459.3075 - Sealed source or device containing sealed source intended for use under specific license: Request for evaluation and registration; manufacture and distribution

459.3075. 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 Federal and State Materials and Environmental Management Programs of the United States Nuclear Regulatory Commission, ATTN: SSDR, 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, 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, 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. In accordance with federal law, a request for review submitted pursuant to subsection 1 will be evaluated in the manner set forth in 10 C.F.R § 32.210(d).

6. 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 certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product or concerning use under an exemption from licensing or general license as applicable for the category of certificate, and 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.

7. Authority to manufacture or initially distribute a sealed source or device to specific licensees may be provided in the license without the issuance of a certificate of registration in the following cases:

(a) Calibration and reference sources containing:

(1) Not more than 37 megabecquerels (1 millicurie) for beta or gamma emitting radionuclides; or

(2) Not more than 0.37 megabecquerel (10 microcurie) for alpha emitting radionuclides; or

(b) The intended recipients are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in any form in the case of unregistered sources or, for registered sealed sources contained in unregistered devices, are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unshielded form, as specified in their licenses and:

(1) The intended recipients are licensed under 10 C.F.R. Part 33 or equivalent regulations of an agreement state;

(2) The recipients are authorized for research and development; or

(3) The sources and devices are to be built to the unique specifications of the particular recipient and contain not more than 740 gigabecquerels (20 curie) of tritium or 7.4 gigabecquerels (200 millicuries) of any other radionuclide.

8. After the certificate is issued, the certificate holder shall allow the Nuclear Regulatory Commission to conduct an additional review as the Nuclear Regulatory Commission determines is necessary to ensure compliance with current regulatory standards and to complete its evaluation in accordance with criteria specified in this section. The certificate holder shall provide the Nuclear Regulatory Commission such additional information as the Nuclear Regulatory Commission considers necessary to conduct its review.

9. A certificate holder who no longer manufactures or initially transfers any sealed source or device covered by a particular certificate issued by the Nuclear Regulatory Commission shall request inactivation of the registration certificate. Such a request must be sent to the Office of Federal and State Materials and Environmental Management Programs of the United States Nuclear Regulatory Commission, ATTN: SSDR, by a method listed in 10 C.F.R. § 30.6(a) and, except as otherwise provided in this subsection, must be made not later than 2 years after the initial distribution of all of the sources or devices covered by the certificate has ceased. If the certificate holder determines that an initial transfer was the last initial transfer more than 2 years after that transfer, the certificate holder must request inactivation of the certificate within 90 days after his or her determination and briefly describe the circumstances of the delay.

10. If a distribution license is to be terminated in accordance with 10 C.F.R. § 30.36, the licensee must request inactivation of its registration certificates associated with that distribution license before the Nuclear Regulatory Commission will terminate the license. Such a request for inactivation of certificates must indicate that the license is being terminated and include the associated specific license number.

11. A specific license to manufacture or initially transfer a source or device covered only by an inactivated certificate no longer authorizes the licensee to initially transfer such sources or certificate, including, without limitation, an inactive certificate.

Added to NAC by Bd. of Health by R085-06, eff. 11-13-2006; A by R144-13A, eff. 10-13-2016

NRS 459.201

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