CFR

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:

(a) The applicant satisfies the general requirements of § 30.33 of this chapter ;

(b) The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including:

(1) Chemical and physical form and maximum quantity of americium 241 or radium-226 in the source;

(2) Details of construction and design;

(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;

(5) Details of quality control procedures to be followed in manufacture of the source;

(6) Description of labeling to be affixed to the source or the storage container for the source;

(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.

Code of Federal Regulations

[30 FR 8192, June 26, 1965, as amended at 43 FR 6923, Feb. 17, 1978; 72 FR 55928, Oct. 1, 2007; 73 FR 42674, July 23, 2008]

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