32.57—Calibration or reference sources containing americium-241 or radium-226: Requirements for license to manufacture or initially transfer.
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 § 31.8 of this chapter, will be approved if:
(b)
The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including:
(3)
Details of the method of incorporation and binding of the americium-241 or radium-226 in the source;
(4)
Procedures for and results of prototype testing of sources, which are designed to contain more than 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;
(7)
Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the source.
(d)
The Commission determines, with respect to any type of source containing more than 0.005 microcurie of americium-241 or radium-226, that:
(1)
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
(2)
The source has been subjected to and has satisfactorily passed the prototype tests prescribed by § 32.102, Schedule C, of this part.