[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR32.74]

[Page 532-533]
 
                            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. 32.74  Manufacture and distribution of sources or devices 
containing byproduct material for medical use.

    (a) An application for a specific license to manufacture and 
distribute sources and devices containing byproduct material to persons 
licensed pursuant to part 35 of this chapter for use as a calibration or 
reference source or for the uses listed in Sec. Sec. 35.400, 35.500, 
and 35.600 of this chapter will be approved if:
    (1) The applicant satisfies the general requirements in Sec. 30.33 
of this chapter;
    (2) The applicant submits sufficient information regarding each type 
of source or device pertinent to an evaluation of its radiation safety, 
including:
    (i) The byproduct material contained, its chemical and physical 
form, and amount;
    (ii) Details of design and construction of the source or device;
    (iii) Procedures for, and results of, prototype tests to demonstrate 
that the source or device will maintain its integrity under stresses 
likely to be encountered in normal use and accidents;
    (iv) For devices containing byproduct material, the radiation 
profile of a prototype device;
    (v) Details of quality control procedures to assure that production 
sources and devices meet the standards of the design and prototype 
tests;
    (vi) Procedures and standards for calibrating sources and devices;
    (vii) Legend and methods for labeling sources and devices as to 
their radioactive content;
    (viii) Instructions for handling and storing the source or device 
from the radiation safety standpoint; these instructions are to be 
included on a durable label attached to the source or device or attached 
to a permanent storage container for the source or device: Provided, 
That instructions which are too lengthy for such label may be summarized 
on the label and printed in detail on a brochure which is referenced on 
the label;
    (3) The label affixed to the source or device, or to the permanent 
storage container for the source or device, contains information on the 
radionuclide, quantity and date of assay, and a statement that the U.S. 
Nuclear Regulatory Commission has approved distribution of the (name of 
source or device) to persons licensed to use byproduct material 
identified in Sec. Sec. 35.65, 35.400, 35.500, and 35.600 as 
appropriate, and to persons who hold an equivalent license issued by an 
Agreement State. However, labels worded in accordance with requirements 
that were in place on March 30, 1987 may be used until March 30, 1989.
    (b)(1) In the event the applicant desires that the source or device 
be required to be tested for leakage of radioactive material at 
intervals longer than six months, he shall include in his application 
sufficient information to demonstrate that such longer interval is 
justified by performance characteristics of the source or device or 
similar sources or devices and by design features that have a 
significant bearing on the probability or consequences of leakage of 
radioactive material from the source.
    (2) In determining the acceptable interval for test of leakage of 
radioactive material, the Commission will consider information that 
includes, but is not limited to:
    (i) Primary containment (source capsule);
    (ii) Protection of primary containment;
    (iii) Method of sealing containment;
    (iv) Containment construction materials;

[[Page 533]]

    (v) Form of contained radioactive material;
    (vi) Maximum temperature withstood during prototype tests;
    (vii) Maximum pressure withstood during prototype tests;
    (viii) Maximum quantity of contained radioactive material;
    (ix) Radiotoxicity of contained radioactive material;
    (x) Operating experience with identical sources or devices or 
similarly designed and constructed sources or devices.
    (c) If an application is filed pursuant to paragraph (a) of this 
section on or before October 15, 1974, for a license to manufacture and 
distribute a source or device that was distributed commercially on or 
before August 16, 1974, the applicant may continue the distribution of 
such source or device to group licensees until the Commission issues the 
license or notifies the applicant otherwise.

[39 FR 26149, July 17, 1974, as amended at 51 FR 36967, Oct. 16, 1986; 
62 FR 59276, Nov. 3, 1997; 67 FR 20370, Apr. 24, 2002]