10 C.F.R. § 32.57 Calibration or reference sources containing americium-241: Requirements for license to manufacture or initially transfer.
Title 10 - Energy
An application for a specific license to manufacture or initially transfer calibration or reference sources containing americium-241, 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 in the source; (2) Details of construction and design; (3) Details of the method of incorporation and binding of the americium-241 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, to demonstrate that the americium-241 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. (c) Each source will contain no more than 5 microcuries of americium-241. (d) The Commission determines, with respect to any type of source containing more than 0.005 microcurie of americium-241, that: (1) The method of incorporation and binding of the americium-241 in the source is such that the americium-241 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. [30 FR 8192, June 26, 1965, as amended at 43 FR 6923, Feb. 17, 1978]
Title 10: Energy
PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
Subpart B—Generally Licensed Items
§ 32.57 Calibration or reference sources containing americium-241: Requirements for license to manufacture or initially transfer.
