Arkansas Administrative Code
Agency 007 - Arkansas Department of Health
Division 14 - Radiation Control and Emergency Management
Rule 007.14.12-001 - Regulations for Control of Sources of Ionizing Radiation

Universal Citation: AR Admin Rules 007.14.12-001

Current through Register Vol. 48, No. 2, February, 2023

SECTION 1. REGISTRATION OF SOURCES OF RADIATION

PART A. GENERAL

RH-1. Authority. Act 96 of 1913, Act 8 of Second Extraordinary Special Session of

1961, as Amended.

RH-2. Effective Date. January 1, 1963.

RH-3. Registration Requirement. Every person possessing a reportable source of radiation shall register in accordance with the provisions of these Regulations.

RH-4. Communications. All communications concerning these Regulations shall be addressed to the, Arkansas Department of Health and Human Services, Division of Health, Radiation Control Section, P.O. Box 1437 Mail Slot H-30, Little Rock, Arkansas 72203-1437.

RH-5. Additional Requirements. In addition to the requirements of this Part, all registrants are subject to the applicable provisions of other Parts of these Regulations.

RH-6. - RH-9. Reserved.

PART B. DEFINITIONS

RH-10. General Definitions. As used in these Regulations. Additional definitions used only in a certain Part will be found in that Part.

a. Act - Act 8 of Second Extraordinary Special Session of 1961, as amended.

b. 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.

c. Department - The Arkansas Department of Health.

d. 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.

e. Installation - The location where one or more reportable sources of radiation are used, operated or stored.

f. 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.

g. Possessing a source of radiation - Using, operating, storing, manufacturing or otherwise having control of a source of radiation in the State of Arkansas.

h. 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.

i. Radiation machine - Any device capable of producing radiation, but excluding particle accelerators and devices which produce radiation only by the use of radioactive material.

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

k. Registrant - Any person who is registering or who has registered with the

Department pursuant to these Regulations.

l. Reportable source of radiation - Any source of radiation as specified under RH-20 of these Regulations.

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

n. These Regulations - The Arkansas State Board of Health Rules and

Regulations for Control of Sources of Ionizing Radiation, Section 1.

RH-11. - RH-19. Reserved.

PART C. REGISTRATION OF RADIATION MACHINES

RH-20. Reportable Sources of Radiation. The following constitute reportable sources of radiation: Radiation machines, except when not installed in such manner as to be capable of producing radiation.

RH-21. Initial Registration. Every person who possesses a reportable source of radiation on January 1, 1963 shall register with the Department prior to April 1, 1963. Every person not already registered who acquires possession of a reportable source of radiation subsequent to January 1, 1963 shall register with the Department within thirty (30) days of the date of acquisition.

RH-22. Renewal of Registration. 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.

RH-23. Registration Form. 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.

RH-24. Separate Installations. Every person who registers shall complete a separate registration form for each installation.

RH-25. Special Registration. 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.

RH-26. Report of Change. Within ten (10) days of change, the registrant shall report in writing to the Department any change in the name or address of the registrant or location of the installation, receipt, sale or disposal of any reportable source of radiation. In the case of disposition of the machine, such notification should specify the recipient of the machine.

RH-27. Report of Discontinuance. 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.

RH-28. Deleted.

RH-29. Reserved.

PART D. REGISTRATION OF VENDOR SERVICES

RH-30. Purpose and Scope. This Part provides for the registration of persons providing radiation machine installation, servicing and/or vendor services to licensees or registrants.

RH-31. Installers of Radiation Machines. 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.

RH-32. Registration Form. 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.

RH-33. Training. 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.

RH-34. Services. 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:

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

b. Installation or servicing of devices containing radioactive material.

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

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

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

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

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

2. Safe use and handling of radioactive material.

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

4. Training provided to Radiation Safety/Protection Officer.

g. Personnel Dosimetry Services.

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

A. Name of exposed individual.

B. Name and address of the registrant or licensee employing the individual.

C. Amount of the exposure.

D. Monitoring year exposed.

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

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

RH-35. Assembler and/or Transfer Requirement.

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

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

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

3. The date of transfer of each radiation machine.

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

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

RH-36.- RH-39. Reserved.

PART E. EXCLUSIONS FROM REGISTRATION

RH-40. Excluded Material and Devices. The following materials and devices do not require registration:

a. Domestic television receivers, providing the dose rate at 5 cm from any outer surface of 10 cm2 area is less than 0.5 mrem per hour.

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

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

RH-41. Excluded Possessors. 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.

RH-42.- RH-49. Reserved.

PART F. INSPECTION, EXEMPTIONS AND ADDITIONAL REQUIREMENTS

RH-50. Radiation Protection Standards. 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 (Radiation Protection Standards).

RH-51. Records to be Maintained. 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.

RH-52. Access to Premises. 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 regulation, 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.

RH-53. Access to Records. 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.

RH-54. Tests. 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:

a. Sources of radiation.

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

c. Radiation detection and monitoring instruments.

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

RH-55. Exemptions.

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

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

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

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

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

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

RH-56. Additional Requirements. 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.

RH-57. Out-of-State Registration. 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:

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

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

RH-58. Registration Fees.

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:

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

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

RH-59. Reserved.

PART G. PROHIBITED USES

RH-60. Hand-Held Fluoroscopic Screens Prohibited. No hand-held fluoroscopic screen shall be used.

RH-61. X-Ray Shoe-Fitting Equipment.

a. X-Ray Shoe-Fitting Equipment Prohibited. No shoe-fitting device or shoe-fitting machine which uses fluoroscopic, x-ray or radiation principles shall be operated or maintained in this state.

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

RH-62.- RH-69. Reserved.

PART H. ENFORCEMENT

RH-70. Violations.

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

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

RH-71.- RH-99. Reserved.

SECTION 2. LICENSING OF RADIOACTIVE MATERIALS

(FOOTNOTES APPEAR AT THE END OF THIS SECTION)

PART A. GENERAL

RH-100. Authority. Act 8 of Second Extraordinary Special Session of 1961, as amended.

RH-101. Effective Date. 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).

RH-102. License Requirement.

a. No person shall receive, possess, use, transfer, own or acquire radioactive material except as authorized in a specific or general license issued pursuant to these Regulations or as otherwise provided in these Regulations. However, nothing in these Regulations shall apply to any person to the extent such person is subject to regulation by the U.S. Nuclear Regulatory Commission.1/

b. In addition to the requirements of this Part, all licensees, except as otherwise noted in these Regulations, are subject to the requirements of Section 3 of these Regulations.

RH-103. License Fees.

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.

a. The Radioactive Material Fees are as follows:

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 [LESS THAN] 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

b. The Accelerator Fees are as follows:

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

c. The Generally Licensed Device Fees are as follows:

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

d. Other fees are as follows:

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	$0.00 for first copy $30.00 for each additional copy
Amendment to existing license	$50.00 per amendment

e. Reciprocity fees are as follows:

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

RH-104. Communications. All communications concerning these Regulations shall be addressed to the Arkansas Department of Health and Human Services, Division of Health, Radiation Control Section, P.O. Box 1437 Mail Slot H-30, Little Rock, Arkansas 72203-1437.

RH-105.- RH-199. Reserved.

PART B. DEFINITIONS

RH-200. General Definitions as used in these Regulations: Additional definitions used in a certain part will be found in that part.

a. Accelerator-produced material - Any material made radioactive by a particle accelerator.

b. Act - Act 8 of Second Extraordinary Special Session of 1961, as amended.

c. 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.

d. Agreement State - Any state with which the U.S. Nuclear Regulatory Commission has entered into an effective agreement under Section 274 b. of the Atomic Energy Act of 1954, as amended (73 STAT. 689).

e. 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.

f. Authorized nuclear pharmacist - A pharmacist who is:

1. Meets the requirements in RH-8317; or

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

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

g. Authorized user - A physician, dentist, or podiatrist who is:

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

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

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

h. 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.

i Byproduct material - Any radioactive material (except special nuclear material) yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear material.

j. CFR - Code of Federal Regulations.

k. Chelating agent - Amine polycarboxylic acids (e.g., EDTA, DTPA),

hydroxycarboxylic acids and polycarboxylic acids (e.g., citric acid, carbolic acid and glucinic acid).

l. Commencement of construction - Any clearing of land, excavation or other substantial action that would adversely affect the environment of a land disposal facility. The term does not mean disposal site exploration, necessary roads for disposal site exploration, borings to determine foundation conditions or other pre-construction monitoring or testing to establish background information related to the suitability of the disposal site or the protection of environmental values.

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

n. Department - Arkansas Department of Health and Human Services.

o. 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.

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

q. 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.

r. 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.

s. 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.

t. 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.

u. 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.

v. Hazardous waste - Those wastes designated as hazardous by

Environmental Protection Agency regulations in 40 CFR Part 261.

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

x. 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.

y. 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.

z. Individual - Any human being.

aa. 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.

ab. 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 Part or engineered structures that provides equivalent protection to the inadvertent intruder.

ac. 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.

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

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

af. 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).

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

ah. 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.

ai. Person - Any individual, corporation, partnership, firm, 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.

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

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

al. 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.

am. 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.

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

ao. 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.

ap. 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.

aq. 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.

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

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

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

au. Research and Development -

1. Theoretical analysis, exploration or experimentation; or

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

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

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

aw. 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.

ax. 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.

ay. Source Material -

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

2. Ores which contain by weight one-twentieth of one percent (0.05 percent) or more of (A) Uranium, (B) Thorium or (C) any combination thereof. Source material does not include special nuclear material.

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

ba. 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

bb. Stability - Structural stability.

bc. 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.

bd. These Regulations - The Arkansas State Board of Health Rules and Regulations for Control of Sources of Ionizing Radiation, Section 2.

be. Unrefined and Unprocessed Ore - Ore in its natural form prior to any processing, such as grinding, roasting, beneficiating or refining.

bf. 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.)

bg. 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 waste has the same meaning as in the Federal Low-Level Waste Policy Act that is radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in Section 11e.(2) of the Atomic Energy Act (Uranium or Thorium tailings and waste).

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

RH-201.- RH-299. Reserved.

PART C. EXEMPTIONS

RH-300. Source Material.

a. Any person is exempt from these Regulations to the extent that such person receives, possesses, uses or transfers source material in any chemical mixture, compound, solution or alloy in which the source material is by weight less than 1/20 of one (1) percent (0.05%) of the mixture, compound, solution or alloy.

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

c. Any person is exempt from this regulation to the extent that such person receives, possesses, uses or transfers:

1. Any quantity of Thorium contained in:

A. Incandescent gas mantles; or

B. Vacuum tubes; or

C. Welding rods; or

D. Electric lamps for illuminating purposes provided that each lamp does not contain more than fifty (50) milligrams of Thorium; or

E. Germicidal lamps, sunlamps and lamps for outdoor or industrial lighting provided that each lamp does not contain more than two (2) grams of Thorium; or

F. Rare earth metals and compounds, mixtures and products containing not more than 0.25% by weight Thorium, Uranium or any combination of these.

G. Personnel neutron dosimeters; provided, that each dosimeter does not contain more than fifty (50) milligrams of Thorium.

2. Source material contained in the following products:

A. Glazed ceramic tableware, provided that the glaze contains not more than twenty (20%) percent by weight source material;

B. Piezoelectric ceramic containing not more than two (2%) percent by weight source material;

3. Photographic film, negatives and prints containing Uranium or Thorium;

4. Any finished product or part fabricated of or containing Tungsten or Magnesium-Thorium alloys; provided that the Thorium content of the alloy does not exceed four (4%) percent by weight and that the exemption contained in this Subparagraph shall not be deemed to authorize the chemical, physical or metallurgical treatment or processing of any such product or part; and

5. Uranium contained in counterweights installed in rockets, projectiles and missiles or stored or handled in connection with installation or removal of such counterweights; provided that:

A. The counterweights are manufactured in accordance with a specific license issued by the Department, the U.S. Nuclear Regulatory Commission or any Agreement State authorizing distribution by the licensee pursuant to this Subparagraph or equivalent regulations of the NRC or any Agreement State;

B. Each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "DEPLETED URANIUM;"2/

C. Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement: "UNAUTHORIZED ALTERATIONS

PROHIBITED;"2/ and

D. The exemption contained in this Subparagraph shall not be deemed to authorize the chemical, physical or metallurgical treatment or processing of any such counterweights other than repair or restoration of any plating or other covering.

6. Uranium used as shielding constituting part of any shipping container which is conspicuously and legibly impressed with the

legend "CAUTION - RADIOACTIVE SHIELDING -URANIUM" and which meets the specifications for containers for radioactive materials prescribed by Section 173.394 or 173.395 of 49 CFR Part 173, of the regulations published by the U.S. Department of Transportation.

7. Thorium contained in finished optical lenses, provided that each lens does not contain more than thirty (30%) percent by weight of Thorium; and that the exemption contained in this Subparagraph shall not be deemed to authorize either:

A. The shaping, grinding or polishing of such lens or manufacturing processes other than the assembly of such lens into optical systems and devices without any alteration of the lens; or

B. The receipt, possession, use or transfer of Thorium contained in contact lenses or in spectacles or in eyepieces in binoculars or other optical instruments.

8. Uranium contained in detector heads for use in fire detection units, provided that each detector head contains not more than 0.005 microcurie of Uranium.

9. Thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that:

A. The Thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (Thorium Dioxide); and

B. The Thorium content in the nickel-thoria alloy does not exceed four (4%) percent by weight.

d. The exemption contained in RH-300.c. shall not be deemed to authorize manufacture, processing or production of any of the products described herein.

RH-301. Other Radioactive Materials.

a. Exempt concentrations.

1. Except as provided in RH-301.a.2. below, any person is exempt from this Part to the extent that such person receives, possesses, uses, transfers, owns or acquires products materials containing radioactive material in concentrations not in excess of those listed in Part I, RH-902. Schedule C.

2. 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.1. or equivalent regulations of the U.S. Nuclear Regulatory Commission or any Agreement State, except in accordance with a license issued pursuant to RH-405.g. or the general license provided in RH-402. of this Section.

b. Certain items containing radioactive material. Except for persons who apply radioactive material to or persons who incorporate radioactive material into, the following products, any person is exempt from these Regulations to the extent that he receives, possesses, uses, transfers, owns or acquires the following products.3/

1. Time pieces or hands or dials containing Radium or not more than the following specified quantities of radioactive material and not exceeding the following specified levels of radiation:

A. 25 millicuries of Tritium per timepiece;

B. 5 millicuries of Tritium per hand;

C. 15 millicuries of Tritium per dial (bezels when used shall be considered as part of the dial);

D. 100 microcuries of Promethium-147 per watch or 200 microcuries of Promethium-147 per other timepiece hand;

E. 20 microcuries of Promethium-147 per watch hand or 40 microcuries of Promethium-147 per other timepiece hand;

F. 60 microcuries of Promethium-147 per watch dial or 120 microcuries of Promethium-147 per other timepiece dial (bezels when used shall be considered as part of the dial);

G. The levels of radiation from hands and dials containing Promethium-147 will not exceed, when measured through 50 milligrams per square centimeter of absorber:

i. For wrist watches, 0.1 millirad per hour at ten (10)

centimeters from any surface;

ii. For any other timepiece, 0.1 millirad per hour at one (1) centimeter from any surface;

iii. For any other timepiece, 0.2 millirad per hour at ten (1) centimeters from any surface.

2. Lock illuminators containing not more than 15 millicuries of Tritium or not more than two (2) millicuries of Promethium-147 installed in automobile locks. The levels of radiation from each lock illuminator containing Promethium-147 will not exceed one (1) millirad per hour at one (1) centimeter from any surface when measured through 50 milligrams per square centimeter of absorber.

3. Balances of precision containing not more than one (1) millicuries of Tritium per balance or not more than 0.5 millicurie of Tritium per balance part.

4. Automobile shift quadrants containing not more than 25 millicuries of Tritium.

5. Marine compasses containing not more than 750 millicuries of Tritium gas and other marine navigational instruments containing not more than 250 millicuries of Tritium gas.

6. Thermostat dials and pointers containing not more than 25 millicuries of Tritium per thermostat.

7. Electron tubes: Provided, that each tube does not contain more than one (1) of the following specified quantities of radioactive material:

A. 150 millicuries of Tritium per microwave receiver protector tube or ten (10) millicuries of Tritium per any electron tube;

B. One (1) microcurie of Cobalt-60;

C. Five (5) microcuries of Nickel-63;

D. Thirty (30) microcuries of Krypton-85;

E. Five (5) microcuries of Cesium-137;

F. Thirty (30) microcuries of Promethium-147;

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/

8. Spark gap irradiators containing not more than one (1) microcurie of Cobalt-60 per spark gap irradiator for use in electrically ignited fuel oil burners having a firing rate of at least three (3) gallons per hour (11.4 liters per hour).

9. Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material; provided that:

A. Each source contains no more than one exempt quantity set forth in Schedule B; and

B. Each instrument contains no more than ten (10) exempt quantities. For purposes of RH-301.b.9, an instrument's source(s) may contain either one type or different types of radionuclides and an individual exempt quantity may be composed of fractional parts of one (1) or more of the exempt quantities in Schedule B, provided that the sum of each fraction shall not exceed unity.

C. For purposes of this RH-301.b.9, 0.05 microcurie of Americium-241 is considered an exempt quantity under Schedule B.

c. Resins containing Scandium-46 and designed for sand consolidation in oil wells. Any person is exempt from these Regulations to the extent that such person receives, possesses, uses, transfers, owns or acquires synthetic plastic resins containing Scandium-46 which are designed for sand consolidation in oil wells. Such resins shall have been manufactured or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission or shall have been manufactured in accordance with the specifications contained in a specific license or equivalent licensing document issued by the Department or any Agreement State to the manufacturer of such resins pursuant to licensing requirements equivalent to those in Section 32.16 and 32.17 of 10 CFR Part 32 of the regulations of the Nuclear Regulatory Commission. This exemption does not authorize the manufacture of any resins containing Scandium-46.

d. Gas and aerosol detectors containing radioactive material.

1. Except for persons who manufacture, process or produce gas and aerosol detectors containing radioactive material, any person is exempt from these Regulations to the extent such person receives, possesses, uses, transfers, owns or acquires byproduct material in gas and aerosol detectors designed to protect life or property from fires and airborne hazards provided that detectors containing radioactive material shall have been manufactured, imported or transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission5/ pursuant to Section 32.26 of 10 CFR Part 32, or any Agreement State, which license authorizes the transfer of the detectors to persons who are exempt from regulatory requirements.

2. Gas and aerosol detectors previously manufactured and distributed to general licensees in accordance with a specific license issued by an Agreement State shall be considered exempt under RH-301.d.1., provided that the device is labeled in accordance with the specific license authorizing distribution of the generally licensed device and provided further that they meet the requirements of RH-405.g.

3. Gas and aerosol detectors containing Naturally Occurring Radioactive Material (NORM) previously manufactured and distributed in accordance with a specific license issued by a Licensing State shall be considered exempt under RH-301.d.A., provided that the device is labeled in accordance with the specific license authorizing distribution and provided further that they

e. Self-luminous products containing Tritium, Krypton-85 or Promethium-147. Except for persons who manufacture, process or produce 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, imported or transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.22 of 10 CFR 32 which authorizes the transfer of the product to persons who are exempt from regulatory requirements. The exemption in this Paragraph e does not apply to Tritium, Krypton-85 or Promethium-147 used in products for frivolous purposes or in toys or adornments.

Radioactive drug: Capsules containing carbon-14 urea for "in vivo" diagnostic use for humans. Except as provided in paragraphs RH-301.f.2. and RH-301.f.3., any person is exempt from the requirements for a license set forth in Section 5(c) of the Atomic Energy Act of 1954, as amended and from the regulations in this Section provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing one (1) microcurie (37 kBq) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for "in vivo" diagnostic use for humans.

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

3. Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive specific license pursuant to RH-405.o.

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

RH-302. Carriers. Common and contract carriers, freight forwarders and warehousemen operating within this state are exempt from these Regulations to the extent that they transport or store sources of radiation in the regular course of their carriage for another or storage incident thereto.

RH-303. U.S. Department of Energy Contractors and U.S. Nuclear Regulatory

Commission Contractors. Any U.S. Department 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:

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

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

c. Prime contractors of the DOE using or operating nuclear reactors or other nuclear devices in a U.S. Government owned vehicle or vessel; and

d. Any other prime contractor or subcontractor of the DOE or of the NRC when the State and the NRC jointly determine:

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

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

RH-304.Other Exemptions. The Department may, upon application therefore or upon its own initiative, grant such exemptions or exceptions from the requirements of these Regulations as it determines are authorized by law and will not result in undue hazard to public health and safety or property.

RH-305. Exempt Quantities.

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

b. Any person who possesses radioactive material received or acquired under the general license formerly provided in RH-402.a is exempt from the requirements for a license set forth in this Part to the extent that such person possesses, uses, transfers or owns such radioactive material.

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

d. No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in Schedule B, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under this Paragraph or equivalent regulations of the U.S. Nuclear Regulatory Commission or any Agreement State, except in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.18 of 10 CFR Part 32 which license states that the radioactive material may be transferred by the licensee to persons exempt under this RH-305. or the equivalent regulations of the U.S. Nuclear Regulatory Commission or any Agreement State.5/

RH-306.- RH-399. Reserved.

PART D. LICENSES

RH-400. Types of Licenses. Licenses for radioactive materials are of two (2) types:

General and Specific.

A General License- is 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 the issuance of a licensing document to a particular person. However, registration with the Department may be required by the particular general license.

Specific Licenses- is issued to named person who has filed an application with the Department for the license under to provisions of these Regulations.

RH-401. General Licenses - Source Material.

a. A general license is hereby issued authorizing use and transfer of not more than fifteen (15) pounds of source material at any one time by persons in the following categories:

1. Pharmacists using the source material solely for the compounding of medicinals;

2. Physicians using the source material for medicinal purposes;

3. Persons receiving possession of source material from pharmacists and physicians in the form of medicinals or drugs;

4. Commercial and industrial firms and research, educational and medical institutions for research, development, educational or commercial purposes; and provided, that no person shall pursuant to this general license, receive more than a total of 150 pounds of source material in any one (1) calendar year.

b. Persons who receive, possess, use or transfer source material pursuant to the general license issued in RH-401.a are exempt from the provisions of Section 3 of these Regulations to the extent that such receipt, possession, use or transfer is within the terms of such general license. Provided, however, that this exemption shall not be deemed to apply to any such person who is also in possession of source material under a specific license issued pursuant to these Regulations.

c. 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, use or transfer source material.

RH-402. General Licenses - Other Radioactive Materials.

a. Certain Devices and Equipment. A general license is hereby issued to transfer, receive, acquire, own, possess and use radioactive material incorporated in a device or equipment which is listed in Part I, RH-900., Schedule A and has been manufactured pursuant to a specific license or equivalent licensing document, issued to the supplier by the Department, the U.S. Nuclear Regulatory Commission or any Agreement State and authorizing distribution under the general license of this Paragraph or its equivalent.

The general license provided in this RH-402.a is subject to the provision of RH-56., RH-60., RH-301.a.2., RH-409., RH-416., RH-500., RH-501., RH-600., RH-601., RH-602., RH-4012., Section 36/ and Section 4 of these Regulations.

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

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

2. The general license in RH-402.b.1. applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in:

A. A specific license issued under RH-405.e. or

B. An equivalent specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement State.

The devices must have been received from one of the specific licensees described in above in RH-402.b.2.A. or through a transfer made under RH-402.b.3.H.

3. Any person who owns, receives, acquires, possesses, uses or transfers radioactive material in a device pursuant to the general license in RH-402.b.1.:

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

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

i. Devices containing only Krypton need not be tested for leakage of radioactive material, and

ii. Devices containing only Tritium or not more than 100 microcuries of other beta and/or gamma emitting material or ten (10) microcuries of alpha emitting material and devices held in storage in the original shipping container prior to initial installation, need not be tested for any purpose;

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

i. In accordance with the instructions provided by the labels; or

ii. By a person holding a specific license from the Department, the U.S. Nuclear Regulatory Commission or an Agreement State to perform such activities;

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

i. Each record of a test for leakage or radioactive material required by RH-402.b.3.B.must be retained for three (3) years after the next required leak test is performed or until the sealed source is transferred or disposed of.

ii. Each record of a test of the on-off mechanism and indicator required by RH-402.b.3.B. section must be retained for three (3) years after the next required test of the on-off mechanism and indicator is performed or until the sealed source is transferred or disposed of.

iii. Each record that is required by RH-402.b.3.C. section must be retained for three (3) years from the date of the recorded event or until the device is transferred or disposed of.

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

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

Arkansas Department of Health & Human Services

Radiation Control

ATTN: General License Registration Program

P.O. Box 1437, Mail Slot H-30

Little Rock, Arkansas 72203-1437

Under these circumstances, the criteria set out in RH-1218., ''Radiological criteria for unrestricted use,'' may be applicable, as determined by the Department on a case-by-case basis;

F. Shall not abandon the device containing radioactive material;

Shall transfer or dispose of the device containing

Radioactive material only by transfer to another general licensee as authorized by RH-402.b.3.H., or to a person authorized to receive the device by a specific license issued under 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.b.3.G.iii.

ii. Shall furnish a report to:

Arkansas Department of Health & Human Services

Radiation Control

ATTN: General License Registration Program

P.O. Box 1437, Mail Slot H-30

Little Rock, Arkansas 72203-1437

within 30 days after the transfer of a device to a specific licensee. The report must contain:

(a) The identification of the device by manufacturer's (or initial transferor's) name, model number, and serial number;

(b) . The name, address, and license number of the person receiving the device (license number not applicable if exported); and

iii. Shall obtain written Department approval before transferring the device to any other specific licensee not specifically identified in RH-402.b.3.G.i.

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

i. The device remains in use at a particular location. In this case, the transferor shall give the transferee a copy of RH-402.b., RH-600., RH-1501., and RH-1502., and any safety documents identified in the label of the device. Within thirty (30) days of the transfer, the transferor shall report to:

Arkansas Department of Health & Human Services

Radiation Control

ATTN: General License Registration Program

P.O. Box 1437, Mail Slot H-30

Little Rock, Arkansas 72203-1437

(a) . The manufacturer's (or initial transferor's) name;

(b) . The model number and the serial number of the device transferred; (c). The transferee's name and mailing address for the location of use; and

(d) The name, title, and phone number of the responsible individual identified by the transferee in accordance with RH-402.b.3.K. to have knowledge of and authority to take actions to ensure compliance with the appropriate regulations and requirements; or

ii. The device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee.

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

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

Shall register, in accordance with RH-402.b.3.L.ii.

and iii. 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, 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.b.3.m.iii., represents a separate general licensee and requires a separate registration and fee.

ii. If in possession of a device meeting the criteria of RH-402.b.3.L.i shall register these devices annually with the Department and shall pay the appropriated fee. Registration must be done by verifying, correcting, and/or adding to the information provided in a request for registration received from the Department. The registration information must be submitted to the Department within thirty (30) days of the date of the request for registration or as otherwise indicated in the request. In addition, a general licensee holding devices meeting the criteria of RH-402.b.3.L.i. is subject to the bankruptcy notification requirement in RH-409.g.

iii. In registering devices, the general licensee shall furnish the following information and any other information specifically requested by the Department:

(a) . Name and mailing address of the general licensee.

(b) . Information about each device: the manufacturer (or initial transferor), model number, serial number, the radioisotope and actively as indicated on label.

(c) . Name, title, and telephone number of the responsible person designated as a representative of the general licensee under RH-402.b.3.K.

(d) . Address or location at which the device(s) are used and/or stored. For portable devices, the address of the primary place of storage.

(e) . Certification by the responsible representative of the general licensee that the information concerning the device(s) has been verified through a physical inventory and checking of label information.

(f) . Certification by the responsible representative of the general licensee that they are aware of the requirements of the general license.

iv. Persons generally licensed by the U.S. Nuclear

Regulatory Commission or an Agreement State with respect to devices meeting the criteria in RH-402.b.3.L.i. are subject to registration requirements if the devices are used in areas subject to Arkansas Department of Health and Human Services jurisdiction. The Department will request registration information from such licensees

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

Arkansas Department of Health & Human Services

Radiation Control

Attention: General License Registration Program,

P.O. Box 1437 Mail Slot H-30,

Little Rock, Arkansas 72203-1437

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.

N. May not hold devices that are not in use for longer than two (2) years. If devices with shutters are not being used, the shutter must be locked in the closed position. The testing required by RH-402.b.3.B. need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use are excluded from the two (2) year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.

4. The general license in RH-402.b.1. does not authorize the manufacture of devices containing radioactive material.

5. The general license provided in this Paragraph is subject to the provisions of RH-56., RH-60., RH-409., RH-416., RH-500., RH-501., RH-600., RH-601., RH-602., RH-4012. and Section 4.

Luminous Safety Devices in Aircraft. A general license is hereby issued to own, receive, acquire, possess and use Tritium or Promethium-147 contained in luminous safety devices for use in aircraft, provided each device contains not more than ten (10) curies of Tritium or 300 millicuries of Promethium-147 and that each device has been manufactured, assembled or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission or each device has been manufactured or assembled in accordance with the specifications contained in a specific license or equivalent licensing document issued by the Department or any Agreement State to the manufacturer or assembler such device pursuant to licensing requirements of equivalent to those in Section 32.53 of CFR Part 32 of the Regulations of the U.S. Nuclear Regulatory Commission.

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

3. This general license does not authorize the manufacture, assembly or repair of luminous safety devices containing Tritium or Promethium-147.

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

5. The general license provided in this Paragraph is subject to the provisions of RH-56., RH-60., RH-409., RH-416., RH-500., RH-501., RH-600., RH-601., RH-602., RH-4012. and Section 4.

Calibration and Reference Sources. A general license is hereby issued to those persons listed below to own, receive, acquire, possess, use and transfer, in accordance with provisions of Subparagraphs 4 and 5 of this Paragraph d, Americium-241 in the form of calibration or reference sources:

A. Any person who holds a specific license issued by the Department which authorizes him to receive, possess, use and transfer radioactive material; and

B. Any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission which authorizes him to receive, possess, use and transfer special nuclear material.

2. A general license is hereby issued to receive possess, use and transfer Plutonium in the form of calibration or reference sources in accordance with the provisions of Subparagraphs 4 and 5 of this Paragraph d to any person who holds a specific license issued by the Department which authorizes him to receive, possess, use and transfer radioactive material.

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

4. The general licenses in Subparagraphs 1 and 2 of this Paragraph apply only to calibration or reference sources which have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer or importer of the sources by the U.S. Nuclear Regulatory Commission pursuant to Section 32.57 of10 CFR Part 32 or Section 70.39 of 10 CFR Part 70 or which have been manufactured in accordance with the specifications contained in a specific license or equivalent licensing document issued to the manufacturer by the Department or any Agreement State pursuant to licensing requirements equivalent to those contained in Section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70 of the Regulations of the U.S. Nuclear Regulatory Commission.

5. The general licenses in Subparagraphs 1 and 2 of this Paragraph are subject to the provisions of RH-56., RH-60., RH-409., RH-416., RH-500., RH-501., RH-600., RH-601., RH-602., RH-4012., Section 3 and Section 4. In addition, persons who own, receive, acquire, possess, use and transfer one (1) or more calibration or reference sources pursuant to these general licenses:

A. Shall not possess at any one time, at any one location of storage or use, more than five (5) microcuries of Americium-241 and five (5) microcuries of Plutonium in such sources; or five (5) microcuries of Radium-226 in such sources;

B. Shall not receive, possess, use or transfer such source unless the source or the storage container bears a label which includes the following statement or a substantially similar statement which contains the information called for in the following statement:

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)*. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

(Name of Manufacturer or Importer)

C. Shall not transfer, abandon or dispose of such source except by transfer to a person authorized by a license from the Department, the U.S. Nuclear Regulatory Commission or an Agreement State to receive the source;

D. Shall store such source, except when the source is being used, in a closed contain eradequately designed and constructed to contain Americium-241, Plutonium or Radium-226 which might otherwise escape during storage; and

E. Shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.

* Showing only the name of the appropriate material.

6. These general licenses do not authorize the manufacture of calibration or reference sources containing Americium-241, Plutonium or Radium-226.

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

f. Ice Detection Devices.

1. A general license is hereby issued to own, receive acquire, possess, use and transfer Strontium-90, contained in ice detection devices, provided each device contains not more than 50 microcuries of Strontium-90 and each device has been manufactured or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission or each device has been manufactured in accordance with the specifications contained in a specific license or equivalent licensing document issued by the Department or any Agreement State to the manufacturer of such device pursuant to licensing requirements equivalent to those in Section 32.61 of 10 CFR Part 32 of the Regulations of the U.S. Nuclear Regulatory Commission.

2. Persons who own, receive, acquire, possess, use or transfer Strontium-90 contained in ice detection devices pursuant to the general license in Subparagraph 1 of this Paragraph f.

A. Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating, to the device, discontinue use of the device until it has been inspected, tested for leakage and repaired by a person holding a specific license or equivalent licensing document from the U.S. Nuclear Regulatory Commission or any Agreement State to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of these Regulations;

B. Shall assure that all labels affixed to the device at the time of receipt and which bear a statement which prohibits removal of the labels, are maintained thereon;

C. Are exempt from the requirements of Section 3 except that such persons shall comply with the provisions of RH-1400., RH-1501. and RH-1502. of these Regulations.

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

4. The general license in this RH-402.f. is subject to the provisions of RH-56. RH-60., RH-409., RH-416., RH-500., RH-501., RH-600., RH-601., RH-602., RH-4012. and Section 4.

g. Intrastate Transportation of Radioactive Material. A general license is hereby issued to any common or contract carrier to transport and store radioactive material in the regular course of their carriage for another or storage incident thereto, provided the transportation and storage is in accordance with the applicable requirements of these Regulations, appropriate to the mode of transport, of the U.S. Department of Transportation insofar as such regulations relate to the loading and storage of packages, placarding of the transporting vehicle and incident reporting.7/ Persons who transport and store radioactive material pursuant to the general license in this Paragraph are exempt from the requirements of Section 3 of these Regulations.

h. General License for Use of Radioactive Material for Certain In Vitro

Clinical or Laboratory Testing.8/

1. A general license is hereby issued to any physician, veterinarian,

clinical laboratory or hospital to receive, acquire, possess, transfer or use, for any of the following stated tests, in accordance with the provisions of RH-402.h., 2., 3., 4., 5. and 6. of this Section, the following radioactive materials in prepackaged units:

A. Carbon-14, in units not exceeding ten (10) micro- curies each for use In Vitro clinical or laboratory tests not involving internal or external administration of radioactive material or the radiation there from, to human beings or animals.

B. Cobalt-57, in units not exceeding ten (10) micro-curies each for use in In Vitro clinical or laboratory tests not involving internal or external administration of radioactive material or the radiation there from, to human beings or animals.

C. Hydrogen-3 (Tritium), in units not exceeding 50 microcuries each for use in In Vitro clinical or laboratory tests not involving internal or external administration of radioactive material or the radiation there from, to human beings or animals.

D. Iodine-125 in units not exceeding ten (10) microcuries each for use in In Vitro clinical or laboratory tests not involving internal or external administration of radioactive material or the radiation there from, to human beings or animals.

E. Iodine-131, in units not exceeding ten (10) microcuries each for use in In Vitro clinical or laboratory tests not involving internal or external administration of radioactive material or the radiation there from, to human beings or animals.

F. Iron-59, in units not exceeding twenty (20) microcuries each for use in In Vitro clinical or laboratory tests not involving internal or external administration of radioactive material or the radiation there from, to human beings or animals.

G. Mock Iodine-125 reference or calibration sources, in units not exceeding 0.05 microcurie of Iodine-129 and 0.005 microcurie of Americium-241 each for use in In Vitro clinical or laboratory tests not involving internal or external administration of radioactive material or the radiation there from, to human beings or animals.

H. Selenium-75, in units not exceeding ten (10) microcuries each for use in In-Vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation there from, to human beings or animals.

2. No person shall receive, acquire, possess, use or transfer radioactive material pursuant to the general license established by RH-402.h.1. until the individual has filed Department Form RH-102. "Registration Certificate - In Vitro Testing With Radioactive Material Under General License" with the Radiation Control Programs, Arkansas Department of Health and Human Services and received from the Department a validated copy of Department Form RH-102. with registration number assigned or until he has been authorized pursuant to RH-405.C.3. to use radioactive material under the general license in RH-402.h. The registrant shall furnish on Department Form RH-102. the following information and such other information as may be required by that form:

A. Name and address of the registrant;

B. The location of use; and

C. A statement that the registrant has appropriate radiation measuring instruments to carry out In Vitro clinical or laboratory tests with radioactive materials as authorized under the general license in RH-402.h., and that such tests will be performed only by personnel competent in the use of such instruments and in the handling of the radioactive materials.

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

A. The general licensee shall not possess at any one (1) time, pursuant to the general license established by RH-402.h.1. at any one location of storage or use, a total amount of Iodine-125, Iodine-131, Selenium-75, Cobalt-57 and/or Iron-59 in excess of 200 microcuries.

B. The general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection.

C. The general licensee shall use the radioactive material only for the uses authorized by RH-402.h.1.

D. The general licensee shall not transfer the radioactive material except by transfer to a person authorized to receive it pursuant to a license issued by the Department, the U.S. Nuclear Regulatory Commission or any Agreement State nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier.

E. The general licensee shall dispose of the Mock Iodine-125 reference or calibration sources described in RH-402.h.1.G. as required by RH-1400.

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

A. Except as prepackaged units which are labeled in accordance with the provisions of a specific license issued by the U.S. Nuclear Regulatory Commission or any Agreement State that authorizes manufacture and distribution of Iodine-125, Iodine-131, Carbon-14, Hydrogen-3 (Tritium), Selenium-75, Iron-59, Cobalt-57 or Mock Iodine-125 for distribution to persons generally licensed under RH-402.h.1.

Unless one of the following statements or a substantially similar statement which contains the information called for in the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

"This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians 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 these Regulations and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority."

( Name of Manufacturer)

5. The registrant possessing or using radioactive materials under the general license of RH-402.h.1. shall report in writing to the Division of Radiation Control Section Chief, any changes in the information furnished by him in the "Registration Certificate - In Vitro Testing with Radioactive Material Under General License", Department Form RH-102. The report shall be furnished within thirty (30) days after the effective date of such change.

6. Any person using radioactive material pursuant to the general license of RH-402.h.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-402.1.G. shall comply with the provisions of RH-1400., RH-1501. and RH-1502.

RH-403. Specific Licenses.

a. Application for specific licenses shall be filed on forms supplied by the Arkansas Department of Health and Human Services, Division of Health, Radiation Control Section, P.O. Box 1437 Mail Slot H-30, Little Rock, Arkansas 72203-1437. The application shall set forth all applicable information called for by the form. An application for a license may request a license for one or more activities.

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

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

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

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

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

g. Requirements For Emergency Response Plans For Certain Licensees

1. Each application to possess radioactive materials in unsealed form,

on foils or plated sources, or sealed in glass in excess of the quantities in RH-905., Schedule F - "Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release," must contain either:

A. An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed 0.5 rem effective dose equivalent or 5 rems to the thyroid; or

B. An emergency plan for responding to a release of radioactive material.

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

A. The radioactive material is physically separated so that only a portion could be involved in an accident;

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

C. The release fraction in the respirable size range would be lower than the release fraction shown in RH-905. due to the chemical or physical form of the material;

D. The solubility of the radioactive material would reduce the dose received;

E. Facility design or engineered safety features in the facility would cause the release fraction to be lower than shown in RH-905.;

F. Operating restrictions or procedures would prevent a release fraction as large as that shown in RH-905.; or

G. Other factors appropriate for the specific facility.

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

A. Facility description. A brief description of the licensee's facility and area near the site.

B. Types of accidents. An identification of each type of radioactive materials accident for which protective actions may be needed.

C. Classification of accidents. A system for classifying each accident as "alert" or "site area emergency."

D. Detection of accidents. Identification of the means of detecting each type of accident in a timely manner.

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

F. Assessment of releases. A brief description of the methods and equipment to assess releases of radioactive materials.

G. Responsibilities. 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.

H. Notification and coordination. 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 and ensure notification of other appropriate offsite response organizations "and not later than one hour after the licensee declares an emergency."

I. Information to be communicated. A brief description of the types of information regarding facility status, radioactive releases and, if necessary, recommended protective actions.

J. Training. 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.

K. Safe shutdown. A brief description of the means of restoring the facility to a safe condition after an accident.

L. Exercises. 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.

M. Hazardous chemicals. 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.

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

h. 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:

1. Identify the source or device by manufacturer and model number as registered with the U.S. Nuclear Regulatory Commission under RH-403.i. or with an Agreement State; or

2. Contains the information identified in RH-403.i.

i. Registration of product information.

1. Any manufacturer or initial distributor of a sealed source or device containing a sealed source whose product is intended for use under a specific license may submit a request to the U.S. Nuclear Regulatory Commission (NRC) for evaluation of radiation safety information about its product and for its registration

2. The request for review must be made in duplicate and sent to the U.S. Nuclear Regulatory Commission; Division of Industrial and Medical Nuclear Safety; Medical, Academic, and Commercial Use Safety Branch; Washington, D.C. 20555.

3. The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.

4. The NRC normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the NRC formulates reasonable standards and criteria with the help of the manufacturer or distributor. The NRC shall use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property.

5. After completion of the evaluation, the Commission issues a certificate of registration to the person making the request. The certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product.

6. The person submitting the request for evaluation and registration of safety information about the product in accordance with:

i. The statements and representations, including quality control program, contained in the request; and

ii. The provisions of the registration certificate.

RH-404. General Requirements for the Issuance of Specific Licenses.

a. A license application will be approved if the Department determines that:

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

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

3. The issuance of the license will not be inimical to the health and safety of the public; and the applicant satisfies any applicable special requirements in RH-405. of these Regulations.

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

c. Orders. The Department may, by order, impose upon any licensee or registrant such requirements, issued in furtherance of these Regulations, as it deems appropriate or necessary to protect health or minimize danger to life or property.

RH-405.

a. Deleted. Refer to RH-8013. and RH-8300.

b. Deleted. Refer to RH-8013.

c. Deleted. Refer to RH-8003., RH-8004., RH-8404., and RH-8405.

d. Deleted. Refer to RH-8610., RH-8615., RH-8621., and RH-8660.

e. Manufacture and Distribution of Devices to Persons Generally Under Part D, RH-402.b. In addition to the requirements set forth in Part D, RH-404., a specific license to distribute certain devices of the types enumerated in Part D, RH-402.b. to persons generally licensed under Part D, RH-402.b. will be issued only if:

1. The applicant submits sufficient information relating to the design,

manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions and potential hazards of the device to provide reasonable assurance that:

A. The device can be safely operated by persons not having training in radiological protection;

B. Under ordinary conditions of handling, storage and 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

C. Under accident conditions (such as fire 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:

Whole body; head and trunk; active blood-forming organs;

gonads; or lens of eye ...... ........ ..........15 rems

Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than one (1) square centimeters ............. 200 rems

Other organs ..................... .............. ..... 50 rems

D. Each device bears a durable, legible, clearly visible label or labels approved by the Department, which contain in a clearly identified and separate statement:

i. Instructions and precautions necessary to assure 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);

ii. The requirement or lack of requirement, for leak 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 or radioactivity and date of determination of the quantity; and iii. The information called for in the following statement in the same or substantially similar form:

The receipt, possession, use and transfer of this device Model ______ , 9/ Serial No. _____ 9/ are subject to a general license or the equivalent and the regulations of the U.S. NRC or 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)

E. Each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number, the isotope and quantity, the words, "Caution-Radioactive Material," the radiation symbol described in RH-1303., and the name of the manufacturer or initial distributor.

F. Each device meeting the criteria of RH-402.b.3.L.i., bears a permanent (e.g., embossed, etched, stamped, or engraved) label affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words, "Caution-Radioactive Material," and, if practicable, the radiation symbol described in RH-1303.

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

A. Primary containment (source capsule);

B. Protection of primary containment;

C. Method of sealing containment;

D. Containment construction materials;

E. Form of contained radioactive material;

F. Maximum temperature withstood during prototype test;

G. Maximum pressure withstood during prototype tests;

H. Maximum quantity of contained radioactive material;

I. Radiotoxicity of contained radioactive material; and

J. Operating experience with identical devices or similarly designed and constructed devices.

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

A. If a device containing radioactive material is to be transferred for use under the general license contained in RH-402.b., each person that is licensed under RH-402.e. shall provide the information specified in this paragraph 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:

i. A copy of the general license contained in RH-402.e.; if paragraphs RH-402.b.3.B. through RH-402.b.3.D. do not apply to the particular device, those paragraphs may be omitted.

ii. A copy of RH-402., RH-600., RH-1501., and RH-1502., and

iii. A list of the services that can only be performed by a specific licensee;

iv. Information on acceptable disposal options including estimated costs of disposal; and

v. An indication that it is the Department's policy is to seek high civil penalties for improper disposal.

B. If radioactive material is to be transferred in a device for under an equivalent general license of an Agreement State, each person that is licensed under RH-402.e. shall provide the information specified in this paragraph 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:

i. A copy of the Agreement State's regulations equivalent to RH-402.b., RH-402., RH-600., RH-1501., and RH-1502., or a copy of RH-402.b., RH-402., RH-600., RH-1501., and RH-1502. If a copy of the Department is provided to a prospective general licensee in lieu of the Agreement State's regulations, it shall be accompanied by a note explaining that use of the device is regulated by the Agreement State; if certain paragraphs of the regulations do not apply to the particular deice, those paragraphs may be omitted.

ii. A list of the services that can only be performed by a specific licensee;

iii. Information on acceptable disposal options including estimated costs of disposal; and

iv. The name or title, address, and phone number of the contact at the Agreement State regulatory agency form which additional information may be obtained.

5. Material transfer reports and records.

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

A. The person shall report to the Radiation Control, Attention: General License Registration Program all transfers of such devices to persons for use under the general license in RH-402.b. and all receipts of devices from persons licensed under RH-402.b. The report must be submitted on a quarterly basis on a Department Form 653 entitled- "Transfers of Industrial Devices Report" or in a clear and legible report containing all of the data required by the form.

i. The required information for transfers to general licensees includes:

(a) . The identity of each general licensee by 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.

(b) . The name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements;

(d) . The type, model number, and serial number of the device transferred; and

(e) . The quantity and type of radioactive material contained in the device.

ii. If one or more intermediate persons will 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).

iii. For devices received from a RH-402.b. general 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.

iv. If the licensee makes changes to a device possessed by a RH-402.b. general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.

v. The report must cover each calendar quarter, must be filed within thirty (30) days of the end of the calendar quarter, and must clearly indicate the period covered by the report.

vi. The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

vii. If no transfers have been made to or from persons generally licensed under RH-402.b. chapter during the reporting period, the report must so indicate.

B. The person shall report all transfers of devices to persons for use under a general license in an Agreement State's or U.S. Nuclear Regulatory Commission regulations that are equivalent to RH-402.b. and all receipts of devices from general licensees in the U.S. Nuclear Regulatory Commission or Agreement State's jurisdiction to the U.S. Nuclear Regulatory Commission or to the responsible Agreement State agency. The report must be submitted on a Department Form 653 entitled "Transfers of Industrial Devices Report" or in a clear and legible report containing all of the data required by the form.

i. The required information for transfers to general licensees includes:

(d) . The type, model number, and serial number of the device transferred; and

(e) . The quantity and type of radioactive material contained in the device.

C. If one or more intermediate persons will 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).

D. For devices received from a general 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.

E. If the licensee makes changes to a device possessed by a general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.

F. The report must cover each calendar quarter, must be filed within thirty (30) days of the end of the calendar quarter, and must clearly indicate the period covered by the report.

G. The report must clearly identify the specific licensee submitting the report and must include the license number of the specific licensee.

H. If no transfers have been made to or from a Nuclear Regulatory Commission jurisdiction or to or from a particular Agreement State during the reporting period, this information shall be reported to the U.S. Nuclear Regulatory Commission or to the responsible Agreement State Agency upon request of the Department.

c. The person shall maintain all information concerning transfers and receipts of devices that supports the reports required by this section. Records required by this paragraph must be maintained for a period of three (3) years following the date of the recorded event.

f. Use of Sealed Sources in Non-medical Radiography. A specific license for use of sealed sources in radiography will be issued only if:

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

2. The applicant will have an adequate program for training radiographers and radiographers' assistants and submits to the Department a schedule or description of such program which specifies the:

A. Initial training;

B. Periodic training;

C. On-the-job training;

D. Means to be used by the licensee to determine the radiographer's knowledge and understanding of and ability to comply with, Department Regulations and licensing requirements and the operating and emergency procedures of the applicant; and

E. Means to be used by the licensee to determine the radiographer's assistant's knowledge and understanding of and ability to comply with the operating and emergency procedures of the applicant; and

3. The applicant has established and submits to the Department satisfactory written operating and emergency procedures as described in RH-1802.b.; and

4. The applicant has established and submits to the Department a description of its internal audit program in accordance with RH-1802.d.; and

5. The applicant submits to the Department a description of his overall organizational structure pertaining to the industrial radiography program including specified delegations of authority and responsibility for operation of the program; and

6. The applicant who desires to conduct his own leak tests has established adequate procedures to be followed in leak testing sealed sources for possible leakage and contamination and submits to the Department a description of such procedures including:

A. Instrumentation to be used;

B. Methods of performing test, e.g., points on equipment to be smeared and method of taking smear; and

C. Pertinent experience of the person who will perform the tests.

g. Licensing the Introduction of Radioactive Material into Products in

Exempt Concentrations. In addition to the requirements set forth in Section RH-404. above, a specific license authorizing the introduction of radioactive material into a product or material owned by or in the possession of the licensee or another to be transferred to persons exempt under RH-301.a.1. will be issued only if:

1. The applicant submits a description of the product or material into which the radioactive material will be introduced, intended use of the radioactive material and the product or material into which it is introduced, method of introduction, initial concentration of the radioactive material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material and estimated concentration of the radioactive material in the product or material at the time of transfer; and

2. The applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in RH-902., Schedule C, that re-concentration of the radioactive material in concentrations exceeding those in RH-902., Schedule C, is not likely, that use of lower concentrations is not feasible and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by or application to, a human being.

Each person licensed under this Paragraph g shall file an annual report with the Department which shall identify the type and quantity of each product or material into which radioactive material has been introduced during the reporting period; name and address of the person who owned or possessed the product or material, into which radioactive material has been introduced, at the time of introduction; the type and quantity of radionuclide introduced into each such product or material; and the initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the licensee. If no transfers of radioactive material have been made pursuant to this Paragraph during the reporting period, the report shall so indicate. The report shall cover the year ending June 30 and shall be filed within thirty (30) days thereafter.

h. Licensing of the Manufacture, Assembly or Repair of Luminous Safety Devices for Use in Aircraft . An application for a specific license to manufacture, assemble or repair luminous safety devices containing Tritium or Promethium-147 for use in aircraft, for distribution to persons generally licensed under RH-402.c. will be approved if:

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

2. The applicant satisfies the requirements of Sections 32.53, 32.54, 32.55, 32.556 and 32.101 of10 CFR Part 32 or their equivalent.

i. Licensing of the Manufacture of Calibration Sources Containing

Americium-241, Plutonium or Radium-226 for Distribution to Persons Generally Licensed Under RH-402.d. An application for a specific license to manufacture calibration and reference sources containing Americium-241, Plutonium or Radium-226 to persons generally licensed under RH-402.d. will be approved if:

1. The applicant satisfies the general requirement of RH-401.; and

2. The applicant satisfies the requirements of Sections 32.57, 32.58, 32.59 and 32.102 of 10 CFR Part 32 and Section 70.39 of 10 CFR Part 70 or their equivalent.

j. Licensing of the Manufacture and Distribution of Radioactive Material for

Certain In Vitro Clinical or Laboratory Testing Under General License. An application for a specific license to manufacture or distribute radioactive material for use under the general license of RH-402.h. will be approved if:

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

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

A. Carbon-14 in units not exceeding 10 microcuries each.

B. Cobalt-57 in units not exceeding 10 microcuries each.

C. Hydrogen-3 (Tritium) in units not exceeding 50 microcuries each.

D. Iodine-125 in units not exceeding 10 microcuries each.

E. Mock Iodine-125 in units not exceeding 0.05 microcurie of Iodine-129 and 0.005 microcurie of Americium-241 each.

F. Iodine-131 in units not exceeding 10 microcuries each.

G. Iron-59 in units not exceeding 20 microcuries each.

H. Selenium-75 in units not exceeding 10 microcuries each.

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

A. Identifying the radioactive contents as to chemical form and radionuclide and indicating that the amount of radioactivity does not exceed10 microcuries of Iodine-125, Iodine-131, Carbon-14, Cobalt-57 or Selenium-75; 50 microcuries of Hydrogen-3 (Tritium); 20 microcuries of Iron-59; or Mock Iodine-125 in units not exceeding 0.05 microcurie of Iodine-129 and 0.005 microcurie of Americium-241 each; and

B. Displaying the radiation caution symbol described in RH-1303.a.1. and 2. and the words, "CAUTION, RADIOACTIVE MATERIAL", and "Not for Internal or External Use in Humans or Animals".

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

"This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for In Vitro clinical or laboratory tests not involving internal or external administration of the material or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to these Regulations and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the

Commission has entered into an agreement for the exercise of regulatory authority."

___________________________________

(Name of Manufacturer)

5. The label affixed to the unit or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements set out in Part E, Section 3 of these Regulations.

k. Licensing the Manufacture and Distribution of Ice Detection Devices. An application for a specific license to manufacture and distribute ice detection devices to persons generally licensed under RH-402.f. will be approved if:

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

2. The criteria of Sections 32.61, 32.62 and 32.103 of 10 CFR Part 32 are met.

l. Manufacture, Preparation, or Transfer for Commercial Distribution of

Radiopharmaceuticals Containing Radioactive Material for Medical Use Under Group Licenses.

1. An application for a specific license to manufacture, prepare, or transfer for commercial distribution radiopharmaceuticals containing radioactive material for use by persons licensed pursuant to RH-405.c. for the uses listed in RH-903. Schedule D Group I, Group II, Group IV or Group V of this Part will be approved if:

A. The applicant satisfies the general requirements specified in RH-404. of this Part;

B. The applicant submits evidence that the applicant is at least one of the following:

i. Registered or licensed with the U.S. Food and Drug

Administration (FDA) as a drug manufacturer;

ii. Registered or licensed with a State Agency as a drug manufacturer;

iii. Licensed as a pharmacy by a State Board of Pharmacy; or iv. Operating as a nuclear pharmacy within a Federal medical institution.

C. The applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per vial, syringe, generator, or other container of the radiopharmaceutical; and the shielding provided by the packaging to show it is appropriate for safe handling and storage of radiopharmaceuticals by group licensees; and

D. The applicant satisfies the following labeling requirements:

i. A label is affixed to each transport radiation shield,

whether it is constructed of lead, glass, plastic, or other material, of a radiopharmaceutical to be transferred for commercial distribution. The label must include the radiation symbol and the words

"CAUTION, RADIOACTIVE MATERIAL"

"DANGER, RADIOACTIVE MATERIAL";

the name of the radiopharmaceutical or its abbreviation; and the quantity of radioactivity at a specified date and time. For radiopharmaceuticals with a half life greater than 100 (one hundred) days, the time may be omitted.

ii. A label is affixed to each syringe, vial, or other container used to hold a radiopharmaceutical to be transferred for commercial distribution. The label must include the radiation symbol and the words

"CAUTION, RADIOACTIVE MATERIAL"

"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.

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

A. May prepare radiopharmaceuticals for medical use, as defined in RH-200., provided that the radiopharmaceutical is prepared by either an authorized nuclear pharmacist, as specified in RH-405.l.2.B. and RH-405.l.2.D. of this Section, or an individual under the supervision of an authorized nuclear pharmacist as specified in RH-404.b.8.

B. May allow a pharmacist to work as an authorized nuclear pharmacist if:

i. This individual qualifies as an authorized nuclear pharmacist as defined in RH-200. and RH-8100.;

ii. This individual meets the requirements specified in RH-8317 (b) and RH-8319. and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist; or

iii. This individual is designated as an authorized nuclear pharmacist in accordance with RH-405.2.D. of this section.

C. The actions authorized in RH-405.l.2.A. and RH-405.l.2.B. of this Section are permitted in spite of more restrictive language in license conditions.

D. May designate a pharmacist (as defined in RH-200.) as an authorized nuclear pharmacist if the individual is identified as of December 2, 1994, as an "authorized user" on a nuclear pharmacy license issued by the Department under this Part.

D. Shall provide to the Department a copy of each individual's certification by the Board of Pharmaceutical Specialties, the Department, the U.S. Nuclear Regulatory Commission, or other Agreement State license, or the permit issued by a licensee of broad scope, and a copy of the State pharmacy licensure or registration, no later than thirty (30) days after the date that the licensee allows, pursuant to RH-405.l.2.B.i. and RH-405.l.2.B.iii. of this Section, the individual to work as an authorized nuclear pharmacist.

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

A. Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and

B. Check each instrument for constancy and proper operation at the beginning of each day of use.

4. 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.

m. Deleted.

n. Manufacture and Distribution of Sources or Devices Containing Radioactive Material for Medical Use.

An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to RH-402. for use as a calibration or reference source or for the uses listed in RH-8600., RH-8620., and RH-8630. will be approved if:

1. The applicant satisfies the general requirements in RH-404. of this Part;

2. The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

A. The radioactive material contained, its chemical and physical form and amount,

B. Details of design and construction of the source or device,

C. Procedures for and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents,

D. For devices containing radioactive material the radiation profile of a prototype device,

E. Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests,

F. Procedures and standards for calibrating sources and devices,

G. Legend and methods for labeling sources and devices as to their radioactive content, and

H. Instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device; provided, that instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label.

3. The label affixed to the source or device or to the permanent storage container for the source or device, contains information on the radionuclide, quantity and date of assay and a statement that the Department has approved distribution of the (name of source or device) to persons licensed to use radioactive material identified in RH-8404., RH-8600., RH-8620., and RH-8630. as appropriate, and to persons who hold an equivalent license issued by the U.S. Nuclear Regulatory Commission or an Agreement State.

4. In the event the applicant desires that the source or device 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; and

5. In determining the acceptable interval for test of leakage of radioactive material, the Department will consider information that includes, but is not limited to:

A. Primary containment or source capsule,

B. Protection of primary containment,

C. Method of sealing containment,

D. Containment construction material,

E. Form of contained radioactive material,

F. Maximum temperature withstood during prototype tests,

G. Maximum pressure withstood during prototype tests,

H. Maximum quantity of contained radioactive material,

I. Radiotoxicity of contained radioactive material,

J. Operation experience with identical sources or devices or similarly designed and constructed sources or devices.

o. Radioactive drug.

Manufacture, preparation, or transfer for commercial distribution of capsules containing carbon-14 urea for "in vivo" diagnostic use for humans to persons exempt from licensing. Requirements for a license:

1. An application for a specific license to manufacture, prepare,

produce, package, repackage, or transfer for commercial distribution of capsules containing carbon-14 capsules containing one (1) microcurie (37 kBq) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for "in vivo" diagnostic use, to persons exempt from licensing under RH-301.f. or the equivalent regulations of the Nuclear Regulatory Commission or of an Agreement State will be approved if:

A. The applicant satisfies the general requirements specified in RH-404., provided that the requirements of RH-404.a.1. and a.2. do not apply to an application for a license to transfer radioactive material manufactured, prepared, processed, produced, packaged, or repackaged pursuant to license issued by the Nuclear Regulatory Commission or another Agreement State;

B. The applicant meets the requirements under RH-405.l.1.B. of this Section;

C. The applicant provides evidence that each capsule contains one (1) microcurie (37 kBq) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process);

D. The carbon -14 urea is not contained in any food, beverage, cosmetic, drug (except as described in this Section) or other commodity designed for ingestion or inhalation by, or topical application to, a human being;

E. The carbon -14 urea is in the form of a capsule, identified as radioactive, and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and

F. The applicant submits copies of prototype labels and brochures and the Department approves these labels and brochures.

2. Nothing in this Section relieves the licensee from complying with applicable Food & Drug Administration (FDA), other Federal, and State requirements governing drugs.

p. Radioactive drug.

1. The immediate container of the capsule(s) must bear adurable, legible label which:

A. Identifies the radioisotope, the physical and chemical form, the quantity of radioactivity of each capsule at a specific date; and

B. Bears the words "Radioactive Material".

2. In addition to the labeling information required by RH-405.p.1., the label affixed to the immediate container, or an accompanying brochure also must:

A. State that the contents are exempt from NRC or Agreement State licensing requirements; and

B. Bear the words:

"Radioactive Material. For "In Vivo" Diagnostic Use Only. This Material Is Not To Be Used For Research Involving Human Subjects and Must Not Be Introduced into Foods, Beverages, Cosmetics, or Other Drugs or Medicinals, or into Products Manufactured For Commercial Distribution. This Material May Be Disposed of in Ordinary Trash."

RH-406. Special Requirements for Specific Licenses of Broad Scope.

This Paragraph prescribes requirements for the issuance of specific licenses of broad scope for radioactive material ("broad licenses")11/ and certain regulations governing holders of such licenses.

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

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

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

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

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

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

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

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

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

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

C. The establishment of appropriate administrative procedures to assure:

i. Control of procurement and use of radioactive material

ii. Completion of safety evaluations proposed uses of radioactive material of 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

iii. Review, approval and recording by the radiation safety committee of safety evaluation of proposed uses prepared in accordance with Subdivision ii of this Subparagraph C prior to use of the radioactive material.

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

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

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

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

B. The establishment of appropriate administrative procedures to assure:

i. Control of procurement and use of radioactive material;

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

iii. Review, approval and recording by the radiological safety officer of safety evaluations of proposed uses prepared in accordance with Subdivision ii of the Subparagraph B prior to use of the radioactive material.

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

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

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

A. A college degree at the bachelor level or equivalent training and experience in the physical or biological sciences or engineering in; and

B. At least forty (40) hours of training and experience in the safe handling of radioactive material and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used; and

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

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

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

A. Conduct tracer studies in the environment involving direct release of radioactive material;

B. Receive, acquire, own, possess, use or transfer devices containing 100,000 curies or more of radioactive material in sealed sources used for irradiation of materials;

C. Conduct activities for which a specific license issued by the Department under RH-405. of this Part is required; or

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

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

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

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

RH-407. Special Requirements for Land Disposal of Radioactive Waste.

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

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

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

A. Identity of the applicant including:

i. The full name, address, telephone number and description of the business or occupation of the applicant;

ii. If the applicant is a partnership, the name and address of each partner and the principal location where the partnership does business;

iii. If the applicant is a corporation or an 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

iv. If the applicant is acting as an agent or representative of another person in filing the application, all information required under this Paragraph must be supplied with respect to the other person.

B. Qualifications of the applicant:

i. The organizational structure of the applicant, both 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;

ii. The technical qualifications, including training and 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;

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

iv. The plan to maintain an adequate complement of trained personnel to carry out waste receipt, handling and disposal operations in a safe manner.

C. A description of:

i. The location of the proposed disposal site;

ii. The general character of the proposed activities;

iii. The types and quantities of radioactive waste to be received, possessed and disposed of;

iv. Plans for use of the land disposal facility for purposes other than disposal of radioactive wastes; and

v. The proposed facilities and equipment.

D. Proposed schedules for construction, receipt of waste and first emplacement of waste at the proposed land disposal facility.

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

A. A description of the natural and demographic disposal site characteristics as determined by disposal site selection and characterization activities. The description must include geologic, geotechnical, hydrologic, meteorologic, climatologic and biotic features of disposal site and vicinity.

B. A description of the design features of the land disposal facility and the disposal units. For near-surface disposal, the description must include those design features related to infiltration of water; integrity of covers for disposal units; structural stability of backfill, waste and covers; contact of wastes with standing water; disposal site drainage; disposal site closure and stabilization; elimination to the extent practicable of long-term disposal site maintenance; inadvertent intrusion; occupational exposures; disposal site monitoring; and adequacy of the size of the buffer zone for monitoring and potential mitigative measures.

C. A description of the principal design criteria and their relationship to the performance objectives.

D. A description of the design basis natural events or phenomena and their relationship to the principal design criteria.

E. A description of codes and standards which the applicant has applied to the design and which will apply to construction of the land disposal facilities.

F. A description of the construction and operation of the land disposal facility. The description must include as a minimum the methods of construction of disposal units; waste emplacement; the procedures for and areas of waste segregation; types of intruder barriers; onsite traffic and drainage systems; survey control program; methods and areas of waste storage; and methods to control surface water and groundwater access to the wastes.

The description 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 Subpart C of this Paragraph.

G. A description of the disposal site closure plan, including those design features which are intended to facilitate disposal site closure and to eliminate the need for ongoing active maintenance.

H. An identification of the known natural resources at the disposal site, the exploitation of which could result in inadvertent intrusion into the low-level wastes after removal of active institutional control.

I. A description of the kind, amount, classification and specifications of the radioactive material proposed to be received, possessed and disposed of at the land disposal facility.

J. A description of the quality assurance program, tailored to

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.

K. A description of the radiation safety program for control and monitoring of radioactive effluents to ensure compliance with the performance objective in RH-407.c.2. and occupational radiation exposure to ensure compliance with the requirements of Section 3 of these Regulations and to control contamination of personnel, vehicles, equipment, buildings and the disposal site. Both routine operations and accidents must be addressed. The program description must include procedures, instrumentation, facilities and equipment.

L. A description of the environmental monitoring program to provide data to evaluate potential health and environmental impacts and the plan for taking corrective measures if migration of radionuclides is indicated.

M. A description of the administrative procedures that the applicant will apply to control activities at the land disposal facility.

N. Technical analyses. The specific technical information must also include the following analyses needed to demonstrate that the performance objectives of Subpart c of this Paragraph will be met:

i. Pathways analyzed in demonstrating protection of 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.

ii. Analyses of the protection of individuals from 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.

iii. Analyses of the protection of individuals during operations must include assessments of expected exposures due to routine operations and likely accidents during handling, storage and disposal of waste. The analyses must provide reasonable assurance that exposures will be controlled to meet the requirements of Section 3 of these Regulations.

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

3. The institutional information must include:

A. A certification by the Federal or State government which owns the disposal site that the Federal or State government is prepared to accept transfer of the license when the provisions of RH-407.b.7. are met and will assume responsibility for custodial care after site closure and post-closure observation and maintenance.

B. Where the proposed disposal site is on land not owned by the Federal or a State government, the applicant must submit evidence that arrangements have been made for assumption of ownership in fee by the Federal or a State government before the Department issues a license.

4. The financial information must be sufficient to demonstrate that the financial qualifications of the applicant are adequate to carry out the activities for which the license is sought and meet other financial assurance requirements as specified in Subpart e of this Part.

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

6. Contents of a application for closure.

A. Prior to final closure of the disposal site or as otherwise directed by the Department, the applicant shall submit an application to amend the license for closure. This closure application must include a final revision and specific details of the disposal site closure plan included as part of the license application submitted under RH-407.b.2.G. that includes each of the following:

i. Any additional geologic, hydrologic or other disposal site data pertinent to the long-term containment of emplaced radioactive wastes obtained during the operational period.

ii. The results of tests, experiments or other analyses 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.

iii. Any proposed revision of plans for:

Decontamination and/or dismantlement of surface facilities;

Backfilling of excavated areas; or

Stabilization of the disposal site for post-closure care.

B. An environmental report or a supplement to an environmental report prepared in accordance with Subpart A of 10 CFR, Part 51 must accompany the application.

C. Upon review and consideration of an application to amend the license for closure submitted in accordance with Subparagraph G.4 of this Paragraph, the Department shall issue an amendment authorizing closure if there is reasonable assurance that the long-term performance objectives of Subpart c of this Paragraph will be met.

D. Following completion of closure authorized in RH-407.b.6, the licensee shall observe, monitor and carry out necessary maintenance and repairs at the disposal site until the license is transferred by the Department in accordance with RH-407.b.7. Responsibility for the disposal site must be maintained by the licensee for five (5) years. A shorter or longer time period for post-closure observation and maintenance may be established and approved as part of the site closure plan, based on site-specific conditions.

7. Transfer of license. Following closure and the period of post-

closure observation and maintenance, the licensee may apply for an amendment to transfer the license to the disposal site owner. The license shall be transferred when the Department finds:

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

B. That reasonable assurance has been provided by the licensee that the performance objectives of Subpart c of this Paragraph are met;

C. That any funds and necessary records for care will be transferred to the disposal site owner;

D. That the post-closure monitoring program is operational for implementation by the disposal site owner; and

E. That the Federal or State government agency which will 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.

c. Performance Objectives

1. General requirement. Land disposal facilities must be sited,

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

2. Protection of the general population from releases of radioactivity. Concentrations of radioactive material which may be released to the general environment in ground water, surface water, air, soil, plants or animals must not result in an annual dose exceeding an equivalent of 25 millirems to the whole body, 75 millirems to the thyroid and 25 millirems to any other organ of any member of the public. Reasonable effort should be made to maintain releases of radioactivity in effluents to the general environment as low as is reasonably achievable.

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

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

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

d. Technical Requirements for Land Disposal Facilities.

1. Disposal site suitability for near-surface disposal.

A. The purpose of this section is to specify the minimum characteristics a disposal site must have to be acceptable for use as a near-surface disposal facility. The primary emphasis in disposal site suitability is given to isolation of wastes, a matter having long-term impacts and to disposal site features that ensure that the long-term performance objectives of Subpart c of this Paragraph are met, as opposed to short-term convenience or benefits.

B. The disposal site shall be capable of being characterized, modeled, analyzed and monitored.

C. Within the region or state where the facility is to be located, a disposal site should be selected so that projected population growth and future developments are not likely to affect the ability of the disposal facility to meet the performance objectives of Subpart c of this Paragraph.

D. Areas must be avoided having known natural resources which, if exploited, would result in failure to meet the performance objectives of Subpart c of this Paragraph.

E. The disposal site must be generally well drained and free of areas of flooding or frequent ponding. Waste disposal shall not take place in a 100-year flood plain, coastal high-hazard area or wetland.

F. Upstream drainage areas must be minimized to decrease the amount of runoff which could erode or inundate waste disposal units.

G. The disposal site must provide sufficient depth to the water table that ground water intrusion, perennial or otherwise, into the waste will not occur. The Department will consider an exception to this requirement to allow disposal below the water table if it can be conclusively shown that disposal site characteristics will result in molecular diffusion being the predominant means of radionuclide movement and the rate of movement will result in the performance objectives of Subpart c of this Paragraph being met. In no case will waste disposal be permitted in the zone of fluctuation of the water table.

H. The hydrogeologic unit used for disposal shall not discharge ground water to the surface within the disposal site.

I. Areas must be avoided where tectonic processes such as 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 of Subpart c of this Paragraph or may preclude defensible modeling and prediction of long-term impacts.

J. Areas must be avoided where surface geologic processes 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 of Subpart c of this Paragraph or may preclude defensible modeling and prediction of long-term impacts.

K. The disposal site must not be located where nearby facilities or activities could adversely impact the ability of the site to meet the performance objectives of Subpart c of this Paragraph or significantly mask the environmental monitoring program.

2. Disposal site design for near-surface disposal.

A. Site design features must be directed toward long-term isolation and avoidance of the need for continuing active maintenance after site closure.

B. The disposal site design and operation must be compatible with the disposal site closure and stabilization plan and lead to disposal site closure that provides reasonable assurance the performance objectives of Subpart c of this Paragraph will be met.

C. The disposal site must be designed to complement and improve, where appropriate, the ability of the disposal site's natural characteristics to assure that the performance objectives of Subpart c of this Paragraph will be met.

D. Covers must be designed to minimize to the extent practicable water infiltration, to direct percolating or surface water away from the disposed waste and to resist degradation by surface geologic processes and biotic activity.

E. Surface features must direct surface water drainage away from disposal units at velocities and gradients which will not result in erosion that will require ongoing active maintenance in the future.

F. The disposal site must be designed to minimize to the extent practicable the contact of water with waste during storage, the contact of standing water with waste during disposal and the contact of percolating or standing water with wastes after disposal.

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

A. Wastes designated as Class A pursuant to RH-407.d.6., must be segregated from other wastes by placing in disposal units which are sufficiently separated from disposal units for the other waste classes so that any interaction between Class A wastes and other wastes will not result in the failure to meet the performance objectives in Subpart c of this Paragraph. This segregation is not necessary for Class A wastes if they meet the stability requirements in RH-407.d.7.B. of this Part.

B. Wastes designated as Class C pursuant to RH-407.d.6. must be disposed of so that the top of the waste is a minimum of five (5) meters below the top surface of the cover or must be disposed of with intruder barriers that are designed to protect against an inadvertent intrusion for at least 500 years.

C. All wastes shall be disposed of in accordance with the requirements of RH-407.d.3.D. through K.

D. Wastes must be emplaced in a manner that maintains the package integrity during emplacement, minimizes the void spaces between packages and permits the void spaces to be filled.

E. Void spaces between waste packages must be filled with earth or other material to reduce future subsidence within the fill.

F. Waste must be placed and covered in a manner that limits the radiation dose rate at the surface of the cover to levels that at a minimum will permit the licensee to comply with all provisions of RH-1208. at the time the license is transferred pursuant to RH-407.b.7.

G. The boundaries and locations of each disposal unit (e.g., trenches) must be accurately located and mapped by means of a land survey. Near-surface disposal units must be marked in such a way that the boundaries of each unit can be easily defined. Three (3) permanent survey marker control points, referenced to United States Geological Survey (USGS) or National Geodetic Survey (NGS) survey control stations, must be established in the site to facilitate surveys. The USGS or NGS control stations must provide horizontal and vertical controls as checked against USGS or NGS record files.

H. Buffer zone of land must be maintained between any buried waste and the disposal site boundary and beneath the disposed waste. The buffer zone shall be of adequate dimensions to carry out environmental monitoring activities specified in RH-407.d.4. and take mitigative measures if needed.

I. Closure and stabilization measures as set forth in the approved site closure plan must be carried out as each disposal unit (e.g., each trench) is filled and covered.

J. Active waste disposal operations must not be have an adverse effect on completed closure and stabilization measures.

K. Only wastes containing or contaminated with radioactive materials shall be disposed of at the disposal site.

4. Environmental monitoring.

A. At the time a license application is submitted, the applicant shall have conducted a preoperational monitoring program to provide basic environmental data on the disposal site characteristics. The applicant shall obtain information about the ecology, meteorology, climate, hydrology, geology, geochemistry and seismology of the disposal site. For those characteristics that are subject to variation, data must cover at least a twelve (12) month period.

B. The licensee must have plans for taking corrective measures if migration of radionuclides would indicate that the performance objectives of Subpart c may not be met.

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

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

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

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

A. Classes of waste:

i. Class A waste is waste that is usually segregated from other waste classes at the disposal site. The physical form and characteristics of Class A waste must meet the minimum requirements set forth in 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.

ii. Class B waste is waste that must meet more rigorous requirements on waste form to ensure stability after disposal. The physical form and characteristics of Class B waste must meet both the minimum and stability requirements set forth in RH-407.d.7.

iii. Class C waste is waste that not only must meet more rigorous requirements waste form to ensure stability but also on 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.

iv. Waste that is not generally acceptable or near-surface disposal is waste for which waste form and disposal methods must be different and in general more stringent, than those specified for Class C waste. In the absence of specific requirements in this Part, proposals for disposal of this waste may be submitted to the Department for approval, pursuant to RH-407.d.9. of this Part.

B. Classification determined by long-lived radionuclides.

If radioactive waste contains only radionuclides listed in Table 1, classification shall be determined as follows:

i. If the concentration does not exceed 0.1 times the 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.

iii. If the concentration exceeds the value in Table 1, the waste is not generally acceptable for near-surface disposal.

iv. For wastes containing mixtures of radionuclides listed in Table 1, the total concentration shall be determined by sum of fractions rule described in the RH-407.d.6.F.

TABLE 1.

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	1100
Pu-241	13,500
Cm-242	120,000

1 Units are nanocuries per gram.

C. Classification determined by short-lived radionuclides. If radioactive waste does not contain any of the radionuclides listed in Table 1, classification shall be determined based on the concentrations shown in Table 2. However, as specified in 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.

i. If the concentration exceeds the value in Column 1, the waste is Class A.

ii. If the concentration exceeds the value in Column 1, but does not exceed the value in Column 2, the waste is Class B.

iii. If the concentration exceeds the value in Column 2, but does not exceed the value in Column 3, the waste is Class C.

iv. If the concentration exceeds the value in Column 3, the waste is not generally acceptable for near-surface disposal.

v. For wastes containing mixtures of the nuclides listed in Table 2, the total concentration shall be determined by the sum of fractions rule described in RH-407.d.6.F.

TABLE 2.

Radionuclide	Concentration, curies per cubic meter
Radionuclide	Col. 1	Col. 2	Col. 3
Total of all nuclides less than 5 year half life	700	(1)	(1)
H-3	40	(1)	(1)
Co-60	700	(1)	(1)
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

1 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 the Class C independent of these nuclides.

D. Classification determined by both long and short-lived radionuclides.

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:

i. If the concentration of a nuclide listed in Table 1 does not exceed 0.1 times the value listed in Table 1, the class shall be that determined by the concentration of nuclides listed in Table 2.

ii. If the concentration of a nuclide listed in Table 1 exceeds 0.1 times the value listed in Table 1 but does not exceed the value in Table 1, the waste shall be Class C, provided the concentration of nuclides listed in Table 2 does not exceed the value shown in Column 3 of Table 2.

E. Classification of wastes with radionuclides other than those listed in Tables 1 and 2. If radioactive waste does not contain any nuclides listed in either Table 1 or 2, it is Class A.

F. The sum of the fractions rule for mixtures of radionuclides. For determining classification for waste that contains a mixture of radionuclides, it is necessary to determine the sum of fractions by dividing each 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.

G. Determination of concentrations in wastes. 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.

7. Waste characteristics.

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

i. Waste must not be packaged for disposal in cardboard or fiberboard boxes.

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

iii. Solid waste containing liquid shall contain as little freestanding and noncorrosive liquid as is reasonably achievable, but in no case shall the liquid exceed one percent (1%) of the volume.

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

v. Waste must not contain or be capable of generating,

quantities of toxic gases, vapors or fumes harmful to persons transporting, handling or disposing of the waste. This does not apply to radioactive gaseous waste packaged in accordance with RH-407.d.6.G.

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

vii. Waste in a gaseous form must be packaged at a pressure that does not exceed 1.5 atmospheres at 200 C. Total activity must not exceed 100 curies per container.

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

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

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

ii. Notwithstanding the provisions in RH-407.d.7.A.ii. 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.

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

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

9. The Department may, upon request or on its own initiative, authorize other provisions for the classification and characteristics of waste on a specific basis, if, after evaluation of the specific characteristics of the waste, disposal site, and method of disposal, it finds reasonable assurance of compliance with the performance objectives in Subpart c of this Paragraph.

10. Institutional requirements.

A. Land ownership. Disposal of radioactive waste received from other persons may be permitted only on land owned in fee by the Federal or a State government.

B. Institutional control. 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.

e. Funding for Disposal Site Closure and Stabilization.

1. The applicant shall provide assurance that sufficient funds will be available to carry out disposal site closure and stabilization, including decontamination or dismantlement of land disposal facility structures; and closure and stabilization of the disposal site so that following transfer of the disposal site to the site owner, the need for ongoing active maintenance is eliminated to the extent practicable and only minor custodial care, surveillance and monitoring are required. These assurances shall be based on Department-approved cost estimates reflecting the Department-approved plan for disposal site closure and stabilization. The applicant's cost estimates must take into account total capital costs that would be incurred if an independent contractor were hired to perform the closure and stabilization work.

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

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

4. The amount of surety liability should change in accordance with the predicted cost of future closure and stabilization. Factors affecting closure and stabilization cost estimates include inflation; increases in the amount of disturbed land; changes in engineering plans; closure and stabilization that has already been accomplished and any other conditions affecting costs. This will yield a surety that is at least sufficient at all times to cover the costs of closure of the disposal units that are expected to be used before the next license renewal.

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

6. Proof of forfeiture must not be necessary to collect the surety so that in the event that the licensee could not provide an acceptable replacement surety within the required time, the surety shall be automatically collected prior to its expiration. The conditions described above would have to be clearly stated on any surety instrument which is not open-ended and must be agreed to by all parties. Liability under the surety mechanism must remain in effect until the closure and stabilization program has been completed and approved by the Department and the license has been transferred to the site owner.

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

RH-408. Issuance of Specific Licenses.

a. Upon a determination that an application meets the requirements of the

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

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

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

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

3. Prevent loss or theft of licensed material.

RH-409. Specific Terms and Conditions of Licenses.

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

b. No license issued or granted under this Part and no right to possess or utilize radioactive material granted by any license issued pursuant to this Part 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.

c. Each person licensed by the Department pursuant to these Regulations shall confine their use and possession of the material licensed to the locations and purposes authorized in the license. Except as otherwise provided in the license, a license issued pursuant to these Regulations in Section 2, shall carry with it the right to receive, acquire, own and possess radioactive material. Preparation for shipment and transport of radioactive material shall be in accordance with the provisions of Section 4 of these Regulations.

d. The Department may incorporate, in any license issued pursuant to Section 2 of these Regulations, at the time of issuance or thereafter by appropriate rule, regulation or order, such additional requirements and conditions with respect to the licensee's receipt, possession, use and transfer of radioactive material as it deems appropriate or necessary in order to:

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

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

e. Each licensee shall notify the Department in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license. This notification requirement applies to all specific licenses issued under Section 2 of these Regulations.

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

g. Bankruptcy notification.

1. Each general licensee that is required to register by RH-402.b.3.L.

and each specific licensee shall notify the Department in writing immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of Title 11 (Bankruptcy) of the United States Code by or against:

A. The licensee;

B. An entity (as that term is defined in 11 U.S.C. 101(14) ) controlling the licensee or listing the license or licensee as property of the estate; or

C. An affiliate (as that term is defined in 11 U.S.C. 101(2) ) of the licensee.

2. This notification must indicate:

A. The bankruptcy Court in which the petition for Bankruptcy was filed; and,

B. The date of the filing of the petition.

h. Financial assurance and record keeping for decommissioning.

1. Each applicant for a specific license authorizing the 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 RH-2300, Appendix B, shall submit a decommissioning funding plan as described in RH-409.h.5. of this section. The decommissioning funding plan must also be submitted when a combination of isotopes is involved if R divided by105 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 B.

2. Each holder of or applicant for a specific license authorizing the possession and use of sealed sources or plated foils of half-life greater than 120 days and in quantities and in quantities exceeding 1012 times the applicable quantities set forth in appendix B or when a combination of isotopes is involved if R, as defined in RH-409.h.1., divided by 1012 is greater than shall either:

A. Submit a decommissioning funding plan as described in RH-409.h.5. of this section. The decommissioning funding plan must be submitted to Department by

December 2, 2007.

B. Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by RH-409.h.4. of this section using one of the methods described in RH-409.h.6. of this section. For an applicant, this certification may state that the appropriate assurance will be obtained after the application has been approved and the license issued but prior to the receipt of licensed material. As part of the certification, a copy of the financial instrument obtained to satisfy the requirements of RH-409.h.6. of this section is to be submitted to the Department.

A. Each holder of a specific license issued on or after

July 27, 1993, which is of a type described in RH-409.h.1. of this section, shall provide financial assurance for decommissioning in accordance with the criteria set forth in this section.

B. Each holder of a specific license issued before July 27, 1993, and of a type described in RH-409.h.3. of this section shall submit, on or before July 27, 1993, a decommissioning funding plan or a certification of financial assurance for decommissioning in an amount at least equal to $1,125,000 in accordance with the criteria set forth in this section. If the licensee submits the certification of financial assurance rather than a decommissioning funding plan at this time, the licensee shall include a decommissioning funding plan in any application for license renewal.

C. Each holder of a specific license issued before July 27, 1993, and of a type described in RH-409.h.2. of this section shall submit, on or before July 27, 1993, a certification of financial assurance for decommissioning or a decommissioning funding plan in accordance with the criteria set forth in this section.

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

Table of required amounts of financial assurance for decommissioning by quantity of material. Greater than 104 but less than or equal to 105 times the applicable quantities of Appendix B of RH-2300. in unsealed form. (For a combination of isotopes, if R, as defined in RH-409.h.1. divided by 104 is greater than 1 but R divided by 105 is less than or equal to )...................$1,125,000

Greater than 103 but less than or equal to 104 times the applicable quantities of Appendix B of RH-2300. in unsealed form. (For a combination of isotopes, if R, As defined RH-409.h.1. divided by 103 is greater than 1 but R divided by 104 is less than or equal to 1.)...............................................................$225,000

Greater than 1010 times the applicable quantities of Appendix B of RH-2300. in sealed sources or plated foils. (For a combination of isotopes, if R, as defined in RH-409.h.1., divided by1010 is greater than.)............................................................ $113,000

5. Each decommissioning funding plan must contain a cost estimate for decommissioning and a description of the method of assuring funds for decommissioning from RH-409.h.6., including means for adjusting cost estimates and associated funding levels periodically over the life of the facility. Cost estimates must be adjusted at intervals not to exceed three (3) years. The decommissioning funding plan must also contain a certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning and a signed original of the financial instrument obtained to satisfy the requirements of RH-409.h.6.

6. Financial assurance for decommissioning must be provided by one or more of the following methods:

A. Prepayment. 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 may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.

B. A surety method, insurance, or other guarantee method. These methods guarantee that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A 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 of this Part. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this Section.

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 of this Section. 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 of this Section. 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 of this Section.

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 contained in Appendix B of this Part. A guarantee by the applicant or licensee may not be used in combination with any other financial methods to satisfy the requirements of this Section or 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:

i. The surety method or insurance must be open-ended 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.

ii. The surety method or insurance must be payable to 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.

iii. The surety method or insurance must remain in effect until the Department has terminated the license.

C. An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected.

An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provisions must be as stated in RH-409.h.6.B.

D. In the case of State or local government licensees, a statement of intent containing a cost estimate for decommissioning or an amount based on the Table in RH-409.h.4. of this Section, and indicating that funds for decommissioning will be obtained when necessary.

E. When a governmental entity is assuming custody and ownership of a site, an arrangement by such governmental entity.

7. Each person licensed under Section 2 shall keep records of information important to decommissioning of the facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned in accordance with RH-409.b., licensees shall transfer all records described in this paragraph to the new licensee. In this case, the new licensee will be responsible for maintaining these records until the license is terminated.

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

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

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

C. Except for areas containing only sealed sources (provided the sources have not leaked and no contamination remains after any leak) or radioactive materials having only half-lives of less than sixty-five (65) days, a list contained in a single document and updated every two (2) years, consisting of the following:

i. All areas designed and formerly designated restricted areas as defined in RH-1100.;

ii. All areas outside of restricted areas that require documentation under RH-409.h.7.A;

iii. All areas outside of restricted areas where current and previous wastes have been buried as documented under RH-1500.g.;

iv. All areas outside of restricted areas which contain material such that, if the license expired, the licensee would be required to either decontaminate to meet the criteria for decommissioning in RH-410. or apply for approval for disposal under RH-1401.

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

RH-410. Expiration and Termination of Licenses and Decommissioning of Sites and

Separate Buildings or Outdoor Areas.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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:

(i) . Procedures would involve techniques not applied routinely during cleanup or maintenance operations;

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

(iii) . Procedures could result in significant greater airborne concentrations of radioactive materials than are present during operation; or

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

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

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

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

(i) . A description of the conditions of the site or separate building or outdoor area sufficient to evaluate the acceptability of the plan;

(ii) . A description of planned decommissioning activities;

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

(iv) . A description of the planned final radiation survey; and

(v) . An updated detailed cost estimate for decommissioning,

comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning.

(vi) . For decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, the plan shall include a justification for the delay based on the criteria in RH-410.h.

5. The proposed decommissioning plan will be approved by the

Department if the information therein demonstrates that the decommissioning will be completed as soon as practicable and that the health and safety of workers and the public will be adequately protected.

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

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

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

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

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

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

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

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

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

1. Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed ADH FORM 314 or equivalent information; and

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

A. Report levels of gamma radiation in units of microroentgen (millisieverts) per hour at one meter from surfaces, and report levels of radioactivity, including alpha and beta, in units of disintegrations per minute or microcuries (megabecquerels) per 100 square centimeters-removable and fixed-for surfaces, microcuries (megabecquerels) per milliliter for water, and picocuries (becquerels) per gram for solids such as soils or concrete; and

B. Specify the survey instrument(s) used and certify that each instrument is properly calibrated and tested.

k. Specific licenses, including expired licenses, will be terminated by written

notice to the licensee when the Department determines that:

1. Radioactive material has been properly disposed;

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

A. A radiation survey has been performed which demonstrates that the premises are suitable for release in accordance with the criteria for decommissioning in RH-1216., RH-1217., and/or RH-1218.; or

B. Other information submitted by the licensee is sufficient that the premises are suitable for release in accordance with the criteria for decommissioning in RH-1216., RH-1217., and/or RH-1218.

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

RH-411. Renewal of Licenses.

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

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

RH-412. Amendment of License at Request of Licensee. Applications for amendment of a license shall be filed in accordance with Part D, RH-403. and shall specify the respects in which the licensee desires his license to be amended and the grounds for such amendment.

RH-413. Department Action on Application to Renew or Amend. In considering an application by a licensee to renew or amend his license, the Department will apply the criteria set forth in Part D, RH-404. and Part D, RH-405., as applicable.

RH-414. Inalienability of Licenses. No license issued or granted under these Regulations and no right to possess or utilize radioactive material granted by any license issued pursuant to these Regulations 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.

RH-415. Reserved.

RH-416. Modification, Revocation and Termination of Licenses.

a. The terms and conditions of all licenses shall be subject to amendment, revision or modification or the license may be suspended or revoked by reason of amendments to the Act or by reason of rules, regulations and orders issued by the Department.

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

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

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

RH-417.- RH-499. Reserved.

PART E. TRANSFER OF MATERIAL

RH-500. Authorization for Transfer. No licensee shall transfer radioactive material except as authorized pursuant to this Part.

RH-501. Condition of Transfer. Any licensee may transfer radioactive material subject to acceptance by the transferee, to:

a. The Department;

b. The U.S. Department of Energy, the U.S. Nuclear Regulatory Commission or any successor thereto;

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

d. Any person licensed to receive such material under terms of a general license or its equivalent or specific license or equivalent licensing document issued by the Department, the U.S. Nuclear Regulatory Commission or any Agreement State or to any person otherwise authorized to receive such material by the Federal Government or any agency thereof, the Department or any other state having an agreement with the U.S. Nuclear Regulatory Commission, pursuant to Section 274 of the Atomic Energy Act of 1954, as amended; or e. Any other person authorized by the Department in writing.

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

g. The following methods for the verification required by RH-501.f. are acceptable:

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

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

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

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

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

RH-502. Preparation of Material. Preparation for shipment and transport of radioactive material shall be in accordance with the provisions of RH-3200. of these Regulations.

RH-503. - RH-599. Reserved.

PART F. RECORDS, REPORTS, AND INSPECTIONS

RH-600. Records.

a. Each person who receives a source of radiation pursuant to a license or registration under this Section shall keep records showing the receipt, transfer and disposal of such sources of radiation as follows:

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

2. The licensee or registrant who transferred the material or source of radiation shall maintain each record of transfer for three (3) years after each transfer unless a specific requirement in another part of the regulations in this Section dictates otherwise.

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

b. Each licensee or registrant shall retain each record that is required by this Section 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 or registration that authorizes the activity that is subject to the recordkeeping requirement.

Records which must be maintained pursuant to this Section 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 or registrant shall maintain adequate safeguards against tampering with and loss of records.

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

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

1. Records of disposal of licensed material made under RH-1401., RH-1402., RH-1404., RH-1405.; and

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

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

1. Records of disposal of licensed material made under RH-1401., RH-1402., RH-1404., RH-1405.; and

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

RH-601. Inspections.

a. Each licensee shall afford, at all reasonable times, to the Department opportunity to inspect radioactive materials and the installation wherein such radioactive materials are used or stored.

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

RH-602. Tests.

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:

a. Sources of radiation;

b. Facilities wherein radioactive materials are used or stored;

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

RH-603.- RH-699. Reserved.

PART G. ENFORCEMENT

RH-700.

a. Violations.

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

b. Impounding.

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

RH-701.- RH-749. Reserved.

PART H. RECIPROCITY

RH-750. Reciprocal Recognition of Licenses.

a. Subject to the provisions of these Regulations, any person who possesses a specific license or equivalent licensing document issued by the U.S. Nuclear Regulatory Commission or any Agreement State, other than this state, may conduct the activities authorized in such licensing document within this state for a period not in excess of one hundred eighty (180) days in any period of twelve (12) consecutive months without obtaining a specific license from the Department, provided that:

1. The licensing document does not limit the activity authorized by such document to specified installations or locations; and

2. The out-of-state licensee notifies the Department in writing at least two (2) days prior to engaging in such activity. Such notification shall indicate the exact location, period and type of proposed possession and use within this state and shall be accompanied by a copy of the pertinent licensing document. If, for a specific case, the two (2) day period would impose an undue hardship on the out-of-state licensee, he may, upon application to the Department, obtain permission to proceed sooner; and

3. The out-of-state licensee complies with all applicable regulations of the Department and with all the terms and conditions of his licensing document, except any such terms and conditions which may be inconsistent with applicable regulations of the Department; and

4. Provided further that the Department may require the out-of-state licensee to supply such other information as the Department may reasonably request.

b. To the extent provided in RH-300., RH-301. and RH-402., any person may transfer, receive, acquire, own, possess and use any equipment, device, commodity or other product containing radioactive material which has been manufactured, processed or produced in accordance with a specific license or equivalent licensing document issued by the U.S. Nuclear Regulatory Commission or any Agreement State.

c. Notwithstanding the provisions of Paragraph a of this Section RH-750., any person who holds a specific license or equivalent licensing document issued by the U.S. Nuclear Regulatory Commission or an Agreement State authorizing the holder to manufacture, install or service a device described in RH-402.b.1. within areas subject to the jurisdiction of the licensing body is hereby granted a general license to install and service such device in this state provided that:

1. Such person shall file a report with the Department within thirty (30) days after the end of each calendar quarter in which any device is transferred to or installed in this state. Each such report shall identify each general licensee by names and address, the type of device transferred and the quantity and type of radioactive material contained in the device;

2. The device has been manufactured, labeled, installed and serviced in accordance with applicable provisions of the specific license or equivalent licensing document issued to such person by the U.S. Nuclear Regulatory Commission or an Agreement State;

3. Such person shall assure that any labels required to be affixed to the device under regulations of the authority which licensed manufacture of the device bear a statement that "Removal of this label is prohibited"; and

4. The holder of the specific license or equivalent licensing document shall furnish to each general licensee to whom he transfers such device or on whose premises he installs such device a copy of the general license contained in RH-402.b.

d. The Department may withdraw, limit or qualify its acceptance of any specific license or equivalent licensing document issued by another agency 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.

RH-751. Additional Requirements.

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.

RH-752.- RH-899. Reserved.

PART I. SCHEDULES

RH-900. Schedule A. Generally Licensed Equipment, When Manufactured in

Accordance With Specific License.

The following devices and equipment incorporating radioactive material, when manufactured, tested and labeled by the manufacturer in accordance with the specifications contained in a specific license or equivalent licensing document issued by the Department, the U.S. Nuclear Regulatory Commission or any Agreement State, are placed under a general license pursuant to Section 2, Part D, RH-402.a.

a. Static Elimination Device. Devices designed for use as static eliminators which contain, as a sealed source or sources radioactive material consisting of a total of not more than 500 microcuries of Polonium-210 per device.

b. Ion Generating Tube. Devices designed for ionization of air which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 microcuries of Polonium 210 per device or of a total of not more than 50 millicuries of Hydrogen-3 (Tritium) per device.

RH-901. Schedule B. Exempt Quantities.

Radioactive M Material c	icro-uries
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)	10
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)	100
Osmium-191m (Os 191m)	100
Osmium-191 (Os 191)	10
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

Alpha emitting radioactive material not listed above	0.01
Any radioactive material listed above other than alpha emitting radioactive material	0.1

Note 1:For purposes of RH-305.a., where there is involved a combination of isotopes, the limit for the combination should be derived as follows:

Determine the amount of each isotope possessed and 1,000 times the amount in Schedule B for each of those isotopes when not in combination. The sum of the ratios of those quantities may not exceed 1. Example.

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RH-902. Schedule C. Exempt Concentrations.

Element (atomic number)	Isotope	Column I Gas concentration Ci/ml12/	Column II Liquid and solid concentration Ci/ml13/
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) --- Indium (49) ----	H 3 In 113m	5 X 10-6 -------	3 X 10-2 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
Polonium (84) -	Po 210	-------	7 X 10-6
Potassium (19)	K 42	-------	3 X 10-3
Praseodymium (50) - Pr 142		-------	3 X 10-4
	Pr 143	-------	5 X 10-4

	Pm 149	-------	4 X 10-4
Radium (88) --	Ra 226	-------	1 X 10-7
	Ra 228	-------	3 X 10-7
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 10-3
	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 10-3
	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 (80) -	Yb 175	--------	1 X 10-3
Yttrium (30) ---	Y 90	--------	2 X 10-4
	Y 91m	--------	3 X 10-2
	Y 91	--------	3 X 10-4
	Y 92		6 X 10-4
			-4
______			-3
-----			-4
			-2
			-4
	Zr 97	--------	2 X 10-4
Beta and/or gamma	emitting
radioactive material	not
listed above with ha	lf-
life less than 3 years	--	1 X 10-10	1 X 10-6

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

NOTE 2: For purposes of RH-301. where there is involved a combination of isotopes, the limit for the combination should be derived as follows: Determine for each isotope in the product the ratio between the concentration present in the product and the exempt concentration established in Schedule C for the specific isotope when not in combination. The sum of such ratios may not exceed "1" (i.e. unity).

Example:

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RH-903. Deleted. Refer to Section 9.

RH-904. Schedule E. 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

RH-905. Schedule F. Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release.

Radioactive Material 15/16/	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	0.001	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
Phosphors-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
Ruthenium-106	.01	200
Samarium-151	.01	4,000
Scandium-46	.01	3,000
Selenium-75	.01	10,000
Silver-110m	.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-6	.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 Irradiated material, any form other than solid noncombustible	.001 .01	10,000 1,000
Irradiated material, solid noncombustible Mixed radioactive waste, beta-gamma Packaged mixed waste, beta-gamma	.001 .01 .001	10,000 1,000 10,000
Any other alpha emitter	.001	2
Contaminated equipment, ALPHA	.0001	20
Packaged waste, alpha 16/	.0001	20
Combinations of radioactive materials listed above 15/	--	--

APPENDIX A:

Criteria Relating to Use of Financial Tests

and Parent Company Guarantees for Providing Reasonable

Assurance of Funds for Decommissioning

I. Introduction

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

II. Financial Test

A. To pass the financial test, the parent company must meet the criteria of either paragraph A.1 or A.2 of this Appendix:

1. The parent company must have:

a. Two of the following three ratios: A ratio of total liabilities to net worth less than 2.0; a ratio of the sum of net income plus depreciation, depletion, and amortization to total liabilities greater than 0.1; and a ratio of current assets to current liabilities greater than 1.5; and

b. Net working capital and tangible net worth each at least six (6) times the current decommissioning cost estimates (or prescribed amount if a certification is used); and

c. Tangible net worth of at least $10 million; and

d. Assets located in the United States amounting to at least ninety (90%) percent of total assets or at least six (6) times the current decommissioning cost estimates (or prescribed amount if a certificate is used).

2. The parent company must have:

a. A current rating for its most recent bond issuance of AAA, AA, A, or BBB, as issued by Standard and Poor's or Aaa, Aa, A or Baa as issued by Moody's; and

b. Tangible net worth at least six (6) times the current decommissioning cost estimate (or prescribed amount if a certification is used); and

c. Tangible net worth of at least $10 million; and

B. The parent company's independent certified public accountant must have compared the data used by the parent company in the financial test, which is derived from the independently audited, year end financial statements for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure the licensee shall inform the Department within ninety (90) days of any matters coming to the auditor's attention which cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test.

1. After the initial financial test, the parent company must repeat the passage of the test within ninety (90) days after the close of each succeeding fiscal year.

2. If the parent company no longer meets the requirements of 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.

III. Parent Company Guarantee

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

A. The parent company guarantee will remain in force unless the guarantor sends notice of cancellation by certified mail to the licensee and the Department. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by both the licensee and the Department, as evidenced by the return receipts.

B. If the licensee fails to provide alternate financial assurance as specified in the Department's regulations within ninety (90) days after receipt by the licensee and Department of a notice of cancellation of the parent company guarantee from the guarantor, the guarantor will provide such alternative financial assurance in the name of the licensee.

C. The parent company guarantee and financial test provisions must remain in effect until the Department has terminated the license.

D. If a trust is established for decommissioning costs, the trustee and trust must be acceptable to the Department. An acceptable trust 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.

APPENDIX B: Criteria Relating to Use of Financial Tests

and Self Guarantees for Providing Reasonable

Assurance of Funds for Decommissioning

I. Introduction

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

II. Financial Test

A. To pass the financial test, a company must meet all of the following criteria:

1. Tangible net worth at least ten (10) times the total current decommissioning cost estimate (or the current amount required if certification is used) for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor.

2. Assets located in the United States amounting to at least 90 percent (90%) of total assets or at least ten (10) times the total current decommissioning cost estimate (or prescribed amount required if certification is used) for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor.

3. A current rating for its most recent bond issuance of AAA, AA, or A as issued by Standard and Poors (S&P), or Aaa, Aa, or A as issued by Moodys.

B. To pass the financial test, a company must meet all of the following additional requirements:

1. The company must have at least one class of equity securities registered under the Securities Exchange Act of 1934.

2. The company's independent certified public accountant must have compared the data used by the company in the financial test which is derived from the independently audited, yearend financial statements for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the licensee shall inform the Department within ninety (90) days of any matters coming to the auditor's attention which cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test.

3. After the initial financial test, the company must repeat the passage of the test within ninety (90) days after the close of each succeeding fiscal year.

C. If the licensee no longer meets the requirements of Section II.A of

Appendix B, the licensee must send notice to the Department of its intent to establish alternate financial assurance as specified in the Department's Regulations within 120 days of such notice.

III. Company Self-Guarantee

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

A. The guarantee will remain in force unless the licensee sends notice of cancellation by certified mail to the Department. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by the Department, as evidenced by the return receipt.

B. The licensee shall provide alternate financial assurance as specified in the Department's regulations within ninety (90) days following receipt by the Department of a notice of cancellation of the guarantee.

C. The guarantee and financial test provisions must remain in effect until the Department has terminated the license or until another financial assurance method acceptable to the Department has been put in effect by the licensee.

D. The licensee will promptly forward to the Department and the licensee's independent auditor all reports covering the latest fiscal year filed by the licensee with the Securities and Exchange Commission pursuant to the requirements of section 13 of the Securities and Exchange Act of 1934.

E. If, at any time, the licensee's most recent bond issuances ceases to be rated in any category of "A" or above by either Standard and Poors or Moodys, the licensee will provide notice in writing of such fact to the Department within twenty (20) days after publication of the change by the rating service. If the licensee's most recent bond issuance ceases to be rated in any category of A or above by both Standard and Poor and Moodys, the licensee no longer meets the requirements of Section II.A of Appendix B.

F. The applicant or licensee must provide to the Department a written guarantee (a written commitment by a corporate officer) which states that the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Department, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning.

APPENDIX C: Criteria Relating to Use of Financial Tests and Self Guarantees for Providing Reasonable Assurance of Funds for Decommissioning by Commercial Companies That Have no Outstanding Rated Bonds

I. Introduction

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

II. Financial Test

A. To pass the financial test, a company must meet all of the following criteria:

1. Tangible net worth greater than $10 million, or at least ten (10)

times the total current decommissioning cost estimate (or the current amount required if certification is used), whichever is greater, for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor.

2. Assets located in the United States amounting to at least ninety percent (90%) of total assets or at least ten (10) times the total current decommissioning cost estimate (or the current amount required if certification is used) for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor.

3. A ratio of cash flow divided by total liabilities greater than 0.15 and a ratio of total liabilities divided by net worth less than 1.5.

B. In addition, to pass the financial test, a company must meet all of the following additional requirements:

1. The company's independent certified public accountant must have compared the data used by the company in the financial test, which is required to be derived from the independently audited year end financial statement based on United States generally accepted accounting practices for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the licensee shall inform the Department within ninety (90) days of any matters that may cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test.

2. After the initial financial test, the company must repeat the passage of the test within ninety (90) days after the close of each succeeding fiscal year.

3. If the licensee no longer meets the requirements of Section II.A of APPENDIX C, the licensee must send notice to the Department of its intent to establish alternate financial assurance as specified in the Department's Regulations. The notice must be sent by certified mail, return receipt requested, within ninety (90) days after the end of the fiscal year for which the yearend financial data show that the licensee no longer meets the financial test requirements. The licensee must provide alternative financial assurance within 120 days after the end of such fiscal year.

III. Company Self-Guarantee

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

A. The guarantee will remain in force unless the licensee sends notice of cancellation by certified mail, return receipt requested, to the Department. Cancellation may not occur until an alternative financial assurance mechanism is in place.

B. The licensee shall provide alternative financial assurance as specified in the Department's regulations within ninety (90) days following receipt by the Department of a notice of cancellation of the guarantee.

D. The applicant or licensee must provide to the Department a written guarantee (a written commitment by a corporate officer) which states that the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Department, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning.

APPENDIX D: Criteria Relating to Use of Financial Tests and Self Guarantees for Providing Reasonable Assurance of Funds for Decommissioning by Nonprofit Colleges, Universities, and Hospitals

I. Introduction

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

II. Financial Test

A. For colleges and universities, to pass the financial test, a college or university must meet either the criteria in Paragraph II.A.1. or the criteria in Paragraph II.A.2. of this Appendix.

1. For applicants or licensees that issue bonds, a current rating for its most recent uninsured, uncollateralized, and unencumbered bond issuance of AAA, AA, or A as issued by Standard and Poors (S&P), or Aaa, Aa, or A as issued by Moodys.

2. For applicants or licensees that do not issue bonds, States of at least $50 million, at least thirty (30) times the total current decommissioning cost estimate (or the current amount required if certification is used), whichever is greater, for all decommissioning activities for which the college or university is responsible as self-guaranteeing licensee and as parent-guarantor.

B. For hospitals, to pass the financial test, a hospital must meet either the criteria in Paragraph II.B.1. or the criteria in Paragraph II.B.2. of this Appendix.

2. For applicants or licensees that do not issue bonds, all the following tests must be met:

a. (Total Revenues less total expenditures) divided by total revenues must be equal to or greater than 0.04.

b. Long term debt divided by net fixed assets must be less than or equal to 0.67

c. (Current assets and depreciation fund) divided by current liabilities must be greater than or equal to 2.55.

d. Operating revenues must be at least 100 times the total current decommissioning cost estimate (or the current amount required if certification is used) for all decommissioning activities for which the hospital is responsible as self-guaranteeing licensee.

C. In addition, to pass the financial test; a licensee must meet all the following requirements:

1. The licensee's independent certified public accountant must have compared the data used by the licensee in the financial test, which is required to be derived from the independently audited yearend financial statements, based on United States generally accepted accounting practices, for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the licensee shall inform the Department within ninety (90) days of any matters that may cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test.

2. After the initial financial test, the licensee must repeat the passage of the test within ninety (90) days after the close of each succeeding fiscal year.

3. If the licensee no longer meets the requirements of Section I of APPENDIX D, the licensee must send notice to the Department of its intent to establish alternate financial assurance as specified in the Department's Regulations. The notice must be sent by certified mail, return receipt requested, within ninety (90) days after the end of the fiscal year for which the yearend financial data show that the licensee no longer meets the financial test requirements. The licensee must provide alternative financial assurance within 120 days after the end of such fiscal year.

III. Self-Guarantee

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

A. The guarantee will remain in force unless the licensee sends notice of cancellation by certified mail, and/or return receipt requested, to the Department. Cancellation may not occur unless an alternate financial assurance mechanism is in place.

D. The applicant or licensee must provide to the Department a written guarantee (a written commitment by a corporate officer or officer of the institution) which states that the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Department, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning.

FOOTNOTES FOR 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 Subdivision B and C of this Subparagraph 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/ Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity or other product containing source or byproduct material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

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/ Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity or other product containing byproduct material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

6/ Attention is directed particularly to the provisions of Section 3 of these

Regulations which relate to the labeling of containers.

7/ Any notification of incidents referred to in those requirements shall be filed with or made to the Department.

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/ The model, serial number and name of manufacturer or distributor may be omitted from this label provided they are elsewhere specified in labeling affixed to the device.

10/ Deleted. Deleted when RH-405.m. was deleted.

11/ Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity or other product containing source or byproduct material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

12/ Values are given in Column 1 only for those materials normally used in gases.

13/ Ci/gm for solids.

14/ These reporting requirements do not supersede or release licensee of complying with the requirements under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Pubic Law 99-499 or other state or federal reporting requirements.

15/ For combinations of radioactive materials, consideration of the need an emergency plan is required if the sum of the ratios of the quantity of for each radioactive material authorized to the quantity listed for that material in Schedule F exceeds one.

16/ Waste packaged in Type B containers does not require an emergency plan.

SECTION 3. STANDARDS FOR PROTECTION AGAINST RADIATION

(FOOTNOTES APPEAR AT THE END OF THIS SECTION)

PART A. GENERAL

RH-1000. Authority. Act 8 of Second Extraordinary Session of 1961, as amended.

RH-1001. Effective Date. The provisions of these Regulations shall become effective on January 1, 1963, except where another effective date is specifically noted.

RH-1002. Purpose and Scope.

a. These Regulations establish standards for protection against radiation hazards. Except as otherwise specifically provided, this Part applies to all licensees or registrants.

b. It is the purpose of the Regulations in this Part to control the receipt, possession, use, transfer, and disposal of licensed material by any licensee or registrant in such a manner that the total dose to an individual (including doses resulting from licensed and unlicensed radioactive material and from radiation sources other than background radiation) does not exceed the standards for protection against radiation prescribed in the Regulations in this Part. However, nothing in this Part shall be construed as limiting actions that may be necessary to protect health and safety.

RH-1003. Communications. All communications concerning these Regulations should be addressed to the Arkansas Department of Health and Human Services, Division of Health, Radiation Control Section Chief, P.O. Box 1437 Mail Slot H-30, Little Rock, Arkansas 72203-1437.

RH-1004. Radiation Protection Programs.

a. Each licensee or registrant shall develop, document, and implement a radiation protection program commensurate with the scope and extent of licensed activities or x-ray equipment use and sufficient to ensure compliance with the provisions of this Part. (See RH-1500. for recordkeeping requirements relating to these programs.)

b. The licensee or registrant shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA).

c. The licensee or registrant shall periodically (at least annually) review the radiation protection program content and implementation.

d. To implement the ALARA requirements in RH-1004.b., and not withstanding the requirements in RH-1208., a constraint on air emissions of radioactive material to the environment, excluding Radon-222 and its daughters, shall be established by licensees such that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of ten (10) mrem (0.1 mSv) per year from these emissions. If a licensee subject to this requirement exceed this dose constraint, the licensee shall report the exceedance as provided in RH-1504. and promptly take appropriate corrective action to ensure against recurrence.

RH-1005. - RH-1099. Reserved.

PART B. DEFINITIONS

RH-1100. Definitions as used in these Regulations. Additional definitions used only in a certain Part will be found in that Part.

a. 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).

b. Act - The Atomic Energy Act of 1954 ( 42 U.S.C. 2011 et seq.), as amended.

c. Activity - The rate of disintegration (transformation or decay of radioactive material. The units of activity) are the curie (Ci) and the becquerel (Bq).

d. Adult - An individual 18 or more years of age.

e. Agreement State - Any State with which the U.S. Nuclear Regulatory Commission has entered into an effective agreement under Section 274 b. of the Atomic Energy Act of 1954 as amended (73 Stat. 689).

f. Airborne radioactive material - Radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

g. Airborne radioactivity area - A room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:

1. In excess of the derived air concentrations (DACs) specified in Appendix G to RH-1000. through RH-2110., or

2. To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 percent of the annual limit on intake (ALI) or 12 DAC-hours.

h. 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.

i. 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 Part 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.

j. 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 1, Columns 1 and 2, of Appendix G to RH-1000. through RH-2110.).

k. Approved qualified expert - An individual who has, prior to offering health physics services, registered with and demonstrated to the satisfaction of the Department that he/she possesses the knowledge and training to measure ionizing radiation parameters, to evaluate safety techniques and to advise regarding radiation protection matters.

l. 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.

m. 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.

n. 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.

o. 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.

p. Byproduct material - Any radioactive material (except special nuclear material) yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear material.

q. 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.

r. 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.

s. 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.

t. 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).

u. Constraint (dose constraint) - a value above which specified licensee or registrant actions are required.

v 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.

w. Critical Group - the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

x. 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.

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

(1) Release of the property for unrestricted use and termination of the license; or

(2) . Release of the property under restricted conditions and termination of the license.

z. 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).

aa. 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.

ab. Department - The Arkansas Department of Health and Human Services or its duly authorized representatives.

ac. 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 ).

ad. 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 1, Column 3, of Appendix G to RH-1000. through RH-2110.

ae. 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).

af. Director - Director of the Arkansas Division of Health.

ag. 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).

ah. 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.

ai. 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.

aj. 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).

ak. 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.

al. 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).

am. Embryo/fetus - The developing human organism from conception until the time of birth.

an. 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.

ao. Exposure - Being exposed to ionizing radiation or to radioactive material.

ap. External dose - That portion of the dose equivalent received from radiation sources outside the body.

aq. Extremity - Hand, elbow, arm below the elbow, foot, knee, and leg below the knee.

ar. 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).

as. 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.

at. Fit factor - A quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the radio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

au. Fit test - The use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

av. 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.

aw. 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.

ax. Gray - See RH-1102. Units of Radiation Dose.

ay. Helmet - A rigid respirator inlet covering that also provides head protection against impact and penetration.

az. 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.

ba. Hood - A respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

bb. Individual - Any human being.

bc. Individual monitoring:

1. The assessment of dose equivalent by the use of devices designed to be worn by an individual;

2. The assessment of committed effective dose equivalent by bioassay (see Bioassay) or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e., DAC-hours; or

3. The assessment of dose equivalent by the use of survey data.

bd. 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.

be. Internal dose - That portion of the dose equivalent received from radioactive material taken into the body.

bf. 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).

bg. License - Except where otherwise specified, means a license issued pursuant to Section 2, Section 6, or Section 7.

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

bi. Licensee - The holder of a license.

bj. Limits (dose limits) - The permissible upper bounds of radiation doses.

bk. Loose-fitting facepiece - A respiratory inlet covering that is designed to form a partial seal with the face.

bl. 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.

bm. Member of the public - Any individual except when that individual is receiving an occupational dose or unrestricted area.

bn. Minor - An individual less than 18 years of age.

bo. Misadministration - Revised in RH-8110.t.

bp. 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.

bq. 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.

br. 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).

bs. 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-1214., from voluntary participation in medical research programs, or as a member of the general public.

bt. 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.

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

bv. Planned special exposure - An infrequent exposure to radiation, separate from and in addition to the annual dose limits.

bw. Positive pressure respirator - a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

bx. 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.

by. Prescribed dosage - Revised in RH-8100.bb.

bz. Prescribed dose - Revised in RH-8100.cc.

ca. 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.

cb. 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-1214, or from voluntary participation in medical research programs.

cc. Qualified Expert - A person qualified by training and experience to calibrate a teletherapy unit and establish procedures for spot-check measurements. This person shall:

1. Be certified by the American Board of Radiology in Therapeutic Radiological Physics, Radiological Physics, Roentgen-Ray and Gamma-Ray Physics or X-ray and Radium Physics; or

2. Is certified by the American Board of Medical Physics in radiation oncology physics; or

3. Have the following minimum training and experience:

A. A Master's Degree or Doctorate in physics, biophysics, radiological physics, or health physics;

B. One year of full-time training in therapeutic radiological physics; and

C. One year of full-time experience in a radiotherapy facility including personal calibration and spot-check of a least one (1) teletherapy unit.

cd. 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.

ce. 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

cf. Quantitative fit test (QNFT) - means an assessment of the adequacy of respirator fit by numerically measuring the leakage into the respirator.

cg. 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.

ch. Rad - See RH-1102. Units of Radiation Dose.

ci. 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.

cj. 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

ck. Radiation machine - Any device capable of producing radiation, but excluding devices which produce radiation only by the use of radioactive material

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

cm. Radioactivity - The transformation of unstable atomic nuclei by the emission of radiation.

cm. Recordable event - This language is no longer used anywhere in the regulations.

co. 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.

cp. Rem - See RH-1102. Units of Radiation Dose.

cq. 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 even if those burials were made in accordance with the provision of Section 3. Part E. Waste Disposal.

cr. Respiratory protective device - An apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

cs. 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.

ct. 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.

cu. Self-contained breathing apparatus (SCBA) - an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

cv. Shallow-dose equivalent (Hs) - (which applies to the external exposure of the skin of the whole body or the skin of an extremity) - Is taken as the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2).

cw. Sievert - See RH-1102. Units of Radiation Dose.

cx. Site boundary - That line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee.

cy. Source material -

1. Uranium or Thorium or any combination of Uranium and Thorium in any physical or chemical form; or

2. Ores that contain, by weight, one-twentieth of one (1%) percent (0.05 percent), or more, of Uranium, Thorium, or any combination of Uranium and Thorium. Source material does not include special nuclear material.

cz. Source of radiation - Any radioactive material or any radiation machine.

da. Special nuclear material -

1. Plutonium, Uranium-233, Uranium enriched in the isotope 233 or in the isotope 235, and any other material that the Department, pursuant to the provisions of Section 51 of the Act, determines to be special nuclear material, but does not include source material, or

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

db. Storage container - A device in which sealed sources are transported or stored.

dc. 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.

dd. 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.

de. 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.

df. 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:

1. Moisture/density measurements;

2. Level measurements;

3. Any portable devices containing radioactive materials; and/or

4. Consulting services included, but not limited to:

A. Calibration of instruments;

B. Repair of devices or sources;

C. Sealed source installation and/or exchange;

D. Decommissioning of sealed sources.

dg. These Regulations - Section 3, Rules and Regulations of the State Board of Health, Standards for Protection Against Radiation.

dh. Tight-fitting facepiece - a respiratory inlet covering that forms a complete seal with the face.

di. Total Effective Dose Equivalent (TEDE) - The sum of the deep-dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

dj. 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.

dk. 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.

dl. 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.

dm. 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).

dn. Week - Seven (7) consecutive days starting on Sunday.

do. 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 dose:

ORGAN DOSE WEIGHTING FACTORS

Organ or Tissue	w T
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.

dp. Whole body - For purposes of external exposure, head, trunk (including male gonads), arms above the elbow, or legs above the knee.

dq. Worker - An individual engaged in work under a license or registration issued by the Department and controlled by a licensee or registrant dr. 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.

ds. 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).

dt. Written directive - Revised in RH-8100.rr.

du. Year - The period of time beginning in January used to determine compliance with the provisions of this Part. 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.

RH-1101. Other Definitions. Definitions of certain other words and phrases as used in these Regulations are set forth in other Paragraphs.

RH-1102. Units of Radiation Dose.

As used in this Part, the units of radiation dose are:

a. Exposure rate - The exposure per unit of time, such as roentgen per minute and milliroentgen per hour.

b. Gray (Gy) - The SI unit of absorbed dose. One gray is equal to an absorbed dose of one (1) joule/kilogram (100 rads).

c. Rad - The special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs/gram or 0.01 joule/kilogram (0.01 gray).

d. Rem - The special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rems is equal to the absorbed dose in rads multiplied by the quality factor (1 rem = 0.01 sievert).

e. Roentgen - the special unit of exposure. One roentgen ( R ) equals 2.58 X 10-4 coulombs/kilogram of air (See "Exposure" in RH-1100).

f. Sievert (Sv) - 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 rems).

g. As used in this Part, the quality factors for converting absorbed dose to dose equivalent are shown in Table 1.

TABLE RH-1102 #1

QUALITY FACTORS AND ABSORBED DOSE EQUIVALENCIES

TYPE OF RADIATION Factor	Quality (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.

h. If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in rems per hour or sieverts per hour, as provided in RH-1102.g. of this Section, 1 rem (0.01 Sv) of neutron radiation of unknown energies may, for purposes of the Regulations in this Part, be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee may use the fluence rate per unit dose equivalent or the appropriate Q value from Table 2 to convert a measured tissue dose in rads to dose equivalent in rems.

TABLE RH-1102 #2

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)	Neutron Energy (MeV)	Quality Factora (Q)	Fluence per Unit Dose Equivalentb (neutrons cm-2 rem-1)	2.5 x 10-8 1 x 10-7 1 x 10-6 1 x 10-5 1 x 10-4 1 x 10-3 1 x 10-2 1 x 10-1	2 2 2 2 2 2 2.5 7.5	980 x 106 980 x 106 810 x 106 810 x 106 840 x 106 980 x 106 1010 x 106 170 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.

RH-1103. Units of Radioactivity.

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.

a. One becquerel = 1 disintegration per second (s-1).

b. One curie = 3.7 x 1010 disintegrations per second = 3.7 x 1010 becquerels = 2.22 x 1012 disintegrations per minute.

RH-1104. Interpretations.

Except as specifically authorized by the Department in writing, no interpretation of the meaning of the Regulations in this Part by an officer or employee of the Department other than a written interpretation by the Department Director or designee will be recognized to be binding upon the Department.

RH-1105. Implementation.

a. The applicable Section of RH-1000. through RH-2110. must be used in lieu of requirements in the standards for protection against radiation in effect prior to January 1, 1994 that are cited in license conditions except as specified in RH-1105.c. through RH-1105.e. of this Section. If the requirements of this Part are more restrictive than the existing license condition, then the licensee shall comply with this Part unless exempted by RH-1105.d. of this Section.

b. Any existing license condition that is more restrictive than a requirement in RH-1000. through RH-2110. remains in force until there is a license amendment or license renewal.

c. If a license condition exempted a licensee from a requirement in the standards for protection against radiation in effect prior to January 1, 1994, it continues to exempt a licensee from the corresponding provision of RH-1000. through RH-2110.

d. If a license condition cites provisions in requirements in the standards for protection against radiation in effect prior to January 1, 1994 and there are no corresponding provisions in RH-1000. through RH-2110., the license condition remains in force until there is a license amendment or license renewal that modifies or removes this condition.

e. Any existing license condition that is more restrictive than a requirement in RH-1000. through RH-2110. remains in force until there is a technical specification change, license amendment, or license renewal.

f. If a license condition exempts a licensee from a provision of this Section in RH-1. through RH-602., it also exempts the licensee from the corresponding provision of RH-1000. through RH-2110.

g. If a license condition cites provisions in Part M 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.

RH-1106 - RH-1199. Reserved

PART C. PERMISSIBLE DOSES, LEVELS, AND CONCENTRATIONS

RH-1200. Occupational Dose Limits for Adults.

a. The licensee or registrant shall control the occupational dose to individual adults, except for planned special exposures under RH-1205, to the following dose limits.

1. An annual limit, which is the more limiting of:

A. The total effective dose equivalent being equal to 5 rems (0.05 Sv), or

B. The sum of the deep-dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 50 rems (0.5 Sv).

2. The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities which are:

A. An lens dose equivalent of 15 rems (0.15 Sv), and

B. A shallow-dose equivalent of 50 rems (0.50 Sv) to the skin of the whole body or to skin of any extremity.

b. Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, must be subtracted from the limits for planned special exposures that the individual may receive during the current year (See RH-1205.e.1.) and during the individual's lifetime (See RH-1205.e.2.).

c. The assigned deep-dose equivalent must be for the part of the body receiving the highest exposure. The assigned shallow-dose equivalent must be the dose averaged over the contiguous ten (10) square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens dose equivalent and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable.

d. Derived air concentration (DAC) and annual limit on intake (ALI) values are presented in Table 1 of Appendix G to RH-1000. through RH-2110. and may be used to determine the individual's dose (See RH-1500.f.) and to demonstrate compliance with the occupational dose limits.

e. In addition to the annual dose limits, the licensee shall limit the soluble Uranium intake by an individual to 10 milligrams in a week in consideration of chemical toxicity (See footnote 3 of Appendix G to RH-1000. through RH-2110.).

f. The licensee shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person (see RH-1500.d.5.).

RH-1201. Compliance with Requirements for Summation of External and Internal Doses.

a. If the licensee is required to monitor under both RH-1302.a.and b., the 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.

b. Intake by inhalation. If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep-dose equivalent divided by the total effective dose equivalent limit, and one of the following, does not exceed unity:

1. The sum of the fractions of the inhalation ALI for each radionuclide, or

2. The total number of derived air concentration-hours (DAC-hours) for all radionuclides divided by 2,000, or

3. The sum of the calculated committed effective dose equivalents to all significantly irradiated1/ organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit.

c. Intake by oral ingestion. If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than ten percent (10%) of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits.

d. Intake through wounds or absorption through skin. The licensee shall evaluate and, to the extent practical account for intakes through wounds or skin absorption.

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.

RH-1202. Determination of External Dose From Airborne Radioactive Material.

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 RH-1000. through RH-2110., footnotes 1 and 2).

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.

RH-1203. Determination of Internal Exposure.

a. For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required under RH-1302., take suitable and timely measurements of:

1. Concentrations of radioactive materials in air in work areas; or

2. Quantities of radionuclides in the body; or

3. Quantities of radionuclides excreted from the body; or

4. Combinations of these measurements.

b. Unless respiratory protective equipment is used, as provided in RH-1303.f. 5., or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

c. When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior or the material in an individual is known, the licensee may:

1. Use that information to calculate the committed effective dose equivalent, and, if used, the licensee shall document that information in the individual's record;

2. Upon prior approval of the Department, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material (e.g., aerosol size distribution or density); and

3. Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of given radionuclide (See Appendix G to RH-1000. through RH-2110.) to the committed effective dose equivalent.

d. If the licensee chooses to assess intakes of Class Y material using the measurements given in RH-1203.a.2. or 3., the licensee may delay the recording and reporting of the assessments for periods up to seven (7) months, unless otherwise required by RH-1502. or RH-1503., in order to permit the licensee to make additional measurements basic to the assessments.

e. If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours must be either:

1. The sum of the ratios of the concentration to the appropriate DAC value (e.g., D, W, Y) from Appendix G to RH-1000. through RH-2110. for each radionuclide in the mixture; or

2. The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.

f. If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture must be the most restrictive DAC of any radionuclide in the mixture.

g. When a mixture of radionuclides in air exists, licensees may disregard certain radionuclides in the mixture if:

1. The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in RH-1200 and in complying with the monitoring requirements in RH-1302.b.;

2. The concentration of any radionuclide disregarded is less than ten (10%) percent of its DAC; and

3. The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed 30 percent.

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.

2. When the ALI (and the associated DAC) is determined by the 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 1 of Appendix G to RH-1000. through RH-2110.

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 limits in RH-1200.a.1.i. and ii. are met.

RH-1204. Reserved.

RH-1205. Planned Special Exposures.

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-1201. provided that each of the following conditions is satisfied:

a. The licensee or registrant authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the dose estimated to result from the planned special exposure are unavailable or impractical.

b. The licensee or registrant (and employer if the employer is not the licensee) specifically authorizes the planned special exposure, in writing, before the exposure occurs.

c. Before a planned special exposure, the licensee or registrant ensures that the individuals involved are:

1. Informed of the purpose of the planned operation;

2. Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and

3. Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present.

d. Prior to permitting an individual to participate in a planned special exposure, the licensee or registrant ascertains prior doses as required by RH-1500.d. during the lifetime of the individual for each individual involved.

e. Subject to RH-1200.b., the licensee or registrant does not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:

1. The numerical values of any of the dose limits in RH-1200.a., in any year; and

2. Five (5) times the annual dose limits in RH-1201.a. during the individual's lifetime.

f. The licensee or registrant maintains records of the conduct of a planned special exposure in accordance with RH-1500.e. and submits a written report in accordance with RH-1504.

g. The licensee or registrant records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within thirty (30) days from the date of the planned special exposure. The dose from planned special exposures is not to be considered in controlling future occupational dose of the individual under RH-1201.a. but is to be included in evaluations required by RH-1205.d. and e.

RH-1206 Occupational Dose Limits for Minors.

The annual occupational dose limits for minors are ten (10%) percent of the annual dose limits specified for adult workers in RH-1200.

RH-1207 Dose to an Embryo/Fetus.

a. The licensee or registrant shall ensure that the dose equivalent to the 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.g.)

b. The licensee or registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in Paragraph a of this Section.

c. The dose equivalent to the embryo/fetus is the sum of:

1. The deep-dose equivalent to the declared pregnant woman; and

2. The dose equivalent to the embryo/fetus resulting from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman.

d. If the dose equivalent to the embryo/fetus is found to have exceeded 0.5 rem (5 mSv), or is within 0.05 rem (0.5 mSv) of this dose, by the time the woman declares the pregnancy to the licensee or registrant, the licensee or registrant shall be deemed to be in compliance with RH-1207.a., if the additional dose to the embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy.

RH-1208 Dose Limits for Individual Members of the Public.

a. Each licensee or registrant shall conduct operations so that:

1. The total effective dose equivalent to individual members of the public from the licensed or registered operation does not exceed 0.1 rem (1 millisievert) in a year, exclusive of the dose contribution from the background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with RH-1214., from voluntary participation in medical research program, and from licensee's disposal of radioactive material into sanitary sewerage in accordance with RH-1402.; and

2. The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and released in accordance with RH-1214., does not exceed 0.002 rem (0.02 millisievert) in any one hour.

b. If the licensee or registrant permits members of the public to have access to controlled areas, the limits for members of the public continue to apply to those individuals.

c. Notwithstanding RH-1208.a.1. of this section, a licensee may permit visitors to an individual who cannot be released, under RH-8420., to receive a radiation dose greater than 0.1 rem (1 mSv) if:

1. The radiation dose received does not exceed 0.5 rem (5 mSv);

2. The authorized user, as defined in Section 9, has determined before the visit that it is appropriate; and

3. Documentation shall be maintained by the licensee.

d. A licensee or license applicant or registrant may apply for prior Department authorization to operate up to an annual dose limit for an individual member of the public of 0.5 rem (5 mSv). The licensee or license applicant or registrant shall include the following information in this application:

1. Demonstration of the need for and the expected duration of operations in excess of the limit in RH-1208.a. of this Section;

2. The licensee's or registrant's program to assess and control dose within the 0.5 rem (5 mSv) annual limit; and

3. The procedures to be followed to maintain the dose as low as is reasonably achievable.

e. In addition to the requirements of this Part, a licensee subject to the provisions of EPA's generally applicable environmental radiation standards in 40 CFR Part 190 shall comply with those standards.

f. The Department may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose.

RH-1209. Compliance with Dose Limits for Individual Members of the Public.

a. The licensee or registrant shall make or cause to be made, as appropriate, surveys of radiation levels in unrestricted and controlled areas and radioactive materials in effluents released to unrestricted and controlled areas to demonstrate compliance with the dose limits for individual members of the public in RH-1208.

b. A licensee or registrant shall show compliance with the annual dose limit in RH-1208. by:

1. Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed operation does not exceed the annual dose limit; or

2. Demonstrating that:

A. The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in Table 2 of Appendix G to RH-1000. through RH-2110.; and

B. If an individual were continually present in an unrestricted area, the dose from external sources would not exceed 0.002 rem (0.02 mSv) in an hour and 0.05 rem (0.5 mSv) in a year.

c. Upon approval from the Department, the licensee may adjust the effluent concentration values in Appendix G to RH-1000. through RH-2110., Table 2, for members of the public, to take into account the actual physical and chemical characteristics of the effluents (e.g., aerosol size distribution, solubility, density, radioactive decay equilibrium, chemical form).

RH-1210. Radioactivity in Effluents to Uncontrolled Areas.

a. A licensee shall not possess, use, or transfer licensed material so as to release to an uncontrolled area radioactive material in concentrations which exceed the limits specified in RH-2200., Appendix A, Table II of this Part, except as authorized pursuant to RH-1401. or Subparagraph b of this Paragraph. For purposes of this Paragraph, concentrations may be averaged over a period not greater than one (1) year.

b. An application for a license or amendment may include proposed limits higher than those specified Subparagraph a of this Paragraph. The Department will in approve the proposed limits if the applicant demonstrates:

1. That the applicant has made a reasonable effort to minimize the radioactivity contained in effluents to uncontrolled areas; and

2. That it is not likely that radioactive material discharged in the effluent would result in the exposure of an individual to concentrations of radioactive material in air or water exceeding the limits specified in RH-2200., Appendix A, Table II of this Section.

c. An application for high limits pursuant to Subparagraph b of this Paragraph shall include information demonstrating that the applicant has made a reasonable effort to minimize the radioactivity discharged in effluents to uncontrolled areas and shall include, as pertinent.

1. Information as to flow rates, total volume of effluent, peak concentration of each radionuclide in the effluent and concentration of each radionuclide in the effluent averaged over a period of one (1) year at the point where the effluent leaves a stack, tube, pipe, or similar conduit.

2. A description of the properties of the effluents, including:

A. Chemical composition;

B. Physical characteristics, including suspended solids content in liquid effluents and nature of gas or aerosol for air effluents;

C. The Hydrogen ion concentrations (pH) of liquid effluents; and

D. The size range of particulates in effluents released into air.

3. A description of the anticipated human occupancy in the uncontrolled area where the highest concentration of radioactive material from the effluent is expected and, in the case of a river or stream, a description of water uses downstream from the point of release of the effluent.

4. Information as to the highest concentration of each radionuclide in an uncontrolled area, including anticipated concentrations averaged over a period of one (1) year:

A. In air at any point of human occupancy; or

B. In water at points of use downstream from the point of release of the effluent.

5. The background concentration of radionuclides in the receiving river or stream prior to the release of liquid effluent.

6. A description of the environmental monitoring equipment, including sensitivity of the system and procedures and calculations to determine concentrations of radionuclides in the uncontrolled area and possible reconcentrations of radionuclides.

7. A description of the waste treatment facilities and procedures used to reduce the concentration of radionuclides in effluents prior to their release.

d. For the purposes of this Paragraph, the concentration limits in RH-2200., Appendix A, Table II of this Section shall apply at the boundary of the controlled area. The concentration of radioactive material discharged through a stack, pipe or similar conduit may be determined with respect to the point where the material leaves the conduit. If the conduit discharges within the controlled area, the concentration at the boundary may be determined by applying appropriate factors for dilution, dispersion or decay between the point of discharge and the boundary.

e. In addition to limiting concentrations in effluent streams, the Department may limit quantities of radioactive materials released in air or water during a specified period of time if it appears that the daily intake resulting from continuous exposure to air or water containing one-third the concentration of radioactive materials specified in RH-2200., Appendix A, Table II of this Section.

f. The provisions of this Paragraph do not apply to disposal of radioactive material into sanitary sewerage systems, which is governed by RH-1402.

g. Soil and vegetation limiting concentrations

1. No licensee shall possess, receive, use, or transfer radioactive material in such a manner as to cause contamination of soil or vegetation the extent that the contamination exceeds the to following on a dry weight basis:

A. In unrestricted areas, the concentration limits specified in RH-2200., Appendix A, Table II, Column 2, with the units changed from µCi/ml to µCi/gm; and

B. In restricted areas, the concentration limits specified in RH-2200., Appendix A, Table I, Column 2, with the units changed from µCi/ml to µCi/gm.

2. Where combinations of radionuclides are involved, the sum of the ratios between the concentrations present and the limits specified in RH-1203.e. shall not exceed one.

3. Notwithstanding the limits imposed by RH-1210., the concentration of Radium-226 or Radium-228 in soil averaged over any 100 square meters shall not exceed the background level by more than:

A. 5 pCi/gm, averaged over the first 15 cm of soil below the surface; and

B. 15 pCi/gm, averaged over 15 cm thick layers of soil more than 15 cm below the surface.

RH-1211. Orders Requiring Furnishing of Bioassay Services.

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.

RH-1212. Leak Tests.

a. Each sealed radioactive source possessed under the provisions of a specific license, other than Hydrogen-3 (Tritium), with a half-life greater than thirty (30) days and in any form other than gas shall be tested for leakage and/or contamination prior to initial use and at intervals specified by the license. If there is reason to suspect that a sealed source might have been damaged, it shall be tested for leakage before further use.

b. Leak tests shall be capable of detecting the presence of 0.005 microcurie of removable contamination. Any test conducted pursuant to RH-1212. which reveals the presence of 0.005 microcurie or more of removable contamination shall be considered evidence that the sealed source is leaking. The licensee shall immediately withdraw the source from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with RH-501.

c. Within five (5) days after obtaining results of the test, the licensee shall file a report with the Department describing the equipment involved, the test results, and the corrective action taken.

d. Where sealed sources are permanently mounted in devices or equipment, tests for contamination and leakage may be made by wiping appropriate accessible surfaces and measuring these wipes for transferred contamination. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the Department.

RH-1213. Surface Contamination Limits for Facilities and Equipment

a. Prior to vacating any facility or releasing areas or equipment for unrestricted use, each licensee shall ensure that radioactive contamination has been removed to levels as low as reasonably achievable. In no case shall the licensee vacate a facility or release areas or equipment for unrestricted use until radioactive surface contamination levels are below the limits specified in RH-1213.b.

b. ACCEPTABLE SURFACE CONTAMINATION LEVELS

NUCLIDE1	AVERAGE2,3,6	MAXIMUM2,4,6	REMOVABLE2,3,5,6
U-nat, U-235, U-238, and associated decay products except Ra-226, Th-230, Ac-227, and Pa-231	5,000 dpm alpha/ 100 cm2	15,000 dpm alpha/ 100 cm2	1,000 dpm alpha/ 100 cm2
Transuranics, Ra-226 Ra-228, Th-230, Th-228, Pa-231, Ac-227, I-129	100 dpm/ 100 cm2	300 dpm/ 100 cm2	20 dpm/ 100 cm2
Th-nat, Th-232, Sr-90, Ra-223, Ra-224, U-232, I-125, I-126, I-131, I-133	1,000 dpm/ 100 cm2	3,000 dpm/ 100 cm2	200 dpm/ 100 cm2
Beta-gamma emitters (nuclides with decay modes other than alpha emission or spontaneous fission) except Sr-90 and others noted above.	5,000 dpm beta, gamma/ 100 cm2	15,000 dpm, beta, gamma/ 100 cm2	1,000 dpm beta gamma/ 100 cm2

FOOTNOTES FOR TABLE RH-1213.b.: ACCEPTABLE SURFACE CONTAMINATION LEVELS

1 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.

2 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.

3 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.

4 The maximum contamination level applies to an area of not more than 100 cm2.

5 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 less surface area is determined, the pertinent levels should be reduced proportionally and the entire surface should be wiped.

6 The average and maximum radiation levels associated with surface contamination resulting from beta-gamma emitters should not exceed 0.2 mrad/hr at one (1) cm and 1.0 mrad/hr at 1 cm, respectively, measured through not more than seven (7) milligrams per square centimeter of total absorber.

RH-1214. Deleted. Refer to RH-8420.

RH-1215. Reserved.

RH-1216. Radiological Criteria for Unrestricted Use.

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.

RH-1217. Criteria for License Termination Under Restricted Conditions.

A site will be considered acceptable for license termination under restricted conditions if:

a. The licensee can demonstrate that further reductions in residual radioactivity necessary to comply with the provisions of RH-1217 would result in net public or environmental harm or were not being made because the residual levels associated with restricted conditions are ALARA. Determination of the levels which are ALARA must take into account consideration of any detriments, such as traffic accidents, expected to potentially result from decontamination and waste disposal;

b. The licensee has made provisions for legally enforceable institutional controls that provide reasonable assurance that the TEDE from residual radioactivity distinguishable from background to the average member of the critical group will not exceed 25 mrem (0.25 mSv) per year;

c. The licensee has provided sufficient financial 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. Acceptable financial assurance mechanisms are:

1. Funds placed into an account segregated from the licensee's assets and outside the licensee's administrative control as described in RH-409.h.6.A.;

2. Surety method, insurance, or other guarantee method as described in RH-409.h.6.B.;

3. A statement of intent in the case of State or local Government licensees, as described in RH-409.h.6.D. or;

4. When a government entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by such governmental entity.

d. The licensee has submitted a decommissioning plan or License

Termination Plan (LTP) to the Department indicating the licensee's intent to decommission in accordance with RH-410.d. and specifying that the licensee intends to decommission by restricting use of the site. The licensee shall document in the LTP or decommissioning plan how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and incorporated, as appropriate, following analysis of that advice.

1. Licensees proposing to decommission by restricting use of the site shall seek advice from such affected parties regarding the following matters concerning the proposed decommissioning:

A. Whether provisions for institutional controls proposed by the licensee:

i. Will provide reasonable assurance that the TEDE

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;

ii. Will be enforceable; and

iii. Will not impose undue burdens on the local community or other affected parties.

B. Whether the licensee has provided sufficient financial 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.

2. In seeking advice on the issues identified in RH-1217.d.1., the licensee shall provide for:

A. Participation by representatives of a broad cross section of community interest who may be affected by the decommissioning:

B. An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and

C. A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues; and

e. Residual radioactivity at the site has been reduced so that if the 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:

1. 100 mrem (1mSv) per year; or

2. 500 mrem (1mSv) per year provided the licensee

A. Demonstrates that further reductions in residual radioactivity necessary to comply with the100 mrem/yr (1mSv/y) value of RH-1217.e.1. are not technically achievable, would be prohibitively expensive, or would result in net public or environmental harm;

B. Makes provisions for durable institutional controls;

C. Provides sufficient financial assurance to enable a 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.

RH-1218. Alternate Criteria for License Termination.

a. The Department may terminate a license using alternate criteria greater than the dose criterion of RH-1216., RH-1217.b., and RH-1217.d.1.i.A., if the licensee:

1. Provides assurance that public health and safety would continue to be protected, and that it is unlikely that the dose from all man-made sources combined, other than medical, would be more than the 100 mrem/y (1 mSv/y) limit of Part C (RH-1208. and RH-1209.), by submitting an analysis of possible sources of exposure;

2. Has employed to the extent practical restrictions on site use according to the provisions of RH-1217. in minimizing exposures at the site; and

3. Reduces doses to ALARA levels, taking into consideration any detriments such as traffic accidents expected to potentially result from decontamination and waste disposal.

4. Has submitted a decommissioning plan or License Termination Plan (LTP) to the Department indicating the licensee's intent to decommission in accordance with RH-410.d. and specifying that the licensee proposes to decommission by use of alternate criteria. The licensee shall document in the decommissioning plan or LTP how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and addressed, as appropriate, following analysis of that advice. In seeking such advice, the licensee shall provide for:

A. Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;

B. An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and

b. The use of alternate criteria to terminate a license requires the approval of 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.

RH-1219. Public Notification and Public Participation.

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:

a. Notify and solicit comments from:

1. Local and State government organizations in the vicinity of the site and any Indian Nation or any other indigenous people that have treaty of statutory rights that could be affected by the decommissioning; and

2. The Environmental Protection Agency (EPA) for cases where the licensee proposes to release a site pursuant to RH-1218.

b. Publish a notice in a forum, such as local newspapers, letters to State or local organizations, or other appropriate forum, that is readily accessible to individuals in the vicinity of the site, and solicit comments from affected parties.

RH-1220. Minimization of Contamination.

Applicants for licenses, other than renewals, shall describe in the application how facility design and procedures for operation will minimize, to the extent practicable, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practicable, the generation of radioactive waste.

RH-1221. Gauge Security. Security requirements for portable gauges.

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

RH-1222. - RH-1299. Reserved.

PART D. PRECAUTIONARY PROCEDURES

RH-1300. Surveys.

a. As used in these Regulations, "survey" means an evaluation of actual or potential radiation hazards incident to the production, use, release, disposal and/or presence of sources of radiation under a specific set of conditions. When appropriate, such evaluation includes, but is not limited to, tests, a physical survey of the location of materials and equipment, and measurements of levels of radiation or concentrations of radioactive material present.

b. Each licensee or registrant shall make or cause to be made, surveys that:

1. May be necessary for the licensee or registrant to comply with the Regulations in this Part; and

2. Are reasonable under the circumstances to evaluate:

A. The magnitude and extent of radiation levels,

B. Concentrations or quantities of radioactive material, and

C. The potential radiological hazards.

c. The licensee or registrant shall ensure that instruments and equipment used for quantitative radiation measurements (e.g., dose rate and effluent monitoring are calibrated periodically for the radiation measured.)

RH-1301. Personnel Monitoring.

a. All personnel dosimeters (except for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to the extremities) that require processing to determine the radiation dose and that are used by licensees or registrants to comply with RH-1302.a., with other applicable provisions of these Regulations, or with conditions specified in a license must be processed and evaluated by a dosimetry processor:

1. Holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology [formerly called National Bureau of Standards], and

2. Approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored.

RH-1302. Conditions Requiring Individual Monitoring of External and Internal Occupational Dose.

Each licensee or registrant shall monitor exposures to radiation and radioactive material at levels sufficient to demonstrate compliance with the occupational dose limits this Part. As a minimum: of

a. Each licensee or registrant shall monitor occupational exposure to radiation and shall supply and require the use of individual monitoring devices by:

1. Adults likely to receive, in one (1) year from sources external to the body, a dose in excess of ten (10%) percent of the limits in RH-1200.a;

2. Minors and declared pregnant women likely to receive, in one (1) year from sources external to the body, a dose in excess of ten (10%) percent of any of the applicable limits in RH-1206. or RH-1207.; and

3. Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv) and

NOTE: All of the occupational doses in RH-1200. continues to be applicable to the declared pregnant worker as long as the embryo/fetus dose limit is not exceeded.

4. Individuals entering a high or very high radiation area.

b. Each licensee or registrant shall monitor (See RH-1203.) the occupational intake of radioactive material by and assess the committed effective dose equivalent to:

1. Adults likely to receive, in one (1) year, an intake in excess of ten (10%) percent of the applicable ALI(s) in Table 1, Columns 1 and 2, of Appendix G to RH-1000. through RH-2110.; and

2. Minors and declared pregnant women likely to receive, in one (1) year, a committed effective dose equivalent in excess of 0.05 rem (0.5 mSv).

RH-1303. Caution Signs, Labels and Signals.

a. Symbol.

1. Except as otherwise authorized by the Department, symbols prescribed by this Section shall use the conventional radiation caution colors (magenta, or purple, or black, on yellow background).

2. The symbol prescribed by this Section is the conventional three-bladed design. The cross-hatched area shall be magenta, or purple, or black and the background yellow.

3. Notwithstanding the requirements of RH-1303.a. of this Section, licensees or registrants are authorized to label sources, source holders, or device components containing sources of licensed materials that are subjected to high temperatures, with conspicuously etched or stamped radiation caution symbols and without a color requirement.

4. In addition to the contents of signs and labels prescribed in this Section, a licensee or registrant may provide on or near such signs and labels any additional information which may be appropriate in aiding individuals to minimize exposure to radiation.

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b. Radiation areas. Each radiation area shall be conspicuously posted with a sign or signs bearing the radiation symbol and the words:

CAUTIONDANGER

or RADIATION AREARADIATION AREA

c. High radiation areas.

1. Each high radiation area shall be conspicuously posted with a sign or signs bearing the radiation symbol and the words:

CAUTIONDANGER

or HIGH RADIATION AREAHIGH RADIATION AREA

2. The licensee or registrant shall ensure that each entrance or access point to a high radiation area has one or more of the following features:

A. A control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep-dose equivalent of 0.1 rem (1 mSv) in one (1) hour at 30 centimeters from the radiation source or from any surface that the radiation penetrates;

B. A control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of the entry; or

C. Entryways that are locked, except during periods when access to the areas is required, with positive control over each individual entry.

3. In place of the controls required by RH-1303.c.2. of this Section for a high radiation area, the licensee or registrant may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.

4. A licensee or registrant may apply to the Department for approval of alternative methods for controlling access to high radiation areas.

5. The licensee or registrant shall establish the controls required by RH-1303.c.2 and RH-1303.c.4 of this Section in a way that does not prevent individuals from leaving a high radiation area.

6. Control is not required for each entrance or access point to a room or other area that is a high radiation area solely because of the presence of radioactive materials prepared for transport and packaged and labeled in accordance with the regulations of the Department of Transportation provided that:

A. The packages do not remain in the area longer than three (3) days; and

B. The dose rate at one (1) meter from the external surface of any package does not exceed 0.01 rem (0.1 mSv) per hour.

7. Control of entrance or access to rooms or other areas in hospitals is 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 Part 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-1311., 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.

2. Posting of very high radiation areas. The licensee or registrant shall post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol and words:

GRAVE DANGER, VERY HIGH RADIATION AREA

e. Very high radiation areas - irradiators.

1. Each area in which there may exist radiation levels in excess of 500 rads (5 grays) in one (1) hour at one (1) meter from a sealed radioactive source2/ that is used to irradiate materials must meet the following requirements.

A. Each entrance or access point must be equipped with entry control devices which:

i. Function automatically to prevent any individual from inadvertently entering the area when very high radiation levels exist;

ii. Permit deliberate entry into the area only after a 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

iii. Prevent operation of the source if the source would produce radiation levels in the area that could result in a deep-dose equivalent to an individual in excess of 0.1 rem (1 mSv) in one (1) hour.

B. Additional control devices must be provided so that upon failure of the entry control devices to function as required by RH-1303.e.1.A. of this Section:

i. The radiation level within the area, from the sealed 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

ii. Conspicuous visible and audible alarm signals are 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.

C. The licensee shall provide control devices so that, upon failure or removal of physical radiation barriers other than the source's shielded storage container:

i. The radiation level from the 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

ii. Conspicuous visible and audible alarm signals are 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.

D. When the shield for the stored source is a liquid, the licensee shall provide means to monitor the integrity of the shield and to signal, automatically, loss of adequate shielding.

E. Physical radiation barriers that comprise permanent structural components, such as walls, that have no credible probability of failure or removal in ordinary circumstances need not meet the requirements of C and D of this Paragraph.

F. Each area must be equipped with devices that will automatically generate conspicuous visible and audible alarm signals to alert personnel in the area before the source can be put into operation and in sufficient time for any individual in the area to operate a clearly identified control device, which must be installed in the area and which can prevent the source from being put into operation.

G. Each area must be controlled by use of such administrative procedures and such devices as are necessary to ensure that the area is cleared of personnel prior to each use of the source.

H. Each area must be checked by a radiation measurement to ensure that, prior to the first individual's entry into the area after any use of the source, the radiation level from the source in the area is 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.

I. The entry control devices required in RH-1303.e.1.A. must have been tested for proper functioning (See RH-1500. for recordkeeping requirements).

i. Testing must be conducted prior to initial operation with the source of radiation on any day (unless operations were continued uninterrupted from the previous day);

ii. Testing must be conducted prior to resumption of operation of the source of radiation after any unintended interruption; and

iii. The licensee shall submit and adhere to a schedule for periodic tests of the entry control and warning systems.

J. The licensee may not conduct operations, other than those necessary to place the source in safe condition or to effect repairs on controls, unless control devices are functioning properly.

K. Entry and exit portals that are used in transporting materials to and from the irradiation area, and that are not intended for use by individuals, must be controlled by such devices and administrative procedures as are necessary to physically protect and warn against inadvertent entry by any individual through these portals. Exit portals for processed materials must be equipped to detect and signal the presence of any loose radiation sources that are carried toward such an exit and to automatically prevent loose radiation sources from being carried out of the area.

2. Persons holding licenses or applicants for licenses for radiation sources that are within the purview of Part D of this Section and that will be used in a variety of positions or in locations, such as open fields or forests, that make it impracticable to comply with certain requirements of Part D of this Section, such as those for the automatic control of radiation levels, may apply to the Radiation Control Section Chief for approval of the use of alternative safety measures. Any alternative safety measures must provide a degree of personnel protection at least equivalent to those specified in Part D of this Section. At least one of the alternative measures must include an entry-preventing interlock control based on a measurement of the radiation that ensures the absence of high radiation levels before an individual can gain access to the area where such radiation sources are used.

3. The entry control devices required by RH-1303.e.1.A. and B. of this Section must be established in such a way that no individual will be prevented from leaving the area

f. Airborne radioactivity area.

1. As used in these Regulations, "airborne radioactivity area" means:

A. Any room, enclosure or operating area in which airborne radioactive materials exist in concentrations in excess of the amounts specified in RH-2200., Appendix A, Table 1, Column 1; or

B. Any room, enclosure or operating area in which airborne radioactive material exists in concentrations which, averaged over the number of hours in any week during which individuals are in the area, exceed 25 percent of the amounts specified in RH-2200., Appendix A, Table 1, Column 1.

2. Each airborne radioactivity area shall be conspicuously posted with a sign or signs bearing the radiation symbol and the words:

CAUTIONDANGER

or AIRBORNE RADIOACTIVITY AREA AIRBORNE RADIOACTIVITY AREA

3. Use of process or other engineering controls. The licensee shall use, to the extent practicable, process or other engineering controls (e.g., containment or ventilation) to control the concentrations of radioactive material in air.

4. Use of other controls.

A. When it is not practicable to apply process or other engineering controls to control the concentrations of radioactive material in air to values below those that define an airborne radioactivity area, the licensee shall, consistent with maintaining the total effective dose equivalent ALARA, increase monitoring and limit intakes by one or more of the following means:

i. Control of access;

ii. Limitation of exposure times;

iii. Use of respiratory protection equipment; or

iv. Other controls.

B. If the licensee performs an ALARA analysis to determine whether or not respirators should be used, the licensee may consider safety factors other than radiological factors. The licensee should also consider the impact of respirator use on workers' industrial health and safety.

5. Use of individual respiratory protection equipment.

A. If the licensee assigns or permits the use of respiratory protection equipment to limit the intake of radioactive material.

i. The licensee shall use only respiratory protection 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 Part.

ii. If the licensee wishes to use equipment that has not 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 Part. The application must include evidence that the material and performance characteristics of the equipment are capable of providing the proposed anticipated conditions of use. This must be demonstrated either by licensee testing or on the basis of reliable test information.

iii. The licensee shall implement and maintain a respiratory protection program that includes:

(a) . Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate doses;

(b) . Surveys and bioassays, as necessary, to evaluate actual intakes;

(c) . Testing of respirators for operability (user seal check for face sealing devices and functional check for others) immediately prior to each use;

(d) . Written procedures regarding:

(i) Monitoring, including air sampling and bioassays;

(ii) Supervision and training of respirator users;

(iii) Fit testing;

(iv) Respirator selection;

(v) Breathing air quality;

(vi) Inventory and control;

(vii) Storage, issuance, maintenance,

repair, testing, and quality assurance of respiratory protection equipment;

(viii) Recordkeeping; and

(ix) Limitations on periods of respirator use and relief from respirator use;

(e) . Determination by a physician that the individual user is medically fit to use respiratory protection equipment; before

(1) The initial fitting of a face sealing respirator;

(2) Before the first field use of a non-face sealing respirator; and

(3) Either every twelve (12) months thereafter, or periodically at a frequency determined by a physician.

(f) . Fit testing, with fit factor greater than or equal to (>) 10 times the APF for negative pressure devices, and a fit factor greater than or equal to (>) 500 for any positive pressure, continuous flow, and pressure-demand devices, before the first field use of tight fitting, face-sealing respirators and periodically thereafter at a frequency not to exceed one (1) year. Fit testing must be performed with the facepiece operating in the negative pressure mode.

iv. The licensee shall advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require such relief.

v. The licensee shall also consider limitations 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.

vi. Standby rescue persons are required whenever one-piece atmosphere-supplying suits, or any combination of supplied air respiratory protection device and personnel protective equipment are used from which an unaided individual would have difficulty extricating himself or herself. The standby persons must be equipped with respiratory protection devices or other apparatus appropriate for the potential hazards. The standby rescue persons shall observe or otherwise maintain continuous communication with the workers (visual, voice, signal line, telephone, radio, or other suitable means), and be immediately available to assist them in case of a failure of the air supply or for any other reason that requires relief from distress. A sufficient number of standby rescue persons must be immediately available to assist all users of this type of equipment and to provide effective emergency rescue if needed.

vii. Atmosphere-supplying respirators must be supplied with respirable air of grade D quality or better as defined by the Compressed Gas Association in publication G-7.1, "Commodity Specification for Air," 1997 and included in the regulations of the Occupational Safety and Health Administration ( 29 CFR 1910.134(i)(1)(ii)(A) through (E). Grade D quality air criteria include:

(1) Oxygen content (v/v) of 19.5-23.5%;

(2) Hydrocarbon (condensed) content of five (5) milligrams per cubic meter of air or less;

(3) Carbon monoxide (CO) content of ten (10) ppm or less;

(4) Carbon dioxide content of 1,000 ppm or less; and

(5) Lack of noticeable odor.

viii. The licensee shall ensure that no objects, materials or substances, such as facial hair, or any conditions that interfere with the face-facepiece seal or valve function, and that are under the control of the respirator wearer, are present between the skin of the wearer's face and the sealing surface of a tight-fitting respirator facepiece.

ix. In estimating the dose to individuals from intake of airborne radioactive materials, the concentration of radioactive material in the air that is inhaled when respirators are worn is initially assumed to be the ambient concentration in air without respiratory protection, divided by the assigned protection factor. If the dose is later found to be greater than the estimated dose, the corrected value must be used. If the dose is later found to be less than the estimated dose, the corrected value may be used.

B. The licensee shall notify, in writing to the Radiation

Control Section Chief at least thirty (30) days before the date that respiratory protection equipment is first used under the provisions of RH-1303.f.5.A.

6. Further restrictions on the use of respiratory protection equipment.

The Department may impose restrictions in addition to those in RH-1303.f.4. and RH-1303.f.5. and Appendix E to RH-1000. through RH-2110. to:

A. Ensure that the respiratory protection program of the licensee is adequate to limit doses to individuals from intakes of airborne radioactive materials consistent with; maintaining total effective dose equivalent ALARA; and

B. Limit the extent to which a licensee may use respiratory protection equipment instead of process or other engineering controls.

7. Application for use of higher assigned protection factors. The licensee shall obtain authorization from the Department before using assigned protection factors in excess of those specified in Appendix E to RH-1000. through RH-2110. The Department may authorize a licensee to use higher assigned protection factors on receipt of an application that:

A. Describes the situation for which a need exists for higher protection factors; and

B. Demonstrates that the respiratory protection equipment provides these protection factors under the proposed conditions of use.

g. Additional requirements.

1. Each area or room in which any radioactive material, other than natural uranium or thorium, is used or stored in an amount exceeding ten (10) times the quantity of radioactive material specified in RH-2300., Appendix B, shall be conspicuously posted with a sign or signs bearing the radiation symbol and the words:

CAUTIONDANGER

RADIOACTIVE MATERIALRADIOACTIVE MATERIAL

2. Each area or room in which natural uranium or thorium is used or stored in an amount exceeding 100 times the quantity specified in RH-2300., Appendix B, shall be conspicuously posted with a sign or signs bearing the radiation symbol and the words:

CAUTIONDANGER

RADIOACTIVE MATERIALRADIOACTIVE MATERIAL

It shall also provide sufficient information3/ to permit individuals handling or using the containers or working in the vicinity thereof, to take precautions to avoid or minimize exposures.

h. Containers.

1. Except as provided in RH-1303.h.3., each container of radioactive material shall bear a durable, clearly visible label identifying the radioactive contents.

2. A label required pursuant to RH-1303.h.1. shall bear the radiation caution symbol and the words:

CAUTIONDANGER

RADIOACTIVE MATERIALRADIOACTIVE MATERIAL

It shall also provide sufficient information3/ to permit individuals handling or using the containers or working in the vicinity thereof, to take precautions to avoid or minimize exposures.

3. Notwithstanding the provisions of RH-1303.h.1., labeling is not required:

A. For containers that do not contain radioactive materials in quantities greater than the applicable quantities listed in RH-2793., Appendix H, of this Part;

B. For containers containing only natural Uranium or Thorium in quantities no greater than ten (10) times the applicable quantities listed in RH-2793., Appendix H, of this Part;

C. For containers that do not contain radioactive materials in concentrations greater than the applicable concentrations listed in Column 2, Table I, RH-2200., Appendix A, of this Part;

D. For containers when they are attended by an individual who takes the precautions necessary to prevent the exposure of any individual to radiation or radioactive materials in excess of the limits established by these Regulations in this Part;

E. For containers when they are in transport and packaged and labeled in accordance with regulations published by the Department of Transportation4/;

F. For containers which are accessible5/ only to individuals authorized to handle or use them or to work in the vicinity thereof, provided that the contents are identified to such individuals by a readily available written record; and

G. For manufacturing and process equipment such as piping and tanks.

i. Each licensee shall, prior to disposal of an empty uncontaminated container to unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive material.

j. All devices and equipment capable of producing radiation when operated shall be appropriately labeled so as to caution individuals that such devices or equipment produce radiation when operated.

k. Each radiation machine, except radiographic and fluoroscopic x-ray 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.

RH-1304. Exceptions From Posting Requirements. Notwithstanding the provisions of RH-1303.:

a. A room or area is not required to be posted with a caution sign because of the presence of a sealed source, provided the radiation level twelve (12) inches (30) centimeters from the surface of the source container or housing does not exceed five (5) millirems (0.05 mSv) per hour.

b. Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs provided that the patient could be released from licensee control pursuant to RH-1214.

c. Caution signs are not required to be posted in areas or rooms containing radioactive materials for periods of less than eight (8) hours provided that:

1. The materials are constantly attended during such periods by an individual who shall take the precautions necessary to prevent the exposure of any individual to radiation or radioactive materials in excess of the limits established in this Part; and

2. Such area or room is subject to the licensee's control.

d. A room or other area is not required to be posted with caution sign and control is not required for each a entrance or access point to a room or other area which is a high radiation area solely because of the presence of radioactive materials prepared for transport and packaged and labeled in accordance with regulations of the Department of Transportation.

RH-1305. Instruction of Personnel; Posting of Notice to Employees.

Instructions required for individuals working in or frequenting any portion of a restricted area are specified in Part N of this Section.

RH-1306. Storage of Sources of Radiation.

a. The licensee or registrant shall secure sources of radiation from unauthorized removal or access.

b. Sources of radiation shall not be stored in residential areas.

RH-1307. Procedures for Picking Up, Receiving and Opening Packages.

a. As used in these Regulations, Special Form means any of the following physical forms of licensed material:

1. The material is in solid form having no dimension less than 0.5 millimeter or at least one dimension greater than five (5) millimeters; does not melt, sublime or ignite in air at a temperature of 1,0000F. (5380C), will not shatter or crumble if subjected to the percussion test described in Appendix B of this Part; and is not dissolved or converted into dispersible form to the extent of more than 0.005 percent by weight by immersion for one week in water at 680F. (200C) or in air at 860F(300C); or

2. The material is securely contained in a capsule having no dimension less than 0.5 millimeter or at least one (1) dimension greater than five (5) millimeters, which will retain its contents if subjected to the tests prescribed in Appendix B of this Part; and which is constructed of materials which do not melt, sublime or ignite in air at 1,4750F (8020C), and do not dissolve or convert into dispersible form to the extent of more than 0.005 percent by weight by immersion for one week in water at 680F (200C) or in air at 860F (300C).

b. Each licensee who expects to receive a package containing quantities of radioactive material in excess of a "Type A" quantity specified in or determined by procedures described in Appendix C of this Section, shall make arrangements:

1. To receive the package when the carrier offers it for delivery; or

2. To receive notification of the arrival of the package at the carrier's terminal and to pick up the package when the carrier offers it for delivery.

c. Each licensee shall:

1. Monitor the external surfaces of a labeled* package for radioactive contamination unless the package contains only radioactive material in the form of a gas or in special form as described in RH-3100.

2. Monitor the external surfaces of a labeled* package for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the Type A quantity as defined RH-3100 and RH-2700; and

3. Monitor all packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as packages that are crushed, wet, or damaged.

d. The licensee shall perform the monitoring required by RH-1307.c. of this Section as soon as practical after receipt of the package, but not later than three (3) hours after the package is received at the licensee's facility if it is received during the licensee's normal working hours, or not later than three (3) hours from the beginning of the next working day if it is received after working hours.

e. The licensee shall immediately notify the final delivery carrier and, by telephone and telegram, mailgram or facsimile, the Department, if packages, other than those transported by exclusive use vehicle, are found to have:

1. Removable radioactive contamination in excess of 0.001 microcurie per 100 square centimeters on the external surfaces of the package; or

2. Radiation levels at the external surface of the package in excess of 200 mRem/hr or at one (1) meter from the external surface of the package in excess of ten (10) mRem/hr.

f. Each licensee or registrant shall establish and maintain procedures for safely opening packages in which radioactive material is received and shall assure that such procedures are followed and that due consideration is given to special instructions for the type of package being opened.

* 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.

g. Licensees transferring special form sources in licensee-owned or licensee-operated vehicles to and from a work site are exempt from the contamination monitoring requirements of RH-1307.c. of this Section, but are not exempt from the survey requirement in RH-1307.c. of this Section for measuring radiation levels that is required to ensure that the source is still properly lodged in its shield.

RH-1308. Control of Material Not in Storage.

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.

RH-1309. - RH-1399. Reserved.

PART E. WASTE DISPOSAL

RH-1400. General Requirements. A licensee shall dispose of licensed material only:

a. By transfer to an authorized recipient as provided in Section 2 of these Regulations; or

b. By decay in storage; or

c. By release in effluents within the limits in RH-1210.; or

d. As authorized under RH-1402., RH-1403., RH-1404., or RH-1405.

e. A person must be specifically licensed to receive waste containing licensed material from other persons for:

1. Treatment prior to disposal;

2. Treatment or disposal by incineration; or

3. Decay in storage.

RH-1401. Method for Obtaining Approval of Proposed Disposal Procedures.

A licensee or applicant for a license may apply to the Department for approval of proposed procedures, not otherwise authorized in the Regulations in this Section, to dispose of licensed material generated in the licensee's activities. Each application shall include:

a. A description of the waste containing licensed material to be disposed of, including the physical and chemical properties important to risk evaluation, and the proposed manner and conditions of waste disposal;

b. An analysis and evaluation of pertinent information on the nature of the environment;

c. The nature and location of other potentially affected licensed and unlicensed facilities; and

d. Analyses and procedures to ensure that doses are maintained ALARA and within the dose limits in this Part.

RH-1402. Disposal by Release Into Sanitary Sewerage.

a. A licensee may discharge licensed material into sanitary sewerage if each of the following conditions is satisfied:

1. The material is readily soluble (or is readily dispersible biological material) in water;

2. The quantity of licensed or other radioactive material that the licensee releases into the sewer in one month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in Table 3 of Appendix G to RH-1000. through RH-2101.; and

3. If more than one (1) radionuclide is released, the following conditions must also be satisfied:

i. The licensee shall determine the fraction of the limit in Table 3 of Appendix G to RH-1000. through RH-2101. represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in Table 3 of Appendix G to RH-1000. through RH-2101.; and

ii. The sum of the fractions for each radionuclide required by

Paragraph a.3.i. of this Section does not exceed unity; and

4. The total quantity of licensed and other radioactive material that the licensee releases into the sanitary sewerage system in a year does not exceed five (5) curies (185 GBq) of Hydrogen-3, one (1) curie (37 GBq) of Carbon-14, and one (1) curie (37 GBq) of all other radioactive materials combined.

b. Excreta from individuals undergoing medical diagnosis or therapy with radioactive material is not subject to the limitations contained in Paragraph a of this Section.

RH-1403. Disposal by Burial in Soil.

No licensee shall dispose of radioactive material by burial in soil unless specific approval has been granted by the Department.

RH-1404. Treatment or Disposal by Incineration.

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.

RH-1405. Disposal of Specific Wastes.

a. Any licensee may dispose of the following licensed material without regard to its radioactivity:

1. 0.05 microcuries (1.85 kBq) or less of Hydrogen-3, Carbon-14 or Iodine-125 per gram of medium, used for liquid scintillation counting; and

2. 0.05 microcuries (1.85 kBq) or less of Hydrogen-3 Carbon-14 or Iodine-125 per gram of animal tissue, averaged over the weight of the entire animal.

b. A licensee may not dispose of tissue under RH-1405.b. of this Section in a manner that would permit its use either as food for humans or as animal feed.

c. The licensee shall maintain records in accordance with RH-1500.h.

d. Nothing in this Section, however, relieves the licensee of maintaining records showing the receipt, transfer and disposal of such byproduct material as specified in RH-600.; and

e. Nothing in this Section relieves the licensee from complying with other applicable federal, state and local regulation governing any other toxic or hazardous property of these materials.

RH-1406. Transfer for Disposal and Manifests.

a. The requirements of this Section and Appendix F and Appendix G to 10 CFR Part 20 are designed to:

1. Control transfers of low-level radioactive waste (LLW) by any waste generator, waste collector, or waste processor licensee, as defined in this Part, who ships low-level waste either directly, or indirectly through a waste collector or waste processor, to a licensed low-level wasteland disposal facility as defined in Section 2 of these Regulations;

2. Establish a manifest tracking system; and

3. Supplement existing requirements concerning transfers and recordkeeping for those wastes.

b. Any licensee shipping radioactive waste intended for ultimate disposal at a licensed land disposal facility must document the information required on the U.S. Nuclear Regulatory Commission's Uniform Low-Level Radioactive Waste Manifest and transfer this recorded manifest information to the intended consignee in accordance with Appendix G to 10 CFR Part 20.

c. Each shipment manifest must include a certification by the waste generator as specified in Section II.

d. Each person involved in the transfer for disposal and disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in Section III of Appendix G to 10 CFR Part 20.

RH-1407. Compliance with Environmental and Health Protection Regulations.

Nothing in this Subpart 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 E.

RH-1408. - RH-1499. Reserved.

PART F. RECORDS, REPORTS, NOTIFICATIONS, AND TESTS

RH-1500.

a. General provisions.

1. Each licensee or registrant shall use the units: curie, rad, rem, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by this Part.

2. In the records required by this Part, the licensee may record quantities in International System of Units (SI) units in parentheses following each of the units specified in RH-1500.a.1. of this section. However, all quantities must be recorded as stated in RH-1500.a.1. of this section.

3. Not withstanding the requirements of RH-1500.a.1. of this Section, when recording information on shipment manifests, as required in RH-1406.b, information must be recorded in the International System of Units (SI) or; in SI and units as specified in RH-1500.a.1. of this Section.

4. The licensee or registrant shall make a clear distinction among the quantities entered on the records required by this Part (e.g., total effective dose equivalent, shallow-dose equivalent, eye dose equivalent, deep-dose equivalent, committed effective dose equivalent).

b. Records of radiation protection programs.

1. Each licensee or registrant shall maintain records of the radiation protection program, including:

A. The provisions of the program; and

B. Audits and other reviews of program content and implementation.

2. The licensee or registrant shall retain the records required by RH-1500.b.1.A. of this Section until the Department terminates each pertinent license or registration requiring the record. The licensee or registrant shall retain the records required by RH-1500.b.1.B. of this Section for three (3) years after the record is made.

c. Records of surveys.

1. Each licensee or registrant shall maintain records showing the results of surveys and calibrations required by RH-1300. and RH-1307. The licensee or registrant shall retain these records for three (3) years after the record is made.

2. The licensee or registrant shall retain each of the following records until the Department terminates each pertinent license or registration requiring the record:

A. Records of the results of surveys to determine the dose from external sources and used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents;

B. Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose;

C. Records showing the results of air sampling, surveys, and bioassays required pursuant to RH-1303.f.5.A.iii.; and

D. Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment.

d. Determination of prior occupational dose.

1. For each individual who may enter the licensee's or registrant's restricted or controlled area and is likely to receive, in a year, an occupational dose requiring monitoring pursuant to RH-1302., the licensee shall:

A. Determine the occupational radiation dose received during the current year; and

B. Attempt to obtain the records of lifetime cumulative occupational radiation dose.

2. Prior to permitting an individual to participate in a planned special exposure, the licensee or registrant shall determine:

A. The internal and external doses from all previous planned special exposures; and

B. All doses in excess of the limits (including doses received during accidents and emergencies) received during the lifetime of the individual.

3. In complying with the requirements of RH-1500.d.1. of this Section, a licensee or registrant may:

A. Accept, as a record of the occupational dose that the individual received during the current year, a written signed statement from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual may have received during the current year;

B. Accept, as the record of lifetime cumulative radiation dose, an up-to-date Department Form Z, or equivalent, signed by the individual and counter-signed by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer (if the individual is not employed by the licensee); and

C. Obtain reports of the individual's dose equivalent(s) from the most recent employer for work involving radiation exposure, or the individual's current employer (if the individual is not employed by the licensee or registrant) by telephone, telegram, electronic media, or letter. The licensee or registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.

4. The licensee or registrant shall record the exposure history, as required by RH-1500.d.1. of this Section, on Department Form Z, or other clear and legible record, of all the information required on that form 6/ . The form or record must show each period in which the individual received occupational exposure to radiation or radioactive material and must be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant shall use the dose shown in the report in preparing Department Form Z. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on Department Form Z indicating the periods of time for which data are not available.

5. If the licensee or registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee or registrant shall assume:

A. In establishing administrative controls under RH-1200.f. for the current year, that the allowable dose limit for the individual is reduced by 1.25 rems (12.5 mSv) for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and

B. That the individual is not available for planned special exposures.

6. The licensee or registrant shall retain the records on Department

Form Z or equivalent until the Department terminates each pertinent license requiring this record. The licensee or registrant shall retain records used in preparing Department Form Z for three (3) years after the record is made.

e. Records of planned special exposures.

1. For each use of the provisions of RH-1205. for planned special exposures, the licensee shall maintain records that describe:

A. The exceptional circumstances requiring the use of a planned special exposure;

B. The name of the management official who authorized the planned special exposure and a copy of the signed authorization;

C. What actions were necessary;

D. Why the actions were necessary;

E. How doses were maintained ALARA; and

F. What individual and collective doses were expected to result, and the doses actually received in the planned special exposure.

2. The licensee shall retain the records until the Department terminates each pertinent license requiring these records.

f. Records of individual monitoring results.

1. Recordkeeping requirement. 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:

A. The deep-dose equivalent to the whole body, eye dose equivalent, shallow-dose equivalent to the skin, and shallow-dose equivalent to the extremities;

B. The estimated intake of radionuclides (See RH-1201.);

C. The committed effective dose equivalent assigned to the intake or body burden of radionuclides;

D. The specific information used to calculate the committed effective dose equivalent pursuant to RH-1203.c.;

E. The total effective dose equivalent when required by RH-1202.; and

F. The total of the deep-dose equivalent and the committed dose to the organ receiving the highest total dose.

2. Recordkeeping frequency. The licensee or registrant shall make entries of the records specified in RH-1500.f.1. of this Section at least annually.

3. Recordkeeping format. The licensee or registrant shall maintain the records specified in RH-1500.f.1. of this Section on Department Form Y, in accordance with the instructions for Department Form Y, or in clear and legible records containing all the information required by that form.

4. Privacy protection. The records required under this Section should be protected from public disclosure because of their personal privacy nature.

5. The licensee or registrant shall maintain the records of dose to an embryo/fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy shall also be kept on file, but may be maintained separately from the dose records.

6. The licensee or registrant shall retain each required form or record until the Department terminates each pertinent license or registration requiring the record.

g. Records of dose to individual members of the public.

1. Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public (See RH-1208.).

2. The licensee or registrant shall retain the records required by RH-1500.g.1. of this Section until the Department terminates each pertinent license or registration requiring the record.

h. Records of waste disposal.

1. Each licensee or registrant shall maintain records of the disposal of licensed materials made under RH-1401., RH-1402., RH-1403., RH-1404., RH-1405., and disposal by burial in soil, including burials authorized before January 28, 1981.8/

2. The licensee or registrant shall retain the records required by RH-1500.h.1. of this Section until the Department terminates each pertinent license requiring the record.

i. Records of testing entry control devices for very high radiation areas.

1. Each licensee or registrant shall maintain records of tests made under RH-1303.e.1.I. on entry control devices for very high radiation areas. These records must include the date, time, and results of each such test of function.

2. The licensee or registrant shall retain the records required by RH-1500.i.1. of this Section for three (3) years after the record is made.

j. Form of records. Each record required by this Part 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.

RH-1501. Reports of Theft or Loss of Sources of Radiation.

Each licensee or registrant shall report promptly by telephone and confirm promptly by letter to the Department of Health and Human Services, Radiation Control Section, P. O. Box 1437, Mail Slot H-30, Little Rock, Arkansas 72203-1437, the theft or loss as soon as such theft or loss becomes known to the licensee or registrant of:

a. Any radiation machine; or

b. Any quantity of radioactive material in excess of a quantity generally licensed under RH-900., Schedule A or RH-901., Schedule B, in Section 2 of these Regulations.

c. Telephone reports.

1. Each licensee shall report by telephone as follows:

A. Immediately after its occurrence becomes known to the licensee, any lost, stolen, or missing licensed material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in Appendix G to RH-1000. through RH-2110. under such circumstances that it appears to the licensee that an exposure could result to persons in unrestricted areas; or

B. Within 30 days after the occurrence of any lost, stolen, or missing licensed material becomes known to the licensee, all licensed material in a quantity greater than ten (10) times the quantity specified in Appendix G to RH-1000. through RH-2110. that is still missing at this time.

2. Reports must be made as follows:

All licensees or registrants shall make reports to the Department at 1-800-633 -1735.

d. Written reports.

1. Each licensee required to make a report under RH-1501 of this

Section shall, within 30 days after making the telephone report, make a written report setting forth the following information:

A. A description of the licensed material involved, including kind, quantity, and chemical and physical form;

B. A description of the circumstances under which the loss or theft occurred;

C. A statement of disposition, or probable disposition, of the licensed material involved;

D. Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas;

E. Actions that have been taken, or will be taken, to recover the material; and

F. Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed material.

2. Reports must be made as follows:

A. All licensees or registrants shall make reports to the Department of Health and Human Services, Division of Health, Radiation Control Section Chief, P.O. Box 1437, Mail Slot H-30, Little Rock, Arkansas 72203-1437.

B. Subsequent to filing the written report, the licensee or registrant shall also report any additional substantive information on the loss or theft within 30 days after the licensee or registrant learns of such information.

C. The licensee or registrant shall prepare any report filed with the Department pursuant to this Section so that names of individuals who may have received exposure to radiation are stated in a separate and detachable part of the report.

RH-1502. Notification of Incidents.

a. Immediate notification. Each licensee or registrant shall immediately notify the Department of Health and Human Services, Division of Health, Radiation Control, P.O. Box 1437, Mail Slot H-30, Little Rock, Arkansas 72203-1437, by telephone and confirming letter of any incident involving any source of radiation possessed by the licensee or registrant and which may have caused or threatens to cause:

1. An individual to receive:

A. A total effective dose equivalent of 25 rems (0.25 Sv) or more; or

B. A lens dose equivalent of 75 rems (0.75 Sv) or more; or

C. A shallow-dose equivalent to the skin or extremities of 250 rads (2.5 Gy) or more; or

2. The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for (twenty-four (24) hours, the individual could have received an intake five (5) times the 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.).

b. Twenty-four hour notification. Each licensee or registrant shall within twenty-four (24) hours notify the Department of Health and Human Services, Division of Health, Radiation Control, P.O. Box 1437 Mail Slot H-30, Little Rock, Arkansas 72203-1437, by telephone and confirming letter of any incident involving any source of radiation possessed by the licensee or registrant and which may have caused or threatens to cause:

1. An individual to receive, in a period of twenty-four (24) hours:

A. A total effective dose equivalent exceeding five (5) rems (0.05 Sv); or

B. A lens dose equivalent exceeding fifteen (15) rems (0.15 Sv); or

C. A shallow-dose equivalent to the skin or extremities exceeding fifty (50) rems (0.5 Sv); or

2. The release of radioactive material, inside or outside of a restricted 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).

c. The licensee or registrant shall prepare any report filed with the Department pursuant to this Section so that names of individuals who have received exposure to radiation or radioactive material are stated in a separate and detachable part of the report.

d. The provisions of this Section do not include doses that result from planned special exposures, that are within the limits for planned special exposures, and that are reported under RH-1504.

e. Immediate report. Each licensee or registrant 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).

f. Twenty-four hour report. Each licensee or registrant shall notify the Department within twenty-four (24) hours after the discovery of any of the following events involving licensed material:

1. An unplanned contamination event that:

A. Requires access to the contamination area, by workers or the public, to be restricted for more than twenty-four (24) hours by imposing additional radiological controls or by prohibiting entry into the area;

B. Involves a quantity of material greater than five (5) times the lowest annual limit on intake specified in Appendix G to RH-1000. through RH-2110. for the material; and

C. Has access to the area restricted for a reason other than to allow isotopes with a half-life of less than twenty-four (24) hours to decay prior to decontamination.

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

A. The equipment is required by regulation or licensee condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident;

B. The equipment is required to be available and operable when it is disabled or fails to function; and

C. No redundant equipment is available and operable to perform the required safety function.

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

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

A. The quantity of material involved is greater than five (5) times the lowest annual limit on intake specified in Appendix G of RH-1000. through RH-2110. of these Regulations for the material; and

B. The damage affects the integrity of the licensed material or its container.

g. Preparation and submission of reports. Reports made by licensees or registrants in response to the requirements of this Section must be made as follows:

1. Licensees or registrants shall make reports required by RH-1502.a. and RH-1502.b. 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:

A. The caller's name and call back telephone number;

B. A description of the event, including date and time;

C. The exact location of the event;

D. The isotopes, quantities, and chemical and physical form of the licensed material involved; and

E. Any personnel radiation exposure data available.

2. Written report. Each licensee or registrant who makes a report required by RH-1502.a. and RH-1502.b. of this Section shall submit a written follow-up report within 30 (thirty) 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 Department of Health and Human Services, Division of Health, Radiation Control, P.O. Box 1437 Mail Slot H-30; Little Rock, Arkansas 72203-1437. The reports must include the following:

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

B. The exact location of the event;

C. The isotopes, quantities and chemical and physical form of the licensed material involved;

D. Date and time of the event;

E. Corrective actions taken or planned and the results of any evaluations or assessments; and

F. The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.

RH-1503. Tests. Each licensee and registrant shall perform upon instructions from the

Department or shall permit the Agency to perform, such reasonable tests as the Department deems appropriate or necessary including, but not limited to, tests of:

a. Sources of radiation;

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

c. Radiation detection and monitoring instruments; and

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

RH-1504. Reports of Exposures, Radiation Levels, and Concentrations of Radioactive Material Exceeding the Limits.

a. Reportable events. In addition to the notification required by RH-1502.,

each licensee or registrant shall submit a written report within 30 days after learning of any of the following occurrences:

1. Any incident for which notification is required by RH-1502.; or

2. Doses in excess of any of the following:

A. The occupational dose limits for adults in RH-1200.; or

B. The occupational dose limits for a minor in RH-1206.; or

C. The limits for an embryo/fetus of a declared pregnant woman in RH-1207.; or

D. The limits for an individual member of the public in RH-1208.; or

E. Any applicable limit in the license; or

F. The ALARA constraints for air emissions established under RH-1004.d.

3. Levels of radiation or concentrations of radioactive material in:

A. A restricted area in excess of any applicable limit in the license; or

B. An unrestricted area in excess of ten (10) times any applicable limit set forth in this Part or in the license (whether or not involving exposure of any individual in excess of the limits in RH-1208.); or

4. For licensees subject to the provisions of EPA's generally applicable environmental radiation standards levels of radiation or releases of radioactive material in excess of those standards, or of license conditions related to those standards.

b. Contents of reports.

1. Each report required by RH-1504.a. of this Section must describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:

A. Estimates of each individual's dose;

B. The levels of radiation and concentrations of radioactive material involved;

C. The cause of the elevated exposures, dose rates, or concentrations; and

D. Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints, generally applicable environmental standards, and associated license conditions.

2. Each report filed pursuant to RH-1504.a. of this Section must include for each occupationally overexposed9/ individual: the name, Social Security account number, and date of birth. The report must be prepared so that this information is stated in a separate and detachable part of the report.

3. The licensee or registrant shall prepare any report filed with the Department pursuant to this Section so that names of individuals who may have received exposure to radiation are stated in a separate and detachable part of the report.

RH-1505. Notifications and Reports to Individuals.

a. Requirements for notification and reports to individuals of exposure to radiation or radioactive material are specified in Part N of this Section.

b. Reports to individuals of exceeding dose limits. When a licensee or registrant is required, pursuant to the provisions of RH-1504., RH-1505.b., or RH-1509., 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, licensee or registrant shall also provide a copy of the report submitted to the Department to the individual. The report must be transmitted at a time no later than the transmittal to the Department.

RH-1506. Vacating Premises.

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.

RH-1507. Deleted. Refer to RH-8703. and RH-8800.

RH-1508. Deleted.

RH-1509. Reports of Individual Monitoring.

a. This Section applies to each person licensed by the Department to:

1. Possess or use radioactive material for purposes of radiography pursuant to Part I of these Regulations; or

2. Possess or use at any time, for processing or manufacturing for distribution pursuant to Section 2 of these Regulations, radioactive material in quantities exceeding any one of the following quantities.

TABLE RH-1509.a.2.

Radionuclide	Quantity of Radionuclidea in Curies
Cesium-137	1
Cobalt-60	1
Gold-198	100
Iodine-131	1
Iridium-192	10
Krypton-85	1,000
Promethium-147	10
Technetium-99m	1,000

a The Department may require as a license condition, or by rule, Regulation, or order pursuant to RH-2002., reports from licensees who are licensed to use radionuclides not on this list, in quantities sufficient to cause comparable radiation levels.

b. Each licensee in a category listed in RH-1509.a. shall complete an annual report of the results of individual monitoring carried out by the licensee for each individual for whom monitoring was required by RH-1302. during that year. The licensee may include additional data for individuals for whom monitoring was provided but not required. The licensee shall use Department Form Y or electronic media containing all the information required by Department Form Y.

c. The licensee shall complete the report required by RH-1509.b., covering the preceding year, on or before May 31 of each year. The licensee shall retain the report and submit it if requested to the Department of Health and Human Services, Division of Health, Radiation Control Section Chief, P. O. Box 1437 Mail Slot H-30, Little Rock, Arkansas 72203-1437.

RH-1510. Deleted. Refer to RH-8308., RH-8703. and RH-8800.

RH-1511. Deliberate Misconduct

a. Any licensee, registrant, certificate of registration holder, applicant for a license or certificate of registration, employee of a licensee or registrant, certificate of registration holder or applicant; or any contractor (including a supplier or consultant), subcontractor, employee of a contractor or subcontractor, of any licensee, registrant or certificate of registration holder or applicant for a license, registration, or certificate of registration, who knowingly provides to any licensee, registrant, applicant, certificate holder, contractor or subcontractor, any components, equipment, materials or other goods or services that relate to a licensee's, registrant's , certificate holder's or applicant's activities subject to this Part may not:

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

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

b. A person who violates RH-1511.a.1. or 2. of this Section may be subject to enforcement action in accordance with the procedures in RH-2110.

c. For purposes of RH-1511.a.1., deliberate misconduct by a person means an intentional act or omission that the person knows:

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

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

RH-1512 Records Required at Temporary Jobsites.

a. Each licensee or registrant conducting activities as defined in RH-1100.df.

shall have the following records available at the temporary jobsite for inspection by the Department:

1. Current copy of appropriate license issued by the Department, the U.S. Nuclear Regulatory Commission, or an Agreement State.

2. A copy of these regulations.

3. Operating and Emergency Procedures.

4. The latest instrument calibration, if applicable.

5. Survey records required pursuant to RH-1803.c. for the period of operation at the jobsite, if applicable.

6. The latest leak test record for the device(s) in use at the jobsite.

7. Daily pocket dosimeter record for the period of operation at the jobsite, if applicable.

RH-1513. - RH-1599. Reserved

PART G.SPECIAL REQUIREMENTS FOR THE USE OF X-RAYS IN THE HEALING ARTS

RH-1600. Scope.

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.

RH-1601. Definitions as Used in these Regulations. Additional definitions used only in a certain Part will be found in that Part.

a. Accessible surface - The external surface of the enclosure or housing provided by the manufacturer.

b. Added filtration - Any filtration which is in addition to the inherent filtration c. Aluminum equivalent - The thickness of type 1100 aluminum alloy11/ affording the same attenuation, under specified conditions, as the material in question.

d. Assembler - Any person engaged in the business of assembling, replacing or installing one or more components into an x-ray system or subsystem.

e. 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.

f. 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").

g. Barrier - See "Protective barrier".

h. Beam axis - A line from the source through the centers of the x-ray fields.

i. Beam-limiting device - A device which provides a means to restrict the dimensions of the x-ray field.

j. Beam monitoring system - A system designed to detect and measure the radiation present in the useful beam.

k. 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.

l. Cephalometric device - A device intended for the radiographic visualization and measurement of the dimensions of the human head.

m. 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.

n. Certified system - Any x-ray system which has one or more certified component(s).

o. Changeable filters - Any filter, exclusive of inherent filtration, which can be removed from the useful beam through any electronic, mechanical or physical process.

p. 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:

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where:

s = Estimated standard deviation of the population.

X = Mean value of observations in sample.

Xi = ith observation in sample.

n = Number of observations in sample.

q. 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.

r. 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.

s. Cooling curve - The graphical relationship between heat units stored and cooling time.

t. Dead-man switch - A switch constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator.

u. Detector - See "Radiation detector".

v. Diagnostic source assembly - The tube housing assembly with a beam-

limiting device attached.

w. 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.

x. Direct scattered radiation - The scattered radiation which has been deviated in direction only by materials irradiated by the useful beam (See "Scattered radiation").

y. Entrance exposure - The roentgens per unit time at the point where the center of the useful beam enters the patient.

z. Equipment - See "X-ray equipment".

aa. 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]).

ab. 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.

ac. Filter - Material placed in the useful beam to absorb preferentially selected radiations.

ad. 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.

ae. 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.

af. Full beam detector - A radiation detector of such size that the total cross section of the maximum size useful beam is intercepted.

ag. General purpose radiographic x-ray system - Any radiographic x-ray system which, by design, is not limited to radiographic examination of specific anatomical regions.

ah. Gonad shield - A protective barrier for the testes or ovaries.

ai. 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.

aj. 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.

ak. Heat unit - A unit of energy equal to the product of the peak kilovoltage, milliampers and seconds, i.e., kVp x mA x second.

al. HVL - See "Half-value layer".

am. Image intensifier - A device, installed in its housing, which instantaneously converts an x-ray pattern into a corresponding light image of higher energy density.

an. 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.

ao. 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.

ap. Inherent filtration - The filtration of the useful beam provided by the permanently installed components of the tube housing assembly.

aq. 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.

ar. Irradiation - The exposure of matter to ionizing radiation.

as. Kilovolts peak - See "Peak tube potential".

at. kV - Kilovolts.

au. kVp - See "Peak tube potential".

av. kWs - Kilowatt second. It is equivalent to 103 kV.mA.sec, i.e.,

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aw. Lead equivalent - The thickness of lead affording the same attenuation, under specified conditions, as the material in question.

ax. Leakage radiation - Radiation emanating from the diagnostic or therapeutic source assembly except for:

1. the useful beam, and

2. radiation produced when the exposure switch or timer is not activated.

ay. Leakage technique factors - The technique factors associated with the tube housing assembly which are used in measuring leakage radiation. They are defined as follows:

1. For capacitor energy storage equipment, the maximum-rated peak tube potential and the maximum-rated number of exposures in an hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being 10 millicoulombs, i.e., 10 milliampere seconds or the minimum obtainable from the unit, whichever is larger.

2. For field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum-rated number of x-ray pulses in an hour for operation at the maximum-rated peak tube potential.

3. For all other equipment, the maximum-rated peak tube potential and the maximum-rated continuous tube current for the maximum-rated peak tube potential.

az. 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.

ba. 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:

Percent line-voltage regulation - 100(Vn-V1)/V1

where

Vn = No-load line potential and V1 = Load line potential.

bb. mA - Milliampere.

bc. mAs - Milliampere second.

bd. Maximum line current - The root-mean-square current in the supply line of an x-ray machine operating at its maximum rating.

be. Mobile equipment - See "X-ray equipment".

bf. Patient - An individual subjected to healing arts examination, diagnosis or treatment.

bg. Peak tube potential - The maximum value of the potential difference across the x-ray tube during an exposure.

bh. Phantom - A volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation.

bi. 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").

bj. PID - See "Position indicating device".

bk. 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.

bl. Primary dose monitoring system - A system which will monitor the useful beam during irradiation and which will terminate irradiation when preselected number of dose monitor units have been acquired.

bm. Primary protective barrier - See "Protective barrier".

bn. Protective apron - An apron made of radiation attenuating materials used to reduce radiation exposure.

bo. Protective barrier - A barrier of radiation attenuating material(s) used to reduce radiation exposure. The types of protective barriers are as follows:

1. Primary protective barrier - The material, excluding filters, placed in the useful beam, for protection purposes, to reduce the radiation exposure.

2. Secondary protective barrier - A barrier sufficient to attenuate the stray radiation to the required degree.

bp. Protective glove - A glove made of radiation attenuating materials used to reduce radiation exposure.

bq. 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.

br. 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.

bs. 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.

bt. Radiograph - An image receptor on which the image is created directly or indirectly by an x-ray pattern and results in a permanent record.

bu. Radiograph imaging system - Any system whereby a permanent or semipermanent image is recorded on an image receptor by the action of ionizing radiation.

bv. Rating - The operating limits as specified by the component manufacturer.

bw. Recording - Producing a permanent form of an image resulting from x-ray photons (e.g., film, video tape).

bx. Response time - The time required for an instrument system to reach 90 percent 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.

by. Scattered radiation - Radiation that, during passage through matter, has been deviated in direction (See "Direct scattered radiation").

bz. Secondary dose monitoring system - A system which will terminate irradiation in the event of failure of the primary system.

ca. Secondary protective barrier - See "Protective barrier".

cb. 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.

cc. SID - See "Source-image receptor distance".

cd. Source - The focal spot of the x-ray tube.

ce. Source-image receptor distance - The distance from the source to the center of the input surface of the image receptor.

cf. Spot check - A procedure which is performed to assure that a previous calibration continues to be valid.

cg. Spot film - A radiograph which is made during a fluoroscopic examination to permanently record conditions which exist during that fluoroscopic procedure.

ch. 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.

ci. SSD - The distance between the source and the skin of the patient.

cj. Stationary equipment - See "X-ray equipment".

ck. Stray radiation - The sum of leakage and scattered radiation.

cl. Technique factors - The conditions of operation. They are specified as follows:

1. For capacitor energy storage equipment, peak tube potential in kV and quantity of charge in mAs.

2. For field emission equipment rated for pulsed operation, peak tube potential in kV and number of x-ray pulses.

3. For all other equipment, peak tube potential in kV and either tube current in mA and exposure time in seconds or the product of tube current and exposure time in mAs.

cm. 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.

cn. 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.

*formerly NBS (National Bureau of Standards)

co. Therapeutic-type housing -

1. For x-ray therapy equipment not capable of operating at 500 kVp or above, the following definition applies: An x-ray tube housing so constructed that the leakage radiation averaged over any 100 cm2 area at a distance of one meter from the source does not exceed one roentgen in an hour when the tube is operated at its maximum rated continuous current for the maximum rated tube potential.

2. For x-ray therapy equipment capable of operation at 500 kVp or above, the following definition applies: An x-ray tube housing so constructed that leakage radiation averaged over any 100 cm2 area at a distance of one meter from the source does not exceed 0.1 percent of the useful beam dose rate at one meter from the source for any of its operating conditions.

cp. 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.

cq. Tube - An x-ray tube, unless otherwise specified.

cr. 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.

cs. Tube rating chart - The set of curves which specify the rated limits of operation of the tube in terms of the technique factors.

ct. 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.

cu. Variable-aperture beam-limiting device - A beam-limiting device which has capacity for stepless adjustment of the x-ray field size at a give SID.

cv. Visible area - That portion of the input surface of the image receptor over which incident x-ray photons are producing a visible image.

cw. Wedge filter - An added filter effecting continuous progressive attenuation on all or part of the useful beam.

cx. 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.

cy. 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.

cz. 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.

da. 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.

db. 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.

dc. X-ray subsystem - Any combination of two or more components of an x-ray system.

dd. X-ray tube - Any electron tube which is designed to be used primarily for the production of x-rays.

RH-1602. General Requirements. Administrative Controls.

a. Registrant. 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).

1. An x-ray system which does not meet the provisions of these

Regulations shall not be operated for diagnostic or therapeutic purposes.

2. Individuals who will be operating the x-ray systems shall be adequately instructed in the safe operating procedures and be competent in the safe use of the equipment.

3. A chart shall be provided in the vicinity of the diagnostic x-ray system's control panel which specifies, for all examinations performed with that system, the following information:

A. Patient's anatomical size versus technique factors to be utilized;

B. Type and size of the film or film-screen combination to be used;

C. Type and focal distance of the grid to be used, if any;

D. Source to image receptor distance to be used; and

E. Type and location of placement of gonad shielding to be used.

F. For mammography, indication of kVp/target/filter combination.

4. Written safety procedures and rules shall be provided to each individual operating x-ray equipment, including any restrictions of the operating technique required for the safe operation of the particular x-ray system. The operator shall be able to demonstrate familiarity with these rules.

5. Except for patients who cannot be moved out of the room, only the staff and ancillary personnel required for the medical procedure or training shall be in the room during the radiographic exposure. Other than the patient being examined:

A. All individuals shall be positioned such that no part of the body will be struck by the useful beam unless protected by 0.5 millimeter lead equivalent.

B. Staff and ancillary personnel shall be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 millimeter lead equivalent.

C. Patients who cannot be removed from the room shall be protected from the direct scatter radiation by whole body protective barriers of 0.25 millimeter lead equivalent or shall be so positioned that the nearest portion of the body is at least two meters from both the tube head and the nearest edge of the image receptor.

6. New gonad shielding of not less than 0.5 millimeter lead equivalent material shall be used for human patients, who have not passed the reproductive age, during radiographic procedures in which the gonads are in the useful beam, except for cases in which this would interfere with the diagnostic procedure.

7. Individuals shall not be exposed to the useful beam except for healing arts purposes and such exposure has been authorized by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure for the following purposes:

A. Exposure of an individual for training, demonstration or other non-healing-arts purposes; and

B. Exposure of an individual for the purpose of healing arts screening except as authorized by RH-1602.a.11.

8. When a patient or film must be provided with auxiliary support during a radiation exposure:

A. Mechanical holding devices shall be used when the technique permits.

B. If a human holder must be utilized:

i. Written safety procedures, as required by RH-1602.a.4. shall indicate the requirements for selecting a holder and the procedure the holder shall follow;

ii. The human holder shall be protected as required by RH-1602.a. 5.;

iii. No individual shall be used routinely to hold film or patients;

iv. Such holding shall be permitted only in very unusual and rare situations;

v. In those cases where the patient must hold the film, except during intra-oral examinations, any portion of the body, other than the area of clinical interest, struck by the useful beam shall be protected by not less than 0.5 millimeter lead equivalent material; and

vi. Each facility shall have leaded aprons and gloves available in sufficient numbers to provide protection to all personnel who are involved with x-ray operations and who are otherwise not shielded.

9. Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized. This is interpreted to include but not limited to:

A. The speed of film or screen and film combinations shall be the fastest speed consistent with the diagnostic objective of the examinations.

B. The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality.

C. Portable or mobile equipment shall be used only for examinations where it is impractical to transfer the patient(s) to a stationary radiographic installation.

D. X-ray systems subject to RH-1604. shall not be utilized in procedures where the source to patient distance is less than thirty (30) centimeters.

i. X-ray systems shall not be utilized in procedures where the source to patient distance is less than thirty (30) centimeters, except for veterinary systems.

ii. If grids are used between the patient and the image receptor to decrease scatter to the film and improve contrast, the grid shall:

(a) Be positioned properly, i.e., tube side facing the right direction, and grid centered to the central ray;

(b) If of the focused type, be of the proper focal distance for the SIDs being used.

10. All individuals who are associated with the operation of an x-ray system are subject to the requirements of RH-1200.

A. When protective clothing or devices are worn on portions of the body and a monitoring device(s) is required, at least one such monitoring device shall be utilized as follows:

i. When an apron is worn, the monitoring device shall be worn at the collar outside of the apron.

ii. The dose to the whole body based on the maximum dose attributed to the most critical organ shall be recorded in the reports required by Part F 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.

B. Exposure of a personnel monitoring device to deceptively indicate a dose delivered to an individual is prohibited.

11. Health arts screening. 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 outdated, the Department will be notified in writing within thirty (30) days.

12. Information and maintenance record and associated information. The registrant shall maintain the following information for each x-ray system for inspection by the Department:

A. Maximum rating of technique factors;

B. Model and serial numbers of all certifiable components;

C. Aluminum equivalent filtration of the useful beam, including any routine variation;

D. Tube rating charts and cooling curves;

E. Records of surveys, calibrations, maintenance and modifications performed on the X-ray system(s) after July 1, 1983 with the names of persons who performed such services;

F. A scale drawing of the room in which a stationary x-ray system is located with such drawing indicating the use of areas adjacent to the room and an estimation of the extent of occupancy by an individual in such areas. In addition, the drawing shall include:

i. The results of a survey for radiation levels present at the operator's position and at pertinent points outside the room at specified test conditions; or

ii. The type and thickness of materials or lead equivalency, of each protective barrier; and

G. A copy of all correspondence with the Department regarding that x-ray system.

13. X-ray log. 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.

b. General Requirements for All Diagnostic X-Ray Systems. In addition to other requirements of this Part, all diagnostic x-ray systems shall meet the following requirements:

1. Warning label. 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."

2. Battery charge indicator. 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.

3. Leakage radiation from the diagnostic source assembly. 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.

4. Radiation from components other than the diagnostic source assembly. 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.

5. Beam quality.

A. Half-value layer.

i. The half-value layer of the useful beam for a given x-ray tube potential shall not be less than the values shown in Table I. If it is necessary to determine such half-value layer at an x-ray tube potential which is not listed in Table I, linear interpolation or extrapolation may be made.

TABLE I

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

ii. The requirements of RH-1602.b.5.A.i. will be considered to have been met if it can be demonstrated that the aluminum equivalent of the total filtration in the primary beam is not less than that shown in Table II.

TABLE II

Filtration Required vs. Operating Voltage
Operating Voltage (kVp)	Total Filtration (inherent plus added) (millimeters aluminum equivalent)
Below 50	0.5 millimeters
50 to 70	1.5 millimeters
Above 70	2.5 millimeters

iii. Beryllium window tubes shall have a minimum of 0.5 millimeter aluminum equivalent filtration permanently installed in the useful beam.

iv. For capacitor energy storage equipment, compliance with the requirements of RH-1602.b.5. shall be determined with the maximum quantity of charge per exposure.

v. The required minimal aluminum equivalent filtration shall include the filtration contributed by all materials which are always present between the source and the patient.

B. Filtration controls. 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.

6. Multiple tubes. 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.

7. Mechanical support of tube head. 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.

c. Other Requirements

1. Pass boxes, if provided, shall be so constructed as to exclude light from the darkroom when cassettes are placed in or removed from boxes, and shall incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film.

2. The darkroom shall be light tight and use proper safelighting such that any film type in use exposed in a cassette to x-radiation sufficient to produce an optical density for one (1) to two (2) when processed shall not suffer an increase in density greater than 0.1 (0.05 mammography) when exposed in the darkroom for two (2) minutes with al safelights on. If used, daylight film handling boxes shall preclude fogging of the film.

3. Darkrooms typically used by more than one individual shall be provided a method to prevent accidental entry while undeveloped films are being handled or processed.

4. Film shall be stored in a cool, dry place and shall be protected from exposure to stray radiation. Film in open packages shall be stored in a light tight container.

5. Film cassettes and intensifying screens shall be inspected periodically and shall be cleaned and replaced as necessary to best assure radiographs of good diagnostic quality.

6. Outdated x-ray film shall not be used for diagnostic radiographs, unless the film has been stored in accordance with manufacturer's recommendations and a sample of the film passes a sensitometric test for normal ranges of base plus fog and speed.

7. Film developing solutions shall be prepared in accordance with the directions given by the manufacturer, and shall be maintained in strength by replenishment or renewal so that full development is accomplished within the time specified by the manufacturer.

A. The technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exposure controls are used, the technique factors which are set prior to the exposure shall be indicated. The requirement may be permanent markings on equipment having fixed technique factors. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist.

B. The requirement may be permanent markings on equipment having fixed technique factors. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist.

8. Maintaining Compliance. 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.

9. Locks. All position locking, holding, and centering devices on x-ray system components and systems shall function as intended.

RH-1603. Fluoroscopic X-Ray Systems.

All fluoroscopic x-ray systems shall meet the following requirements:

a. Limitation of Useful Beam.

1. Primary barrier.

A. The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any Source Image Distance (SID).

B. The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in position to intercept the entire useful beam.

2. Fluoroscopic beam limitation.

A. For certified fluoroscopic systems with or without a spot film device, neither the length nor the width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than three (3%) percent of the SID. The sum of the excess length and the excess width shall be no greater than four (4%) percent of the SID.

B. For uncertified fluoroscopic systems with a spot film device, the x-ray beam with the shutter fully opened (during fluoroscopy or spot filming) shall be no larger than the largest spot film size for which the device is designed. Measurements shall be made at the maximum SID available but at no less than twenty (20) centimeters from the tabletop to the film plane distance.

C. For uncertified fluoroscopic systems without a spot film device, the requirements of RH-1603. apply.

D. Other requirements for fluoroscopic beam limitation:

i. Means shall be provided to permit further limitation 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;

ii. All equipment with a fixed SID and a visible area of 300 square centimeters or less shall be provided either with stepless adjustment of the x-ray field or with means to further limit the x-ray field size at the plane of the image receptor to 125 square centimeters or less;

iii. If provided, stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum attainable to a field size of five (5) centimeters by five (5) centimeters or less;

iv. For equipment manufactured after February 25, 1978, when the angle between the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor;

v. For noncircular x-ray fields used with circular 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.

3. Spot-film beam limitation. Spot-film devices shall meet the following requirements:

A. Means shall be provided between the source and the patient for adjustment of the x-ray field size in the plane of the film to the size of that portion of the film which has been selected on the spot film automatically accomplished except when the x-ray field size in the plane of the film is smaller than that of the selected portion of the film. For spot-film devices manufactured after June 21, 1979, if the x-ray field size is less than the size of the selected portion of the film, the means for adjustment of the field size shall be only at the operator's option;

B. Neither the length nor the width of the x-ray field in the plane of the image receptor shall differ from the corresponding dimensions of the selected portion of the image receptor by more than three (3%) percent of the SID when adjusted for full coverage of the selected portion of the image receptor. The sum, without regard to sign, of the length and width differences shall not exceed four (4%) percent of the SID;

C. It shall be possible to adjust the x-ray field size in the plane of the film to a size smaller than the selected portion of the film. The minimum field size at the greatest SID shall be equal to, or less than, five (5) centimeters by five (5) centimeters;

D. The center of the x-ray field in the plane of the film shall be aligned with the center of the selected portion of the film to within two (2%) percent of the SID; and

F. On spot-film devices manufactured after

February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.

4. Override. If a means exists to override any of the automatic x-ray field size adjustments required that means:

A. Shall be designed for use only in the event of system failure;

B. Shall incorporate a signal visible at the fluoroscopist's position which will indicate whenever the automatic field size adjustment is overridden; and

C. Shall have a clear and durable label as follows:

i. For x-ray fields.

ii. Limitation system failure.

iii. Activation of the fluoroscopic tube.

iv. X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the fluoroscopist for the entire time of any exposure. When recording serial fluoroscopic images, the fluoroscopist shall be able to terminate the x-ray exposure(s) at any time, but means may be provided to permit completion of any single exposure of the series in process.

b. Exposure rate limits.

1. Entrance exposure rate allowable limits.

A. Fluoroscopic equipment that is provided with automatic exposure rate control shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of ten (10) roentgens (2.6 mC/kg) per minute at the point where the center of the useful beam enters the patient, except:

i. During recording of fluoroscopic images; or

ii. When an optional high level control is provided. 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.

B. Fluoroscopic equipment which is not provided with automatic exposure rate control 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, except:

i. During recording of fluoroscopic images; or

ii. When the mode or modes have an optional high 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.

C. Compliance with the requirements of RH-1603. shall be determined as follows:

i. Movable grids and compression devices shall be removed from the useful beam during the measurement;

ii. If the source is below the table, exposure rate shall be measured one (1) centimeter above the table top or cradle;

iii. If the source is above the table, the exposure rate shall be measured at 30 centimeters above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement;

iv. All C-arm fluoroscopes, both stationary and mobile, shall meet the entrance exposure rate limits at 30 centimeters from the input surface of the fluoroscopic imaging assembly with the source positioned at any available SID provided that the end of the spacer assembly or beam-limiting device is not closer than 30 centimeters from the input surface of the fluoroscopic imaging assembly.

v. For a lateral type fluoroscope, the exposure rate 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.

D. Fluoroscopic equipment which is provided with both 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:

i. During recording of fluoroscopic images; or

ii. When the mode or modes have an optional high-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.

E. Any fluoroscopic equipment manufactured after May 19, 1995, which can exceed five (5) roentgens (1.3 mC/kg) per minute shall be equipped with an automatic exposure rate control. All entrance exposure rate limits shall be ten (10) roentgens (2.6 mC/kg) per minute with an upper limit of 20 roentgens (5.2 mC/kg) per minute when the high level control is activated.

F. Conditions of periodic measurement of maximum entrance exposure rate are as follows:

i. The measurement shall be made under the conditions that satisfy the requirements of;

ii. The kVp, mA, or other selectable parameters shall be adjusted to those settings which give the maximum entrance exposure rate;

iii. The x-ray system(s) that incorporates automatic exposure rate control shall have sufficient attenuative material placed in the useful beam to produce either a milliamperage or kilovoltage or both to satisfy the conditions of RH-1603.

c. Barrier transmitted radiation rate limits.

1. The exposure rate due to transmission through the primary protective barrier with the attenuation block in the useful beam, combined with radiation from the image intensifier, if provided, shall not exceed two (2) milliroentgens (0.516 µC/kg) per hour at ten (10) centimeters from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor for each roentgen per minute of entrance exposure rate.

2. Measuring compliance of barrier transmission.

A. The exposure rate due to transmission through the primary protective barrier combined with radiation from the image intensifier shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

B. If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 centimeters above the tabletop.

C. If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 centimeters.

D. Movable grids and compression devices shall be removed from the useful beam during the measurement.

3. Indication of potential and current. During fluoroscopy and cinefluorography the kV and the mA shall be continuously indicated.

d. Source-to-skin distance. The SSD shall not be less than:

1. 38 centimeters on stationary fluoroscopes installed on or after August 1, 1974;

2. 35.5 centimeters on stationary fluoroscopes which were in operation prior to August 1, 1974, 30 centimeters on all mobile fluoroscopes;

3. 20 centimeters for mobile fluoroscopes used for specific surgical application;

4. The written safety procedures must provide precautionary measures to be adhered to during the use of this device in addition to the procedures provided in RH-1603.

e. Fluoroscopic timer.

1. Means shall be provided to preset the cumulative on-time of the fluoroscopic x-ray tube. The maximum cumulative time of the timing device shall not exceed five (5) minutes without resetting.

2. A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative on-time. Such signal shall continue to sound while x-rays are produced until the timing device is reset.

f. Control of scattered radiation.

1. Fluoroscopic table designs when combined with procedures utilized shall be such that no unprotected part of any staff or ancillary individual's body shall be exposed to un-attenuated scattered radiation which originates from under the table. The attenuation required shall be not less than 0.25 millimeter lead equivalent.

2. Equipment configuration when combined with procedures shall be such that no portion of any staff or ancillary individual's body, except the extremities, shall be exposed to the un-attenuated scattered radiation emanating from above the tabletop unless that individual:

A. Is at least 120 centimeters from the center of the useful beam, or

B. The radiation has passed through not less than 0.25 millimeter lead equivalent material including, but not limited to, drapes, Bucky-slot cover panel, or self-supporting curtains, in addition to any lead equivalency provided by the protective apron referred to in RH-1603.

3. The Department may grant exemptions where a sterile field will not permit the use of the normal protective barriers. Where the use of prefitted sterilized covers for the barriers is practical, the Department shall not permit such exemption.

g. Spot-film exposure reproducibility. Fluoroscopic systems equipped with spot-film (radiographic) mode shall meet the exposure reproducibility requirements when operating in the spot-film mode.

1. Radiation therapy simulation systems shall be exempt from all the requirements provided that:

A. Such systems are designed and used in such a manner that no individual other than the patient is in the x-ray room during periods of time when the system is producing x-rays; and

B. Systems which do not meet the requirements are provided with a means of indicating the cumulative time that an individual patient has been exposed to x-rays. Procedures shall require in such cases that the timer be reset between examinations.

h. Special Procedures Estimated Patient Exposure Documentation.

1. Each facility using fluoroscopic equipment for procedures including, but not limited to:

A. Pacemaker implantation;

B. Diagnostic cardiac procedures (catheterization); and

C. Therapeutic cardiac procedures:

i. Angioplasty-balloon;

ii. Stent;

iii. Directional coronary atherectomy;

D. Radio frequency ablation;

E. Intravascular brachytherapy;

F. All neurointerventional procedures including:

i. Embolizations;

ii. Interventional radiology procedures such as:

(a) . TIPS;

(b) . Vascular embolizations;

(d) . Angioplasty;

G. Infusion drug procedures:

i. Complex biliary cases;

ii. Complex gastrointestinal cases; and

iii. Complex genitourinary procedures.

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.

i. Equipment operation.

1. All imaging formed by the use of fluoroscopic x-ray systems shall be directly viewed and interpreted by a licensed practitioner of the healing arts.

2. Overhead fluoroscopy shall not be used as a positioning tool for general purpose radiographic examinations.

3. Facilities that use fluoroscopic x-ray systems shall maintain a 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.

j. Periodic measurements.

1. Periodic measurement of entrance exposure rate shall be performed by a qualified expert for both typical and maximum values as follows:2/

A. Such measurements shall be made annually or after any maintenance of the system which might affect the exposure rate.

B. Results of these measurements shall be available where any fluoroscopist may have ready access to such results while using the fluoroscope. The measurement results shall be stated in coulombs per kilogram or mR/hr and included the technique factors used in measurements and the date the measurements were performed shall be included in the results.

C. Conditions of periodic measurement of typical entrance exposure rate are as follows:

i. The measurement shall be made under the conditions that satisfy the requirement;

ii. The kVp, mA, and/or other selectable parameters shall be adjusted to those settings typical of clinical use on 23 cm thick abdominal patient;

iii. The x-ray system that incorporates automatic exposure rate control shall have sufficient attenuative material placed in the useful beam to produce a milliamperage and/or kilovoltage to satisfy the conditions.

D. Conditions of periodic measurement of maximum entrance exposure rate are as follows:

i. The measurements shall be made under the conditions that satisfy the requirements;

ii. The kVp, mA and/or other selectable parameters shall be adjusted to those settings which give the maximum entrance exposure rate;

iii. The x-ray system(s) that incorporates automatic exposure rate control shall have sufficient attenuative material placed in the useful beam to produce the maximum entrance exposure rate of the system.

RH-1604. Radiographic Systems Other than Fluoroscopic, Dental Intraoral, Veterinarian, or Computed Tomography Systems:

a. Beam Limitation:

1. The useful beam shall be limited to the area of clinical interest.

This shall be considered met if a positive beam-limiting device meeting manufacturer's specifications have been properly used or if evidence of collimation is shown on at least three sides or three corners of the film (for example, projections from the shutters of the collimator, cone cutting at the corners, or borders at the film's edge.)

2. General purpose stationary and mobile x-ray systems and veterinarian systems (other than portable) installed after July 1, 1998.

A. Only x-ray systems provided with means for independent stepless adjustment of at least two (2) dimensions of the x-ray field shall be used.

B. A method shall be provided for visually defining the perimeter of the x-ray field.

i. Illuminance shall be greater than 7.5 foot-candles or 80.3 LUX at 100 centimeters or maximum SID whichever is less.

ii. The total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or width of the visually defined field shall not exceed two (2%) percent of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the x-ray beam.

iii. The Department may grant an exemption on non-certified x-ray provided the registrant makes a written application for such exemption and in that application demonstrates it is impractical to comply and the purpose will be met by other methods.

3. Additional requirements for stationary general purpose x-ray systems. In addition to the requirements for stationary general purpose x-ray systems, both certified and non-certified, shall meet the following requirements:

A. Method shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, to align the center of the x-ray field with respect to the center of the image receptor to within two (2%) percent of the SID, and to indicate the SID to within two (2%) percent;

B. The beam-limiting device shall indicate numerically the field size in the plane of the image receptor to which it is adjusted; and

C. Indication of field size dimensions and SIDs shall be specified in inches or centimeters, and shall be such that aperture adjustments result in x-ray field dimensions in the plane of the image receptor which correspond to those indicated by the beam-limiting device to within two (2%) percent of the SID when the beam axis is indicated to be perpendicular to the plane of the image receptor.

5. X-ray systems designed for one (1) image receptor size. 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 (2%) percent 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.

6. Other x-ray systems and veterinary systems installed prior to July 1, 1998, and all portable veterinary x-ray systems:

A. Means shall be provided to limit the x-ray field in the plane of the image receptor so that such field does not exceed each dimension of the image receptor by more than two (2%) percent of the SID when the axis of the x-ray beam is perpendicular to the plane of the image receptor.

B. Means shall be provided to align the center of the x-ray field with the center of the image receptor to within two (2%) percent of the SID, or means shall be provided 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. Compliance shall be determined with the axis of the x-ray beam perpendicular to the plane of the image receptor.

C. Alignment requirements may be met with either:

i. An assortment of removable, fixed-aperture, beam- limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed with each such device having clear and permanent markings to indicate the image receptor size and SID for which it is designed; or

ii. A beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use.

b. Radiation exposure control devices.

1. Timers

A. Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action.

B. Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. In addition, it shall not be possible to make an exposure when the timer is set to a "zero" or "off" position if either position is provided. Except for dental panoramic systems, termination of an exposure shall cause automatic resetting of the timer to its initial setting or to "zero."

2. X-ray control. Manual exposure control.

A. An x-ray control shall be incorporated into each x-ray system such that an exposure can be terminated by the operator at any time except for exposure of one-half second or less, or during serial radiography when means shall be provided to permit completion of any single exposure of the series in process.

B. Each x-ray control shall be located in such a way as to meet the following requirements:

i. Stationary x-ray systems (except dental, podiatry and veterinary units) shall be required to have the x-ray exposure switch permanently mounted in a protected area so that the operator is required to remain in that protected area during the entire exposure and so that the operator can view the patient while making any exposures;

ii. Mobile and portable x-ray systems which are:

(a) . Used for greater than one (1) week in the same location, i.e., a room or suite; or

(b) . Used for greater than one (1) hour and less than one (1) week at the same location, i.e., a room or suite; or

(c) . In a clinical setting for routine extremities only, or where moving the x-ray system from room to room is impractical;

(d) . Shall meet the requirement of the above paragraph or be provided which for:

(1) . Equipment installed or relocated after January 1, 2006 is placed at least nine (9) feet (2.7 meters) from the tube housing assembly.

(2) . Equipment installed before January 1, 2006 is placed at least six (6) feet (1.8 meters) from the tube housing assembly.

(e) . Written procedures must instruct the operator to remain in the protected area during the entire exposure.

iii.

(a) . Stationary Podiatric systems installed or relocated after January 1, 2006, which do not meet the above requirements shall be provided with a nine (9) foot exposure button cord which allows the operator to remain behind a protective barrier during the entire exposure.

(b) . Stationary Podiatric systems installed before January 1, 2006, which do not meet the above requirements shall be provided with a six (6) foot exposure button which allows the operator to remain behind a protective barrier during the entire exposure.

(c) . If the protective barrier is moveable, written procedures must be on file at the facility, which dictate that the operator will remain behind the barrier during the entire exposure.

C. The x-ray control shall provide 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.

3. Automatic exposure controls. When an automatic exposure control is provided:

A. Indication shall be made on the control panel when this mode of operation is selected;

B. If the x-ray tube potential is equal to or greater than 50 kVp, the minimum exposure time for field emission equipment rated for pulsed operation shall be equal to or less than a time interval equivalent to two (2) pulses;

C. The minimum exposure time for all equipment shall be equal to or less than one-sixtieth second or a time interval required to deliver five (5) mAs, whichever is greater;

D. Either the product of peak x-ray tube potential, current, and exposure time shall be limited to not more than 60 kWs per exposure, or the product of x-ray tube current and exposure time shall be limited to not more than 600 mAs per exposure except that, when the x-ray tube potential is less than 50 kVp, the product of x-ray tube current and exposure time shall be limited to not more than 2000 mAs per exposure; and

E. A visible signal shall indicate when an exposure has been terminated, and manual resetting shall be required before further automatically timed exposures can be made.

4. Reproducibility.

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)

5. Exposure duration (timer) linearity.

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) [LESS THAN] 0.1 (X1 + X2)

where X1 and X2 are the average C kg-1s-1 (mR/s) values.

c. Source-to-skin distance.

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.

d. Exposure reproducibility.

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.

e. Radiation from capacitor energy storage equipment in standby status.

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.

f. Accuracy.

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 (10) percent of the indicated value for kVp and twenty (20%) percent for time mA/mAs linearity.

g. 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 40 percent to 100 percent of the maximum rated:

1. Equipment having independent selection of x-ray tube current (mA). 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 [LESS THAN] 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.

(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 [LESS THAN] 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.

3. Measuring compliance.

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.

h. Additional requirements applicable to certified systems only.

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).

i. Beam limitation for stationary and mobile general purpose x-ray systems.

1. There shall be provided a means of stepless adjustment of the x-ray field. The minimum field size at an SID of 100 centimeters shall be equal to or less than five (5) centimeters by five (5) centimeters.

2. When a light localizer is used to define the x-ray field, it shall provide an average illumination of not less than 160 lux or 15 foot-candles at 100 centimeters or at the maximum SID, whichever is less. The average illumination shall be based upon measurements made in the approximate center of each quadrant of the light field. Radiation therapy simulation systems manufactured on and after May 27, 1980, are exempt from this requirement.

3. The edge of the light field at 100 centimeters or at the maximum SID, whichever is less, shall have a contrast ratio, corrected for ambient lighting, of not less than four (4) in the case of beam-limiting devices designed for use on stationary equipment, and a contrast ratio of not less than three (3) in the case of beam-limiting devices designed for use on mobile equipment. The contrast ratio is defined as I1/I2 where I1 is the illumination three (3) millimeters from the edge of the light field toward the center of the field; and I2 is the illumination three (3) millimeters from the edge of the light field away from the center of the field.

4. Compliance shall be determined with a measuring instrument aperture of one (1) millimeter in diameter.

j. Beam limitation and alignment on stationary general purpose x-ray

systems equipped with Positive Beam Limitation (PBL).

If PBL is being used, the following requirements shall be met:

1. PBL shall prevent the production of x-rays when:

A. Either the length or width of the x-ray field in the plane of the image receptor differs from the corresponding image receptor dimensions by more than three (3%) percent of the SID; or

B. The sum of the length and width differences, without regard to sign exceeds four (4%) percent of the SID;

C. Compliance shall be determined when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor. Compliance shall be determined no sooner than five (5) seconds after insertion of the image receptor;

D. The PBL system shall be capable of operation, at the discretion of the operator, such that the size of the field may be made smaller than the size of the image receptor through stepless adjustment of the field size. The minimum field size at an SID of 100 centimeters shall be equal to or less than five (5) centimeters by five (5) centimeters;

E. The PBL system shall be designed such that if a change in image receptor does not cause an automatic return to PBL function, then any change of image receptor size or SID must cause the automatic return.

2. Beam limitation for portable x-ray systems. Beam limitation for portable x-ray systems shall meet the beam limitation requirements.

3. Tube stands for portable x-ray systems. 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.

k. Systems used in a clinical (non-surgical) setting shall be restricted to one room within a location or suite which meets the requirements.

RH-1605. Reserved.

RH-1606. Intraoral Dental Radiographic Systems. The requirements for general x-ray tubes apply to the intraoral dental machines.

a. Source-to-skin distance. X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit source-to-skin distance to not less than:

1. 18 centimeters if operable above 50 kVp, or

2. 10 centimeters if not operable above 50 kVp.

b. Beam limitation. Radiographic systems designed for use with an intraoral image receptor shall be provided with means to limit the X-ray beam such that:

1. If the minimum source-to-skin distance (SSD) is 18 centimeters or more, the x-ray field, at the minimum SSD, shall be containable in a circle having a diameter of no more than seven (7) centimeters; and

2. If the minimum SSD is less than 18 centimeters, the x-ray field, at the minimum SSD, shall be containable in a circle having a diameter of no more than six (6) centimeters.

3. The position indicating device shall be shielded and open-ended. The shielding shall be equivalent to the requirements.

c. Exposure control. Exposure initiation.

A. Means shall be provided to initiate the radiation exposure by deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action; and

B. It shall not be possible to make an exposure when the timer is set to a "zero" or "off" position if either position is provided.

d. Exposure indication. 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.

e. Exposure termination.

1. Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. In addition:

A. Termination of exposure shall cause automatic resetting of the timer to its initial setting or to "zero."

B. An x-ray control shall be incorporated into each x-ray system such that an exposure can be terminated by the operator at any time, except for exposures of one-half (½) second or less.

2. Exposure duration (timer) linearity.

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) [LESS THAN] 0.1 (X1 + X2) where X1 and X2 are the average values.

3. Each x-ray exposure switch shall be located in such a way as to meet the following requirements:

A. Stationary x-ray systems shall be required to have the x-ray exposure switch located in a protected area or have an exposure switch cord of sufficient length to permit the operator to activate the unit while in a protected area, e.g., corridor outside the operatory. The procedures must instruct the operator to remain in the protected area during the entire exposure.

B. Mobile and portable x-ray systems which are:

i. Used for greater than one (1) week in the same location, i.e., a room or suite, shall meet the other requirements.

ii. Used for greater than one (1) hour and less than one week at the same location, i.e., a room or suite, shall meet the requirements of the above paragraph or be provided with a 6.5 foot (1.98 meters) high protective barrier or means to allow the operator to be at least nine (9) feet (2.7 meters) from the tube housing assembly while making exposure 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 while making exposure.

4. Reproducibility. 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.

f. mA/mS linearity.

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 40 percent to 100 percent of the maximum rated:

1. Equipment having independent selection of x-ray tube current (mA). The average ratios (X1) of exposure to the indicated milliampere-seconds product, in units of C kg-1 mAs-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) [LESS THAN] 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.

2. Equipment having a combined x-ray tube current-exposure time product (mAs) selector, but not a separate tube current (mA) selector. The average ratios (X1) of exposure to the indicated milliampere-seconds product, in units of C kg-1 mAs-1 (or mR/mAs), obtained at any two (2) consecutive mAs selector settings shall not differ by more than 0.10 times their sum:

(X1 - X2) [LESS THAN] 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.

3. Measuring compliance. 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.

g. Accuracy.

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 (10%) percent.

h. kVp limitations. 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.

i. Administrative controls:

1. Patient and film holding devices shall be used when the techniques permit.

2. The tube housing and the Patient Imaging Device (PID) shall not be hand-held during an exposure.

3. The x-ray system shall be operated in such a manner that the useful beam at the patient's skin does not exceed the requirements.

4. Dental fluoroscopy without image intensification shall not be used.

NOTE: In many cases structural materials of ordinary walls suffice as a protective barrier without addition of special shielding material.

RH-1607. Therapeutic X-Ray Systems of Less Than One MeV.

a. Equipment Requirements.

1. Leakage radiation. When the tube is operated at its leakage technique factors, the leakage radiation shall not exceed the value specified at the distance specified for the classification of the x-ray system.

A. Contact therapy systems. Leakage radiation shall not exceed 100 milliroentgens per hour at five (5) centimeters from the surface of the tube housing assembly.

B. 0-150 kVp systems. Systems which are manufactured or installed prior to the July 1, 1983 date shall have a leakage radiation which does not exceed one (1) roentgen in one hour at one (1) meter from the source.

C. 0-150 kVp systems. Systems which are manufactured on or after July 1, 1983 shall have a leakage radiation which does not exceed 100 milliroentgens in one (1) hour at one (1) meter from the source.

D. 151 to 999 kVp systems. The leakage radiation shall not exceed one (1) roentgen in one hour at one (1) meter from the source except systems that operate in excess of 500 kVp may have a leakage radiation at one (1) meter from the source equivalent to the exposure within one hour of the useful beam at one (1) meter from the source multiplied by a factor of 0.001.

2. Permanent beam limiting devices. Permanent fixed diaphragms or cones used for limiting the useful beam shall provide the same or higher degree of protection as required by the tube housing assembly.

3. Removable and adjustable beam limiting devices.

A. Removable beam limiting devices shall, for the portion of the useful beam to be blocked by these devices, transmit not more than one (1%) percent of the original x-ray beam at the maximum kilovoltage and maximum treatment filter. This requirement does not apply to auxiliary blocks or materials placed in the useful beam to shape the useful beam to the individual patient.

B. Adjustable beam limiting devices installed after July 1, 1983 shall meet the requirements of RH-1607.a.3.A.

C. Adjustable beam limiting devices installed before July 1, 1983 shall, for the portion of the x-ray beam to be blocked by these devices, transmit not more than five (5%) percent of the original x-ray beam at the maximum kilovoltage and maximum treatment filter.

4. Filter system. The filter system shall be so designed that:

A. Filters cannot be accidentally displaced from the useful beam at any possible tube orientation;

B. Each filter is marked as to its material of construction and its thickness or wedge angle for wedge filters; and

C. It shall be possible for the operator to determine the presence or absence of each filter and the orientation of each wedge filter in the useful beam when the operator is at the control panel, either by display at the control panel or by direct observation.

D. The radiation at five (5) centimeters from the filter insertion slot opening does not exceed 30 roentgens per hour under any operating conditions.

5. Tube immobilization. The tube housing assembly shall be capable of being immobilized during stationary treatments.

6. Focal spot marking. The tube housing assembly shall be so marked that it is possible to determine the location of the focal spot to within five (5) millimeters and such marking shall be readily accessible for use during calibration procedures.

7. Beam block. Contact therapy tube housing assemblies shall have a removable shield of at least 0.5 millimeter lead equivalence at 100 kVp that can be positioned over the entire useful beam exit port during periods when the beam is not in use.

8. Beam monitor system. Systems of greater than 150 kVp manufactured after July 1, 1983 shall be provided with a beam monitor system which:

A. Shall include a transmission detector which is a full beam detector and which is placed on the patient side of any fixed added filters other than a wedge filter;

B. Shall have the detector interlocked to prevent incorrect positioning in the useful beam;

C. Shall not allow irradiation until a pre-selected value of exposure (i.e. roentgens, rads/unit time, etc.) has been made at the treatment control panel;

D. Shall independently terminate irradiation when the preselected exposure has been reached;

E. Shall be so designed that, in the event of a system malfunction or electrical power failure, the dose administered to a patient prior to the system malfunction or power failure can be accurately determined;

F. Shall have a display at the control panel from which the dose at the reference point in the treatment volume can be calculated;

G. Shall have a control panel display which maintains the reading until intentionally reset to zero; and

H. Shall have a control panel display which does not have scale multiplying factors and utilizes a design such that increasing dose is displayed by increasing numbers.

9. Timer.

A. A timer shall be provided which has a display at the treatment control panel. The timer shall be graduated in minutes and fraction of minutes. The timer shall have a pre-set timer selector and an elapsed time indicator.

B. The timer shall be a cumulative timer which activates with the radiation and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to cycle the pre-set time selector through zero time.

C. The timer shall terminate irradiation when pre-selected time has elapsed if any dose a monitoring system present has not previously terminated irradiation.

D. The timer shall permit accurate pre-setting and determination of exposure times as short as one (1) second.

E. The timer shall not permit an exposure if set at zero.

F. The timer shall comply with the provisions of RH-1607.a.13. where applicable.

G. The timer shall not activate until the shutter is opened when patient irradiation is controlled by a shutter mechanism.

10. Control panel functions. The control panel, in addition to the displays required in other provision of RH-1607., shall have:

A. An indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible;

B. An indication of whether x-rays are being produced;

C. Means for indicating kV and x-ray tube current;

D. The means for terminating an exposure at any time;

E. A locking device which will prevent unauthorized use of the x-ray system; and

F. For x-ray equipment manufactured after July 1, 1983, a positive display of specific filter(s) in the beam.

11. Multiple tubes. When a control panel may energize more than one x-ray tube:

A. It shall be possible to activate only one (1) x-ray tube during any time interval;

B. There shall be an indication at the control panel identifying which x-ray tube is energized; and

C. There shall be an indication at the tube housing assembly when that tube is energized.

12. Source-to-patient distance. There shall be means of determining the source-to-patient distance to within one (1) centimeter.

13. Shutters. Unless it is possible to bring the x-ray output to the prescribed exposure parameters within five (5) seconds, the entire useful beam shall be automatically attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly. In addition,

A. After the unit is at operating parameters, the shutter shall be controlled electrically by the operator from the control panel; and

B. An indication of shutter position shall appear at the control panel.

14. Low filtration x-ray tubes. Each x-ray system equipped with a beryllium or other low-filtration window shall be clearly labeled as such upon the tube housing assembly and at the control panel.

b. Facility Design Requirements for Systems Capable of Operating Above 50 kVp. In addition to shielding adequate to meet requirements of Section 2 and Section 3, the treatment room shall meet the following design requirements:

1. Warning lights. Treatment rooms to which access is possible through more than one entrance shall be provided with warning lights, in a readily observable position near the outside of all access doors, which will indicate when the useful beam is "on".

2. Voice communication. Provision shall be made for two-way aural communication between the patient and the operator at the control panel; however, where excessive noise levels make aural communication impractical, other methods of communication shall be used.

3. Viewing systems. Windows, mirrors or closed-circuit television or an equivalent system shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel. When the primary viewing system is by electronic means (e.g., television), an alternate viewing system shall be available for use in the event of electronic failure.

4. Additional requirements for x-ray systems capable of operation

above 150 kVp.

A. All protective barriers shall be fixed except for entrance doors or beam interceptors.

B. The control panel shall be outside the treatment room;

C. All doors of the treatment room shall be electrically connected to the control panel such that x-ray production cannot occur unless all doors are closed;

D. If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel.

E. When any door is opened while the x-ray tube is activated, the exposure at a distance of one (1) meter from the source shall be reduced to less than 100 milliroentgens per hour within one (1) second.

F. After the radiation output of the x-ray tube has been affected by the opening of any door referred to in RH-1607.b.4.C., it shall be possible to restore the x-ray system to full operation only upon:

i. closing the door; and subsequently,

ii. reinitiating the exposure at the control panel.

c. Surveys, Calibrations, Spot Checks and Operating Procedures.

1. Surveys.

A. All new facilities and existing facilities not previously surveyed shall have a survey made by or under the direction of, a qualified expert. Such surveys shall also be done after any change in the facility or equipment which might cause a significant increase in radiation hazard.

B. The registrant shall obtain a written report of the survey from the qualified expert and a copy of the report shall be transmitted by the registrant to the Department within thirty (30) days of receipt of the report.

C. The survey and report shall indicate all instances where the installation, in the opinion of the qualified expert, is in violation of applicable regulations and shall cite all items of noncompliance.

2. Calibrations.

A. The calibration of an x-ray system shall be performed at intervals not to exceed one (1) year and after any change or replacement of components which could cause a change in the radiation output.

B. The calibration of the radiation output of the x-ray system shall be performed by or under the direction of a qualified expert who is physically present at the facility during such calibration.

C. Calibration of the radiation output of an x-ray system shall be performed with a calibrated instrument. The calibration of such instrument shall be directly traceable to a national standard. The instrument shall have been calibrated within the preceding two (2) years.

D. The calibrations made pursuant to RH-1607.c.2. shall be such that the dose at a reference point in soft tissue can be calculated to within five (5%) percent.

E. The calibration of the x-ray system shall include, but not be limited to, the following determinations:

i. Verification that the x-ray system is operating in compliance with the design specifications;

ii. The exposure rates for each combination of field size technique factors, filter and treatment distance used;

iii. The degree of congruence between the radiation field and the field indicated by the localizing device if such device is present; and

iv. An evaluation of the uniformity of the radiation field symmetry for the field sizes used and any dependence upon tube housing assembly orientation.

F. Records of calibration performed pursuant to RH-1607.c.2. shall be maintained by the registrant for five (5) years after completion of the calibration.

G. A copy of the most recent x-ray system calibration shall be available for use by the operator at the control panel.

3. Spot checks. Spot checks shall be performed on x-ray systems capable of operation at greater than 150 kVp. Such spot checks shall meet the following requirements:

A. The spot check procedures shall be in writing and shall have been developed by a qualified expert. A copy shall be submitted to the Department prior to its implementation.

B. If a qualified expert does not perform the spot-check measurement, the results of the spot-check measurements shall be reviewed by a qualified expert within fifteen (15) days.

C. The measurements taken during the spot checks shall demonstrate the degree of consistency of the operating characteristics which can affect the radiation output of the x-ray system.

D. The spot check procedure shall specify the frequency at which tests or measurements are to be performed and the acceptable tolerance for each parameter measured in the spot check when compared to the value for that parameter determined in the calibration specified in RH-1607.c.2.

E. The cause for a parameter exceeding a tolerance set by the qualified expert shall be investigated and corrected before the system is used for patient irradiation.

F. The procedure shall also note conditions which shall require that the system be recalibrated in accordance with RH-1607.c.2.

G. Records of spot check measurements performed pursuant to RH-1607.c.3. shall be maintained by the registrant for two (2) years following such measurement.

H. Where a spot check involves a radiation measurement, such measurement shall be obtained using a system satisfying the requirements of RH-1607.c.2. or which has been inter-compared with a system meeting those requirements within the previous year.

4. Operation procedures.

A. Therapeutic x-ray systems shall not be left unattended unless the system is secured pursuant to RH-1607.a.10.E.

B. When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used.

C. The tube housing assembly shall not be held by an individual during exposures unless the system is designed to require such holding and the peak tube potential of the system does not exceed 50 kVp. In such cases, the holder shall wear protective gloves and apron of not less than 0.5 mm lead equivalency at 100 kVp.

D. No individual other than the patient shall be in the treatment room unless such individual is protected by a barrier sufficient to meet the requirements of RH-1200. No individual other than the patient shall be in the treatment room during exposures when the kVp exceeds 150.

E. The x-ray system shall not be used in the administration of radiation therapy unless the requirements of RH-1607.c.2. and RH-1507.c.3.D. have been met.

RH-1608. X-Ray and Electron Therapy Systems with Energies of One MeV and Above. Section 6 shall apply to medical facilities using therapy systems with energies one MeV and above.

a. Definitions. In addition to the definitions provided in RH-1601., the following definitions shall be applicable to RH-1608.

1. Applicator - A structure which indicates the extent of the treatment field at a given distance from the virtual source and which may or may not incorporate the beam limiting device.

2. Beam scattering filter - A filter used in order to scatter a beam of electrons.

3. Central axis of the beam - A line passing through the virtual source and the center of the plane figure formed by the edge of the final beam limiting device.

4. Depth dose - The absorbed dose at a specified depth in a phantom.

5. Dose monitoring system - A system of devices for the detection and display of quantities of radiation.

6. Dose monitor unit - A unit from which the absorbed dose can be calculated.

7. Existing equipment - Therapy systems subject to RH-1608 which were manufactured before the effective date of these Regulations.

8. Field flattening filter - A filter used to homogenize the dose rate over the area of a useful beam of x-rays.

9. Field size - The dimensions along the major axes of an area in a plane perpendicular to the specified direction of the beam of incident radiation at the normal treatment distance and defined by the intersection of the major axes and the 50 percent isodose line. Material shall be placed in the beam such that dose maximum is produced at the normal treatment distance when field size is being determined.

10. Gantry - The part of the system supporting and allowing possible movements of the radiation head.

11. Interruption of irradiation - The stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.

12. Isocenter - A fixed point in space located at the intersection of the rotation axes of the principal movements of the therapy system.

13. Moving beam therapy - Radiation therapy with relative displacement of the useful beam and the patient during irradiation. This includes arc therapy, skip therapy and rotational therapy.

14. New equipment - Systems subject to RH-1608 which were manufactured after the effective date of these Regulations.

15. Normal treatment distance:

A. For electron irradiation, this distance is the virtual source to surface distance along the central axis of the useful beam as specified by the manufacturer for the applicator.

B. For x-ray irradiation this distance is the virtual source to isocenter distance along the central axis of the useful beam. For non-isocentric equipment this distance shall be that specified by the manufacturer.

16. Patient - An individual subjected to examination and treatment.

17. Phantom - A volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation.

18. Primary dose monitoring system - A system which will monitor the quantity of radiation produced during irradiation and which will terminate irradiation when a pre-selected number of dose monitor units have been acquired.

19. Radiation treatment prescription - The absorbed dose which is intended to be delivered to the treatment volume.

20. Radiation head - The structure from which the useful beam emerges.

21. Redundant dose monitoring combination - A combination of two dose monitoring systems in which both systems are arranged to terminate irradiation in accordance with a pre-selected number of dose monitor units.

22. Secondary dose monitoring system - A system which will terminate irradiation in the event of failure of the primary system.

23. Shadow tray - A device attached to the radiation head to support auxiliary beam limiting material.

24. Spot check - A procedure which is performed to assure that a previous calibration continues to be valid.

25. Stationary beam therapy - Radiation therapy without relative displacement of the useful beam and the patient during irradiation.

26. Target - The part of a radiation head which intercepts a beam of accelerated particles with subsequent emission of other radiation.

27. 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.

28. Treatment field - The area of the patient's skin which is to be irradiated.

29. Virtual source - A point from which radiation appears to originate.

b. Requirements for Equipment.

1. Leakage radiation inside patient area.

A. New equipment shall meet the following requirements:

i. For all operating conditions, the dose in rads (grays)

due to leakage radiation, including x-rays, electrons and neutrons, at any point in a circular plane of two (2) meters radius centered on a perpendicular to the central axis of the beam at the normal treatment distance and outside the maximum useful beam, shall not exceed 0.1 percent of the maximum dose in rads (grays) of the un-attenuated useful beam measured at the point of intersection of the central axis of the beam and the plane surface.

Measurements excluding those for neutrons shall be averaged over an area up to but not exceeding 100 square centimeters at the positions specified. Measurements of the portion of the leakage radiation dose contributed by neutrons shall be averaged over an area up to but not exceeding 200 square centimeters.

ii. For each system the licensee shall determine or obtain from the manufacturer, the leakage radiation existing at the positions specified in RH-1608.b.1.A.i. for specified operating conditions. Records on leakage radiation shall be maintained at the installation for inspection by the Department.

B. Existing equipment shall meet the following requirements:

i The leakage radiation, excluding neutrons, at any point in the area specified by RH-1608.b.1.A.i. where such area intercepts the central axis of the beam one (1) meter from the virtual source, shall not exceed 0.1 percent of the maximum dose in rads of the un-attenuated useful beam measured at the point of intersection of the central axis of the beam and the circular plane specified in RH-1608.b.1.A.i.

ii. For each system, the licensee shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in RH-1608.b.1.B.i. for specified operating conditions. Records on radiation leakage shall be maintained at the installation for inspection by the Department.

2. Leakage radiation outside the patient area.

A. The dose equivalent in rem due to leakage radiation, except in the area specified in RH-1608.b.1.A.i., when measured at any point one (1) meter from the path of the charged particle, before the charged particle strikes the target or window, shall not exceed 0.1 percent for x-ray leakage nor 0.5 percent for neutron leakage of the maximum dose equivalent in rem of the un-attenuated useful beam measured at the point of intersection of the central axis of the beam and the circular plane specified in RH-1608.b.1.A.i.

B. The licensee shall determine or obtain from the manufacturer, the actual leakage radiation existing at the positions specified in RH-1608.b.2.A. for specified operating conditions. Measurements, excluding neutrons, shall be averaged over an area up to but not exceeding 100 square centimeters at the positions specified. Neutron measurements shall be averaged over an area up to but not exceeding 200 square centimeters.

3. Beam limiting devices. Adjustable or interchangeable beam limiting devices shall be provided and such devices shall transmit no more than two (2%) percent of the useful beam for the portion of the useful beam which is to be attenuated by the beam limiting device. The neutron component of the useful beam shall not be included in this requirement. Measurements shall be averaged over an area up to but not exceeding 100 square centimeters at the normal treatment distance.

4. Filters.

A. If the absorbed dose rate information required by RH-1608.b.16. related exclusively to operation with a field flattening or beam scattering filter in place, such filter shall be removable only by the use of tools.

B. In systems which utilize a system of wedge filters, interchangeable field flattening or interchangeable beam scattering filters:

i. Irradiation shall not be possible until a selection of a filter has been made at the treatment control panel;

ii. An interlock system shall be provided to prevent irradiation if the filter selected is not in the correct position;

iii. An indication of the wedge filter orientation with respect to the treatment field shall be provided at the control panel, by direct observation or by electronic means, when wedge filters are used;

iv. A display shall be provided at the treatment control panel showing the filter(s) in use;

v. Each filter which is removable from the system shall be clearly marked with an identification number. Documentation available at the control panel shall contain a description of the filter. For wedge filters, the wedge angle shall appear on the wedge or wedge tray.

vi. An interlock shall be provided to prevent irradiation if any filter selection operation carried out in the treatment room does not agree with the filter selection operation carried out at the treatment control panel.

5. Beam quality. The licensee shall determine or obtain from the manufacturer, data sufficient to assure that the following beam quality requirements are met:

A. The absorbed dose resulting from x-rays in a useful electron beam at a point on the central axis of the beam ten (10) centimeters greater than the practical range of the electrons shall not exceed the values stated in Table III. Linear interpolation shall be used for values not stated.

TABLE III

Maximum Energy of Electron Beam in MeV	X-ray Absorbed Dose as a Fraction of Maximum Absorbed Dose
1	0.03
15	0.05
35	0.10
50	0.20

B. Compliance with RH-1608.b.5.A. shall be determined using:

i. A measurement within a phantom with the incident surface of the phantom at the normal treatment distance and normal to the central axis of the beam;

ii. The largest field size available which does not exceed 15 centimeters by 15 centimeters; and

iii. A phantom whose cross-sectional dimensions exceed the measurement radiation field by at least five (5) centimeters and whose depth is sufficient to perform the required measurement.

C. The absorbed dose at a surface located at the normal treatment distance, at the point of intersection of that surface with the central axis of the useful beam during x-ray irradiation, shall not exceed the limits stated in Table IV. Linear interpolation shall be used for values not stated.

TABLE IV

Maximum Photon Energy in MeV	Absorbed Dose at the Surface as a Fraction of the Maximum Absorbed Dose
1	0.80
2	0.70
5	0.60
15	0.50
35	0.40
50	0.20

D. Compliance with RH-1608.b.5.C. shall be determined by:

i. Measurements made within a phantom using an instrument which will allow extrapolation to the surface absorbed dose;

ii. Use of a phantom whose size and placement meet the requirements of RH-1608.b.5.B.;

iii. Removal of all beam modifying devices which can be removed without the use of tools, except for beam scattering or beam flattening filters; and

iv. The largest field size available which does not exceed 15 centimeters by 15 centimeters.

E. The licensee shall determine or obtain from the manufacturer the maximum percentage absorbed dose in the useful beam due to neutrons, excluding stray neutron radiation, for specified operating conditions.

6. Beam monitors. All therapy systems shall be provided with radiation detectors in the radiation head.

A. New equipment shall be provided with at least two (2) radiation detectors. The detectors shall be incorporated into two monitoring systems arranged either as a primary/primary combination or as a primary/secondary combination.

B. Existing equipment shall be provided with at least one radiation detector. This detector shall be incorporated into a primary system.

C. The detectors and system into which the detector is incorporated shall meet the following requirements:

i. Each primary system shall have a detector which is a transmission detector and a full beam detector and which is placed on the patient side of any fixed added filters other than a wedge filter.

ii. The detectors shall be removable only with tools and shall be interlocked to prevent incorrect positioning.

iii. Each detector shall be capable of independently monitoring and controlling the useful beam.

iv. Each detector shall form part of a dose monitoring system from whose readings in dose monitor units the absorbed dose at a reference point in the treatment volume can be calculated.

v. For new equipment the design of the dose monitoring systems of RH-1608.b.6.C.iv. shall assure that the malfunctioning of one system shall not affect the correct functioning of the second system. In addition:

(a) . The failure of any element which may be common to both systems shall terminate the useful beam.

(b) . The failure of any element common to both systems which could affect the correct function of both systems shall terminate irradiation.

vi. Each dose monitoring system shall have a legible display at the treatment control panel. Each display shall:

(a) . Maintain a reading until intentionally reset to zero;

(b) . Have only one scale and no scale multiplying factors in new equipment; and

(c) . Utilize a design such that increasing dose is displayed by increasing numbers and shall also be so designed that, in the event of an over-dosage of radiation, the absorbed dose may be accurately determined under all normal conditions of use or foreseeable failures.

vii. In the event of power failure, the dose monitoring information required in RH-1608.b.6.C.vi. displayed at the control panel at the time of failure shall be retrievable in at least one system for a twenty (20) minute period of time.

7. Beam symmetry.

A. In new equipment inherently capable of producing useful beams with asymmetry exceeding five (5%) percent, at least four (4) different parts of the radiation beam shall be monitored before the beam passes through the beam limiting device and facilities shall be provided so that if the difference in dose rate between any two (2) of these different parts exceeds five (5%) percent an indication of this condition is made at the control panel and so that if the difference in dose rates between any two (2) of these different parts exceeds twenty (20%) percent the irradiation is terminated.

B. Beam symmetry requirements of RH-1608.a.7. A. shall be met if the user can demonstrate to the satisfaction of the Department that adequate fail-safe protection against the beam asymmetry is incorporated into the inherent design of the accelerator.

C. On existing equipment where the Department has determined that beam symmetry is inadequate, the use of an automatic beam asymmetry warning system may be required.

8. Selection and display of dose monitor units.

A. Irradiation shall not be possible until a selection of a number of dose monitor units has been made at the treatment control panel.

B. After useful beam termination, it shall be necessary to manually reset the pre-selected dose monitor units before treatment can be reinitiated.

C. The pre-selected number of dose monitor units shall be displayed at the treatment control panel until reset manually for the next irradiation.

D. After termination of irradiation, it shall be necessary to reset the dosimeter display to zero before subsequent treatment can be initiated.

9. Termination of irradiation by the dose monitoring system.

A. Each of the required monitoring systems shall be capable of independently terminating irradiation. Provisions shall be made to test the correct operation of each system.

B. Each primary system shall terminate irradiation when the pre-selected number of dose monitor units has been detected by the system.

C. If original design of the equipment included a second dose monitoring system, that system shall be capable of terminating irradiation when not more than 40 dose monitor units above the pre-selected number of dose monitor units set at the control panel has been detected by the second dose monitoring system.

D. For new equipment a second dose monitoring system shall be present. That system shall be capable of terminating irradiation when not more than ten (10%) percent or 25 dose monitor units above the pre-selected number of dose monitor units set at the control panel has been detected by the second dose monitor system.

E. For new equipment an indicator on the control panel shall show which dose monitoring system has terminated irradiation.

10. Interruption switches. It shall be possible to interrupt irradiation and equipment movements at any time from the operator's position at 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 the equipment shall go to termination condition.

11. Termination switches. It shall be possible to terminate irradiation and equipment movements or go from an interruption condition to termination condition, at any time from the operator's position at the treatment control panel.

12. Timer.

A. A timer shall be provided which has a display at the treatment control panel. The timer shall be graduated in minutes and decimals of minutes. The timer shall have a pre-set time selector and an elapsed time indicator.

B. The timer shall be a cumulative timer which switches on and off with the radiation and retains its reading after irradiation is interrupted or terminated. It shall be necessary to zero and subsequently reset the elapsed time indicator and the pre-set time selector after irradiation is terminated before irradiation shall again be possible.

C. The timer shall terminate irradiation with a pre-selected time has elapsed if the dose monitoring systems fail to do so.

13. Selection of radiation type. Equipment capable of both X-ray therapy and electron therapy shall meet the following requirements:

A. Irradiation shall not be possible until a selection of radiation type has been made at the treatment control panel.

B. An interlock system shall be provided to insure that the equipment can emit only the radiation type which has been selected.

C. An interlock system shall be provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment control panel.

D. An interlock system shall be provided to prevent irradiation with x-rays when electron applicators are fitted and irradiation with electrons when accessories specific for x-ray therapy are fitted.

E. The radiation type selected shall be displayed at the treatment control panel before and during irradiation.

14. Selection of energy. Equipment capable of generating radiation beams of different energies shall meet the following requirements:

A. Irradiation shall not be possible until a selection of energy has been made at the treatment control panel.

B. An interlock system shall be provided to insure that the equipment can emit only the energy of radiation which has been selected.

D. The energy selected shall be displayed at the treatment control panel before and during irradiation.

E. For new equipment, an interlock system shall be provided to terminate irradiation if the energy of the electrons striking the x-ray target or electron window deviates by more than plus twenty percent (+ 20%) or plus three (+ 3) MeV, whichever is smaller, from the selected nominal energy.

15. Selection of stationary beam therapy or moving beam therapy. Equipment capable of both stationary beam therapy and moving beam therapy shall meet the following requirements:

A. Irradiation shall not be possible until a selection of stationary beam therapy or moving beam therapy has been made at the treatment control panel.

B. An interlock system shall be provided to insure that the equipment can operate only in the mode which has been selected.

D. An interlock system shall be provided to terminate irradiation if the movement stops during moving beam therapy.

E. The mode of operation shall be displayed at the treatment control panel.

F. For new equipment, an interlock system shall be provided to terminate irradiation if:

i. Movement of the gantry occurs during stationary beam therapy; or

ii. Movement of the gantry stops during moving beam therapy unless such stoppage is a preplanned function.

G. Moving beam therapy shall be controlled to obtain the selected relationships between incremental dose monitor units and incremental angle of movement.

i. For new equipment, an interlock system shall be provided to terminate irradiation if the number of dose monitor units delivered in any ten (10) degrees of arc differs by more than twenty (20%) percent from the selected value.

ii. For new equipment, where gantry angle terminates the irradiation in arc therapy, the dose monitor units shall differ by less than five (5%) percent from the value calculated from the absorbed dose per unit angle relationship.

H. Where the dose monitor system terminates the irradiation in arc therapy, the termination of irradiation shall be as required by RH-1608.b.9.

16. Absorbed dose rate.

For new equipment, a system shall be provided from whose readings the absorbed dose rate at a reference point in the treatment volume can be calculated.12/ In addition:

A. The quotient of the number of dose monitor units by time shall be displayed at the treatment control panel.

B. If the equipment can deliver under any conditions an absorbed dose rate at the normal treatment distance more than twice the maximum value specified by the manufacturer's anticipated dose rate for any machine parameters utilized, a device shall be provided which terminates irradiation when the absorbed dose rate exceeds a value twice the specified maximum. The value at which the irradiation will be terminated shall be a record maintained by the licensee.

17. Location of focal spot and beam orientation.

The licensee shall determine, or obtain from the manufacturer, the location with reference to an accessible point on the radiation head of:

A. The x-ray target or the virtual source of x-rays.

B. The electron window or the scattering foil.

C. All possible orientations of the useful beam.

18. System checking facilities. Capabilities shall be provided so that all radiation safety interlocks can be checked. When pre-selection of any of the operating conditions requires action in the treatment room and/or at the treatment control panel, selection at one location shall not give a display at the other location until the requisite selected operations in both locations have been completed.

19. Shadow trays shall be designed such that the skin entrance dose due to electrons produced within the shadow tray are minimized.

c. Facility and Shielding Requirements. In addition to Section 3, the following design requirements shall apply:

1. Except for entrance doors or beam interceptors, all the required barriers shall be fixed barriers.

2. The treatment control panel shall be located outside the treatment room.

3. Windows, mirrors, close-circuit television, or other equivalent viewing systems shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator may observe the patient from the treatment control panel. When the viewing system is by electronic means (e.g., television), an alternate viewing system shall be provided for use in the event of failure of the primary system.

4. Provision shall be made for two-way aural communication between the patient and the operator at the treatment control panel. However, where excessive noise levels makes aural communications impractical, other methods of communications shall be used.

5. Treatment rooms to which access is possible through more than one entrance shall be provided with warning lights, which will indicate when the useful beam is "on" in a readily observable position near the outside of all access doors.

6. Interlocks shall be provided such that all entrance doors shall be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall be possible to restore the machine to operation only by closing the door and reinitiating exposure by manual action at the control panel.

A. A licensee shall install in each treatment room a permanent radiation monitor capable of continuously monitoring beam status.

B. Each radiation monitor must be capable of providing visible notice of a therapy unit malfunction that results in failure to terminate the useful beam. The visible indicator of high radiation levels must be observable by an individual entering the treatment room.

C. Each radiation monitor must be equipped with an emergency power supply separate from the power supply to the therapy unit. This emergency power supply may be a battery system.

D. Each radiation monitor must be checked for proper operation each day before the therapy unit is used for treatment of patients.

E. A licensee shall maintain a record of the check required by Paragraph D of this Section for two (2) years. The record must include the date of the check, notation that the monitor indicates when the useful beam is "off" and "on" and the initials of the individual who performed the check.

F. If a radiation monitor is inoperable for any reason, the licensee shall require any individual entering the treatment room to use a survey instrument or audible alarm personal dosimeter to monitor for any malfunction of the unit that may result in failure to terminate the useful beam. The instrument or dosimeter must be checked for proper operation at the beginning of each day of use.

G. A licensee shall promptly repair or replace the radiation monitor if it is inoperable.

d. Surveys, Calibrations, Spot Checks, and Operating Procedures.

1. Survey.

A. All new facilities and existing facilities not previously surveyed, shall have a survey made by, or under the direction of, a qualified expert. Such surveys shall also be done after any change in the facility or equipment which might cause a significant increase in radiation hazard.

B. The licensee shall obtain a written report of the survey from the qualified expert and a copy of the report shall be transmitted by the licensee to the Department within thirty (30) days of receipt of the report.

C. The survey and report shall indicate all instances where the installation, in the opinion of the qualified expert, is in violation of applicable regulations and shall cite the Section violated.

2. Calibrations.

A. The full calibration of systems subject to RH-1608. shall be performed in accordance with an established calibration protocol13/ before the system is first used for irradiation of a patient and thereafter at time intervals which do not exceed twelve (12) months and after any change which might significantly alter the calibration, spatial distribution or other characteristics of the therapy beam.

B. The full calibration shall be performed under the direct supervision of a qualified expert.

C. Calibration of the dose equivalent of the therapy beam shall be performed with a dosimeter system.

i. Having a calibration factor for Cobalt-60 gamma rays traceable to a national standard;

ii. Which has been calibrated within the previous two (2) years and after any servicing that may have affected its calibration;

iii. Which has been calibrated in such a fashion that an uncertainty can be stated for the radiation quantities monitored by the system; and

iv. Which has had constancy checks performed on the system as specified by a radiological physicist.

D. Calibrations made pursuant to RH-1608.d.2. shall be such that the dose at a reference point in soft tissue can be calculated with plus or minus five (+ 5%) percent.

E. The calibration of the therapy beam shall include but not be limited to the following determinations:

i. Verification that the equipment is operating in compliance with the design specifications concerning the light localizer, the side light and back-pointer alignment with the isocenter, when applicable, variation in the axis of rotation for the table, gantry and jaw system and beam flatness and symmetry at specified depths.

ii. The absorbed dose rate at various depths of water for the range of field sizes used, for each effective energy, that will verify the accuracy of the dosimetry of all therapy procedures utilized with that therapy beam.

iii. The congruence between the radiation field and the field indicated by the localizing device.

iv. The uniformity of the radiation field and its dependency upon the direction of the useful beam.

v. The calibration determinations above shall be provided in sufficient detail such that the absorbed dose to tissue in the useful beam may be calculated to within plus or minus five (+ 5%) percent.

vi. Verification of depth-dose data and isodose curves applicable to the specific machine continue to be valid or are updated to existing machine conditions.

vii. Verification of the applicability of transmission factors of all accessories such as wedges, shadow trays, compensators; and their effects on electron buildup.

F. Records of the calibration performed pursuant to RH-1608.d.2.A. shall be maintained by the licensee for five (5) years after completion of the calibration.

G. A copy of the latest calibration performed pursuant to RH-1608.d.2.A. shall be available for use by the operator at the treatment control panel.

3. Spot checks.

Spot checks shall be performed on systems subject to RH-1608. during full calibrations and thereafter at intervals not to exceed one (1) month.

NOTE: Spot checks shall include absorbed dose

measurements at a minimum of two (2) depths in a phantom at intervals not to exceed one (1) month. Such spot checks shall meet the following requirements:

A. The spot check procedures shall be in writing and shall have been developed by a qualified expert. A copy of the procedure shall be submitted to the Department prior to its implementation.

B. The measurements taken during spot checks shall demonstrate the degree of consistency of the operating characteristics which can affect the radiation output of the system or the radiation delivered to a patient during a therapy procedure.

C. If a qualified expert does not perform the spot-check measurements, these measurements shall be reviewed by a qualified expert within fifteen (15) days.

D. The spot check procedures shall specify the acceptable tolerance for each parameter measured in the spot check when compared to the value for that parameter determined in the full calibration.

E. For systems in which beam quality can vary significantly, spot checks shall include quality checks.

F. Where a system has built-in devices which provide a measurement of any parameter during irradiation, such measurement shall not be utilized as a spot check measurement.

G. Where a system has built-in devices which provide a self-check of any parameter during irradiation, the spot check procedures shall require that the parameter be independently verified at specific time intervals.

H. The reasons for spot checks which are erratic or inconsistent with calibration data shall be promptly investigated and corrected before the system is used for patient irradiation.

I. Whenever a spot check indicates a significant change, as specified in the qualified expert's spot check procedures, in the operating characteristics of a system, the system shall be recalibrated as required in RH-1608.d.2.

J. Records of spot-check measurements performed pursuant to RH-1608.d.3. shall be maintained by the licensee for a period of two (2) years.

K. Where a spot check involves a radiation measurement, such measurement shall be obtained using an instrument satisfying the requirements of RH-1608.d.2.C. or which as been inter-compared with an instrument meeting those requirements within the previous year.

4. Operating procedures.

A. No individual other than the patient shall be in the treatment room during treatment of a patient.

B. If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used.

C. The system shall not be used in the administration radiation therapy unless RH-1608.d.1., 2. and 3. have been met.

RH-1609. Veterinary Medicine.

a. Equipment.

1. The protective tube housing shall be equivalent to general x-ray tube.

2. Diaphragms or cones shall be provided for collimating the useful beam to the area of clinical interest and shall provide the same degree of protection as is required of the housing.

3. The total filtration permanently in the useful beam shall not be less than 0.5 millimeters aluminum equivalent for machines operating up to 50 kVp, 1.5 millimeters aluminum equivalent for machines operating between 50 and 70kVp, and 2.5 millimeters aluminum equivalent for machines operating above 70 kVp.

b. Operator protection.

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.

c. Operating procedures.

1. No individual other than the operator shall be in the x-ray room while exposures are being made unless such individual's assistance is required, and

2. The operator shall stand behind the protective barrier of nine (9) feet from the useful beam and the animal during radiographic exposures, or

3. When an animal must be held in position during radiography, mechanical supporting or restraining devices should be used. If the animal must be held by an individual, that individual shall be protected with appropriate shielding devices, such as protective gloves and apron, and shall be so positioned that no part of the holder's body will be struck by the useful beam. The exposure of any individual used for this purpose shall be monitored.

RH-1610. Mammography Systems.

a. Definitions.

1. Accreditation body or body means - an entity that has been approved by FDA accredit mammography facilities.

2. Action limits or action levels means - 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.

3. Air kerma means - 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 ® of exposure.

4. Breast implant means - a prosthetic device implanted in the breast.

5. Calendar quarter means - 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.

6. Category I means - medical educational activities that have been designed 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.

7. Certificate means - the certificate described in 21 CFR Part 900 the Quality Mammography Standards; Final Rule section 900.11(a).

8. Certification means - the process of approval of a facility by FDA to provide mammography services.

9. Clinical image means - a mammogram.

10. Consumer means - 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).

11. Continuing education unit or continuing education credit means -one (1) contact hour of training of training.

12. Contact hour means - an hour of training received through direct instruction.

13. 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.

14. Direct instruction means - 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).

15. Direct Supervision of Interpreting Physicians means - that: 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.

16. Direct Supervision of Radiologic Technologists means - that: 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.

17. Established operating level means - the value of a particular quality assurance parameter that has been established as an acceptable normal level by the facility's quality assurance program.

18. Facility means - 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.

19. FDA means - the Food and Drug Administration.

20. First allowable time means - 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.

21. Interim regulations means - 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.

22. Interpreting physician means - a licensed physician who interprets mammograms and who meets the requirements set forth in 21 CFR Part 900 the Quality Mammography Standards; Final rule section 900.12(a)(1).

23. Kerma means - the sum of the initial energies of all the charged particles liberated by uncharged ionizing particles in a material of given mass.

24. Laterality means - the designation of either the right or left breast.

25. Lead interpreting physician means - the interpreting physician assigned the general responsibility for ensuring that a facility's quality assurance program meets all of the requirements of 21 CFR Parts 16 and 900 the Quality Mammography Standards; Final Rule section 900.12(d) through (f). The administrative title and other supervisory responsibilities of the individual, if any, are left to the discretion of the facility.

26. Mammogram means - a radiographic image produced through mammography.

27. Mammographic Modality means - a technology, within the scope of 42 U.S.C. 263b, for radiography of the breast. Examples are screen-film mammography and digital mammography.

28. Mammography means - 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.

29. Mammography equipment evaluation means - 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 in 21 CFR Part 900 the Quality Mammography Standards; Final Rule section 900.12(b) and (e).

30. Mammography medical outcomes audit means - a systematic collection of mammography results and the comparison of those results with outcomes data.

31. Mammography unit or units means - 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.

32. Mean optical density means - 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.

33. Medical physicist means - 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 21 CFR Part 900 the Quality Mammography Standards; Final Rule section 900.12(a)(3).

34. MQSA means - the Mammography Quality Standards Act.

35. Multi-reading means - two (2) or more physicians, at least one (1) of whom is an interpreting physician, interpreting the same mammogram.

36. Patient means - any individual who undergoes a mammography evaluation in a facility, regardless of whether the person is referred by a physician or is self-referred.

37. Phantom means - a test object used to simulate radiographic characteristics of compressed breast tissue and containing components that radiographically model aspects of breast disease and cancer.

38. Phantom image means - a radiographic image of a phantom.

39. Physical science means - physics, chemistry, radiation science (including medical physics and health physics), and engineering.

40. Positive mammogram means - a mammogram that has an overall assessment of findings that are either "suspicious" or "highly suggestive of malignancy."

41. Provisional certificate means - the provisional certificate described in section 900.11(b)(2).

42. Qualified instructor means - 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 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

43. Quality control technologist means - an individual meeting the requirements of 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.

44. Radiographic equipment means - x-ray equipment used for the production of static x-ray images.

45. Radiologic technologist means - 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 section 900.12(a)(2).

46. Review physician means - a physician who, by meeting the requirements set out in Section 900.4(c)(5), is qualified to review clinical images on behalf of the accreditation body.

47. 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.

48. Serious adverse event means - 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.

49. Serious compliant means - a report of a serious adverse event.

50. Standard breast means - a 4.2 centimeter (cm) thick compressed breast consisting of fifth (50%) percent glandular and fifty (50%) percent adipose tissue.

51. Survey means - an onsite physics consultation and evaluation of a facility quality assurance program performed by a medical physicist.

52. Time cycle means - the film development time.

53. Traceable to a national standard means - 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 (+/- 3) percent of the national standard in the mammography energy range.

b. Accreditation

1. All facilities performing screening or diagnostic mammography shall be accredited every three (3) years by the Arkansas Department of Health and Human Services or the American College of Radiology. Such accreditation shall in accordance with Food and Drug Administration (FDA) Mammography Quality Standards 21 CFR Parts 16 and 900 the Quality Mammography Standards; Final Rule.

2. No mammography shall be performed in an unaccredited facility after January 1, 1990. The owners of any unaccredited facility where in mammography is performed after January 1, 1990 shall be subject to a civil penalty imposed by the Arkansas Department of Health and Human Services in an amount not to exceed one hundred dollars ($100) for each day the facility operates without accreditation by the Department.

c. Quality Standards.

1. Personnel. The following requirements apply to personnel involved in any aspect of mammography, including production, processing, and interpretation of mammograms and related quality assurance activities.

A. Interpreting Physicians. Interpreting Physicians shall meet the minimum requirements of 21 CFR Part 900.12(a)(1) of the Food and Drug Administration's Quality Mammography Standards; Final Rule.

B. Radiological Technologist.

i. Radiological Technologists shall meet the minimum requirements of 21 CFR Part 900.12.(a)(2) of the Food and Drug Administration (FDA) Quality Mammography Standards; Final Rule.

ii. Licensed by the State of Arkansas as a Registered

Radiologic Technologist.

C. Mammography Imaging Medical Physicist.

i. Mammography Imaging Medical Physicists shall meet the minimum requirements of 21 CFR Part 900.12.(a)(3) of the Quality Mammography Standards; Final Rule.

ii. All Mammography Imaging Medical Physicists must be registered with the State as a vendor as required by RH-34.

2. Medical Physicist's Survey Requirements.

A. Medical Physicist's Surveys must be performed at least annually.

B. A Mammography Medical Physicist who meets the qualification requirements of RH-1610.c.1.C. must sign all physicist survey reports.

C. Mammography Medical Physicists who sign a facility survey report must have been present in that facility during the survey.

D. Medical Physicist's Surveys must meet the requirements of the Food and Drug Administration (FDA) 21 CFR Part 900.12(e)(9).

3. Obtaining and preserving records.

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 the Food and Drug Administration (FDA) 21 CFR Part 900.12(c).

4. Equipment. The equipment used to perform mammography should be specifically designed for mammography and must meet the following standards:

A. Food and Drug Administration (FDA) Standards Quality Mammography Standards; Final Rule: 21 CFR Part 900.12(b).

B. Food and Drug Administration (FDA) Standards. Certified 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.

C. Focal spot size. The measured focal spot size of the x-ray tube should not exceed 0.7 mm.

D. Control panel indicators. 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.

E. All mammography units must be registered with the State of Arkansas as required by RH-21.

F. Mammography equipment evaluations. All variable parameters of the equipment must be evaluated and adjusted as needed to comply with the Food and Drug Administration (FDA) Quality Mammography Standards; Final Rule 21 CFR Part 900.12(e)(10). This includes but is not limited to the following:

i. When the equipment is installed;

ii. After any major changes or replacement of parts;

iii. When quality assurance tests indicate that calibration or other maintenance is needed;

iv. When equipment is disassembled and reassembled.

5 Safety standards. 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.

A. Safety precautions. Proper safety precautions must be maintained. This includes adequate shielding for patients, personnel, and facilities. The equipment must be operable only form a shielded position.

B. Exposure badges. Personnel operating the equipment must be monitored in accordance with RH-1301. and RH-1302.

C. Equipment inspection. 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.

D. Protection against electrical hazards. All equipment must be shockproof and grounded.

6. Quality assurance. Each facility must establish and maintain a quality assurance program that meets the requirements of 21 CFR Part 900.12(d) of the Food and Drug Administration (FDA) Quality Mammography Standards; Final Rule.

A. Responsibilities for the Lead Interpreting Physician. The Lead interpreting physician has the following responsibility:

i. Ensuring that the facility's quality assurance program meets all the requirements of 21 CFR Part 900.12(d) Food and Drug Administration (FDA) Quality Mammography Standards; Final Rule.

B. Responsibilities for the Mammography Medical Physicist. 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:

i. The duties outlined in 21 CFR Part 900.12 (d)(iii) of the Food and Drug Administration (FDA) Quality Mammography Standards; Final Rule.

ii. Conducting or training others to conduct equipment performance monitoring functions;

iii. Analyzing the monitoring results to determine if there are any problems requiring correction; and

iv. Carrying out or arranging for the necessary corrective actions as well as for the calibrations and other preventive maintenance.

v. Conduct an annual survey of the facility's equipment quality assurance program as required by the Food and Drug Administration (FDA) Quality Mammography Standards; Final Rule 21 CFR Part 900.12(e)(10).

vi. Submit a written report describing the results of the survey as required by the Food and Drug Administration Quality Mammography Standards; Final Rule 21 CFR Part 900.12(e)(9)(iii).

C. Responsibilities of the Quality Control Technologist. 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.

D. Quality Assurance. The facility must ensure the quality of mammography by maintaining a quality assurance program that meets the requirements of the Food and Drug Administration (FDA) Quality Mammography Standards; Final Rule 21 CFR Part 900.12(e) and verifying that the action limits described in Part 900.12(e) have been met. These tests and their frequencies are as follows

i. Daily: processor Performance tests, which includes assessment of base plus fog density, mid-density, and density difference.

ii. Weekly: image quality evaluation test using a FDA

approved phantom.

iii. Quarterly: fixer retention in film test, repeat film analysis.

iv. Semi-annually: dark room fog evaluation, screen film contact test and compression device evaluation.

v. Annual testing: 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.

vi. Mobile Units. 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 this section. 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.

vii. Quality control tests - other modalities. 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 Food and Drug Administration (FDA) 21 CFR Part 900.12 (e)(5)(vi).

viii. The facility shall establish and implement adequate protocols for maintaining darkroom, screen, and view box cleanliness and shall document that all cleaning procedures are performed at the frequencies specified in the protocols.

ix. Infection control. 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 of the Food and Drug Administration (FDA) Quality Mammography Standards; Final Rule 21 CFR Part 900.12(e)(13).

E. Evaluation of monitoring results. 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 the Food and Drug Administration (FDA) Quality Mammography Standards; Final Rule 21 CFR Part 900.12(e)(8). The responsible individuals are limited to the Lead Interpreting Physician, the Medical Physicist and the Quality Control Technologist.

F. Medical Outcomes Audit. 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 the Food an Drug Administration (FDA) Quality Mammography Standards; Final Rule 21 CFR Part 900.12(f).

G. Procedures and Techniques for Mammography of patients with breast implants. Each facility must have procedures, which specify techniques, and procedures for imaging patients with breast implants. These procedures must comply with the Food and rug Administration (FDA) Quality Mammography Standards; Final Rule 21 CFR Part 900.12(g).

H. Consumer Complaint Mechanism. Each facility must have a consumer complaint mechanism. This mechanism must comply with the Food and Drug Administration (FDA) Quality Mammography Standards; Final Rule 21 CFR Part 900.12(h).

7. Standards For Diagnostic Mammography. Facilities who wish to be accredited for diagnostic mammography shall, in addition to meeting all of the requirements for mammography also:

A. Have the interpreting physician as defined in RH-1610.c.1.A. present during all diagnostic mammography for direct supervision of the exam and film interpretation.

B. Have mammography systems with cone down compression and magnification capabilities, to enhance film interpretation.

d. Applications and Fees. 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.

e. Additional Review and Patient Notification

1. When quality assurance tests indicate that calibration is needed, 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.

2. If the Department determines that any activity related to the 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.

f. Retention of Personnel Records. 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.

g. Quality Assurance Record Keeping. All quality assurance record keeping shall meet the requirements of the Food and Drug Administration (FDA) Quality Mammography Standards; Final Rule 21 CFR Part 900.12(d)(2): 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, and protection 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 this section 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.

h. Clinical Image Quality. 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.

RH-1611. Bone Densitometry

a. Bone densitometry systems shall be:

1. Certified by the U.S. Department of Health and Human Services

2. Registered in accordance with these regulations; and

3. Maintained and operated in accordance with the manufacturer's specifications.

b. Operators of bone densitometry systems shall be:

1. Licensed, certified, or permitted as a radiologic technologist by the Department; or

2. Licensed as a practitioner of the healing arts; or

3. Permitted or approved by the Department as a bone densitometry operator.

c. During the operation of any bone densitometry system:

1. The operator, ancillary personnel, and members of the general public shall be positioned at least one meter from the patient and bone densitometry system during the examination.

2. The operator shall advise the patient the bone densitometry examination is a type of x-ray procedure.

d. The registrant shall keep maintenance records for bone densitometry systems as prescribed. These records shall be maintained for inspection by the Department recordkeeping timelines as appropriate.

e. Bone densitometry on human patients shall be conducted only:

1. Under a prescription of a licensed practitioner of the healing arts; or

2. Under a screening program approved by the Department.

f. Any person proposing to conduct a bone densitometry screening program shall submit the information outlined in Schedule A of this Part with the exception of g, h, i, j, k, and m, and include the name and address of the individual who will interpret the screening results.

Schedule A

INFORMATION TO BE SUBMITTED BY PERSONS

PROPOSING TO CONDUCT HEALING ARTS SCREENING

Persons requesting that the Agency approve a healing arts screening program shall submit the following information and evaluation:

a. Name and address of the applicant and, where applicable, the names and addresses of agents within this State;

b. Diseases or conditions for which the x-ray examinations are to used in diagnoses;

c. A detailed description of the x-ray examinations proposed in the screening program;

d. Description of the population to be examined in the screening program, i.e., age, sex, physical condition, and other appropriate information;

e. An evaluation of any known alternate methods not involving ionizing radiation which could achieve the goals of the screening program and why these methods are not used instead of the x-ray examinations;

f. An evaluation by a qualified expert of the x-ray system(s) to be used in the screening program. The evaluation by the qualified expert shall show that such system(s) do satisfy all requirements of these regulations. The evaluation shall include a measurement of patient exposures from the x-ray examinations to be performed;

g. A description of the diagnostic x-ray quality control program;

h. A copy of the technique chart for the x-ray examination procedures to be used;

i. The qualifications of each individual who will be operating the x-ray system(s);

j. The qualifications of the individual who will be supervising the operators of the x-ray system(s). The extent of supervision and the method of work performance evaluation shall be specified;

k. The name and address of the individual who will interpret the radiograph(s);

l. A description of the procedures to be used in advising the individual screening procedure and any further medical needs indicated;

m. A description of the procedures for the retention or disposition of the radiographs and other records pertaining to the x-ray examinations;

n. An indication of the frequency of screening and the duration of the entire screening program.

PART G. RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT

RH-1612. Scope and Purpose.

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.

a. Definitions.

1. Analytical x-ray equipment - X-Ray equipment used for x-ray diffraction fluorescence analysis or spectroscopy.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

b. Equipment Requirements.

1. Safety device. 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:

A. A description of the various safety devices that have been evaluated;

B. The reason each of these devices cannot be used; and

C. A description of the alternative methods that will be employed to minimize the possibility of an accidental exposure, including procedures to assure that operators and others in the area will be informed of the absence of safety devices.

2. Warning devices.

A. Open-beam configurations shall be provided with a readily discernible indication of:

B. X-ray tube status (ON-OFF) located near the radiation source housing, if the primary beam is controlled in this manner and/or;

C. Shutter status (OPEN-CLOSED) located near each port on the radiation source housings, if the primary beam is controlled in this manner.

E. Warning devices shall be labeled so that their purpose is easily identified. On equipment installed after January 1,1979, warning devices shall have fail-safe characteristics.

E. Ports. Unused ports on radiation machine source housings shall be secured in the closed position in a manner which will prevent casual opening.

F. Labeling. All analytical x-ray equipment shall be labeled with a readily discernible sign or signs bearing the radiation symbol and the words:

i. "CAUTION - HIGH INTENSITY X-RAY

BEAM", or words having a similar intent, on the x-ray source housing; and .

ii. "CAUTION RADIATION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED," or words having a similar intent, near any switch that energizes an x-ray tube.

G. Shutters.

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.

H. Warning lights.

i. An easily visible warning light labeled with the words "X-RAY ON," or words having a similar intent, shall be located near any switch that energizes an x-ray tube and shall be illuminated only when the tube is energized.

ii. On equipment installed after January 1, 1979, warning lights shall have fail-safe characteristics.

I Radiation source housing.

Each radiation source housing shall be subject to the following requirements:

i. Each x-ray tube housing shall be equipped with an interlock that shuts off the tube if it is removed from the radiation source housing or if the housing is disassembled.

J. Generator cabinet.

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.

K. Area Requirements.

1. Radiation levels. 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.

L. Surveys.

1. Radiation surveys, as required by RH-1300., of all analytical x-ray systems sufficient to show compliance with RH-1612.a. shall be performed:

(a) . Upon installation of the equipment;

(b) . Following any change in the initial arrangement, number or type of local components in the system;

(d) . During the performance of maintenance and 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;

(e) . Any time a visual inspection of the local components in the system reveals an abnormal condition; and

(f) . Whenever personnel monitoring devices show a significant increase over the previous monitoring period or the readings are approaching the limits specified in RH-1200.

2. Radiation survey measurements shall not be required if a registrant can demonstrate compliance to the satisfaction of the Department with RH-1612.a. in some other manner.

3. Posting. 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.

M. Operating Requirements.

1. Procedures.

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.

2. Bypassing.

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.

3. Repair or modification of x-ray tube systems.

Except as specified in RH-1612.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.

N. Personnel Requirements.

1. Instruction.

(a) . No person shall be permitted to operate or maintain analytical x-ray equipment unless such person has received instruction in and demonstrated competence as to:

(b) . Identification of radiation hazards associated with the use of the equipment;

(c) . Significance of the various radiation warning and 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;

(d) . Proper operating procedures for the equipment;

(e) . Symptoms of an acute localized exposure; and

(f) . Proper procedures for reporting an actual or suspected exposure.

2. Personnel monitoring.

A. Finger or wrist dosimetric devices shall be provided to and shall be used by:

i. Analytical x-ray equipment workers using systems having an open-beam configuration and not equipped with a safety device; and .

ii. Personnel maintaining analytical x-ray equipment if 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.

B. Reported dose values shall not be used for the purpose of determining compliance with RH-1200. and RH-1208. unless evaluated by a qualified expert.

RH-1613. Computed Tomography

a. Definitions.

1. "Computed tomography dose index," - means 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.

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.

2. "Contrast scale" - means the change in the linear attenuation coefficient per CTN relative to water, that is:

CTNx = of the material of interest. CTNw = of water.

3. "CT conditions of operation" - means 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.

4. "CT gantry" - means the tube housing assemblies, beam-limiting devices, detectors, and the supporting structures and frames that hold these components.

5. "CT number" - means the number used to represent the x-ray attenuation associated with each elemental area of the CT image.

k (ux - Uw) CTN = |j,w

Where: k = A constant, a normal value of 1,000 when the Houndsfield scale of CTN is used;

Linear attenuation coefficient of the material of interest;

|j,w = Linear attenuation coefficient of water.

6. "Dose profile" - means the dose as a function of position along a line.

7. "Elemental area" - means the smallest area within a tomogram for which the x-ray attenuation properties of a body are depicted (see also "Picture element").

8. "Multiple tomogram system" - means a computed tomography x-ray system that obtains x-ray transmission data simultaneously during a single scan to produce more than one tomogram.

9. "Noise" - means the standard deviation of the fluctuation in CTN expressed as a percentage of the attenuation coefficient of water. Its estimate (Ss) is calculated using the following expression:

Click here to view image

Where: CS = Linear attenuation coefficient of the material of interest.

|j,w = Linear attenuation coefficient of water. s = Standard deviation of the CTN of picture elements in a specified area of the CT image.

10. "Nominal tomographic section thickness" - means 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.

11. "Picture element" - means an elemental area of a tomogram.

12. "Reference plane" - means a plane that is displaced from and parallel to the tomographic plane.

13. "Scan" - means 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.

14. "Scan increment - means 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.

15. "Scan sequence" - means a pre-selected set of two or more scans performed consecutively under pre-selected CT conditions of operation.

16. "Scan time" - means the period of time between the beginning and end of x-ray transmission data accumulation for a single scan.

17. "Single tomogram system" - means a CT x-ray system that obtains x-ray transmission data during a scan to produce a single tomogram.

18. "Tomographic plane" - means that geometric plane which is identified as corresponding to the output tomogram.

19. "Tomographic section" - means the volume of an object whose x-ray attenuation properties are imaged in a tomogram.

b. Requirements for equipment.

1. Termination of exposure.

A. Means shall be provided to terminate the x-ray exposure automatically by either de-energizing the x-ray source or shuttering the x-ray beam in the event of equipment failure affecting data collection. Such termination shall occur within an interval that limits the total scan time to no more than 110 percent of its preset value through the use of either a backup timer or devices which monitor equipment function.

B. A visible signal shall indicate when the x-ray exposure has been terminated

C. The operator shall be able to terminate the x-ray exposure at any time during a scan, or series of scans under CT x-ray system control, of greater than one-half second duration.

2. Tomographic plane indication and alignment.

A. For any single tomogram system, means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane.

B. For any multiple tomogram system, means shall be provided to permit visual determination of the location of a reference plane. This reference plane can be offset from the location of the tomographic planes.

C. If a device is using a light source, the light source shall provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to 500 lux.

3. Beam-on and shutter status indicators and control switches.

A. The CT x-ray control and gantry shall provide visual indication whenever x-rays are produced and, if applicable, whether the shutter is open or closed.

B. Each emergency button or switch shall be clearly labeled as to its function.

4. Indication of CT conditions of operation.

A. The CT x-ray system shall be designed such that the CT

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.

B. Extraneous radiation. 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.

C Maximum surface Computed Tomography Dose Index (CTDI) identification. The angular position where the maximum surface CTDI occurs shall be identified to allow for reproducible positioning of a CT dosimetry phantom.

5. Additional requirements applicable to CT x-ray systems containing a gantry manufactured after September 3, 1985.

A. The total error in the indicated location of the tomographic plane or reference plane shall not exceed five (5) millimeters.

B. If the x-ray production period is less than one-half second, the indication of x-ray production shall be actuated for at least one-half second. Indicators at or near the gantry shall be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible.

C. The deviation of indicated scan increment versus actual increment shall not exceed plus or minus 1 millimeter with any mass from 0 to 100 kilograms resting on the support device. The patient support device shall be incremented from a typical starting position to the maximum incremented distance or 30 centimeters, whichever is less, and then returned to the starting position. Measurement of actual versus indicated scan increment may be taken anywhere along this travel.

D. Premature termination of the x-ray exposure by the operator shall necessitate resetting of the CT conditions of operation prior to the initiation of another scan.

c. Facility design requirements.

1. Aural communication.

A. Provision shall be made for two-way aural communication between the patient and the operator at the control panel.

2. Viewing systems.

A. Windows, mirrors, closed-circuit television, or an equivalent shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel.

B. When the primary viewing system is by electronic means, an alternate viewing system (which be electronic may) shall be available for use in the event of failure of the primary viewing system.

d. Surveys, calibrations, spot checks, and operating procedures.

1. Surveys.

A. All CT x-ray systems shall have a survey made by, or under the direction of, a qualified expert. In addition, such surveys shall be done after any change in the facility or equipment which might cause a significant increase in radiation hazard.

B. The registrant shall obtain a written report of the survey from the qualified expert, and a copy of the report shall be made available to the Department upon request.

2. Radiation calibrations.

A. The calibration of the radiation output of the CT x-ray system shall be performed by, or under the direction of, a qualified expert who is physically present at the facility during such calibration.

B. The calibration of a CT x-ray system shall be performed at intervals specified by a qualified expert and after any change or replacement of components that, in the opinion of the qualified expert, could cause a change in the radiation output.

C. The calibration of the radiation output of a CT x-ray system shall be performed with a calibrated dosimetry system. The calibration of such system shall be traceable to a national standard. The dosimetry system shall have been calibrated within the preceding two (2) years.

D. CT dosimetry phantom(s) shall be used in determining the radiation output of a CT x-ray system. Such phantom(s) shall meet the following specifications and conditions of use:

i. CT dosimetry phantom(s) shall be right circular 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;

ii. CT dosimetry phantom(s) shall provide means for 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;

iii. Any effects on the doses measured due to the removal of phantom material to accommodate dosimeters shall be accounted for through appropriate corrections to the reported data or included in the statement of maximum deviation for the values obtained using the phantom; and

iv. All dose measurements shall be performed with the CT dosimetry phantom placed on the patient couch or support device without additional attenuation materials present.

E. The calibration shall be required for each type of head, body, or whole-body scan performed at the facility.

F. Calibration shall meet the following requirements:

i. The dose profile along the center axis of the CT

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 thick nesses can be selected, the dose profile determination shall be performed for each available nominal tomographic section thickness;

ii. The CTDI along the two (2) axes shall be measured.

(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.)

G. 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 spot checks shall be made.

H. Calibration procedures shall be in writing. Records of calibrations performed shall be maintained for inspection by the Department.

3. Spot checks.

A. The spot-check procedures shall be in writing and shall have been developed by a qualified expert.

B. The spot-check procedures shall incorporate the use of a CT dosimetry phantom which has a capability of providing an indication of contrast scale, noise, nominal tomographic section thickness, the resolution capability of the system for low and high contrast objects, and measuring the mean CTN for water or other reference material.

C. All spot checks shall be included in the calibration required and at time intervals and under system conditions specified by a qualified expert.

D. Spot checks shall include acquisition of images obtained with the CT dosimetry phantom(s) using the same processing mode and CT conditions of operation as are used to perform calibrations. The images shall be retained, until a new calibration is performed, in two (2) forms as follows:

i. Photographic copies of the images obtained from the image display device; and

ii. Images stored in digital form on a storage medium compatible with the CT x-ray system.

E. Written records of the spot checks performed shall be maintained for inspection by the Department.

4. Operating procedures.

A. The CT x-ray system shall not be operated except by an individual who has been specifically trained in its operation.

B. Information shall be available at the control panel regarding the operation and calibration of the system. Such information shall include the following:

i. Dates of the latest calibration and spot checks and the location within the facility where the results of those tests may be obtained;

ii. Instructions on the use of the CT dosimetry 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;

iii. The distance in millimeters between the 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.

C. If the calibration or spot check of the CT x-ray system identifies that a system operating parameter has exceeded a tolerance established by the qualified expert, use of the CT x-ray system on patients shall be limited to those uses permitted by established written instructions of the qualified expert.

RH-1614. - RH-1699. Reserved.

PART H.SPECIAL REQUIREMENTS FOR THE USE OF SEALED RADIOACTIVE SOURCES IN THE HEALING ARTS

RH-1700. Deleted. Refer to RH-8600. and RH-8630.

RH-1701. Deleted. Refer to RH-8601. through RH-8607.

RH-1702. Deleted. Refer to RH-8630. through RH-8650.

RH-1703. - RH-1799. Reserved.

PART I. RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS

RH-1800. General Provisions.

a. Purpose. The Regulations in this Part establish radiation safety requirements for persons utilizing sources of radiation for industrial radiography. The requirements of this Part are in addition to and not in substitution for other applicable requirements of these Regulations.

b. Scope. The Regulations in this Part apply to all licensees or registrants who use sources of radiation for industrial radiography. Except for the Regulations in this Part clearly applicable only to sealed radioactive sources, both radiation machines and sealed radioactive sources are covered by this Part. The provisions of this Part are not applicable to systems designed exclusively for microscopic examination of material, e.g., x-ray diffraction, spectroscopic and electron microscope equipment or to systems for intentional exposure of humans to x-rays.

c. Definitions. As used in these Regulations. Additional definitions used only in a certain part will be found in that part.

1. 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.

2. 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 Section 3, Part C. PERMISSIBLE DOSES, LEVELS, AND CONCENTRATIONS 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.

3. 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.

4. Aperture - Any opening in the outside surface of the cabinet, other than a port, which remains open during generation of x-radiation.

5. 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.

6. Becquerel (Bq) - One (1) disintegration per second.

7. 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.

8. 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.

9. 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.

10. Certifying Entity - An independent certifying organization meeting the requirements in Appendix "IRC" or an Agreement State meeting the requirements in Appendix "IRC", Parts II and III of this Part.

11. Collimator - A device used to limit the size and direction of 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.

12. Control (drive) cable - The cable that is connected to the source assembly and used to drive the source to and from the exposure location.

13. Control drive mechanism - A device that enables the source assembly to be moved to and from the exposure device.

14. Control tube - A protective sheath for guiding the control cable. The control tube connects the control drive mechanism to the radiographic exposure device.

15. 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.

16. Enclosed radiography - Industrial radiography conducted in an enclosed cabinet or room and includes cabinet radiography, cabinet x-ray systems and shielded room radiography.

17. 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).

18. 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.

19. Field station - A facility where licensed material or registered x-ray equipment may be stored or used and from which equipment is dispatched.

20. Floor - The underside external surface of the cabinet.

21. 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.

22. Ground fault - An accidental electrical grounding of an electrical conductor.

23. 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 and to the exposure head. The guide tube may also include the connections necessary for attachment to the exposure device and to the exposure head.

24. Hands-on experience - Experience in all of those areas considered to be directly involved in the radiography process.

25. Independent Certifying Organization - An independent organization that meets all the criteria of Appendix "IRC".

26. Industrial radiography (radiography) - An examination of the structure of materials by non-destructive methods, utilizing ionizing radiation to make radiographic images.

27. Lay-barge radiography - Industrial radiography performed on any water vessel used for laying pipe.

28. Offshore platform radiography - Industrial radiography performed from a platform over a body of water.

29. Permanent radiographic installation - An enclosed shielded room, cell, or vault, not located at a temporary jobsite, in which radiography is performed.

30. Personal supervision - Supervision such that the supervisor is physically present at the radiography site and in such proximity that contact can be maintained and immediate assistance given as required.

31. 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.

32. Practical Examination - A demonstration through practical application of the safety rules and principles in industrial radiography including use of all appropriate equipment and procedures.

33. Primary beam - The x-radiation emitted directly from the target and passing through the window of the x-ray tube.

34. 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.

35. 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.

36. Radiographer's assistant - Any individual who, under the direct supervision of a radiographer, uses radiographic exposure devices, sealed sources or related handling tools, or radiation survey instrumentation in industrial radiography.

37. Radiographer certification - Written approval received from a certifying entity stating that an individual has satisfactorily met certain established radiation safety, testing, and experience criteria.

38. Radiographer instructor - Any radiographer who has been listed on a specific license from the Department and meeting the requirements of RH-1803.f.5.

39. 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.

40. Radiographic operations - All activities associated with the presence of radioactive sources in a radiographic exposure device or x-ray equipment during use of the device or transport (except when being transported by a common or contract transport), to include surveys to confirm the adequacy of boundaries, setting up equipment and any activity inside restricted area boundaries.

41. Radiography - The examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive materials.

42. 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.

43. Sealed source - Any radioactive material that is encased in a capsule designed to prevent leakage or escape of the radioactive material.

44. 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 condition for an unrestricted area as specified in RH-1208.

45. Shielded position - The location within the radiographic exposure device or source changer where the sealed source is secured and restricted from movement.

46. 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 (1Sv = 100 rems).

47. 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.

48. 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.

49. S-tube - A tube through which the radioactive source travels when inside a radiographic exposure device.

50. 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.

51. Storage container - A container in which sealed sources are secured and stored.

52. 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.

53. 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.

54. Underwater radiography - Industrial radiography performed when the radiographic exposure device and/or related equipment are beneath the surface of the water.

55. X-ray system - An assemblage of components for the controlled generation of x-rays.

56. X-ray tube - Any electron tube which is designed for the conversion of electrical energy into x-ray energy.

d. Recordkeeping Requirements.

1. Records of the specific license for industrial radiography.

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.

2. Records of receipt and transfer of sealed sources.

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.

3. Records of radiation survey instruments

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.

4. Records of leak testing of sealed sources and devices containing depleted uranium (DU).

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.

5. Records of quarterly inventory.

A. Each licensee shall maintain records of the quarterly inventory of sealed sources and of devices containing depleted uranium (DU) as required by RH-1801.g. and retain each record for three (3) years after it is made.

B. The record must include the date of the inventory, name of the individual conducting the inventory, radionuclide, number of curies (becquerels) or mass (for DU) in each device, location of sealed source and/or devices, and manufacturer, model, and serial number of each sealed source and/or device, as appropriate.

6. Utilization Logs

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.

B. The licensee or registrant shall retain the logs required by RH-1800.d.6.i.for three (3) years after the log is made.

7. Records of inspection and maintenance of radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments.

A. Each licensee or registrant shall maintain records specified in RH-1801.i. of equipment problems found in daily checks and quarterly inspections of radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments; and retain each record for three (3) years after it is made.

B. The record must include the date of the check or inspection, name of the inspector, equipment involved, any problems found, and what repair and/or maintenance, if any, was done.

8. Records of alarm system and entrance control checks at permanent radiographic installation.

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.

9. Records of training and certification.

Each licensee or registrant shall maintain the following records (of training and certification) for three (3) years after the record is made:

A. Records of training of each radiographer and each radiographer's assistant. The record must include radiographer certification documents and verification of certification status, copies of written tests, dates of oral and practical examinations, and names of individuals conducting and receiving the oral and practical examinations; and

B. Records of annual refresher safety training and semi-annual inspections of job performance for each radiographer and each radiographer's assistant. The records must list the topics discussed during the refresher safety training, the dates the annual refresher safety training was conducted, and the names of the instructors and attendees. For inspections of job performance, the records must also include a list showing the items checked and any non-compliances observed by the Radiation Safety Officer (RSO).

10. Copies of Operating and Emergency Procedures.

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.

11. Records of Personnel Monitoring Procedures.

Each licensee or registrant shall maintain the following exposure records specified in RH-1802.f.

A. Direct reading dosimeter readings and yearly operability checks required by RH-1802.f.2. and f.3. for three (3) years after the record is made.

B. Records of alarm ratemeter calibrations for three (3) years after the record is made.

C. Personnel dosimeter results received from the accredited NVLAP processor until the Department terminates the license or registration.

D. Records of estimates of exposures as a result of: off-scale personal direct reading dosimeters, or lost or damaged personnel dosimeters until the Department terminates the license or registration.

12. Records of Radiation Surveys.

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.

13. Form of Records.

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.

14. Location of documents and records.

i. Each licensee or registrant shall maintain copies of records required by RH-1800.d. and other applicable regulations at the location specified in the licensee's license application.

ii. Each licensee or registrant shall also maintain copies of the following documents and records sufficient to demonstrate compliance at each applicable field station and each temporary jobsite:

A. The license or certificate of registration authorizing the use of licensed material or x-ray equipment;

B. A current copy of the Arkansas Rules and Regulations for Control of Sources of Ionizing Radiation

C. Utilization records for each radiographic exposure device dispatched from that location as required by RH-1800.d.6.

D. Records of equipment problems identified in daily checks of equipment as required by RH-1800.d.7.

E. Records of alarm system and entrance control checks as required by RH-1801.j. if applicable

F. Records of direct reading dosimeters such as pocket dosimeter and/or electronic personal dosimeters readings as required by RH-1800.d.11.

G. Operating and emergency procedures as required by RH-1802.e.

H. Evidence of the latest calibration of the radiation survey instruments in use at the site as required by RH-1801.e.

I. Evidence of the latest calibration of alarm rate-

meters and operability checks of pocket dosimeters and/or electronic personal dosimeters as required by RH-1800.d.11.

J. Latest survey records as required by RH-1803.c.

K. The shipping papers for the transportation of radioactive materials as required by the U.S. Department of Transportation Regulations 49 CFR Parts 170 through 187; and

L. When operating under reciprocity pursuant to

RH-750, a copy of the Agreement State or Nuclear Regulatory Commission license authorizing the use of licensed materials.

RH-1801. Equipment Control.

a. Performance requirements for radiography equipment. Equipment used in industrial radiographic operations must meet the following minimum criteria:

1. Each radiographic exposure device, source assembly or sealed 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 has been approved for incorporation by Radiation Control. This publication may be purchased from the American National Standards Institute, Inc., 1430 Broadway, New York, New York 10018 Telephone (212) 642-4900.

A copy of the document is available for inspection in the office of Arkansas Department of Health and Human Services, Division 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.

2. In addition to the requirements specified in RH-1801.a.1., the following requirements apply to radiographic exposure devices, source changers, source assemblies and sealed sources.

A. The licensee shall ensure that each radiographic exposure device has attached to it by the user a durable, legible, clearly visible label bearing the:

i. Chemical symbol and mass number of the radionuclide in the device;

ii. Activity and the date on which this activity was last measured;

iii. Model number (or product code) and serial number of the sealed source;

iv. Manufacturer's identity of the sealed source; and

v. Licensee's name, address, and telephone number.

B. Radiographic exposure devices intended for use as Type B transport containers must meet the applicable requirements of Section 4, Transportation of Radioactive Materials.

C. Modification of radiographic exposure devices, source changers, source assemblies, and associated equipment is prohibited, unless the design of any replacement component, including the source holder, source assembly, controls or guide tubes would not compromise the design safety features of the system.

3. In addition to the requirements specified in RH-1801.a.1. and 2.,

the following requirements apply to radiographic exposure devices, source assemblies, and associated equipment that allow the source to be moved out of the device for radiographic operation or to source changers.

A. The coupling between the source assembly and the control cable must be designed in such a manner that the source assembly will not become disconnected if cranked outside the guide tube. The coupling must be such that it cannot be unintentionally disconnected under normal and reasonably foreseeable abnormal conditions.

B. The device must automatically secure the source assembly when it is cranked back into the fully shielded position within the device. This securing system may only be released by means of a deliberate operation on the exposure device.

C. The outlet fittings, lock box, and drive cable fittings on each radiographic exposure device must be equipped with safety plugs or covers which must be installed during storage and transportation to protect the source assembly from water, mud, sand, or other foreign matter.

D. Each sealed source or source assembly must have attached to it or engraved on it, a durable, legible, visible label with the words "DANGER - RADIOACTIVE". The label must not interfere with the safe operation of the exposure device or associated equipment.

E. The guide tube must be able to withstand a crushing test that closely approximates the crushing forces that are likely to be encountered during use and be able to withstand a kinking resistance test that closely approximates the kinking forces likely to be encountered during use.

F. Guide tubes must be used when moving the source out of the device.

G. An exposure head or similar device designed to prevent the source assembly from passing out of the end of the guide tube must be attached to the outermost end of the guide tube during industrial radiographic operations.

H. The guide tube exposure head connection must be able to withstand the tensile test for control units specified in ANSI N432- 1980.

I. Source changers must provide a system for ensuring that the source will not be accidentally withdrawn from the changer when connecting or disconnecting the drive cable to or from a source assembly.

4. All radiographic exposure devices and associated equipment in use after January 10, 1996 must comply with the requirements of this Section.

5. Notwithstanding RH-1801.a.1. equipment used in industrial 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.

b. Limits on external radiation levels from storage containers and source

changers.

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.

c. Locking of radiographic exposure devices, storage containers, and source changers.

1. Each radiographic exposure device must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. The exposure device and/or its container must be kept locked (and if a keyed-lock, with the key removed at all times) when not under the direct surveillance of a radiographer or a radiographer's assistant except at permanent radiographic installations as in RH-1803.a. In addition, during radiographic operations the sealed source assembly must be secured in the shielded position each time the source is returned to that position.

2. Each sealed source storage container and source changer must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. Storage containers and source changers must be kept locked (and if a keyed-lock, with the key removed at all times) when containing sealed sources except when under the direct surveillance of a radiographer or a radiographer's assistant.

3. The control panel of each radiation machine shall be equipped with a lock that will prevent the unauthorized use of an x-ray system or the accidental production of radiation. The radiation machine shall be kept locked and the key removed at all times except when under the direct usual surveillance of a radiographer or a radiographer's assistant.

d. Storage precautions.

1. Locked radiographic exposure devices, storage containers and radiation machines shall be physically secured to prevent tampering or removal by unauthorized personnel. The licensee shall store radioactive material in a manner which will minimize danger from explosion or fire.

2. Radiographic exposure devices, source changers, or transport containers that contain radioactive material may not be stored in residential locations. This rule does not apply to storage of radioactive material in a vehicle in transit for use at temporary job sites, if the licensee complies with RH-1801.d.3. and if the vehicle does not constitute a permanent storage location as described in RH-1801.d.4.

3. If a vehicle is to be used for storage of radioactive material, a vehicle survey shall be performed after securing radioactive material in the vehicle and before transport to ensure that radiation levels do not exceed the limits specified in RH-1208. at the exterior surface of the vehicle.

4. A storage or use location is permanent if radioactive material is stored or used at the location for more than ninety (90) days and any one (1) or more of the following applies to the location:

A. Telephone service is established by the licensee;

B. Industrial radiographic services are advertised for or from the location;

C. Industrial radiographic operations are conducted at other sites due to arrangements made from the location.

e. Radiation survey instruments.

1. The licensee or registrant shall keep sufficient calibrated and 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.

2. Instrumentation required by this Part must be capable of measuring a range from two (2) milliroentgens (0.02 millisieverts) per hour through one (1) roentgen (0.01 sievert) per hour.

3. The licensee or registrant shall have each radiation survey instrument required in RH-1801.e.1.calibrated:

A. At intervals not to exceed three (3) months and after each instrument servicing, except for battery changes;

B. For linear scale instruments, at two (2) points located approximately one-third and two-thirds of full-scale; for logarithmic scale instruments, at midrange of each decade and at two (2) points on at least one decade, and for digital instruments at three (3) points between 2 and 1000 millirems (0.02 and 10 millisieverts) per hour; and

C. So that an accuracy within plus or minus twenty (+20%) percent of the calibration source can be demonstrated at each point checked.

4. The licensee shall maintain records of these calibrations in accordance with RH-1800.d.3.

5. Each radiation survey instrument shall be checked with a radiation source at the beginning of each day of use and at the beginning of each work shift to ensure it is operating properly.

f. Leak testing and replacement of sealed sources.

1. The replacement of any sealed source fastened to or contained in a radiographic exposure device and leak testing of any sealed source must be performed only by persons specifically authorized to do so by the Department, the U.S. Nuclear Regulatory Commission, or an Agreement State.

2. The opening, repair, or modification of any sealed source must be performed only by persons specifically authorized to do so by the Department, the U.S. Nuclear Regulatory Commission, or an Agreement State.

3. Testing and recordkeeping requirements.

A. Each licensee who uses a sealed source shall have the source tested for leakage at intervals not to exceed six (6) months. The leak testing of the source must be performed using a method approved by the Department, the U.S. Nuclear Regulatory Commission, or an Agreement State. The wipe sample should 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 microcurie (185 Bq) of radioactive material on the test sample and must be performed by a person specifically authorized by the Department, or designee, the U.S. Nuclear Regulatory Commission, or an Agreement State to perform the analysis.

B. The licensee shall maintain records of the leak tests in accordance with RH-1800.d.4.

C. Unless a sealed source is accompanied by a certificate from the transferor that shows that it has been leak tested within six (6) months before the transfer, it may not be used by the licensee until tested for leakage. Sealed sources that are in storage and not in use do not require leak testing, but must be tested before use or transfer to another person if the interval of storage exceeds six (6) months.

4. Any test conducted pursuant to the requirements of RH-1801.f. which reveals the presence of 0.005 microcurie (185 Bq) or more of removable radio active material must be considered evidence that the sealed source is leaking. The licensee shall immediately withdraw the equipment involved from use and shall cause it to be decontaminated and repaired or disposed of in accordance with Regulations of the Department. A report must be filed with the Department within five (5) days of any test with results that exceed the threshold in this subsection describing the equipment involved, the test results, and the corrective action taken.

5. Each exposure device using depleted uranium (DU) shielding and 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.

g. Quarterly inventory.

1. Each licensee shall conduct a quarterly physical inventory to account for all sealed sources and for devices containing depleted uranium (DU) received and possessed under this license.

2 The licensee shall maintain records of the quarterly inventory in accordance with RH-1800.d.5.

h. Utilization logs. 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:

1. A description, including the make, model and serial number of each radiation machine, each radiographic exposure device or transport or storage container in which a sealed source is located, and each sealed source;

2. The identity and signature of the radiographer to whom assigned;

3. Locations where used and dates of use; and

4. The date(s) each source of radiation is removed from storage and returned to storage.

i. Inspection and maintenance of radiographic exposure devices, transport

and storage containers, associated equipment, source changers, and survey instruments.

1. The licensee or registrant shall perform visual and operability checks on survey meters, radiographic exposure devices, transport and storage containers, associated equipment, source changers, and shutters on x-ray units before use on each day the equipment is used to ensure that the equipment is in good working condition, that the sources are adequately shielded, and that required labeling is present. Survey instrument operability must be performed using check sources or other appropriate means. If equipment problems are found, the equipment must be removed from service until repaired.

2. Each licensee or registrant shall have written procedures for:

A. Inspection and routine maintenance of radiographic exposure devices, source changers, associated equipment, transport and storage containers, and survey instruments at intervals not to exceed three (3) months or before the first use thereafter to ensure the proper functioning of components important to safety. Replacement components shall meet design specifications. If equipment problems are found, the equipment must be removed from service until repaired.

B. Inspection and maintenance necessary to maintain the Type B packaging used to transport radioactive materials. The inspection and maintenance program must include procedures to assure that Type B packages are shipped and maintained in accordance with the certificate of compliance or other approval.

C. Records of equipment problems and of any maintenance performed under RH-1801.i.1.and i.2. must be made in accordance with RH-1800.d.7.

j. Permanent radiographic installations.

1. Each entrance that is used for personnel access to the high radiation area in a permanent radiographic installation must have either:

A An entrance control of the type described in RH-1303.c.2. through 4. 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.

2. The alarm system must be tested for proper operation with a radiation source each day before the installation is used for radiographic operations. The test must include a check of both the visible and audible signals. Entrance control devices that reduce the radiation level upon entry (designated in RH-1801.j.A.(1)) must be tested monthly. If an entrance control device or an alarm is operating improperly, it must be immediately labeled as defective and repaired within seven (7) calendar days.

The facility may continue to be used during this seven (7) day period, provided the licensee or registrant implements the continuous surveillance requirements or 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.

k. Notifications

1. In addition to the reporting requirements specified in RH-1502.

and under other Sections, each licensee or registrant shall provide a written report to the Arkansas Department of Health & Human Services, Radiation Control, P.O. Box 1437 Mail Slot H-30, Little Rock, Arkansas 72203-1437 within thirty (30) days of the occurrence of any of the following incidents involving radiographic equipment:

A. Unintentional disconnection of the source assembly from the control cable.

B. Inability to retract the source assembly to its fully shielded position and secure it in this position.

C. Failure of any component (critical to safe operation of the device) to properly perform its intended function.

C. An indicator on a radiation machine fails to show that radiation is being produced, an exposure switch fails to terminate production of radiation when turned to the "OFF" position, or a safety interlock fails to terminate x-ray production.

2. The licensee or registrant shall include the following information in each report submitted under RH-1801.k.1. and in each report of overexposure submitted under RH-1504. which involves failure of safety components of radiography equipment:

A. A description of the equipment problem.

B. Cause of each incident, if known.

C. Name of the manufacturer and model number of equipment involved in the incident.

D. Place, time, and date of the incident.

E. Actions taken to establish normal operations.

F. Corrective actions taken or planned to prevent recurrence.

G. Qualifications of personnel involved in the incident.

3. Any licensee or registrant conducting radiographic operations or storing radioactive material at any location not listed on the license or registration for a period in excess of 180 days in a calendar year, shall notify the Department prior to exceeding the 180 days.

l. Labeling, storage, and transportation.

1. The licensee may not use a source changer or a container to store radioactive material unless the source changer or the storage container has securely attached to it a durable, legible, and clearly visible label bearing the standard trefoil radiation caution symbol in conventional colors, i.e., magenta, purple or black on a yellow background having a minimum diameter of 25 mm, and the wording:

"CAUTION" * RADIOACTIVE MATERIAL NOTIFY CIVIL AUTHORITIES (or "NAME OF COMPANY")

* or "DANGER"

2. The licensee may not transport licensed material unless the material is packaged, and the package is labeled, marked, and accompanied with appropriate shipping papers in accordance with regulations set out in SECTION 4. TRANSPORTATION OF RADIOACTIVE MATERIALS.

3. Locked radiographic exposure devices, storage containers source changers and radiation machines must be physically secured to prevent tampering or removal by unauthorized personnel. The licensee shall store radioactive material in a manner which will minimize danger from explosion or fire.

4. The licensee shall lock and physically secure the transport package containing radioactive material in the transport vehicle to prevent accidental loss, tampering, or unauthorized removal of the radioactive material from the vehicle.

RH-1802. Personnel Radiation Safety Requirements for Radiographers and Radiographer's Assistants.

a. Conducting industrial radiographic operations.

1. Whenever radiography is performed at a location other than a permanent radiographic installation, the radiographer must be accompanied by at least one other qualified radiographer or an individual who has at a minimum met the requirements of RH-1802.b.3. The additional qualified individual shall observe the operations and be capable of providing immediate assistance to prevent unauthorized entry. Radiography may not be performed if only one (1) qualified individual is present.

2. All radiographic operations conducted at locations of use authorized on the license or on the x-ray registration must be conducted in a permanent radiographic installation, unless specifically authorized by the Department.

3. A licensee or registrant may conduct lay-barge or underwater radiography only if the procedures have been approved by the Department, by an Agreement State, or by the Nuclear Regulatory Commission.

b. Training.

1. The licensee or registrant may not permit any individual to act as a radiographer until the individual:

A. 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 Appendix IRC.

2. In addition, the licensee or registrant may not permit any individual to act as a radiographer until the individual:

A. Has received copies of and instructions in the requirements described in this Part; RH-1511.; in the applicable sections of Section 3.

"STANDARDS FOR PROTECTION AGAINST RADIATION" including its Part N: "NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS: INSPECTIONS"

and in applicable Department of Transportation (DOT) as referenced in the Nuclear Regulatory Commission's (NRC) 10 CFR Part 71, in the Department license(s) under which the radiographer will perform industrial radiography, the licensee's or registrant's operating and emergency procedures;

B. Has demonstrated understanding of the licensee's license and the licensee's or registrant's operating and emergency procedures by successful completion of a written or oral examination covering this material.

C. Has received training in the use of the licensee's or registrant's radiographic exposure devices, sealed sources, in the daily inspection of devices and associated equipment, and in the use of radiation survey instruments.

D. Has demonstrated understanding of the use of radiographic exposure devices, sources, survey instruments and associated equipment described above in RH-1802.b.2.A. and RH-1802.b.2.C. by the successful completion of a practical examination covering this material.

3. The licensee or registrant may not permit any individual to act as a radiographer's assistant until the individual:

A. Has received copies of and instructions in the requirements described in this Part; RH-1511.; in the applicable sections of Section 3.

"STANDARDS FOR PROTECTION AGAINST RADIATION" including its Part N: "NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS: INSPECTIONS"

B. Has developed competence in the use, under the personal supervision of the radiographer, radiographic exposure devices, sealed sources, associated equipment, and radiation survey instruments that the assistant will use; and

C. Has demonstrated understanding of the instructions provided above in RH-1802.b.3.A. by the successful completion of a written test on the subjects covered and has demonstrated competence in the use of hardware described in RH-1802.b.3.B. by the successful completion of a practical examination on the use of such hardware.

4. The licensee or registrant shall provide annual refresher safety training for each radiographer and radiographer's assistant at intervals not to exceed twelve (12) months.

5. Except as provided in RH-1802.b.5.d., the RSO or designee shall conduct an inspection program of the job performance of each radiographer and radiographer's assistant to ensure that the Department's regulations, license requirements, and the applicant's operating emergency procedures are followed. The inspection program must:

A. Include observation of the performance of each radiographer and radiographer's assistant during an actual industrial radiographic operation, at intervals not to exceed six (6) months; and

B. Provide that, if a radiographer or radiographer's assistant has not participated in an industrial radiographic operation for more than six (6) months since the last inspection, the radiographer must demonstrate knowledge of the training requirements of RH1802.b.2.C. and the radiographer's assistant must re-demonstrate knowledge of the training requirements of RH-1802.b.3.B. by a practical examination before these individuals can next participate in a radiographic operation.

C. The Department may consider alternatives in those situations where the individual serves as both radiographer and RSO.

D. In those operations where a single individual serves as both radiographer and RSO, and performs all radiography operations, an inspection program is not required.

6. The licensee or registrant shall maintain records of the above training to include certification documents, written and practical examinations, refresher safety training and inspections of job performance in accordance with RH-1800.d.9.

7. The licensee or registrant shall include the subjects detailed in RH-1804.

8. Records of radiographer certification maintained in accordance with RH-1800.d.9. provide appropriate affirmation of certification requirements specified in RH-1802.b.1.A.

c. Radiographer Certificate Card Confiscation.

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. T

Arkansas Administrative CodeAgency 007 - Arkansas Department of HealthDivision 14 - Radiation Control and Emergency ManagementRule 007.14.12-001 - Regulations for Control of Sources of Ionizing Radiation

Arkansas Administrative Code
Agency 007 - Arkansas Department of Health
Division 14 - Radiation Control and Emergency Management
Rule 007.14.12-001 - Regulations for Control of Sources of Ionizing Radiation