NAC459.3075. Sealed source or device containing sealed source intended for use under specific license: Request for evaluation and registration; manufacture and distribution.

     1. A manufacturer or initial distributor of a sealed source or device containing a sealed source whose product is intended for use under a specific license may submit a request to the Nuclear Regulatory Commission or an agreement state for evaluation of the radiation safety information concerning its product and for registration of the product.

     2. A request for review submitted pursuant to subsection 1 must be sent to the Office of Nuclear Material Safety and Safeguards of the United States Nuclear Regulatory Commission by a method listed in 10 C.F.R. § 30.6(a) or to the equivalent agency of an agreement state.

     3. A request for review of a sealed source submitted pursuant to subsection 1 must include, without limitation, sufficient information concerning the:

     (a) Design of the sealed source;

     (b) Manufacture of the sealed source;

     (c) Prototype testing of the sealed source;

     (d) Quality control program proposed for the sealed source;

     (e) Labeling of the sealed source;

     (f) Proposed uses of the sealed source; and

     (g) Leak testing of the source,

Ê to provide reasonable assurance that the radiation safety properties of the sealed source are adequate to protect health and minimize the danger to life and property.

     4. A request for review of a device containing a sealed source submitted pursuant to subsection 1 must include, without limitation, sufficient information concerning the:

     (a) Design of the device;

     (b) Manufacture of the device;

     (c) Prototype testing of the device;

     (d) Quality control program proposed for the device;

     (e) Labeling of the device;

     (f) Proposed uses of the device;

     (g) Leak testing of the device;

     (h) Installation of the device;

     (i) Service and maintenance of the device;

     (j) Operating and safety instructions concerning the device; and

     (k) Potential hazards associated with the device,

Ê to provide reasonable assurance that the radiation safety properties of the device are adequate to protect health and minimize the danger to life and property.

     5. If the Nuclear Regulatory Commission or agreement state completes an evaluation pursuant to a request made pursuant to subsection 1 and issues a certificate of registration to the manufacturer or initial distributor of a sealed source or device containing a sealed source who made the request pursuant to subsection 1, the manufacturer or initial distributor shall manufacture and distribute the product in accordance with:

     (a) The statements and representations, including, without limitation, the quality control program, contained in the request submitted pursuant to subsection 1; and

     (b) The provisions of the certificate of registration.

     (Added to NAC by Bd. of Health by R085-06, eff. 11-13-2006)