[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: 10CFR32.27]

[Page 519]
 
                            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. 32.27  Same: Safety criteria.

    An applicant for a license under Sec. 32.26 shall demonstrate that 
the product is designed and will be manufactured so that:
    (a) In normal use and disposal of a single exempt unit, and 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 dose to the 
appropriate organ as specified in Column I of the table in Sec. 32.28.
    (b) 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.
    (c) In use and disposal of a single exempt unit and 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 II of the table in Sec. 32.28, 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 III of the table in Sec. 32.28. \1\
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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.
    Negligible--not more than one such failure per year for each one 
million exempt units distributed.

[34 FR 6654, Apr. 18, 1969]