[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: 10CFR32.61]

[Page 528-529]
 
                            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. 32.61  Ice detection devices containing strontium-90; requirements 
for license to manufacture or initially transfer.

    An application for a specific license to manufacture or initially 
transfer ice detection devices containing strontium-90 for distribution 
to persons generally licensed under Sec. 31.10 of this chapter will be 
approved if:
    (a) The applicant satisfies the general requirements specified in 
Sec. 30.33 of this chapter;
    (b) The applicant submits sufficient information regarding each type 
of device pertinent to evaluation of the potential radiation exposure, 
including:
    (1) Chemical and physical form and maximum quantity of strontium-90 
in the device;
    (2) Details of construction and design of the source of radiation 
and its shielding;
    (3) Radiation profile of a prototype device;
    (4) Procedures for and results of prototype testing of devices to 
demonstrate that the strontium-90 contained in each device will not be 
released or be removed from the device under the most severe conditions 
likely to be encountered in normal handling and use;
    (5) Details of quality control procedures to be followed in 
manufacture of the device;
    (6) Description of labeling to be affixed to the device;
    (7) Instructions for handling and installation of the device;
    (8) Any additional information, including experimental studies and 
tests, required by the Commission to facilitate a determination of the 
safety of the device;
    (c) Each device will contain no more than 50 microcuries of 
strontium-90 in an insoluble form;
    (d) Each device will bear durable, legible labeling which includes 
the radiation caution symbol prescribed by Sec. 20.1901(a) of this 
chapter, a statement that the device contains strontium-90 and the 
quantity thereof, instructions for disposal and statements that the 
device may be possessed pursuant to a general license, that the 
manufacturer

[[Page 529]]

or civil authorities should be notified if the device is found, that 
removal of the labeling is prohibited and that disassembly and repair of 
the device may be performed only by a person holding a specific license 
to manufacture or service such devices;
    (e) The Commission determines that:
    (1) The method of incorporation and binding of the strontium-90 in 
the device is such that the strontium-90 will not be released from the 
device under the most severe conditions which are likely to be 
encountered in normal use and handling of the device;
    (2) The strontium-90 is incorporated or enclosed so as to preclude 
direct physical contact by any individual with it and is shielded so 
that no individual will receive a radiation exposure to a major portion 
of his body in excess of 0.5 rem in a year under ordinary circumstances 
of use;
    (3) The device is so designed that it cannot be easily disassembled;
    (4) The device has been subjected to and has satisfactorily passed 
the prototype tests prescribed by Sec. 32.103; and
    (5) Quality control procedures have been established to satisfy the 
requirements of Sec. 32.62.

[30 FR 9905, Aug. 10, 1965, as amended at 43 FR 6923, Feb. 17, 1978; 56 
FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993]