[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: 10CFR32.61]

[Page 530-531]
 
                            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;

[[Page 531]]

    (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 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]