Radiation machines, except when not installed in such manner as to be capable of producing radiation.
To SECTION 1, Part D. the following is added:
Paragraph RH-30Ub) will add the following:
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:
"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
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:
Paragraph RH-405(c) is changed to read as follows:
Paragraph RH-408 is changed as follows:
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:
Paragraph RH-903, Schedule D, Group III will add the following:
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.
Group V. Prepared Radiopharmaceuticals for Certain Therapeutic Uses
That Normally Require Hospitalization for Purposes of Radiation Safety.
Paragraph RH-904, Schedule E is retitled as follows:
Paragraph RH-1303(c) will add the following:
'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}.
Paragraph RH-1401 is changed to read as follows:
Paragraph RH-1402(d) is changed to read as follows:
Paragraph RH-1403 will add the following:
Paragraph RH-1404 1s changed to read:
Paragraph RH-1405, Disposal of Specific Wastes, will be added as follows:
Paragraph RH-1602(a) will add the following:
Paragraph RH-1603 will add the following:
Paragraph RH-1604(a)(2) is changed to read as follows:
Paragraph RH-1607 is changed to read as follows:
Paragraph RH-1608 is changed to read:
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 |
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 |
The radiation detectors specified in Paragraph RH-1608;b)(6) may form part of this system.
However, where excessive noise levels makes aural communication impractical, other methods of communication shall be used.
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.
Paragraph RH-1701 will add the following:
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.
The "distance measuring " device streating humans;
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.
Paragraph RH-1800(c) will add the following:
NOTE: Changes will be incorporated such that the definitions will be in alphabetical order.
Paragraph RH-1801(h) and (i) are changed as follows;
Paragraph RH-1802(a){1) will add the fonowing;
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:
Paragraph RH-18a2(c) will add the following:
Paragraph RH-1803(d) will change as follows:
Paragraph RH-1803(e) will add the following title to the existing contents:
Paragraph RH-1803(f) will add the following title to the existing contents:
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.
watching the performance of the operation in such proximity that contact can be maintained and immediate assistance given as required.
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.
Appropriate warnings may include:
Paragraph RH-2300 Appendix B has added the following to the title:
Paragraph RH-3200 is changed to read as follows:
Paragraph RH-3201 is added as follows:
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.
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:
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:
* 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.
Each licensee shall maintain for one year a record of the name of the individual contacted.
Paragraph RH-3300 is changed to read as follows;
007.14.82 Ark. Code R. § 001