[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR32.23]

[Page 504-505]
 
                            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 A--Exempt Concentrations and Items
 
Sec. 32.23  Same: Safety criteria.

    An applicant for a license under Sec. 32.22 shall demonstrate that 
the product is designed and will be manufactured so that:
    (a) In normal use and disposal of a single exempt unit, it is 
unlikely that the external radiation dose in any one year, or the dose 
commitment resulting from the intake of radioactive material in any one 
year, to a suitable sample of the group of individuals expected to be 
most highly exposed to radiation or radioactive material from the 
product will exceed the dose to the appropriate organ as specified in 
Column I of the table in Sec. 32.24 of this part.
    (b) In normal handling and storage of the quantities of exempt units 
likely to accumulate in one location during marketing, distribution, 
installation, and servicing of the product, it is unlikely that the 
external radiation dose in any one year, or the dose commitment 
resulting from the intake of radioactive material in any one year, to a 
suitable sample of the group of individuals expected to be most highly 
exposed to radiation or radioactive material from the product will 
exceed the

[[Page 505]]

dose to the appropriate organ as specified in Column II of the table in 
Sec. 32.24.
    (c) It is unlikely that there will be a significant reduction in the 
effectiveness of the containment, shielding, or other safety features of 
the product from wear and abuse likely to occur in normal handling and 
use of the product during its useful life.
    (d)\1\ In use and disposal of a single exempt unit, or in handling 
and storage of the quantities of exempt units likely to accumulate in 
one location during marketing, distribution, installation, and servicing 
of the product, the probability is low that the containment, shielding, 
or other safety features of the product would fail under such 
circumstances that a person would receive an external radiation dose or 
dose commitment in excess of the dose to the appropriate organ as 
specified in Column III of the table in Sec. 32.24, and the probability 
is negligible that a person would receive an external radiation dose or 
dose commitment in excess of the dose to the appropriate organ as 
specified in Column IV of the table in Sec. 32.24.
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    \1\ It is the intent of this paragraph that as the magnitude of the 
potential dose increases above that permitted under normal conditions, 
the probability that any individual will receive such a dose must 
decrease. The probabilities have been expressed in general terms to 
emphasize the approximate nature of the estimates which are to be made. 
The following values may be used as guides in estimating compliance with 
the criteria:
    Low--not more than one such failure per year for each 10,000 exempt 
units distributed.
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    Negligible--not more than one such failure per year for each 1 
million exempt units distributed.

[34 FR 9027, June 6, 1969]