[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR32.57]

[Page 529-530]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN 
ITEMS CONTAINING BYPRODUCT MATERIAL--Table of Contents
 
                   Subpart B--Generally Licensed Items
 
Sec. 32.57  Calibration or reference sources containing americium-241: 
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, for 
distribution to persons generally licensed under Sec. 31.8 of this 
chapter, will be approved if:
    (a) The applicant satisfies the general requirements of Sec. 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.

[[Page 530]]

    (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 Sec. 32.102, Schedule C, of this 
part.

[30 FR 8192, June 26, 1965, as amended at 43 FR 6923, Feb. 17, 1978]