[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: 10CFR32.22]

[Page 503-504]
 
                            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. 32.22  Self-luminous products containing tritium, krypton-85 or promethium-147: Requirements for license to manufacture, process, produce, or initially 
          transfer.

    (a) An application for a specific license to manufacture, process, 
or produce self-luminous products containing tritium, krypton-85, or 
promethium-147, or to initially transfer such products for use pursuant 
to Sec. 30.19 of this chapter or equivalent regulations of an Agreement 
State, will be approved if:
    (1) The applicant satisfies the general requirements specified in 
Sec. 30.33 of this chapter: Provided, however, That the requirements of 
Sec. 30.33(a) (2) and (3) do not apply to an application for a license 
to transfer tritium, krypton-85, or promethium-147 in self-luminous 
products manufactured, processed, or produced pursuant to a license 
issued by an Agreement State.
    (2) The applicant submits sufficient information relating to the 
design,

[[Page 504]]

manufacture, prototype testing, quality control procedures, labeling or 
marking, and conditions of handling, storage, use, and disposal of the 
self-luminous product to demonstrate that the product will meet the 
safety criteria set forth in Sec. 32.23. The information should include:
    (i) A description of the product and its intended use or uses.
    (ii) The type and quantity of byproduct material in each unit.
    (iii) Chemical and physical form of the byproduct material in the 
product and changes in chemical and physical form that may occur during 
the useful life of the product.
    (iv) Solubility in water and body fluids of the forms of the 
byproduct material identified in paragraphs (a)(2) (iii) and (xii) of 
this section.
    (v) Details of construction and design of the product as related to 
containment and shielding of the byproduct material and other safety 
features under normal and severe conditions of handling, storage, use, 
and disposal of the product.
    (vi) Maximum external radiation levels at 5 and 25 centimeters from 
any external surface of the product, averaged over an area not to exceed 
10 square centimeters, and the method of measurement.
    (vii) Degree of access of human beings to the product during normal 
handling and use.
    (viii) Total quantity of byproduct material expected to be 
distributed in the product annually.
    (ix) The expected useful life of the product.
    (x) The proposed method of labeling or marking each unit with 
identification of the manufacturer or initial transferor of the product 
and the byproduct material in the product.
    (xi) Procedures for prototype testing of the product to demonstrate 
the effectiveness of the containment, shielding, and other safety 
features under both normal and severe conditions of handling, storage, 
use, and disposal of the product.
    (xii) Results of the prototype testing of the product, including any 
change in the form of the byproduct material contained in the product, 
the extent to which the byproduct material may be released to the 
environment, any increase in external radiation levels, and any other 
changes in safety features.
    (xiii) The estimated external radiation doses and dose commitments 
relevant to the safety criteria in Sec. 32.23 and the basis for such 
estimates.
    (xiv) A determination that the probabilities with respect to the 
doses referred to in Sec. 32.23(d) meet the criteria of that paragraph.
    (xv) Quality control procedures to be followed in the fabrication of 
production lots of the product and the quality control standards the 
product will be required to meet.
    (xvi) Any additional information, including experimental studies and 
tests, required by the Commission.
    (b) Notwithstanding the provisions of paragraph (a) of this section, 
the Commission may deny an application for a specific license under this 
section if the end uses of the product cannot be reasonably foreseen.

[34 FR 9026, June 6, 1969, as amended at 43 FR 6923, Feb. 17, 1978]