[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: 10CFR32.15]

[Page 514-515]
 
                            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. 32.15  Same: Quality assurance, prohibition of transfer, and labeling.

    (a) Each person licensed under Sec. 32.14 shall:
    (1) Maintain quality assurance practices in the manufacture of the 
part or product, or the installation of the part into the product;
    (2) Subject inspection lots to such testing as may be required as a 
condition of the license issued under Sec. 32.14 taking a random sample 
of the size required by the tables in Sec. 32.110, and for Lot 
Tolerance Percent Defective of 5.0 percent, accept or reject inspection 
lots in accordance with the directions of Sec. 32.110; and
    (3) Visually inspect each unit, except electron tubes containing 
byproduct material, in inspection lots. Any unit which has an observable 
physical defect that could affect containment of the byproduct material 
shall be considered as a defective unit.
    (b) An application for a license or for amendment of a license may 
include a description of procedures proposed as alternatives to those 
prescribed by paragraph (a)(2) of this section, and proposed criteria 
for acceptance under those procedures. The Commission will approve the 
proposed alternative procedures if the applicant demonstrates that the 
operating characteristic curve or confidence interval estimate for the 
alternative procedures provides a Lot Tolerance Percent Defective of 5.0 
percent at the consumer's risk of 0.10.
    (c) No person licensed under Sec. 32.14 shall transfer to other 
persons for use under Sec. 30.15 of this chapter or equivalent 
regulations of an Agreement State:
    (1) Any part or product which has been tested and found defective 
under

[[Page 515]]

the criteria and procedures specified in the license issued under Sec. 
32.14, unless the defective units have been repaired or reworked and 
have then met such criteria as may be required as a condition of the 
license issued under Sec. 32.14; or
    (2) Any inspection lot which has been rejected as a result of the 
procedures in Sec. 32.110 or alternative procedures in paragraph (b) of 
this section, unless the defective units have been sorted and removed or 
have been repaired or reworked and have then met such criteria as may be 
required as a condition of the license issued under Sec. 32.14.
    (d) Label or mark each unit, except timepieces or hands or dials 
containing tritium or promethium-147, and its container so that the 
manufacturer or initial transferor of the product and the byproduct 
material in the product can be identified.

[31 FR 5317, Apr. 2, 1966, as amended at 34 FR 6652, Apr. 18, 1969; 39 
FR 22129, June 20, 1974; 43 FR 6922, Feb. 17, 1978]