s), high-voltage switches, electrical protective devices and other appropriate elements.
X-ray system- An assemblage of components for the controlled production of x-rays. It includes an x-ray high-voltage generator, an x-ray control, a tube housing assembly, a beam-limiting device and the necessary supporting structures. Additional components which function with the system are considered integral parts of the system.
X-ray subsystem- Any combination of two or more components of an x-ray system.
X-ray tube- Any electron tube which is designed to be used primarily for the production of x-rays.
The registrant shall be responsible for directing the operation of the x-ray systems which have been registered with the Department. The registrant or the registrant's agent shall assure that the requirements of RH-1602.a. are met in the operation of the x-ray system(s).
where the source to patient distance is less than thirty (30) centimeters, except for veterinary systems.
receptor to decrease scatter to the film and improve contrast, the grid shall:
the right direction, and grid centered to the central ray;
be worn at the collar outside of the apron.
dose attributed to the most critical organ shall be recorded in the reports required by Part F to Section 3 of these Regulations. If more than one device is used and a record is made of the data, each dose shall be identified with the area where the device was worn on the body.
Any person proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the Department. When requesting such approval, that person shall submit the information as deemed necessary by the Department. If any information submitted to the Department becomes invalid or out-dated, the Department will be notified in writing within thirty (30) days.
The registrant shall maintain the following information for each x-ray system for inspection by the Department:
at the operator's position and at pertinent points outside the room at specified test conditions; or
equivalency, of each protective barrier; and
Each facility shall maintain an x-ray log containing the patient I.D., the type of examinations and the dates the examinations were performed. When the patient or film must be provided with human auxiliary support, the name of the human holder shall be recorded.
In addition to other requirements of this Part, all diagnostic x-ray systems shall meet the following requirements:
The control panel containing the main power switch shall bear the warning statement or its equivalent, legible and accessible to view: "WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed."
On battery-powered x-ray generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.
The leakage radiation from the diagnostic source assembly measured at a distance of one (1) meter in any direction from the source shall not exceed 100 milliroentgens in one (1) hour when the x-ray tube is operated at its leakage technique factors. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.
The radiation emitted by a component other than the diagnostic source assembly shall not exceed two (2) milliroentgens in one (1) hour at five (5) centimeters from any accessible surface of the component when it is operated in an assembled x-ray system under any conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than twenty (20) centimeters.
TABLE I TO RH-1602.
|
Design Operating Range (Kilovolts peak) |
Measured Potential (Kilovolts peak) |
Half-value Layer (millimeters of aluminum) |
|
--Below 50-- |
30 |
0.3 |
|
40 |
0.4 |
|
|
49 |
0.5 |
|
|
--50 to 70-- |
50 |
1.2 |
|
60 |
1.3 |
|
|
70 |
1.5 |
|
|
--Above 70-- |
71 |
2.1 |
|
80 |
2.3 |
|
|
90 |
2.5 |
|
|
100 |
2.7 |
|
|
110 |
3.0 |
|
|
120 |
3.2 |
|
|
130 |
3.5 |
|
|
140 |
3.8 |
|
|
150 |
4.1 |
TABLE II TO RH-1602.
|
Filtration Required vs. Operating Voltage |
|
|
Operating Voltage (kVp) |
Total Filtration (inherent plus added) (millimeters aluminum equivalent) |
|
Below 50 |
0.5 |
|
50 to 70 |
1.5 |
|
Above 70 |
2.5 |
For x-ray systems which have variable kVp and variable filtration for the useful beam, a device shall link the kVp selector with the filter(s) and shall prevent an exposure unless the minimum amount of filtration required by RH-1602.b.5.A.i. or ii. is in the useful beam for the given kVp which has been selected.
Where two or more radiographic tubes are controlled by one exposure switch, the tube or tubes which have been selected shall be clearly indicated prior to initiation of the exposure. This indication shall be both on the x-ray control panel and at or near the tube housing assembly which has been selected.
The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the x-ray system.
Diagnostic x-ray systems and their associated components used on humans and certified pursuant to the Federal X-Ray Equipment Performance Standard ( 21 CFR Part 1020) shall be maintained in compliance with applicable requirements of that standard.
All position locking, holding, and centering devices on
x-ray system components and systems shall function as intended.
All fluoroscopic x-ray systems shall meet the following requirements:
of the field. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID or a visible area of greater than 300 square centimeters shall be provided with means for stepless adjustment of the x-ray field;
image receptors, the error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor.
If a means exists to override any of the automatic x-ray field size adjustments required, that means:
When so provided, the equipment shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of five (5) roentgens (1.3 mC/kg) per minute at the point where the center of the useful beam enters the patient unless the high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.
level control, in which case the mode or modes shall not be operable at any combination of tube potential and current which shall result in an exposure rate in excess of 5 roentgens (1.3 mC/kg) per minute at the point where the center of the useful beam enters the patient, unless the high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.
removed from the useful beam during the measurement;
be measured one (1) centimeter above the table top or cradle;
shall be measured at a point 15 centimeters from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 centimeters to the centerline of the x-ray table.
automatic exposure rate control mode and a manual mode shall not be operable at any combination of tube potential and current which shall result in an exposure rate in excess of ten (10) roentgens (2.6 mC/kg) per minute in either mode at the point where the center of the useful beam enters the patient, except:
level control, in which case the mode or modes shall not be operable at any combination of tube potential and current which shall result in an exposure rate in excess of five (5) roentgens (1.3 mC/kg) per minute at the point where the center of the useful beam enters the patient, unless the high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.
conditions that satisfy the requirements;
be adjusted to those settings which give the maximum entrance exposure rate;
During fluoroscopy and cinefluorography, the kV and the mA shall be continuously indicated.
fluoroscopic x-ray tube. The maximum cumulative time of the timing device shall not exceed five (5) minutes without resetting.
of any preset cumulative on-time. Such signal shall continue to sound while x-rays are produced until the timing device is reset.
Fluoroscopic systems equipped with spot-film (radiographic) mode shall meet the exposure reproducibility requirements when operating in the spot-film mode.
shall include in a log for Department review the estimated patient radiation exposure received per procedure. Estimated adult skin doses that exceed 300 rad and estimated skin doses for children (under the age of 18) that exceed 100 rad must be reviewed by the facility's radiation safety committee.
The review must document the reason why an estimated skin dose exceeded 300 rad for adults or 100 rad for children, and the reason must be documented in the committee's minutes. If a facility does not have a radiation safety committee, the facility must provide the Department, within thirty (30) days of the event, documentation stating why the patient's estimated dose exceeded 300 rad for adults or 100 rad for children.
record of cumulative fluoroscopic exposure time used and the number of spot films for each examination. This record shall indicate patient identification, type of examination, date of examination, and operator's name.
by a qualified expert for both typical and maximum values as follows:
conditions that satisfy the requirements;
shall be adjusted to those settings typical of clinical use on a 23 cm thick abdominal patient;
conditions that satisfy the requirements;
shall be adjusted to those settings which give the maximum entrance exposure rate;
In addition to the requirements for stationary general purpose x-ray systems, both certified and non-certified systems shall also meet the following requirements:
Radiographic equipment designed for only one (1) image receptor size at a fixed SID shall be provided with means to limit the field at the plane of the image receptor to dimensions no greater than those of the image receptor, and to align the center of the x-ray field with the center of the image receptor to within two percent (2%) of the SID, or shall be provided with means to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor.
3-126
C. Written procedures must instruct the operator to remain in the protected area during the entire exposure.
When an automatic exposure control is provided:
With a timer setting of 0.5 seconds or less, the average exposure period (T) shall be greater than or equal to five (5) times the maximum exposure period (Tmax) minus the minimum exposure period (Tmin) when four timer tests are performed:
T > 5 (Tmax - Tmin)
For systems having independent selection of exposure time settings, the average ratios (X1) of exposure to the indicated timer setting, in units of C kg-1s-1 (mR/s), obtained at any two clinically used timer settings shall not differ by more than 0.10 times their sum. This is written as:
(X1 - X2) < 0.1 (X1 + X2)
where X1 and X2 are the average C kg-1s-1 (mR/s) values.
All mobile or portable radiographic systems shall be provided with means to limit the source-to-skin distance to equal to or greater than thirty (30) centimeters except for veterinary systems.
When all technique factors are held constant, including control panel selections associated with automatic exposure control systems, the coefficient of variation of exposure for both manual and automatic exposure control systems shall not exceed 0.05. This requirement applies to clinically used techniques.
Radiation emitted from the x-ray tube when the system is fully charged and the exposure switch or timer is not activated shall not exceed a rate of two (2) milliroentgens (0.516 µC/kg) per hour at five (5) centimeters from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open.
Deviation of measured technique factors from indicated values of kVp and exposure time shall not exceed the limits specified for that system by its manufacturer. In the absence of manufacturer's specifications, the deviation shall not exceed ten percent (10%) of the indicated value for kVp and twenty percent (20%) for time mA/mAs linearity.
The average ratios (X1) of exposure to the indicated milliampere-seconds product (C kg-1mAs-1 (or mR/mAs)) obtained at any two (2) consecutive tube current settings shall not differ by more than 0.10 times their sum:
X1 - X2 < 0.10 (X1 + X2)
where X1 and X2 are the average values obtained at each of two (2) consecutive tube current settings, or at two settings differing by no more than a factor of two (2) where the tube current selection is continuous.
The average ratios (X1) of exposure to the indicated milliampere-seconds product, in units of mR/mAs (or C kg-1mAs-1), obtained at any two consecutive mAs selector settings shall not differ by more than 0.10 times their sum:
X1 - X2 < 0.10 (X1 + X2)
where X1 and X2 are the average values obtained at any two (2) consecutive mAs selector settings, or at two (2) settings differing by no more than a factor of two (2) where the mAs selector provides continuous selection.
Determination of compliance shall be based on ten (10) exposures taken within a time period of one (1) hour, at each of the two (2) settings. These two (2) settings may include any two focal spot sizes except where one is equal to or less than 0.45 millimeters and the other is greater than 0.45 millimeters. For purposes of this requirement, focal spot size is the nominal focal spot size specified by the x-ray tube manufacturer.
Diagnostic x-ray systems incorporating one or more certified component(s) shall be required to comply with the following additional requirement(s) which relate to that certified component(s).
If PBL is being used, the following requirements shall be met:
Beam limitation for portable x-ray systems shall meet the beam limitation requirements.
A tube stand or other mechanical support shall be used for portable x-ray systems, so that the x-ray tube housing assembly need not be handheld during exposures.
The requirements for general x-ray tubes apply to the intraoral dental machines.
Radiographic systems designed for use with an intraoral image receptor shall be provided with means to limit the X-ray beam such that:
Means shall be provided for visual indication observable at or from the operator's protected position whenever x-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated except in x-ray systems that cannot be altered to meet this requirement.
interval, preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. In addition:
For systems having independent selection of exposure time settings, the average ratios (X1) of exposure to the indicated timer setting, in units of C kg-1s-1 (mR/s), obtained at any two clinically used timer settings shall not differ by more than 0.10 times their sum. This is written as:
(X1 - X2) < 0.1 (X1 + X2) where X1 and X2 are the average values.
For equipment installed before January 1, 2006, there must exist a means to allow the operator to be at least six (6) feet (1.8 meters) from the tube housing assembly while making exposure.
When the equipment is operated on an adequate power supply as specified by the manufacturer, the estimated coefficient of variation of radiation exposures shall be no greater than 0.05, for any specific combination of selected technique factors.
The following requirements apply when the equipment is operated on a power supply as specified by the manufacturer for any fixed x-ray tube potential within the range of forty percent (40%) to one hundred percent (100%) of the maximum rated:
(mA) . The average ratios (X1) of exposure to the indicated milliampere-seconds product, in units of C kg-1mAs-1 (or mR/mAs), obtained at any two (2) consecutive tube current settings shall not differ by more than 0.10 times their sum:
(X1 - X2) < 0.1 (X1 + X2)
where X1 and X2 are the average values obtained at each of two (2) consecutive tube current settings, or at two settings differing by no more than a factor of two (2) where the tube current selection is continuous.
(X1 - X2) < 0.1 (X1 + X2)
where X1 and X2 are the average values obtained at any two (2) mAs selector settings, or at two (2) settings differing by no more than a factor of two (2) where the mAs selector provides continuous selection.
Determination of compliance shall be based on ten (10) exposures taken within a time period of one (1) hour, at each of the two (2) settings. These two (2) settings may include any two (2) focal spot sizes except where one (1) is equal to or less than 0.45 millimeters and the other is greater than 0.45 millimeters. For purposes of this requirement, focal spot size is the nominal focal spot size specified by the x-ray tube manufacturer.
Deviation of technique factors from indicated values for kVp and exposure time (if time is independently selectable) shall not exceed the limits specified for that system by its manufacturer. In the absence of manufacturer's specifications, the deviation shall not exceed ten percent (10%).
Dental x-ray machine with a nominal fixed kVp of less than 50 kVp shall not be used to make diagnostic dental radiographs of humans.
NOTE:In many cases structural materials of ordinary walls suffice as a protective barrier without addition of special shielding material.
All wall, ceiling, and floor areas shall be equivalent or provided with applicable protective barriers. Stationary, mobile or portable x-ray systems shall be provided with either a two (2) meter (6.5 feet) high protective barrier for operator protections during exposures, or shall be provided with means to allow the operator to be at least 2.7 meters (9 feet) from the tube housing assembly during exposures if the equipment has been installed or relocated after January 1, 2006.
For equipment installed before January 1, 2006, there must exist a means to allow the operator to be at least six (6) feet (1.8 meters) from the tube housing assembly during exposures.
Accreditation body or body - An entity that has been approved by FDA accredit mammography facilities.
Action limits or action levels - The minimum and maximum values of a quality assurance measurement that can be interpreted as representing acceptable performance with respect to the parameter being tested. Values less than the minimum or greater than the maximum action limit or level indicate that corrective action must be taken by the facility. Action limits or levels are also sometimes called control limits or levels.
Air kerma - Kerma in a given mass of air. The unit used to measure the quantity of air kerma is the Gray (Gy). For x-rays with energies less than 300 kiloelectronvolts (keV), 1 Gy = 100 rad. In air, 1 Gy of absorbed dose is delivered by 114 roentgens (R) of exposure.
Breast implant - A prosthetic device implanted in the breast.
Calendar quarter - Any one of the following time periods during a given year: January 1 through March 31, April 1 through June 30, July 1 through September 30, or October 1 through December 31.
Category I - Medical educational activities that have been designated as Category I by the Accreditation Council for Continuing Medical Education (ACCME), the American Osteopathic Association (AOA), a state medical society, or an equivalent organization.
Certificate - The certificate described in the "Mammography Quality Standards Act," Subchapter I to Title 21 of the Code of Federal Regulations, paragraph (a) of Section 900.11.
Certification - The process of approval of a facility by FDA to provide mammography services.
Clinical image - A mammogram.
Consumer - An individual who chooses to comment or complain in reference to a mammography examination, including the patient or representative of the patient (e.g., family member or referring physician).
Continuing education unit or continuing education credit - One (1) contact hour of training.
Contact hour - An hour of training received through direct instruction.
Diagnostic Mammography - A problem solving radiographic procedure of higher intensity than screening mammography provided to women who are suspected to have breast pathology. Patients are usually referred for analyses of palpable abnormalities or for further evaluation of mammographically detected abnormalities. All images are immediately reviewed by the physicians interpreting the study, and additional views are obtained as needed. Physical examinations of the breast by the interpreting physician to correlate the radiologic findings is often performed as part of the study.
Direct instruction - Face-to-face interaction between instructor(s) and student(s), as when the instructor provides a lecture, conducts demonstrations, or reviews student performance; or the administration and correction of student examinations by an instructor(s) with subsequent feedback to the student(s).
Direct Supervision of Interpreting Physicians - During joint interpretation of mammograms, the supervising interpreting physician reviews, discusses, and confirms the diagnosis of the physician being supervised and signs the resulting report before it is entered into the patient's records.
Direct Supervision of Radiologic Technologists - During the performance of a mammography examination or survey of the facility's equipment and quality assurance program, the supervisor is present to observe and correct, as needed, the performance of the individual being supervised who is performing the examination or conducting the survey.
Established operating level - The value of a particular quality assurance parameter that has been established as an acceptable normal level by the facility's quality assurance program.
Facility - A hospital, outpatient department, clinic, radiology practice, mobile unit, office of a physician, or other facility that conducts mammography activities, including the following: operation of equipment to produce a mammogram, processing of the mammogram, initial interpretation of the mammogram, and maintaining viewing conditions for the interpretation. This term does not include a facility of the Department of Veterans Affairs.
FDA - The Food and Drug Administration.
First allowable time - The earliest time a resident physician is eligible to take the diagnostic radiology boards from an FDA-designated certifying body. The "first allowable time" may vary with the certifying body.
Interim regulations - The regulations entitled "Requirements for Accrediting Bodies of Mammography Facilities" (58 FR 67558-67565), published by FDA on December 21, 1993, and amended on September 30, 1994 (59 FR 49808-49813). These regulations established the standards that had to be met by mammography facilities in order to lawfully operate between October 1, 1994, and April 28, 1999.
Interpreting physician - A licensed physician who interprets mammograms and who meets the requirements set forth in the "Mammography Quality Standards Act," Subchapter I to Title 21 of the Code of Federal Regulations, paragraph (a)(1) of Section 900.12.
Kerma - The sum of the initial energies of all the charged particles liberated by uncharged ionizing particles in a material of given mass.
Laterality -The designation of either the right or left breast.
Lead interpreting physician - The interpreting physician assigned the general responsibility for ensuring that a facility's quality assurance program meets all of the requirements in 21 CFR Part 16 and the "Mammography Quality Standards Act," Subchapter I to 21 CFR, paragraphs (d) through (f) of Section 900.12. The administrative title and other supervisory responsibilities of the individual, if any, are left to the discretion of the facility.
Mammogram - A radiographic image produced through mammography.
Mammographic modality - A technology, within the scope of 42 U.S.C. 263b, for radiography of the breast. Examples are screen-film mammography and digital mammography.
Mammography - Radiography of the breast, but for the purposes of this part, does not include: radiography of the breast performed during invasive interventions for localization or biopsy procedures; or radiography of the breast performed with an investigational mammography device as part of a scientific study conducted in accordance with FDA's investigational device exemption regulations.
Mammography equipment evaluation - An onsite assessment of mammography unit or image processor performance by a medical physicist for the purpose of making a preliminary determination as to whether the equipment meets all of the applicable standards set forth in the "Mammography Quality Standards Act," Subchapter I to Title 21 of the Code of Federal Regulations, paragraphs (b) and (e) of Section 900.12.
Mammography medical outcomes audit - A systematic collection of mammography results and the comparison of those results with outcomes data.
Mammography unit or units - An assemblage of components for the production of x-rays for use during mammography, including, at a minimum: an x-ray generator, and x-ray control, a tube housing assembly, a beam limiting device, and the supporting structures for these components.
Mean optical density - The average of the optical densities measured using phantom thickness of two (2), four (4), and six (6) centimeters with values of kilovolt peak (kVp) clinically appropriate for those thicknesses.
Medical physicist - A person trained in evaluating the performance of mammography equipment and facility quality assurance programs and who meets the qualifications for a medical physicist set forth in the "Mammography Quality Standards Act," Subchapter I to Title 21 of the Code of Federal Regulations, paragraph (a)(3) of Section 900.12.
MQSA - The Mammography Quality Standards Act.
Multi-reading - Two (2) or more physicians, at least one (1) of whom is an interpreting physician, interpreting the same mammogram.
Patient - Any individual who undergoes a mammography evaluation in a facility, regardless of whether the person is referred by a physician or is self-referred.
Phantom - A test object used to simulate radiographic characteristics of compressed breast tissue and containing components that radiographically model aspects of breast disease and cancer.
Phantom image - A radiographic image of a phantom.
Physical science - Physics, chemistry, radiation science (including medical physics and health physics), and engineering.
Positive mammogram - A mammogram that has an overall assessment of findings that are either "suspicious" or "highly suggestive of malignancy."
Provisional certificate - The provisional certificate described in 21 CFR Section 900.11(b)(2).
Qualified instructor - An individual whose training and experience adequately prepares him or her to carry out specified training assignments. Interpreting physicians, radiologic technologists, or medical physicists who meet the requirements of 21 CFR Section 900.12(a) would be considered qualified instructors in their respective areas of mammography. Other examples of individuals who may be qualified instructors for the purpose of providing training to meet the regulations of this part include, but are not limited to, instructors in a post-high school training institution and manufacturer's representatives
Quality control technologist - An individual meeting the requirements of 21 CFR Section 900.12(a)(2) who is responsible for those quality assurance responsibilities not assigned to the lead interpreting physician or to the medical physicist.
Radiographic equipment - X-ray equipment used for the production of static x-ray images.
Radiologic technologist - An individual specifically trained in the use of radiographic equipment and the positioning of patients for radiographic examinations and who meets the requirements set forth in 21 CFR Section 900.12(a)(2).
Review physician - A physician who, by meeting the requirements set out in 21 CFR Section 900.4(c)(5), is qualified to review clinical images on behalf of the accreditation body.
Screening mammography - Radiographic procedure provided to a woman, who has no signs or symptoms of breast cancer, for the purpose of early detection of breast cancer. The procedure entails two views of each breast and includes a physician's interpretation of the results of the procedure.
Serious adverse event - An adverse event that may significantly compromise clinical outcomes, or an adverse event for which a facility fails to take appropriate corrective action in a timely manner.
Serious compliant - A report of a serious adverse event.
Standard breast - A 4.2 centimeter (cm) thick compressed breast consisting of fifty percent (50%) glandular and fifty percent (50%) adipose tissue.
Survey - An on-site physics consultation and evaluation of a facility quality assurance program performed by a medical physicist.
Time cycle - The film development time.
Traceable to a national standard - An instrument is calibrated at either the National Institute of Standards and Technology (NIST) or at a calibration laboratory that participates in a proficiency program with NIST at least once every two (2) years and the results of the proficiency test conducted within 24 months of calibration show agreement within plus or minus three percent (± 3%) of the national standard in the mammography energy range.
The following requirements apply to personnel involved in any aspect of mammography, including production, processing, and interpretation of mammograms and related quality assurance activities.
Interpreting physicians shall meet the minimum requirements of 21 CFR Part 900.12 (a)(1) of the Food and Drug Administration's "Mammography Quality Standards Act."
requirements of 21 CFR Part 900.12.(a)(2) of the Food and Drug Administration's "Mammography Quality Standards Act."
Radiologic Technologist.
meet the minimum requirements of 21 CFR Part 900.12.(a)(3) of the Food and Drug Administration's "Mammography Quality Standards Act."
be registered with the State as a vendor as required by RH-34.
All reasonable efforts must be made to obtain any of the beneficiary's previous mammogram records, including original images and films, copies of written reports prepared by interpreting physicians, and other relevant information pertinent to previous mammograms that might be available from others, for comparison with current mammogram records. All reporting and record keeping must meet the requirements of 21 CFR Part 900.12(c) of the Food and Drug Administration (FDA).
The equipment used to perform mammography should be specifically designed for mammography and must meet the following standards:
Certified equipment must meet the FDA performance standards for diagnostic x-ray systems and their major components at 21 CFR 1020.30 and FDA's standards for radiographic equipment at 21 CFR 1020.31.
The measured focal spot size of the x-ray tube should not exceed 0.7 mm.
The equipment must have a control panel that includes a device (usually a milliammeter) or means for an audible signal to give positive indication of the production of x-rays whenever the x-ray tube is energized. The control panel must include appropriate indicators (labeled control settings of meters that show the physical factors such as kilovoltage potential [kVp], milliampere seconds [mAs], exposure time, or whether timing is automatic) used for exposure.
All variable parameters of the equipment must be evaluated and adjusted as needed to comply with 21 CFR Part 900.12(e)(10) of the FDA's "Mammography Quality Standards Act." This includes but is not limited to the following:
Mammograms must be conducted using equipment and operating procedures free of unnecessary hazards and providing minimum radiation exposure to patients, personnel, and other persons in the immediate environment.
Proper safety precautions must be maintained. This includes adequate shielding for patients, personnel, and facilities. The equipment must be operable only from a shielded position.
Personnel operating the equipment must be monitored in accordance with RH-1301. and RH-1302.
Periodic inspection of equipment and shielding must be made by a staff or consultant medical physicist or by a physicist approved by an appropriate State or local government agency as meeting the qualification requirements of RH-1610. Identified hazards must be promptly corrected.
All equipment must be shockproof and grounded.
Each facility must establish and maintain a quality assurance program that meets the requirements of 21 CFR Part 900.12(d) of the FDA's "Mammography Quality Standards Act."
The lead interpreting physician has the following responsibility:
The person furnishing medical physics support has the overall responsibility for establishing and conducting the ongoing equipment quality assurance program. That individual's specific duties must include:
the FDA's "Mammography Quality Standards Act."
performance monitoring functions;
corrective actions as well as for the calibrations and other preventive maintenance.
equipment quality assurance program as required by 21 CFR Part 900.12(e)(9) of the FDA's "Mammography Quality Standards Act."
The quality control technologist must perform the tasks within the quality assurance program that are not assigned to the lead interpreting physician or the medical physicist.
The facility must ensure the quality of mammography by maintaining a quality assurance program that meets the requirements found in 21 CFR Part 900.12(e) of the FDA's "Mammography Quality Standards Act" and verifying that the action limits described in Part 900.12(e) have been met. These tests and their frequencies are as follows:
Processor performance tests, which includes assessment of base plus fog density, mid-density, and density difference.
Image quality evaluation test using an FDA-approved phantom.
Fixer retention in film test, repeat film analysis.
Dark room fog evaluation, screen film contact test and compression device evaluation.
Automatic exposure control performance, kilovoltage peak (kVp) accuracy and reproducibility, focal spot condition, breast entrance air kerma and AEC reproducibility, dosimetry, x-ray field/light field/image receptor/compression paddle alignment, uniformity of screen speed, radiation output, system artifacts, and decompression.
The facility shall verify that mammography units used to produce mammograms at more than one location meet the requirements in paragraphs (e)(1) through (e)(6) of 21 CFR Part 900.12. In addition, at each examination location, before any examinations are conducted, the facility shall verify satisfactory performance of such units using a test method that establishes the adequacy of the image quality produced by the unit.
For systems with image receptor modalities other than screen-film, the quality assurance program shall be substantially the same as the quality assurance program recommended by the image receptor manufacturer, except that the maximum allowable dose shall not exceed the maximum allowable dose for screen-film systems in the FDA 21 CFR Part 900.12 (e)(5)(vi).
Facilities shall establish and comply with a system specifying procedures to be followed by the facility for cleaning and disinfecting mammography equipment after contact with blood or other potentially infectious materials. This system shall specify the methods for documenting facility compliance with the infection control procedures established and shall comply with the requirements in the FDA 21 CFR Part 900.12(e)(13).
Quality assurance test results must be evaluated in a timely manner by the individual that is responsible for performing the test to ensue compliance with 21 CFR Part 900.12(e)(8) of the FDA "Mammography Quality Standards Act." The responsible individuals are limited to the lead interpreting physician, the medical physicist and the quality control technologist.
Each facility must establish and maintain a medical outcomes audit program to follow-up positive mammographic assessments and to correlate pathology results to the interpreting physician's findings. This program must comply with 21 CFR Part 900.12(f) of the FDA "Mammography Quality Standards Act."
Each facility must have procedures, which specify techniques, and procedures for imaging patients with breast implants. These procedures must comply with 21 CFR Part 900.12(g) of the FDA "Mammography Quality Standards Act."
Each facility must have a consumer complaint mechanism. This mechanism must comply with 21 CFR Part 900.12(h) of the FDA "Mammography Quality Standards Act."
Facilities who wish to be accredited for diagnostic mammography shall, in addition to meeting all of the requirements for mammography also:
Applications for accreditation or renewal shall be made on forms supplied by the Department. Evidence of compliance with all of the requirements for performing screening and/or diagnostic mammography and the accreditation fee must be included with the application.
and the Department believes that mammography quality at a facility has been compromised and may present a serious risk to human health, the facility shall provide clinical images and other relevant information, as specified by the Department, for review by the accreditation body. This additional mammography review will help the Department to determine whether the facility is in compliance with RH-1610. and, if not, whether there is a need to notify affected patients, their physicians or the public that the reliability, clarity and accuracy of interpretation of mammograms has been compromised.
provision of mammography at a facility may present a serious risk to human health such that patient notification is necessary, the facility shall notify patients or their designees, their physicians or the public of action that may be taken to minimize the effects of the risk. Such notification shall occur within a timeframe and in a manner specified and approved by the Department.
Facilities shall maintain records to document the qualifications of all personnel who worked at the facility as interpreting physicians, radiologic technologists, or medical physicists. These records must be available for review by the MQSA inspectors. Records of personnel no longer employed by the facility should not be discarded until the next annual inspection has been completed, and FDA has determined that the facility is in compliance with MQSA personnel requirements.
All quality assurance record keeping shall meet the requirements of 21 CFR Part 900.12(d)(2) of the Food and Drug Administration (FDA) "Mammography Quality Standards Act." The lead interpreting physician, quality control technologist, and medical physicist shall ensure that records concerning mammography technique and procedures, quality control (including monitoring data, problems detected by analysis of that data, corrective actions, and the effectiveness of the corrective actions), safety, protection, and employee qualifications to meet assigned quality assurance tasks, are properly maintained and updated. The quality control records shall be kept for each test specified in paragraphs (e) and (f) of 21 CFR Part 900.12 until the next annual inspection has been completed, and FDA has determined that the facility is in compliance with the quality assurance requirements or until the test has been performed two additional times at the required frequency, whichever is longer.
Clinical images produced by any certified facility must continue to comply with the standards for clinical image quality established by that facility's accreditation body.
SCHEDULE A TO SECTION 3
INFORMATION TO BE SUBMITTED BY PERSONS PROPOSING TO CONDUCT HEALING ARTS SCREENING
Persons requesting that the Department approve a healing arts screening program shall submit the following information and evaluation:
This Part provides special requirements for analytical x-ray equipment. The requirements of this Part are in addition to, and not in substitution for, applicable requirements in other Parts of these Regulations.
Analytical x-ray equipment - X-Ray equipment used for x-ray diffraction fluorescence analysis or spectroscopy.
Analytical x-ray system - A group of local and remote components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials. Local components include those that are struck by x-rays such as radiation source housings, port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors and shielding. Remote components include power supplies, transformers, amplifiers, readout devices, and control panels.
Fail-safe characteristics - A design feature which causes beam port shutters to close or otherwise prevents emergence of the primary beam, upon the failure of a safety or warning device.
Local components - Part of an analytical x-ray system and include areas exposed to x-rays, such as radiation source housings, port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors and shielding, but does not include power supplies, transformers, amplifiers, readout devices and control panels.
Normal operating procedures - Operating procedures for conditions suitable for analytical purposes with shielding and barriers in place. These do not include maintenance but do include routine alignment procedures. Routine and emergency radiation safety considerations are part of these procedures.
Open-beam configuration - An analytical x-ray system in which an individual could accidentally place some part of his/her body in the primary beam path during normal operation.
Primary beam - Ionizing radiation which passes through an aperture of the source housing by a direct path from the x-ray tube located in the radiation source housing.
A device which prevents the entry of any portion of an individual's body into the primary x-ray beam path or which causes the beam to be shut off upon entry into its path shall be provided on all open-beam configurations. A registrant may apply to the Department for an exemption from the requirement of a safety device. Such application shall include:
radiation source housing, if the primary beam is controlled in this manner; and/or
port on the radiation source housings, if the primary beam is controlled in this manner.
Unused ports on radiation machine source housings shall be secured in the closed position in a manner which will prevent casual opening.
All analytical x-ray equipment shall be labeled with a readily discernible sign or signs bearing the radiation symbol and the words:
.
On open-beam configurations installed after January 1, 1979, each port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a coupling has been connected to the port.
Each radiation source housing shall be subject to the following requirements:
interlock that shuts off the tube if it is removed from the radiation source housing or if the housing is disassembled.
Each x-ray generator shall be supplied with a protective cabinet which limits leakage radiation measured at a distance of five (5) centimeters from its surface such that it is not capable of producing a dose in excess of 0.25 millirem in one hour.
The local components of an analytical x-ray system shall be located and arranged and shall include sufficient shielding or access control such that no radiation levels exist in any area surrounding the local component group which could result in a dose to an individual present therein in excess of the dose limits given in RH-1208. These levels shall be met at any specified tube rating.
analytical x-ray systems sufficient to show compliance with RH-1612.c.1. shall be performed:
number or type of local components in the system;
disassembly or removal of a local component in the system;
alignment procedures, if the procedures require the presence of a primary x-ray beam when any local component in the system is disassembled or removed;
components in the system reveals an abnormal condition; and
Each area or room containing analytical x-ray equipment shall be conspicuously posted with a sign or signs bearing the radiation symbol and the words "CAUTION - X-RAY EQUIPMENT" or words having a similar intent.
Normal operating procedures shall be written and available to all analytical x-ray equipment workers. No person shall be permitted to operate analytical x-ray equipment in any manner other than that specified in the procedures unless such person has obtained written approval of the Radiation Safety Officer.
No person shall bypass a safety device unless such person has obtained the approval of the Radiation Safety Officer. When a safety device has been bypassed, a readily discernible sign bearing the words "SAFETY DEVICE NOT WORKING," or words having a similar intent, shall be placed on the radiation source housing.
Except as specified in RH-1612.d.2., no operation involving removal of covers, shielding materials or tube housings or modifications to shutters, collimators or beam stops shall be performed without ascertaining that the tube is off and will remain off until safe conditions have been restored. The main switch, rather than interlocks, shall be used for routine shutdown in preparation for repairs.
analytical x-ray equipment unless such person has received instruction in and demonstrated competence as to:
the use of the equipment;
safety devices incorporated into the equipment or the reasons they have not been installed on certain pieces of equipment and the extra precautions required in such cases;
suspected exposure.
having an open-beam configuration and not equipped with a safety device; and
the maintenance procedures require the presence of a primary x-ray beam when any local component in the analytical x-ray system is disassembled or removed.
Computed tomography dose index (CTDI) - The integral from 7T to +7T of the dose profile along a line perpendicular to the tomographic plane divided by the product of the nominal tomographic section thickness and the number of tomograms produced in a single scan.
NOTE:This definition assumes that the dose profile is centered around z = 0
and that, for a multiple tomogram system, the scan increment between adjacent scans is nT.
Contrast scale (CS) - The change in the linear attenuation coefficient per CTN relative to water, that is:
CTN x = of the material of interest; and CTN w = of water.
CT conditions of operation - All selectable parameters governing the operation of a CT x-ray system including, but not limited to, nominal tomographic section thickness, filtration, and the technique factors as defined.
CT gantry - The tube housing assemblies, beam-limiting devices, detectors, and the supporting structures and frames that hold these components.
CT number (CTN) - The number used to represent the x-ray attenuation associated with each elemental area of the CT image.
k( µ - µ w) CTN =-------
where: k = A constant, a normal value of 1,000 when the Houndsfield scale of CTN is used;
µx = Linear attenuation coefficient of the material of interest; and
µw = Linear attenuation coefficient of water.
Dose profile - The dose as a function of position along a line.
Elemental area - The smallest area within a tomogram for which the x-ray attenuation properties of a body are depicted. (See also "Picture element.")
Multiple tomogram system - A computed tomography x-ray system that obtains x-ray transmission data simultaneously during a single scan to produce more than one tomogram.
Noise - The standard deviation of the fluctuation in CTN expressed as a percentage of the attenuation coefficient of water. Its estimate (Sn) is calculated using the following expression:
where: CS = Linear attenuation coefficient of the material of interest;
µw = Linear attenuation coefficient of water; and
s = Standard deviation of the CTN of picture
elements in a specified area of the CT image.
Nominal tomographic section thickness - The full width at half-maximum of the sensitivity profile taken at the center of the cross-sectional volume over which x-ray transmission data are collected.
Picture element - An elemental area of a tomogram.
Reference plane - A plane that is displaced from and parallel to the tomographic plane.
Scan - The complete process of collecting x-ray transmission data for the production of a tomogram. Data can be collected simultaneously during a single scan for the production of one or more tomograms.
Scan increment - The amount of relative displacement of the patient with respect to the CT x-ray system between successive scans measured along the direction of such displacement.
Scan sequence - A pre-selected set of two or more scans performed consecutively under pre-selected CT conditions of operation.
Scan time - The period of time between the beginning and end of x-ray transmission data accumulation for a single scan.
Single tomogram system - A CT x-ray system that obtains x-ray transmission data during a scan to produce a single tomogram.
Tomographic plane - That geometric plane which is identified as corresponding to the output tomogram.
Tomographic section - The volume of an object whose x-ray attenuation properties are imaged in a tomogram..
conditions of operation to be used during a scan or a scan sequence shall be indicated prior to the initiation of a scan or a scan sequence. On equipment having all or some of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions of operation shall be visible from any position from which scan initiation is possible.
When data are not being collected for image production, the radiation adjacent to the tube port shall not exceed that permitted by RH-1602.b.3.
(CTDI) identification.
The angular position where the maximum surface CTDI occurs shall be identified to allow for reproducible positioning of a CT dosimetry phantom.
cylinders of polymethyl methacrylate of density 1.19 plus or minus 0.01 grams per cubic centimeter. The phantom(s) shall be at least 14 centimeters in length and shall have diameters of 32.0 centimeters for testing CT x-ray systems designed to image any section of the body and 16.0 centimeters for systems designed to image the head or for whole body scanners operated in the head scanning mode;
the placement of a dosimeter(s) along the axis of rotation and along a line parallel to the axis of rotation 1.0 centimeter from the outer surface and within the phantom. Means for the placement of dosimeters or alignment devices at other locations may be provided;
dosimetry phantom for the minimum, maximum, and midrange values of the nominal tomographic section thickness used by the registrant shall be measurable. Where less than three (3) nominal tomographic thicknesses can be selected, the dose profile determination shall be performed for each available nominal tomographic section thickness;
(For the purpose of determining the CTDI, the manufacturer's statement as to the nominal tomographic section thickness for that particular system may be utilized.) The CT dosimetry phantom shall be oriented so that the measurement point 1.0 centimeter from the outer surface and within the phantom is in the same angular position within the gantry as the point of maximum surface CTDI identified. The CT conditions of operation shall correspond to typical values used by the registrant; and
the image display device; and
compatible with the CT x-ray system.
the location within the facility where the results of those tests may be obtained;
phantom(s) including a schedule of spot checks appropriate for the system, allowable variations for the indicated parameters, and the results of at least the most recent spot checks conducted on the system;
tomographic plane and the reference plane if a reference plane is utilized; and a current technique chart available at the control panel which specifies for each routine examination the CT conditions of operation and the number of scans per examination.
LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS
A person, as defined in RH-1100., shall file an application for a specific license authorizing the use of sealed sources in industrial radiography in accordance RH-403. and RH-404.
An application for a specific license for the use of licensed material in industrial radiography will be approved if:
instruments and/or alarming ratemeters describes methods to be used and the experience of the individual(s) who will perform the calibrations. All calibrations must be performed according to the procedures described and at the intervals prescribed in RH-1801.e.3. and RH-1802.f.7.D.
field stations and permanent radiographic installations; and
Access panel - Any barrier or panel which is designed to be removed or opened for maintenance or service purposes, requires tools to open and permits access to the interior of the cabinet.
ALARA (acronym for "as low as is reasonably achievable") - Making every reasonable effort to maintain exposures to radiation as far below the dose limits specified in Part C, "Permissible Doses, Levels, and Concentrations," of Section 3 as is practical, consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvement in relation to benefits to the public health and safety, and other societal and socio-economic considerations, and in relation to utilization of nuclear energy, licensed materials, and x-ray equipment in the public interest.
Annual refresher safety training - A review conducted or provided by the licensee or registrant for its employees on radiation safety aspects of industrial radiography. The review may include, as appropriate, the results of internal inspections, new procedures or equipment, new or revised regulations, accidents or errors that have been observed, and should also provide opportunities for employees to ask safety questions.
Aperture - Any opening in the outside surface of the cabinet, other than a port, which remains open during generation of x-radiation.
Associated equipment - Equipment that is used in conjunction with a radiographic exposures device to make radiographic exposures that drives, guides, or comes in contact with the source, (e.g., guide tube, control tube, control (drive) cable, removable source stop, "J" tube and collimator when it is used as an exposure head.)
Becquerel (Bq) - One (1) disintegration per second.
Cabinet radiography - Industrial radiography conducted in an enclosed cabinet which is so shielded that every location on the exterior meets conditions for an unrestricted area as specified in RH-1208.
Cabinet x-ray system - An x-ray system with the x-ray tube installed in an enclosure (hereinafter termed "cabinet") which, independently of existing architectural structures except the floor on which it may be placed, is intended to contain at least that portion of a material being irradiated, provide radiation attenuation and exclude personnel from its interior during generation of x-radiation. Included are all x-ray systems designed primarily for the inspection of carry-on baggage at airline, railroad and bus terminals and in similar facilities. An x-ray tube used within a shielded part of a building or x-ray equipment which may temporarily or occasionally incorporate portable shielding is not considered a cabinet x-ray system.
Certified cabinet system - X-ray systems which are subject to regulations promulgated under Public Law 90-602, the Radiation Control for Health and Safety Act of 1968.
Certifying Entity - An independent certifying organization meeting the requirements in Schedule B of this Section or an Agreement State meeting the requirements in Schedule B, Parts II and III.
Collimator - a radiation shield that is placed on the end of the guide tube or directly onto a radiographic exposure device to restrict the size of the radiation beam when the sealed source is cranked into position to make a radiographic exposure.
Control (drive) cable - The cable that is connected to the source assembly and used to drive the source to and from the exposure location.
Control drive mechanism - A device that enables the source assembly to be moved to and from the exposure device.
Control tube - A protective sheath for guiding the control cable. The control tube connects the control drive mechanism to the radiographic exposure device.
Door - Any barrier which is designed to be movable or opened for routine operations purposes, does not generally require tools to open and permits access to the interior of the cabinet. For the purposes of RH-1803.g.1.A. of this Section, inflexible hardware rigidly affixed to the door shall be considered part of the door.
Enclosed radiography - Industrial radiography conducted in an enclosed cabinet or room and includes cabinet radiography, cabinet x-ray systems and shielded room radiography.
Exposure head - A device that locates the gamma radiography sealed source in the selected working position. (An exposure head is also known as a source stop).
External surface - The outside surface of the cabinet x-ray system, including the high-voltage generator, doors, access panels, latches, control knobs and other permanently mounted hardware and including the plane across any aperture or port.
Field station - A facility where licensed material or registered x-ray equipment may be stored or used and from which equipment is dispatched.
Floor - The underside external surface of the cabinet.
Gray - The SI unit of absorbed dose. A gray is equal to an absorbed dose of one (1) Joule/kilogram. It is also equal to 100 rads.
Ground fault - An accidental electrical grounding of an electrical conductor.
Guide tube (Projection sheath) - A flexible or rigid tube (i.e., "J" tube) for guiding the source assembly and the attached control cable from the exposure device to the exposure head. The guide tube may also include the connections necessary for attachment to the exposure device and to the exposure head.
Hands-on experience - Experience in all of those areas considered to be directly involved in the radiography process.
Independent Certifying Organization - An independent organization that meets all the criteria of Schedule B to Section 3.
Industrial radiography (radiography) - An examination of the structure of materials by non-destructive methods, utilizing ionizing radiation to make radiographic images.
Lay-barge radiography - Industrial radiography performed on any water vessel used for laying pipe.
Offshore platform radiography - Industrial radiography performed from a platform over a body of water.
Permanent radiographic installation - An enclosed shielded room, cell, or vault, not located at a temporary jobsite, in which radiography is performed.
Port - Any opening in the outside surface of the cabinet which is designed to remain open, during generation of x-rays, for the purpose of conveying material to be irradiated into and out of the cabinet or for partial insertion for irradiation of an object whose dimensions do not permit complete insertion into the cabinet.
Practical examination - A demonstration through practical application of the safety rules and principles in industrial radiography including use of all appropriate equipment and procedures.
Primary beam - The x-radiation emitted directly from the target and passing through the window of the x-ray tube.
Radiation Safety Officer for industrial radiography - An individual with the responsibility for the overall radiation safety program on behalf of the licensee or registrant and who meets the requirements of RH-1802.d.
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 direct supervision of a radiographer, uses radiographic exposure devices, sources of radiation, related handling tools, or radiation survey instrumentation in industrial radiography.
Radiographer certification - Written approval received from a certifying entity stating that an individual has satisfactorily met certain established radiation safety, testing, and experience criteria.
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.
Radiographic operations - All activities associated with the presence of x-ray machines, accelerators, or radioactive sources in radiographic exposure devices, during use of the machine, accelerator, or device, or transport (except when being transported by a common or contract carrier), to include surveys to confirm the adequacy of boundaries, setting up equipment, and any activity inside restricted area boundaries. Transporting a radiation machine or accelerator is not considered a radiographic operation.
Radiography - See "industrial radiography."
Safety interlock - A device which is intended to prevent the generation of x-radiation when access by any part of the human body to the interior of the cabinet x-ray system through a door or access panel is possible.
Sealed source - Any radioactive material that is encased in a capsule designed to prevent leakage or escape of the radioactive material.
Shielded room radiography - Industrial radiography conducted in an enclosed room, the interior of which is not occupied during radiographic operations, which is so shielded that every location on the exterior meets the conditions for an unrestricted area as specified in RH-1208.
Shielded position - The location within the radiographic exposure device or source changer where the sealed source is secured and restricted from movement.
Sievert - The SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor (1 Sv = 100 rem).
Source Assembly - An assembly that consists of the sealed source and a connector that attaches the source to the control cable. The source assembly may also include a stop ball used to secure the source in the shielded position.
Source changer - A device designed and used for replacement of sealed sources in radiographic exposure devices, including those also used for transporting and storage of sealed sources.
S-tube - A tube through which the radioactive source travels when inside a radiographic exposure device.
Storage area - Any location, facility, or vehicle which is used to store, to transport, or to secure a radiographic exposure device, a storage container, or a sealed source when it is not in use and which is locked or has a physical barrier to prevent accidental exposure, tampering with, or unauthorized removal of the device, container, or source.
Storage container - A container in which sealed sources are secured and stored.
Temporary job site - A location where radiographic operations are conducted and where licensed material may be stored other than the location(s) of use authorized on the license or registration.
Transport container - A package that is designed to provide radiation safety and security when sealed sources are transported and meets all applicable requirements of the U.S. Department of Transportation.
Underwater radiography - Industrial radiography performed when the radiographic exposure device and/or related equipment are beneath the surface of the water.
X-ray system - An assemblage of components for the controlled generation of x-rays.
X-ray tube - Any electron tube which is designed for the conversion of electrical energy into x-ray energy.
Each licensee shall maintain a copy of its license, license conditions, documents incorporated by reference, and amendments to each of these items until superseded by new documents approved by the Department or until the Department terminates the license.
A Each licensee shall maintain records showing the receipts
and transfers of sealed sources and devices using depleted uranium (DU) for shielding and retain each record for three (3) years after it is made.
B These records must include the date, the name of the
individual making the record, radionuclide, number of curies (becquerels) or mass (for depleted uranium (DU)) and manufacturer, model, and serial number of each sealed source and/or device, as appropriate.
Each licensee or registrant shall maintain records of the calibrations of its radiation survey instruments that are required in RH-1801.e. and retain each record for three (3) years after it is made.
Each licensee shall maintain records of leak test results for sealed sources and for devices containing depleted uranium (DU). The results must be stated in units of microcuries (bequerels). The licensee shall retain each record for three (3) years after it is made or until the source in storage is removed.
A Each licensee or registrant shall maintain utilization logs
showing for each sealed source or x-ray unit the following information:
i A description, including the make, model, and serial
number of the radiographic exposure device or transport or storage container in which the sealed source or x-ray tube is located;
ii The identity and signature of the radiographer to
whom assigned; and
iii The plant or site where used and dates of use,
including the dates removed and returned to storage.
Each licensee or registrant shall maintain records of alarm system and entrance control device tests required under RH-1801.j. and retain each record for three (3) years after it is made.
Each licensee or registrant shall maintain the following records (of training and certification) for three (3) years after the record is made:
Each licensee or registrant shall maintain a copy of current operating and emergency procedures until the Department terminates the license or registration. Superseded material must be retained for three (3) years after the change is made.
Each licensee or registrant shall maintain the following exposure records specified in RH-1802.f.
Each licensee or registrant shall maintain a record of each exposure device survey conducted before the device is placed in storage as specified in RH-1803.c.3. if that survey is the last one performed in the workday. Each record must be maintained for three (3) years after it is made.
Each record required by RH-1800.d. must be legible throughout the specified retention period. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of reproducing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, must include all pertinent information, such as stamps, initials, and signatures. The licensee or registrant shall maintain adequate safeguards against tampering with and loss of records.
the use of licensed material or x-ray equipment;
Health Rules and Regulations for Control of Sources of Ionizing Radiation.
checks as required by RH-1801.j., if applicable.
radioactive materials as required by RH-3005; and
Equipment used in industrial radiographic operations must meet the following minimum criteria:
source, and all associated equipment must meet the requirements specified in American National Standards Institute N432-1980, "Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography," (published as NBS Handbook 136, issued January 1981).
This publication may be purchased from the American National Standards Institute, Inc., 25 West 43rd Street, New York, New York 10036; Telephone: (212) 642-4900.
A copy of the document is available for inspection in the office of the Arkansas Department of Health, Radiation Control, 5800 West 10th Street, Suite 100, Little Rock, Arkansas 72204.
Engineering analysis may be submitted by an applicant or licensee to demonstrate the applicability of previously performed testing on similar individual radiography equipment components. Upon review, the Department may find this an acceptable alternative to actual testing of the component pursuant to the above referenced standard.
radionuclide in the device;
measured;
the source will not be accidentally withdrawn from the changer when connecting or disconnecting the drive cable to or from a source assembly.
after January 10, 1996 must comply with the requirements of this section.
radiographic operations need not comply with Section 8.9.2(c) of the Endurance Test in American National Standards Institute N432-1980, if the prototype equipment has been tested using a torque value representative of the torque that an individual using the radiography equipment can realistically exert on the lever or crankshaft of the drive mechanism.
The maximum exposure rate limit for storage containers and source changers are 200 millirem (2 millisieverts) per hour at any exterior surface and ten (10) millirem (0.1 millisieverts) per hour at one (1) meter from any exterior surface with the sealed source in the shielded position.
operable radiation survey instruments at each location where radioactive material or industrial radiographic x-ray equipment is present to make the radiation surveys as required by this Part and RH-1300.
an "S" tube configuration must be tested for DU contamination at intervals not to exceed twelve (12) months. The analysis must be capable of detecting the presence of 0.005 microcurie (185 Bq) of radioactive material on the test sample and must be performed by a person specifically authorized by the Department, the U.S. Nuclear Regulatory Commission, or an Agreement State to perform the analysis.
Should such testing reveal the presence of 0.005 microcurie (185 Bq) or more of removable DU contamination, the exposure device must be removed from use until an evaluation of the wear on the S-tube has been made. Should the evaluation reveal that the S-tube is worn through, the device may not be used again. DU shielded devices do not have to be tested for DU contamination while in storage and not in use. Before using or transferring such a device however, the device must be tested for DU contamination if the interval of storage exceeds twelve (12) months. A record of the DU leak test must be made in accordance with RH-1800.d.4.
Each licensee or registrant shall maintain current logs, which shall be kept available for inspection by the Department, showing for each source of radiation the following information:
A An entrance control of the type described in RH- 1303.c.2.A. that reduces the radiation level upon entry into the area, or B Both conspicuous visible and audible warning signals to warn of the presence of radiation. The visible signal must be activated by radiation whenever the source is exposed. The audible signal must be actuated when an attempt is made to enter the installation while the source is exposed.
The facility may continue to be used during this seven (7) day period, provided the licensee or registrant implements the continuous surveillance requirements of RH-1803.a. and uses an alarming ratemeter. Test records for entrance controls and audible and visual alarm must be maintained in accordance with RH-1800.d.8.
under other Sections, each licensee or registrant shall provide a written report to the Arkansas Department of Health, Radiation Control Section, 4815 West Markham Street, Slot 30, Little Rock, Arkansas, 72205-3867 within thirty (30) days of the occurrence of any of the following incidents involving radiographic equipment:
"OFF" position, or a safety interlock fails to terminate x-ray production.
"CAUTION,*
RADIOACTIVE MATERIAL,
NOTIFY CIVIL AUTHORITIES [or name of company]."
*or DANGER
radiographer until the individual has received training in RH-1804., in addition to a minimum of two (2) months of on-the-job training under the supervision of a radiographer, and is certified through a radiographer certification program by a certifying entity in accordance with the criteria specified in Schedule B to Section 3.
The Department may confiscate any radiographer's certification card should there be serious health and safety violations relating to the Regulations, license conditions, and/or licensee operating and emergency procedures. The radiographer will be restricted from conducting radiographic operations within the State of Arkansas.
The Radiation Safety Officer (RSO) shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's or registrant's program.
A Establishing and overseeing all operating, emergency, and
ALARA procedures as required by this Section, "Standards for Protection Against Radiation," and reviewing them regularly to ensure that the procedures in use conform to current Section 3 procedures, conform to other Department regulations, and to the license conditions.
must include as a minimum, instructions in the following:
personnel in the event a pocket dosimeter is found to be off-scale or an alarm ratemeter alarms unexpectedly.
an accident;
accident;
operating and emergency procedures in accordance with RH-1800.d.10.and RH-1800.d.14.
radiographer or a radiographer's assistant unless, at all times during radiographic operations, each individual wears, on the trunk of the body, a combination of a direct reading pocket dosimeter, an operable alarm ratemeter, and a personnel dosimeter that is processed and evaluated by an accredited National Voluntary Laboratory Accreditation Program (NVLAP) processor. At permanent radiography installations where other appropriate alarming or warning devices are in routine use, the wearing of an alarming ratemeter is not required.
Department shall maintain the certification upon which the reciprocal recognition was granted, or prior to the expiration of such certification, shall meet the requirements of RH-1802.b.1.
During each radiographic operation, the radiographer or the other individual present as required in RH-1802.a. shall maintain continuous, direct visual surveillance of the operation to protect against unauthorized entry into a high radiation area, as defined in Section 3, Part D, RH-1303.c., except at permanent radiographic installations where all entryways are locked and the requirements of RH-1801.j. are met.
All areas in which industrial radiography is being performed must be conspicuously posted as required by RH-1303.b.1. and b.2. Exceptions listed in RH-1304. do not apply to industrial radiographic operations.
The licensee or registrant shall:
Whenever a radiographer's assistant uses radiographic exposure devices, associated equipment or sealed sources or conducts radiation surveys required by RH-1803.c.2. to determine that the sealed source has returned to the shielded position after an exposure, the assistant shall be under the personal supervision of a radiographer. The personal supervision shall include:
Each licensee or registrant conducting industrial radiography at temporary job sites shall have the following records available at that site for inspection by the Department:
shall not exceed an exposure of 0.5 milliroentgen in one hour at any point five (5) centimeters outside the external surface.
A cabinet x-ray system shall have a permanent floor. Any support surface to which a cabinet x-ray system is permanently affixed may be deemed the floor of the system.
through any port into the primary beam shall not be possible.
through any aperture shall not be possible.
minimum of two (2) safety interlocks. One (1), but not both, of the required interlocks shall be such that door opening results in physical disconnection of the energy supply circuit to the high-voltage generator, and such disconnection shall not be dependent upon any moving part other than the door.
interlock.
A ground fault shall not result in the generation of x-rays.
For all systems to which this section is applicable, there shall be provided:
generation is not possible with the key removed.
generation of x-rays other than by functioning of a safety interlock or the main power control.
For cabinet x-ray systems designed to admit humans, there shall also be provided:
Part and RH-1208. of these Regulations. If such a system is a certified cabinet x-ray system, it shall comply with all applicable requirements of this Part and 21 CFR 1020.40.
assure compliance with the applicable requirements as specified in RH-1803.g.1.A. Records of these evaluations shall be maintained for inspection by the Department for a period of (5) years after the evaluation.
terminating x-ray generation, which cannot be reset, over-ridden or bypassed from the outside of the cabinet.
cabinet which are actuated for at least ten (10) seconds immediately prior to the first initiation of x-ray generation after closing any door designed to admit humans. Failure of any single component of the cabinet x-ray system shall not cause failure of both the audible and visible warning signals.
CAUTION: X-RAYS PRODUCED WHEN ENERGIZED
CAUTION: DO NOT INSERT ANY PART OF THE BODY WHEN SYSTEM IS ENERGIZED- X-RAY HAZARD
provide for purchasers and to others upon request at a cost not to exceed the cost of preparation and distribution, manuals and instructions which shall include at least the following technical and safety information: Potential, current and duty cycle ratings of the x-ray generation equipment; adequate instructions concerning any radiological safety procedures and precautions which may be necessary because of unique features of the system; and a schedule of maintenance necessary to keep the system in compliance with this section.
intended to be assembled or installed by the purchaser, shall provide instructions for assembly, installation, adjustment and testing of the cabinet x-ray system adequate to assure the system is in compliance with applicable provisions of this section when assembled, installed, adjusted and tested as directed.
X-ray systems designed primarily for the inspection of carry-on baggage at airline, railroad and bus terminals and at similar facilities, shall be provided with means, pursuant to RH-1803.g.1.J.i. and ii., to insure operator presence at the control area in a position which permits surveillance of the ports and doors during generation of x-radiation.
Cabinet radiography units are exempt from other requirements of this Part; however,
Shielded room radiography shall comply with all applicable requirements of this Part.
Industrial radiography performed with a sealed source which is not fastened to or contained in a radiographic exposure device (fish pole technique) is prohibited unless specifically authorized in a license issued by the Department.
SCHEDULE B TO SECTION 3 RADIOGRAPHIC CERTIFICATION
An independent certifying organization shall:
All certification programs must:
All examinations must be:
LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS AND SUBSURFACE TRACER STUDIES
The Regulations in this Part apply to all licensees who use sources of radiation for wireline service operations including mineral logging, radioactive markers or subsurface tracer studies.
The Regulations in this Part establish radiation safety requirements for persons utilizing sources of radiation for wireline service operations including mineral logging, radioactive markers and subsurface tracer studies. The requirements of this Part are in addition to and not in substitution for other applicable requirements of these Regulations.
Energy compensation source (ECS) - A small sealed source, with an activity not exceeding 100 microcuries (3.7 MBq), used within a logging tool, or other tool components, to provide a reference standard to maintain the tool's calibration when in use.
Field station - A facility where radioactive sources may be stored or used and from which equipment is dispatched to temporary job sites.
Fresh water aquifer - A geologic formation that is capable of yielding fresh water to a well or spring.
Injection tool - A device used for controlled subsurface injection of radioactive tracer material.
Irretrievable well logging source - Any sealed source containing radioactive material that is pulled off or not connected to the wireline that suspends the source in the well and for which all reasonable effort at recovery has been expended.
Logging assistant - Any individual who, under the personal supervision of a logging supervisor, handles sealed sources, tracers, or radiation producing machines that are not in logging tools or shipping containers or who performs surveys required by RH-1967.
Logging supervisor - Any individual who uses radioactive material or radiation producing machines, or provides personal supervision in the use of radioactive material or radiation producing machines at a temporary jobsite and who is responsible to the licensee for assuring compliance with the requirements of the Department's Regulations and the conditions of the license.
Logging tool - Any device used subsurface to perform well-logging.
Mineral logging - Any logging performed for the purpose of mineral exploration other than oil or gas.
Parti cle accelerator - Any machine capable of accelerating elections, 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 one (1) MeV.
Personal supervision - Guidance and instruction by the logging supervisor who is physically present at the job site and watching the performance of the operation in such proximity that contact can be maintained and immediate assistance given as required.
Radioactive marker - Radioactive material placed subsurface or on a structure intended for subsurface use for the purpose of depth determination or direction orientation.
Radioactive material - Byproduct, source or special nuclear material received, processed, used or transferred under a license issued by the Arkansas State Board of Health, Arkansas Department of Health under the regulations of this Part.
Sealed source - Any radioactive material that is encased in a capsule designed to prevent leakage or escape of the radioactive material.
Source holder - A housing or assembly into which a radioactive source is placed for the purpose of facilitating the handling and use of the source in well-logging operations.
Subsurface tracer study - the release of a substance tagged with radioactive material for the purpose of tracing the movement or position of the tagged substance in the well-bore or adjacent formation.
Surface casing for protecting fresh water aquifers - a pipe or tube used as a lining in a well to isolate fresh water aquifers from the well.
Temporary jobsite - A location to which radioactive materials have been dispatched to perform wireline service operations or subsurface tracer studies.
Tritium neutron generator target source - A tritium source used within a neutron generator tube to produce neutrons for use in well-logging applications.
Uranium sinker bar - A weight containing depleted uranium used to pull a logging tool toward the bottom of a well.
Well-bore - A drilled hole in which wireline service operations and subsurface tracer studies are performed.
Well-logging - the lowering and raising of measuring devices or tools which may contain sources of radiation into well-bores or cavities for the purpose of obtaining information about the well and/or adjacent formations.
Wireline - A cable containing one or more electrical conductors which is used to lower and raise logging tools in the well-bore.
Wireline service operation - Any evaluation or mechanical service which is performed in the well-bore using devices on a wireline.
A person, as defined in RH-1100., shall file an application for a specific license authorizing the use of radioactive material in well logging in accordance with RH-403. and RH-404.
The Department will approve an application for a specific license for the use of radioactive material in well logging if the applicant meets the following requirements:
years after.
Each license is issued with the condition that the licensee will, at any time before expiration of the license, upon the Department's request, submit written statements, signed under oath or affirmation, to enable the Department to determine whether or not the license should be modified, suspended, or revoked.
that contains radioactive material unless the smallest component that is transported as a separate piece of equipment with the radioactive material inside bears a durable, legible, and clearly visible marking or label. The marking or label must contain the radiation symbol specified in RH-1303.a.1. and 2., without the conventional color requirements, and the wording
"DANGER (or CAUTION) RADIOACTIVE MATERIAL."
"CAUTION,* RADIOACTIVE MATERIAL, NOTIFY CIVIL AUTHORITIES [or name of company] IF FOUND."
* or DANGER
instrument capable of detecting beta and gamma radiation at each field station and temporary jobsite to make the radiation surveys required by this Part and by other Parts of Section 3. To satisfy this requirement, the radiation survey instrument must be capable of measuring 0.1 mrem (0.001 mSv) per hour through at least 50 mrem (0.5 mSv) per hour.
Each licensee who uses a sealed source shall have the source leak tested for leakage in accordance with RH-1212. and as prescribed in this section. The licensee shall keep a record of leak test results in units of microcuries and retain the record for inspection by the Department for three (3) years after the leak test is performed.
The wipe of a sealed source must be performed using a leak test kit or method approved by the Department, the U.S. Nuclear Regulatory Commission, or an Agreement State. The wipe sample must be taken from the nearest accessible point to the sealed source where contamination might accumulate. The wipe sample must be analyzed for radioactive contamination. The analysis must be capable of detecting the presence of 0.005 microcuries (185 Bq) of radioactive material on the test sample and must be performed by a person approved by the Department, the U.S. Nuclear Regulatory Commission, or an Agreement State to perform the analysis.
reveals the presence of 0.005 microcuries (185 Bq) or more of removable radioactive material, the licensee shall remove the sealed source from service immediately and have it decontaminated, repaired, or disposed of by a Department, U.S. Nuclear Regulatory Commission, or an Agreement State licensee that is authorized to perform these functions. The licensee shall check the equipment associated with the leaking source for radioactive contamination and, if contaminated, have it decontaminated or disposed of by a Department, U.S. Nuclear Regulatory Commission, or an Agreement State licensee that is authorized to perform these functions.
days of receiving the test results. The report must describe the equipment involved in the leak, the test results, any contamination which resulted from the leaking source, and the corrective actions taken up to the time the report is made.
The following sealed sources are exempt from the periodic leak requirements set out in RH-1935.a. through RH-1935.d.:
Each licensee shall conduct a quarterly physical inventory to account for all radioactive material received and possessed under the license. The licensee shall retain records of the inventory for three (3) years from the date of the inventory for inspection by the Department. The inventory must indicate the quantity and type of radioactive material, the location of the radioactive material, the date of the inventory, and the name of the individual conducting the inventory.
The test source must be held at - 40º C for 20 minutes, 600º C for one (1) hour, and then be subject to a thermal shock test with a temperature drop from 600º C to 20º C within 15 seconds.
A 5 kg steel hammer, 2.5 cm in diameter, must be dropped from a height of one (1) meter onto the test source.
The test source must be subject to a vibration from 25 Hz to 500 Hz at 5 gram amplitude for 30 minutes.
A one (1) gram hammer and pin, 0.3 cm pin diameter, must be dropped from a height of one (1) meter onto the test source.
The test source must be subject to an external pressure of 24,600 pounds per square inch absolute (1.695 x 10 7 pascals).
No licensee shall permit above-ground testing of particle accelerators that results in the production of radiation, except in areas or facilities controlled or shielded so as to meet the requirements of RH-1200. and RH-1208. of these Regulations, as applicable.
The licensee may use radioactive markers in wells only if the individual markers contain quantities of radioactive material not exceeding the quantities specified in RH-901., Schedule B. The use of markers is subject to the requirements of RH-1937.
The licensee may use a uranium sinker bar in well logging applications after July 14, 1988, only if it is legibly impressed with the words
"CAUTION - RADIOACTIVE - DEPLETED URANIUM"
and "NOTIFY CIVIL AUTHORITIES [or name of company] IF FOUND."
The licensee may use a sealed source in a well without a surface casing for protecting fresh water aquifers only if the licensee follows a procedure for reducing the probability of the source becoming lodged in the well. The procedure must be approved by the Department pursuant to RH-1913.
The licensee may use an energy compensation source (ECS) which is contained within a logging tool, or other tool components, only if the ECS contains quantities of licensed material not exceeding 100 microcuries (3.7 MBq).
RH-1956- RH-1960. Reserved.
until that person:
Each licensee shall develop and follow written operating and emergency procedures that cover:
materials, in accordance with RH-1307.;
and personnel;
jobsites;
tools, injection tools, source handling tools, storage containers, transport containers, and uranium sinker bars as required by RH-1943.;
prevent the spread of contamination and minimize inhalation and ingestion of radioactive materials and actions to obtain suitable radiation survey instruments as required by RH-1933.b.; and
required by RH-1935.d.2. and RH-1977.a., b., and d. of these regulations.
radioactive materials have caused contamination, the licensee shall initiate immediately the emergency procedures required by RH-1963.
Each licensee shall maintain the following documents and records at the field station:
Each licensee conducting operations at a temporary jobsite shall maintain the following documents and records at the temporary jobsite until the well-logging operation is completed:
classified as irretrievable, make a report in writing to the Department. The licensee shall send a copy of the report to each appropriate State or Federal agency that issued permits or otherwise approved the drilling operation. The report shall contain the following information:
The Department may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this Part as it determines are authorized by law and will not result in undue hazard to public health and safety or property, and are otherwise in the public interest.
SCHEDULE C TO SECTION 3
EXAMPLE OF PLAQUE FOR IDENTIFYING WELLS CONTAINING SEALED SOURCES CONTAINING RADIOACTIVE MATERIAL ABANDONED DOWNHOLE
The size of the plaque should be convenient for use on active or inactive wells, e.g., a 7 inch square. Letter size of the word "CAUTION" should be approximately twice the letter size of the rest of the information, e.g., 1/2-inch and 1/4-inch letter size, respectively.
The Department may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this Section as it determines are authorized by law and will not result in undue hazard to public health and safety or property, and are otherwise in the public interest.
The Department may, by rule, regulation, or order, impose upon any licensee such requirements in addition to those established in the regulations in this Section as it deems appropriate or necessary to minimize danger to public health and safety or property.
Sources of radiation shall be subject to impounding pursuant to Section 5 of these Regulations.
This Part establishes requirements for notices, instructions, and reports by licensees or registrants to individuals engaged in work under a license or registration; and options available to such individuals in connection with Department inspection of licensees or registrants to ascertain compliance with the provisions of the Act and the regulations, orders, and licenses issued thereunder regarding radiological working conditions. The Regulations in this Part apply to all persons who receive, possess, use, own, or transfer sources of radiation licensed by or registered with the Department pursuant to these Regulations in Sections 1 and 2, Part I to Section 3, Part J to Section 3, and Sections 6, 7, 8, and 9.
"This report is furnished to you under the provisions of Arkansas Department of Health Regulations entitled 'Standards for Protection Against Radiation.' You should preserve this report for further reference."
TEDE or 100 mrem (1 mSv) to any individual organ or tissue; or
or RH-1504. to report to the Department any exposure of an individual to radiation or radioactive material, the licensee or the registrant shall also provide the individual a report on his or her exposure data included in the report to the Department. The report must be transmitted no later than the transmittal to the Department.
inspectors are authorized to refuse to permit accompaniment by any individual who deliberately interferes with a fair and orderly inspection. With regard to any area containing proprietary information, the workers' representative for that area shall be an individual previously authorized by the licensee or registrant to enter that area.
the Act, these Regulations or license conditions exists or has occurred in work under a license or registration with regard to radiological working conditions in which the worker is engaged, may request an inspection by giving notice of the alleged violation to the Department. Any such notice shall be in writing, shall set forth the specific grounds for the notice and shall be signed by the worker or representative of the workers. A copy shall be provided to the licensee or registrant by the Department no later than at the time of the inspection except that, upon the request of the worker giving such notice, his/her name and the name of individuals referred to therein shall not appear in such copy or on any record published, released or made available by the Department, except for good cause shown.
requirements of RH-2807.a. have not been met, he/she shall notify the complainant in writing of such determination. Such determination shall be without prejudice to the filing of a new complaint meeting the requirements of RH-2807.a.
RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT
This Part provides special requirements for analytical x-ray equipment. The requirements of this Part are in addition to, and not in substitution for, applicable requirements in other parts of these Regulations.
Analytical x-ray equipment - X-Ray equipment used for x-ray diffraction fluorescence analysis or spectroscopy.
Analytical x-ray system - A group of local and remote components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials. Local components include those that are struck by x-rays such as radiation source housings, port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors and shielding. Remote components include power supplies, transformers, amplifiers, readout devices, and control panels.
Fail-safe characteristics- A design feature which causes beam port shutters to close or otherwise prevents emergence of the primary beam, upon the failure of a safety or warning device.
Local components- Part of an analytical x-ray system and include areas exposed to x-rays, such as radiation source housings, port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors and shielding, but does not include power supplies, transformers, amplifiers, readout devices and control panels.
Normal operating procedures- Operating procedures for conditions suitable for analytical purposes with shielding and barriers in place. These do not include maintenance but do include routine alignment procedures. Routine and emergency radiation safety considerations are part of these procedures.
Open-beam configuration- An analytical x-ray system in which an individual could accidentally place some part of his/her body in the primary beam path during normal operation.
Primary beam- Ionizing radiation which passes through an aperture of the source housing by a direct path from the x-ray tube located in the radiation source housing.
A device which prevents the entry of any portion of an individual's body into the primary x-ray beam path or which causes the beam to be shut off upon entry into its path shall be provided on all open-beam configurations. A registrant may apply to the Department for an exemption from the requirement of a safety device. Such application shall include:
Unused ports on radiation machine source housings shall be secured in the closed position in a manner which will prevent casual opening.
All analytical x-ray equipment shall be labeled with a readily discernible sign or signs bearing the radiation symbol and the words:
On open-beam configurations installed after January 1, 1979, each port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a coupling has been connected to the port.
Each radiation source housing shall be subject to the following requirements:
Each x-ray generator shall be supplied with a protective cabinet which limits leakage radiation measured at a distance of 5 centimeters from its surface such that it is not capable of producing a dose in excess of 0.25 millirem in one hour.
The local components of an analytical x-ray system shall be located and arranged and shall include sufficient shielding or access control such that no radiation levels exist in any area surrounding the local component group which could result in a dose to an individual present therein in excess of the dose limits given in RH-1208. These levels shall be met at any specified tube rating.
systems sufficient to show compliance with RH-2903.a. shall be performed:
can demonstrate compliance to the satisfaction of the Department with RH-2903.a. in some other manner.
Each area or room containing analytical x-ray equipment shall be conspicuously posted with a sign or signs bearing the radiation symbol and the words "CAUTION - X-RAY EQUIPMENT" or words having a similar intent.
Normal operating procedures shall be written and available to all analytical x-ray equipment workers. No person shall be permitted to operate analytical x-ray equipment in any manner other than that specified in the procedures unless such person has obtained written approval of the Radiation Safety Officer.
No person shall bypass a safety device unless such person has obtained the approval of the Radiation Safety Officer. When a safety device has been bypassed, a readily discernible sign bearing the words "SAFETY DEVICE NOT WORKING," or words having a similar intent, shall be placed on the radiation source housing.
Except as specified in RH-2904.b., no operation involving removal of covers, shielding materials or tube housings or modifications to shutters, collimators or beam stops shall be performed without ascertaining that the tube is off and will remain off until safe conditions have been restored. The main switch, rather than interlocks, shall be used for routine shutdown in preparation for repairs.
APPENDIX A TO SECTION 3
Deleted. (See Appendix G to Section 3.)
APPENDIX B TO SECTION 3
Deleted. (For RH-409.h. purposes, see Appendix E to Section 2. For RH-1303.b.5. purposes,
see Appendix H to Section 3.)
APPENDIX C TO SECTION 3
Deleted. (For "Determination of A1 and A2 Quantities," see Appendix A to Section 4.)
APPENDIX D TO SECTION 3
NATIONALLY TRACKED SOURCE THRESHOLDS
(for use with RH-1513.)
The Terabecquerel (TBq) values are the regulatory standard. The curie (Ci) values specified are obtained by converting from the TBq value. The curie values are provided for practical usefulness only and are rounded after conversion.
|
Radioactive material |
Category 1 (TBq) |
Category 1 (Ci) |
Category 2 (TBq) |
Category 2 (Ci) |
|
Actinium-227 |
20 |
540 |
0.2 |
5.4 |
|
Americium-241 |
60 |
1,600 |
0.6 |
16 |
|
Americium-241/Be |
60 |
1,600 |
0.6 |
16 |
|
Califomium-252 |
20 |
540 |
0.2 |
5.4 |
|
Cobalt-60 |
30 |
810 |
0.3 |
8.1 |
|
Curium-244 |
50 |
1,400 |
0.5 |
14 |
|
Cesium-137 |
100 |
2,700 |
1 |
27 |
|
Gadolinium-153 |
1,000 |
27,000 |
10 |
270 |
|
Iridium-192 |
80 |
2,200 |
0.8 |
22 |
|
Plutonium-238 |
60 |
1,600 |
0.6 |
16 |
|
Plutonium-239/Be |
60 |
1,600 |
0.6 |
16 |
|
Polonium-210 |
60 |
1,600 |
0.6 |
16 |
|
Promethium-147 |
40,000 |
1,100,000 |
400 |
11,000 |
|
Radium-226 |
40 |
1,100 |
0.4 |
11 |
|
Selenium-75 |
200 |
5,400 |
2 |
54 |
|
Strontium-90 |
1,000 |
27,000 |
10 |
270 |
|
Thorium-228 |
20 |
540 |
0.2 |
5.4 |
|
Thorium-229 |
20 |
540 |
0.2 |
5.4 |
|
Thulium-170 |
20,000 |
540,000 |
200 |
5,400 |
|
Ytterbium-169 |
300 |
8,100 |
3 |
81 |
APPENDIX E TO SECTION 3 ASSIGNED PROTECTION FACTORS FOR RESPIRATORS a/
|
RESPIRATOR TYPE |
OPERATING MODE |
ASSIGNED PROTECTION FACTOR |
|
I. Air Purifying Respirators [Particulate b/ only]c/ |
||
|
Filtering facepiece disposable d/ |
Negative Pressure |
( d/ ) |
|
Facepiece, half e/ |
Negative Pressure |
10 |
|
Facepiece, full |
Negative Pressure |
100 |
|
Facepiece, half |
Powered air-purifying respirators |
50 |
|
Facepiece, full |
Powered air-purifying respirator |
1000 |
|
Helmet/hood |
Powered air-purifying respirator |
1000 |
|
Facepiece, loose-fitting |
Powered air-purifying respirator |
25 |
|
II. Atmosphere supplying respirators [particulate, gases and vapors f/ ] |
||
|
1. Air-line respirators |
||
|
Facepiece, half |
Demand |
10 |
|
Facepiece, half |
Continuous flow |
50 |
|
Facepiece, half |
Pressure demand |
50 |
|
Facepiece, full |
Demand |
100 |
|
Facepiece, full |
Continuous flow |
1000 |
|
Facepiece, full |
Pressure demand |
1000 |
|
Helmet/hood |
Continuous flow |
1000 |
|
Facepiece, loose-fitting |
Continuous flow |
25 |
|
Suit |
Continuous flow |
( g/ ) |
|
2. Self-contained breathing apparatus (SCBA) |
||
|
Facepiece, full |
Demand |
100 h/ |
|
Facepiece, full |
Pressure demand |
10,000 i/ |
|
Facepiece, full |
Demand, re-circulating |
100 h/ |
|
Facepiece, full |
Positive pressure recirculating |
10,000 i/ |
|
III. Combination Respirators |
||
|
Any combination of air-purifying and atmosphere-supplying respirators |
Assigned protection factor for type and mode of operation as listed above |
|
Footnotes for Appendix E to Section 3:
a/ These assigned protection factors apply only in a respiratory protection program that meets the
requirements of this Section. They are applicable only to airborne radiological hazards and may not be appropriate to circumstances when chemical or other respiratory hazards exist instead of, or in addition to, radioactive hazards. Selection and use of respirators for such circumstances must also comply with Department of Labor regulations. Radioactive contaminants for which the concentration values in Table I, Column 3 of Appendix G to Section 3 are based on internal dose due to inhalation may, in addition, present external exposure hazards at higher concentrations. Under these circumstances, limitation on occupancy may have to be governed by external dose limits.
b/ Air purifying respirators with APF <100 must be equipped with particulate filters that are at least
ninety-five percent (95%) efficient. Air purifying respirators with APF = 100 must be equipped with particulate filters that are at least ninety-nine percent (99%) efficient. Air purifying respirators with APFs > 100 must be equipped with particulate filters that are at least 99.97 percent (99.97%) efficient.
c/ The licensee may apply to the Department for the use of an APF greater than one (1) for sorbent
cartridges as protection against airborne radioactive gases and vapors (e.g., radioiodine).
d/ Licensees may permit individuals to use this type of respirator who have not been medically
screened or fit tested on the device provided that no credit be taken for their use in estimating intake or dose. It is also recognized that it is difficult to perform an effective positive or negative pressure pre-use seal check on this type of device. All other respiratory protection program requirements listed in RH-1303.f. apply. An assigned protection factor has not been assigned for these devices. However, an APF equal to ten (10) may be used if the licensee can demonstrate a fit factor of at least 100 by use of a validated or evaluated, qualitative or quantitative fit test.
e/ Under-chin type only. No distinction is made in this Appendix between elastomeric half-masks
with replaceable cartridges and those designed with the filter medium as an integral part of the facepiece (e.g., disposable or reusable disposable). Both types are acceptable so long as the seal area of the latter contains some substantial type of seal-enhancing material such as rubber or plastic, the two or more suspension straps are adjustable, the filter medium is at least ninety-five percent (95%) efficient and all other requirement of this Part are met.
f/ The assigned protection factors for gases and vapors are not applicable to radioactive
contaminants that present an absorption or submersion hazard. For tritium oxide vapor, approximately one-third of the intake occurs by absorption through the skin so that an overall protection factor of three (3) is appropriate when atmosphere-supplying respirators are used to protect against tritium oxide. Exposure to radioactive noble gases is not considered a significant respiratory hazard, and protective actions for these contaminants should be based on external (submersion) dose considerations.
g/ No NIOSH approval schedule is currently available for atmosphere supplying suits. This
equipment may be used in an acceptable respiratory protection program as long as all the other minimum program requirements, with the exception of fit testing, are met (i.e., RH-1303.f.).
h/ The licensee should implement institutional controls to assure that these devices are not used in
areas immediately dangerous to life or health (IDLH).
Footnotes for Appendix E to Section 3 (Cont'd):
i/ This type of respirator may be used as an emergency device in unknown concentrations for
protection against inhalation hazards. External radiation hazards and other limitation to permitted exposure such as skin absorption shall be taken into account in these circumstances. This device may not be used by any individual who experiences perceptible outward leakage of breathing gas while wearing the device.
APPENDIX F TO SECTION 3 LIST OF ELEMENTS FOR USE WITH APPENDIX G TO SECTION 3
|
Name |
Symbol |
Atomic number |
|
Actinium |
Ac |
89 |
|
Aluminum |
Al |
13 |
|
Americium |
Am |
95 |
|
Antimony |
Sb |
51 |
|
Argon |
Ar |
18 |
|
Arsenic |
As |
33 |
|
Astatine |
At |
85 |
|
Barium |
Ba |
56 |
|
Berkelium |
Bk |
97 |
|
Beryllium |
Be |
4 |
|
Bismuth |
Bi |
83 |
|
Bromine |
Br |
35 |
|
Cadmium |
Cd |
48 |
|
Calcium |
Ca |
20 |
|
Californium |
Cf |
98 |
|
Carbon |
C |
6 |
|
Cerium |
Ce |
58 |
|
Cesium |
Cs |
55 |
|
Chlorine |
Cl |
17 |
|
Chromium |
Cr |
24 |
|
Cobalt |
Co |
27 |
|
Copper |
Cu |
29 |
|
Curium |
Cm |
96 |
|
Dysprosium |
Dy |
66 |
|
Einsteinium |
Es |
99 |
|
Erbium |
Er |
68 |
|
Europium |
Eu |
63 |
|
Fermium |
Fm |
100 |
|
Fluorine |
F |
9 |
|
Francium |
Fr |
87 |
|
Gadolinium |
Gd |
64 |
|
Gallium |
Ga |
31 |
|
Germanium |
Ge |
32 |
|
Gold |
Au |
79 |
|
Hafnium |
Hf |
72 |
|
Holmium |
Ho |
67 |
|
Hydrogen |
H |
1 |
|
Indium |
In |
49 |
|
Iodine |
I |
53 |
|
Iridium |
Ir |
77 |
|
Iron |
Fe |
26 |
|
Krypton |
Kr |
36 |
|
Lanthanum |
La |
57 |
|
Lead |
Pb |
82 |
|
Lutetium |
Lu |
71 |
|
Magnesium |
Mg |
12 |
|
Manganese |
Mn |
25 |
|
Mendelevium |
Md |
101 |
|
Mercury |
Hg |
80 |
|
Molybdenum |
Mo |
42 |
|
Neodymium |
Nd |
60 |
|
Neptunium |
Np |
93 |
|
Nickel |
Ni |
28 |
|
Niobium |
Nb |
41 |
|
Nitrogen |
N |
7 |
|
Osmium |
Os |
76 |
|
Oxygen |
O |
8 |
|
Palladium |
Pd |
46 |
|
Phosphorus |
P |
15 |
|
Platinum |
Pt |
78 |
|
Plutonium |
Pu |
94 |
|
Polonium |
Po |
84 |
|
Potassium |
K |
19 |
|
Praseodymium |
Pr |
59 |
|
Promethium |
Pm |
61 |
|
Protactinium |
Pa |
91 |
|
Radium |
Ra |
88 |
|
Radon |
Rn |
86 |
|
Rhenium |
Re |
75 |
|
Rhodium |
Rh |
45 |
|
Rubidium |
Rb |
37 |
|
Ruthenium |
Ru |
44 |
|
Samarium |
Sm |
62 |
|
Scandium |
Sc |
21 |
|
Selenium |
Se |
34 |
|
Silicon |
Si |
14 |
|
Silver |
Ag |
47 |
|
Sodium |
Na |
11 |
|
Strontium |
Sr |
38 |
|
Sulfur |
S |
16 |
|
Tantalum |
Ta |
73 |
|
Technetium |
Tc |
43 |
|
Tellurium |
Te |
52 |
|
Terbium |
Tb |
65 |
|
Thallium |
Tl |
81 |
|
Thorium |
Th |
90 |
|
Thulium |
Tm |
69 |
|
Tin |
Sn |
50 |
|
Titanium |
Ti |
22 |
|
Tungsten |
W |
74 |
|
Uranium |
U |
92 |
|
Vanadium |
V |
23 |
|
Xenon |
Xe |
54 |
|
Ytterbium |
Yb |
70 |
|
Yttrium |
Y |
39 |
|
Zinc |
Zn |
30 |
|
Zirconium |
Zr |
40 |
APPENDIX G TO SECTION 3
ANNUAL LIMITS ON INTAKE (ALIs) AND DERIVED AIR CONCENTRATIONS (DACs)
OF RADIONUCLIDES FOR OCCUPATIONAL EXPOSURE;
EFFLUENT CONCENTRATIONS;
CONCENTRATIONS FOR RELEASE TO SEWERAGE
Introduction
For each radionuclide, Table I indicates the chemical form which is to be used for selecting the appropriate ALI or DAC value. The ALIs and DACs for inhalation are given for an aerosol with an activity median aerodynamic diameter (AMAD) of 1 µm (micron), and for three classes (D,W,Y) of radioactive material, which refer to their retention (approximately days, weeks or years) in the pulmonary region of the lung. This classification applies to a range of clearance half-times for D if less than 10 days, for W from 10 to 100 days, and for Y greater than 100 days. The class (D, W, or Y) given in the column headed "Class" applies only to the inhalation ALIs and DACs given in Table I, column 2 and 3. Table II provides concentration limits for airborne and liquid effluents released to the general environment. Table III provides concentration limits for discharges to sanitary sewerage.
Note: The values in Tables I, II, and III are presented in the computer "E" notation. In this notation a value of 6E-02 represents a value of 6 x 10-2 or 0.06, 6E+2 represents 6 x 102 or 600, and 6E+0 represents 6 x 100 or 6.
Table I: Occupational Values
Note that the columns in Table I of this appendix captioned "Oral Ingestion ALI," "Inhalation ALI," and "DAC," are applicable to occupational exposure to radioactive material.
The ALIs in this appendix are the annual intakes of given radionuclide by "Reference man" which would result in either (1) a committed effective dose equivalent of 0.05 sievert (5 rem), stochastic ALI, or (2) a committed dose equivalent of 0.5 sievert (50 rem) to an organ or tissue, non-stochastic ALI. The stochastic ALIs were derived to result in a risk, due to irradiation of organs and tissues, comparable to the risk associated with deep dose equivalent to the whole body of 0.05 sievert (5 rem). The derivation includes multiplying the committed dose equivalent to an organ or tissue by a weighting factor, wT. This weighting factor is the proportion of the risk of stochastic effects resulting from irradiation of the organ or tissue, T, to the total risk of stochastic effects when the whole body is irradiated uniformly. The values of wT are listed under the definition of weighting factor in RH-1100. The non-stochastic ALIs were derived to avoid non-stochastic effects, such as prompt damage to tissue or reduction in organ function.
A value of wT = 0.06 is applicable to each of the 5 organs or tissues in the "remainder" category receiving the highest dose equivalents, and the dose equivalents of all other remaining tissues may be disregarded. The following portions of the GI tract - stomach, small intestine, upper large intestine, and lower large intestine - are to be treated as 4 separate organs.
Note that the dose equivalents for an extremity, skin and lens of the eye are not considered in computing the committed effective dose equivalent, but are subject to limits that must be met separately.
When an ALI is defined by the stochastic dose limit, this value alone is given. When an ALI is determined by the non-stochastic dose limit to an organ, the organ or tissue to which the limit applies is shown, and the ALI for the stochastic limit is shown in parentheses. Abbreviated organ or tissue designations are used:
LLI wall = lower large intestine wall; St. wall = stomach wall; Blad wall = bladder wall; and Bone surf = bone surface.
The use of the ALIs listed first, the more limiting of the stochastic and non-stochastic ALIs, will ensure that non-stochastic effects are avoided and that the risk of stochastic effects is limited to an acceptably low value. If, in a particular situation involving a radionuclide for which the non-stochastic ALI is limiting, use of that non-stochastic ALI is considered unduly conservative, the licensee may use the stochastic ALI to determine the committed effective dose equivalent. However, the licensee shall also ensure that the 0.5 sievert (50 rem) dose equivalent limit for any organ or tissue is not exceeded by the sum of the external deep dose equivalent plus the internal committed dose equivalent to that organ, not the effective dose. For the case where there is no external dose contribution, this would be demonstrated if the sum of the fractions of the nonstochastic ALIs (ALIns) that contribute to the committed dose equivalent to the organ receiving the highest dose does not exceed unity, that is, (intake (in µCi) of each radionuclide/ALIns) <1.0. If there is an external deep dose equivalent contribution of Hd, then this sum must be less than 1 - (Hd/50), instead of < 1.0.
Note that the dose equivalents for an extremity, skin, and lens of the eye are not considered in computing the committed effective dose equivalent, but are subject to limits that must be met separately.
The derived air concentration (DAC) values are derived limits intended to control chronic occupational exposures. The relationship between the DAC and the ALI is given by:
DAC = ALI(in µCi)/(2000 hours per working year x 60 minutes/hour x 2 x 10 ml per minute)
= [ALI/2.4 x 109] µCi/ml,
where 2 x 10 ml is the volume of air breathed per minute at work by Reference man under working conditions of "light work."
The DAC values relate to 1 of 2 modes of exposure: either external submersion or the internal committed dose equivalents resulting from inhalation of radioactive materials. DACs based upon submersion are for immersion in a semi-infinite cloud of uniform concentration and apply to each radionuclide separately.
The ALI and DAC values include contributions to exposure by the single radionuclide named and any ingrowth of daughter radionuclides produced in the body by decay of the parent. However, intakes that include both the parent and daughter radionuclides should be treated by the general method appropriate for mixtures.
The values of ALI and DAC do not apply directly when the individual both ingests and inhales a radionuclide, when the individual is exposed to a mixture of radionuclides by either inhalation or ingestion or both, or when the individual is exposed to both internal and external irradiation. See RH-1201. When an individual is exposed to radioactive materials which fall under several of the translocation classifications of the same radionuclide, such as Class D, Class W, or Class Y, the exposure may be evaluated as if it were a mixture of different radionuclides.
It should be noted that the classification of a compound as Class D, W, or Y is based on the chemical form of the compound and does not take into account the radiological half-life of different radionuclides. For this reason, values are given for Class D, W, and Y compounds, even for very short-lived radionuclides.
Table II : Effluent Concentrations
The columns in Table II of this appendix captioned "Effluents," "Air" and "Water" are applicable to the assessment and control of dose to the public, particularly in the implementation of the provisions of RH-1209. The concentration values given in Columns 1 and 2 of Table II are equivalent to the radionuclide concentrations which, if inhaled or ingested continuously over the course of a year, would produce a total effective dose equivalent of 0.5 millisievert (0.05 rem).
Consideration of non-stochastic limits has not been included in deriving the air and water effluent concentration limits because non-stochastic effects are presumed not to occur at or below the dose levels established for individual members of the public. For radionuclides, where the non-stochastic limit was governing in deriving the occupational DAC, the stochastic ALI was used in deriving the corresponding airborne effluent limit in Table II. For this reason, the DAC and airborne effluent limits are not always proportional as was the case in Appendix B to 10 CFR Part 20.1-20.601.
The air concentration values listed in Table II, Column 1 were derived by one of two methods. For those radionuclides for which the stochastic limit is governing, the occupational stochastic inhalation ALI was divided by 2.4 x 109 (ml), relating the inhalation ALI to the DAC, as explained above, and then divided by a factor of 300. The factor of 300 includes the following components: a factor of 50 to relate the 0.05 sievert (5 rem) annual occupational dose limit to the 1 millisievert (0.1 rem) limit for members of the public, a factor of 3 to adjust for the difference in exposure time and the inhalation rate for a worker and that for members of the public; and a factor of 2 to adjust the occupational values, derived for adults, so that they are applicable to other age groups.
For those radionuclides for which submersion, that is external dose, is limiting, the occupational DAC in Table I, Column 3 was divided by 219. The factor of 219 is composed of a factor of 50, as described above, and a factor of 4.38 relating occupational exposure for 2,000 hours per year to full-time exposure (8,760 hours per year). Note that an additional factor of 2 for age considerations is not warranted in the submersion case.
The water concentrations were derived by taking the most restrictive occupational stochastic oral ingestion ALI and dividing by 7.3 x 107. The factor of 7.3 x 107 (ml) includes the following components: the factors of 50 and 2 described above and a factor of 7.3 x 105 (ml) which is the annual water intake of "Reference man."
Note 2 of this appendix provides groupings of radionuclides which are applicable to unknown mixtures of radionuclides. These groupings, including occupational inhalation ALIs and DACs, air and water effluent concentrations and releases to sewer, require demonstrating that the most limiting radionuclides in successive classes are absent. The limit for the unknown mixture is defined when the presence of one of the listed radionuclides cannot be definitely excluded as being present either from knowledge of the radionuclide composition of the source or from actual measurements.
Table III: Releases to Sewers
The monthly average concentrations for release to sanitary sewers are applicable to the provisions in RH-1402. The concentration values were derived by taking the most restrictive occupational stochastic oral ingestion ALI and dividing by 7.3 x 106 (ml). The factor of 7.3 x 106 (ml) is composed of a factor of 7.3 x 105 (ml), the annual water intake by "Reference Man," and a factor of 10, such that the concentrations, if the sewage released by the licensee were the only source of water ingested by a reference man during a year, would result in a committed effective dose equivalent of 0.5 rem.
Footnotes for Appendix G to Section 3:
a/ "Submersion" means that values given are for submersion in a hemispherical semi-infinite cloud of airborne material.
b/ These radionuclides have radiological half-lives of less than 2 hours. The total effective dose equivalent received during operations with these radionuclides might include a significant contribution from external exposure. The DAC values for all radionuclides, other than those designated Class "Submersion," are based upon the committed effective dose equivalent due to the intake of the radionuclide into the body and do NOT include potentially significant contributions to dose equivalent from external exposures. The licensee may substitute 1E-7 µ Ci/ml for the listed DAC to account for the submersion dose prospectively, but should use individual monitoring devices or other radiation measuring instruments that measure external exposure to demonstrate compliance with the limits. (See RH-1202.)
c/ For soluble mixtures of U-238, U-234, and U-235 in air, chemical toxicity may be the limiting factor. (See RH-1200.e.) If the percent by weight (enrichment) of U-235 is not greater than 5, the concentration value for a 40-hour workweek is 0.2 milligrams uranium per cubic meter of air average. For any enrichment, the product of the average concentration and time of exposure during a 40-hour workweek shall not exceed 8E-3 (SA) µ Ci-hr/ml, where SA is the specific activity of the uranium inhaled. The specific activity for natural uranium is 6.77E-7 curies per gram U. The specific activity for other mixtures of U-238, U-235, and U-234, if not known, shall be:
SA = 3.6E-7 curies/gram U U-depleted
SA = [0.4 + 0.38 (enrichment) + 0.0034 (enrichment)2] E-6, enrichment > 0.72
where enrichment is the percentage by weight of U-235, expressed as percent.
Note:
Footnotes for Appendix G to Section 3 (Cont'd)
Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage
Note (Cont'd):
Example: If radionuclides "A," "B," and "C" are present in concentrations Ca, Cb, and CC, and if the applicable DACs are DACa, DACb, and DACC, respectively, then the concentrations shall be limited so that the following relationship exists:
APPENDIX H TO SECTION 3
QUANTITIESa/ OF LICENSED MATERIAL REQUIRING LABELING
(In order of atomic number)
|
Radionuclide |
Quantity (nCif |
|
Hydrogen-3 |
1,000 |
|
Beryllium-7 |
1,000 |
|
Beryllium-10 |
1 |
|
Carbon-11 |
1,000 |
|
Carbon-14 |
100 |
|
Fluorine-18 |
1,000 |
|
Sodium-22 |
10 |
|
Sodium-24 |
100 |
|
Magnesium-28 |
100 |
|
Aluminum-26 |
10 |
|
Silicon-31 |
1,000 |
|
Silicon-32 |
1 |
|
Phosphorus-32 |
10 |
|
Phosphorus-33 |
100 |
|
Sulfur-35 |
100 |
|
Chlorine-36 |
10 |
|
Chlorine-38 |
1,000 |
|
Chlorine-39 |
1,000 |
|
Argon-39 |
1,000 |
|
Argon-41 |
1,000 |
|
Potassium-40 |
100 |
|
Potassium-42 |
1,000 |
|
Potassium-43 |
1,000 |
|
Potassium-44 |
1,000 |
|
Potassium-45 |
1,000 |
|
Calcium-41 |
100 |
|
Calcium-45 |
100 |
|
Calcium-47 |
100 |
|
Scandium-43 |
1,000 |
|
Scandium-44m |
100 |
|
Scandium-44 |
100 |
|
Scandium-46 |
10 |
|
Scandium-47 |
100 |
|
Scandium-48 |
100 |
|
Scandium-49 |
1,000 |
|
Titanium-44 |
1 |
|
Titanium-45 |
1,000 |
|
Vanadium-47 |
1,000 |
|
Vanadium-48 |
100 |
|
Vanadium-49 |
1,000 |
|
Chromium-48 |
1,000 |
|
Chromium-49 |
1,000 |
|
Chromium-51 |
1,000 |
|
Manganese-51 |
1,000 |
|
Manganese-52m |
1,000 |
|
Manganese-52 |
100 |
|
Manganese-53 |
1,000 |
|
Manganese-54 |
100 |
|
Manganese-56 |
1,000 |
|
Iron-52 |
100 |
|
Iron-55 |
100 |
|
Iron-59 |
10 |
|
Iron-60 |
1 |
|
Cobalt-55 |
100 |
|
Cobalt-56 |
10 |
|
Cobalt-57 |
100 |
|
Cobalt-58m |
1,000 |
|
Cobalt-58 |
100 |
|
Cobalt-60m |
1,000 |
|
Cobalt-60 |
1 |
|
Cobalt-61 |
1,000 |
|
Cobalt-62m |
1,000 |
|
Nickel-56 |
100 |
|
Nickel-57 |
100 |
|
Nickel-59 |
100 |
|
Nickel-63 |
100 |
|
Nickel-65 |
1,000 |
|
Nickel-66 |
10 |
|
Copper-60 |
1,000 |
|
Copper-61 |
1,000 |
|
Copper-64 |
1,000 |
|
Copper-67 |
1,000 |
|
Zinc-62 |
100 |
|
Zinc-63 |
1,000 |
|
Zinc-65 |
10 |
|
Zinc-69m |
100 |
|
Zinc-69 |
1,000 |
|
Zinc-71m |
1,000 |
|
Zinc-72 |
100 |
|
Gallium-65 |
1,000 |
|
Gallium-66 |
100 |
|
Gallium-67 |
1,000 |
|
Gallium-68 |
1,000 |
|
Gallium-70 |
1,000 |
|
Gallium-72 |
100 |
|
Gallium-73 |
1,000 |
|
Germanium-66 |
1,000 |
|
Germanium-67 |
1,000 |
|
Germanium-68 |
10 |
|
Germanium-69 |
1,000 |
|
Germanium-71 |
1,000 |
|
Germanium-75 |
1,000 |
|
Germanium-77 |
1,000 |
|
Germanium-78 |
1,000 |
|
Arsenic-69 |
1,000 |
|
Arsenic-70 |
1,000 |
|
Arsenic-71 |
100 |
|
Arsenic-72 |
100 |
|
Arsenic-73 |
100 |
|
Arsenic-74 |
100 |
|
Arsenic-76 |
100 |
|
Arsenic-77 |
100 |
|
Arsenic-78 |
1,000 |
|
Selenium-70 |
1,000 |
|
Selenium-73m |
1,000 |
|
Selenium-73 |
100 |
|
Selenium-75 |
100 |
|
Selenium-79 |
100 |
|
Selenium-81m |
1,000 |
|
Selenium-81 |
1,000 |
|
Selenium-83 |
1,000 |
|
Bromine-74m |
1,000 |
|
Bromine-74 |
1,000 |
|
Bromine-75 |
1,000 |
|
Bromine-76 |
100 |
|
Bromine-77 |
1,000 |
|
Bromine-80m |
1,000 |
|
Bromine-80 |
1,000 |
|
Bromine-82 |
100 |
|
Bromine-83 |
1,000 |
|
Bromine-84 |
1,000 |
|
Krypton-74 |
1,000 |
|
Krypton-76 |
1,000 |
|
Krypton-77 |
1,000 |
|
Krypton-79 |
1,000 |
|
Krypton-81 |
1,000 |
|
Krypton-83m |
1,000 |
|
Krypton-85m |
1,000 |
|
Krypton-85 |
1,000 |
|
Krypton-87 |
1,000 |
|
Krypton-88 |
1,000 |
|
Rubidium-79 |
1,000 |
|
Rubidium-81m |
1,000 |
|
Rubidium-81 |
1,000 |
|
Rubidium-82m |
1,000 |
|
Rubidium-83 |
100 |
|
Rubidium-84 |
100 |
|
Rubidium-86 |
100 |
|
Rubidium-87 |
100 |
|
Rubidium-88 |
1,000 |
|
Rubidium-89 |
1,000 |
|
Strontium-80 |
100 |
|
Strontium-81 |
1,000 |
|
Strontium-83 |
100 |
|
Strontium-85m |
1,000 |
|
Strontium-85 |
100 |
|
Strontium-87m |
1,000 |
|
Strontium-89 |
10 |
|
Strontium-90 |
0.1 |
|
Strontium-91 |
100 |
|
Strontium-92 |
100 |
|
Yttrium-86m |
1,000 |
|
Yttrium-86 |
100 |
|
Yttrium-87 |
100 |
|
Yttrium-88 |
10 |
|
Yttrium-90m |
1,000 |
|
Yttrium-90 |
10 |
|
Yttrium-91m |
1,000 |
|
Yttrium-91 |
10 |
|
Yttrium-92 |
100 |
|
Yttrium-93 |
100 |
|
Yttrium-94 |
1,000 |
|
Yttrium-95 |
1,000 |
|
Zirconium-86 |
100 |
|
Zirconium-88 |
10 |
|
Zirconium-89 |
100 |
|
Zirconium-93 |
1 |
|
Zirconium-95 |
10 |
|
Zirconium-97 |
100 |
|
Niobium-88 |
1,000 |
|
Niobium-89m (66 min) |
1,000 |
|
Niobium-89 (122 min) |
1,000 |
|
Niobium-90 |
100 |
|
Niobium-93m |
10 |
|
Niobium-94 |
1 |
|
Niobium-95m |
100 |
|
Niobium-95 |
100 |
|
Niobium-96 |
100 |
|
Niobium-97 |
1,000 |
|
Niobium-98 |
1,000 |
|
Molybdenum-90 |
100 |
|
Molybdenum-93m |
100 |
|
Molybdenum-93 |
10 |
|
Molybdenum-99 |
100 |
|
Molybdenum-101 |
1,000 |
|
Technetium-93m |
1,000 |
|
Technetium-93 |
1,000 |
|
Technetium-94m |
1,000 |
|
Technetium-94 |
1,000 |
|
Technetium-96m |
1,000 |
|
Technetium-96 |
100 |
|
Technetium-97m |
100 |
|
Technetium-97 |
1,000 |
|
Technetium-98 |
10 |
|
Technetium-99m |
1,000 |
|
Technetium-99 |
100 |
|
Technetium-101 |
1,000 |
|
Technetium-104 |
1,000 |
|
Ruthenium-94 |
1,000 |
|
Ruthenium-97 |
1,000 |
|
Ruthenium-103 |
100 |
|
Ruthenium-105 |
1,000 |
|
Ruthenium-106 |
1 |
|
Rhodium-99m |
1,000 |
|
Rhodium-99 |
100 |
|
Rhodium-100 |
100 |
|
Rhodium-101m |
1,000 |
|
Rhodium-101 |
10 |
|
Rhodium-102m |
10 |
|
Rhodium-102 |
10 |
|
Rhodium-103m |
1,000 |
|
Rhodium-105 |
100 |
|
Rhodium-106m |
1,000 |
|
Rhodium-107 |
1,000 |
|
Palladium-100 |
100 |
|
Palladium-101 |
1,000 |
|
Palladium-103 |
100 |
|
Palladium-107 |
10 |
|
Palladium-109 |
100 |
|
Silver-102 |
1,000 |
|
Silver-103 |
1,000 |
|
Silver-104m |
1,000 |
|
Silver-104 |
1,000 |
|
Silver-105 |
100 |
|
Silver-106m |
100 |
|
Silver-106 |
1,000 |
|
Silver-108m |
1 |
|
Silver-110m |
10 |
|
Silver-111 |
100 |
|
Silver-112 |
100 |
|
Silver-115 |
1,000 |
|
Cadmium-104 |
1,000 |
|
Cadmium-107 |
1,000 |
|
Cadmium-109 |
1 |
|
Cadmium-113m |
0.1 |
|
Cadmium-113 |
100 |
|
Cadmium-115m |
10 |
|
Cadmium-115 |
100 |
|
Cadmium-117m |
1,000 |
|
Cadmium-117 |
1,000 |
|
Indium-109 |
1,000 |
|
Indium-110 (69.1 min) |
1,000 |
|
Indium-110 (4.9 h) |
1,000 |
|
Indium-111 |
100 |
|
Indium-112 |
1,000 |
|
Indium-113m |
1,000 |
|
Indium-114m |
10 |
|
Indium-115m |
1,000 |
|
Indium-115 |
100 |
|
Indium-116m |
1,000 |
|
Indium-117m |
1,000 |
|
Indium-117 |
1,000 |
|
Indium-119m |
1,000 |
|
Tin-110 |
100 |
|
Tin-111 |
1,000 |
|
Tin-113 |
100 |
|
Tin-117m |
100 |
|
Tin-119m |
100 |
|
Tin-121m |
100 |
|
Tin-121 |
1,000 |
|
Tin-123m |
1,000 |
|
Tin-123 |
10 |
|
Tin-125 |
10 |
|
Tin-126 |
10 |
|
Tin-127 |
1,000 |
|
Tin-128 |
1,000 |
|
Antimony-115 |
1,000 |
|
Antimony-116m |
1,000 |
|
Antimony-116 |
1,000 |
|
Antimony-117 |
1,000 |
|
Antimony-118m |
1,000 |
|
Antimony-119 |
1,000 |
|
Antimony-120 (16 min) |
1,000 |
|
Antimony-120 (5.76 d) |
100 |
|
Antimony-122 |
100 |
|
Antimony-124m |
1,000 |
|
Antimony-124 |
10 |
|
Antimony-125 |
100 |
|
Antimony-126m |
1,000 |
|
Antimony-126 |
100 |
|
Antimony-127 |
100 |
|
Antimony-128 (10.4 min) |
1,000 |
|
Antimony-128 (9.01 h) |
100 |
|
Antimony-129 |
100 |
|
Antimony-130 |
1,000 |
|
Antimony-131 |
1,000 |
|
Tellurium-116 |
1,000 |
|
Tellurium-121m |
10 |
|
Tellurium-121 |
100 |
|
Tellurium-123m |
10 |
|
Tellurium-123 |
100 |
|
Tellurium-125m |
10 |
|
Tellurium-127m |
10 |
|
Tellurium-127 |
1,000 |
|
Tellurium-129m |
10 |
|
Tellurium-129 |
1,000 |
|
Tellurium-131m |
10 |
|
Tellurium-131 |
100 |
|
Tellurium-132 |
10 |
|
Tellurium-133m |
100 |
|
Tellurium-133 |
1,000 |
|
Tellurium-134 |
1,000 |
|
Iodine-120m |
1,000 |
|
Iodine-120 |
100 |
|
Iodine-121 |
1,000 |
|
Iodine-123 |
100 |
|
Iodine-124 |
10 |
|
Iodine-125 |
1 |
|
Iodine-126 |
1 |
|
Iodine-128 |
1,000 |
|
Iodine-129 |
1 |
|
Iodine-130 |
10 |
|
Iodine-131 |
1 |
|
Iodine-132m |
100 |
|
Iodine-132 |
100 |
|
Iodine-133 |
10 |
|
Iodine-134 |
1,000 |
|
Iodine-135 |
100 |
|
Xenon-120 |
1,000 |
|
Xenon-121 |
1,000 |
|
Xenon-122 |
1,000 |
|
Xenon-123 |
1,000 |
|
Xenon-125 |
1,000 |
|
Xenon-127 |
1,000 |
|
Xenon-129m |
1,000 |
|
Xenon-131m |
1,000 |
|
Xenon-133m |
1,000 |
|
Xenon-133 |
1,000 |
|
Xenon-135m |
1,000 |
|
Xenon-135 |
1,000 |
|
Xenon-138 |
1,000 |
|
Cesium-125 |
1,000 |
|
Cesium-127 |
1,000 |
|
Cesium-129 |
1,000 |
|
Cesium-130 |
1,000 |
|
Cesium-131 |
1,000 |
|
Cesium-132 |
100 |
|
Cesium-134m |
1,000 |
|
Cesium-134 |
10 |
|
Cesium-135m |
1,000 |
|
Cesium-135 |
100 |
|
Cesium-136 |
10 |
|
Cesium-137 |
10 |
|
Cesium-138 |
1,000 |
|
Barium-126 |
1,000 |
|
Barium-128 |
100 |
|
Barium-131m |
1,000 |
|
Barium-131 |
100 |
|
Barium-133m |
100 |
|
Barium-133 |
100 |
|
Barium-135m |
100 |
|
Barium-139 |
1,000 |
|
Barium-140 |
100 |
|
Barium-141 |
1,000 |
|
Barium-142 |
1,000 |
|
Lanthanum-131 |
1,000 |
|
Lanthanum-132 |
100 |
|
Lanthanum-135 |
1,000 |
|
Lanthanum-137 |
10 |
|
Lanthanum-138 |
100 |
|
Lanthanum-140 |
100 |
|
Lanthanum-141 |
100 |
|
Lanthanum-142 |
1,000 |
|
Lanthanum-143 |
1,000 |
|
Cerium-134 |
100 |
|
Cerium-135 |
100 |
|
Cerium-137m |
100 |
|
Cerium-137 |
1,000 |
|
Cerium-139 |
100 |
|
Cerium-141 |
100 |
|
Cerium-143 |
100 |
|
Cerium-144 |
1 |
|
Praseodymium-136 |
1,000 |
|
Praseodymium-137 |
1,000 |
|
Praseodymium-138m |
1,000 |
|
Praseodymium-139 |
1,000 |
|
Praseodymium-142m |
1,000 |
|
Praseodymium-142 |
100 |
|
Praseodymium-143 |
100 |
|
Praseodymium-144 |
1,000 |
|
Praseodymium-145 |
100 |
|
Praseodymium-147 |
1,000 |
|
Neodymium-136 |
1,000 |
|
Neodymium-138 |
100 |
|
Neodymium-13 9m |
1,000 |
|
Neodymium-139 |
1,000 |
|
Neodymium-141 |
1,000 |
|
Neodymium-147 |
100 |
|
Neodymium-149 |
1,000 |
|
Neodymium-151 |
1,000 |
|
Promethium-141 |
1,000 |
|
Promethium-143 |
100 |
|
Promethium-144 |
10 |
|
Promethium-145 |
10 |
|
Promethium-146 |
1 |
|
Promethium-147 |
10 |
|
Promethium-148m |
10 |
|
Promethium-148 |
10 |
|
Promethium-149 |
100 |
|
Promethium-150 |
1,000 |
|
Promethium-151 |
100 |
|
Samarium-141m |
1,000 |
|
Samarium-141 |
1,000 |
|
Samarium-142 |
1,000 |
|
Samarium-145 |
100 |
|
Samarium-146 |
1 |
|
Samarium-147 |
100 |
|
Samarium-151 |
10 |
|
Samarium-153 |
100 |
|
Samarium-155 |
1,000 |
|
Samarium-156 |
1,000 |
|
Europium-145 |
100 |
|
Europium-146 |
100 |
|
Europium-147 |
100 |
|
Europium-148 |
10 |
|
Europium-149 |
100 |
|
Europium-150 (12.62 h) |
100 |
|
|
Europium-150 (34.2 y) |
1 |
|
|
Europium-152m |
100 |
|
|
Europium-152 |
1 |
|
|
Europium-154 |
1 |
|
|
Europium-155 |
10 |
|
|
Europium-156 |
100 |
|
|
Europium-157 |
100 |
|
|
Europium-158 |
1,000 |
|
|
Gadolinium-145 |
1,000 |
|
|
Gadolinium-146 |
10 |
|
|
Gadolinium-147 |
100 |
|
|
Gadolinium-148 |
0.001 |
|
|
Gadolinium-149 |
100 |
|
|
Gadolinium-151 |
10 |
|
|
Gadolinium-152 |
100 |
|
|
Gadolinium-153 |
10 |
|
|
Gadolinium-159 |
100 |
|
|
Terb |
ium-147 |
1,000 |
|
Terb |
ium-149 |
100 |
|
Terb |
ium-150 |
1,000 |
|
Terb |
ium-151 |
100 |
|
Terb |
ium-153 |
1,000 |
|
Terb |
ium-154 |
100 |
|
Terb |
ium-155 |
1,000 |
|
Terb |
lum-156m (5.0 h) |
1,000 |
|
Terb |
lum-156m (24.4 h) |
1,000 |
|
Terb |
ium-156 |
100 |
|
Terb |
ium-157 |
10 |
|
Terb |
ium-158 |
1 |
|
Terb |
ium-160 |
10 |
|
Terbium-161 |
100 |
|
|
Dysprosium-155 |
1,000 |
|
|
Dysprosium-157 |
1,000 |
|
|
Dysprosium-159 |
100 |
|
|
Dysprosium-165 |
1,000 |
|
|
Dysprosium-166 |
100 |
|
|
Holn |
iium-155 |
1,000 |
|
Holmium-157 |
1,000 |
|
Holmium-159 |
1,000 |
|
Holmium-161 |
1,000 |
|
Holmium-162m |
1,000 |
|
Holmium-162 |
1,000 |
|
Holmium-164m |
1,000 |
|
Holmium-164 |
1,000 |
|
Holmium-166m |
1 |
|
Holmium-166 |
100 |
|
Holmium-167 |
1,000 |
|
Erbium-161 |
1,000 |
|
Erbium-165 |
1,000 |
|
Erbium-169 |
100 |
|
Erbium-171 |
100 |
|
Erbium-172 |
100 |
|
Thulium-162 |
1,000 |
|
Thulium-166 |
100 |
|
Thulium-167 |
100 |
|
Thulium-170 |
10 |
|
Thulium-171 |
10 |
|
Thulium-172 |
100 |
|
Thulium-173 |
100 |
|
Thulium-175 |
1,000 |
|
Ytterbium-162 |
1,000 |
|
Ytterbium-166 |
100 |
|
Ytterbium-167 |
1,000 |
|
Ytterbium-169 |
100 |
|
Ytterbium-175 |
100 |
|
Ytterbium-177 |
1,000 |
|
Ytterbium-178 |
1,000 |
|
Lutetium-169 |
100 |
|
Lutetium-170 |
100 |
|
Lutetium-171 |
100 |
|
Lutetium-172 |
100 |
|
Lutetium-173 |
10 |
|
Lutetium-174m |
10 |
|
Lutetium-174 |
10 |
|
Lutetium-176m |
1,000 |
|
Lutetium-176 |
100 |
|
Lutetium-177m |
10 |
|
Lutetium-177 |
100 |
|
Lutetium-178m |
1,000 |
|
Lutetium-178 |
1,000 |
|
Lutetium-179 |
1,000 |
|
Hafnium-170 |
100 |
|
Hafnium-172 |
1 |
|
Hafnium-173 |
1,000 |
|
Hafnium-175 |
100 |
|
Hafnium-177m |
1,000 |
|
Hafnium-178m |
0.1 |
|
Hafnium-179m |
10 |
|
Hafnium-180m |
1,000 |
|
Hafnium-181 |
10 |
|
Hafnium-182m |
1,000 |
|
Hafnium-182 |
0.1 |
|
Hafnium-183 |
1,000 |
|
Hafnium-184 |
100 |
|
Tantalum-172 |
1,000 |
|
Tantalum-173 |
1,000 |
|
Tantalum-174 |
1,000 |
|
Tantalum-175 |
1,000 |
|
Tantalum-176 |
100 |
|
Tantalum-177 |
1,000 |
|
Tantalum-178 |
1,000 |
|
Tantalum-179 |
100 |
|
Tantalum-180m |
1,000 |
|
Tantalum-180 |
100 |
|
Tantalum-182m |
1,000 |
|
Tantalum-182 |
10 |
|
Tantalum-183 |
100 |
|
Tantalum-184 |
100 |
|
Tantalum-185 |
1,000 |
|
Tantalum-186 |
1,000 |
|
Tungsten-176 |
1,000 |
|
Tungsten-177 |
1,000 |
|
Tungsten-178 |
1,000 |
|
Tungsten-179 |
1,000 |
|
Tungsten-181 |
1,000 |
|
Tungsten-185 |
100 |
|
Tungsten-187 |
100 |
|
Tungsten-188 |
10 |
|
Rhenium-177 |
1,000 |
|
Rhenium-178 |
1,000 |
|
Rhenium-181 |
1,000 |
|
Rhenium-182 (12.7 h) |
1,000 |
|
Rhenium-182 (64.0 h) |
100 |
|
Rhenium-184m |
10 |
|
Rhenium-184 |
100 |
|
Rhenium-186m |
10 |
|
Rhenium-186 |
100 |
|
Rhenium-187 |
1,000 |
|
Rhenium-188m |
1,000 |
|
Rhenium-188 |
100 |
|
Rhenium-189 |
100 |
|
Osmium-180 |
1,000 |
|
Osmium-181 |
1,000 |
|
Osmium-182 |
100 |
|
Osmium-185 |
100 |
|
Osmium-189m |
1,000 |
|
Osmium-191m |
1,000 |
|
Osmium-191 |
100 |
|
Osmium-193 |
100 |
|
Osmium-194 |
1 |
|
Iridium-182 |
1,000 |
|
Iridium-184 |
1,000 |
|
Iridium-185 |
1,000 |
|
Iridium-186 |
100 |
|
Iridium-187 |
1,000 |
|
Iridium-188 |
100 |
|
Iridium-189 |
100 |
|
Iridium-190m |
1,000 |
|
Iridium-190 |
100 |
|
Iridium-192m (1.4 min) |
10 |
|
Iridium-192 (73.8 d) |
1 |
|
Iridium-194m |
10 |
|
Iridium-194 |
100 |
|
Iridium-195m |
1,000 |
|
Iridium-195 |
1,000 |
|
Platinum-186 |
1,000 |
|
Platinum-188 |
100 |
|
Platinum-189 |
1,000 |
|
Platinum-191 |
100 |
|
Platinum-193m |
100 |
|
Platinum-193 |
1,000 |
|
Platinum-195m |
100 |
|
Platinum-197m |
1,000 |
|
Platinum-197 |
100 |
|
Platinum-199 |
1,000 |
|
Platinum-200 |
100 |
|
Gold-193 |
1,000 |
|
Gold-194 |
100 |
|
Gold-195 |
10 |
|
Gold-198m |
100 |
|
Gold-198 |
100 |
|
Gold-199 |
100 |
|
Gold-200m |
100 |
|
Gold-200 |
1,000 |
|
Gold-201 |
1,000 |
|
Mercury-193m |
100 |
|
Mercury-193 |
1,000 |
|
Mercury-194 |
1 |
|
Mercury-195m |
100 |
|
Mercury-195 |
1,000 |
|
Mercury-197m |
100 |
|
Mercury-197 |
1,000 |
|
Mercury-199m |
1,000 |
|
Mercury-203 |
100 |
|
Thallium-194m |
1,000 |
|
Thallium-194 |
1,000 |
|
Thallium-195 |
1,000 |
|
Thallium-197 |
1,000 |
|
Thallium-198m |
1,000 |
|
Thallium-198 |
1,000 |
|
Thallium-199 |
1,000 |
|
Thallium-200 |
1,000 |
|
Thallium-201 |
1,000 |
|
Thallium-202 |
100 |
|
Thallium-204 |
100 |
|
Lead-195m |
1,000 |
|
Lead-198 |
1,000 |
|
Lead-199 |
1,000 |
|
Lead-200 |
100 |
|
Lead-201 |
1,000 |
|
Lead-202m |
1,000 |
|
Lead-202 |
10 |
|
Lead-203 |
1,000 |
|
Lead-205 |
100 |
|
Lead-209 |
1,000 |
|
Lead-210 |
0.01 |
|
Lead-211 |
100 |
|
Lead-212 |
1 |
|
Lead-214 |
100 |
|
Bismuth-200 |
1,000 |
|
Bismuth-201 |
1,000 |
|
Bismuth-202 |
1,000 |
|
Bismuth-203 |
100 |
|
Bismuth-205 |
100 |
|
Bismuth-206 |
100 |
|
Bismuth-207 |
10 |
|
Bismuth-210m |
0.1 |
|
Bismuth-210 |
1 |
|
Bismuth-212 |
10 |
|
Bismuth-213 |
10 |
|
Bismuth-214 |
100 |
|
Polonium-203 |
1,000 |
|
Polonium-205 |
1,000 |
|
Polonium-207 |
1,000 |
|
Polonium-210 |
0.1 |
|
Astatine-207 |
100 |
|
Astatine-211 |
10 |
|
Radon-220 |
1 |
|
Radon-222 |
1 |
|
Francium-222 |
100 |
|
Francium-223 |
100 |
|
Radium-223 |
0.1 |
|
Radium-224 |
0.1 |
|
Radium-225 |
0.1 |
|
Radium-226 |
0.1 |
|
Radium-227 |
1,000 |
|
Radium-228 |
0.1 |
|
Actinium-224 |
1 |
|
Actinium-225 |
0.01 |
|
Actinium-226 |
0.1 |
|
Actinium-227 |
0.001 |
|
Actinium-228 |
1 |
|
Thorium-226 |
10 |
|
Thorium-227 |
0.01 |
|
Thorium-228 |
0.001 |
|
Thorium-229 |
0.001 |
|
Thorium-230 |
0.001 |
|
Thorium-231 |
100 |
|
Thorium-232 |
100 |
|
Thorium-234 |
10 |
|
Thorium-natural |
100 |
|
Protactinium-227 |
10 |
|
Protactinium-228 |
1 |
|
Protactinium-230 |
0.1 |
|
Protactinium-231 |
0.001 |
|
Protactinium-232 |
1 |
|
Protactinium-233 |
100 |
|
Protactinium-234 |
100 |
|
Uranium-230 |
0.01 |
|
Uranium-231 |
100 |
|
Uranium-232 |
0.001 |
|
Uranium-233 |
0.001 |
|
Uranium-234 |
0.001 |
|
Uranium-235 |
0.001 |
|
Uranium-236 |
0.001 |
|
Uranium-237 |
100 |
|
Uranium-238 |
100 |
|
Uranium-239 |
1,000 |
|
Uranium-240 |
100 |
|
Uranium-natural |
100 |
|
Neptunium-232 |
100 |
|
Neptunium-233 |
1,000 |
|
Neptunium-234 |
100 |
|
Neptunium-235 |
100 |
|
Neptunium-236 (1.15E+5 y) |
0.001 |
|
Neptunium-236 (22.5 h) |
1 |
|
Neptunium-237 |
0.001 |
|
Neptunium-238 |
10 |
|
Neptunium-239 |
100 |
|
Neptunium-240 |
1,000 |
|
Plutonium-234 |
10 |
|
Plutonium-235 |
1,000 |
|
Plutonium-236 |
0.001 |
|
Plutonium-237 |
100 |
|
Plutonium-238 |
0.001 |
|
Plutonium-239 |
0.001 |
|
Plutonium-240 |
0.001 |
|
Plutonium-241 |
0.01 |
|
Plutonium-242 |
0.001 |
|
Plutonium-243 |
1,000 |
|
Plutonium-244 |
0.001 |
|
Plutonium-245 |
100 |
|
Americium-237 |
1,000 |
|
Americium-238 |
100 |
|
Americium-239 |
1,000 |
|
Americium-240 |
100 |
|
Americium-241 |
0.001 |
|
Americium-242m |
0.001 |
|
Americium-242 |
10 |
|
Americium-243 |
0.001 |
|
Americium-244m |
100 |
|
Americium-244 |
10 |
|
Americium-245 |
1,000 |
|
Americium-246m |
1,000 |
|
Americium-246 |
1,000 |
|
Curium-238 |
100 |
|
Curium-240 |
0.1 |
|
Curium-241 |
1 |
|
Curium-242 |
0.01 |
|
Curium-243 |
0.001 |
|
Curium-244 |
0.001 |
|
Curium-245 |
0.001 |
|
Curium-246 |
0.001 |
|
Curium-247 |
0.001 |
|
Curium-248 |
0.001 |
|
Curium-249 |
1,000 |
|
Berkelium-245 |
100 |
|
Berkelium-246 |
100 |
|
Berkelium-247 |
0.001 |
|
Berkelium-249 |
0.1 |
|
Berkelium-250 |
10 |
|
Californium-244 |
100 |
|
Californium-246 |
1 |
|
Californium-248 |
0.01 |
|
Californium-249 |
0.001 |
|
Californium-250 |
0.001 |
|
Californium-251 |
0.001 |
|
Californium-252 |
0.001 |
|
Californium-253 |
0.1 |
|
Californium-254 |
0.001 |
|
Einsteinium-250 |
100 |
|
Einsteinium-251 |
100 |
|
Einsteinium-253 |
0.1 |
|
Einsteinium-254m |
1 |
|
Einsteinium-254 |
0.01 |
|
Fermium-252 |
1 |
|
Fermium-253 |
1 |
|
Fermium-254 |
10 |
|
Fermium-255 |
1 |
|
Fermium-257 |
0.01 |
|
Mendelevium-257 |
10 |
|
Mendelevium-258 |
0.01 |
|
Any alpha emitting radionuclide not listed above or mixtures of alpha emitters of unknown composition |
0.001 |
|
Any radionuclide other than alpha emitting radionuclides not listed above, or mixtures of beta emitters of unknown composition |
0.01 |
Note:
For purposes of RH-1310.a. and RH-1501.c. where there is involved a combination of radionuclides in known amounts, the limit for the combination shall be derived as follows: determine, for each radionuclide in the combination, the ratio between the quantity present in the combination and the limit otherwise established for the specific radionuclide when not in combination. The sum of such ratios for all radionuclides in the combination may not exceed "1" - that is, unity.
Footnotes for Appendix H to Section 3:
a/ The quantities listed above were derived by taking 1/10th of the most restrictive ALI listed in Table I, Columns 1 and 2, of Appendix G to Section 3, rounding to the nearest factor of 10, and constraining the values listed between 37 Bq and 37 MBq (0.001 and 1,000 µCi). Values of 3.7 MBq (100 µCi) have been assigned for radionuclides having a radioactive half-life in excess of E+9 years, except rhenium, 37 MBq (1,000 µCi), to take into account their low specific activity.
b/ To convert µCi to kBq, multiply the µCi value by 37.
NOTICE TO EMPLOYEES
Arkansas Department of Health STANDARDS FOR PROTECTION AGAINST RADIATION
The Arkansas Department of Health (ADH) has adopted regulations with standards to protect you from hazards associated with radioactive materials and radiation emitting machines which are licensed or registered by ADH. In particular, the following information is available for your review:
Section 3 : Standards for Protection Against Radiation
Part N : Notice, Instructions, and Reports to Workers; Inspections
Any other documents your employer must provide.
These may be found at the following location:
YOUR EMPLOYER'S RESPONSIBILITY
Your employer is required to:
YOUR RESPONSIBILITY AS A WORKER
You should:
REPORTS OF YOUR RADIATION EXPOSURE HISTORY
INSPECTIONS:All licensed or registered activities are subject to inspection by the ADH.
INQUIRIES Direct all inquiries on matters outlined above to: ADH, Radiation Control Section, 4815 West Markham Street, Slot 30, Little Rock, Arkansas, 72205-3867 or to (501)661-2301. For emergencies, call (800) 633-1735. POSTING REQUIREMENT: In accordance with RH-2802, copies of this notice must be posted in every establishment where employees are engaged in activities licensed or registered by the ADH. Posting must permit employees working in or frequenting any portion of a restricted area to observe a copy on the way to or from their place of employment.
APPENDIX K TO SECTION 3
Deleted.
APPENDIX L TO SECTION 3
Deleted.
FOOTNOTES TO SECTION 3
1/ An organ or tissue is deemed to be significantly irradiated if, for that organ or
tissue, the product of the weighting factors, WT, and the committed dose equivalent, HT,50, per unit intake is greater than ten percent (10%) of the maximum weighted value of HT,50 (i.e., WTHT,50) per unit intake for any organ or tissue. HT,50 was H50.
2/ This section applies to radiation from byproduct, source, or special nuclear materials that are used in sealed sources in non-self-shielded irradiators. This section does not apply to radioactive sources that are used in teletherapy, in industrial radiography, or in completely self-shielded irradiators in which the source is both stored and operated within the same shielding radiation barrier and, in the designed configuration of the irradiator cannot create high levels of radiation in an area that is accessible to any individual. This section also does not apply to sources from which the radiation is incidental to some other use or to nuclear reactor-generated radiation.
3/ Deleted.
4/ Labeled with a Radioactive White I, Yellow II, or Yellow III label as specified in U. S. Department of Transportation regulations, 49 CFR 172.403 and 172.436-440.
5/ Labeling of packages containing radioactive materials is required by the Department of Transportation (DOT) if the amount and type of radioactive material exceeds the limits for an excepted quantity or article as defined and limited by DOT regulations 49 CFR 173.403 and 173.421-426.
6/ Licensees are not required to partition historical dose between external dose equivalent(s) and internal committed dose equivalent(s). Further, occupational exposure histories obtained and recorded on RC FORM 111 (formerly known as Department Form Z or Department Form RH-1), or equivalent, before January 1, 1994, might not have included effective dose equivalent, but may be used in the absence of specific information on the intake of radionuclides by the individual.
7/ Assessments of dose equivalent and records made using units in effect before the licensee's adoption of this Section need not be changed.
8/ A previous RH-1403. permitted certain burials of small quantities of licensed materials in soil before January 1, 1983, without specific Department authorization. As of January 1, 1983, these burials had to receive specific approval by the Department, in accordance with the revised RH-1403. Disposal by burial in soil came to be regulated under RH-1401.
9/ With respect to the limit for the embryo/fetus (RH-1207), the identifiers should be those of the declared pregnant woman.
10/ Deleted.
11/ The nominal chemical composition of type 1100 aluminum alloy is 99.00 percent (99%) minimum aluminum, 0.12 percent copper.
12/ Deleted.
13/ Deleted.
14/ An example of a suggested plaque is shown at the end of this Part.
15/ Appropriate warnings may include:
SECTION 4. TRANSPORTATION OF RADIOACTIVE MATERIALS
Exemptions from Section 4 requirements are specified in Part C of
this Section. General licenses for which no NRC package approval is required are issued in RH-3304. through RH-3306. The general license in RH-3301. requires that an NRC Certificate of Compliance or other package approval be issued for the package to be used under this general license.
material to a carrier for transport, shall comply with the operating control requirements of Part F; the quality assurance requirements of Part G; and the general provisions of Part A, including referenced U.S. Department of Transportation regulations.
Except as authorized in a general license or a specific license issued by the Department, or as exempted in this Section, no licensee may:
specified in the Department license, or where transport is on public highways, or who delivers licensed material to a carrier for transport, shall comply with the applicable requirements of the DOT regulations in 49 CFR parts 107, 171 through 180, and 390 through 397, appropriate to the mode of transport.
§§ 172.500 through 172.519 and 172.556; and appendices B and C.
the licensee shall conform to the standards and requirements of the DOT specified in RH-3005.a. of this section to the same extent as if the shipment or transportation were subject to DOT regulations. A request for modification, waiver, or exemption from those requirements, and any notification referred to in those requirements, must be filed with, or made to, the Arkansas Department of Health, Radiation Control Section, 4815 West Markham Street, Slot 30, Little Rock, Arkansas, 72205-3867.
Except as specifically authorized by the Department in writing, no interpretations of the meaning of the regulations in this Section by an officer or employee of the Department other than a written interpretation by the Department Director or designee will be recognized as binding upon the Department.
The following terms are as defined for the purpose of this Section. To ensure compatibility with international transportation standards, all limits in this Section are given in terms of dual units: The International System of Units (SI) followed or preceded by U.S. standard or customary units. The U.S. customary units are not exact equivalents, but rounded to a convenient value, providing a functionally equivalent unit. For the purpose of this Section, either unit may be used.
A1 - Maximum activity of special form of radioactive material permitted in a Type A package. These values are either listed in Table A-1 of Appendix A to this Section or may be derived in accordance with the procedure prescribed in Appendix A.
A2 - Maximum activity of radioactive material, other than special form, LSA and SCO material, permitted in a Type A package. These values are either listed in Table A-1 of Appendix A to this Section or may be derived in accordance with the procedure prescribed in Appendix A.
Act - Act 8 of Second Extraordinary Session of 1961, as amended.
Carrier - A person engaged in the transportation of passengers or property by land or water as a common, contract, or private carrier, or by civil aircraft.
Certificate Holder - a person who has been issued a Certificate of Compliance or other package approval by the U.S. Nuclear Regulatory Commission.
Certificate of Compliance (CoC) - the certificate issued by the U.S. Nuclear Regulatory Commission which approves the design of a package for the transportation of radioactive material.
CFR - Code of Federal Regulations.
Close reflection by water - immediate contact by water of sufficient thickness for maximum reflection of neutrons.
Consignment - Each shipment of a package or groups of packages or load of radioactive material offered by a shipper for transport.
Containment system - the assembly of components of the packaging intended to retain the radioactive material during transport.
Contamination - The presence of a radioactive substance on a surface in quantities in excess of 0.4 Bq/cm2 (1 x 10-5 µ Ci/cm2) for beta and gamma emitters and low toxicity alpha emitters, or 0.04 Bq/cm2 (1 x 10-6 µ Ci/cm2) for all other alpha emitters.
Conveyance -
Criticality Safety Index (CSI) - The dimensionless number (rounded up to the next tenth) assigned to and placed on the label of a fissile material package, to designate the degree of control of accumulation of packages, overpacks, or freight containers containing fissile material during transportation. Determination of the criticality safety index is described in RH-3305., RH-3306., and in 10 CFR 71.59. The criticality safety index for an overpack, freight container, consignment, or conveyance containing fissile material packages is the arithmetic sum of the criticality safety indices of all the fissile material packages contained within the overpack, freight container, consignment, or conveyance.
Deuterium - For the purposes of RH-3203. and RH-3305., deuterium and any deuterium compounds, including heavy water, in which the ratio of deuterium atoms to hydrogen atoms exceeds 1:5000.
DOT - The U.S. Department of Transportation.
Exclusive use (also referred to in other regulations as "sole") - The sole use of a conveyance by a single consignor of a conveyance for which all initial, intermediate, and final loading and unloading are carried out in accordance with the direction of the consignor or consignee. The consignor and the carrier must ensure that any loading or unloading is performed by personnel having radiological training and resources appropriate for safe handling of the consignment. The consignor must issue specific instructions, in writing, for maintenance of exclusive use shipment controls, and include them with the shipping paper information provided by the consignor.
Fissile material - The radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium, that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in RH-3203.
Graphite - For the purposes of RH-3203 and RH-3305, graphite with a boron equivalent content less than five (5) parts per million and density greater than 1.5 grams per cubic centimeter.
Indian Tribe - An Indian or Alaska native Tribe, band, nation, pueblo, village, or community that the Secretary of the Interior acknowledges to exist as an Indian Tribe pursuant to the Federally Recognized Indian Tribe List Act of 1994, 25 U.S.C. 479a.
Licensed material - Radioactive material received, possessed, used, or transferred under a general or specific license issued by the Department pursuant to the regulations in this Section.
Low Specific Activity (LSA) - Radioactive material with limited specific activity which is nonfissile or is excepted under RH-3203. and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. The LSA material must be in one of three groups:
Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 CFR 71.77, in which:
collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);
shielding material, does not exceed 2 x 10-3A2/g.
Low toxicity alpha emitters - natural uranium, depleted uranium, natural thorium; uranium-235, uranium-238, thorium-232, thorium-228, or thorium-230 when contained in ores or physical or chemical concentrates or tailings; or alpha emitters with a half-life of less than ten (10) days.
Maximum normal operating pressure - the maximum gauge pressure that would develop in the containment system in a period of one (1) year under the heat condition specified in 10 CFR 71.71(c)(1) in the absence of venting, external cooling by an ancillary system, or operational controls during transport.
Natural thorium - Thorium with the naturally occurring distribution of thorium isotopes (essentially 100 weight percent thorium-232).
Normal form radioactive material - Radioactive material that has not been demonstrated to qualify as "special form radioactive material."
Optimum interspersed hydrogenous moderation - The presence of hydrogenous material between packages to such an extent that the maximum nuclear reactivity results.
Package - Packaging together with its radioactive contents as presented for transport.
There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see DOT regulations in 49 CFR Part 173 . A
Type B package approved prior to September 6, 1983, was designated only as Type B. Limitations on its use are specified in 10 CFR 71.19.
Packaging - Assembly of components necessary to ensure compliance with the packaging requirements of this Section. It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system, and auxiliary equipment may be designated as part of the packaging.
Special form radioactive material - Radioactive material that satisfies the following conditions:
Specific activity of a radionuclide - The radioactivity of the radionuclide per unit mass of that nuclide. The specific activity of a material in which the radionuclide is essentially uniformly distributed is the radioactivity per unit mass of the material.
Spent nuclear fuel or Spent fuel - Fuel that has been withdrawn from a nuclear reactor following irradiation, has undergone at least one (1) year's decay since being used as a source of energy in a power reactor, and has not been chemically separated into its constituent elements by reprocessing. Spent fuel includes the special nuclear material, byproduct material, source material, and other radioactive materials associated with fuel assemblies.
State - A State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.
Surface Contaminated Object (SCO) - A solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two (2) groups with surface activity not exceeding the following limits:
Transport index - The dimensionless number (rounded up to the next tenth) placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. (The transport index is the number determined by multiplying the maximum radiation level in millisievert (mSv) per hour at one (1) meter (3.3 ft) from the external surface of the package by 100 (equivalent to the maximum radiation level in millirem per hour at one (1) meter (3.3 ft)).
Tribal official - The highest ranking individual that represents Tribal leadership, such as the Chief, President, or Tribal Council leadership.
Type A quantity - A quantity of radioactive material, the aggregate radioactivity of which does not exceed A1 for special form radioactive material or A2 for normal form radioactive material, where A1 and A2 are given in Table A-1 of Appendix A to this Section or may be determined by procedures described in Appendix A to this Section.
Type B quantity - A quantity of radioactive material greater than a Type A quantity.
Unirradiated uranium - Uranium containing not more than 2 x 103 Bq of plutonium per gram of uranium-235, not more than 9 x 106 Bq of fission products per gram of uranium-235, and not more than 5 x 10-3 g of uranium-236 per gram of uranium-235.
Uranium - natural, depleted, enriched.
The Department may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this Section as it determines are authorized by law and will not result in undue hazard to public health and safety or property, and are otherwise in the public interest.
Any physician, as defined in RH-200., licensed by the State of Arkansas to dispense drugs in the practice of medicine is exempt from RH-3005 with respect to transport by the physician of licensed material for use in the practice of medicine. However, any physician operating under this exemption must be licensed by the Department under Section 9 of these Regulations, U.S. Nuclear Regulatory Commission's 10 CFR Part 35 regulations or the equivalent Agreement State regulations.
A licensee is exempt from all the requirements of this Section with respect to shipment or carriage of the following low-level materials:
Fissile material meeting the requirements of at least one of the paragraphs a. through f. of this section are exempt from classification as fissile material and from the fissile material package standards of 10 CFR 71.55 and 71.59, but are subject to all other requirements of this Section, except as noted.
Low concentrations of solid fissile material commingled
with solid nonfissile material, provided that:
deuterium may be present in the package but must not be included in determining the required mass of solid nonfissile material.
The value for the CSI must be greater than or equal to the number calculated by the following equation:
Table 71-1. - Mass Limits for General License Packages Containing Mixed Quantities of Fissile Material or Uranium-235 of Unknown Enrichment per RH-3305.e.
|
Fissile material |
Fissile material mass mixed with moderating substances having an average hydrogen density less than or equal to H2O (grams) |
Fissile material mass mixed with moderating substances having an average hydrogen density greater than H2Oa (grams) |
|
235U (X) |
60 |
38 |
|
233U (Y) |
43 |
27 |
|
239Pu or 241Pu (Z) |
37 |
24 |
a When mixtures of moderating substances are present, the lower mass limits shall be used if more than fifteen percent (15%) of the moderating substance has an average hydrogen density greater than H2O.
Table 71-2. - Mass Limits for General License Packages Containing Uranium-235 of Known Enrichment per RH-3305.e.
|
Uranium enrichment in weight percent of 235U not exceeding |
Fissile material mass of 235U (X) (grams) |
|
24 |
60 |
|
20 |
63 |
|
15 |
67 |
|
11 |
72 |
|
10 |
76 |
|
9.5 |
78 |
|
9 |
81 |
|
8.5 |
82 |
|
8 |
85 |
|
7.5 |
88 |
|
7 |
90 |
|
6.5 |
93 |
|
6 |
97 |
|
5.5 |
102 |
|
5 |
108 |
|
4.5 |
114 |
|
4 |
120 |
|
3.5 |
132 |
|
3 |
150 |
|
2.5 |
180 |
|
2 |
246 |
|
1.5 |
408 |
|
1.35 |
480 |
|
1 |
1,020 |
|
0.92 |
1,800 |
The value for the CSI must be greater than or equal to the number calculated by the following equation:
that this provision does not apply to private carriers, if exposed personnel under their control wear radiation dosimetry devices in conformance with RH-1302.
A licensee subject to this Section, who, under a general or specific license, transports licensed material or delivers licensed material to a carrier for transport, shall comply with the requirements of this Part F, with the quality assurance requirements of Part G of this Section, and with the general provisions of Part A of this Section.
When the isotopic abundance, mass, concentration, degree of irradiation, degree of moderation, or other pertinent property of fissile material in any package is not known, the licensee shall package the fissile material as if the unknown properties have credible values that will cause the maximum neutron multiplication.
Before the first use of any packaging for the shipment of licensed material, the licensee shall ascertain that the determinations in paragraphs (a) through (c) of 10 CFR 71.85 have been made.
Prior to each shipment of licensed material, the licensee shall ensure that the package with its contents satisfies the applicable requirements of this Section and the license. The licensee shall determine that:
package during transport is rendered inoperable for that purpose unless it satisfies design requirements of 10 CFR 71.45.
external surfaces of each package offered for shipment is as low as reasonably achievable, and within the limits specified in DOT regulations in 49 CFR 173.443;
applicable, will not exceed the limits specified in RH-3400 at any time during transportation; and
specified in 10 CFR 71.43(g) at any time during transportation.
notwithstanding any exemptions stated directly in this Section or included indirectly by citation of the U.S. Department of Transportation regulations (49 CFR Chapter 1), as may be applicable, the licensee shall assure that plutonium in any form, whether for import, export, or domestic shipment, is not transported by air, or delivered to a carrier for air transport, unless:
Before delivery of a package to a carrier for transport, the licensee shall ensure that any special instructions needed to safely open the package have been sent to, or otherwise made available to, the consignee for the consignee's use in accordance with RH-1307.f.
a record of each shipment of licensed material not exempt under 10 CFR 71.14, showing where applicable:
The written report must include the following:
including all component or system failures that contributed to the event and significant corrective action taken or planned to prevent recurrence.
identification) of each component that failed during the event; and
quantities and chemical and physical form(s) of the package contents.
The reports submitted by licensees under this section must be of sufficient quality to permit reproduction and micrographic processing.
As specified in paragraphs b., c., and d. of this section, each
licensee shall provide advance notification to the governor of a State, or the governor's designee, of the shipment of licensed material, within or across the boundary of the State, before the transport, or delivery to a carrier, for transport, of licensed material outside the confines of the licensee's plant or other place of use or storage.
11, 2013, each licensee shall provide advance notification to the Tribal official of participating Tribes referenced in paragraph c.3.C of this section, or the official's designee, of the shipment of licensed material, within or across the boundary of the Tribe's reservation, before the transport, or delivery to a carrier, for transport, of licensed material outside the confines of the licensee's plant or other place of use or storage.
Each advance notification of shipment of irradiated reactor fuel or nuclear waste must contain the following information:
A licensee who finds that schedule information previously furnished to a governor or governor's designee or a Tribal official or Tribal official's designee, in accordance with this section, will not be met, shall telephone a responsible individual in the office of the governor of the State or of the governor's designee or the Tribal official or the Tribal official's designee and inform that individual of the extent of the delay beyond the schedule originally reported. The licensee shall maintain a record of the name of the individual contacted for three (3) years.
This Part, in conjunction with Subpart H of 10 CFR Part 71, describes quality assurance requirements applying to design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, and modification of components of packaging that are important to safety. As used in this Part and Subpart H of 10 CFR Part 71, "quality assurance" comprises all those planned and systematic actions necessary to provide adequate confidence that a system or component will perform satisfactorily in service. Quality assurance includes quality control, which comprises those quality assurance actions related to control of the physical characteristics and quality of the material or component to predetermined requirements. Each certificate holder and applicant for a package approval is responsible for satisfying the quality assurance requirements in Subpart H of 10 CFR Part 71 that apply to design, fabrication, testing, and modification of packaging. Each Department licensee is responsible for satisfying the quality assurance requirements that apply to its use of a packaging for the shipment of licensed material subject to this Part.
Each licensee shall establish, maintain, and execute a quality assurance program satisfying each of the applicable criteria of this Part and satisfying any specific provisions that are applicable to the licensee's activities including procurement of packaging. The licensee shall execute the applicable criteria in a graded approach to an extent that is commensurate with the quality assurance requirement's importance to safety.
Before the use of any package for the shipment of licensed material subject to this Part, each licensee shall obtain Department approval of its quality assurance program. Each licensee shall submit to the Department a description of its quality assurance program, including a discussion of which requirements of this Part are applicable and how they will be satisfied.
A program for transport container inspection and maintenance limited to radiographic exposure devices, source changers, or packages transporting these devices and meeting the requirements of RH-1801.i.2. or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirement, is deemed to satisfy the requirements of RH-3301.b. and RH-3600.b.
Department a description of a proposed change to its Department-approved quality assurance program that will reduce commitments in the program description as approved by the Department. The quality assurance program approval holder shall not implement the change before receiving Department approval.
The licensee shall establish measures to control, in accordance with instructions, the handling, storage, shipping, cleaning, and preservation of materials and equipment to be used in packaging to prevent damage or deterioration. When necessary for particular products, special protective environments, such as inert gas atmosphere, and specific moisture content and temperature levels must be specified and provided.
The licensee shall establish measures to control materials, parts, or components that do not conform to the licensee's requirements to prevent their inadvertent use or installation. These measures must include, as appropriate, procedures for identification, documentation, segregation, disposition, and notification to affected organizations. Nonconforming items must be reviewed and accepted, rejected, repaired, or reworked in accordance with documented procedures.
The licensee shall establish measures to assure that conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformances, are promptly identified and corrected. In the case of a significant condition adverse to quality, the measures must assure that the cause of the condition is determined and corrective action taken to preclude repetition. The identification of the significant condition adverse to quality, the cause of the condition, and the corrective action taken must be documented and reported to appropriate levels of management.
The licensee shall maintain sufficient written records to describe the activities affecting quality. These records must include changes to the quality assurance program as required by RH-3602.e.; the instructions, procedures, and drawings required by 10 CFR 71.111 to prescribe quality assurance activities; and closely related specifications such as required qualifications of personnel, procedures, and equipment. The records must include the instructions or procedures that establish a records retention program that is consistent with applicable regulations and designates factors such as duration, location, and assigned responsibility. The licensee shall retain these records for three (3) years beyond the date when the licensee last engages in the activity for which the quality assurance program was developed. If any portion of the quality assurance program, written procedures, or instructions is superseded, the licensee shall retain the superseded material for three (3) years after it is superseded.
The licensee shall carry out a comprehensive system of planned and periodic audits to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program. The audits must be performed in accordance with written procedures or checklists by appropriately trained personnel not having direct responsibilities in the areas being audited. Audited results must be documented and reviewed by management having responsibility in the area audited. Follow-up action, including re-audit of deficient areas, must be taken where indicated.
Sources of radiation shall be subject to impounding pursuant to Section 5 of these Regulations.
APPENDIX A TO SECTION 4 DETERMINATION OF A1 AND A2
For individual radionuclides whose identities are known, but which are not listed in Table
A-1, the A1 and A2 values contained in Table A-3 may be used. Otherwise, the licensee shall obtain prior Department approval of the A1 and A2 values for radionuclides not listed in Table A-1, before shipping the material.
where B(i) is the activity of radionuclide i in special form, and A1(i) is the A1 value for radionuclide i.
where B(i) is the activity of radionuclide i in normal form, and A2(i) is the A2 value for radionuclide i.
where B(i) is the activity of radionuclide i as special form radioactive material, A1(i) is the A1 value for radionuclide i, C(j) is the activity of radionuclide j as normal form radioactive material, and A2(j) is the A2 value for radionuclide j.
where f(i) is the fraction of activity for radionuclide i in the mixture, and A1(i) is the appropriate A1 value for radionuclide i.
where f(i) is the fraction of activity for radionuclide i in the mixture, and A2(i) is the appropriate A2 value for radionuclide i.
where f(i) is the fraction of activity concentration of radionuclide i in the mixture, and [A](i) is the activity concentration for exempt material containing radionuclide i.
where f(i) is the fraction of activity of radionuclide i in the mixture, and A(i) is the activity limit for exempt consignments for radionuclide i.
When the identity of each radionuclide is known, but the individual activities of some of the radionuclides are not known, the radionuclides may be grouped and the lowest A1 or A2 value, as appropriate, for the radionuclides in each group may be used in applying the formulas in paragraph IV. of this Appendix. Groups may be based on the total alpha activity and the total beta/gamma activity when these are known, using the lowest A1 or A2 values for the alpha emitters and beta/gamma emitters, respectively.
TABLE A-1-A1 AND A2 VALUES FOR RADIONUCLIDES
|
Symbol of |
Element and atomic number |
A1 (TBq) |
A1(Ci)b |
A2 (TBq) |
A2(Ci)b |
Specific activity |
|
|
radionuclide |
(TBq/g) |
(Ci/g) |
|||||
|
Ac-225 (a) |
Actinium (89) |
8.0X10-1 |
2.2X101 |
6.0X10-3 |
1.6X10-1 |
2.1X103 |
5.8X104 |
|
Ac-227 (a) |
9.0X10-1 |
2.4X101 |
9.0X10-5 |
2.4X10-3 |
2.7 |
7.2X101 |
|
|
Ac-228 |
6.0X10-1 |
1.6X101 |
5.0X10-1 |
1.4X101 |
8.4X104 |
2.2X106 |
|
|
Ag-105 |
Silver (47) |
2.0 |
5.4X101 |
2.0 |
5.4X101 |
1.1X103 |
3.0X104 |
|
Ag-108m (a) |
7.0X10-1 |
1.9X101 |
7.0X10-1 |
1.9X101 |
9.7X10-1 |
2.6X101 |
|
|
Ag-110m (a) |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
1.8X102 |
4.7X103 |
|
|
Ag-111 |
2.0 |
5.4X101 |
6.0X10-1 |
1.6X101 |
5.8X103 |
1.6X105 |
|
|
Al-26 |
Aluminum (13) |
1.0X10-1 |
2.7 |
1.0X10-1 |
2.7 |
7.0X10-4 |
1.9X10-2 |
|
Am-241 |
Americium (95) |
1.0X101 |
2.7X102 |
1.0X10-3 |
2.7X10-2 |
1.3X10-1 |
3.4 |
|
Am-242m (a) |
1.0X101 |
2.7X102 |
1.0X10-3 |
2.7X10-2 |
3.6X10-1 |
1.0X101 |
|
|
Am-243 (a) |
5.0 |
1.4X102 |
1.0X10-3 |
2.7X10-2 |
7.4X10-3 |
2.0X10-1 |
|
|
Ar-37 |
Argon (18) |
4.0X101 |
1.1X103 |
4.0X101 |
1.1X103 |
3.7X103 |
9.9X104 |
|
Ar-39 |
4.0X101 |
1.1X103 |
2.0X101 |
5.4X102 |
1.3 |
3.4X101 |
|
|
Ar-41 |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
1.5X106 |
4.2X107 |
|
|
As-72 |
Arsenic (33) |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
6.2X104 |
1.7X106 |
|
As-73 |
4.0X101 |
1.1X103 |
4.0X101 |
1.1X103 |
8.2X102 |
2.2X104 |
|
|
As-74 |
1.0 |
2.7X101 |
9.0X10-1 |
2.4X101 |
3.7X103 |
9.9X104 |
|
|
As-76 |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
5.8X104 |
1.6X106 |
|
|
As-77 |
2.0X101 |
5.4X102 |
7.0X10-1 |
1.9X101 |
3.9X104 |
1.0X106 |
|
|
At-211 (a) |
Astatine (85) |
2.0X101 |
5.4X102 |
5.0X10-1 |
1.4X101 |
7.6X104 |
2.1X106 |
|
Au-193 |
Gold (79) |
7.0 |
1.9X102 |
2.0 |
5.4X101 |
3.4X104 |
9.2X105 |
|
Au-194 |
1.0 |
2.7X101 |
1.0 |
2.7X101 |
1.5X104 |
4.1X105 |
|
|
Au-195 |
1.0X101 |
2.7X102 |
6.0 |
1.6X102 |
1.4X102 |
3.7X103 |
|
|
Au-198 |
1.0 |
2.7X101 |
6.0X10-1 |
1.6X101 |
9.0X103 |
2.4X105 |
|
|
Au-199 |
1.0X101 |
2.7X102 |
6.0X10-1 |
1.6X101 |
7.7X103 |
2.1X105 |
|
|
Ba-131 (a) |
Barium (56) |
2.0 |
5.4X101 |
2.0 |
5.4X101 |
3.1X103 |
8.4X104 |
|
Ba-133 |
3.0 |
8.1X101 |
3.0 |
8.1X101 |
9.4 |
2.6X102 |
|
|
Ba-133m |
2.0X101 |
5.4X102 |
6.0X10-1 |
1.6X101 |
2.2X104 |
6.1X105 |
|
|
Ba-140 (a) |
5.0X10-1 |
1.4X101 |
3.0X10-1 |
8.1 |
2.7X103 |
7.3X104 |
|
|
Be-7 |
Beryllium (4) |
2.0X101 |
5.4X102 |
2.0X101 |
5.4X102 |
1.3X104 |
3.5X105 |
|
Be-10 |
4.0X101 |
1.1X103 |
6.0X10-1 |
1.6X101 |
8.3X10-4 |
2.2X10-2 |
|
|
Bi-205 |
Bismuth (83) |
7.0X10-1 |
1.9X101 |
7.0X10-1 |
1.9X101 |
1.5X103 |
4.2X104 |
|
Bi-206 |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
3.8X103 |
1.0X105 |
|
|
Bi-207 |
7.0X10-1 |
1.9X101 |
7.0X10-1 |
1.9X101 |
1.9 |
5.2X101 |
|
|
Bi-210 |
1.0 |
2.7X101 |
6.0X10-1 |
1.6X101 |
4.6X103 |
1.2X105 |
|
|
Bi-210m (a) |
6.0X10-1 1.6X101 |
2.0X10-2 5.4X10-1 |
2.1X10-5 5.7X10-4 |
||||
|
Bi-212 (a) |
7.0X10-1 |
1.9X101 |
6.0X10-1 |
1.6X101 |
5.4X105 |
1.5X107 |
|
|
Bk-247 |
Berkelium (97) |
8.0 |
2.2X102 |
8.0X10-4 |
2.2X10-2 |
3.8X10-2 |
1.0 |
|
Bk-249 (a) |
4.0X101 |
1.1X103 |
3.0X10-1 |
8.1 |
6.1X101 |
1.6X103 |
|
|
Br-76 |
Bromine (35) |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
9.4X104 |
2.5X106 |
|
Br-77 |
3.0 |
8.1X101 |
3.0 |
8.1X101 |
2.6X104 |
7.1X105 |
|
|
Br-82 |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
4.0X104 |
1.1X106 |
|
|
C-11 |
Carbon (6) |
1.0 |
2.7X101 |
6.0X10-1 |
1.6X101 |
3.1X107 |
8.4X108 |
|
C-14 |
4.0X101 |
1.1X103 |
3.0 |
8.1X101 |
1.6X10-1 |
4.5 |
|
|
Ca-41 |
Calcium (20) |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
3.1X10-3 |
8.5X10-2 |
|
Ca-45 |
4.0X101 1.1X103 |
1.0 |
2.7X101 |
6.6X102 1.8X104 |
|||
|
Ca-47 (a) |
3.0 |
8.1X101 |
3.0X10-1 |
8.1 |
2.3X104 |
6.1X105 |
|
|
Cd-109 |
Cadmium (48) |
3.0X101 |
8.1X102 |
2.0 |
5.4X101 |
9.6X101 |
2.6X103 |
|
Cd-113m |
4.0X101 |
1.1X103 |
5.0X10-1 |
1.4X101 |
8.3 |
2.2X102 |
|
|
Cd-115 (a) |
3.0 |
8.1X101 |
4.0X10-1 |
1.1X101 |
1.9X104 |
5.1X105 |
|
|
Cd-115m |
5.0X10-1 |
1.4X101 |
5.0X10-1 |
1.4X101 |
9.4X102 |
2.5X104 |
|
|
Ce-139 |
Cerium (58) |
7.0 |
1.9X102 |
2.0 |
5.4X101 |
2.5X102 |
6.8X103 |
|
Ce-141 |
2.0X101 |
5.4X102 |
6.0X10-1 |
1.6X101 |
1.1X103 |
2.8X104 |
|
|
Ce-143 |
9.0X10-1 |
2.4X101 |
6.0X10-1 |
1.6X101 |
2.5X104 |
6.6X105 |
|
|
Ce-144 (a) |
2.0X10-1 |
5.4 |
2.0X10-1 |
5.4 |
1.2X102 |
3.2X103 |
|
|
Cf-248 |
Californium (98) 4.0X101 1.1X103 |
6.0X10-3 1.6X10-1 |
5.8X101 1.6X103 |
||||
|
Cf-249 |
3.0 |
8.1X101 |
8.0X10-4 |
2.2X10-2 |
1.5X10-1 |
4.1 |
|
|
Cf-250 |
2.0X101 |
5.4X102 |
2.0X10-3 |
5.4X10-2 |
4.0 |
1.1X102 |
|
|
Cf-251 |
7.0 |
1.9X102 |
7.0X10-4 |
1.9X10-2 |
5.9X10-2 |
1.6 |
|
|
Cf-252 |
1.0X10-1 |
2.7 |
3.0X10-3 |
8.1X10-2 |
2.0X101 |
5.4X102 |
|
|
Cf-253 (a) |
4.0X101 |
1.1X103 |
4.0X10-2 |
1.1 |
1.1X103 |
2.9X104 |
|
|
Cf-254 |
1.0X10-3 |
2.7X10-2 |
1.0X10-3 |
2.7X10-2 |
3.1X102 |
8.5X103 |
|
|
Cl-36 |
Chlorine (17) |
1.0X101 |
2.7X102 |
6.0X10-1 |
1.6X101 |
1.2X10-3 |
3.3X10-2 |
|
Cl-38 |
2.0X10-1 |
5.4 |
2.0X10-1 |
5.4 |
4.9X106 |
1.3X108 |
|
|
Cm-240 |
Curium (96) |
4.0X101 |
1.1X103 |
2.0X10-2 |
5.4X10-1 |
7.5X102 |
2.0X104 |
|
Cm-241 |
2.0 |
5.4X101 |
1.0 |
2.7X101 |
6.1X102 |
1.7X104 |
|
|
Cm-242 |
4.0X101 |
1.1X103 |
1.0X10-2 |
2.7X10-1 |
1.2X102 |
3.3X103 |
|
|
Cm-243 |
9.0 |
2.4X102 |
1.0X10-3 |
2.7X10-2 |
1.9X10-3 5.2X101 |
||
|
Cm-244 |
2.0X101 |
5.4X102 |
2.0X10-3 |
5.4X10-2 |
3.0 |
8.1X101 |
|
|
Cm-245 |
9.0 |
2.4X102 |
9.0X10-4 |
2.4X10-2 |
6.4X10-3 |
1.7X10-1 |
|
|
Cm-246 |
9.0 |
2.4X102 |
9.0X10-4 |
2.4X10-2 |
1.1X10-2 |
3.1X10-1 |
|
|
Cm-247 (a) |
3.0 |
8.1X101 |
1.0X10-3 |
2.7X10-2 |
3.4X10-6 |
9.3X10-5 |
|
|
Cm-248 |
2.0X10-2 |
5.4X10-1 |
3.0X10-4 |
8.1X10-3 |
1.6X10-4 |
4.2X10-3 |
|
|
Co-55 |
Cobalt (27) |
5.0X10-1 |
1.4X101 |
5.0X10-1 |
1.4X101 |
1.1X105 |
3.1X106 |
|
Co-56 |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
1.1X103 |
3.0X104 |
|
|
Co-57 |
1.0X101 |
2.7X102 |
1.0X101 |
2.7X102 |
3.1X102 |
8.4X103 |
|
|
Co-58 |
1.0 |
2.7X101 |
1.0 |
2.7X101 |
1.2X103 |
3.2X104 |
|
|
Co-58m |
4.0X101 |
1.1X103 |
4.0X101 |
1.1X103 |
2.2X105 5.9X106 |
||
|
Co-60 |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
4.2X101 |
1.1X103 |
|
|
Cr-51 |
Chromium (24) |
3.0X101 |
8.1X102 |
3.0X101 |
8.1X102 |
3.4X103 |
9.2X104 |
|
Cs-129 |
Cesium (55) |
4.0 |
1.1X102 |
4.0 |
1.1X102 |
2.8X104 |
7.6X105 |
|
Cs-131 |
3.0X101 |
8.1X102 |
3.0X101 |
8.1X102 |
3.8X103 |
1.0X105 |
|
|
Cs-132 |
1.0 |
2.7X101 |
1.0 |
2.7X101 |
5.7X103 |
1.5X105 |
|
|
Cs-134 |
7.0X10-1 |
1.9X101 |
7.0X10-1 |
1.9X101 |
4.8X101 |
1.3X103 |
|
|
Cs-134m |
4.0X101 |
1.1X103 |
6.0X10-1 |
1.6X101 |
3.0X105 |
8.0X106 |
|
|
Cs-135 |
4.0X101 |
1.1X103 |
1.0 |
2.7X101 |
4.3X10-5 |
1.2X10-3 |
|
|
Cs-136 |
5.0X10-1 |
1.4X101 |
5.0X10-1 |
1.4X101 |
2.7X103 |
7.3X104 |
|
|
Cs-137 (a) |
2.0 |
5.4X101 |
6.0X10-1 |
1.6X101 |
3.2 |
8.7X101 |
|
|
Cu-64 |
Copper (29) |
6.0 |
1.6X102 |
1.0 |
2.7X101 |
1.4X105 |
3.9X106 |
|
Cu-67 |
1.0X101 |
2.7X102 |
7.0X10-1 |
1.9X101 |
2.8X104 |
7.6X105 |
|
|
Dy-159 |
Dysprosium (66) |
2.0X101 |
5.4X102 |
2.0X101 |
5.4X102 |
2.1X102 |
5.7X103 |
|
Dy-165 |
9.0X10-1 |
2.4X101 |
6.0X10-1 |
1.6X101 |
3.0X105 |
8.2X106 |
|
|
Dy-166 (a) |
9.0X10-1 |
2.4X101 |
3.0X10-1 |
8.1 |
8.6X103 |
2.3X105 |
|
|
Er-169 |
Erbium (68) |
4.0X101 |
1.1X103 |
1.0 |
2.7X101 |
3.1X103 |
8.3X104 |
|
Er-171 |
8.0X10-1 |
2.2X101 |
5.0X10-1 |
1.4X101 |
9.0X104 |
2.4X106 |
|
|
Eu-147 |
Europium (63) |
2.0 |
5.4X101 |
2.0 |
5.4X101 |
1.4X103 |
3.7X104 |
|
Eu-148 |
5.0X10-1 |
1.4X101 |
5.0X10-1 |
1.4X101 |
6.0X102 |
1.6X104 |
|
|
Eu-149 |
2.0X101 |
5.4X102 |
2.0X101 |
5.4X102 |
3.5X102 |
9.4X103 |
|
|
Eu-150 (short lived) |
2.0 |
5.4X101 |
7.0X10-1 |
1.9X101 |
6.1X104 |
1.6X106 |
|
|
Eu-150 (long lived) |
7.0X10-1 |
1.9X101 |
7.0X10-1 |
1.9X101 |
6.1X104 1.6X106 |
||
|
Eu-152 |
1.0 |
2.7X101 |
1.0 |
2.7X101 |
6.5 |
1.8X102 |
|
|
Eu-152m |
8.0X10-1 |
2.2X101 |
8.0X10-1 |
2.2X101 |
8.2X104 |
2.2X106 |
|
|
Eu-154 |
9.0X10-1 |
2.4X101 |
6.0X10-1 |
1.6X101 |
9.8 |
2.6X102 |
|
|
Eu-155 |
2.0X101 |
5.4X102 |
3.0 |
8.1X101 |
1.8X101 |
4.9X102 |
|
|
Eu-156 |
7.0X10-1 |
1.9X101 |
7.0X10-1 |
1.9X101 |
2.0X103 |
5.5X104 |
|
|
F-18 |
Fluorine (9) |
1.0 |
2.7X101 |
6.0X10-1 |
1.6X101 |
3.5X106 |
9.5X107 |
|
Fe-52 (a) |
Iron (26) |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
2.7X105 |
7.3X106 |
|
Fe-55 |
4.0X101 |
1.1X103 |
4.0X101 |
1.1X103 |
8.8X101 |
2.4X103 |
|
|
Fe-59 |
9.0X10-1 |
2.4X101 |
9.0X10-1 |
2.4X101 |
1.8X103 |
5.0X104 |
|
|
Fe-60 (a) |
4.0X101 |
1.1X103 |
2.0X10-1 |
5.4 |
7.4X10-4 |
2.0X10-2 |
|
|
Ga-67 |
Gallium (31) |
7.0 |
1.9X102 |
3.0 |
8.1X101 |
2.2X104 |
6.0X105 |
|
Ga-68 |
5.0X10-1 |
1.4X101 |
5.0X10-1 |
1.4X101 |
1.5X106 |
4.1X107 |
|
|
Ga-72 |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
1.1X105 |
3.1X106 |
|
|
Gd-146 (a) |
Gadolinium (64) |
5.0X10-1 |
1.4X101 |
5.0X10-1 |
1.4X101 |
6.9X102 |
1.9X104 |
|
Gd-148 |
2.0X101 |
5.4X102 |
2.0X10-3 |
5.4X10-2 |
1.2 |
3.2X101 |
|
|
Gd-153 |
1.0X101 |
2.7X102 |
9.0 |
2.4X102 |
1.3X102 |
3.5X103 |
|
|
Gd-159 |
3.0 |
8.1X101 |
6.0X10-1 |
1.6X101 |
3.9X104 |
1.1X106 |
|
|
Ge-68 (a) |
Germanium (32) |
5.0X10-1 |
1.4X101 |
5.0X10-1 |
1.4X101 |
2.6X102 |
7.1X103 |
|
Ge-71 |
4.0X101 |
1.1X103 |
4.0X101 |
1.1X103 |
5.8X103 |
1.6X105 |
|
|
Ge-77 |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
1.3X105 3.6X106 |
||
|
Hf-172 (a) |
Hafnium (72) |
6.0X10-1 |
1.6X101 |
6.0X10-1 |
1.6X101 |
4.1X101 |
1.1X103 |
|
Hf-175 |
3.0 |
8.1X101 |
3.0 |
8.1X101 |
3.9X102 |
1.1X104 |
|
|
Hf-181 |
2.0 |
5.4X101 |
5.0X10-1 |
1.4X101 |
6.3X102 |
1.7X104 |
|
|
Hf-182 |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
8.1X10-6 |
2.2X10-4 |
|
|
Hg-194 (a) |
Mercury (80) |
1.0 |
2.7X101 |
1.0 |
2.7X101 |
1.3X10-1 |
3.5 |
|
Hg-195m (a) |
3.0 |
8.1X101 |
7.0X10-1 |
1.9X101 |
1.5X104 |
4.0X105 |
|
|
Hg-197 |
2.0X101 |
5.4X102 |
1.0X101 |
2.7X102 |
9.2X103 |
2.5X105 |
|
|
Hg-197m |
1.0X101 |
2.7X102 |
4.0X10-1 |
1.1X101 |
2.5X104 |
6.7X105 |
|
|
Hg-203 |
5.0 |
1.4X102 |
1.0 |
2.7X101 |
5.1X102 |
1.4X104 |
|
|
Ho-166 |
Holmium (67) |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
2.6X104 |
7.0X105 |
|
Ho-166m |
6.0X10-1 |
1.6X101 |
5.0X10-1 |
1.4X101 |
6.6X10-2 |
1.8 |
|
|
I-123 |
Iodine (53) |
6.0 |
1.6X102 3.0 |
8.1X101 |
7.1X104 1.9X106 |
||
|
I-124 |
1.0 |
2.7X101 |
1.0 |
2.7X101 |
9.3X103 |
2.5X105 |
|
|
I-125 |
2.0X101 |
5.4X102 |
3.0 |
8.1X101 |
6.4X102 |
1.7X104 |
|
|
I-126 |
2.0 |
5.4X101 |
1.0 |
2.7X101 |
2.9X103 |
8.0X104 |
|
|
I-129 |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
6.5X10-6 |
1.8X10-4 |
|
|
I-131 |
3.0 |
8.1X101 |
7.0X10-1 |
1.9X101 |
4.6X103 |
1.2X105 |
|
|
I-132 |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
3.8X105 |
1.0X107 |
|
|
I-133 |
7.0X10-1 |
1.9X101 |
6.0X10-1 |
1.6X101 |
4.2X104 |
1.1X106 |
|
|
I-134 |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
9.9X105 |
2.7X107 |
|
|
I-135 (a) |
6.0X10-1 |
1.6X101 |
6.0X10-1 |
1.6X101 |
1.3X105 |
3.5X106 |
|
|
In-111 |
Indium (49) |
3.0 |
8.1X101 3.0 |
8.1X101 |
1.5X104 4.2X105 |
||
|
In-113m |
4.0 |
1.1X102 |
2.0 |
5.4X101 |
6.2X105 |
1.7X107 |
|
|
In-114m (a) |
1.0X101 |
2.7X102 |
5.0X10-1 |
1.4X101 |
8.6X102 |
2.3X104 |
|
|
In-115m |
7.0 |
1.9X102 |
1.0 |
2.7X101 |
2.2X105 |
6.1X106 |
|
|
Ir-189 (a) |
Iridium (77) |
1.0X101 |
2.7X102 |
1.0X101 |
2.7X102 |
1.9X103 |
5.2X104 |
|
Ir-190 |
7.0X10-1 |
1.9X101 |
7.0X10-1 |
1.9X101 |
2.3X103 |
6.2X104 |
|
|
Ir-192 |
c1.0 |
c2.7X101 |
6.0X10-1 |
1.6X101 |
3.4X102 |
9.2X103 |
|
|
Ir-194 |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
3.1X104 |
8.4X105 |
|
|
K-40 |
Potassium (19) |
9.0X10-1 |
2.4X101 |
9.0X10-1 |
2.4X101 |
2.4X10-7 |
6.4X10-6 |
|
K-42 |
2.0X10-1 |
5.4 |
2.0X10-1 |
5.4 |
2.2X105 |
6.0X106 |
|
|
K-43 |
7.0X10-1 1.9X101 6.0X10-1 1.6X101 |
1.2X105 3.3X106 |
|||||
|
Kr-79 |
Krypton (36) |
4.0 |
1.1x102 |
2.0 |
5.4x101 |
4.2x104 |
1.1x106 |
|
Kr-81 |
4.0X101 |
1.1X103 |
4.0X101 |
1.1X103 |
7.8X10-4 |
2.1X10-2 |
|
|
Kr-85 |
1.0X101 |
2.7X102 |
1.0X101 |
2.7X102 |
1.5X101 |
3.9X102 |
|
|
Kr-85m |
8.0 |
2.2X102 |
3.0 |
8.1X101 |
3.0X105 |
8.2X106 |
|
|
Kr-87 |
2.0X10-1 |
5.4 |
2.0X10-1 |
5.4 |
1.0X106 |
2.8X107 |
|
|
La-137 |
Lanthanum (57) |
3.0X101 |
8.1X102 |
6.0 |
1.6X102 |
1.6X10-3 |
4.4X10-2 |
|
La-140 |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
2.1X104 |
5.6X105 |
|
|
Lu-172 |
Lutetium (71) |
6.0X10-1 |
1.6X101 |
6.0X10-1 |
1.6X101 |
4.2X103 |
1.1X105 |
|
Lu-173 |
8.0 |
2.2X102 |
8.0 |
2.2X102 |
5.6X101 |
1.5X103 |
|
|
Lu-174 |
9.0 |
2.4X102 |
9.0 |
2.4X102 |
2.3X101 |
6.2X102 |
|
|
Lu-174m |
2.0X101 |
5.4X102 |
1.0X101 |
2.7X102 |
2.0X102 |
5.3X103 |
|
|
Lu-177 |
3.0X101 8.1X102 7.0X10-1 1.9X101 |
4.1X103 1.1X105 |
|||||
|
Mg-28 (a) |
Magnesium (12) |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
2.0X105 |
5.4X106 |
|
Mn-52 |
Manganese (25) |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
1.6X104 |
4.4X105 |
|
Mn-53 |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
6.8X10-5 |
1.8X10-3 |
|
|
Mn-54 |
1.0 |
2.7X101 |
1.0 |
2.7X101 |
2.9X102 |
7.7X103 |
|
|
Mn-56 |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
8.0X105 |
2.2X107 |
|
|
Mo-93 |
Molybdenum (42) |
4.0X101 |
1.1X103 |
2.0X101 |
5.4X102 |
4.1X10-2 |
1.1 |
|
Mo-99 (a) (h) |
1.0 |
2.7X101 |
6.0X10-1 |
1.6X101 |
1.8X104 |
4.8X105 |
|
|
N-13 |
Nitrogen (7) |
9.0X10-1 |
2.4X101 |
6.0X10-1 |
1.6X101 |
5.4X107 |
1.5X109 |
|
Na-22 |
Sodium (11) |
5.0X10-1 |
1.4X101 |
5.0X10-1 |
1.4X101 |
2.3X102 |
6.3X103 |
|
Na-24 |
2.0X10-1 5.4 |
2.0X10-1 5.4 |
3.2X105 8.7X106 |
||||
|
Nb-93m |
Niobium (41) |
4.0X101 |
1.1X103 |
3.0X101 |
8.1X102 |
8.8 |
2.4X102 |
|
Nb-94 |
7.0X10-1 |
1.9X101 |
7.0X10-1 |
1.9X101 |
6.9X10-3 |
1.9X10-1 |
|
|
Nb-95 |
1.0 |
2.7X101 |
1.0 |
2.7X101 |
1.5X103 |
3.9X104 |
|
|
Nb-97 |
9.0X10-1 |
2.4X101 |
6.0X10-1 |
1.6X101 |
9.9X105 |
2.7X107 |
|
|
Nd-147 |
Neodymium (60) |
6.0 |
1.6X102 |
6.0X10-1 |
1.6X101 |
3.0X103 |
8.1X104 |
|
Nd-149 |
6.0X10-1 |
1.6X101 |
5.0X10-1 |
1.4X101 |
4.5X105 |
1.2X107 |
|
|
Ni-59 |
Nickel (28) |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
3.0X10-3 |
8.0X10-2 |
|
Ni-63 |
4.0X101 |
1.1X103 |
3.0X101 |
8.1X102 |
2.1 |
5.7X101 |
|
|
Ni-65 |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
7.1X105 |
1.9X107 |
|
|
Np-235 |
Neptunium (93) |
4.0X101 1.1X103 4.0X101 1.1X103 |
5.2X101 1.4X103 |
||||
|
Np-236 (short-lived) |
2.0X101 |
5.4X102 |
2.0 |
5.4X101 |
4.7X10-4 |
1.3X10-2 |
|
|
Np-236 (long-lived) |
9.0X100 |
2.4X102 |
2.0X10-2 |
5.4X10-1 |
4.7X10-4 |
1.3X10-2 |
|
|
Np-237 |
2.0X101 |
5.4X102 |
2.0X10-3 |
5.4X10-2 |
2.6X10-5 |
7.1X10-4 |
|
|
Np-239 |
7.0 |
1.9X102 |
4.0X10-1 |
1.1X101 |
8.6X103 |
2.3X105 |
|
|
Os-185 |
Osmium (76) |
1.0 |
2.7X101 |
1.0 |
2.7X101 |
2.8X102 |
7.5X103 |
|
Os-191 |
1.0X101 |
2.7X102 |
2.0 |
5.4X101 |
1.6X103 |
4.4X104 |
|
|
Os-191m |
4.0X101 |
1.1X103 |
3.0X101 |
8.1X102 |
4.6X104 |
1.3X106 |
|
|
Os-193 |
2.0 |
5.4X101 |
6.0X10-1 |
1.6X101 |
2.0X104 |
5.3X105 |
|
|
Os-194 (a) |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
1.1X101 |
3.1X102 |
|
|
P-32 |
Phosphorus (15) |
5.0X10-1 |
1.4X101 |
5.0X10-1 |
1.4X101 |
1.1X104 |
2.9X105 |
|
P-33 |
4.0X101 |
1.1X103 |
1.0 |
2.7X101 |
5.8X103 |
1.6X105 |
|
|
Pa-230 (a) |
Protactinium (91) |
2.0 |
5.4X101 |
7.0X10-2 |
1.9 |
1.2X103 |
3.3X104 |
|
Pa-231 |
4.0 |
1.1X102 |
4.0X10-4 |
1.1X10-2 |
1.7X10-3 |
4.7X10-2 |
|
|
Pa-233 |
5.0 |
1.4X102 |
7.0X10-1 |
1.9X101 |
7.7X102 |
2.1X104 |
|
|
Pb-201 |
Lead (82) |
1.0 |
2.7X101 |
1.0 |
2.7X101 |
6.2X104 |
1.7X106 |
|
Pb-202 |
4.0X101 |
1.1X103 |
2.0X101 |
5.4X102 |
1.2X10-4 |
3.4X10-3 |
|
|
Pb-203 |
4.0 |
1.1X102 |
3.0 |
8.1X101 |
1.1X104 |
3.0X105 |
|
|
Pb-205 |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
4.5X10-6 |
1.2X10-4 |
|
|
Pb-210 (a) |
1.0 |
2.7X101 |
5.0X10-2 |
1.4 |
2.8 |
7.6X101 |
|
|
Pb-212 (a) |
7.0X10-1 |
1.9X101 |
2.0X10-1 |
5.4 |
5.1X104 |
1.4X106 |
|
|
Pd-103 (a) |
Palladium (46) |
4.0X101 |
1.1X103 |
4.0X101 |
1.1X103 |
2.8X103 |
7.5X104 |
|
Pd-107 |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
1.9X10-5 |
5.1X10-4 |
|
|
Pd-109 |
2.0 |
5.4X101 |
5.0X10-1 |
1.4X101 |
7.9X104 |
2.1X106 |
|
|
Pm-143 |
Promethium (61) |
3.0 |
8.1X101 |
3.0 |
8.1X101 |
1.3X102 |
3.4X103 |
|
Pm-144 |
7.0X10-1 |
1.9X101 |
7.0X10-1 |
1.9X101 |
9.2X101 |
2.5X103 |
|
|
Pm-145 |
3.0X101 |
8.1X102 |
1.0X101 |
2.7X102 |
5.2 |
1.4X102 |
|
|
Pm-147 |
4.0X101 |
1.1X103 |
2.0 |
5.4X101 |
3.4X101 |
9.3X102 |
|
|
Pm-148m (a) |
8.0X10-1 |
2.2X101 |
7.0X10-1 |
1.9X101 |
7.9X102 |
2.1X104 |
|
|
Pm-149 |
2.0 |
5.4X101 |
6.0X10-1 |
1.6X101 |
1.5X104 |
4.0X105 |
|
|
Pm-151 |
2.0 |
5.4X101 |
6.0X10-1 |
1.6X101 |
2.7X104 |
7.3X105 |
|
|
Po-210 |
Polonium (84) |
4.0X101 |
1.1X103 |
2.0X10-2 |
5.4X10-1 |
1.7X102 |
4.5X103 |
|
Pr-142 |
Praseodymium (59) |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
4.3X104 |
1.2X106 |
|
Pr-143 |
3.0 |
8.1X101 |
6.0X10-1 |
1.6X101 |
2.5X103 |
6.7X104 |
|
|
Pt-188 (a) |
Platinum (78) |
1.0 |
2.7X101 |
8.0X10-1 |
2.2X101 |
2.5X103 |
6.8X104 |
|
Pt-191 |
4.0 |
1.1X102 |
3.0 |
8.1X101 |
8.7X103 |
2.4X105 |
|
|
Pt-193 |
4.0X101 |
1.1X103 |
4.0X101 |
1.1X103 |
1.4 |
3.7X101 |
|
|
Pt-193m |
4.0X101 |
1.1X103 |
5.0X10-1 |
1.4X101 |
5.8X103 |
1.6X105 |
|
|
Pt-195m |
1.0X101 |
2.7X102 |
5.0X10-1 |
1.4X101 |
6.2X103 |
1.7X105 |
|
|
Pt-197 |
2.0X101 |
5.4X102 |
6.0X10-1 |
1.6X101 |
3.2X104 |
8.7X105 |
|
|
Pt-197m |
1.0X101 |
2.7X102 |
6.0X10-1 |
1.6X101 |
3.7X105 |
1.0X107 |
|
|
Pu-236 |
Plutonium (94) |
3.0X101 |
8.1X102 |
3.0X10-3 |
8.1X10-2 |
2.0X101 |
5.3X102 |
|
Pu-237 |
2.0X101 |
5.4X102 |
2.0X101 |
5.4X102 |
4.5X102 |
1.2X104 |
|
|
Pu-238 |
1.0X101 |
2.7X102 |
1.0X10-3 |
2.7X10-2 |
6.3X10-1 |
1.7X101 |
|
|
Pu-239 |
1.0X101 2.7X102 |
1.0X10-3 2.7X10-2 |
2.3X10-3 6.2X10-2 |
||||
|
Pu-240 |
1.0X101 |
2.7X102 |
1.0X10-3 |
2.7X10-2 |
8.4X10-3 |
2.3X10-1 |
|
|
Pu-241 (a) |
4.0X101 |
1.1X103 |
6.0X10-2 |
1.6 |
3.8 |
1.0X102 |
|
|
Pu-242 |
1.0X101 |
2.7X102 |
1.0X10-3 |
2.7X10-2 |
1.5X10-4 |
3.9X10-3 |
|
|
Pu-244 (a) |
4.0X10-1 |
1.1X101 |
1.0X10-3 |
2.7X10-2 |
6.7X10-7 |
1.8X10-5 |
|
|
Ra-223 (a) |
Radium (88) |
4.0X10-1 |
1.1X101 |
7.0X10-3 |
1.9X10-1 |
1.9X103 |
5.1X104 |
|
Ra-224 (a) |
4.0X10-1 |
1.1X101 |
2.0X10-2 |
5.4X10-1 |
5.9X103 |
1.6X105 |
|
|
Ra-225 (a) |
2.0X10-1 |
5.4 |
4.0X10-3 |
1.1X10-1 |
1.5X103 |
3.9X104 |
|
|
Ra-226 (a) |
2.0X10-1 |
5.4 |
3.0X10-3 |
8.1X10-2 |
3.7X10-2 |
1.0 |
|
|
Ra-228 (a) |
6.0X10-1 |
1.6X101 |
2.0X10-2 |
5.4X10-1 |
1.0X101 |
2.7X102 |
|
|
Rb-81 |
Rubidium (37) 2.0 |
5.4X101 |
8.0X10-1 2.2X101 |
3.1X105 8.4X106 |
|||
|
Rb-83 (a) |
2.0 |
5.4X101 |
2.0 |
5.4X101 |
6.8X102 |
1.8X104 |
|
|
Rb-84 |
1.0 |
2.7X101 |
1.0 |
2.7X101 |
1.8X103 |
4.7X104 |
|
|
Rb-86 |
5.0X10-1 |
1.4X101 |
5.0X10-1 |
1.4X101 |
3.0X103 |
8.1X104 |
|
|
Rb-87 |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
3.2X10-9 |
8.6X10-8 |
|
|
Rb(nat) |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
6.7X106 |
1.8X108 |
|
|
Re-184 |
Rhenium (75) |
1.0 |
2.7X101 |
1.0 |
2.7X101 |
6.9X102 |
1.9X104 |
|
Re-184m |
3.0 |
8.1X101 |
1.0 |
2.7X101 |
1.6X102 |
4.3X103 |
|
|
Re-186 |
2.0 |
5.4X101 |
6.0X10-1 |
1.6X101 |
6.9X103 |
1.9X105 |
|
|
Re-187 |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
1.4X10-9 |
3.8X10-8 |
|
|
Re-188 |
4.0X10-1 1.1X101 |
4.0X10-1 1.1X101 |
3.6X104 9.8X105 |
||||
|
Re-189 (a) |
3.0 |
8.1X101 |
6.0X10-1 |
1.6X101 |
2.5X104 |
6.8X105 |
|
|
Re(nat) |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
0.0 |
2.4X10-8 |
|
|
Rh-99 |
Rhodium (45) |
2.0 |
5.4X101 |
2.0 |
5.4X101 |
3.0X103 |
8.2X104 |
|
Rh-101 |
4.0 |
1.1X102 |
3.0 |
8.1X101 |
4.1X101 |
1.1X103 |
|
|
Rh-102 |
5.0X10-1 |
1.4X101 |
5.0X10-1 |
1.4X101 |
4.5X101 |
1.2X103 |
|
|
Rh-102m |
2.0 |
5.4X101 |
2.0 |
5.4X101 |
2.3X102 |
6.2X103 |
|
|
Rh-103m |
4.0X101 |
1.1X103 |
4.0X101 |
1.1X103 |
1.2X106 |
3.3X107 |
|
|
Rh-105 |
1.0X101 |
2.7X102 |
8.0X10-1 |
2.2X101 |
3.1X104 |
8.4X105 |
|
|
Rn-222 (a) |
Radon (86) |
3.0X10-1 |
8.1 |
4.0X10-3 |
1.1X10-1 |
5.7X103 |
1.5X105 |
|
Ru-97 |
Ruthenium (44) |
5.0 |
1.4X102 |
5.0 |
1.4X102 |
1.7X104 |
4.6X105 |
|
Ru-103 (a) |
2.0 |
5.4X101 |
2.0 |
5.4X101 |
1.2X103 |
3.2X104 |
|
|
Ru-105 |
1.0 |
2.7X101 |
6.0X10-1 |
1.6X101 |
2.5X105 |
6.7X106 |
|
|
Ru-106 (a) |
2.0X10-1 |
5.4 |
2.0X10-1 |
5.4 |
1.2X102 |
3.3X103 |
|
|
S-35 |
Sulphur (16) |
4.0X101 |
1.1X103 |
3.0 |
8.1X101 |
1.6X103 |
4.3X104 |
|
Sb-122 |
Antimony (51) |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
1.5X104 |
4.0X105 |
|
Sb-124 |
6.0X10-1 |
1.6X101 |
6.0X10-1 |
1.6X101 |
6.5X102 |
1.7X104 |
|
|
Sb-125 |
2.0 |
5.4X101 |
1.0 |
2.7X101 |
3.9X101 |
1.0X103 |
|
|
Sb-126 |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
3.1X103 |
8.4X104 |
|
|
Sc-44 |
Scandium (21) |
5.0X10-1 |
1.4X101 |
5.0X10-1 |
1.4X101 |
6.7X105 |
1.8X107 |
|
Sc-46 |
5.0X10-1 |
1.4X101 |
5.0X10-1 |
1.4X101 |
1.3X103 |
3.4X104 |
|
|
Sc-47 |
1.0X101 |
2.7X102 |
7.0X10-1 |
1.9X101 |
3.1X104 |
8.3X105 |
|
|
Sc-48 |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
5.5X104 |
1.5X106 |
|
|
Se-75 |
Selenium (34) |
3.0 |
8.1X101 |
3.0 |
8.1X101 |
5.4X102 |
1.5X104 |
|
Se-79 |
4.0X101 |
1.1X103 |
2.0 |
5.4X101 |
2.6X10-3 |
7.0X10-2 |
|
|
Si-31 |
Silicon (14) |
6.0X10-1 |
1.6X101 |
6.0X10-1 |
1.6X101 |
1.4X106 |
3.9X107 |
|
Si-32 |
4.0X101 |
1.1X103 |
5.0X10-1 |
1.4X101 |
3.9 |
1.1X102 |
|
|
Sm-145 |
Samarium (62) |
1.0X101 |
2.7X102 |
1.0X101 |
2.7X102 |
9.8X101 |
2.6X103 |
|
Sm-147 |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
8.5X10-1 |
2.3X10-8 |
|
|
Sm-151 |
4.0X101 |
1.1X103 |
1.0X101 |
2.7X102 |
9.7X10-1 |
2.6X101 |
|
|
Sm-153 |
9.0 |
2.4X102 |
6.0X10-1 |
1.6X101 |
1.6X104 |
4.4X105 |
|
|
Sn-113 (a) |
Tin (50) |
4.0 |
1.1X102 |
2.0 |
5.4X101 |
3.7X102 |
1.0X104 |
|
Sn-117m |
7.0 |
1.9X102 |
4.0X10-1 |
1.1X101 |
3.0X103 |
8.2X104 |
|
|
Sn-119m |
4.0X101 |
1.1X103 |
3.0X101 |
8.1X102 |
1.4X102 |
3.7X103 |
|
|
Sn-121m (a) |
4.0X101 |
1.1X103 |
9.0X10-1 |
2.4X101 |
2.0 |
5.4X101 |
|
Sn-123 |
8.0X10-1 |
2.2X101 |
6.0X10-1 |
1.6X101 |
3.0X102 |
8.2X103 |
|
|
Sn-125 |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
4.0X103 |
1.1X105 |
|
|
Sn-126 (a) |
6.0X10-1 |
1.6X101 |
4.0X10-1 |
1.1X101 |
1.0X10-3 |
2.8X10-2 |
|
|
Sr-82 (a) |
Strontium (38) |
2.0X10-1 |
5.4 |
2.0X10-1 |
5.4 |
2.3X103 |
6.2X104 |
|
Sr-85 |
2.0 |
5.4X101 |
2.0 |
5.4X101 |
8.8X102 |
2.4X104 |
|
|
Sr-85m |
5.0 |
1.4X102 |
5.0 |
1.4X102 |
1.2X106 |
3.3X107 |
|
|
Sr-87m |
3.0 |
8.1X101 |
3.0 |
8.1X101 |
4.8X105 |
1.3X107 |
|
|
Sr-89 |
6.0X10-1 |
1.6X101 |
6.0X10-1 |
1.6X101 |
1.1X103 |
2.9X104 |
|
|
Sr-90 (a) |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
5.1 |
1.4X102 |
|
|
Sr-91 (a) |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
1.3X105 |
3.6X106 |
|
|
Sr-92 (a) |
1.0 |
2.7X101 |
3.0X10-1 |
8.1 |
4.7X105 |
1.3X107 |
|
|
T(H-3) |
Tritium (1) |
4.0X101 |
1.1X103 |
4.0X101 |
1.1X103 |
3.6X102 |
9.7X103 |
|
Ta-178 (long-lived) |
Tantalum (73) |
1.0 |
2.7X101 |
8.0X10-1 |
2.2X101 |
4.2X106 |
1.1X108 |
|
Ta-179 |
3.0X101 |
8.1X102 |
3.0X101 |
8.1X102 |
4.1X101 |
1.1X103 |
|
|
Ta-182 |
9.0X10-1 |
2.4X101 |
5.0X10-1 |
1.4X101 |
2.3X102 |
6.2X103 |
|
|
Tb-157 |
Terbium (65) |
4.0X101 |
1.1X103 |
4.0X101 |
1.1X103 |
5.6X10-1 |
1.5X101 |
|
Tb-158 |
1.0 |
2.7X101 |
1.0 |
2.7X101 |
5.6X10-1 |
1.5X101 |
|
|
Tb-160 |
1.0 |
2.7X101 |
6.0X10-1 |
1.6X101 |
4.2X102 |
1.1X104 |
|
|
Tc-95m (a) |
Technetium (43) |
2.0 |
5.4X101 |
2.0 |
5.4X101 |
8.3X102 |
2.2X104 |
|
Tc-96 |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
1.2X104 |
3.2X105 |
|
|
Tc-96m (a) |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
1.4X106 |
3.8X107 |
|
|
Tc-97 |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
5.2X10-5 |
1.4X10-3 |
|
|
Tc-97m |
4.0X101 |
1.1X103 |
1.0 |
2.7X101 |
5.6X102 |
1.5X104 |
|
|
Tc-98 |
8.0X10-1 |
2.2X101 |
7.0X10-1 |
1.9X101 |
3.2X10-5 |
8.7X10-4 |
|
|
Tc-99 |
4.0X101 |
1.1X103 |
9.0X10-1 |
2.4X101 |
6.3X10-4 |
1.7X10-2 |
|
|
Tc-99m |
1.0X101 |
2.7X102 |
4.0 |
1.1X102 |
1.9X105 |
5.3X106 |
|
|
Te-121 |
Tellurium (52) |
2.0 |
5.4X101 |
2.0 |
5.4X101 |
2.4X103 |
6.4X104 |
|
Te-121m |
5.0 |
1.4X102 |
3.0 |
8.1X101 |
2.6X102 |
7.0X103 |
|
|
Te-123m |
8.0 |
2.2X102 |
1.0 |
2.7X101 |
3.3X102 |
8.9X103 |
|
|
Te-125m |
2.0X101 |
5.4X102 |
9.0X10-1 |
2.4X101 |
6.7X102 |
1.8X104 |
|
|
Te-127 |
2.0X101 |
5.4X102 |
7.0X10-1 |
1.9X101 |
9.8X104 |
2.6X106 |
|
|
Te-127m (a) |
2.0X101 |
5.4X102 |
5.0X10-1 |
1.4X101 |
3.5X102 |
9.4X103 |
|
Te-129 |
7.0X10-1 |
1.9X101 |
6.0X10-1 |
1.6X101 |
7.7X105 |
2.1X107 |
|
|
Te-129m (a) |
8.0X10-1 |
2.2X101 |
4.0X10-1 |
1.1X101 |
1.1X103 |
3.0X104 |
|
|
Te-131m (a) |
7.0X10-1 |
1.9X101 |
5.0X10-1 |
1.4X101 |
3.0X104 |
8.0X105 |
|
|
Te-132 (a) |
5.0X10-1 |
1.4X101 |
4.0X10-1 |
1.1X101 |
1.1X104 |
3.0X105 |
|
|
Th-227 |
Thorium (90) |
1.0X101 |
2.7X102 |
5.0X10-3 |
1.4X10-1 |
1.1X103 |
3.1X104 |
|
Th-228 (a) |
5.0X10-1 |
1.4X101 |
1.0X10-3 |
2.7X10-2 |
3.0X101 |
8.2X102 |
|
|
Th-229 |
5.0 |
1.4X102 |
5.0X10-4 |
1.4X10-2 |
7.9X10-3 |
2.1X10-1 |
|
|
Th-230 |
1.0X101 |
2.7X102 |
1.0X10-3 |
2.7X10-2 |
7.6X10-4 |
2.1X10-2 |
|
|
Th-231 |
4.0X101 |
1.1X103 |
2.0X10-2 |
5.4X10-1 |
2.0X104 |
5.3X105 |
|
|
Th-232 |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
4.0X10-9 |
1.1X10-7 |
|
|
Th-234 (a) |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
8.6X102 |
2.3X104 |
|
|
Th(nat) |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
8.1X10-9 |
2.2X10-7 |
|
|
Ti-44 (a) |
Titanium (22) |
5.0X10-1 |
1.4X101 |
4.0X10-1 |
1.1X101 |
6.4 |
1.7X102 |
|
Tl-200 |
Thallium (81) |
9.0X10-1 |
2.4X101 |
9.0X10-1 |
2.4X101 |
2.2X104 |
6.0X105 |
|
Tl-201 |
1.0X101 |
2.7X102 |
4.0 |
1.1X102 |
7.9X103 |
2.1X105 |
|
|
Tl-202 |
2.0 |
5.4X101 |
2.0 |
5.4X101 |
2.0X103 |
5.3X104 |
|
|
Tl-204 |
1.0X101 |
2.7X102 |
7.0X10-1 |
1.9X101 |
1.7X101 |
4.6X102 |
|
|
Tm-167 |
Thulium (69) |
7.0 |
1.9X102 |
8.0X10-1 |
2.2X101 |
3.1X103 |
8.5X104 |
|
Tm-170 |
3.0 |
8.1X101 |
6.0X10-1 |
1.6X101 |
2.2X102 |
6.0X103 |
|
|
Tm-171 |
4.0X101 |
1.1X103 |
4.0X101 |
1.1X103 |
4.0X101 |
1.1X103 |
|
|
U-230 (fast lung absorption) (a)(d) |
Uranium (92) |
4.0X101 |
1.1X103 |
1.0X10-1 |
2.7 |
1.0X103 |
2.7X104 |
|
U-230 (medium lung absorption) (a)(e) |
4.0X101 |
1.1X103 |
4.0X10-3 |
1.1X10-1 |
1.0X103 |
2.7X104 |
|
|
U-230 (slow lung absorption) (a)(f) |
3.0X101 |
8.1X102 |
3.0X10-3 |
8.1X10-2 |
1.0X103 |
2.7X104 |
|
|
U-232 (fast lung absorption) (d) |
4.0X101 |
1.1X103 |
1.0X10-2 |
2.7X10-1 |
8.3X10-1 |
2.2X101 |
|
|
U-232 (medium lung absorption) (e) |
4.0X101 |
1.1X103 |
7.0X10-3 |
1.9X10-1 |
8.3X10-1 |
2.2X101 |
|
|
U-232 (slow lung absorption) (f) |
1.0X101 |
2.7X102 |
1.0X10-3 |
2.7X10-2 |
8.3X10-1 |
2.2X101 |
|
|
U-233 (fast lung absorption) (d) |
4.0X101 |
1.1X103 |
9.0X10-2 |
2.4 |
3.6X10-4 |
9.7X10-3 |
|
U-233 (medium lung absorption) (e) |
4.0X101 |
1.1X103 |
2.0X10-2 |
5.4X10-1 |
3.6X10-4 |
9.7X10-3 |
|
|
U-233 (slow lung absorption) (f) |
4.0X101 |
1.1X103 |
6.0X10-3 |
1.6X10-1 |
3.6X10-4 |
9.7X10-3 |
|
|
U-234 (fast lung absorption) (d) |
4.0X101 |
1.1X103 |
9.0X10-2 |
2.4 |
2.3X10-4 |
6.2X10-3 |
|
|
U-234 (medium lung absorption) (e) |
4.0X101 |
1.1X103 |
2.0X10-2 |
5.4X10-1 |
2.3X10-4 |
6.2X10-3 |
|
|
U-234 (slow lung absorption) (f) |
4.0X101 |
1.1X103 |
6.0X10-3 |
1.6X10-1 |
2.3X10-4 |
6.2X10-3 |
|
|
U-235 (all lung absorption types) (a),(d),(e),(f) |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
8.0X10-8 |
2.2X10-6 |
|
|
U-236 (fast lung absorption) (d) |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
2.4X10-6 |
6.5X10-5 |
|
|
U-236 (medium lung absorption) (e) |
4.0X101 |
1.1X103 |
2.0X10-2 |
5.4X10-1 |
2.4X10-6 |
6.5X10-5 |
|
|
U-236 (slow lung absorption) (f) |
4.0X101 |
1.1X103 |
6.0X10-3 |
1.6X10-1 |
2.4X10-6 |
6.5X10-5 |
|
|
U-238 (all lung absorption types) (d),(e),(f) |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
1.2X10-8 |
3.4X10-7 |
|
|
U (nat) |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
2.6X10-8 |
7.1X10-7 |
|
|
U (enriched to 20% or less) (g) |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
See Table A-4 |
See Table A-4 |
|
|
U (dep) |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
See Table A-4 |
(See Table A-3) |
|
|
V-48 |
Vanadium (23) |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
6.3X103 |
1.7X105 |
|
V-49 |
4.0X101 |
1.1X103 |
4.0X101 |
1.1X103 |
3.0X102 |
8.1X103 |
|
|
W-178 (a) |
Tungsten (74) |
9.0 |
2.4X102 |
5.0 |
1.4X102 |
1.3X103 |
3.4X104 |
|
W-181 |
3.0X101 |
8.1X102 |
3.0X101 |
8.1X102 |
2.2X102 |
6.0X103 |
|
|
W-185 |
4.0X101 |
1.1X103 |
8.0X10-1 |
2.2X101 |
3.5X102 |
9.4X103 |
|
|
W-187 |
2.0 |
5.4X101 |
6.0X10-1 |
1.6X101 |
2.6X104 |
7.0X105 |
|
|
W-188 (a) |
4.0X10-1 |
1.1X101 |
3.0X10-1 |
8.1 |
3.7X102 |
1.0X104 |
|
|
Xe-122 (a) |
Xenon (54) |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
4.8X104 |
1.3X106 |
|
Xe-123 |
2.0 |
5.4X101 |
7.0X10-1 |
1.9X101 |
4.4X105 |
1.2X107 |
|
Xe-127 |
4.0 |
1.1X102 |
2.0 |
5.4X101 |
1.0X103 |
2.8X104 |
|
|
Xe-131m |
4.0X101 |
1.1X103 |
4.0X101 |
1.1X103 |
3.1X103 |
8.4X104 |
|
|
Xe-133 |
2.0X101 |
5.4X102 |
1.0X101 |
2.7X102 |
6.9X103 |
1.9X105 |
|
|
Xe-135 |
3.0 |
8.1X101 |
2.0 |
5.4X101 |
9.5X104 |
2.6X106 |
|
|
Y-87 (a) |
Yttrium (39) |
1.0 |
2.7X101 |
1.0 |
2.7X101 |
1.7X104 |
4.5X105 |
|
Y-88 |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
5.2X102 |
1.4X104 |
|
|
Y-90 |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
2.0X104 |
5.4X105 |
|
|
Y-91 |
6.0X10-1 |
1.6X101 |
6.0X10-1 |
1.6X101 |
9.1X102 |
2.5X104 |
|
|
Y-91m |
2.0 |
5.4X101 |
2.0 |
5.4X101 |
1.5X106 |
4.2X107 |
|
|
Y-92 |
2.0X10-1 |
5.4 |
2.0X10-1 |
5.4 |
3.6X105 |
9.6X106 |
|
|
Y-93 |
3.0X10-1 |
8.1 |
3.0X10-1 |
8.1 |
1.2X105 |
3.3X106 |
|
|
Yb-169 |
Ytterbium (70) |
4.0 |
1.1X102 |
1.0 |
2.7X101 |
8.9X102 |
2.4X104 |
|
Yb-175 |
3.0X101 |
8.1X102 |
9.0X10-1 |
2.4X101 |
6.6X103 |
1.8X105 |
|
|
Zn-65 |
Zinc (30) |
2.0 |
5.4X101 |
2.0 |
5.4X101 |
3.0X102 |
8.2X103 |
|
Zn-69 |
3.0 |
8.1X101 |
6.0X10-1 |
1.6X101 |
1.8X106 |
4.9X107 |
|
|
Zn-69m (a) |
3.0 |
8.1X101 |
6.0X10-1 |
1.6X101 |
1.2X105 |
3.3X106 |
|
|
Zr-88 |
Zirconium (40) |
3.0 |
8.1X101 |
3.0 |
8.1X101 |
6.6X102 |
1.8X104 |
|
Zr-93 |
Unlimited |
Unlimited |
Unlimited |
Unlimited |
9.3X10-5 |
2.5X10-3 |
|
|
Zr-95 (a) |
2.0 |
5.4X101 |
8.0X10-1 |
2.2X101 |
7.9X102 |
2.1X104 |
|
|
Zr-97 (a) |
4.0X10-1 |
1.1X101 |
4.0X10-1 |
1.1X101 |
7.1X104 |
1.9X106 |
a A1 and/or A2 values include contributions from daughter nuclides with half-lives less than 10 days, as listed in the following:
|
Mg-28 |
Al-28 |
|
Ca-47 |
Sc-47 |
|
Ti-44 |
Sc-44 |
|
Fe-52 |
Mn-52m |
|
Fe-60 |
Co-60m |
|
Zn-69m |
Zn-69 |
|
Ge-68 |
Ga-68 |
|
Rb-83 |
Kr-83m |
|
Sr-82 |
Rb-82 |
|
Sr-90 |
Y-90 |
|
Sr-91 |
Y-91m |
|
Sr-92 |
Y-92 |
|
Y-87 |
Sr-87m |
|
Zr-95 |
Nb-95m |
|
Zr-97 |
Nb-97m, Nb-97 |
|
Mo-99 |
Tc-99m |
|
Tc-95m |
Tc-95 |
|
Tc-96m |
Tc-96 |
|
Ru-103 |
Rh-103m |
|
Ru-106 |
Rh-106 |
|
Pd-103 |
Rh-103m |
|
Ag-108m |
Ag-108 |
|
Ag-110m |
Ag-110 |
|
Cd-115 |
In-115m |
|
In-114m |
In-114 |
|
Sn-113 |
In-113m |
|
Sn-121m |
Sn-121 |
|
Sn-126 |
Sb-126m |
|
Te-127m |
Te-127 |
|
Te-129m |
Te-129 |
|
Te-131m |
Te-131 |
|
Te-132 |
I-132 |
|
I-135 |
Xe-135m |
|
Xe-122 |
I-122 |
|
Cs-137 |
Ba-137m |
|
Ba-131 |
Cs-131 |
|
Ba-140 |
La-140 |
|
Ce-144 |
Pr-144m, Pr-144 |
|
Pm-148m |
Pm-148 |
|
Gd-146 |
Eu-146 |
|
Dy-166 |
Ho-166 |
|
Hf-172 |
Lu-172 |
|
W-178 |
Ta-178 |
|
W-188 |
Re-188 |
|
Re-189 |
Os-189m |
|
Os-194 |
Ir-194 |
|
Ir-189 |
Os-189m |
|
Pt-188 |
Ir-188 |
|
Hg-194 |
Au-194 |
|
Hg-195m |
Hg-195 |
|
Pb-210 |
Bi-210 |
|
Pb-212 |
Bi-212, Tl-208, Po-212 |
|
Bi-210m |
Tl-206 |
|
Bi-212 |
Tl-208, Po-212 |
|
At-211 |
Po-211 |
|
Rn-222 |
Po-218, Pb-214, At-218, Bi-214, Po-214 |
|
Ra-223 |
Rn-219, Po-215, Pb-211, Bi-211, Po-211, Tl-207 |
|
Ra-224 |
Rn-220, Po-216, Pb-212, Bi-212, Tl-208, Po-212 |
|
Ra-225 |
Ac-225, Fr-221, At-217, Bi-213, Tl-209, Po-213, Pb-209 |
|
Ra-226 |
Rn-222, Po-218, Pb-214, At-218, Bi-214, Po-214 |
|
Ra-228 |
Ac-228 |
|
Ac-225 |
Fr-221, At-217, Bi-213, Tl-209, Po-213, Pb-209 |
|
Ac-227 |
Fr-223 |
|
Th-228 |
Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208, Po-212 |
|
Th-234 |
Pa-234m, Pa-234 |
|
Pa-230 |
Ac-226, Th-226, Fr-222, Ra-222, Rn-218, Po-214 |
|
U-230 |
Th-226, Ra-222, Rn-218, Po-214 |
|
U-235 |
Th-231 |
|
Pu-241 |
U-237 |
|
Pu-244 |
U-240, Np-240m |
|
Am-242m |
Am-242, Np-238 |
|
Am-243 |
Np-239 |
|
Cm-247 |
Pu-243 |
|
Bk-249 |
Am-245 |
|
Cf-253 |
Cm-249 |
b The values of A1 and A2 in Curies (Ci) are approximate and for information only; the regulatory standard units are Terabecquerels (TBq). See Appendix A to Section 4 - Determination of A1 and A2, Section I.
c The activity of Ir-192 in special form may be determined from a measurement of the rate of decay or a measurement of the radiation level at a prescribed distance from the source.
d These values apply only to compounds of uranium that take the chemical form of UF6, UO2F2 and UO2(NO3)2 in both normal and accident conditions of transport.
e These values apply only to compounds of uranium that take the chemical form of UO3, UF4, UCl4 and hexavalent compounds in both normal and accident conditions of transport.
f These values apply to all compounds of uranium other than those specified in notes (d) and (e) of this table.
g These values apply to unirradiated uranium only.
h A2 = 0.74 TBq (20 Ci) for Mo-99 for domestic use.
TABLE A-2-EXEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES
|
Symbol of radionuclide |
Element and atomic number |
Activity concentration for exempt material (Bq/g) |
Activity concentration for exempt material (Ci/g) |
Activity limit for exempt consignment (Bq) |
Activity limit for exempt consignment (Ci) |
|
Ac-225 |
Actinium (89) |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
Ac-227 |
1.0X10-1 |
2.7X10-12 |
1.0X103 |
2.7X10-8 |
|
|
Ac-228 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Ag-105 |
Silver (47) |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
Ag-108m (b) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Ag-110m |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Ag-111 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Al-26 |
Aluminum (13) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
Am-241 |
Americium (95) |
1.0 |
2.7X10-11 |
1.0X104 |
2.7X10-7 |
|
Am-242m (b) |
1.0 |
2.7X10-11 |
1.0X104 |
2.7X10-7 |
|
|
Am-243 (b) |
1.0 |
2.7X10-11 |
1.0X103 |
2.7X10-8 |
|
|
Ar-37 |
Argon (18) |
1.0X106 |
2.7X10-5 |
1.0X108 |
2.7X10-3 |
|
Ar-39 |
1.0X107 |
2.7X10-4 |
1.0X104 |
2.7X10-7 |
|
|
Ar-41 |
1.0X102 |
2.7X10-9 |
1.0X109 |
2.7X10-2 |
|
|
As-72 |
Arsenic (33) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
As-73 |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
|
As-74 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
As-76 |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
As-77 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
At-211 |
Astatine (85) |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
Au-193 |
Gold (79) |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
Au-194 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Au-195 |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
|
Au-198 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Au-199 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
Ba-131 |
Barium (56) |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
Ba-133 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Ba-133m |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Ba-140 (b) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Be-7 |
Beryllium (4) |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
Be-10 |
1.0X104 |
2.7X10-7 |
1.0X106 |
2.7X10-5 |
|
|
Bi-205 |
Bismuth (83) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Bi-206 |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Bi-207 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Bi-210 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Bi-210m |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Bi-212 (b) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Bk-247 |
Berkelium (97) |
1.0 |
2.7X10-11 |
1.0X104 |
2.7X10-7 |
|
Bk-249 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Br-76 |
Bromine (35) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
Br-77 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Br-82 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
C-11 |
Carbon (6) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
C-14 |
1.0X104 |
2.7X10-7 |
1.0X107 |
2.7X10-4 |
|
|
Ca-41 |
Calcium (20) |
1.0X105 |
2.7X10-6 |
1.0X107 |
2.7X10-4 |
|
Ca-45 |
1.0X104 |
2.7X10-7 |
1.0X107 |
2.7X10-4 |
|
|
Ca-47 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Cd-109 |
Cadmium (48) |
1.0X104 |
2.7X10-7 |
1.0X106 |
2.7X10-5 |
|
Cd-113m |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Cd-115 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Cd-115m |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Ce-139 |
Cerium (58) |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
Ce-141 |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
|
Ce-143 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Ce-144 (b) |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
Cf-248 |
Californium (98) |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
Cf-249 |
1.0 |
2.7X10-11 |
1.0X103 |
2.7X10-8 |
|
Cf-250 |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
Cf-251 |
1.0 |
2.7X10-11 |
1.0X103 |
2.7X10-8 |
|
|
Cf-252 |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
Cf-253 |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
Cf-254 |
1.0 |
2.7X10-11 |
1.0X103 |
2.7X10-8 |
|
|
Cl-36 |
Chlorine (17) |
1.0X104 |
2.7X10-7 |
1.0X106 |
2.7X10-5 |
|
Cl-38 |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Cm-240 |
Curium (96) |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
Cm-241 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Cm-242 |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
Cm-243 |
1.0 |
2.7X10-11 |
1.0X104 |
2.7X10-7 |
|
|
Cm-244 |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
Cm-245 |
1.0 |
2.7X10-11 |
1.0X103 |
2.7X10-8 |
|
|
Cm-246 |
1.0 |
2.7X10-11 |
1.0X103 |
2.7X10-8 |
|
|
Cm-247 |
1.0 |
2.7X10-11 |
1.0X104 |
2.7X10-7 |
|
|
Cm-248 |
1.0 |
2.7X10-11 |
1.0X103 |
2.7X10-8 |
|
|
Co-55 |
Cobalt (27) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Co-56 |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Co-57 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Co-58 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Co-58m |
1.0X104 |
2.7X10-7 |
1.0X107 |
2.7X10-4 |
|
|
Co-60 |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Cr-51 |
Chromium (24) |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
Cs-129 |
Cesium (55) |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
Cs-131 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Cs-132 |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Cs-134 |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
Cs-134m |
1.0X103 |
2.7X10-8 |
1.0X105 |
2.7X10-6 |
|
|
Cs-135 |
1.0X104 |
2.7X10-7 |
1.0X107 |
2.7X10-4 |
|
|
Cs-136 |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Cs-137 (b) |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
Cu-64 |
Copper (29) |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
Cu-67 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Dy-159 |
Dysprosium (66) |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
Dy-165 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Dy-166 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Er-169 |
Erbium (68) |
1.0X104 |
2.7X10-7 |
1.0X107 |
2.7X10-4 |
|
Er-171 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Eu-147 |
Europium (63) |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
Eu-148 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Eu-149 |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
|
Eu-150 (short lived) |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Eu-150 (long lived) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Eu-152 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Eu-152m |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Eu-154 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Eu-155 |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
|
Eu-156 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
F-18 |
Fluorine (9) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Fe-52 |
Iron (26) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Fe-55 |
1.0X104 |
2.7X10-7 |
1.0X106 |
2.7X10-5 |
|
|
Fe-59 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Fe-60 |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
Ga-67 |
Gallium (31) |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
Ga-68 |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Ga-72 |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Gd-146 |
Gadolinium (64) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Gd-148 |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
Gd-153 |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
|
Gd-159 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Ge-68 |
Germanium (32) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
Ge-71 |
1.0X104 |
2.7X10-7 |
1.0X108 |
2.7X10-3 |
|
|
Ge-77 |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
Hf-172 |
Hafnium (72) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Hf-175 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Hf-181 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Hf-182 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Hg-194 |
Mercury (80) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Hg-195m |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Hg-197 |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
|
Hg-197m |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Hg-203 |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
Ho-166 |
Holmium (67) |
1.0X103 |
2.7X10-8 |
1.0X105 |
2.7X10-6 |
|
Ho-166m |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
I-123 |
Iodine (53) |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
I-124 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
I-125 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
I-126 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
I-129 |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
I-131 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
I-132 |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
I-133 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
I-134 |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
I-135 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
In-111 |
Indium (49) |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
In-113m |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
In-114m |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
In-115m |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Ir-189 |
Iridium (77) |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
Ir-190 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Ir-192 |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
Ir-194 |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
K-40 |
Potassium (19) |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
K-42 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
K-43 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Kr-79 |
Krypton (36) |
1.0X103 |
2.7X10-8 |
1.0X105 |
2.7X10-6 |
|
Kr-81 |
1.0X104 |
2.7X10-7 |
1.0X107 |
2.7X10-4 |
|
|
Kr-85 |
1.0X105 |
2.7X10-6 |
1.0X104 |
2.7X10-7 |
|
|
Kr-85m |
1.0X103 |
2.7X10-8 |
1.0X1010 |
2.7X10-1 |
|
|
Kr-87 |
1.0X102 |
2.7X10-9 |
1.0X109 |
2.7X10-2 |
|
|
La-137 |
Lanthanum (57) |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
La-140 |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Lu-172 |
Lutetium (71) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Lu-173 |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
|
Lu-174 |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
|
Lu-174m |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
|
Lu-177 |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
|
Mg-28 |
Magnesium (12) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
Mn-52 |
Manganese (25) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
Mn-53 |
1.0X104 |
2.7X10-7 |
1.0X109 |
2.7X10-2 |
|
|
Mn-54 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Mn-56 |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Mo-93 |
Molybdenum (42) |
1.0X103 |
2.7X10-8 |
1.0X108 |
2.7X10-3 |
|
Mo-99 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
N-13 |
Nitrogen (7) |
1.0X102 |
2.7X10-9 |
1.0X109 |
2.7X10-2 |
|
Na-22 |
Sodium (11) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Na-24 |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Nb-93m |
Niobium (41) |
1.0X104 |
2.7X10-7 |
1.0X107 |
2.7X10-4 |
|
Nb-94 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Nb-95 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Nb-97 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Nd-147 |
Neodymium (60) |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
Nd-149 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Ni-59 |
Nickel (28) |
1.0X104 |
2.7X10-7 |
1.0X108 |
2.7X10-3 |
|
Ni-63 |
1.0X105 |
2.7X10-6 |
1.0X108 |
2.7X10-3 |
|
|
Ni-65 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Np-235 |
Neptunium (93) |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
Np-236 (shortlived) |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
|
Np-236 (long-lived) |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
Np-237 (b) |
1.0 |
2.7X10-11 |
1.0X103 |
2.7X10-8 |
|
|
Np-239 |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
|
Os-185 |
Osmium (76) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Os-191 |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
|
Os-191m |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
|
Os-193 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Os-194 |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
P-32 |
Phosphorus (15) |
1.0X103 |
2.7X10-8 |
1.0X105 |
2.7X10-6 |
|
P-33 |
1.0X105 |
2.7X10-6 |
1.0X108 |
2.7X10-3 |
|
|
Pa-230 |
Protactinium (91) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Pa-231 |
1.0 |
2.7X10-11 |
1.0X103 |
2.7X10-8 |
|
|
Pa-233 |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
|
Pb-201 |
Lead (82) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Pb-202 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Pb-203 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Pb-205 |
1.0X104 |
2.7X10-7 |
1.0X107 |
2.7X10-4 |
|
|
Pb-210 (b) |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
Pb-212 (b) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Pd-103 |
Palladium (46) |
1.0X103 |
2.7X10-8 |
1.0X108 |
2.7X10-3 |
|
Pd-107 |
1.0X105 |
2.7X10-6 |
1.0X108 |
2.7X10-3 |
|
|
Pd-109 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Pm-143 |
Promethium (61) |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
Pm-144 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Pm-145 |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
|
Pm-147 |
1.0X104 |
2.7X10-7 |
1.0X107 |
2.7X10-4 |
|
|
Pm-148m |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Pm-149 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Pm-151 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
Po-210 |
Polonium (84) |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
Pr-142 |
Praseodymium (59) |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
Pr-143 |
1.0X104 |
2.7X10-7 |
1.0X106 |
2.7X10-5 |
|
|
Pt-188 |
Platinum (78) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Pt-191 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Pt-193 |
1.0X104 |
2.7X10-7 |
1.0X107 |
2.7X10-4 |
|
|
Pt-193m |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
|
Pt-195m |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Pt-197 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Pt-197m |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Pu-236 |
Plutonium (94) |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
Pu-237 |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
|
Pu-238 |
1.0 |
2.7X10-11 |
1.0X104 |
2.7X10-7 |
|
|
Pu-239 |
1.0 |
2.7X10-11 |
1.0X104 |
2.7X10-7 |
|
|
Pu-240 |
1.0 |
2.7X10-11 |
1.0X103 |
2.7X10-8 |
|
|
Pu-241 |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
Pu-242 |
1.0 |
2.7X10-11 |
1.0X104 |
2.7X10-7 |
|
|
Pu-244 |
1.0 |
2.7X10-11 |
1.0X104 |
2.7X10-7 |
|
|
Ra-223 (b) |
Radium (88) |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
Ra-224 (b) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Ra-225 |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
Ra-226 (b) |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
Ra-228 (b) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Rb-81 |
Rubidium (37) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Rb-83 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Rb-84 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Rb-86 |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
Rb-87 |
1.0X104 |
2.7X10-7 |
1.0X107 |
2.7X10-4 |
|
|
Rb(nat) |
1.0X104 |
2.7X10-7 |
1.0X107 |
2.7X10-4 |
|
|
Re-184 |
Rhenium (75) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Re-184m |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Re-186 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
Re-187 |
1.0X106 |
2.7X10-5 |
1.0X109 |
2.7X10-2 |
|
|
Re-188 |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
Re-189 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Re(nat) |
1.0X106 |
2.7X10-5 |
1.0X109 |
2.7X10-2 |
|
|
Rh-99 |
Rhodium (45) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Rh-101 |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
|
Rh-102 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Rh-102m |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Rh-103m |
1.0X104 |
2.7X10-7 |
1.0X108 |
2.7X10-3 |
|
|
Rh-105 |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
|
Rn-222 (b) |
Radon (86) |
1.0X101 |
2.7X10-10 |
1.0X108 |
2.7X10-3 |
|
Ru-97 |
Ruthenium (44) |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
Ru-103 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Ru-105 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Ru-106 (b) |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
S-35 |
Sulphur (16) |
1.0X105 |
2.7X10-6 |
1.0X108 |
2.7X10-3 |
|
Sb-122 |
Antimony (51) |
1.0X102 |
2.7X10-9 |
1.0X104 |
2.7X10-7 |
|
Sb-124 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Sb-125 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Sb-126 |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Sc-44 |
Scandium (21) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
Sc-46 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Sc-47 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Sc-48 |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Se-75 |
Selenium (34) |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
Se-79 |
1.0X104 |
2.7X10-7 |
1.0X107 |
2.7X10-4 |
|
|
Si-31 |
Silicon (14) |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
Si-32 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Sm-145 |
Samarium (62) |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
Sm-147 |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
Sm-151 |
1.0X104 |
2.7X10-7 |
1.0X108 |
2.7X10-3 |
|
|
Sm-153 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
Sn-113 |
Tin (50) |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
Sn-117m |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Sn-119m |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
|
Sn-121m |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
|
Sn-123 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Sn-125 |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
Sn-126 |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Sr-82 |
Strontium (38) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
Sr-85 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Sr-85m |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
|
Sr-87m |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Sr-89 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Sr-90 (b) |
1.0X102 |
2.7X10-9 |
1.0X104 |
2.7X10-7 |
|
|
Sr-91 |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
Sr-92 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
T(H-3) |
Tritium (1) |
1.0X106 |
2.7X10-5 |
1.0X109 |
2.7X10-2 |
|
Ta-178 (long-lived) |
Tantalum (73) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Ta-179 |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
|
Ta-182 |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
Tb-157 |
Terbium (65) |
1.0X104 |
2.7X10-7 |
1.0X107 |
2.7X10-4 |
|
Tb-158 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Tb-160 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Tc-95m |
Technetium (43) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Tc-96 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Tc-96m |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
|
Tc-97 |
1.0X103 |
2.7X10-8 |
1.0X108 |
2.7X10-3 |
|
|
Tc-97m |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
|
Tc-98 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Tc-99 |
1.0X104 |
2.7X10-7 |
1.0X107 |
2.7X10-4 |
|
|
Tc-99m |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
|
Te-121 |
Tellurium (52) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Te-121m |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Te-123m |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
|
Te-125m |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
|
Te-127 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Te-127m |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
|
Te-129 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Te-129m |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Te-131m |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Te-132 |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
|
Th-227 |
Thorium (90) |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
Th-228 (b) |
1.0 |
2.7X10-11 |
1.0X104 |
2.7X10-7 |
|
|
Th-229 (b) |
1.0 |
2.7X10-11 |
1.0X103 |
2.7X10-8 |
|
|
Th-230 |
1.0 |
2.7X10-11 |
1.0X104 |
2.7X10-7 |
|
|
Th-231 |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
|
Th-232 |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
Th-234 (b) |
1.0X103 |
2.7X10-8 |
1.0X105 |
2.7X10-6 |
|
|
Th (nat) (b) |
1.0 |
2.7X10-11 |
1.0X103 |
2.7X10-8 |
|
|
Ti-44 |
Titanium (22) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
Tl-200 |
Thallium (81) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Tl-201 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Tl-202 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Tl-204 |
1.0X104 |
2.7X10-7 |
1.0X104 |
2.7X10-7 |
|
|
Tm-167 |
Thulium (69) |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
Tm-170 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Tm-171 |
1.0X104 |
2.7X10-7 |
1.0X108 |
2.7X10-3 |
|
|
U-230 (fast lung absorption) (b),(d) |
Uranium (92) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
U-230 (medium lung absorption) (e) |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
U-230 (slow lung absorption) (f) |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
U-232 (fast lung absorption) (b),(d) |
1.0 |
2.7X10-11 |
1.0X103 |
2.7X10-8 |
|
|
U-232 (medium lung absorption) (e) |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
U-232 (slow lung absorption) (f) |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
U-233 (fast lung absorption) (d) |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
U-233 (medium lung absorption) (e) |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
U-233 (slow lung absorption) (f) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
U-234 (fast lung absorption) (d) |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
U-234 (medium lung absorption) (e) |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
U-234 (slow lung absorption) (f) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
|
U-235 (all lung absorption types) (b),(d),(e),(f) |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
U-236 (fast lung absorption) (d) |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
U-236 (medium lung absorption) (e) |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
U-236 (slow lung absorption) (f) |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
U-238 (all lung absorption types) (b),(d),(e),(f) |
1.0X101 |
2.7X10-10 |
1.0X104 |
2.7X10-7 |
|
|
U (nat) (b) |
1.0 |
2.7X10-11 |
1.0X103 |
2.7X10-8 |
|
|
U (enriched to 20% or less) (g) |
1.0 |
2.7X10-11 |
1.0X103 |
2.7X10-8 |
|
|
U (dep) |
1.0 |
2.7X10-11 |
1.0X103 |
2.7X10-8 |
|
|
V-48 |
Vanadium (23) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
|
V-49 |
1.0X104 |
2.7X10-7 |
1.0X107 |
2.7X10-4 |
|
|
W-178 |
Tungsten (74) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
W-181 |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
|
W-185 |
1.0X104 |
2.7X10-7 |
1.0X107 |
2.7X10-4 |
|
|
W-187 |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
W-188 |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
Xe-122 |
Xenon (54) |
1.0X102 |
2.7X10-9 |
1.0X109 |
2.7X10-2 |
|
Xe-123 |
1.0X102 |
2.7X10-9 |
1.0X109 |
2.7X10-2 |
|
|
Xe-127 |
1.0X103 |
2.7X10-8 |
1.0X105 |
2.7X10-6 |
|
|
Xe-131m |
1.0X104 |
2.7X10-7 |
1.0X104 |
2.7X10-7 |
|
|
Xe-133 |
1.0X103 |
2.7X10-8 |
1.0X104 |
2.7X10-7 |
|
|
Xe-135 |
1.0X103 |
2.7X10-8 |
1.0X1010 |
2.7X10-1 |
|
|
Y-87 |
Yttrium (39) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Y-88 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Y-90 |
1.0X103 |
2.7X10-8 |
1.0X105 |
2.7X10-6 |
|
|
Y-91 |
1.0X103 |
2.7X10-8 |
1.0X106 |
2.7X10-5 |
|
|
Y-91m |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Y-92 |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
Y-93 |
1.0X102 |
2.7X10-9 |
1.0X105 |
2.7X10-6 |
|
|
Yb-169 |
Ytterbium (70) |
1.0X102 |
2.7X10-9 |
1.0X107 |
2.7X10-4 |
|
Yb-175 |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
|
Zn-65 |
Zinc (30) |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
Zn-69 |
1.0X104 |
2.7X10-7 |
1.0X106 |
2.7X10-5 |
|
|
Zn-69m |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
|
Zr-88 |
Zirconium (40) |
1.0X102 |
2.7X10-9 |
1.0X106 |
2.7X10-5 |
|
Zr-93 (b) |
1.0X103 |
2.7X10-8 |
1.0X107 |
2.7X10-4 |
|
|
Zr-95 |
1.0X101 |
2.7X10-10 |
1.0X106 |
2.7X10-5 |
|
|
Zr-97 (b) |
1.0X101 |
2.7X10-10 |
1.0X105 |
2.7X10-6 |
a [Reserved]
b Parent nuclides and their progeny included in secular equilibrium are listed as follows:
|
Sr-90 |
Y-90 |
|
Zr-93 |
Nb-93m |
|
Zr-97 |
Nb-97 |
|
Ru-106 |
Rh-106 |
|
Ag-108m |
Ag-108 |
|
Cs-137 |
Ba-137m |
|
Ce-144 |
Pr-144 |
|
Ba-140 |
La-140 |
|
Bi-212 |
Tl-208 (0.36), Po-212 (0.64) |
|
Pb-210 |
Bi-210, Po-210 |
|
Pb-212 |
Bi-212, Tl-208 (0.36), Po-212 (0.64) |
|
Rn-222 |
Po-218, Pb-214, Bi-214, Po-214 |
|
Ra-223 |
Rn-219, Po-215, Pb-211, Bi-211, Tl-207 |
|
Ra-224 |
Rn-220, Po-216, Pb-212, Bi-212, Tl-208(0.36), Po-212 (0.64) |
|
Ra-226 |
Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210, Po-210 |
|
Ra-228 |
Ac-228 |
|
Th-228 |
Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64) |
|
Th-229 |
Ra-225, Ac-225, Fr-221, At-217, Bi-213, Po-213, Pb-209 |
|
Th-nat |
Ra-228, Ac-228, Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64) |
|
Th-234 |
Pa-234m |
|
U-230 |
Th-226, Ra-222, Rn-218, Po-214 |
|
U-232 |
Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64) |
|
U-235 |
Th-231 |
|
U-238 |
Th-234, Pa-234m |
|
U-nat |
Th-234, Pa-234m, U-234, Th-230, Ra-226, Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210, Po-210 |
|
Np-237 |
Pa-233 |
|
Am-242m |
Am-242 |
|
Am-243 |
Np-239 |
c [Reserved]
d These values apply only to compounds of uranium that take the chemical form of UF6, UO2F2 and UO2(NO3)2 in both normal and accident conditions of transport.
e These values apply only to compounds of uranium that take the chemical form of UO3, UF4, UCl4 and hexavalent compounds in both normal and accident conditions of transport.
f These values apply to all compounds of uranium other than those specified in notes (d) and (e) of this table.
g These values apply to unirradiated uranium only.
TABLE A-3-GENERAL VALUES FOR A1 AND A2
|
Contents |
A1 |
A2 |
Activity concentration for exempt material (Bq/g) |
Activity concentration for exempt material (Ci/g) |
Activity limits for exempt consignments (Bq) |
Activity limits for exempt consignments (Ci) |
||
|
(TBq) |
(Ci) |
(TBq) |
(Ci) |
|||||
|
Only beta or gamma emitting nuclides are known to be present |
1 x 10-1 |
2.7 x 100 |
2 x 10 -2 |
5.4 x 10-1 |
1 x 101 |
2.7 x 10-10 |
1 x 104 |
2.7 x10-7 |
|
Alpha emitting nuclides, but no neutron emitters, are known to be presenta |
2 x 10-1 |
5.4 x 100 |
9 x 10-5 |
2.4 x 10-3 |
1 x 10-1 |
2.7 x 10-12 |
1 x 103 |
2.7 x10-8 |
|
Neutron emitting nuclides are known to be present or no relevant data are available |
1 x 10-3 |
2.7 x 10-2 |
9 x 10-5 |
2.4 x 10-3 |
1 x 10-1 |
2.7 x 10-12 |
1 x 103 |
2.7 x 10-8 |
a If beta or gamma emitting nuclides are known to be present, the A1 value of 0.1 TBq (2.7 Ci) should be used.
TABLE A-4-ACTIVITY-MASS RELATIONSHIPS FOR URANIUM
|
UraniumEnrichment1 wt % U-235 present |
Specific Activity |
|
|
TBq/g |
Ci/g |
|
|
0.45 |
1.8 x 10-8 |
5.0 x 10-7 |
|
0.72 |
2.6 x 10-8 |
7.1 x 10-7 |
|
1 |
2.8 x 10-8 |
7.6 x 10-7 |
|
1.5 |
3.7 x 10-8 |
1.0 x 10-6 |
|
5 |
1.0 x 10-7 |
2.7 x 10-6 |
|
10 |
1.8 x 10-7 |
4.8 x 10-6 |
|
20 |
3.7 x 10-7 |
1.0 x 10-5 |
|
35 |
7.4 x 10-7 |
2.0 x 10-5 |
|
50 |
9.3 x 10-7 |
2.5 x 10-5 |
|
90 |
2.2 x 10-6 |
5.8 x 10-5 |
|
93 |
2.6 x 10-6 |
7.0 x 10-5 |
|
95 |
3.4 x 10-6 |
9.1 x 10-5 |
1 The figures for uranium include representative values for the activity of the uranium-234 that is concentrated during the enrichment process.
SECTION 5. RULES OF PRACTICE
This Section contains the requirements applicable to and governing the proceeding of any administrative hearing pertinent to these Regulations.
Except as specifically authorized by the Department in writing, no interpretations of the meaning of the regulations in this Section by an officer or employee of the Department other than a written interpretation by the Department Director or designee will be recognized as binding upon the Department.
Applications for the issuance of a license, amendment of a license at the request of the holder, and renewal of a license will be given a docket or other identifying number for administrative examination. The applicant may be required to submit additional information and may be requested to confer informally regarding the application. The Department will give to others such notice of the filing of applications as is required under the applicable provisions of these Regulations and such additional notices as it deems appropriate.
In the case of an application for renewal, if the licensee has made application for the renewal of a subsisting license at least thirty (30) days prior to its expiration date, the license shall not be deemed to have expired until such application shall have been determined.
In any case described in RH-4008. of this Regulation, the Department may issue to the licensee a notice to comply with the applicable provisions of the Act or the rules and regulations of the Arkansas State Board of Health or any order issued by the Department. The order shall apprise the licensee that he/she has the right to request a hearing within thirty (30) days by making a written request therefore to the Director. In the event a request for a hearing is received by the Director within the time specified, a notice of hearing shall be issued by the Department in accordance with RH-4028. of these Regulations.
Whenever the Department finds that an emergency exists requiring immediate action to protect the public health and safety, the Department may, without notice or hearing, issue a regulation or order reciting the existence of such emergency and requiring that such action be taken as is necessary to meet the emergency. Notwithstanding any provision of the Act (Act 8 of Second Extraordinary Session of 1961), such regulation or order shall be effective immediately. Any person to whom such regulation or order is directed shall comply therewith immediately, but on application to the Department shall be afforded a hearing within ten (10) days. On the basis of such hearing, the emergency regulation or order shall be continued, modified or revoked within thirty (30) days after such hearing. Any final order entered in any proceeding under this paragraph may be appealed within twenty (20) days from the date of issuance thereof, to the Circuit Court of Pulaski County.
In case of the failure on the part of any person, firm or corporation to comply with any lawful order of the Director or with process or in case of the refusal of any witness to testify concerning any matter on which he/she may be lawfully interrogated, the Circuit Court or a Judge thereof having jurisdiction may, on application of the Director, compel obedience by proceeding as in contempt cases.
The Department shall have the authority in the event of an emergency to impound or order the impounding of sources of ionizing radiation in the possession of any person who is not equipped to observe or fails to observe the provisions of the Act or any rules or regulations issued thereunder. As promptly as possible and not later than ten (10) days from the impounding, the Department shall serve upon the licensee or registrant an appropriate order for revocation of his/her license or registration together with a notice which shall give the licensee or registrant the right to request a formal hearing concerning the revocation of his/her license or registration and the restoration of the material of which he/she has been deprived.
Unless otherwise specified, papers required to be filed with the Department shall be filed with the Arkansas Department of Health, Radiation Control Section, 4815 West Markham Street, Slot 30, Little Rock, Arkansas, 72205-3867. Papers required to be filed with the Department shall be deemed filed upon actual receipt with the Department at the place specified, accompanied by proof of service upon the parties required to be served as provided in RH-4016. of these Regulations. Unless otherwise specified, the filing, when by mail or telegram, shall, upon actual receipt, be deemed complete as of the date of deposit in the mail or with the telegraph company. Papers may be filed in person at the Department's offices at Little Rock, Arkansas.
The time within which any Act under these Regulations is to be accomplished shall be computed by excluding the first day and including the last, unless the last day is Sunday or is a holiday as defined or fixed by statutes now or hereafter in force in this State, and then it shall also be excluded. If the day succeeding such Sunday or holiday is also a holiday or a Sunday, then such succeeding day shall also be excluded.
Extensions of time for filing or performing any Act required or allowed to be accomplished, and continuances of any proceeding or hearing, may be granted at the discretion of the Department upon application and good cause shown by any party, or upon the initiative of the Department or stipulation of all parties. Where a Hearing Officer has been designated for hearing, the discretion in granting extensions of time and continuances in matters relating to the hearing shall rest with the Hearing Officer.
Subpoenas for the attendance of witnesses from any place in the State of Arkansas or the production of books, papers, accounts or documents at a hearing in a pending proceeding will be issued by the Department upon its own motion or upon application in writing incorporating a showing that such subpoena is reasonably required.
A person permitted to intervene becomes a party to the proceeding.
Upon motion and good cause shown or upon its own initiative, the Department or Hearing Officer may consolidate two or more proceedings.
Any oath or affirmation required by or pursuant to the provisions of these Regulations may be administered by any person authorized to administer oaths by the laws of the State of Arkansas.
The procedure to be followed in informal hearings shall be such as will best serve the purpose of the hearing. For example, an informal hearing may consist of the submission of written data, views or arguments with or without oral argument, or may partake of the nature of a conference or may assume some of the aspects of a formal hearing in which the subpoena of witnesses and the production of evidence may be permitted or directed. A formal transcript is not necessarily required.
The parties to a formal hearing shall be the Department, the licensee, registrant or applicant as the case may be and any person permitted to intervene pursuant to RH-4018. of these Regulations.
With the consent of the Hearing Officer, limited appearances may be entered by persons who are not parties to a hearing without request for or grant of permission to intervene. With the consent of the Hearing Officer and on due notice to the parties, such persons may make oral or written statements of their position on the issues involved in the proceeding but may not otherwise participate in the hearing.
The hearings herein provided for may be conducted by the Director or the Director may designate Hearing Officers who shall have the power and authority to conduct hearings in the name of the Department at any reasonable time and place.
The function of the Hearing Officer is to schedule and conduct hearings on behalf and in the name of the Department on all matters referred for hearing by the Director. It is the duty of the Hearing Officer to cause to be prepared and furnished to the Director for decision, a complete written transcript of the record of the hearing which contains all evidence introduced at the hearing and all pleas, motions, objections and ruling of the Hearing Officer.
In appropriate cases the Department may file and serve a reply to the answer or, if the answer affects other parties to the proceeding, the Director or the Hearing Officer may permit such parties to file and serve a reply.
Failure of a party to file and serve an answer within the time provided in the notice of hearing or as prescribed herein or to appear at a hearing shall be deemed to authorize the Department, at its discretion, as to such party:
After answer has been filed, any party may file and serve upon the opposing side a written request for the admission of the genuineness and authenticity of any relevant documents described in or attached to the request or for the admission of the truth of any relevant matters of fact stated in the request. Each matter for which an admission is requested shall be deemed admitted unless within the time designated in the request, but not less than ten (10) days after service thereof or such further time as the Hearing Officer may allow upon motion and notice, the party to whom the request is directed serves upon motion and notice, the party to whom the request is directed serves upon the requesting party a sworn statement either denying the matters upon which the admission is requested or setting up the reasons why he/she cannot truthfully admit or deny such matters.
All formal hearings shall be public except in cases involving restricted data.
Briefs may be filed within ten (10) days after the close of the hearing provided, however, that the Director may, upon written application, grant an additional period of time not in excess of sixty (60) days within which briefs may be filed.
The Director shall, after reviewing the entire record of the hearing, make his/her findings and enter his/her order. The findings and order shall be in writing and shall contain a statement of findings and conclusions upon all material issues of fact and law and shall be signed by the Director. The original thereof shall be filed as a part of the record of the case which shall be retained in the custody of the Director unless an appeal is taken therefrom, and one certified copy of the findings and order shall be served on all parties to the proceeding.
Any person who is aggrieved by any ruling, decision, or action of the Director may appeal to the State Board of Health within thirty (30) days after service of said ruling, decision, or action by filing with the President of the State Board of Health a written complaint setting out the ruling, decision, or action complained of, the reason that such person is aggrieved and the relief sought by such person. A copy of such complaint shall also be served by the appealing party upon any other party in interest. No new evidence shall be introduced, and the appeal shall be tried upon the record prepared by the Director or Hearing Officer. Additional briefs and oral arguments may be granted by the State Board of Health. The State Board of Health may affirm the Findings and Order of the Director or may reverse, modify, or remand the case for further proceedings. Copies of the State Board of Health Order shall be served upon the parties in interest as provided in RH-4037. of this Regulation.
The parties to any hearing may agree to waive any one or more of the procedural steps which would otherwise precede the reaching of a final decision by the Department.
Except as provided below, all records shall be deemed public records and shall be open to inspection by the public. The following are not to be considered public records which are available for public inspection:
inspection if disclosure of its contents is not required in the public interest and would adversely affect the interest of a person concerned. Such withholding from public inspection shall not, however, affect the right of persons properly and directly concerned to inspect the document. Persons requesting that documents or information therein be withheld from public disclosure shall make prompt application identifying the material and giving the reasons. Where the applicant is responsible for the preparation of the document, he/she shall, insofar as is possible, segregate in a separate paper the information for which the special treatment is requested. The Department may honor the request upon a finding that public inspection is not required in the public interest and would adversely affect the interest of the person concerned. If the request is denied, the applicant will be notified thereof with a statement of the reasons.
SECTION 6.
LICENSES AND RADIATION SAFETY REQUIREMENTS FOR PARTICLE ACCELERATORS
In accordance with Act 596 of 2011, codified at Arkansas Code Annotated § 20-21-217, annual fees for licensing shall be paid. Nonpayment of fees shall result in escalated enforcement action and/or revocation of license.
|
CATEGORY |
FEE |
|
Particle accelerator, non-medical |
$200.00 |
|
Medical, therapy, non-hospital unit |
$250.00 per unit ($175.00 for each additional unit) |
|
Particle accelerator, medical, non-hospital unit |
$450.00 per unit ($300.00 for each additional unit) |
|
Cyclotron/accelerator for the production of radioactive material |
$3,750.00 |
|
CATEGORY |
FEE |
|
Arkansas State Board of Health Rules and Regulations for Control of Sources of Ionizing |
$0.00 for first copy $30.00 for each additional copy |
|
Radiation |
|
|
Amendment to existing license |
$50.00 per amendment |
Except where otherwise specified, all communications concerning these Regulations may be addressed to the Arkansas Department of Health, Radiation Control Section, 4815 West Markham Street, Slot 30, Little Rock, Arkansas, 72205-3867.
Except as specifically authorized by the Department in writing, no interpretations of the meaning of the regulations in this Section by an officer or employee of the Department other than a written interpretation by the Department Director or designee will be recognized as binding upon the Department.
Accelerator or 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 MeV. Therapeutic radiation machines capable of generating energies at or above 500 kV/keV shall be considered particle accelerators.
Accelerator License - Except where otherwise specified, a license issued pursuant to these Regulations.
Act - Act 8 of Second Extraordinary Session of 1961, as amended.
Calibration - The determination of the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or the strength of a source of radiation relative to a standard.
Control panel - The part of the radiation machine where the switches, knobs, push buttons, and other hardware necessary for manually setting the technique factors are located. For purposes of this Section, console is an equivalent term.
Department - Arkansas Department of Health.
Dosimetry system - A system of devices used for the detection, measurement, and display of qualitative and quantitative radiation exposures.
High Radiation Area - An area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 0.1 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates.
Human use - The internal or external administration of radiation or radioactive material to human beings.
Individual - Any human being.
Industrial radiography - The examination of the structure of materials by nondestructive methods utilizing a particle accelerator.
Interlock - A device preventing the start or continued operation of equipment unless certain predetermined conditions prevail.
Licensee - Any person who is licensed by the Department in accordance with these Regulations and the Act.
Operator - A person qualified by training and experience to assume responsibility for the safe operation of a particle accelerator.
Person - Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this State, any other State or political subdivision or agency thereof and any legal successor, representative, agent or agency of the foregoing, other than the U.S. Nuclear Regulatory Commission and other federal government agencies.
Personnel monitoring equipment - Devices designed to be worn by a single individual for the assessment of dose equivalent. Examples of personnel monitoring equipment are film badges, thermoluminescent dosimeters (TLDs), pocket ionization chambers, optically stimulated luminescence (OSL) dosimeters and personal ("lapel") air sampling devices.
Qualified Expert - An individual specifically approved by the Department as having the knowledge and training to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection matters. Individuals shall be certified in an appropriate field, commensurate with his/her duties, either by the American Board of Radiology, the American Board of Health Physics, the American Board of Medical Physics, or the Canadian College of Physicists in Medicine, or individuals may have equivalent qualifications. An individual that meets the qualifications in RH-10200.d. for a Qualified Medical Physicist also meets the qualifications of a Qualified Expert.
Radiation - Ionizing radiation, i.e., gamma rays and x-rays, alpha and beta particles, neutrons, high speed electrons, high speed protons, and other particles capable of producing ions. Radiation, as used in these Regulations, does not include non-ionizing radiation, such as radio waves or microwaves, or visible, infrared, or ultraviolet light.
Radiation Safety Officer - An individual who has the knowledge and responsibility to apply appropriate radiation protection regulations and has been assigned such responsibility by the licensee.
Research and Development -
Research and Development does not include the internal or external administration of radiation or radioactive material to human beings.
Test - The process of verifying compliance with an applicable regulation.
Very high radiation area - An area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of 500 rads (5 grays) in one (1) hour at one (1) meter from a radiation source or from any surface that the radiation penetrates.
Note: At very high doses received at high dose rates, units of absorbed dose (e.g., rads and grays) are appropriate, rather than units of dose equivalent (e.g., rems and sieverts).
No person shall receive, possess, use, transfer, own or acquire a particle accelerator except as authorized in a license issued pursuant to this Section.
Radiation Control Section Arkansas Department of Health 4815 West Markham Street, Slot 30 Little Rock, Arkansas 72205-3867
The application shall set forth all applicable information called for by the form.
A license application will be approved if the Department determines that:
In addition to the requirements set forth in RH-5202., a license for use of a particle accelerator in medical therapy will be issued only if:
In addition to the requirements of RH-5202., a license for the use of a particle accelerator in research and development will be issued only if:
In addition to the requirements of RH-5202., a license for the use of a particle accelerator to produce radioactive material will be issued only if:
In addition to the requirements of RH-5202., a license for the use of a particle accelerator in industrial radiography will be issued only if:
radiographers and radiographer's assistants in accordance with the provisions of RH-5411.
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 or necessary to effectuate the purposes of the Act.
provisions of the Act, now or hereafter in effect, and to all rules, regulations, and orders of the Department.
following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title II (Bankruptcy) of the United States Code by or against:
If a licensee does not submit an application for renewal of the
license in accordance with RH-5207, the licensee shall, on or before the expiration date specified in the license:
gamma radiation at 1 centimeter and 1 meter from surfaces (in units, multiples, or submultiples of rem or seiverts per hour or microroentgens per hour);
units, multiples, or submultiples of curies or becquerels per 100 square centimeters or in disintegrations per minute per 100 square centimeters);
to activities conducted under the license is detected, the licensee shall submit a certification that no detectable radioactive contamination was found. The Department will notify the licensee, in writing, of the termination of the license, once the certification has been approved.
contamination attributable to activities conducted under the license are found, the license continues in effect beyond the expiration date, if necessary, until the Department notifies the licensee, in writing, that the license is terminated.
material and whose license is to be terminated pursuant to paragraph d or e of this section shall:
Applications for amendment of a license shall be filed in accordance with RH-5201. and shall specify the respects in which the licensee desires the license to be amended and the grounds for such amendment.
In considering an application by a licensee to renew or amend the license, the Department will apply the criteria set forth in RH-5202. and RH-5203., and in Sections 3, 6, and 11 as applicable.
The licensee shall notify the Department in writing before making any change that would render the information contained in the license application and/or the license no longer accurate.
RADIATION SAFETY REQUIREMENTS FOR THE USE OF PARTICLE ACCELERATORS
This Part establishes radiation safety requirements for the use of particle accelerators. The provisions of this Part are in addition to, and not in substitution for, other applicable provisions of these Regulations.
unauthorized use.
conveyance system, a means shall be provided that either terminates the irradiation or prevents entry if an individual attempts to access the irradiation room.
system shall be provided to permit continuous observation of material being irradiated and any transfer or conveyance of material within an irradiation room. The viewing system shall be so located that the operator can observe the material being irradiated from the control panel. The accelerator shall not be used for irradiation unless at least one viewing system is operational.
shall be maintained, including the names of persons who performed the services. The licensee shall keep these records for inspection by the Department for five (5) years.
accordance with the licensee's written procedures.
continuously monitored. The monitoring devices shall be electrically independent of the accelerator control and safety interlock systems. The monitoring devices shall be capable of providing a remote and local readout with visible and/or audible alarms at both the control panel and monitoring stations. The monitoring devices shall be set to activate at a level of at least 100 mrem/hr.
Portable monitoring equipment shall be tested for proper operation
by way of a reference check performed at the following frequencies:
unrestricted area may be exposed to levels of radiation greater than those permitted by RH-1208.a. and RH-1208.b., the licensee shall ensure the following:
submitted to the Department within thirty (30) days following completion of the action that initiated the record requirement. Annual radiation protection surveys shall not be submitted unless it is discovered that radiation levels in unrestricted and/or restricted areas exceed the dose limits specified in Section 3 of these Regulations.
with written procedures approved by the Department to ensure that any particulate radioactivity present will not result in doses in excess of the limits specified in Section 3 of these Regulations. Records of surveys for airborne radioactivity shall be maintained for five (5) years.
performed in accordance with written procedures approved by the Department in order to quantify residual activity in target and other pertinent areas. Records of surveys for ambient radiation levels and removable contamination shall be maintained for five (5) years.
accelerators capable of generating energies above 10 MV (10 MeV) in order to request Department approval for release of the area for unrestricted use. Records of surveys pursuant to this paragraph shall be maintained for five (5) years.
with written procedures established by a Qualified Expert or the Radiation Safety Officer of the accelerator facility.
system. The dosimetry system calibration shall be traceable to a national standard. The calibration shall have been performed within the previous twenty-four (24) months and after any servicing that may have affected system calibration. Records of dosimetry system calibrations shall be maintained for five (5) years.
as to meet applicable requirements in "Permissible Doses, Levels, and Concentrations," Part C of Section 3.
instructions in at least the following:
Operators shall have received instruction in and shall have demonstrated an understanding of at least the following subjects in order to meet the requirements of RH-5401.a.1.:
equipment.
the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, the signature of the individual who performed the calibration, and the date of calibration.
EXEMPTIONS, ADDITIONAL REQUIREMENTS, INSPECTIONS, AND TESTS
NRC when the State and the NRC jointly determine:
its own initiative, grant such exemptions from the requirements of the regulations in this Section as it determines are authorized by law and will not result in undue hazard to public health and safety or property, and are otherwise in the public interest.
The Department may, by rule, regulation or order, impose upon any licensee such requirements in addition to those established in these Regulations as it deems appropriate or necessary to minimize danger to public health and safety or property.
Upon instruction from the Department, each licensee shall perform or cause to have performed and shall permit the Department to perform, such reasonable tests as the Department deems appropriate or necessary, including, but not limited to, tests of:
Sources of radiation shall be subject to impounding pursuant to Section 5 of these Regulations.
Each licensee shall maintain records of receipt, transfer, and disposal of accelerators specific to each authorized use location. The records shall include the following information and shall be kept until termination of the license:
Each record required by this Section must be legible throughout the specified retention period. The record may be the original or a reproduced copy or microform if such reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by Department regulations. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
SECTION 7. NATURALLY OCCURRING RADIOACTIVE MATERIAL (NORM)
The provisions and requirements of this Section shall take effect on June 1, 1992 and shall apply to all facilities or sites owned or controlled by a person on that date. Products distributed and disposals made prior to that date are not subject to the provisions of this Section.
This Section establishes radiation protection standards for the possession, use, transfer, and disposal of naturally occurring radioactive materials (NORM) not subject to regulation by the U.S. Nuclear Regulatory Commission.
These Regulations apply to any person who engages in the extraction, mining, beneficiating, processing, use, transfer, or disposal of NORM in such a manner as to alter the chemical properties or physical state of the NORM or its potential exposure pathway to humans.
The Regulations in this Section address the introduction of NORM into products in which neither the NORM nor the radiation emitted from the NORM is considered to be beneficial to the products. The manufacture and distribution of products containing NORM in which the NORM and/or its associated radiation(s) is considered to be a beneficial attribute are licensed under the provisions of Section 2. This Section also addresses waste management and disposal standards.
Beneficial attribute or beneficial to the product - The radioactivity of the product is necessary to the use of the product.
Beneficiating - The processing of materials for the purpose of altering the chemical or physical properties to improve the quality, purity, or assay grade.
Breathing zone - Used in determining respiratory requirements, the area of the body within one (1) foot of the mouth and nose of a worker.
Confirmatory survey - A survey by the potential general licensee of potentially contaminated land, equipment, or sites in order to establish, with reasonable certainty, the absence or magnitude of NORM contamination.
Designated facility - A specific-licensed facility capable of receiving NORM shipments for the purpose of processing, storage, or disposal of NORM.
Department - Arkansas Department of Health.
Dose commitment - The total radiation dose to a section 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.
General environment - The total terrestrial, atmospheric, and aquatic environments outside sites within which any activity, operation, or process authorized by a general or specific license issued under this Section is performed.
Licensing State - Means any State with regulations equivalent to the Suggested State Regulation for Control of Radiation relating to, and an effective program for, the regulatory control of NORM and which has been granted final designation by the Conference of Radiation Control Program Directors, Inc.
Major processor - A user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material, or exceeding four (4) times Type B quantities as sealed sources. Type A and B quantities are defined in RH-3100.
Natural radioactivity - Radioactivity of naturally occurring nuclides.
Naturally occurring radioactive material (NORM) - Any nuclide which is radioactive in its natural physical state (i.e., not man-made), but does not include byproduct, source, or special nuclear material.
NORM facility identification number - The number assigned by the Department to a specific facility of a NORM general licensee having more than one site possessing radioactive material exceeding the exemption criteria specified in RH-6005.
NORM field supervisor - An individual who answers to the corporate NORM RSO approved by the Department as being qualified to oversee radiation protection of workers after attending at least forty (40) hours of classroom training in NORM-related health physics and six (6) months documented on-the-job training with a Department-approved qualified third party Radiation Safety Officer.
NORM general license number - The number assigned by the Department to the generator or other responsible party possessing radioactive material exceeding the exemption criteria specified in RH-6005.
NORM Radiation Safety Officer (RSO) - An individual approved by the Department as being qualified to oversee radiation protection of workers after attending at least forty (40) hours of classroom training in NORM-related health physics and six (6) months documented on-the-the job training with a Department-approved qualified third party Radiation Safety Officer.
NORM surveyor - An individual who has completed at least sixteen (16) hours of classroom training and three (3) months documented on-the-job training in NORM-related surveying techniques and health physics approved by the State as being qualified to perform NORM confirmatory and release surveys at NORM job sites.
NORM waste management plan - The plan for the management, i.e., handling, interim storage and disposal, of NORM.
NORM worker - An individual who has completed at least eight (8) hours of classroom training in NORM-related health physics concerning the protection of the worker, hazards involved in dealing with NORM, and other subjects outlined in RH-6018.
Notifier - The person or party meeting the definition of a general licensee according to RH-6010. and therefore, subject to the notification requirement stated in RH-6010.a.1.
Product - Something produced, made, manufactured, refined, or beneficiated.
Regulations of the U.S. Department of Transportation - The regulations in 49 CFR Parts 100-189.
Release survey - The survey required to release either equipment or land for unrestricted use. A land release survey must be approved by the Department before land will be released for unrestricted use.
Working Level (WL) - Any combination of short-lived radon decay products in one liter of air that will result in the ultimate emission of alpha particles with a total energy of 130 billion electron volts.
The materials contain or are contaminated at concentrations less than 5 picocuries per gram of radium-226 and/or radium-228, 0.05% by weight of uranium or thorium, or 150 picocuries per gram of any other NORM radionuclide, provided that these concentrations are not exceeded at any time.
oil and crude oil products as fuel are exempt from the requirements of these Regulations. The distribution of natural gas and crude oil and the manufacturing and distribution of natural gas and crude oil products are exempt from the specific license requirements of this Section but are subject to the general license requirements in RH-6010.
A general license is hereby issued to mine, extract, receive, possess, own, use, process, and dispose of NORM not exempted in RH-6005. without regard to quantity. This general license does not authorize the manufacturing or distribution of products containing NORM in concentrations greater than those specified in RH-6005.a. nor the disposal of wastes from other entities. Persons subject to the general license shall notify the Department by filing the Notification of a NORM Facility Form with the Department. The Notification of NORM Facility Form is available from the Department.
NOTE: The Department recommends a general
licensee under RH-6010.a.1. conduct or arrange to have conducted a confirmatory survey to determine the extent and magnitude of the NORM contamination at the general licensee's facility.
The transfer of NORM not exempt from these Regulations from
one general licensee to another general licensee may be authorized by the Department if:
licensee who makes the transfer from the responsibilities of assessing the extent of NORM contamination or material present, evaluating the hazards of the NORM, informing the general licensee receiving the NORM of these assessments and evaluations, and maintaining records required by these Regulations.
license shall manage and dispose of wastes containing NORM:
Environmental Protection Agency for disposal of such wastes;
by the Department for five (5) years.
If the designated facility or receiving licensee is located outside the State of Arkansas, the generating or originating licensee must report the irregularities to the Department.
"I hereby declare that the contents of this consignment are fully and accurately described above by proper shipping name and are classified, packed, marked and labeled, and are in all respects in proper condition for transport according to applicable international and national government regulations."
This section describes the requirements for confirmatory site release surveys, and the training required before an individual may use survey instruments to release a NORM site or previously NORM contaminated equipment.
demonstrate competence in prior to being approved as a NORM surveyor.
A Worker Protection Plan must be submitted to the Department which includes, but may not be limited to, the following items:
The use of a respirator appropriate for radioactive particulates shall be worn or engineering controls should be utilized to prevent the potential airborne contaminates.
requirements:
radioactivity, including different sources of radioactivity (including NORM).
concerning worker's rights and responsibilities.
months on-the-job training.
radioactivity, including different sources of radioactivity (including NORM).
concerning worker's rights and responsibilities.
manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the NORM material or product to demonstrate that the material or product will meet the safety criteria set forth in RH-6023. The information shall include:
the material or product with identification of the manufacturer and/or initial transferor of the product and the radionuclide(s) and quantity of NORM in the material or product;
product to demonstrate the effectiveness of the containment, shielding, and other safety features under both normal and severe conditions of handling, storage, use, reuse, and disposal;
product, including any change in the form of the NORM contained in it, the extent to which the NORM may be released to the environment, any change in radiation levels, and any other changes in safety features;
commitments relevant to the safety criteria in RH-6023. and the basis for such estimates;
production of production lots of the material or product, and the quality control standards the material or product will be required to meet; and
an application for a specific license if the end uses of the product are frivolous or cannot be reasonably foreseen.
An applicant for a license under RH-6022.c. shall demonstrate that the product is designed and will be manufactured so that:
|
Part of Body |
Column I* Dose in Rem |
Column II* Dose in Rem |
|
Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye |
0.005 |
0.5 |
|
Hands and forearms; feet and ankles; localized area of skin averaged over areas no larger than 1 square centimeter |
0.075 |
7.5 |
|
Other organs |
0.015 |
1.5 |
* Dose limit is the dose above background from the product
bankruptcy was filed; and
Each licensee shall notify the Department, in writing, at least five (5) days prior to commencing decontamination or remediation activities at a customer's site. If, for a specific case, the five (5) day period would pose an undue hardship on the licensee, the licensee may, upon application to the Department, obtain permission to proceed sooner. The notification shall specify the following:
Each licensee shall notify the Department, in writing, within thirty (30) days following completion of NORM decontamination or remediation work. The notification shall specify the following:
stored. (If a street address is not available, a map must be provided.)
Each person licensed under RH-6022.c. shall:
If a licensee does not submit an application for license renewal
under RH-6028., the licensee shall on or before the expiration date specified in the license:
conducted under the license are found, the license continues in effect beyond the expiration date, if necessary, with respect to possession of residual NORM until the Department notifies the licensee in writing that the license is terminated. During this time, the licensee is subject to the provisions of RH-6027.e. In addition to the information submitted under RH-6027.d.l.D., the licensee shall submit a plan, if appropriate, for decontaminating the location(s) and disposing of the residual NORM.
following the expiration date specified in the license, shall:
Applications for amendment of a license shall be filed in accordance with RH-6021. and shall specify the respects in which the licensee desires the license to be amended and the grounds for such amendment.
In considering an application by a licensee to renew or amend the license, the Department will apply the criteria set for in RH-6022.
Each specific licensee shall, no less than thirty (30) days before vacating or relinquishing possession or control of premises which may have been contaminated with Naturally Occurring Radioactive Material as a result of the activities, notify the Department in writing of intent to vacate. When deemed necessary by the Department, the licensee shall decontaminate the premises in such a manner as the Department may specify.
Each specific licensee shall be subject to the financial assurance and recordkeeping for decommissioning under RH-409.h. of these Regulations.
Subject to 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:
APPENDIX A TO SECTION 7 ACCEPTABLE SURFACE CONTAMINATIONa LEVELS FOR NORM
|
Averageb,c,f |
Maximumb,d,f |
Removableb,c,e,f |
|
|
Alpha |
5,000 dpm/100 cm2 |
15,000 dpm/100 cm2 |
1,000 dpm/100 cm2 |
|
Beta-gamma |
5,000 dpm /100 cm2 |
15,000 dpm/100 cm2 |
1,000 dpm /100 cm2 |
a Where surface contamination by both alpha and beta-gamma emitting nuclides exists, the
limits established for alpha and beta-gamma emitting nuclides should apply independently.
b As used in this table, dpm (disintegrations per minute) means the rate of emission by
radioactive material as determined by correcting the counts per minute observed by an appropriate detector for background, efficiency, and geometric factors associated with the instrumentation.
c Measurements of average contamination level should not be averaged over more than one
square meter. For objects of less surface area, the average should be derived for each object.
d The maximum contamination level applies to an area of not more than 100 cm2.
e The amount of removable radioactive material per 100 cm2 of surface area should be determined by wiping that area with dry filter or soft absorbent paper, applying moderate pressure, and assessing the amount of radioactive material on the wipe with an appropriate instrument of known efficiency. When removable contamination on objects of surface area A (where A is less than 100 sq. cm) is determined, the entire surface should be wiped and the contamination level multiplied by 100/A to convert to a "per 100 sq. cm" basis.
f The average and maximum radiation levels associated with surface contamination resulting from beta-gamma emitters should not exceed 0.2 mrad/hr (2 µGy/hr) at one (1) cm and 1.0 mR/hr (10 µGy/hr) at 1 cm, respectively, measured through not more than seven (7) milligrams per square centimeter of total absorber.
SECTION 8. LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS
Act- Act 8 of Second Extraordinary Session of 1961, as amended. Annually - Either:
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.
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:
Doubly encapsulated sealed source - A sealed source in which the radioactive material is sealed within a capsule and that capsule is sealed within another capsule.
Irradiator - A facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding 5 grays (550 rads) per hour exist at one (1) meter from the sealed radioactive sources in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.
Irradiator operator - An individual who has successfully completed the training and testing described in RH-7051. and is authorized by the terms of the license to operate the irradiator without a supervisor present.
Panoramic dry-source-storage irradiator - An irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored in shields made of solid materials. The term includes beam-type dry-source-storage irradiators in which only a narrow beam of radiation is produced for performing irradiations.
Panoramic irradiator - An irradiator in which the irradiations are done in air in areas potentially accessible to personnel. The term includes beam-type irradiators.
Panoramic wet-source-storage irradiator - An irradiator in which the irradiations are done in air in areas potentially accessible to personnel and in which the sources are stored under water in a storage pool.
Pool irradiator - Any irradiator at which the sources are stored or used in a pool of water including panoramic wet-source-storage irradiators and underwater irradiators.
Product conveyor system - A system for moving the product to be irradiated to, from, and within the area where irradiation takes place.
Radiation room - A shielded room in which irradiations take place. Underwater irradiators do not have radiation rooms.
Radiation safety officer - An individual with responsibility for the overall radiation safety program at the facility.
Sealed source - Any radioactive material that is used as a source of radiation and is encased in a capsule designed to prevent leakage or escape of the radioactive material.
Seismic area - Any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in 250 years is greater than ten percent (10%), as designated by the U.S. Geological Survey.
Underwater irradiator - An irradiator in which the sources always remain shielded under water and humans do not have access to the sealed sources or the space subject to irradiation without entering the pool.
Except where otherwise specified, all communications concerning these Regulations may be addressed to the Arkansas Department of Health, Radiation Control Section, 4815 West Markham Street, Slot 30, Little Rock, Arkansas, 72205-3867.
Except as specifically authorized by the Department in writing, no interpretations of the meaning of the regulations in this Section by an officer or employee of the Department other than a written interpretation by the Department Director or designee will be recognized as binding upon the Department.
A person, as defined in RH-1100., shall file an application for a specific license authorizing the use of sealed sources in an irradiator in accordance with RH-403. and RH-404.
The Department will approve an application for a specific license for the use of licensed material in an irradiator if the applicant meets the requirements contained in this section.
including the frequency of the checks required by RH-7061.
The applicant may not begin construction of a new irradiator prior to the submission to the Department of both an application for a license for the irradiator and the fee required. As used in this section, the term "construction" includes the construction of any portion of the permanent irradiator structure on the site but does not include: engineering and design work, purchase of a site, site surveys or soil testing, site preparations, site excavation, construction of warehouse or auxiliary structures, and other similar tasks. Any activities undertaken prior to the issuance of a license are entirely at the risk of the applicant and having no bearing on the issuance of a license with respect to the requirements of the Act, and rules, regulations, and orders issued under the Act.
further information necessary to enable the Department to determine whether the application should be granted or denied.
before expiration of the license, upon the Department's request, submit written statements to enable the Department to determine whether the license should be modified, suspended, or revoked.
movable shielding, it must not be possible to operate the irradiator unless the shielding is in its proper location. This requirement may be met by interlocks that prevent operation if shielding is not placed properly or by an operating procedure requiring inspection of shielding before operating.
pool which must be locked to prevent access when the irradiator is not attended. Only operators and facility management may have access to keys to the personnel access barrier. There must be an intrusion alarm to detect unauthorized entry when the personnel access barrier is locked. Activation of the intrusion alarm must alert an individual (not necessarily onsite) who is prepared to respond or summon assistance.
detectors. The detectors must activate an audible alarm. The alarm must be capable of alerting a person who is prepared to summon assistance promptly. The sources must automatically become fully shielded if a fire is detected.
extinguishing system capable of extinguishing a fire without the entry of personnel into the room. The system for the radiation room must have a shut-off valve to control flooding into unrestricted areas.
require a key to actuate. Actuation of the mechanism must cause an audible signal to indicate that the sources are leaving the shielded position. Only one key may be in use at any time, and only operators or facility management may possess it. The key must be attached to a portable radiation survey meter by a chain or cable. The lock for source control must be designed so that the key may not be removed if the sources are in an unshielded position. The door to the radiation room must require the same key.
In either case, the licensee shall have a method to safely store the sources during repairs of the pool.
If the product to be irradiated moves on a product conveyor system, the source rack and the mechanism that moves the rack must be protected by a barrier or guides to prevent products and product carriers from hitting or touching the rack or mechanism.
Irradiators whose construction begins after January 1, 1997, must meet the design requirements of this section.
If the irradiator will use more than 2 x 1017 becquerels (5 million curies) of activity, the licensee shall evaluate the effects of heating of the shielding walls by the irradiator sources.
the number, location, and spacing of the smoke and heat detectors are appropriate to detect fires and that the detectors are protected from mechanical and radiation damage. The licensee shall verify that the design of the fire extinguishing system provides the necessary discharge patterns, densities, and flow characteristics for complete coverage of the radiation room and that the system is protected from mechanical and radiation damage.
the source rack will automatically return to the fully shielded position if offsite power is lost for more than ten (10) seconds.
licensee shall design the reinforced concrete radiation shields to retain their integrity in the event of an earthquake by designing to the seismic requirements of an appropriate source such as American Concrete Institute Standard ACI 318-89, "Building Code Requirements for Reinforced Concrete," Chapter 21, "Special Provisions for Seismic Design," or local building codes, if current.
wiring and electrical equipment in the radiation room are selected to minimize failures due to prolonged exposure to radiation.
These requirements must be met for irradiators whose construction begins after January 1, 1997. The requirements must be met prior to loading sources.
ability of the heat and smoke detectors to detect a fire, to activate alarms, and to cause the source rack to automatically become fully shielded. The licensee shall test the operability of the fire extinguishing system.
that the source racks can be returned to their fully shielded positions without offsite power.
to control the access control system, the licensee shall verify that the access control system will operate properly if offsite power is lost and shall verify that the computer has security features that prevent an irradiator operator from commanding the computer to override the access control system when it is required to be operable.
electrical wiring and electrical equipment that were installed meet the design specifications.
PART D.
RADIATION SAFETY REQUIREMENTS FOR THE
OPERATION OF IRRADIATORS
Department approval only if all of the following conditions are met:
If the licensee uses a radiation monitor on a pool water circulating system, the detection of above normal radiation levels must activate an alarm. The alarm set-point must be set as low as practical, but high enough to avoid false alarms. The licensee may reset the alarm set point to a higher level if necessary to operate the pool water purification system to clean up contamination in the pool if specifically provided for in written emergency procedures.
leaking source from service and have it decontaminated, repaired, or disposed of by a Department, U.S. Nuclear Regulatory Commission, or Agreement State licensee that is authorized to perform these functions. The licensee shall promptly check its personnel, equipment, facilities, and irradiated product for radioactive contamination. No product may be shipped until the product has been checked and found free of contamination. If a product has been shipped that may have been inadvertently contaminated, the licensee shall arrange to locate and survey that product for contamination. If any personnel are found to be contaminated, decontamination must be performed promptly. If contaminated equipment, facilities, or products are found, the licensee shall arrange to have them decontaminated or disposed of by a Department, U.S. Nuclear Regulatory Commission, or Agreement State licensee that is authorized to perform these functions. If a pool is contaminated, the licensee shall arrange to clean the pool until the contamination levels do not exceed the appropriate concentration in Table II-Column 2 of Appendix G to Section 3. (See RH-601. for reporting requirements.)
include, as a minimum, each of the following at the frequency specified in the license or license application:
must be repaired without undue delay.
The licensee shall maintain the following records at the irradiator for the periods specified.
of contamination checks required by RH-7059.b. for three (3) years from the date of each test.
three (3) years.
or irregularities, and major operating problems that involve required radiation safety equipment for three (3) years after repairs are completed.
as required by Part F and RH-600. of Section 2 of these Regulations.
control checks as required by RH-7041. until the license is terminated. The records must be signed and dated. The title or qualification of the person signing must be included.
Regulations, the licensee shall report the following events if not reported under other Sections of the Department Regulations:
as described in RH-1502.g.1. and a written report within thirty (30) days as described in RH-1502.g.2.
Sources of radiation shall be subject to impounding pursuant to Section 5 of these Regulations.
SECTION 9. USE OF RADIONUCLIDES IN THE HEALING ARTS
This Section establishes additional requirements and provisions for the specific use of radionuclides in the healing arts. These requirements and provisions provide for the protection of public health and safety. The requirements and provisions of this Section are in addition to, and not in substitution for, others in these Regulations. The requirements and provisions of these Regulations apply to applicants and licensees subject to this Section unless specifically exempted.
Each record required by Section 9 must be legible throughout the retention period specified by each Department regulation. The record may be the original, a reproduced copy, or a microform provided that the copy or microform is authenticated by authorized personnel and the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability of reproducing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
Nothing in this Section relieves the licensee from complying with applicable U.S. Food and Drug Administration, other Federal, and State requirements governing radioactive drugs or devices.
A licensee may conduct research involving human subjects using radioactive material provided:
Except where otherwise specified, all communications concerning these Regulations may be addressed to the Arkansas Department of Health, Radiation Control Section, 4815 West Markham Street, Slot 30, Little Rock, Arkansas, 72205-3867.
Except as specifically authorized by the Department in writing, no interpretations of the meaning of the regulations in this Section by an officer or employee of the Department other than a written interpretation by the Department Director or designee will be recognized as binding upon the Department.
management.
A licensee shall apply for and must receive a license amendment:
certification and the written attestation(s), signed by a preceptor, the Nuclear Regulatory Commission or Agreement State license, the permit issued by an NRC master material licensee, the permit issued by an NRC or Agreement State licensee of broad scope, the permit issued by an NRC master material license broad scope permittee, and for each individual no later than thirty (30) days after the date that the licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, or an authorized medical physicist, under RH-8011.b. For individuals permitted to work under RH-8011.b.4., within the same 30-day time frame, the licensee shall also provide, as appropriate, verification of completion of:
an authorized user under RH-8550.
days after:
A licensee possessing a Type A specific license of broad scope for medical use is exempt from:
The Department may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this Section as it determines are authorized by law and will not result in undue hazard to public health and safety or property, and are otherwise in the public interest.
Act - Act 8 of Second Extraordinary Session of 1961, as amended.
Address of use - The building or buildings that are identified on the license and where radioactive material may be received, prepared, used, or stored.
Agreement State - Any state with which the Atomic Energy Commission or the U.S. Nuclear Regulatory Commission has entered into an effective agreement under subsection 274 b. of the Atomic Energy Act of 1954 (68 Stat. 919), including any amendments thereto. Non-agreement State means any other State.
Area of use - A portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing radioactive material.
Authorized medical physicist means an individual who:
Authorized nuclear pharmacist means a pharmacist who:
Authorized user means a physician, dentist, or podiatrist who:
material license broad scope committee that is authorized to permit the medical use of radioactive material.
Brachytherapy - A method of radiation therapy on which plated, embedded, activated, or sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, intraluminal or interstitial application.
Brachytherapy source - A radioactive source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.
Client's address (as used in this Section) - The address of use or a temporary jobsite for the purpose of providing mobile medical service in accordance with RH-8425.
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.
Dedicated check source - A radioactive source that is used to assure the consistent response of a radiation detection or measurement device over several months or years.
Dentist - An individual licensed to practice dentistry by the state in which the Department is located.
Diagnostic clinical procedures manual - A collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration, or in the case of sealed sources for diagnosis, the procedure.
High dose-rate remote afterloader - A brachytherapy device that remotely delivers a dose rate in excess of 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.
Low dose-rate remote afterloader - A brachytherapy device that remotely delivers a dose rate of less than or equal to 2 gray (200 rads) per hour at the point or surface where the dose is prescribed.
Management - The chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.
Manual brachytherapy - A type of therapy in which brachytherapy sources are manually applied or inserted.
Medical institution - An organization in which several medical disciplines are practiced.
Medical use - The intentional internal or external administration of radioactive material or the radiation from radioactive material to patients or human research subjects under the supervision of an authorized user.
Medium dose-rate remote afterloader - A brachytherapy device that remotely delivers a dose rate of greater than 2 gray (200 rads) per hour, but less than or equal to 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.
Misadministration - An event that meets the criteria in RH-8800.a.
Mobile medical service - The transportation of radioactive material or its medical use at the client's address.
Output - The exposure rate, dose rate, or a quantity related in a known manner to these rates from a brachytherapy source, or a teletherapy, remote afterloader, or gamma stereotactic radiosurgery unit for a specified set of exposure conditions.
Patient intervention - Actions by the patient or human research subject, whether intentional or unintentional, such as dislodging or removing treatment devices or prematurely terminating the administration.
Pharmacist (as used in this Section) - An individual licensed by the appropriate authority to practice pharmacy in the state in which the Department is located.
Physician (as used in this Section) - A doctor of medicine or doctor of osteopathy licensed by the appropriate authority to prescribe drugs in the practice of medicine in the state in which the Department is located.
Podiatrist - An individual licensed by the appropriate authority to practice podiatry in the state in which the Department is located.
Positron Emission Tomography (PET) radionuclide production facility - A facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.
Preceptor - An individual who provides, directs, or verifies the training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, or a Radiation Safety Officer.
Prescribed dosage - the specified activity or range of activity of a radioactive drug as documented:
Prescribed dose:
Pulsed dose-rate remote afterloader - A special type of remote afterloading device that uses a single source capable of delivering dose rates in the "high dose-rate" range, but:
Radiation Safety Officer means an individual who:
Radioactive drug - Any chemical compound containing radioactive material that may be used on or administered to patients or human research subjects as an aid in the diagnosis, treatment, or prevention of disease or other abnormal condition.
Sealed source (as used in this Section) - Any 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 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.
Stereotactic radiosurgery - the use of external radiation in conjunction with a stereotactic guidance device to precisely deliver a dose to a treatment site.
Structured educational program - An educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training.
Teletherapy (as used in this Section) - A method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject.
Temporary jobsite (as used in this Section) - A location where mobile medical services are conducted other than the location(s) of use authorized on the license.
Therapeutic dosage - A dosage of unsealed radioactive material that is intended to deliver a radiation dose to a patient or human research subject for palliative or curative treatment.
Therapeutic dose - A radiation dose delivered from a sealed source containing radioactive material to a patient or human research subject for palliative or curative treatment.
Treatment site - The anatomical description of the tissue intended to receive a radiation dose, as described in a written directive.
Type of use - Use of radioactive material as specified under RH-8500., RH-8530., RH-8550., RH-8600., RH-8620., RH-8630., or RH-8670.
Unit Dosage - A dosage that:
Written directive - An authorized user's written order for the administration of radioactive material or radiation from radioactive material to a specific patient or human research subject, as specified in RH-8307.
Department approval if:
If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive will be acceptable, provided that the information contained in the oral directive is documented as soon as possible in writing in the patient's record and a written directive is prepared within 48 hours of the oral directive.
If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented as soon as possible in the patient's record and a revised written directive is signed by the authorized user within 48 hours of the oral revision.
Except as provided in RH-8318., the licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in RH-8300. to be an individual who:
recognized by the Nuclear Regulatory Commission or an Agreement State
and who meets the requirements in paragraphs (d) and (e) of RH-8315.
(The names of board certifications which have been recognized
by the Nuclear Regulatory Commission or an Agreement State will be
posted on the NRC's Web page.) To have its certification process
recognized, a specialty board shall require all candidates for certification
to:
college or university in physical science or engineering or biological science with a minimum of 20 college credits in physical science;
physics, other physical science, engineering, or applied mathematics from an accredited college or university;
certified in medical physics by a specialty board recognized by the Nuclear Regulatory Commission or an Agreement State; or
diagnostic and/or therapeutic services under the direction of physicians who meet the requirements for authorized users in RH-8318., RH-8540., or RH-8560.;
Has completed a structured educational program consisting of
both:
radiation surveys;
of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides;
radioactive contamination and using proper decontamination procedures;
Is a medical physicist who has been certified by a specialty board
whose certification process has been recognized by the Nuclear Regulatory Commission or an Agreement State under RH-8316.a. and has experience in radiation safety for similar types of use of radioactive material for which the licensee is seeking the approval of the individual as Radiation Safety Officer and who meets the requirements in paragraphs d. and e. of RH-8315.; or
nuclear pharmacist identified on the licensee's license and has experience with the radiation safety aspects of similar types of use of radioactive material for which the individual has Radiation Safety Officer responsibilities; and
is supervised by a Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user, as appropriate, who is authorized for the type(s) of use for which the licensee is seeking approval.
Except as provided in RH-8318., the licensee shall require the authorized medical physicist to be an individual who:
recognized by the Nuclear Regulatory Commission or an Agreement State and who meets the requirements in paragraphs b.2. and c. of RH-8316. (The names of board certifications which have been recognized by the Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's Web page.) To have its certification process recognized, a specialty board shall require all candidates for certification to:
Holds a master's or doctor's degree in physics, medical
physics, other physical science, engineering, or applied mathematics from an accredited college or university; and has completed one (1) year of full-time training in medical physics and an additional year of full-time work experience under the supervision of an individual who meets the requirements for an authorized medical physicist for the type(s) of use for which the individual is seeking authorization.
This training and work experience must be conducted in clinical radiation facilities that provide high-energy, external beam therapy (photons and electrons with energies greater than or equal to one (1) million electron volts) and brachytherapy services and must include:
satisfactorily completed the requirements in paragraphs c. and a.1. and a.2., or b.1. and c. of RH-8316., and has achieved a level of competency sufficient to function independently as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation must be signed by a preceptor authorized medical physicist who meets the requirements in RH-8316., RH-8318., or equivalent Nuclear Regulatory Commission or Agreement State requirements for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status; and
includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system. This training requirement may be satisfied by satisfactorily completing either a training program provided by the vendor or by training supervised by an authorized medical physicist authorized for the type(s) of use for which the individual is seeking authorization.
Except as provided in RH-8318, the licensee shall require the authorized nuclear pharmacist to be a pharmacist who:
recognized by the Department, the U.S. Nuclear Regulatory Commission or an Agreement State and who meets the requirements in paragraph (b)(2) of RH-8317. (The names of board certifications which have been recognized by the Department, U.S. Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's Web page.) To have its certification process recognized, a specialty board shall require all candidates for certification to:
Has completed 700 hours in a structured educational program
consisting of both:
radiation surveys;
of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha-or beta-emitting radionuclides;
events in the administration of radioactive material; and
radioactive contamination and using proper decontamination procedures; and
nuclear pharmacist, that the individual has satisfactorily completed the requirements in paragraphs (a)(1), (a)(2), and (a)(3) or (b)(1) of RH-8317. and has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist.
An individual identified as a Radiation Safety Officer, a
teletherapy or medical physicist, or a nuclear pharmacist on a Nuclear Regulatory Commission or Agreement State license or a permit issued by a Nuclear Regulatory Commission or Agreement State board scope licensee or master material license permit or by a master material license permittee of broad scope before October 1, 2006, need not comply with the training requirements of RH-8315., RH-8316., or RH-8317., respectively.
authorized medical physicist, or an authorized nuclear pharmacist on a Nuclear Regulatory Commission or Agreement State license or a permit issued by a Nuclear Regulatory Commission or Agreement State broad scope licensee or master material license permit or by a master material license permittee of broad scope between October 1, 2006 and October 1, 2012 need not comply with the training requirements of RH-8315., RH-8316., or RH-8317., respectively.
pharmacist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses or in the practice of nuclear pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, need not comply with the training requirements of RH-8315., RH-8316, or RH-8317., respectively, when performing the same uses.
A nuclear pharmacist, who prepared only radioactive drugs containing accelerator-produced radioactive materials, or a medical physicist, who used only accelerator-produced radioactive materials, at the locations and time period identified in this paragraph, qualifies as an authorized nuclear pharmacist or an authorized medical physicist, respectively, for those materials and uses performed before these dates, for purposes of Section 9, "Use of Radionuclides in the Healing Arts."
Physicians, dentist, or podiatrists identified as authorized users for
the medical use of radioactive material on a license issued by the Nuclear Regulatory Commission or Agreement State, a permit issued by a Nuclear Regulatory Commission master material licensee, a permit issued by a Nuclear Regulatory Commission or Agreement State broad scope licensee, or a permit issued by a broad scope permittee before October 1, 2006, who perform only those medical uses for which they were authorized on that date need not comply with the training requirements of RH-8510., RH-8540., RH-8560., RH-8570., RH-8580., RH-8590., RH-8610., RH-8615., RH-8621., and RH-8660 (Parts E through I of this Section).
the medical use of radioactive material on a license issued by the Nuclear Regulatory Commission or Agreement State, a permit issued by a Nuclear Regulatory Commission master material licensee, a permit issued by a Nuclear Regulatory Commission or Agreement State board scope licensee, or a permit issued by a Nuclear Regulatory Commission master material license broad scope permittee who perform only those medical uses for which they were authorized between October 1, 2006 and October 1, 2012 need not comply with the training requirements RH-8510., RH-8540., RH-8560., RH-8570., RH-8580., RH-8590., RH-8610., RH-8615., RH-8621., and RH-8660 (Parts E through I of this Section).
in this section may serve as preceptors for, and supervisors of, applicants seeking authorization on Department licenses for the same uses for which these individuals are authorized.
The training and experience specified in Section 9's Part C (General Administrative Requirements), Part E (Unsealed Radioactive Material - Written Directive Not Required), Part F (Unsealed Radioactive Material - Written Directive Required), Part G (Manual Brachytherapy), Part H (Sealed Sources for Diagnosis), and Part I (Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units) must have been obtained within the seven (7) years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed.
Each licensee shall establish written quality control procedures for all diagnostic equipment used for radionuclide studies. As a minimum, quality control procedures and frequencies shall be those recommended by equipment manufacturers or procedures, which have been approved by the Department. The licensee shall conduct quality control procedures in accordance with written procedures.
installation over the range of volumes and volume configurations for which it will be used.
exceed twelve (12) months or after instrument servicing, except for battery changes;
Any person authorized by RH-8005. for medical use of radioactive material may receive, possess, and use the following radioactive material for check, calibration and reference use:
Each syringe and vial that contains a radioactive drug shall be labeled to identify the radioactive drug. Each syringe shield and vial shield shall also be labeled unless the label on the syringe or vial is visible when shielded.
A licensee shall require each individual preparing or handling a vial that contains a radioactive drug to keep the vial in a vial radiation shield.
detection survey instrument at the end of each day of use all areas where radioactive drugs containing radioactive material were prepared for use or administered.
area(s) where patients or human research subjects are confined when they cannot be released pursuant to RH-8420.
who has been administered unsealed radioactive material or implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 0.5 rem (5 mSv) per year.
RH-8421- RH-8424. Reserved.
UNSEALED RADIOACTIVE MATERIAL - WRITTEN DIRECTIVE NOT REQUIRED
Except for quantities that require a written directive under RH-8307., a licensee may use any unsealed radioactive material prepared for medical use for uptake, dilution, or excretion studies that is:
A licensee authorized to use radioactive material for uptake, dilution, and excretion studies shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range of one (1) microsievert (0.1 mrem) per hour to 500 microsieverts (50 mrems) per hour. The instrument shall be operable and calibrated in accordance with RH-8402.
Except as provided in RH-8318., the licensee shall require an authorized user of unsealed radioactive material for the uses authorized under RH-8500. to be a physician who:
Has completed 60 hours of training and experience, including a
minimum of eight (8) hours of classroom and laboratory training in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for uptake, dilution, and excretion studies. The training and experience must include:
user who meets the requirements in RH-8318., RH-8510., RH-8540., or RH-8560., or equivalent Nuclear Regulatory Commission or Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph a.1. or c.1. of RH-8510. and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under RH-8500.
Except for quantities that require a written directive under RH-8307., a licensee may use any unsealed radioactive material prepared for medical use for imaging and localization studies that is:
the requirements in RH-8540, or RH-8560 and RH-8540.c.1.B.vii., or
of the authorized nuclear pharmacist in paragraph (b)(1) of RH-8530. or the physician who is an authorized user in paragraph (b)(2) of RH-8530.;
A licensee authorized to use radioactive material for imaging and localization studies shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range of one (1) microsievert (0.1 mrem) per hour to 500 microsieverts (50 mrems) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range of ten (10) microsieverts (1 mrem) per hour to ten (10) millisieverts (1000 mrems) per hour. The instruments shall be operable and calibrated in accordance with RH-8402.
Except as provided in RH-8318., the licensee shall require an authorized user of unsealed radioactive material for the uses authorized under RH-8530. to be a physician who:
been recognized by the Nuclear Regulatory Commission or an Agreement State and who meets the requirements in paragraph c.2. of RH-8540. (The names of board certifications which have been recognized by the Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's Web page.) To have its certification process recognized, a specialty board shall require all candidates for certification to:
Has completed 700 hours of training and experience, including a
minimum of 80 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for imaging and localization studies. The training and experience must include, at a minimum:
preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and
user who meets the requirements in RH-8318., RH-8540., or RH-8560. and RH-8540.c.1.B.vii., or equivalent Nuclear Regulatory Commission or Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph a.1. or c.1. of RH-8540. and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under RH-8500. and RH-8530.
UNSEALED RADIOACTIVE MATERIAL - WRITTEN DIRECTIVE REQUIRED
A licensee may use any unsealed radioactive material prepared for medical use and for which a written directive is required that is:
In addition to the requirements of RH-2803. of these regulations:
therapy and hospitalized for compliance with RH-8420., a licensee shall:
user shall be notified immediately if the patient or human research subject dies or has a medical emergency.
A licensee authorized to use radioactive material for which a written directive is required shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range of one (1) microsievert (0.1 mrem) per hour to 500 microsieverts (50 mrems) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range of ten (10) microsieverts (1 mrem) per hour to ten (10) millisieverts (1000 mrems) per hour. The instruments shall be operable and calibrated in accordance with RH-8402.
Except as provided by RH-8318, the licensee shall require an authorized user of radioactive material for the uses authorized under RH-8550. to be a physician who:
Has completed 700 hours of training and experience, including a
minimum of 200 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material requiring a written directive. The training and experience must include:
user who meets the requirements in RH-8318., RH-8560. or equivalent Nuclear Regulatory Commission or Agreement State requirements. A supervising authorized user who meets the requirements in RH-8560.b. must also have experience in administering dosages in the same dosage category or categories (i.e., RH-8560.b.1.B.vii.) as the individual requesting authorized user status. The work experience must involve:
materials safely and performing the related radiation surveys;
instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;
material safely and using proper decontamination procedures;
emitter, or a photon-emitting radionuclide with a photon energy less than 150 keV, for which a written directive is required; and/or
radionuclide, for which a written directive is required; and
satisfactorily completed the requirements in paragraphs a.1. and b.1.B.vii. or b.1. of RH-8560. and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under RH-8550. The written attestation must be signed by a preceptor authorized user who meets the requirements in RH-8318., RH-8560., or equivalent Nuclear Regulatory Commission or Agreement State requirements. The preceptor authorized user who meets the requirements in RH-8560.b. must have experience in administering dosages in the same dosage category or categories (i.e., RH-8560.b.1.B.vii.) as the individual requesting authorized user status.
Except as provided in RH-8318., the licensee shall require an authorized user for the oral administration of sodium iodide I-131 in quantities less than or equal to 1.22 gigabecquerels (33 millicuries), for which a written directive is required, to be a physician who:
Has successfully completed 80 hours of classroom and laboratory
training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training must include:
Except as provided in RH-8318., the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries) to be a physician who:
Has successfully completed 80 hours of classroom and laboratory
training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training must include:
who meets the requirements in RH-8318., RH-8560., RH-8580., or equivalent Nuclear Regulatory Commission or Agreement State requirements. A supervising authorized user, who meets the requirements in RH-8560.b., must also have experience in administering dosages as specified in RH-8560.b.1.B.vii.(b). The work experience must involve:
completed the requirements in paragraphs c.1. and c.2. of RH-8580., and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under RH-8550. The written attestation must be signed by a preceptor authorized user who meets the requirements in RH-8318., RH-8560., RH-8580., or equivalent Nuclear Regulatory Commission or Agreement State requirements. A preceptor authorized user, who meets the requirements in RH-8560.b., must also have experience in administering dosages as specified in RH-8560.b.1.B.vii.(b).
Except as provided in RH-8318., the licensee shall require an authorized user for the parenteral administration requiring a written directive, to be a physician who:
Has successfully completed 80 hours of classroom and
laboratory training, applicable to parenteral administrations, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required. The training must include:
who meets the requirements in RH-8318., RH- 8560., RH-8590., or equivalent Nuclear Regulatory Commission or Agreement State requirements, in the parenteral administration, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required. A supervising authorized user who meets the requirements in RH-8560. must have experience in administering dosages as specified in RH-8560.b.1.B.vii.(c) and/or RH-8560.b.1.B.vii.(d). The work experience must involve:
satisfactorily completed the requirements in paragraph b. or c. of RH-8590., and has achieved a level of competency sufficient to function independently as an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive. The written attestation must be signed by a preceptor authorized user who meets the requirements in RH-8318., RH-8560., RH-8590., or equivalent Nuclear Regulatory Commission or Agreement State requirements. A preceptor authorized user, who meets the requirements in RH-8560., must have experience in administering dosages as specified in RH-8560.b.1.B.vii.(c) and/or RH-8560.b.1.B.vii.(d).
A licensee shall use only brachytherapy sources for therapeutic medical uses:
In addition to the requirements of RH-2803.:
and cannot be released in accordance with RH-8420., a licensee shall:
The licensee shall perform acceptance testing on the treatment planning system in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:
A licensee authorized to use manual brachytherapy sources shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range of one (1) microsievert (0.1 mrem) per hour to 500 microsieverts (50 mrems) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range of ten (10) microsieverts (1 mrem) per hour to ten (10) millisieverts (1000 mrems) per hour. The instruments shall be operable and calibrated in accordance with RH-8402.
Except as provided in RH-8318., the licensee shall require an authorized user of a manual brachytherapy source for the uses authorized under RH-8600. to be a physician who:
Has completed a structured educational program in basic
radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes:
Except as provided in RH-8318., the licensee shall require the authorized user of strontium-90 for ophthalmic radiotherapy to be a physician who:
Has completed 24 hours of classroom and laboratory training
applicable to the medical use of strontium-90 for ophthalmic radiotherapy. The training must include:
supervision of an authorized user at a medical institution, clinic, or private practice that includes the use of strontium-90 for the ophthalmic treatment of five individuals. This supervised clinical training must involve:
user who meets the requirements in RH-8318., RH-8610., RH-8615., or equivalent Nuclear Regulatory Commission or Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph b. of RH-8615. and has achieved a level of competency sufficient to function independently as an authorized user of strontium-90 for ophthalmic use.
A licensee shall use only sealed sources for diagnostic medical uses:
Except as provided in RH-8318., the licensee shall require the authorized user of a diagnostic sealed source for use in a device authorized under RH-8620. to be a physician, dentist, or podiatrist who:
PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS
A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units for therapeutic medical uses:
Regulatory Commission or an Agreement State shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source(s), reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).
treatment room entrance door is closed;
treatment room, to respond to a source that inadvertently:
output or activity is determined by the manufacturer, a licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two (2) conditions must be met.
traceable to the National Institute of Standards and Technology (NIST) and published protocols accepted by nationally recognized bodies; or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration must have been performed within the previous two (2) years and after any servicing that may have affected system calibration; or
years; 18 to 30 months after that calibration, the system must have been intercompared with another dosimetry system that was calibrated within the past 24 months by NIST or by a calibration laboratory accredited by the AAPM. The results of the inter-comparison must have indicated that the calibration factor of the licensee's system had not changed by more than two percent (2%). The licensee may not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating sealed sources for therapeutic units, the licensee shall use a comparable unit with beam attenuators or collimators, as applicable, and sources of the same radionuclide as the source used at the licensee's facility.
perform full calibration measurements on each teletherapy unit:
must include determination of:
perform output spot-checks on each teletherapy unit once in each calendar month that include determination of:
The licensee shall perform acceptance testing on the treatment planning system in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:
A licensee authorized to use radioactive material in remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range of one (1) microsievert (0.1 mrem) per hour to 500 microsieverts (50 mrems) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range of ten (10) microsieverts (1 mrem) per hour to ten (10) millisieverts (1000 mrems) per hour. The instruments shall be operable and calibrated in accordance with RH-8402.
Except as provided in RH-8318., the licensee shall require an authorized user of a sealed source for a use authorized under RH-8630. to be a physician who:
Has completed a structured educational program in basic
radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes:
periodic spot-checks;
doses and times;
radiation therapy, under an authorized user who meets the requirements in RH-8318., RH-8660., or equivalent Nuclear Regulatory Commission or Agreement State requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by paragraph b.1.B. of RH-8660.; and
satisfactorily completed the requirements in paragraph a.1. or paragraphs b.1. and b.2., and paragraph c. of RH-8660., and has achieved a level of competency sufficient to function independently as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The written attestation must be signed by a preceptor authorized user who meets the requirements in RH-8318., RH-8660., or equivalent Nuclear Regulatory Commission or Agreement State requirements for an authorized user for each type of therapeutic medical unit for which the individual is requesting authorized user status; and
use for the type(s) of use for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an authorized user or authorized medical physicist, as appropriate, who is authorized for the type(s) of use for which the individual is seeking authorization.
OTHER MEDICAL USES OF RADIOACTIVE MATERIAL OR RADIATION FROM RADIOACTIVE MATERIAL
A licensee may use radioactive material or a radiation source approved for medical use that is not specifically addressed in Section 9 if:
A licensee shall retain a record of each radiation protection program change made in accordance with RH-8301.a. for five (5) years. The record must include a copy of the old and new procedures; the effective date of the change; and the signature of the licensee management that reviewed and approved the change.
A licensee shall retain a copy of each written directive as required by RH-8307. for three (3) years.
A licensee shall retain a record of misadministrations reported in accordance with RH-8800. for three (3) years. The record must contain the licensee's name; names of the individuals involved; the social security number or other identification number, if one has been assigned, of the individual who is the subject of the misadministration; a brief description of the event; why it occurred; the effect, if any, on the individual; the actions, if any, taken, or planned, to prevent recurrence; and, whether the licensee notified the individual (or the individual's responsible relative or guardian) and, if not, whether such failure to notify was based on guidance from the referring physician.
A licensee shall retain a record of a dose to an embryo/fetus or a nursing child reported in accordance with RH-8801 for three (3) years. The record must contain the licensee's name; names of all the individuals involved; social security number or other identification number if one has been assigned to the pregnant individual or nursing child who is the subject of the event; a brief description of the event; why it occurred; the effect, if any, on the embryo/fetus or nursing child; the actions, if any, taken, or planned, to prevent recurrence; and whether the licensee notified the pregnant individual or mother (or the mother's or child's responsible relative or guardian) and, if not, whether such failure to notify was based on guidance from the referring physician.
A licensee shall maintain a record of instrument checks and tests required by RH-8401. for three (3) years, excluding geometry test records where only the most current record must be maintained. The records must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.
A licensee shall maintain a record of survey instrument calibrations required by RH-8402. for three (3) years. The record must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.
A licensee shall maintain a record of dosage determinations required by RH-8403. for three (3) years. The record must contain the radioactive drug; the patient's or human research subject's name, or identification number if one has been assigned; prescribed dosage; the determined dosage, or a notation that the total activity is less than 1.1 megabecquerel (30 µCi); the date and time of the dosage determination; and the name of the individual who determined the dosage.
A licensee shall retain a record of the quarterly physical inventory of sealed sources and brachytherapy sources required by RH-8405.e. for three (3) years. The inventory record must contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its nominal activity, the location of each source, and the name of the individual who performed the inventory.
A licensee shall retain a record of each survey required by RH-8408. for three (3) years. The record must include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.
for authorizing the release of an individual pursuant to RH-8420.a., if the total effective dose equivalent is calculated by:
A licensee shall maintain records of the disposal of licensed materials, as required by RH-8410., for three (3) years. The record must include the date of the disposal, the survey instrument used, the background radiation level, the radiation level measured at the surface of each waste container, and the name of the individual who performed the survey.
A licensee shall maintain a record of the radionuclide contaminant concentration tests required by RH-8531. for three (3) years. The record must include, for each measured elution of radionuclide used to prepare a radioactive drug, the ratio of the measures expressed as kilobecquerel of contaminant per megabecquerel of desired radionuclide (microcuries/millicuries), or microgram of contaminant per megabecquerel of desired radionuclide (microgram/millicuries), the time and date of the measurement, and the name of the individual who made the measurement.
A licensee shall maintain a record of safety instructions and training required by RH-8551., RH-8603., and RH-8633. for three (3) years. The record must include a list of the topics covered, the date of the instruction or training, the name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction.
A licensee shall maintain a record of the surveys required by RH-8601. and RH-8631. for three (3) years. Each record must include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey.
A licensee shall maintain a record of the calibrations on brachytherapy sources required by RH-8605. for three (3) years after the last use of the source. The record must include the date of the calibration; the manufacturer's name, model number, and serial number for the source and the instruments used to calibrate the source; the source output or activity; source positioning accuracy within applicators; and the signature of the authorized medical physicist.
A licensee shall maintain a record of the of the activity of a strontium-90 source required by RH-8605. for the life of the source. The record must include the date and initial activity of the source as determined under RH-8605., and for each decay calculation, the date, the source activity, and the signature of the authorized medical physicist.
A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units as required by RH-8632. for three (3) years. For each installation, maintenance, adjustment, and repair, the record must include the date, description of the service, and name(s) of the individual(s) who performed the work.
check and the signature of the authorized medical physicist who reviewed the record of the spot-check.
research subject, a licensee shall report any event in which the administration of radioactive material or radiation from radioactive material results in:
site that exceeds by 0.5 Sievert (50 rem) to an organ or tissue and fifty percent (50%) of the dose expected from the administration defined in the written directive (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site).
To meet the requirements of this paragraph, the notification of the individual who is the subject of the misadministration may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, the licensee shall inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide such a written description if requested.
To meet the requirements of this paragraph, the notification may be made to the mother's or child's responsible relative or guardian instead of the mother, when appropriate. If a verbal notification is made, the licensee shall inform the mother, or the mother's or child's responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide such a written description if requested.
A licensee shall file a report with the Department within five (5) days if a leakage test required by RH-8405. reveals the presence of 185 Becquerel (0.005 µCi) or more of removable contamination. The written report must include the model number and serial number, if assigned, of the leaking source; the radionuclide and its estimated activity; the results of the test; the date of the test; and the action taken.
Sources of radiation shall be subject to impounding pursuant to Section 5 of these Regulations.
SECTION 10. [RESERVED]
SECTION 11. THERAPEUTIC RADIATION MACHINES
A licensee or registrant may use therapeutic radiation machines to conduct research involving human subjects, provided the research is conducted, funded, supported, or regulated by a Federal Agency that has implemented the Federal Policy for the Protection of Human Subjects. Otherwise, a licensee or registrant shall apply for and receive approval of a specific amendment to its Department license or registration before conducting such research. Both types of licensees/registrants shall, at a minimum, obtain prior informed consent from the human subjects and obtain prior review and approval of the research activities by an Institutional Review Board in accordance with the meaning of these terms as defined and described in the Federal Policy for the Protection of Human Subjects.
Nothing in this Section relieves the licensee or registrant from complying with applicable U.S. Food and Drug Administration, other Federal, and State requirements governing therapeutic radiation machines or auxiliary devices.
Except where otherwise specified, all communications concerning these Regulations may be addressed to the Arkansas Department of Health, Radiation Control Section, 4815 West Markham Street, Slot 30, Little Rock, Arkansas, 72205-3867.
Except as specifically authorized by the Department in writing, no interpretations of the meaning of the regulations in this Section by an officer or employee of the Department other than a written interpretation by the Department Director or designee will be recognized as binding upon the Department.
The Department may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this Section as it determines are authorized by law and will not result in undue hazard to public health and safety or property, and are otherwise in the public interest.
Absorbed dose (D) - The mean energy imparted by ionizing radiation to matter. Absorbed dose is determined as the quotient of dE by dM, where dE is the mean energy imparted by ionizing radiation to matter of mass dM. The SI unit of absorbed dose is joule per kilogram, and the special name of the unit of absorbed dose is the gray (Gy). The previously used special unit of absorbed dose (rad) is being replaced by the gray.
Absorbed dose rate - Absorbed dose per unit time, for machines with timers, or dose monitor unit per unit time for linear accelerators.
Accessible surface - Surface of equipment or of an equipment part that can be easily or accidentally touched by persons without the use of a tool.
Act - Act 8 of Second Extraordinary Session of 1961, as amended.
Added filtration - Any filtration which is in addition to the inherent filtration.
Air kerma (K) - The kinetic energy released in air by ionizing radiation. Kerma is determined as the quotient of dE by dM, where dE is the sum of the initial kinetic energies of all the charged ionizing particles liberated by uncharged ionizing particles in air of mass dM. The SI unit of air kerma is joule per kilogram and the special name for the unit of kerma is the gray (Gy).
Barrier - See "protective barrier."
Beam axis - The axis of rotation of the beam limiting device.
Beam-limiting device - A field defining collimator, integral to the therapeutic radiation machine, which provides a means to restrict the dimensions of the useful beam.
Beam monitoring system - A system designed and installed in the radiation head to detect and measure the radiation present in the useful beam.
Beam scattering foil - A thin piece of material (usually metallic) placed in the beam to scatter a beam of electrons in order to provide a more uniform electron distribution in the useful beam.
Bent beam linear accelerator - A linear accelerator geometry in which the accelerated electron beam must change direction by passing through a bending magnet.
Beam quality - A term that describes the penetrating power of the x-ray beam. This is identified numerically by half-value layer and is influenced by kilovolt peak (kVp) and filtration.
Beam quality (accelerator) - A term that describes the type and penetrating power of the ionizing radiation produced for certain machine settings.
Central axis of the beam - An imaginary line passing through the center of the useful beam and the center of the plane figure formed by the edge of the first beam-limiting device.
Changeable filters - Any filter, exclusive of inherent filtration, which can be removed from the useful beam through any electronic, mechanical, or physical process.
Collimator - A device or mechanism by which the x-ray beam is restricted in size.
Contact therapy system - A therapeutic radiation machine with a short target-skin distance (TSD), usually less than 5 centimeters.
Conventional simulator - Any x-ray system designed to reproduce the geometric conditions of the radiation therapy equipment.
Detector - See "radiation detector."
Diaphragm - A device or mechanism by which the x-ray beam is restricted in size.
Dose monitor unit (DMU)- A unit response from the beam monitoring system from which the absorbed dose can be calculated.
Dosimetry system- A system of devices used for the detection, measurement, and display of qualitative and quantitative radiation exposures.
Electronic brachytherapy- A method of radiation therapy where an electrically generated source of ionizing radiation is placed in or near the tumor or target tissue to deliver therapeutic radiation dosage.
Electronic brachytherapy device- The system used to produce and deliver therapeutic radiation including the x-ray tube, the control mechanism, the cooling system, and the power source.
Electronic brachytherapy source- The x-ray tube component used in an electronic brachytherapy device.
External beam radiation therapy- Therapeutic irradiation in which the source of radiation is at a distance from the body.
Field-flattening filter- A filter used to homogenize the absorbed dose rate over the radiation field.
Field size- The dimensions along the major axes of an area in a plane perpendicular to the central axis of the beam at the normal treatment or examination source to image distance and defined by the intersection of the major axes and the 50% isodose line.
Filter- Material placed in the useful beam to change beam quality in therapeutic radiation machines subject to RH-10301.
Gantry- That part of a radiation therapy system supporting and allowing movements of the radiation head about a center of rotation.
Gray (Gy)- The SI unit of absorbed dose, kerma, and specific energy imparted equal to 1 joule per kilogram. The previous unit of absorbed dose (rad) is being replaced by the gray (1 Gy=100 rad).
Half-value layer (HVL)- The thickness of a specified substance which, when introduced into the path of a given beam of radiation, reduces the radiation field quantity to one-half its original value.
Healing arts- Any treatment, operation, diagnosis, prescription, or practice for the ascertainment, cure, relief, palliation, adjustment, or correction of any human disease, ailment, deformity, injury, or unhealthy or abnormal physical or mental condition.
Institutional Review Board (IRB)- Any board, committee, or other group formally designated by an institution to review, approve the initiation of, and conduct periodic review of biomedical research involving human subjects.
Intensity Modulated Radiation Therapy (IMRT)- Radiation therapy that uses non-uniform radiation beam intensities which have been determined by various computer-based optimization techniques.
Interlock- A device preventing the start or continued operation of equipment unless certain predetermined conditions prevail.
Interruption of irradiation- The stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.
Irradiation- The exposure of a living being or matter to ionizing radiation.
Isocenter- The center of the sphere through which the useful beam axis passes while the gantry moves through its full range of motions.
Kilovolt (kV) [kilo electron volt (keV)] - The energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one thousand volts in a vacuum. (Note: current convention is to use kV for photons and keV for electrons.)
Kilovolt peak (kVp) - See "peak tube potential."
Lead equivalence - The thickness of lead affording the same attenuation, under specified conditions, as the material in question.
Leakage radiation - Radiation emanating from the radiation therapy system except for the useful beam.
Light field - The area illuminated by light, simulating the radiation field.
mA- Milliampere.
Megavolt (MV) [mega electron volt (MeV)] -The energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one million volts in a vacuum. (Note: current convention is to use MV for photons and MeV for electrons.)
Misadministration - An event that meets the criteria in RH-10201.b.
Mobile Electronic Brachytherapy Service - Transportation of an electronic brachytherapy device to provide electronic brachytherapy at an address that is not the address of record.
Monitor unit (MU) - See "dose monitor unit."
Moving beam radiation therapy - Radiation therapy with any planned displacement of radiation field or patient relative to each other, or with any planned change of absorbed dose distribution. It includes arc, skip, conformal, intensity modulation, and rotational therapy.
Nominal treatment distance -
Output - The exposure rate (air kerma rate), dose rate, or a quantity related to these rates from a therapeutic radiation machine.
Patient - An individual subjected to machine produced radiation for the purposes of medical therapy. The term "patient" also applies to a human research subject.
Patient intervention - Actions by the patient or human research subject, whether intentional or unintentional, such as prematurely terminating the administration.
Peak tube potential - The maximum value of the potential difference in kilovolts across the x-ray tube during an exposure.
Periodic quality assurance check - A procedure which is performed to ensure that a previous parameter or condition continues to be valid.
Phantom - An object behaving in essentially the same manner as tissue, with respect to absorption or scattering of the ionizing radiation in question.
Prescribed dose - The total dose and dose per fraction as documented in the written directive. The prescribed dose is an estimation from measured data from a specified therapeutic machine using assumptions that are clinically acceptable for that treatment technique and historically consistent with the clinical calculations previously used for patients treated with the same clinical technique.
Primary dose monitoring system - A system that will monitor the useful beam during irradiation and that will terminate irradiation when a pre-selected number of dose monitor units have been delivered.
Primary protective barrier - See "protective barrier."
Protective barrier - A barrier of radiation absorbing material(s) used to reduce radiation exposure. The types of protective barriers are as follows:
Qualified Medical Physicist - An individual qualified in accordance with RH-10200.d.
Radiation detector - A device that in the presence of radiation provides, by either direct or indirect means, a signal or other indication suitable for use in measuring one or more quantities of incident radiation.
Radiation field - See "useful beam."
Radiation head - The structure from which the useful beam emerges.
Radiation therapy system - An x-ray system that utilizes prescribed doses of ionizing radiation for treatment.
Redundant beam monitoring system - A combination of two independent dose monitoring systems in which each system is designed to terminate irradiation in accordance with a pre-selected number of dose monitor units.
Scattered radiation - Ionizing radiation emitted by interaction of ionizing radiation with matter, the interaction being accompanied by a change in direction of the radiation. Scattered primary radiation means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam.
Secondary dose monitoring system - A system which will terminate irradiation in the event of failure of the primary dose monitoring system.
Secondary protective barrier - See "protective barrier."
Shutter- A device attached to the tube housing assembly which can totally intercept the useful beam and which has a lead equivalency not less than that of the tube housing assembly.
Sievert (Sv)- The SI unit of dose equivalent. The unit of dose equivalent is the joule per kilogram. The previous unit of dose equivalent (rem) is being replaced by the sievert (1 Sv=100 rem).
Simulator (radiation therapy simulation system)- Any x-ray system intended for localizing the volume to be exposed during radiation therapy and establishing the position and size of the therapeutic irradiation field. (See "conventional simulator" and "virtual simulator.")
Source - The region and/or material from which the radiation emanates.
Source-skin distance (SSD)- See "target-skin distance."
Stationary beam radiation therapy- Radiation therapy without displacement of one or more mechanical axes relative to the patient during irradiation.
Stray radiation- The sum of leakage and scattered radiation.
Target- That part of an x-ray tube or accelerator onto which a beam of accelerated particles is directed to produce ionizing radiation or other particles.
Target-skin distance (TSD)- The distance measured along the beam axis from the center of the front surface of the x-ray target and/or electron virtual source to the surface of the irradiated object or patient.
Tenth-value layer (TVL)- The thickness of a specified substance which, when introduced into the path of a given beam of radiation, reduces the radiation field quantity to one-tenth of its original value.
Termination of irradiation- The stopping of irradiation in a fashion which will not permit continuance of irradiation without the resetting of operating conditions at the control panel.
Therapeutic radiation machine- X-ray or electron-producing equipment designed and used for external beam radiation therapy. For the purpose of these Regulations, devices used to administer electronic brachytherapy shall also be considered therapeutic radiation machines.
Tube- An x-ray tube, unless otherwise specified.
Tube housing assembly - The tube housing with tube installed. It includes high-voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing.
Useful beam- The radiation emanating from the tube housing port or the radiation head and passing through the aperture of the beam limiting device when the exposure controls are in a mode to cause the therapeutic radiation machine to produce radiation.
Virtual simulator - A computed tomography (CT) unit used in conjunction with relevant software which recreates the treatment machine; and that allows import, manipulation, display, and storage of images from CT and/or other imaging modalities.
Virtual source - A point from which radiation appears to originate.
Wedge filter - A filter which effects continuous change in transmission over all or a part of the useful beam.
Written directive - An order in writing for the administration of radiation to a specific patient or human research subject. Written directives shall meet the requirements in RH-10201.
X-ray tube - Any electron tube which is designed to be used primarily for the production of x-rays.
The licensee or registrant shall be responsible for directing the operation of the therapeutic radiation machines that have been licensed/registered with the Department. The licensee or registrant or an agent of the licensee/registrant shall ensure that the requirements of Section 11 are met in the operation of the therapeutic radiation machine(s).
shall require the Authorized User to be a physician who:
Oncology or Therapeutic Radiology; or
prior to 1976 (combined diagnostic and therapeutic radiology program); or
Oncology; or
classroom and laboratory training shall include:
measurement of ionization radiation; and
experience, training shall be under the supervision of an Authorized User and shall include:
supervised clinical experience, training shall include one (1) year in a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education (ACGME) or the Council on Postdoctoral Training (COPT) of the American Osteopathic Association and an additional two (2) years of clinical experience in therapeutic radiology under the supervision of an Authorized User. The supervised clinical experience shall include:
machine doses and collaborating with the Authorized User in the review of patients' progress and consideration of the need to modify originally prescribed doses and/or treatment plans as warranted by patients' reaction to radiation; and
shall require the Qualified Medical Physicist to be an individual who:
Radiation Oncology Physics; or
This training and work experience shall be conducted in clinical radiation facilities that provide high-energy external beam radiation therapy (photons and electrons with energies greater than or equal to one MV/one MeV). During the year of work experience, the tasks listed in RH-10300.a., RH-10301.p./RH-10302.t., and RH-10301.q./RH-10302.u. shall have been performed under the supervision of an individual who meets the requirements for a Qualified Medical Physicist.
Notwithstanding the provisions of RH-10200.g., a licensee or registrant may permit any physician to act as a Visiting Authorized User under the terms of the licensee's or registrant's license/registration for up to sixty (60) days per calendar year under the following conditions:
machine shall be instructed in and shall comply with the provisions of the licensee's or registrant's quality management program. In addition to the requirements of Section 11, these individuals are also subject to the requirements of RH-1200., RH-1302., and RH-1500.d. of these Regulations.
The licensee or registrant shall maintain the following information in a separate file for each therapeutic radiation machine, for inspection by the Department:
license/registration number;
prescribing physician;
To meet the requirements of this subparagraph, the notification may be made to the pregnant individual's responsible relative or guardian instead of to the pregnant individual. If a verbal notification is made, the licensee or registrant shall inform the pregnant individual, or the pregnant individual's responsible relative or guardian, that a written description of the event can be obtained from the licensee/registrant upon request. The licensee or registrant shall provide such a written description if requested.
the United States Food and Drug Administration (FDA) to Title 21, CFR Part 1020 shall maintain copies of those variances at the pertinent authorized use locations until transfer or disposal of the therapeutic radiation machine or termination of the license or registration.
Each record required by this Section must be legible throughout the specified retention period. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, must include all pertinent information, such as stamps, initials, and signatures. The licensee or registrant shall maintain adequate safeguards against tampering with and loss of records.
Each licensee, registrant, or applicant subject to RH-10301., RH-10302., or RH-10307. shall develop, implement, and maintain a quality management program to provide high confidence that radiation will be administered as directed by the Authorized User.
The quality management program shall address, at a minimum, the following specific objectives:
If because of the patient's/human research subject's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's/human research subject's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented as soon as possible in writing in the patient's/human research subject's record and a revised written directive is signed by an Authorized User within 48 hours of the oral revision.
The licensee or registrant shall develop, implement, and maintain written procedures to provide high confidence that:
calculations to verify they are correct and in accordance with the written directive; and
intervention of a patient or human research subject in which the administration of therapeutic radiation machine radiation results, or will result in, unintended permanent functional damage to an organ or a physiological system as determined by a physician.
individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the licensee/registrant upon request. The licensee or registrant shall provide such a written description if requested.
A licensee or registrant shall retain a record of misadministrations reported in accordance with RH-10201.b. for five (5) years. The record shall contain the following:
facility, in the opinion of the Qualified Medical Physicist, is in violation of applicable regulations. Any deficiencies detected during the survey shall be corrected prior to using the therapeutic radiation machine.
If the survey required by RH-10300.a. indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by RH-1208.a. and RH-1208.b., before beginning the treatment program the licensee or registrant shall ensure the following:
radiation shielding is added to ensure compliance with RH-1208.a. and RH-1208.b.;
system calibration and comparison for five (5) years. For each calibration or comparison, the record shall include the following: the date of the calibration or comparison; the manufacturer's name, model numbers, and serial numbers of the instruments that were calibrated or compared as required by RH-10300.c.1. and RH-10300.c.2.; the correction factors that were determined; the names of the individuals who performed the calibration or comparison; and evidence that the comparison was performed by, or under the direct supervision and in the physical presence of, a Qualified Medical Physicist.
The licensee or registrant for any therapeutic radiation machine subject to RH-10301. or RH-10302. shall furnish a copy of the records required in RH-10300.a.. and RH-10300.b. to the Department within thirty (30) days following completion of the action that initiated the record requirement. Annual radiation protection surveys shall not be submitted unless it is discovered that radiation levels in unrestricted and/or restricted areas exceed the dose limits specified in Section 3 of these Regulations.
When the x-ray tube is operated at its maximum rated tube current for the maximum kV, the leakage air kerma rate shall not exceed the value specified at the distance specified for that classification of therapeutic radiation machine:
The leakage air kerma rate measured at any position 5 centimeters from the tube housing assembly shall not exceed 100 mrad (1 mGy) in any one hour.
The leakage air kerma rate measured at a distance of 1 meter from the target in any direction shall not exceed 1 rad (1 cGy) in any 1 hour. This air kerma rate measurement may be averaged over areas no larger than one hundred square centimeters (100 cm2). In addition, the air kerma rate at a distance of 5 centimeters from the surface of the tube housing assembly shall not exceed 30 rad (30 cGy) per hour.
Permanent diaphragms or cones used for limiting the useful beam shall provide at least the same degree of attenuation as required for the tube housing assembly.
The filter system shall be so designed that:
The tube housing assembly shall be so marked that it is possible to determine the location of the source to within five (5) millimeters, and such marking shall be readily accessible for use during calibration procedures.
Contact therapy tube housing assemblies shall have a removable shield of material, equivalent in attenuation to 0.5 millimeters of lead at 100 kV, that can be positioned over the entire useful beam exit port during periods when the beam is not in use.
A suitable irradiation control device shall be provided to terminate the irradiation after a pre-set time interval.
In addition to other applicable requirements specified in Section 11, the control panel shall also:
When a control panel may energize more than one x-ray tube:
There shall be a means of determining the central axis TSD to within one (1) centimeter and of reproducing this measurement to within two (2) millimeters thereafter.
Unless it is possible to bring the x-ray output to the prescribed exposure parameters within 5 seconds after the x-ray "ON" switch is energized, the beam shall be attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly. In addition, after the unit is at operating parameters, the shutter shall be controlled by the operator from the control panel. An indication of shutter position shall appear at the control panel.
Each therapeutic radiation machine equipped with a beryllium or other low-filtration window shall be clearly labeled as such upon the tube housing assembly and shall be provided with a permanent warning device on the control panel that is activated when no additional filtration is present, to indicate that the dose rate is very high.
In addition to shielding adequate to meet requirements of RH-10305., the treatment room shall meet the following design requirements:
Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel. The therapeutic radiation machine shall not be used for irradiation of patients unless continuous two-way aural communication is possible.
Provision shall be made to permit continuous observation of the patient during irradiation, and the viewing system shall be so located that the operator can observe the patient from the control panel. The therapeutic radiation machine shall not be used for irradiation of patients unless at least one viewing system is operational.
Treatment rooms that contain a therapeutic radiation machine capable of operating above 150 kV shall meet the following additional requirements:
indicate that the radiation output differs by more than five percent (5%) from the value obtained at the last full calibration and the difference cannot be reconciled; and
repair, or modification of components that could significantly affect the characteristics of the radiation beam.
with multi-energy capabilities is required only for those modes and/or energies that are not within their acceptable range; and
affect all energies, full calibration shall be performed on the affected energy that is in most frequent clinical use at the facility. The remaining energies may be validated with quality assurance check procedures against the criteria in RH-10301.p.1.C.i.
check required by RH-10301.q. for five (5) years. The record shall include the results of the check plus the following: the date of the quality assurance check; the manufacturer's name, model number, and serial number of the therapeutic radiation machine; the manufacturer's name, model numbers, and serial numbers for the instruments used to measure the radiation output of the therapeutic radiation machine; the name of the individual who performed the periodic quality assurance check; and the signature of the Qualified Medical Physicist who reviewed the quality assurance check.
Each facility location authorized to use a therapeutic radiation machine in accordance with RH-10301. shall possess appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 mrem (10 µSv) per hour to 1000 mrem (10 mSv) per hour. The survey instrument(s) shall be operable in accordance with RH-10303. and shall be calibrated in accordance with RH-10304.
Each facility location authorized to use a therapeutic radiation machine in accordance with RH-10302. shall possess appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range of 1 mrem (10 µSv) per hour to 1000 mrem (10 mSv) per hour. The survey instrument(s) shall be operable in accordance with RH-10303. and shall be calibrated in accordance with RH-10304.
any point outside the maximum sized useful beam, but within a circular plane of radius two (2) meters which is perpendicular to and centered on the central axis of the useful beam at the nominal treatment distance (i.e., patient plane), shall not exceed a maximum of 0.2 percent and an average of 0.1 percent of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements shall be averaged over an area not exceeding one hundred square centimeters (100 cm2) at a minimum of sixteen (16) points uniformly distributed in the plane.
All adjustable or interchangeable beam limiting devices shall attenuate the useful beam such that at the nominal treatment distance, the maximum absorbed dose anywhere in the area shielded by the beam limiting device(s) shall not exceed two percent (2%) of the maximum absorbed dose on the central axis of the useful beam measured in a 100 cm2 radiation field, or maximum available field size if less than 100 cm2;
All adjustable or interchangeable electron applicators shall attenuate the radiation, including but not limited to photon radiation generated by electrons incident on the beam limiting device and electron applicator and other parts of the radiation head, such that the absorbed dose in a plane perpendicular to the central axis of the useful beam at the nominal treatment distance shall not exceed:
Measurements of leakage radiation through the beam limiting devices shall be made with the beam limiting devices closed and any residual aperture blocked by at least two (2) tenth value layers of suitable absorbing material. In the case of overlapping beam limiting devices, the leakage radiation through each set shall be measured independently at the depth of maximum dose. Measurements shall be made using a radiation detector of area not exceeding ten square centimeters (10 cm2);
Measurements of leakage radiation through the electron applicators shall be made with the electron beam directed into the air and using a radiation detector of area up to but not exceeding one (1) square centimeter suitably protected against radiation which has been scattered from material beyond the radiation detector. Measurements shall be made using one (1) centimeter of water equivalent build up material.
For equipment manufactured after November 30, 2014, the licensee shall determine during acceptance testing, or obtain from the manufacturer, data sufficient to ensure that x-ray stray radiation in the useful electron beam, absorbed dose at the surface during x-ray irradiation, and stray neutron radiation in the useful x-ray beam are in compliance with the most current revision of International Electrotechnical Commission (IEC) Document 60601-2-1.
All therapeutic radiation machines subject to RH-10302. shall be provided with redundant beam monitoring systems. The sensors for these systems shall be fixed in the useful beam during treatment to indicate the dose monitor unit rate.
correct functioning of the other system(s); and
scale multiplying factors;
of dose monitor units has been made at the treatment control panel;
A system shall be provided from whose readings the air kerma rate or absorbed dose rate at a reference point can be calculated. The radiation detectors specified in RH-10302.f. may form part of this system. In addition:
It shall be possible to terminate irradiation and equipment movement or go from an interruption condition to termination condition at any time from the operator's position at the treatment control panel.
If a therapeutic radiation machine has an interrupt mode, it shall be possible to interrupt irradiation and equipment movements at any time from the treatment control panel. Following an interruption it shall be possible to restart irradiation by operator action without any reselection of operating conditions. If any change is made of a pre-selected value during an interruption, irradiation and equipment movements shall be automatically terminated.
A suitable irradiation control device shall be provided to terminate the irradiation after a pre-set time interval.
control panel. The timer shall have a pre-set time selector and an elapsed time indicator;
Equipment capable of both x-ray therapy and electron therapy shall meet the following additional requirements:
Equipment capable of generating radiation beams of different energies shall meet the following requirements:
made at the treatment control panel;
Therapeutic radiation machines capable of both stationary beam radiation therapy and moving beam radiation therapy shall meet the following requirements:
In addition to shielding adequate to meet requirements of RH-10305., the following design requirements shall apply:
All protective barriers shall be fixed, except for access doors to the treatment room or movable beam interceptors;
In addition to other applicable requirements specified in Section 11, the control panel shall also:
Windows, mirrors, closed-circuit television, or an equivalent viewing system shall be provided to permit continuous observation of the patient following positioning and during irradiation and shall be so located that the operator may observe the patient from the treatment control panel. The therapeutic radiation machine shall not be used for irradiation of patients unless at least one viewing system is operational;
Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel. The therapeutic radiation machine shall not be used for irradiation of patients unless continuous two-way aural communication is possible;
Treatment room entrances shall be provided with warning lights in a readily observable position near the outside of all access doors. These warning lights shall indicate when the useful beam is "ON" and when it is "OFF";
Interlocks shall be provided such that all access controls are activated before treatment can be initiated or continued. If the radiation beam is interrupted by any access control, it shall not be possible to restore the machine to operation without resetting the access control and reinitiating irradiation by manual action at the control panel;
If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with RH-1208.a. and RH-1208.b., interlocks shall be provided to prevent the production of radiation, unless the beam interceptor is in place, whenever the useful beam is directed at the designated barrier(s);
At least 1 emergency power cutoff switch shall be located in the radiation therapy room and shall terminate all equipment electrical power including radiation and mechanical motion. This switch is in addition to the termination switch required by RH-10302.k. All emergency power cutoff switches shall include a manual reset so that the therapeutic radiation machine cannot be restarted from the unit's control console without resetting the emergency cutoff switch;
All safety interlocks shall be designed so that any defect or component failure in the safety interlock system prevents or terminates operation of the therapeutic radiation machine; and
Surveys for residual activity shall be conducted on all therapeutic radiation machines capable of generating energies above 10 MV (10 MeV) prior to machining, removing, or working on therapeutic radiation machine components which may have become activated due to photo-neutron production. Records of surveys pursuant to this subparagraph shall be maintained for five (5) years.
facilities having therapeutic radiation machines with energies of 500 kV and above. The Qualified Medical Physicist shall be responsible for:
the licensee, the operating procedures required by RH-10302.s. shall also specifically address how the Qualified Medical Physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the Qualified Medical Physicist can be reached for instruction.
Quality assurance for Intensity-Modulated Radiation Therapy (IMRT) shall:
of a reference check performed at the following frequencies:
Quality assurance for a conventional or virtual simulator shall:
performance; and
Each facility location authorized to use an electronic brachytherapy device in accordance with RH-10307. shall possess appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range of 1 mrem (10 µSv) per hour to 1000 mrem (10 mSv) per hour. The survey instrument(s) shall be operable in accordance with RH-10303. and shall be calibrated in accordance with RH-10304. for the applicable electronic brachytherapy source energy.
In addition to shielding adequate to meet requirements of RH-10305., the treatment room shall meet the following design requirements:
cycle unless each treatment room entrance door is closed;
door is opened; and
In addition to other applicable requirements specified in Section 11, the control panel shall also:
A suitable irradiation control device (timer) shall be provided to terminate the irradiation after a pre-set time interval or integrated charge on a dosimeter-based monitor.
maintained at the electronic brachytherapy device control console.
following:
and the names of the individuals responsible for implementing corrective actions; and
Authorized Users, the Qualified Medical Physicist, and the Radiation Safety Officer to be contacted if the device or console operates abnormally.
chamber.
The registrant shall perform acceptance testing on the treatment planning system of electronic brachytherapy-related computer systems in accordance with current published recommendations from a recognized national professional association with expertise in electronic brachytherapy (when available). In the absence of an acceptance testing protocol published by a national professional association, the manufacturer's acceptance testing protocol shall be followed.
The following training requirements are in addition to the training and experience requirements of RH-10200.c. for therapeutic radiation machine Authorized Users and RH-10200.d. for Qualified Medical Physicists:
A registrant providing mobile electronic brachytherapy service shall, at a minimum:
A person shall not utilize any device which is designed to electrically generate a source of ionizing radiation to deliver therapeutic radiation dosage, and which is not appropriately regulated under any existing category of therapeutic radiation machine, until:
with:
Department to utilize the device in accordance with the regulations and specific conditions the Department considers necessary for the medical use of the device.
Sources of radiation shall be subject to impounding pursuant to Section 5 of these Regulations.
APPENDIX A TO SECTION 11 INFORMATION ON RADIATION SHIELDING REQUIRED FOR PLAN REVIEWS
In addition to the requirements listed in Section I above, therapeutic radiation machine facilities which produce only photons with a maximum energy less than or equal to 150 kV shall submit shielding plans which contain, at a minimum, the following additional information:
In addition to the requirements listed in Section I above, therapeutic radiation machine facilities that produce photons with a maximum energy in excess of 150 kV and/or electrons shall submit shielding plans which contain, at a minimum, the following additional information:
In addition to the requirements listed in Section III above, therapeutic radiation machine facilities that are capable of generating energies above 10 MV (10 MeV) shall submit shielding plans which contain, at a minimum, the following additional information:
FOOTNOTES TO SECTION 11
1/ Electronic brachytherapy devices are subject to the requirements of RH-10307.
and are exempt from the requirements of RH-10301.
2/ "IMRT Commissioning: Multiple Institution Planning and Dosimetry
Comparisons, a Report from AAPM Task Group 119" - AAPM Report No. 119, prepared by the Work Group on IMRT Task Group No. 119, and "Dosimetry Tools and Techniques for IMRT" - AAPM Report No. 120, prepared by the Work Group on IMRT Task Group No. 120, provide further recommendations.
3/ "Comprehensive QA for Radiation Oncology," - AAPM Report No. 46, prepared
by the Radiation Therapy Committee Task Group No. 40, provides recommendations regarding conventional simulators. "Quality Assurance for Computed-Tomography Simulators and the Computed-Tomography-Simulation Process: Report of the AAPM Radiation Therapy Committee Task Group No. 66," - AAPM Report No. 83, prepared by the Radiation Therapy Committee Task Group No. 66, provides recommendations regarding virtual simulators.
SECTION 12.
PHYSICAL PROTECTION OF CATEGORY 1 AND CATEGORY 2 QUANTITIES OF RADIOACTIVE MATERIAL
This Section has been established to provide the requirements for the physical protection program for any licensee that possesses an aggregated category 1 or category 2 quantity of radioactive material listed in Appendix A to this Section. These requirements provide reasonable assurance of the security of category 1 or category 2 quantities of radioactive material by protecting these materials from theft or diversion. Specific requirements for access to material, use of material, transfer of material, and transport of material are included. No provision of this Section authorizes possession of licensed material.
Access control - A system for allowing only approved individuals to have unescorted access to the security zone and for ensuring that all other individuals are subject to escorted access.
Act - Act 8 of the Second Extraordinary Session of 1961, as amended.
Aggregated - Accessible by the breach of a single physical barrier that would allow access to radioactive material in any form, including any devices that contain the radioactive material, when the total activity equals or exceeds a category 2 quantity of radioactive material.
Agreement State - Any state with which the Atomic Energy Commission or the U.S. Nuclear Regulatory Commission has entered into an effective agreement under subsection 274 b. of the Atomic Energy Act of 1954 (68 Stat. 919), including any amendments thereto. Non-agreement State means any other State.
Approved individual - An individual whom the licensee has determined to be trustworthy and reliable for unescorted access in accordance with Part B of this Section and who has completed the training required by RH-11043.c.
Background investigation - The investigation conducted by a licensee or applicant to support the determination of trustworthiness and reliability.
Carrier - A person engaged in the transportation of passengers or property by land or water as a common, contract, or private carrier, or by civil aircraft.
Category 1 quantity of radioactive material - A quantity of radioactive material meeting or exceeding the category 1 threshold in Table 1 of Appendix A to this Section. This is determined by calculating the ratio of the total activity of each radionuclide to the category 1 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds 1, the quantity would be considered a category 1 quantity. Category 1 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.
Category 2 quantity of radioactive material - A quantity of radioactive material meeting or exceeding the category 2 threshold but less than the category 1 threshold in Table 1 of Appendix A to this Section. This is determined by calculating the ratio of the total activity of each radionuclide to the category 2 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds 1, the quantity would be considered a category 2 quantity. Category 2 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.
Diversion - The unauthorized movement of radioactive material subject to this Section to a location different from the material's authorized destination inside or outside of the site at which the material is used or stored.
Escorted access - Accompaniment while in a security zone by an approved individual who maintains continuous direct visual surveillance at all times over an individual who is not approved for unescorted access.
Fingerprint orders - The orders issued by the U.S. Nuclear Regulatory Commission or the legally binding requirements issued by Agreement States that require fingerprints and criminal history records checks for individuals with unescorted access to category 1 and category 2 quantities of radioactive material or safeguards information-modified handling.
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.
License issuing authority - The licensing agency that issued the license, i.e., the Department, the appropriate agency of an Agreement State, or the U.S. Nuclear Regulatory Commission.
Local law enforcement agency (LLEA) - A public or private organization that has been approved by a federal, state, or local government to carry firearms and make arrests, and is authorized and has the capability to provide an armed response in the jurisdiction where the licensed category 1 or category 2 quantity of radioactive material is used, stored, or transported.
Lost or missing licensed material - Licensed material whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.
Mobile device - A piece of equipment containing licensed radioactive material that is either mounted on wheels or casters, or otherwise equipped for moving without a need for disassembly or dismounting; or designed to be hand carried. Mobile devices do not include stationary equipment installed in a fixed location.
Movement control center - An operations center that is remote from transport activity and that maintains position information on the movement of radioactive material, receives reports of attempted attacks or thefts, provides a means for reporting these and other problems to appropriate agencies and can request and coordinate appropriate aid.
No-later-than arrival time - The date and time that the shipping licensee and receiving licensee have established as the time at which an investigation will be initiated if the shipment has not arrived at the receiving facility. The no-later-than arrival time may not be more than six (6) hours after the estimated arrival time for shipments of category 2 quantities of radioactive material.
Person -
Reviewing official - The individual who shall make the trustworthiness and reliability determination of an individual to determine whether the individual may have, or continue to have, unescorted access to the category 1 or category 2 quantities of radioactive materials that are possessed by the licensee.
Sabotage - Deliberate damage, with malevolent intent, to a category 1 or category 2 quantity of radioactive material, a device that contains a category 1 or category 2 quantity of radioactive material, or the components of the security system.
Safe haven - A readily recognizable and readily accessible site at which security is present or from which, in the event of an emergency, the transport crew can notify and wait for the local law enforcement authorities.
Security zone - Any temporary or permanent area determined and established by the licensee for the physical protection of category 1 or category 2 quantities of radioactive material during use or storage.
State - A State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.
Telemetric position monitoring system - A data transfer system that captures information by instrumentation and/or measuring devices about the location and status of a transport vehicle or package between the departure and destination locations.
Trustworthiness and reliability - Characteristics of an individual considered dependable in judgment, character, and performance, such that unescorted access to category 1 or category 2 quantities of radioactive material by that individual does not constitute an unreasonable risk to the public health and safety or security. A determination of trustworthiness and reliability for this purpose is based upon the results from a background investigation.
Unescorted access - Solitary access to an aggregated category 1 or category 2 quantity of radioactive material or the devices that contain the material.
United States - When used in a geographical sense, includes Puerto Rico and all territories and possessions of the United States.
Except where otherwise specified, all communications concerning these Regulations may be addressed to the Arkansas Department of Health, Radiation Control Section, 4815 West Markham Street, Slot 30, Little Rock, Arkansas, 72205-3867.
Except as specifically authorized by the Department in writing, no interpretations of the meaning of the regulations in this Section by an officer or employee of the Department other than a written interpretation by the Department Director or designee will be recognized as binding upon the Department.
The licensee's access authorization program must ensure that the individuals specified in paragraph c.1. of this section are trustworthy and reliable.
authorization program:
trustworthiness and reliability determinations that allow individuals to have unescorted access to category 1 or category 2 quantities of radioactive materials possessed by the licensee.
Any individual who is applying for unescorted access authorization shall disclose the personal history information that is required by the licensee's access authorization program for the reviewing official to make a determination of the individual's trustworthiness and reliability. Refusal to provide, or the falsification of, any personal history information required by this Part is sufficient cause for denial or termination of unescorted access.
unfavorably terminate, maintain, or administratively withdraw an individual's unescorted access authorization based on an evaluation of all of the information collected to meet the requirements of this Part.
Licensees shall develop, implement, and maintain written procedures for implementing the access authorization program. The procedures must include provisions for the notification of individuals who are denied unescorted access. The procedures must include provisions for the review, at the request of the affected individual, of a denial or termination of unescorted access authorization. The procedures must contain a provision to ensure that the individual is informed of the grounds for the denial or termination of unescorted access authorization and allow the individual an opportunity to provide additional relevant information.
trustworthiness and reliability of individual employees for three (3) years from the date the individual no longer requires unescorted access to category 1 or category 2 quantities of radioactive material.
Before allowing an individual unescorted access to category 1 or category 2 quantities of radioactive material or to the devices that contain the material, licensees shall complete a background investigation of the individual seeking unescorted access authorization. The scope of the investigation must encompass at least the seven (7) years preceding the date of the background investigation or since the individual's eighteenth birthday, whichever is shorter. The background investigation must include at a minimum:
Licensees shall verify the true identity of the individual who is applying for unescorted access authorization to ensure that the applicant is who he or she claims to be. A licensee shall review official identification documents (e.g., driver's license; passport; government identification; certificate of birth issued by the state, province, or country of birth) and compare the documents to personal information data provided by the individual to identify any discrepancy in the information. Licensees shall document the type, expiration, and identification number of the identification document, or maintain a photocopy of identifying documents on file in accordance with RH-11031. Licensees shall certify in writing that the identification was properly reviewed, and shall
maintain the certification and all related documents for review upon inspection;
Licensees shall complete an employment history verification, including military history. Licensees shall verify the individual's employment with each previous employer for the most recent seven (7) years before the date of application;
Licensees shall verify that the individual participated in the education process during the claimed period;
Licensees shall complete reference checks to determine the character and reputation of the individual who has applied for unescorted access authorization. Unless other references are not available, reference checks may not be conducted with any person who is known to be a close member of the individual's family, including but not limited to the individual's spouse, parents, siblings, or children, or any individual who resides in the individual's permanent household. Reference checks under this Part must be limited to whether the individual has been and continues to be trustworthy and reliable;
Licensees shall conduct a reinvestigation every 10 years for any individual with unescorted access to category 1 or category 2 quantities of radioactive material. The reinvestigation shall consist of fingerprinting and an FBI identification and criminal history records check in accordance with RH-11027. The reinvestigations must be completed within ten (10) years of the date on which these elements were last completed.
history records check solely for the purpose of determining an individual's suitability for unescorted access authorization to category 1 or category 2 quantities of radioactive materials, access to safeguards information, or safeguards information-modified handling.
to the U.S. Nuclear Regulatory Commission, Director, Division of Facilities and Security, 11545 Rockville Pike, Rockville, Maryland 20852, ATTN: Criminal History Program, Mail Stop TWB-05 B32M, one completed, legible standard fingerprint card (Form FD-258, ORIMDNRCOOOZ), electronic fingerprint scan or, where practicable, other fingerprint record for each individual requiring unescorted access to category 1 or category 2 quantities of radioactive material. Copies of these forms may be obtained by writing the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by calling 1-630-829 -9565, or by email to FORMS.Resource@nrc.gov. Guidance on submitting electronic fingerprints can be found at https://www.nrc.gov/site-help/e-submittals.html.
required by section 149 of the Atomic Energy Act of 1954, as amended, and other elements of the background investigation are not required for the following individuals prior to granting unescorted access to category 1 or category 2 quantities of radioactive materials:
required by section 149 of the Atomic Energy Act of 1954, as amended, are not required for an individual who has had a favorably adjudicated U.S. Government criminal history records check within the last five (5) years, under a comparable U.S. Government program involving fingerprinting and an FBI identification and criminal history records check provided that he or she makes available the appropriate documentation. Written confirmation from the agency/employer that reviewed the criminal history records check must be provided to the licensee. The licensee shall retain this documentation for a period of three (3) years from the date the individual no longer requires unescorted access to category 1 or category 2 quantities of radioactive material. These programs include, but are not limited to:
Each licensee shall establish, implement, and maintain a security program that is designed to monitor and, without delay, detect, assess, and respond to an actual or attempted unauthorized access to category 1 or category 2 quantities of radioactive material.
Each licensee's security program must include the program features, as appropriate, described in RH-11043., RH-11045., RH-11047., RH-11049., RH-11051., RH-11053., and RH-11055.
record for three (3) years after the procedure is no longer needed. Superseded portions of the procedure must be retained for three (3) years after the record is superseded.
access to category 1 or category 2 quantities of radioactive material, safeguards information, or safeguards information-modified handling, the licensee must complete a background investigation to determine the individual's trustworthiness and reliability. A trustworthiness and reliability determination shall be conducted by the reviewing official and shall include the background investigation elements contained in RH-11025.a.2. through a.7.
document is no longer needed:
Licensees shall immediately assess each actual or attempted unauthorized entry into the security zone to determine whether the unauthorized access was an actual or attempted theft, sabotage, or diversion.
For personnel and automated or electronic systems supporting the licensee's monitoring, detection, and assessment systems, licensees shall:
Licensees shall immediately respond to any actual or attempted unauthorized access to the security zones, or actual or attempted theft, sabotage, or diversion of category 1 or category 2 quantities of radioactive material at licensee facilities or temporary job sites. For any unauthorized access involving an actual or attempted theft, sabotage, or diversion of category 1 or category 2 quantities of radioactive material, the licensee's response shall include requesting, without delay, an armed response from the LLEA.
Each licensee that possesses mobile devices containing category 1 or category 2 quantities of radioactive material must:
must be followed within a period of thirty (30) days by a written report submitted to the Department by an appropriate method listed in RH-11007. The report must include sufficient information for Department analysis and evaluation, including identification of any necessary corrective actions to prevent future instances.
A licensee transferring a category 1 or category 2 quantity of radioactive material to a licensee of the Department, U.S. Nuclear Regulatory Commission, or an Agreement State shall meet the license verification provisions listed below instead of those listed in RH-501.c.:
material shall comply with the requirements for physical protection during transit contained in RH-11079.a.2., a.3., and b.2.; and RH-11081.b., d., f., g., and h. for the domestic portion of the shipment.
As specified in paragraphs a. and b. of this section, each licensee shall provide advance notification to the Department and to the governor of a State, or the governor's designee, of the shipment of licensed material in a category 1 quantity, through or across the boundary of the State, before the transport, or delivery to a carrier for transport, of the licensed material outside the confines of the licensee's facility or other place of use or storage.
the Department at least four (4) days before the transport of the shipment commences and must reach the office of the governor or the governor's designee at least four (4) days before transport of a shipment within or through the State.
Each advance notification of shipment of category 1 quantities of radioactive material must contain the following information, if available at the time of notification:
at the time of the initial notification, as soon as the information becomes available but not later than commencement of the shipment, to the governor of the State or the governor's designee and to the Department.
governor's designee of any changes to the information provided in accordance with paragraphs b. and c.1. of this section. The licensee shall also immediately notify the Department of any such changes.
Each licensee who cancels a shipment for which advance notification has been sent shall send a cancellation notice to the governor of each State or to the governor's designee previously notified and to the Department. The licensee shall send the cancellation notice before the shipment would have commenced or as soon thereafter as possible. The licensee shall state in the notice that it is a cancellation and identify the advance notification that is being cancelled.
The licensee shall retain a copy of the advance notification and any revision and cancellation notices as a record for three (3) years.
State officials, State employees, and other individuals, whether or not licensees of the Department, the NRC, or of an Agreement State, who receive schedule information of the kind specified in RH-11077.b. shall protect that information against unauthorized disclosure as specified in RH-11043.d.
in a single shipment, a category 1 quantity of radioactive material shall:
address:
enforcement agencies;
protocols must include a strategy for the use of authentication codes and duress codes and provisions for refueling or other stops, detours, and locations where communication is expected to be temporarily lost;
category 1 quantities of radioactive material shall ensure that drivers, accompanying personnel, and movement control center personnel have access to the normal and contingency procedures.
systems. An established package tracking system is a documented, proven, and reliable system routinely used to transport objects of value. In order for a package tracking system to maintain constant control and/or surveillance, the package tracking system must allow the shipper or transporter to identify when and where the package was last and when it should arrive at the next point of control.
systems. An established package tracking system is a documented, proven, and reliable system routinely used to transport objects of value. In order for a package tracking system to maintain constant control and/or surveillance, the package tracking system must allow the shipper or transporter to identify when and where the package was last and when it should arrive at the next point of control.
Each licensee who makes arrangements for the shipment of category 1 quantities of radioactive material shall immediately conduct an investigation upon the discovery that a category 1 shipment is lost or missing. Each licensee who makes arrangements for the shipment of category 2 quantities of radioactive material shall immediately conduct an investigation, in coordination with the receiving licensee, of any shipment that has not arrived by the designated no-later-than arrival time.
appropriate method listed in RH-11007., any additional substantive information on the event within thirty (30) days after the licensee learns of such information.
Each record required by this Section must be legible throughout the retention period specified by each Department regulation. The record may be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
Licensees shall maintain the records that are required by the regulations in this Section for the period specified by the appropriate regulation. If a retention period is not otherwise specified, these records must be retained until the Department terminates the facility's license. All records related to this Section may be destroyed upon Department termination of the facility license.
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.
APPENDIX A TO SECTION 12
CATEGORY 1 AND CATEGORY 2 RADIOACTIVE MATERIALS
TABLE 1-CATEGORY 1 AND CATEGORY 2 THRESHOLDS
The terabecquerel (TBq) values are the regulatory standard. The curie (Ci) values specified are obtained by converting from the TBq value. The curie values are provided for practical usefulness only.
| Radioactive material | Category 1 (TBq) | Category 1 (Ci) | Category 2 (TBq) | Category 2 (Ci) |
| Americium-241 ...................................................................................... | 60 | 1,620 | 0.6 | 16.2 |
| Americium-241/Be ................................................................................. | 60 | 1,620 | 0.6 | 16.2 |
| Californium-252 ..................................................................................... | 20 | 540 | 0.2 | 5.40 |
| 30 50 | 810 1,350 | 0.3 0.5 | 8.10 13.5 | |
| Curium-244 ............................................................................................ | ||||
| Cesium-137 ........................................................................................... | 100 | 2,700 | 1 | 27.0 |
| Iridium-192 ............................................................................................ | 80 | 2,160 | 0.8 | 21.6 |
| Plutonium-238 ....................................................................................... | 60 | 1,620 | 0.6 | 16.2 |
| Plutonium-239/Be .................................................................................. | 60 | 1,620 | 0.6 | 16.2 |
| Promethium-147 .................................................................................... | 40,000 | 1,080,000 | 400 | 10,800 |
| Radium-226 ........................................................................................... | 40 | 1,080 | 0.4 | 10.8 |
| Selenium-75 .......................................................................................... | 200 | 5,400 | 2 | 54.0 |
| Strontium-90 .......................................................................................... | 1,000 | 27,000 | 10 | 270 |
| Thulium-170 .......................................................................................... | 20,000 | 540,000 | 200 | 5,400 |
| Ytterbium-169 ........................................................................................ | 300 | 8,100 | 3 | 81.0 |
Note: Calculations Concerning Multiple Sources or Multiple Radionuclides
The "sum of fractions" methodology for evaluating combinations of multiple sources or multiple radionuclides is to be used in determining whether a location meets or exceeds the threshold and is thus subject to the requirements of this Section.
R1 = total activity for radionuclide 1 R2 = total activity for radionuclide 2 RN = total activity for radionuclide n
AR1 = activity threshold for radionuclide 1 AR2 = activity threshold for radionuclide 2 ARN = activity threshold for radionuclide n
SEVERABILITY
If any provision of these Rules and Regulations or the application thereof to any person or circumstance is held invalid, such invalidity shall not affect other provisions or applications of these Rules and Regulations which can give effect without the invalid provisions or applications, and to this end the provisions hereto are declared severable.
REPEAL
All regulations and parts of regulations in conflict herewith are hereby repealed.
CERTIFICATION
This will certify that the foregoing Rules and Regulations for Control of Sources of Ionizing Radiation were adopted by the Arkansas Board of Health at a regular session of the Board held in Little Rock, Arkansas, on the 3 day of August 2017.
Arkansas Department of Health
Proposed Rules Pertaining to the ASBH
Rules and Regulations for Control of Sources of Ionizing Radiation
Public Comments Received
A public hearing was conducted March 8, 2017, at 10:00 a.m. in Room 902 of the Freeway Medical Tower building, 5800 West 10th Street, Little Rock, Arkansas.
No oral or written comments were received during the hearing.
During the public comment period, non-substantive comments were received from the U.S. Nuclear Regulatory Commission (NRC) via a February 2, 2017, letter and teleconference. The Department's response to the non-substantive comments is as follows:
| Comment | Response | |
| 1 2
3 4 5 |
Arkansas regulations in RH-3301.b., 3304.b., 3305.b., 3306.b., 3600.b.,c., and 3602.a. should refer to their Agency and not to the NRC. Also, cross-references should be to AR regulations, as this requirement applies to the AR licensee's quality assurance program. | These regulations will maintain current rule language that lists the Department and its requirements as governing Arkansas licensee quality assurance programs instead of proposed language that indicates NRC has the authority. |
| Arkansas regulation RH-3301.c. should contain the AR point of contact. | Paragraph c.3. of the "General License for NRC-Approved Packages" states the third requirement that each Arkansas general licensee must do and that is register with the NRC (not Arkansas) before first use of the package. Registration with the NRC is per U.S. DOT 49 CFR 173.471(a) and is for any offeror of a Type B(U), Type B(M), or fissile material package that has been approved by the NRC. Paragraph c.3. will retain proposed language with a correction to the NRC Division name listed. | |
| Arkansas needs to include the phrase "design, fabrication, and assembly records; results of reviews...and the action taken in connection with any deficiencies noted" in RH-3506.c. after the reference to RH-3502. | Paragraph c. will maintain current rule language that lists these records to be maintained by the licensee as evidence of quality of packaging, instead of proposed language that removes this list. | |
| Arkansas may remove references in Section 4 to certificate holders and applicants for Certificates of Compliance due to these being NRC licensees and therefore not regulated by the State of Arkansas. | References to certificate holders and applicants for Certificates of Compliance will be stricken from RH-3600.b., 3601.a., 3602.a.,b.,d.,e., and 3603.-3608. leaving "licensee." | |
| Arkansas needs to remove the sentence "Each certificate holder and applicant for a package approval is responsible for satisfying the quality assurance requirements that apply to design, fabrication, testing, and modification of packaging subject to this Part." from RH-3600.a. as this applies to NRC certificate holders and applicants, or otherwise modify | Explanatory language will be added to paragraph a., "Purpose," in order to clarify agency authorities. There will be no change in requirements. | |
| 6 7 8
9 |
this paragraph to meet the essential objectives. | |
| Arkansas may remove references in paragraphs b. and c. of RH-3602. to certificate holders and applicants for Certificates of Compliance due to these being NRC licensees and therefore not regulated by the State of Arkansas, or otherwise modify these paragraphs to meet the essential objectives. | Explanatory language will be added to paragraphs b. and c. in order to better direct Arkansas licensees. There will be no change in requirements. | |
| Arkansas needs to reference their Agency and not the NRC in RH-3602.e. as the State would approve their licensee's quality assurance program. Also, the cross-reference in paragraph e. should be to AR regulations, as this requirement applies to the AR licensee's quality assurance program. | This regulation will indicate that Arkansas quality assurance programs, including changes, are approved by the Department pursuant to its requirements, like that of Comment 1. | |
| In RH-600.a.2., Arkansas omits the phrase, "until the Commission terminates each license that authorizes the activity that is subject to the recordkeeping requirement." As written, AR's regulation is less restrictive than 10 CFR 40.61(a)(2) as it only requires the licensee to retain the records for three years, and not until the license is terminated. AR needs to add their equivalent regulation as indicated above. | RH-600.a.2. as it currently reads was approved by the NRC in Department regulations effective July 1, 2002. The retention period for radioactive material transfer records was also approved by the NRC on May 12, 2010, as part of the Conference of Radiation Control Program Director's Suggested State Regulations. Arkansas does not have the authority to regulate the same types of Part 40, "source material," licensees that the NRC does (e.g., uranium mills, enrichment facilities, and UF6 production facilities); therefore, three years is an adequate retention period for Arkansas source material licensees. This retention period meets the essential objective. | |
| In RH-11027.c.1., Arkansas needs to update the Mail Stop and phone number listed to Mail Stop TWB-05 B32M and 1-630-829 -9565. | Paragraph c.1. will be revised to reflect the change in Mail Stop and phone number as well as the zip code and the use of "https" instead of "http." |
Three administrative, non-substantive changes will also be addressed as follows:
| Comment | Response | |
| 10 | Unclear language exists in RH-3002.d.1., "Purpose and Scope." | The language will be simplified so that readers will be more clearly directed to Part C of Section 4 that contains the exemption requirements. |
| 11 | For consistency and simplicity, "this Section" should be used in RH-3305.a. and RH-3306.a. | "This Section," instead of the Section number and its title, will be used. |
| 12 | A type-o exists where paragraph c. of RH-3508. is incorrectly shown as paragraph d. | Paragraph c. will be shown as such. |
