New Hampshire Code of Administrative Rules
He - Department of Health and Human Services
Subtitle He-P - Former Division of Public Health Services
Chapter He-P 4000 - NEW HAMPSHIRE RULES FOR THE CONTROL OF RADIATION
Part He-P 4032 - SPECIFIC LICENSES FOR MANUFACTURE OR TRANSFER OF CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
Section He-P 4032.14 - Special Requirements for License to Manufacture or Initially Transfer Calibration Sources Containing Americium-241 or Radium-226 for Distribution to Persons Generally Licensed Under He-P 4031.04(r)

Universal Citation: NH Admin Rules He-P 4032.14

Current through Register No. 40, October 3, 2024

(a) An application for a specific license to manufacture or initially transfer calibration or reference sources containing americium-241 or radium-226 for distribution to persons generally licensed under He-P 4031.04(r) , shall be approved if:

(1) The applicant satisfies the general requirements of He-P 4030.09;

(2) The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including:
a. Chemical and physical form and maximum quantity of americium-241 or radium-226 in the source;

b. Details of construction and design;

c. Details of the method of incorporation and binding of the americium-241 or radium-226 in the source;

d. Procedures for and results of prototype testing of sources, which are designed to contain more than 185 becquerel (0.005 microcurie) of americium-241 or radium-226, to demonstrate that the americium-241 or radium-226 contained in each source will not be released or be removed from the source under normal conditions of use;

e. Details of quality control procedures to be followed in manufacture of the source;

f. Description of labeling to be affixed to the source or the storage container for the source; and

g. Any additional information, including experimental studies and tests, required by DHHS/RHS to facilitate a determination of the safety of the source;

(3) Each source will contain no more than 185 kilobecquerel (5 microcurie) of americium-241 or radium-226; and

(4) DHHS/RHS determines, with respect to any type of source containing more than 185 becquerel (0.005 microcurie) of americium-241 or radium-226, that:
a. The method of incorporation and binding of the americium-241 or radium-226 in the source is such that the americium-241 or radium-226 will not be released or be removed from the source under normal conditions of use and handling of the source; and

b. The source has been subjected to and has satisfactorily passed the appropriate tests prescribed by He-P 4032.14(d) .

(b) Each person licensed under He-P 4032.14 shall affix to each source, or storage container for the source, a label which shall contain sufficient information relative to safe use and storage of the source and shall include the following statement or information:

"The receipt, possession, use and transfer of this source, Model __, Serial No. __, are subject to a general license and the regulations of the DHHS/RHS, the NRC, an Agreement State, or a Licensing State. Do not remove this label. CAUTION-RADIOACTIVE MATERIAL- THIS SOURCE CONTAINS (AMERICIUM-241) OR (RADIUM-226) . DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE (Name of Manufacturer or Transferor) ."

(c) Each person licensed under He-P 4032.14 shall perform a dry wipe test upon each source containing more than 3.7 kilobecquerel (0.1 microcurie) of americium-241 or radium-226 before transferring the source to a general licensee under He-P 4031.04(r) . This test shall be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the paper shall be measured using methods capable of detecting 185 becquerel (0.005 microcurie) of americium-241 or radium-226. If a source has been shown to be leaking or losing more than 185 becquerel (0.005 microcurie) of americium-241 or radium-226 by the methods described in He-P 4032(c), the source shall be rejected and shall not be transferred to a general license under He-P 4031.04(r) , or equivalent regulations of the NRC, an agreement state or a licensing state.

(d) The applicant shall subject at least five prototypes of each source that is designed to contain more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 to tests as follows:

(1) The initial quantity of radioactive material deposited on each source is measured by direct counting of the source;

(2) The sources are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment or binding of americium-241 or radium-226, such as physical handling, moisture, and water immersion;

(3) The sources are inspected for evidence of physical damage and for loss of americium-241 or radium-226, after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in He-P 4032.14(d) (4); and

(4) Source designs are rejected for which the following has been detected for any unit: Removal of more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 from the source or any other evidence of physical damage.

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