Arkansas Administrative Code
Agency 007 - ARKANSAS DEPARTMENT OF HEALTH
Division 14 - Radiation Control and Emergency Management
Rule 007.14.82-001 - Control of Sources of Ionizing Radiation

Universal Citation: AR Admin Rules 007.14.82-001

Current through Register Vol. 49, No. 2, February 2024

SECTION 1 , Part C, is changed as follows:

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 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 January of every odd-numbered year, commencing 1965, 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 of registration 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 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 instaMationr-rece-iptr-said 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 10 days of such action.

RH-28 Registration Shall Not Imply Approval. No person, in any advertisement, shall refer to the fact that a source of radiation is registered with the Department and no person shall state or imply that any activity so registered has been approved by the Department.

SECTION 1 , Part D. is changed as follows:

PART D. REGISTRATION OF RADIATION MACHINE SERVICING AND SERVICES RH-30 ^ Purpose and Scope, This part provides for the registration of persons providing radiation machine installation, services and/or services.

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 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. 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.

(1) Each registrant described in this part shall not provide the services until such person provides evidence that he has been regi stered with the Department.

(b) Calibration of radiation machines or radiation measurement instruments or devices.

(1) Any individual offering or furnishing personnel dosimetry services, to a Department licensee or registrant, shall report each-quarter-to the Department, all radiation-exposure levels'greater than the limits set forth in RM-1200(a) within 10 days after the start of the next quarter. 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.

(D) Monitoring quarter 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.

SECTION 1 Part D. adds the following:

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 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 within 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.

To SECTION 1, Part D. the following is added:

RH-36 Registration Shall Not Imply Approval. No person, in any advertisement, shall refer to the fact that the person or organization is registered with the Department and no person shall state or imply that any activity under such registration has been approved by the Department.

SECTION 1.

Part F. INSPECTION, EXEMPTIONS AND ADDITIONAL REQUIREMENTS is changed as follows:

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 this Chapter (Radiation Protection Standards).

SECTION 1 , "Registration of Sources of Radiation" will chc^nge as follows;

PART G. PROHIBITED USES RH-eO. 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 maehine-which-use GopiG -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 this regulation 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), and each day that such violation shall continue shall constitute a separate offense.

SECTION 1 , Part H is added as follows:

PART H. ENFORCEMENT

RH-70. Violations. Any person who violates any of the provisions of this 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.

Paragraph RH-30Ub) will add the following:

(b)

(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 exempt quantities. For purposes of-Paragraph-RH 30T(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 or more of the exempt quantities in Schedule B, provided that the sum of such fractions shall not exceed unity.

(C) For purposes of this Paragraph RH-3pl(b)(9), 0.05 microcurie of Americium-241 is considered an exempt quantity under Schedule B. Baragraph RH-402, General Licenses - Other Radioactive Materials, is changed by adding titles to Subparagraphs (a) through (g) as follows:

Subparagraph (a) is entitled:

Certain Devices and Equipment

Subparagraph (b) is entitled:

Certain Measuring, _Gaugi.ng...or_.ControlIing.,Deyices

Subparagraph (c) is entitled:

Luminous Safety Devices in Aircraft

Subparagraph (d) is entitle'd:

Calibration and Reference Sources

Subparagraph (e) is entitled:

Ownership of Radioactive Material

Subparagraph (f) is entitled: Ice Detection Devices

Subparagraph (g) is entitled:

Intrastate Transportation of Radioactive Material

Subparagraph (h) is changed as follows:

(h) General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing.

(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 paragraphs RH-402(h)(2), (3), (4). (5) and (6) of this section, the following radioactive;, materials in prepackaged units:

(A) Iodine-125, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(B) Iodine-131, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radiqactive material, or the radiation therefrom, to human beings or animals.

(C) Carbon-14, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(D) 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 therefrom, to human beings or animals.

(E) Iron-59, in units not exceeding 20 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(F) Selenium-75, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, 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 therefrom, to human beings or animals.

(2) No person shall receive, acquire, possess, use, or transfer radioactive material pursuant to the general license established by Paragraph RH-402(h)(l) until the individual has filed Department Form RH-102 "Registration Certificate -In Vitro Testing With Radioactive Material Under General License" with the Director of Radiological Health Section, Arkansas Department of Health 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 Paragraph RH-404(d) to use radioactive material under the general license in Paragraph 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 radioactivematerials as authorized under the general license in Paragraph RH-402(h), and that such tests will be performed only by personnel competent in the use of such instrumen~ts~lind~fn"the handling of the radioactive materials.

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

(A) The general licensee shall not possess at any one time, pursuant to the general license in Paragraph RH-402{h)(l), at any one location of storage or use, a total amount of Iodine-125, Iodine-131, SelGnium-75, 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.

(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 Paragraph RH-402(h)(l)(GJ as required by Paragraph RH-1400.

(4) The general licencee shall not receive, use radioactive material pursuant to Paragraph 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, or Mock Iodine-125 for distribution to persons generally licensed under Paragraph RH-402(h){l).

(B) Unless the following statement, or a substantially similar statement which contains the information called for in the following 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 in the practice of veterinary medicine, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for theexercise of regulatory^ authority Name of Manufacturer

(5) The registrant possessing or using radioactive materials under" the general license of Paragraph RH-402(h')(l) shall report in writing to the Director of Radiological Health Section any changes in the information furnished by him in the " Regi stration Certificate - In Vitro Testing with Radioactive Material Under General License", Department Form RH-102 The report shall be furnished within 30 days after the effective date of such change.

(6) Any person using radioactive material pursuant to the general license of Paragraph RH-402(h)(l) 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 Paragraph RH-402(1)(G) shall comply with the provisions of Paragraphs RH-1400, RH-1501, and RH-T502.

Paragraph RH-404(d) will be added as follows:(d) Any licensee who is licensed pursuant to Paragraph RH-405(c) for one or more of the medical use groups in Schedule D also is authorized to use radioactive material under the general license in Paragraph RH-402(h) for the specified in vitro uses without filing Department Form RH-102 as required by Paragraph RH-402(h){2) provided, that-the licensee. Js..subject_to. other pxpy.isions of Paragraph RH-402(h).

Paragraph RH-405(b) changed to read:

(b) Licensing of Individual Physicians for Human Use of Radioactive Materials.

(1) An application by an individual physician or group of physicians for a specific license for human use of radioactive material will be approved if:

(A) The applicant satisfies the general requirements specified in Paragraph RH-404.

(B) The application is for use in the applicant's practice in an office outside a medical institution;

(C) The applicant has access to a hospital possessing adequate facilities to hospitalize and monitor the applicant's radioactive patients whenever 1t is advisable; and

(D) The applicant has extensive experience in the proposed use, the handling and administration of radioisotopes, and where applicable, the clinical management of radioactive patients.

(2) The Department will not approve an application by an individual physician or group of physicians for a specific license to receive, possess, or use radioactive material on the premises of a medical institution unless:

(A) The use of radioactive material is limited to:

(i) The administration of radiopharmaceuticals for diagnostic or therapeutic purposes;

(ii) The performance of diagnostic studies on patients to whom a radiopharmaceutical has been administered;

(iii) The performance of in vitro diagnostic -studies; -or (1v) The calibration and quality control checks of radioactive assay instrumentation, radiation safety instrumentation and diagnostic instrumentation;

(B) The physician brings the radioactive material with him/her and removes the radioactive material when he/she departs, (The institution cannot receive, possess, or store radioactive material other than the amount of material remaining in the patient); and

(D) The physician obtains written approval from the institution's administration authorizing he/she to bring radioactive material into the institution.

Paragraph RH-405(c) is changed to read as follows:

(1) Subject to the provisions of Paragraph RH-405(c)(2) ,(3), and (4), an application for a specific license pursuant to Paragraphs (a), (b) or (d) of this Section for any medical use or-uses-of radioactive material specified in one or more of Groups I to V, inclusive, of Schedule D will be approved for all of the uses within the group or groups which include the use or uses specified in the application if:

(A) the applicant satisfies the requirements of Paragraphs (a), (b) or (d) of this Section;

(B) the applicant, or the physician designated in the application as the individual user, has adequate clinical experience in the types of uses included in the group or groups;

(C) the applicant, or the physicians and all other personnel who will be involved in the preparation and use of the radioactive material, have adequate training and experience In the handling of radioactive material appropriate to their participation in the uses Included in the group or groups;

(D) the applicant's radiation detection and measuring instrumentation is adequate for conducting the procedures involved in the uses included in the group or groups; and

(E) the applicant's radiation safety operating procedures are adequate for handling and disposal of the radioactive material involved in the uses included in the group or groups.

(2) Any licensee - whois authorized to use radioactive material pursuant to one or more groups in Paragraph RH-405(c)(l) and Schedule D is subject to the following conditions:

(A) For groups I, II, IV, and V, no licensee shall receive, possess, or use radioactive material except as a radiopharmaceutical manufactured in the form to be administered to the patient, labeled, packaged, and distributed in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.72 of 10 CFR Part 32, or a specific license issued by an Agreement State pursuant to equivalent regulations.

(B) For Group III, no licensee shall receive, possess, or use generators or reagent kits containing radioactive material or shall use reagent kits that do not contain radioactive material to prepare radiopharmaceuticals containing radioactive material, except:

(i) reagent kits not containing radioactive material that are approved by the Department, the U.S. Nuclear Regulatory Commission, or an Agreement state for use by persons licensed pursuant to Paragraph RH-405(c) and Schedule D or equivalent regulations; or

(ii) generators or reagent kits containing radioactive material that are manufactured, labeled, packaged, and distributed in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Sec. 32.73 of 10 CFR Part 32, or a specific license issued by an Agreement State pursuant to equivalent regulations.

(i) Elute the generator, or process radioactive material with the reagent kit, in accordance with instructions approved by the Nuclear Regulatory Commission or an Agreement State and furnished by the manufacturer on the label attached to or in the leaflet or brochure that accompanies the generator or reagent kit;

(ii) Before administration to patients, cause each elution or extraction of Technetium-99m from a Molybdenum-99/ Technetium-99m generator to be tested to determine either the total Molybdenum-99 activity or the concentration of Molybdenum-99. This testing shall be conducted according to written procedures and by personnel who have been specifically trained to perform the test;

(iii) Prohibit the administration to patients of Technetium-99m containing more than 1 microcurie of Molybdenum-99 per millicurie of"TechnetiUm-99m, or ' more than 5 microcuries of Molybdenum-99 per administered dose, at the time of administration; and

(iv) Maintain for 2 years for Department inspection records of the Molybdenum-99 test conducted on each elution from the generator.

(3) Any licensee who is licensed pursuant to Paragraph RH-405(c)(l) for one or more of the medical use groups in Schedule 0 also is authorized to use radioactive material under the general license in Paragraph RH-402(h) for the specified in vitro uses without filing Department Form RH-102 as required by Paragraph RH-402(h); provided, that the licensee is subject to the other provisions of Paragraph RH-402(h).

(4) Any licensee who is licensed pursuant to Paragraph RH-405(c)(l) for one or more of the medical use groups in Schedule D also is authorized, subject to the provisions of Paragraph RH-405(c) (4) and (5), to receive, possess, and use for calibration and reference standards:

(A) any radioactive material listed in Group I, Group II, or Group III of Schedule D of this part with a half-life not longer than 100 days, in amounts not to exceed 15 millicuries total;

(B) any radioactive material listed in Group I, Group 11, or Group III of Schedule D of this part with half-life greater than 100 days in amounts not to exceed 200 microcuries total;

(D) any radioactive material, in amounts not to exceed 3 millicuries per source, contained in calibration or reference sources that have been manufactured, labeled, packaged, and distributed in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.74 of 10 CFR Part 32, or a specific license issued to the manufacturer by an Agreement State pursuant to equivalent renulations.

(5)

(A) Any licensee who possesses sealed sources as calibration or reference sources pursuant to Paragraph RH-405(c)(4) shall cause each sealed source containing radioactive material, other than Hydrogen-3, with a half-life greater than 30 days in any form other than gas, to be tested for leakage and/or contamination at intervals not to exceed 6 months. In the absence of a certificate from a transferor indicating that a test has been made within 6 months prior to the transfer, the sealed sources should not be used until tested, provided, however, that no leak tests are required when:

(i) the source contains 100 microcuries or less of beta and/or gamma emitting material or 10 microcuries or less of alpha emitting material, or

(ii) the sealed source is stored and is not being used; such sources shall, however, be-tested for leakage prior to any use or transfer unless they have, been leak tested within 6 months prior to the date of use or transfer.

(B) The leak test shall be capable of detecting the presence of 10,005 microcurie of radioactive material on the test sample. The test sample shall be taken from the sealed source or from the surfaces of the device in which the sealed source is mounted or stored on which contamination might be expected to accumulate. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the Department.

(C) If the leak test reveals the presence of 0.005 microcurie or more of removable contamination, the licensee shall immediately withdraw the sealed source from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with Section 2 and Section 3 of these regulations. A report shall be filed within 5 days of the test with the Department describing the equipment involved, the test results, and the corrective action taken.

(6) Any licensee . who possesses and uses calibration and reference sources pursuant to Paragraph RH-405(c)(4)(iv) shall:

(A) follow the radiation safety and handling instructions approved by the Department, the U.S. Nuclear Regulatory Conmission or an Agreement State and furnished by the " manufacturer on "the label-attached to the source, or permanent container-there of or in the-leaflet-or brociiure that accompanies the source, and maintain such instruction in a legible and conveniently available form; and

(B) conduct a quarterly physical inventory to account for all sources received and possessed. Records of the inventories shall be maintained for inspection by the Department and shall include the quantities and kinds of radioactive material, location of sources, and the date of the inventory.

Paragraph RH-408 is changed as follows:

RH-408. Specific Terms and Conditions of Licenses.

(a) Each license issued pursuant to this regulation 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) Neither the license nor any right under the license shall be assigned or otherwise transferred in violation of the provisions of the Act.

(c) Each person licensed by the Department pursuant to this regulation 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 the 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 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) Each licensee preparing Technetium-99m radiopharmaceuticals from Molybdenum-99/Technetium-99m generators shall test the generator eluates for Molybdenum-99 breakthrough in accordance with Paragraph RH-405(c)(2)(C)(ii thru iv).

Paragraph RH-750, Reciprocal Recognition of Licenses is changed as follows:

Subparagraph (a) is changed in part as follows:

Line 6 changed to read "excess of one hundred eighty (180) days in any period"

Subparagraph (a)(2) is changed in part as follows:

Line 3 changed to read "___ notification shall indicate the exact location.

Paragraph RH-902, Schedule C,Exempt Concentrations, (Continued), is changed to read as follows:

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 establTshed in Schedule"C"for the specific isotope- when not in combination. The sum of such ratios may not exceed "1" (i.e. unity). Example:

Concentration of Isotope A in Product + Concentration of Isotope B in Product Exempt concentration of Isotope A Exempt concentration of Isotope B Values are given in Column I only for those materials normally used as gases.

Paragraph RH-903. Schedule D, Group I will add the following;

(14) Iodine-123 as sodium iodide for measurement of thyroid uptake.

Paragraph RH-903,Schedule D, Group III will be corrected as follows:

(3)

(1) Gluceptate sodium for brain imaging and renal perfusion studies.

Paragraph RH-903, Schedule D, Group III will add the following:

(3)

(m) Oxidronate sodium for bone imaging.

(n) Disofenin for imaging hepatobiliary.

(o) Succimer (DMSA) for renal imaging.

Paragraph RH-903. Schedule D. will add the following:

Group IV. Prepared Radiopharmaceuticals for Certain Therapeutic Uses That Do Not Normally Require Hospitalization for Purposes of Radiation Safety.

(1) Iodine-131 as iodide for treatment of hyperthyroidism and cardiac dysfunction.

(2) Phosphorus-32 as soluble phosphate for treatment of polycythemia vera, leukemia, and bone metastases.

(3) Phosphorus-32 as colloidal chromic phosphate for intracavitary treatment of malignant effusions.

Group V. Prepared Radiopharmaceuticals for Certain Therapeutic Uses

That Normally Require Hospitalization for Purposes of Radiation Safety.

(1) Gold-198 as colloid for intracavitary treatment of malignant effusions.

(2) Iodine-131 as iodide for treatment of thyroid carcinoma.

Paragraph RH-904, Schedule E is retitled as follows:

RH-904 Schedule E Limits for Broad Licenses.

Paragraph RH-1303(c) will add the following:

(6) Each area in which there may exist radiation levels in excess of 500 rems in one hour at 1 meter from a sealed radioactive source^ that is used to irradiate materials shall:

(A) Have each entrance or,access point equipped with entry control devices which shall function automatically to prevent any individual from inadvertently entering the - area when such radiation levels exist; permit deliberate entry into the area only after a control device 1s actuated that shall cause 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 dose In excess of 100 mrem in one hour; and prevent operation of the source if the source would produce radiation levels in the area that could result in a dose to an Individual In excess of 100 mrem in one hour. The entry control devices required by this paragraph(c)(6) shall be established 1n such a way that no individual will be prevented from leaving the area.

'Paragraph RH-1303(c)(6) does not apply to radioactive sources that are used In teletherapy, in radiography, or in completely self-shielded irradiators in which the source is both stored and operated within the same shielding radiation barrier and, in the designed configuration of the Irradiator, is always physically Inaccessible to any individual and cannot create high levels of radiation in an area that is accessible to any individual. Paragraph RH-1303(c)(6) also does not apply to sources from which the radiation is incidental to some other use. Radiation from radioactive materials that are used in sealed sources in non-self-shielded irradiators applies to Paragraph RH-1303(c)(6}.

(B) Be equipped with additional controT devices such that upon failure of the entry control devices to function as required by Paragraph RH-1303(c)(6)(A) the radiation level within the area, from the sealed source, shall be reduced below that at which it would be possible for an individual to receive a dose in excess of TOO mrem in one hour; and visible and audible alarm signals shall be generated to make an individual attempting to enter the area aware of the hazard and the licensee or at least one other individual, who is familiar with the activity and prepared I 'to render or summon assistance, aware of such failure of the entry control devices.

(C) Be equipped with control devices such that upon failure or removal of physical radiation barriers other than the source's shielded storage container the radiation level from the source shall be reduced below that at which it would be possible for an individual to receive a dose in excess of 100 mrem in one hour; and visible and audible alarm signals shall be 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. When the shield for the stored source is a liquid, means shall be provided to monitor the integrity of the shield and to signal, automatically, loss of adequate shielding. , 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 Paragraph RH-l!303(c){6)(C).

(D) Be equipped with devices that will automatically generate 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 shall be installed in the area and which can prevent the source i from being put into operation.

(E) Be controlled by use of such administrative procedures and such devices as are necessary to assure that the area is cleared of personnel prior to each use of the source preceding which use it might have been possible for an individual to have entered the area.

(F) Be checked by a physical radiation measurement to assure 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 dose in excess of 100 mrem in one hour.

(G) Have entry control devices required in Paragraph RH-1303 {c)(6)(A) of this section which have been tested for proper functioning prior to initial operation with such source of radiation on any day that operations are not uninterruptedly continued from the previous day or before resuming operations after any unintended interruption, and for which records are kept of the dates, times, and results of such tests of function. No operations other than those necessary to place the source in safe condition or to effect repairs on controls shall be conducted with such Source unless control devices are functioning properly. The licensee shall submit an acceptable schedule for more I complete periodic tests of the entry control and warning systems to be established and adhered to as a condition of the license.

(H) Have those entry and exit portal^ . that are used in transporting materials to and from the irradiation,area, and that are not intended for use by individuals, controlled by such devices and administrative procedures as are necessary to physically protect and warn against inadvertent entry by any individual through such portals. Exit portals for processed materials shall be equipped to detect and signal the presence of loose radiation sources that are carried toward such an exit and to automatically prevent such loose sources from being carried out of the area.

(I) Licensees with, or applicants for, licenses for radiation sources that are within the purview of Paragraph RH-1303(c)(6), and that must be used in a variety of positions or in peculiar locations, such as open fields or forests, that make it impracticable to comply with certain requirements to Paragraph RH-1303(c)(6) of this section, such as those for the automatic control of radiation levels may apply to the Department for approval, prior to use of safety measures that are alternative to those specified in Paragraph RH-1303 (c)(6), and that will provide at least an equivalent degree of personnel protection in the use of such sources. At least one of the alternative measures must include an entry-preventing interlock control based on a physical measurement of radiation that assures the absence of high radiation levels before an individual can gain access to an area where such sources are used.

Paragraph RH-1401 is changed to read as follows:

RH-1401. Method for Obtaining Approval of Proposed Disposal Procedures,

(a) Any person may apply to the Department for approval of proposed procedures to dispose of radioactive material in a manner not otherwise authorized in this Regulation. Each application shall include a description of the radioactive material, including the quantities and kinds of radioactive material and the levels of radioactivity involved and the proposed manner and conditions of disposal. The application, where appropriate, shall also include an analysis and evaluation of pertinent information as to the ; nature of the environment, including topographical, geological, meteorological and hydrological characteristics; usage of ground and surface waters in the general area; the nature and location of other potentially affected facilities; and procedures to be observed to minimize the risk of unexpected or hazardous exposures.

(b) The Department will not approve any application for a license to receive radioactive material from other persons for disposal on land not owned by the State or the Federal Government.

Paragraph RH-1402(d) is changed to read as follows:

(d) The gross quantity of licensed and other radioactive material, excluding Hydrogen-3 and Carbon-14, released into the sewerage system by the licensee does not exceed one curie per year. The quantities of Hydrogen-3 and Carb6n-14 released into the sanitary sewerage system may not exceed 5 curies per year for Hydrogen-3 and 1 curie per year for Carbon-14.

Paragraph RH-1403 will add the following:

(d) Specific apfiroval has been granted by the Department.

Paragraph RH-1404 1s changed to read:

RH-1404 Treatment or Disposa by incineratio. No licensee shall dispose I of radioactive material or prepare it for disposal by incineration except for materials listed under Paragraph RH-1405 or as specifically approved by the Department pursuant to Paragraphs RH-1204 and

RH-1401

Paragraph RH-1405, Disposal of Specific Wastes, will be added as follows:

RH-1405 Disposalof Specific Wastes. Any licensee may dispose of the following licensed material without regard to its radioactivity;

(a) 0.05 microcuries or less of Hydrogen-3 or Carbon-14, per gram of medium, used for liquid scintillation counting; and

(b) 0.05 microcuries or less of Hydrogen-3 or Carbon-14, per gram of animal tissue averaged over the weight of the entire animal; provided however, tissue may not be disposed of under this section in a manner that would permit Its use either as food for humans or as animal feed.

(c) Nothing in this section, however, relieves the licensee of maintaining records showing the receipt, transfer and disposal of such byproduct material as specified in Paragraph RH-600, and

(d) Nothing in this section relieves the licensee from complying with other applicable federal, state and local regulations governing any other toxic or hazardous property of these materials.

Paragraph RH-1602(a) will add the following:

(10) Information arid 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;

(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.

Paragraph RH-1603 will add the following:

(i) Radiation Therapy Sirnulatioh Systems. Radiation therapy simulation systems shall be exempt from all the requirements of Paragraph RH-1603(a), (c)(2), and (f) 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) such systems as do not meet the requirements of Paragraph RH-1603(f) 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.

Paragraph RH-1604(a)(2) is changed to read as follows:

(2) For systems with variable aperture beam limiting devices, means shall be provided for visually defining the perimeter of the X-ray field.

(A) The beam-limiting device shall numerically indicate . the field size in the plane of the image receptor to which it is adjusted; and

(B) Indication of field size dimensions and SID's shall be specified in inches and/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 2 percent of the SID when the beam axis is indicated to be perpendicular to the plane of the image receptor.

(C) The X-ray field shall not exceed the visually defined field such that the total misalignment of the X-ray field along either the length or width of the visually defined field exceeds 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.

Paragraph RH-1607 is changed to read as follows:

RH-1607 Therapeutic X-ray Systems of Less Than One MeV.

(a) Equipment Requirements.

(1) Lea_kage 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 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 1 roentgen in one hour at 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 hour at 1 meter from the source.

(D) 151 to 999 kVp Systems. The leakage radiation shall not exceed 1 roentgen in one hour at 1 meter from the source except systems that operate in excess of 500 kVp may have a leakage radiation at 1 meter from the source equivalent to the exposure within one hour of the useful beam at 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 1 percent of the original X-ray beam at the maximum kilovoltage and maximum treatment filter.

(B) Adjustable beam limiting devices installed after July 1, 1983 shall meet the requirements of Parag|raph 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 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 can not be accidently 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 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 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 equivalency at TOO kVp that can be positioned over the entire useful beam exit port during periods when the beam is not in use.

(8) 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 ("1 .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, a 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 fractions 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 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.

(D) The timer shall permit accurate pre-setting and determination of exposure times as short as one second.

(E) The timer shall not permit an exposure if set at zero.

(F) The timer shall comply with the provisions of Paragraph 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 provisions of Paragraph 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;

(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 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

(12) Source-to-Patient Distance. There shall be means of determining the source-to-patient distance to within 1 centimeter.

(13) Shutters. Unless it is possible to bring the X-ray output to the prescribed exposure parameters within five steconds, 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 labelled as such upon the tube housing assembly and at the control panel.

(b) Faci'lity Design Requireniehts 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. Treatment rooms which contain an X-ray system capable of operating above 150 kVp shall meet the following additional requirements:

(A) all necessary shielding, except for any beam interceptor, shall be provided by fixed barriers;

(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) when the doors referred to in Paragraph RH-1607(b)(4)(C) are opened while the X-ray tube is activated:

(i) X-ray production shall terminate within one second, or

(ii) the radiation at a distance of 1 meter from the source -shall be reduced to less than|100 milliroentgens per hour within one second; and

(E) after the radiation output of the X-ray tube has been affected by the opening of any door referred to in Paragraph 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.

(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 expert shall report his findings In writing to the person in charge of the facility and a copy of the report shall be maintained by the registrant for inspection by the Department.

(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 cite all items of noncompliance.

(2) Calibrations,

(A) The calibration of an X-ray system shall be performed at intervals not to exceed one year and after any change or replacement of components which could cause a change in the radilation : 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 years.

(D) The calibrations made pursuant to Paragraph RH-1607{c)(2) shall be such that the dose at a reference point in soft tissue can be calculated to within *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 Paragraph RH-1607(c){2) shall be maintained by the registrant for two 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;

(B) 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 procedure shall also note conditions which shall require that the system be recalibrated in accordance with Paragraph RH-1607{c)(2); and

(E) records of spot check measurements performed pursuant to Paragraph RH-1607(c){3) shall be maintained by the registrant for two years following such measurement.

(4) Operating Procedures.

(A) Therapeutic X-ray systems shall not be left unattended unless the system is secured pursuant to Paragraph 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.

(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 Paragraph 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 Paragraphs RH-1607(c)C2) and RH-1607(c)(3)(D) have been met.

Paragraph RH-1608 is changed to read:

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 1 MeV and above.

(a) Deof efinitions. In addition to the definitions provided in Paragraph RH-1601, the following definitions shall be applicable to Paragraph RH-1608.

(1) "Applicator" means 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" means a filter used in order to scatter a beam of electrons.

(3) "Central axis of the beam" means 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) "Dose monitoring system" means a system of devices for the detection and display of quantities of radiation.

(5) "Dose monitor unit" means a unit from which the absorbed dose can be calculated.

(6) "Existing equipment" means therapy systems subject to Paragraph RH-1600 which were manufactured on or before July 1, 1983.

(7) "Field flattening filter" means a filter used to homogenize the dose rate over the area of a useful beam of X-rays.

(8) "Field size" means the dimensions of an area in a plane perpendicular to the specified direction of the beam of incident radiation at a specified depth in a phantom anc| defined by specified isodose lines. (9) "Gantry" means that part of the system supporting and allowing possible movements of the radiation head.

(10) "Interruption of irradiation" means the stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.

(11) "Isocenter" means a fixed point in space located at the intersection of the rotation axes of the principal movements of the therapy system.

(12) "Moving beam therapy" means radiation therapy 'with relative displacement of the useful beam and the patient during irradiation.

(13) "New equipment" means systems subject to Paragraph RH-1608 which were manufactured after July 1, 1983.

(14) "Normal treatment distance" means the distance between the virtual source and a reference point on the central axis of the beam. The reference point is located at a position where the patient will be placed during radiation therapy.

(15) "Patient" means an individual subjected to examination and treatment.

(16) "Phantom" means a volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation.

(17) "Primary dose monitoring system" means 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.

(18) "Radiation treatment prescription" means the absorbed dose which is intended to be delivered to the treatment volume.

(19) "Radiation head" means the structure from which the useful beam emerges.

(20) "Redundant dose monitoring combination" means 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.

(21) "Secondary dose monitoring system" means a system which will terminate irradiation in the event of failure of the primary system.

(22) "Shadow tray" means a device attached to the radiation head to support auxiliary beam limiting material.

(23) "Stationary beam therapy" means radiation therapy without relative displacement of the useful beam and the patient during irradiation.

(24) "Target" means that part of a radiation source which intercepts a beam of accelerated particles with subsequent emission of other radiation.

(25) "Termination of irradiation" means the stopping of irradiation in a fashion which will not permit continuance of irradiation without the resetting of operating conditions at the control panel.

(26) "Treatment field" means the area of the patient's skin which is to be irradiated.

(27) "Virtual source" means a point from which radiation appears to originate.

(b) Requirements for Equipment.

(1) Leakage Radiation to the Patient Area.

(A) New equipment shall meet the following requirements:

(i) (For all operating conditions, the dose inrads due to leakage radiation, including X-rays, electrons, and neutrons, at any point in a circular plane of 2 meters radiufe centered on and 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 equivalent in rads of the unattenuated useful beam measured at the point of intersection of the central axis of the beam and the plane surface.) Measurements shall be averaged over an area up to but not exceeding 100 square centimeters at the positions specified.

(ii) For each system the registrant shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in Paragraph RH-1608 (b)(l)(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 Paragraph RH-(b)(l){A)(i) where such area intercepts the central axis of the beam 1 meter from the virtual source, shall not exceed 0.1 percent of the maximum dose 9f the unattenuated useful beam measured at the point of intersection of the central axis of the beam and the surface of the referenced circular plane.) Measurements shall be averaged over an area up to but not exceeding 100 square centimeters at the positions specified.

(ii) For each system, the licensee shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in Paragraph RH-1607(b)(l){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 th_e Patient Area.

(A) . The dose equivalent in rem due to leakage radiation,except in the area specified in Paragraph RH-1608(b){l)(A)(i), when measured at any point 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 unattenuated useful beam measured at the point of intersection of the central axis of the beam and the circular plane specified in Paragraph 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 Paragraph RH-1608;b)(2)(A) for specified operating conditions. Measurements shall be averaged over an area up to but not exceeding 100 square centimeters at the positions specified.

(3) Beam Limiting Devices. Adjustable or interchangeable beam limiting dev|ices shall be provided and such devices shall transmit no more than 2 percent of the useful beam for the portion of the useful beam which is to 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 TOO square centimeters at the normal treatment distance.

(4) Filters.

(A) If the absorbed dose rate information required by Paragraph RH-1608(b)(l6) relates 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 filters, 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 identified as to that filter's material of construction, thickness, and the wedge angle for wedge filters; and

(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 registrant 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 axisof the beam 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 HI

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 Paragraph 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 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 Paragraph 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 Paragraph RH- (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 due to stray neutrons in the useful beam 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 radiation detectors. The detectors shall be incorporated into two monitoring systems arranged either as a primary/ primary combination or as primary/secondary combination.

(B) Existing equipment shall be provided with at least one radiation detector. This detector shall be incorporated into a primary system.

(i) Each primary system shall have a detector whichis 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 Paragraph RH-l608(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 be so designed that, in the event of an overdosage 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 Paragraph RH-1608(b){6)(C){vi) displayed at the control panel at the time of failure shall be retrievable in at least one system.

(7) Beam Symmetry.

(A) For new equipment, each therapy machine shall have the capability of comparing the dose rates in each of the four quadrants of the central 80 percent of the useful beam. Beam symmetry information shall be displayed at ( the treatment control panel, and such display shall be capable of indicating a differential of more than _ 5 percent between any two of the quandrant dose rates. Beam asymmetry in excess of 20 percent shall automatically terminate the useful beam.

(B) Beam symmetry requirements of Paragraph RH-^608 (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 theinherent design of the accelerator.

(C) On existing equipment where the Department has determined that beam syrmetry 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.

(9) Termination of Irradiation by the DoseMonitorihg 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) Each secondary system shall terminate irradi-ation when 102 percent of the pre-selected number of dose monitor units has been detected by the system,

(D) For new equipment, indicators on the control panel shall show which monitoring system has terminated the beam.

(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 conditions, 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 when 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 s'election 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.

(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.

(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 terminate irradiation if the movement stops during moving beam therapy.

(E) Moving beam therapy shall be so controlled that the required relationship between the-number of dose monitor units and movement is obtained.

(F) The mode of operation shall be displayed at the treatment control panel.

(16) Absorbed Dose t^ate. 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._/ In addition:

(A) The quotient of the number of dose monitor units by time i 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 termiaa:tes irradiation when the absorbed dose rate exceeds a value twice the 3 specified maximum. The value at which the irradiation will be terminated shall be a record maintained by the registrant.

The radiation detectors specified in Paragraph RH-1608;b)(6) may form part of this system.

(17) . Location of Focal Spot and Beani Orientation. The registrant 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.

(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 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.

(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 communication impractical, other methods of communication 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 1s "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.

(d) Surveys, Calibrations, Spot Checks, and Operating Procedures.

(1) Survey.

(B) The registrant shall obtain a written report of the survey from qualified expert and a copy of the report shall be transmitted by the registrant to the Department.

(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 calibration of systems subject to Paragraph RH-1607 shall be performed before the system is first used for irradiation of patient and thereafter at time intervals which do not exceed six months and after any change which might significantly alter the calibration, spatial distribution, or other-.characteristics of the therapy beam.

(B) The 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 measurement instrument the calibration of which is directly traceable to national standards of exposure or absorbed dose and which shall have been calibrated within the preceding two years.

(D) Calibrations made pursuant to Paragraph RH-1608(a)(2) shall be such that the dose at a reference point in soft tissue can be calculated within +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 incompliance with the design specifications concerning the light localizer, the side light and back-pointer alignmentjwith 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 exposure rate or dose rate in air and/or at various depths of water for the range of field sizes used, for each effective energy, and for-each treatment -distance used for radiation therapy.

(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 +5 percent.

(F) Records of the calibration performed pursuant to Paragraph RH- 'd)(2)(A) shall be maintained by the registrant for two years after completion of the calibration.

(G) A copy of the latest calibration performed pursuant to Paragraph 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 Paragraph RH-1608. 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.

(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.

(D) For systems in which beam quality can vary significantly, spot checks shall include quality checks.

(E) 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,

(F) 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.

(G) 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 Paragraph RH-1608(d)(2).

(H) Records of spot-check measurements performed pursuant to Paragraph'RH-1608{d)(3) shall be maintained by the registrant for a period of two years.

(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 of radiation therapy unless Paragraph RH-1608(d)(l), (2), and (3) have been met.

Paragraph RH-1701 will add the following:

(1) The maximum radiation level at a distance of 1 meter from the patient in whom brachytherapy sources have been inserted shall be determined by measurement or calculation. This radiation level shall be documented and maintained for inspection by the Department,

(2) The radiation levels in the patient's room and the surrounding area shall be determined, recorded, and maintained for inspection by the Department.

(d) Signs arid Records.

(1) In addition to the requirements outlined in Paragraph RH-1303, the bed, cubicle, or room of the hospital brachytherapy patient shall be marked with a sign indicating the presence of brachytherapy sources. This sign shall incorporate the radiation symbol and specify the radionuclide, the activity, date, and the individual(s) to contact for radiation safety instructions. The sign is not required provided the exception in Paragraph RH-1304 is met.

(2) The following information shall be documented and maintained for review by the Department:

(A) the radionuclide administered, number of sources, activity in millicuries and time and date of administration;

(B) the exposure rate at 1 meter, the time the^determination I was made, and by whom;

(D) the precautionary instructions necessary to assure that the exposure of individuals does not exceed that permitted under Paragraph RH-1200.

Paragraph RH-1702(a)(10) Is deleted. This requirement will be incorporated as RH-1702(c).

Paragraph RH-1702(c) is changed to read as follows:

RH-1702. (c) Testing for Leakage and Contamination, Teletherapy sources shall be tested for leakage and contamination in accordance with the procedures described in Paragraph RH-T701(b) except that the leak . tests shall be capable of detecting 0.05 microcuries of removable contamination, and a source shall be considered to be leaking if the test reveals the presence of 0.05 microcuries or more of removable contaminatlon Tests_of.,leakage may be made by wiping accessible surfaces of the housing port or collimator while the source is in the "off" position and measuring these wipes for transferred contamination.

Paragraph RH-1702(d) 1s changed to read as follows:

RH-1702. (d) Operation. No individual shall be in the treatment room during irradiation unless that individual is the patient. Mechanical restraining or supporting devices shall be used for positioning the patient, if necessary.

Subparagraphs (e) through (t) will be added to RH-1702 as follows:

RH-1702.

(e) Requirement to perform full calibration itieasureniehts of teletherapy units.

(1) Any licensee authorized under Paragraph RH-405(d) to use teletherapy units for treating humans shall cause full calibration measurements to be performed on each teletherapy unit:

(A) Prior to" the firsfus^e of' the unit fbV'treatingTumans;

(B) Prior to treating humans:

(i) Whenever spot-check measurements indicate that the output value differs by more than 5 percent from the value obtained at the last full calibration corrected mathematically for physical decay;

(ii) Following replacement of the radiation source or following reinstallation of the teletherapy unit in a new location;

(iii) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly.

(2) Full calibration measurements required by paragraph RH-1702(c)(l) of this section shall include determination of:

(A) The exposure rate or dose rate to an accuracy within- 3 percent for the range of field sizes and. for the range of distances (or for the axis distance) used in radiation therapy:

(B) The congruence between the radiation field and the field indicated by the light beam localizing device;

(D) Timer accuracy; and

(E) Theaccuracy of all distance "menas" used for treating humans.

(3) Full calibration measurements shall be made in accordance with the procedures recommended by the Scientific Committee on Radiation Dosimetry of the American Association of Physicists in Medicine (Physics in Medicine and Biology, Vol. 16, No. 3, 1971, pp. 379-396).

(4) The exposure rate or dose rate values determined in Paragraph RH-1702(e)(2)(A) shall be corrected mathematically for physical decay for intervals not exceeding one month.

(5) Full calibration measurements required by Paragraph RH-1702(e)(l) of this section and physical decay corrections required by Paragraph RH-1702(e)(4) shall be performed by an expert qualified by training and experience in accordance with Paragraph RH-1702(h).

(f) Requirement to perform periodic spot-check measurements of tele therapy units.

(1) Any licensee authorized under Paragraph RH-405(d) to use teletherapy units for treating humans shall cause spot-check measurements to be performed on each teletherapy unit at ' intervals not exceeding one month.

(2) Spot-check measurements required by Paragraph RH-1702(e)(l) shall include determination of:

(A) Timer accuracy;

(B) The congruence between the radiation field and the field indicated by the light beam localizing device;

The "distance measuring " device streating humans;

(D) The exposure rate, dose rate, or a quantity related in a known manner to these rates for one typical set of operating conditions; and

(E) The difference between the measurement made in Paragraph RH-1702(f)(2)(D) and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay).

(3) Spot-check measurements required by Paragraph RH-1702(f)(1) shall be performed in accordance with procedures established by an expert qualified by training and experience in accordance with Paragraph RH-1702(h). (A qualified expert need not actually perform the spot-check measurements.) If a qualified expert does not perform the spot-check measurements, the results of the spot-check measurements shall be reviewed by a qualified expert within 15 days.

(g) Reqiiireitieht to calibrate instruitiehts used for full calibration and sp6t-ch6ck measurements. !

(1) Full calibration measurements required by Paragraph RH-1702(e) shall be performed using a dosimetry system that has been calibrated by the National Bureau of Standards or by a Regional Calibration Laboratory accredited by the American Association of Physicists in Medicine. The dosimetry system shall have been Calibrated within the previous"two^"years~and~after any - -servicing that may have affected system calibration.

(2) Spot-check measurements required by Paragraph RH-1702(f) shall be performed using a dosimetry system that has been calibrated in accordance with Paragraph RH-1762(g)(l). Alternatively, a dosimetry system used solely for spot-check measurements may be calibrated by direct intercomparison with a system that has been calibrated in accordance with Paragraph RH-1702(g)(l). This alternative calibration method shall have been performed within the previous one year and after each servicing that may have affected system calibration. Dosimetry systems calibrated by this alternative method shall not be used for full calibration measurements.

(h) Qualified expert. The licensee shall determine if a person is an expert qualified by training and experience to calibrate a teletherapy unit and establish procedures for (and review the results of) spot-check measurements. The licensee shall determine that the qualified expert:

(1) Is 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) Has 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 at least one teletherapy unit.

Licensees that have their teletherapy units calibrated by persons who do not meet these criteria for minimum training and experience may request a license amendment excepting them from the requirements of Paragraph RH-1702(h). The request, should include the name of the proposed qualified expert, a description of the individual's training and experience including information similar to that specified in Paragraph RH-1702(h)(2), reports of at least one calibration and spot-check program based on measurements personally made by the proposed expert within the last 10 years, and written endorsement of the technical qualifications of the proposed expert from personal knowledge by a physicist certified by the American Board of Radiology in one of the specialities listed in Paragraph RH-1702{h){l). The individual's qualifications will be evaluated by the Department.

(i) Records. The licensee shall maintain, for inspection by the Department, records of the measurements, tests, corrective actions, and instrument calibrations made under the provisions of Paragraph RH-1702 (e) through (g), and records of the licensee's evaluation of the qualified expert's training and experience made under Paragraph RH-1702(h).

(1) Records of:

(A) full calibration measurements under Paragraph RH-J702(e) and;

(B) calibration of the instruments used to make these measurements under Paragraph RH-1702(g)i, shall be preserved for five years after completion of the full calibration.

(2) Records of:

(A) spot-check measurements and corrective actions under Paragraph RH-1702 and;

(B) calibration of instruments used to make spot-check measurements under Paragraph RH-1702(g) shall be preserved for two years after completion of the spot-check measurements and corrective actions.

(3) Records of the licensee's evaluation of the qualified expert's training and experience under Paragraph RH-1702(h) shall be preserved for five years after the qualified expert's last performance of a full calibration on the licensee's teletherapy unit.

Paragraph RH-1800(c) will add the following:

NOTE: Changes will be incorporated such that the definitions will be in alphabetical order.

(25) "Radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive materials.

(26) "Sealed source" means any radioactive material that is encased in a capsule designed to prevent leakage or escape of the radioactive material.

(27) "Source changer" means 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.

(28) "Permanent radiographic installation" means a shielded installation or structure designed or intended for radiography in which radiography is regularly performed.

Paragraph RH-1801(h) and (i) are changed as follows;

(h) Inspection arid Maln.teharice of Radidgraphic Exposure Devices And Storage Containers.

(1) The licensee shall check for obvious defects in radiographic exposure devices, storage containers, and source changers prior to use each day the equipment is used.

(2) Each licensee or registrant shall conduct a program of quarterly inspection and maintenance of radiographic exposure devices and. storage containers, and source changers, to assure proper functioning of components important to safety. Records of inspection and main|tenance shall be maintained for inspection by the Department for at least two years from the date of inspection and maintenance. All important parts shall be maintained in accordance with the manufacturer's specifications.

(3) If any inspection conducted pursuant to Paragraph RH-1801 (h)(l) or (2) reveals damage to components critical to radiation safety, the device shall be removed from service until repairs have been made.

(i) Permanent Radiographic Installations.

(1) Permanent radiographic installations having high radiation area entrance controls of the types described in Paragraph RH-1303 (c)(2)(B), (2)(C) or (4) shall also meet the following special requirements:

(A) Each entrance that is used for personnel access to thehigh radiation area in a permanent radiographic installation to which this section applies shall have both visible and audible warning signals to warn of the presence of I radiation. The visible signal shall be activated:by radiation whenever the source is exposed. The audible signal shall be actuated when an attempt is made to enter the installation while the source is exposed.

(B) The alarm system shall be tested monthly while in use or at the be^nn~ing of^each period of use. "Records tests shall be maintained for inspection by the Department.

Paragraph RH-1802(a){1) will add the fonowing;

(D) Has demonstrated understanding of the instructions in Paragraph RH-1802(a) by successful completion of a written test and a field examination on the subjects covered.

Paragraph RH-1802(a)(2) will add the following:

Paragraph RH-1802(b) by successfully completing a written or oral test and a field examination on the subjects covered.

Paragraph RH-1802(b) will add the following:

(11) Steps that must be taken immediately by radiography personnel in the event a pocket dosimeter is found to be off-scale.

Paragraph RH-1802(c)(2) will be changed to read as follows:

(2) Pocket dosimeters shall be read and exposures recorded daily.

Paragraph RH-18a2(c) will add the following:

(3) Pocket dosimeters shall be checked at periods not to exceed one year for correct response to radiation. Acceptable dosimeters shall read within plus or minus 30 percent of the true radiation exposure.

(4) If an individual's pocket dosimeter Is discharged beyond its range, his film badge or thermoluminescent dosimeter shall be immediately sent for processing.

(5) Reports received from the film badge or thermoluminescent dosimeter processor shall be maintained for inspection by the Department until it authorizes their disposal. Records of daily pocket dosimeter readings shall be kept for two years.

Paragraph RH-1803(d) will change as follows:

(d) Supervision'-pf Radiographers' Assistants, Whenever a radiographer's assistant uses radiographic exposure devices/uses sealed sources or related source handling tools, or conducts radiation surveys required by Paragraph RH-1803(c)(2) to determine that the sealed source has returned to the shielded position after an exposure, he shall be under the personal supervision of a radiographer.H include:

(1) the radiographer's personal presence at the site where the sealed sources are being used,

(2) the ability of the radiographer to give immediate ,assistance if required, and

(3) the radiographer's watching the assistant's performance of the operations referred to in this section.

Paragraph RH-1803(e) will add the following title to the existing contents:

(e) Records Required at Temporary Job Sites.

Paragraph RH-1803(f) will add the following title to the existing contents:

(f) Special Requirement and Exemptions for Enclosed Radiography.

Paragraph RH-1803 (e)(2)(B) changed to read:

A cabinet radiography unit shall not be operated until a physical radiation survey of the unit and areas adjacent to the unit has been performed. The licensee or registrant shall perform survey with a properly calibrated instrument as described in Paragraph RH-1801(e) to determine conformance with Paragraph RH-1203.

SECTION 3 Part J 1s retitled and changed to read:

Part J RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS AND SUBSURFACE TRACER STUDIES

RH-1900. General Provisions.

(a) Scope. The regulations in this part apply to all licensees' who use sources of radiation for wireline service operations including mineral logging, radioactive markers, or subsurface tracer studies.

(b) Purpose. The regulations in this part establish radiation safety requirements for persons utilizing sources of radiation for wireline service operations including mineral logging, radioactive markers, and subsurface tracer studies. The requirements of this part are in addition to, and not in substitution for other applicable requirements of these regulations.

(1) "Field stations" means a facility where radioactive sources may be stored or used and from which equipment is dispatched to temporary job sites.

(2) "Injection tool" means a device used for controlled subsurface injection of radioactive tracer material.

(3) "Logging supervisor" means the individual who provides personal supervision of the utilization of sources of radiation at the well site.

(4) "Logging tool" means a device used subsurface to perform well-logging.

(5) "Mineral logging" means any logging performed for the purpose of mineral exploration other than oil or gas.

(6) "Personal supervision" means guidance and instruction by the supervisor who is physically present at the job site and

watching the performance of the operation in such proximity that contact can be maintained and immediate assistance given as required.

(7) "Radioactive marker" means radioactive material placed subsurface or on a structure intended for subsurface use for the purpose of depth determination" or^direction-orientationr-

(8) "Source holder" means a housing or assembly into which a radioactive source is placed for the purpose of facilitating the handling and use of the source in well-logging operations.

(9) "Subsurface tracer study" means the release of a substance tagged with radioactive material for the purpose of tracing the movement or position of the tagged substance in the well-bore or adjacent formation.

(10) "Temporary jobsite" means a location to which radioactive materials have been dispatched to perform wireline service operations or subsurface tracer studies.

(11) "Well-bore" means a drilled hole in which wireline service operations and subsurface tracer studies are performed.

(12) "Well-logging" means the lowering and raising of measuring devices or tools which may contain sources of radiation into well-bores or cavities for the purpose of obtaining information about the well and/or adjacent formations.

(13) "Wireline" means a cable containing one or more electrical conductors which is used to lower and raise logging tools in the well-bore.

(14) "Wireline service operation" means any evaluation or mechanical service which is performed in the well-bore using devices on a wireline.

(d) Prohibition, No licensee shall perform wireline service operations unless'; operation, the licensee has a written agreement with the well operator, well owner, drilling contractor, or land owner that:

(1) in the event a sealed source is lodged downhole, a reasonable effort at recovery will be made; and

(2) in the event a decision is made to abandon the sealed source downhole, the requirements of Paragraph RH-1904 (a)(3)_ shall be met.

RH-1901. Equipment Control.

(a) Limits on Levels of Radiation, Sources of radiation shall be used, stored and transported in such a manner that the requirements of Paragraphs RH-1002(b), RH-1200, RH-1203, and RH-3202 are met.

(b) Storage Precautions.

(1) Each source of radiation, except accelerators, shall be provided with a storage and/or transport container. The container shall be provided with a lock, or tamper seal for calibration sources, to prevent unauthorized removal of, or exposure to, the source of radiation,

(2) ' Source of radiation shall be stored in a manner which will minimize danger from explosion and/or fire.

(c) Transport Precaution^. Transport containers shall be physically secured to the transporting vehicle to prevent accidental loss, tampering or unauthorized removal.

(d) Radiation Survey Instruments.

(1) The licensee shall maintain sufficient calibrated and operable radiation survey instruments at each field station to make physical radiation surveys as required by this part and by Paragraph RH-1300. Instrumentation shall be capable I of measuring 0.1 milliroentgen per hour through at least 20 milliroentgens per hour.

(2) Each radiation survey instrument shall be calibrated:

(A) at intervals not to exceed 6 months and after each instrument servicing;

(B) at energies and radiation levels appropriate for use; and

(3) Calibration records shall be maintained for a period of 2 years for inspection by the Department.

(e) Leak Testing of Sealed Sources.

(1) Requirements. Each licensee using sealed sources of radioactive material shall have the sources tested for leakage. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the Department.

(2) Method of Testing. Tests for leakage shall be performed only by persons specifically authorized to perform such tests by the Department, another Agreement State, or the U.S. Nuclear Regulatory Commission. The test sample shall be taken from the surface of the source, source holder, or from the surface of the device in which the source is stored or mounted and on which one might expect contamination to accumulate. The test sample shall be analyzed for radioactive contamination, and the analysis shall be capable of detecting the presence of 0.005 microcurie of radioactive material on the test sample.

(3) Interval of Testing. Each sealed source of radioactive material shall be tested at intervals not to exceed 6 months. In the absence of a certificate from a transferor indicating that a test has been made prior to the transfer, the sealed source shall not be put into use until tested. If, for any reason, it is suspected that a sealed source may be leaking, it shall be removed from service immediately and tested for leakage as soon as practical.

(4) Leaking or Contaminated Sources. If the test reveals the presence of 0.005 microcurie or more of leakage or contamination, the licensee shall immediately withdraw the source from use and shall cause it to be decontaminated, repaired, or disposed of in accordance with these regulations. A report describing the equipment involved, the test results and the corrective action taken shall be filed with the Department (within 5 days of the test).

(5) Exemptions. The following sources are exempted from the periodic leak test requirements of RH-1901(e)(l) through (4):

(A) Hydrogen-3 sources;

(B) sources of radioactive material with a half-life of 30 days or less;

(D) sources of beta and/or gamma emitting radioactive material with an activity of 100 microcuries or less; and

(E) sources of alpha emitting radioactive material with an activity of 10 microcuries or less.

(f) Quarterly Inventory. - Each licensee shall conduct a quarterly physical inventory to account for all sources of radiation. Records of inventories shall be maintained for 2 years from the date of the inventory for inspection by the Department and shall include the quantities and kinds of sources of radiation, the location where sources of radiation are assigned, the date of the inventory, and the name of the individual conducting the inventory.

(g) Utilization Records. Each licensee shall maintain current records, which shall be kept available for inspection by the Department for 2 years from the date of the recorded event, showing the following information for each source of radiation:

(1) make, model number, and a serial number or a description of each source of radiation used;

(2) the identity of the well-logging supervisor or field unit to whom assigned;

(3) locations where used and dates of use.;

{4) In the case of tracer materials and radioactive markers, the utilization record shall indicate the radionuclide and activity used in a particular well.

(h) Design, Performance, and Certification Criteria for Sealed Sources Used in Downhole Operations.

(1) Each sealed source, except those containing radioactive material in"ga:seous-form that is-used-in downhole-operations and manufactured after July 1, 1983, shall be certified by the manufacturer, or other testing organization acceptable to the Department, to meet the following minimum criteria:

(A) be of doubly encapsulated construction;

(B) contain radioactive material whose chemical and physical forms are as insoluble and non-dispersible as practical; and

(2) For sealed sources, except those containing radioactive material in gaseous form, acquired after July 1, 1983, in the absence of a certificate from a transferor certifying that an individual sealed source meets the requirements of Paragraph RH-1901{h)(l), the sealed source shall not be put into use until such determinations and testing have been performed.

(3) Each sealed source, except those containing radioactive material in gaseous form, that is used in downhole operations after July 1, 1983, shall be certified by the manufacturer, or othertesting organization acceptable to the Department, as meeting the sealed source performance requirements for oil well-logging as contained in American National Standard N542-1977, "Sealed Radioactive Sources, Classification." (4) Certification documents shall be maintained for inspection by the Department for a period of 2 years after source disposal.

(i) Labeling.

material shall bear a durable, legible, and clearly visible marking or label, which has, as a minimum, the standard radiation caution symbol, without the conventional color requirement, and the following wording:

DANGER RADIOACTIVE

This labeling shall be on the smallest component transported as a separate piece of equipment.

(2) Each transport container shall have permanently attached to it a durable, legible and clearly visible label which has, as a minimum, the standard radiation caution symbol and the following wording:

(J) Inspection arid Maintenance.

(1) Each licensee shall conduct, at intervals not to exceed 6 months, a program of inspection and maintenance of source holders, logging tools, source handling tools, storage containers, transport containers, and injection tools to assure proper labeling and physical condition. Records of inspection and maintenance shall be maintained for a period of 2 years for inspection by the Department.

(2) If any inspection conducted pursuant to Paragraph RH-1901(j){l) reveals damage to labeling or components critical to radiation safety, the device shaVl be-removed from-service until repairs have been made.

(3) The repair, opening, or modification of any sealed source shall be performed only by persons specifically authorized to do so by the Department, another Agreement State, or the U.S. Nuclear Regulatory Commission.

RH-1902. Requirements for Personnel Safety.

(a) Training Requirements.

(1) No licensee shall permit any individual to act as a logging supervisor as defined in this part until such individual has:

(A) received, in a course recognized by the Department,another Agreement State, or the U.S. Nuclear Regulatory Commission, instruction in the subjects outlined in Paragraph RH-1905 and shall have demonstrated an understanding thereof;

(B) read and received instruction in the regulations contained in this Part and the applicable requirements of Sections 1, 2, and 3 of these regulations or their equivalent, conditions of appropriate license and the licensee's operating and emergency procedures, and shall have demonstrated an understanding thereof; and

(C) demonstrated eompetenee-to-use-sourees-of-radiation, related handling tools and radiation survey instruments which will be used on the job.

(2) No licensee shall permit any individual to assist in the handling of sources of radiation until such individual has:

(A) read or received instruction in the licensee's operating and emergency procedures, and shall have demonstrated an understanding thereof; and

(B) demonstrated competence to use, under the personal supervision of the logging supervisor, the sources of radiation, related handling tools and radiation survey instruments which will be used on the job.

(3) Records of the above training shall be maintained, for inspection by the Department, during the period of employment by the licensee or for a two year period, whichever is longer.

(b) Operating and Emergency Procedures. The licensee's operating and emergency procedures shall include instructions in at least the following:

(1) handling and use of sources of radiation to be employed so that no individual is likely to be exposed to radiation doses in excess of the limits established in Section 3, Part C, of these regulations. Every reasonable effort shall be made to keep radiation exposures and releases of radioactive material in effluents to unrestricted areas as low as is reasonably achievable (See Paragraph RH-1002(b));

(2) methods and,occasions for conducting radiation surveys;

(3) methods and occasions for locking and securing sources of radiation;

(4) personnel monitoring and the use of personnel monitoring equipment;

(5) transportation to temporary jobsites and field stations, including the packaging and placing of sources of radiation in the vehicles, placarding of vehicles, and securing sources of radiation during transportation;

(6) minimizing exposure of individuals in the event of an accident;

(7) the procedure for notifying proper personnel in the event of an accident;

(8) maintenance of records;

(9) the inspection and maintenance of source holders, logging tools, source handling tools, storage containers, transport containers, and injection tools;

(10) the procedure to be followed in the event a sealed source is lodged downhole; and (n) the procedures to be used for picking up, receiving and opening packages containing radioactive material.

(1) No licensee shall permit any individual to act as a logging supervisor or to assist in the handling of sources of radiation unless each such individual wears either a film badge or a thermoluminescent dosimeter (TLD) at all times during wireline operations utilizing sources of radiation. Each film badge or TLD shall be assigned to and worn by only one individual.

(2) Personnel monitoring records shall be maintained for inspection by the Department until it authorizes their disposal.

RH-1903. Precautionary Procedures in Logging and Subsurface Tracer Qperat1on_s.

(a) Security. During each logging or tracer application, the logging supervisor or other designated employee shall maintain direct surveillance of the operation to protect against unauthorized and/or unnecessary entry into a restricted area, as defined in Section C, Part D of these regulations.

(b) Handling Tools. The licensee shall provide and require the use of tools that will assure remote handling of sealed sources other than low activity calibration sources.

(1) Protective gloves and other protective clothing, as appropriate, shall be used by all personnel handling radioactive tracer material. Precautions shall be taken to avoid ingestion or inhalation of radioactive material.

(2) No licensee shall cause the injection of radioactive material into potable aquifers without prior written authorization from the Department.

(d) Particle Accelerators. No licensee shall permit above-ground testing of particle accelerators, designed for use in well-logging, which results in the production of radiation, except in areas or facilities controlled or shielded so that the requirements of Paragraph RH-1200 and Paragraph RH-T203, as applicabal are met.

(e) Radiation Surveys and Records.

(1) Radiation surveys and/or calculations shall be made of and recorded for each area where radioactive materials are stored.

(2) Radiation surveys and/or calculations shall be made of and recorded for the radiation levels in occupied positions and on the exterior of each vehicle used to transport radioactivematerials. Such surveys and/or calculations shall include each source of radiation or combination of sources to be transported in the vehicle.

(3) After removal of the sealed source from the logging tool and before departing the jobsite, the logging tool detector shall be energized, or a survey meter used, to assure that the logging tool is free of contamination.

(4) Radiation surveys shall be made and recorded at the jobsite or well-head for each tracer operation, except those using Hydrogen-3, Carbon-14, and Sulfur-35. These surveys shall include measurements of radiation levels before and after the operation.

(f) Records required pursuant to Paragraph RH-1903(e)(l) through (4) shall include the dates, the identification of individual(s) making the survey, the identification of survey instrument(s) used, and an exact description of the location of the survey. Records of these surveys shall be maintained for inspection by the Department -for-2-years-after completion of the-survey.

(g) Documents and Records Required at Field Stations. Each licensee shall maintain, for inspection by the Department, the following documents and records for the specific devices and sources used at the field station:

(1) appropriate license;

(2) operating and emergency procedures;

(3) applicable regulations;

(4) records of the latest survey instrument calibrations pursuant to Paragraph RH-1903(e)

(5) records of the latest leak test results pursuant to Paragraph RH-1901(e)

(6) quarterly inventories required pursuant to Paragraph RH-1901(f)

(7) utilization records required pursuant to Paragraph RH-1901(g)

(8) records of inspection and maintenance required pursuant to Paragraph RH-1901(j); and

(9) survey records required pursuant to Paragraph RH-1903(e)

(h) Documents and Records Required at Temporary Jdbsites. Each liicensee conducting operations at a temporary job site shall have the following documents and records available at that site for inspection by the Department:

(1) operating and emergency procedures;

(2) survey records required pursuant to Paragraph RH-1903{e) for the period of operation at the site;

(3) "evidenceof'CurrentcaT1-bration-for the radiation survey instruments in use at the site; and (4) when operating in the State under reciprocity, a copy of the appropriate license, or equivalent document(s).

RH-1904. Notification.

(a) Notification of Incidents, Abandonment, and Lost Sources.

(1) Notification of incidents and sources lost in other than downhole logging operations shall be made in accordance with appropriate provisions of Section 3 of these regulations.

(2) Whenever a sealed source or device containing radioactive material is lodged downhole, the licensee shall:

(A) monitor at the surface for the presence of radioactive contamination with a radiation survey instrument or logging tool during logging tool recovery operations; and

(B) notify the Department immediately by telephone if radioactive contamination is detected at the surface or if the source appears to be damaged.

(3) When it becomes apparent that efforts to recover the radioactive source will not be successful, the licensee shall:

(A) advise the well-operator of the regulations of the Department regarding abandonment and an appropriate method of abandonment, which shall include:

(i) the immobilization and sealing in place of theradioactive source with a cement plug,

(ii) the setting of a whipstock or other, deflection device, and

(iii) the mounting of a permanent identification plaque, at the surface of the well, containing the appropriate Information required by Paragraph RH-J904(a)(!4)

(B) notify the .-Department by telephone, giving the circumstances of the loss, and request approval of the proposed . ! abandonment procedures; and

(C) file a written report with the Department within 30 days of the abandonment, setting forth the following information;

(i) date of occurrence and a brief description of attempts to recover the source,

(ii) a description of the radioactive source involved, including radionuclide, quantity, and chemical and physical form,

(iii) surface location and identification of well,

(iv) results of efforts to immobilize and set the source in place,

(v) depth of the radioactive source,

(vi) depth of the top of the cement plug,

(vii) depth of the well, and

(viii) information contained on the permanent identification plaque,

(4) Whenever a sealed source .containing radioactive material is abandoned downhole, the licensee shall provide a permanent plaque^ for-posting the weM or well-bore. This plaque shall:

(A) be constructed of long-lasting material, such as stainlesssteel or monel; and

(b) contain the following information engraved on its face;

(i) the word "CAUTION,"

(ii) the radiation symbol without the conventional color requirement,

(iii) the date of abandonment;

(iv) the name of the well operator or well owner,

(v) the well name and well identification number(s) or other designation,

(vi) the sealed source(s) by radionuclide and quantity of activity,

(vii) the source depth and the depth to the top of the plug, and 2 An example of a suggested plaque is shown in Appendix B of this Part.

(viii) an appropriate warm'ngj depending on the specific circumstances of each abandonment.(5) The licensee shall immediately notify the Department bytelephone and subsequently by confirming letter if the licensee knows or has reason to believe that radioactive material has been lost in or to an underground potable water source. Such notice shall designate the well location and shall describe the magnitude and extent of loss of radioactive material, assess the consequences of such loss and explain efforts planned or being taken to mitigate these consequences.

Appropriate warnings may include:

(a) "Do not drill below plug back depth;"

(b) "Do not enlarge casing;" or

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RH-1905. Subjects to be Included in Training Courses for Logging Supervisors.

(a) Fundatfientals of Radiation Safety.

(1) Characteristics of radiation

(2) Units of radiation dose (rem) and quantity of radioactivity (Curie)

(3) Significance of radiation dose

(A) Radiation protection standards

(B) Biological effects of radiation dose

(4) levels of radiation from sources.of radiation.

(5) Methods of minimizing radiation dose

(A) Working time

(B) Working distances

(b) Radiation Detection Instrumentation to be Used,

(1) Use of radiation survey instruments

(A) Operation

(B) Calibration

(2) Survey techniques

(3) Use of personnel monitoring equipment

(1) Handling Equipment

(2) Sources of Radiation

(3) Storage and control of equipment.

(4) Operation and control of equipment

(d) The Requirements of Pertinent Federal and State Regulations

(e) The Licensee's Written Opefatirig arid Emergency Procedures

(f) The licensee's Record Keeping Procedures

Paragraph RH-2300 Appendix B has added the following to the title:

RH-2300 Appendix B (For use in RH-1303, RH-1402, and RH-1403)

Paragraph RH-3200 is changed to read as follows:

RH-3200 Transportation of Radioactive Material. No person shall deliver radioactive material to a carrier for transport or transport radioactive material except as authorized in a general or specific license issued by the Department or as exempted in Paragraph RH-3300.

Paragraph RH-3201 is added as follows:

RH-3201. Intrastate Transport of Radioactive Materials.

(a) A general license is hereby issued to any common or contract carrier to receive, possess, 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 the regulations, appropriate to themode of transport, of the US. Department of Transportation insofar as such regulations relate to the loading and storage of packages, placarding of the transporting vehicle, 9 and incident reporting.

(b) A general license is hereby issued to any private carrier to transport radioactive material, provided the transportation is in accordance with the applicable requirements of the 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 9 reporting.

(c) Persons who transport radioactive material pursuant to the general licenses in Paragraph RH-3201(a) or (b) are exempt from the requirements of Section 3 of these regulations to the extent that they transport radioactive material.

Any notification of incidents referred to in those requirements shall be filed with, or made to , the Department.

Paragraph RH-3202 will be added as follows:

RH-3202. Preparatibh of Radioactive Material for Transport. A general licenseis hereby issued to deliver radioactive material to a carrier for transport provided that:

(a) The licensee complies with the applicable requirements of the regulations, appropriate to the mode of transport, of the U.S. Department of Transportation insofar as such regulations relate to the packaging of radioactive-material ,-and-to the monito.ri.ng,_marking and labeling. of those packages.

(b) The licensee has established procedures for safely opening and closing packages in which radioactive material is transported and to assure that, prior to the delivery to a carrier for transport, each package is properly closed for transport,

(c) Prior to delivery of a package to a carrier for transport, the licensee shall assure that any special instructions needed to safely openthe package are sent to or have been made available to the consignee.

For the purpose of this regulation, a licensee who transports his own licensed material as a private carrier is considered to have delivered such material to a carrier for transport.

Paragraph RH-3203 will be added as follows:

RH-3203. Advance Notification of Transport of Nuclear Waste.* :

(a) Prior to the transport of any nuclear waste outside of the confines of the licensee's facility or other place of use or storage, or prior to the delivery of any nuclear waste to a carrier for transport, each licensee shall provide advance notification of such transport to the governor (or governor's designee) of each State through-which the waste-will be transported.

(b) Each advance notification required by Paragraph RH-3203(a) shall contain the following information:

(1) The name, address, and telephone number of the shipper, carrier, and receiver of the shipment;

(2) A description of the nuclear waste contained in the shipment as required by the regulations of the U.S. Department of Transportation in 49 CFR 172.202 and 172.203(d);

(3) The point of origin of the shipment and the seven-day period during which departure of the shipment is estimated to occur;

(4) The seven-day period during which arrival of the shipment at State boundaries is estimated to occur;

(5) The destination of the shipment, and the seven-day period during which arrival of the shipment is estimated to occur; and

(6) A point of contact with a telephone number for current shipment information.

* For the purpose of this section "nuclear waste" means any large quantity of source, byproduct, or special nuclear material required to be in Type B packaging while transported to , through or across State boundaries to a disposal site, or to a collection point for transport to a disposal site.

(c) The notification required by Paragraph RH-3203(a) shall be made in writing to the office of each appropriate governor (or governor's designee) and to the Department. A notification delivered by mail must be postmarked at least seven days before the beginning of the seven-day period during which departure of the shipment is estimated to occur. A notification delivered by messenger must reach the office of the governor (or go^ei^nor's designee) at least four days before the beginning of the seven-day period during which departure of the shipment is estimated to occur. A copy of the notification shall be retained by the ^ licensee for one year.

(d) The licensee shall notify each appropriate governor (or governor's designee) and the Department of any changes to schedule information provided pursuant to Paragraph RH-3203(a). Such notification shall be by telephone to a responsible individual in the office of the governor (or governor's designee) of the appropriate State or States.

Each licensee shall maintain for one year a record of the name of the individual contacted.

(e) Each licensee who cancels a nuclear waste shipment for which advance notification has been sent shall send a cancellation notice to the governor (or governor's designee) of each appropriate State and to the Department. A copy of the notice shall be retained by the licensee for one year.

Paragraph RH-3300 is changed to read as follows;

RH-3300. Exemptions.

(a) Common and contract carriers, freight forwarders, and warehousemen who are subject to the rules and regulations of the U.S. Department of Transportation or the U.S. Postal Service are exempt from these regulations to the extent that they transport or store radioactive material in the regular course of their carriage for another or storage incident thereto. Common and contract carriers who are not subject to the rules and regulations of the U.S. Department of Transportation or U.S. Postal Service are subject to Paragraph RH-3200 and other applicable sections of these regulations.

(b) Physicians, as defined in Paragraph RH-200, are exempt from the requirements of Paragraph RH-3202 to the extent that they transport radioactive material for use in the practice of medicine.

(c) Any licensee is exempt from Paragraph RH-3200 to the extent that he delivers to a carrier for transport packages each of which contains no radioactive material having a specific activity in excess of 0.002 microcurie per gram.

(d) Any licensee who delivers radioactive material to a carrier for transport, where such transport is subject to the regulations of the U.S. Postal Service, is exempt from the provisions of Paragraph RH-3200.

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Arkansas Administrative CodeAgency 007 - ARKANSAS DEPARTMENT OF HEALTHDivision 14 - Radiation Control and Emergency ManagementRule 007.14.82-001 - Control of Sources of Ionizing Radiation

Arkansas Administrative Code
Agency 007 - ARKANSAS DEPARTMENT OF HEALTH
Division 14 - Radiation Control and Emergency Management
Rule 007.14.82-001 - Control of Sources of Ionizing Radiation