180 Neb. Admin. Code, ch. 3, § 031

Current through September 17, 2024

Section 180-3-031 - REGISTRATION OF PRODUCT INFORMATION

This section addresses registration of product information.

031.01REQUEST FOR EVALUATION. Any manufacturer or initial distributor of a sealed source or device containing a sealed source must submit a request to the Department for evaluation of radiation safety information about its product and for its registration.

031.02REQUEST FOR REVIEW. The request for review must be sent to the Department at the address in 180 NAC 1-012.

031.03REQUIREMENTS FOR REQUEST FOR REVIEW OF A SEALED SOURCE OR A DEVICE. The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.

031.04STANDARDS AND CRITERIA. The Department evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the Department will formulate reasonable standards and criteria with the help of the manufacturer or distributor. The Department will use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property. 10 CFR 32, Subpart A includes specific criteria that apply to certain exempt products, 180 NAC 3-014.04 through 3-014.09 includes specific criteria applicable to certain generally licensed devices, and 180 NAC 3-014.10, 3-014.12, and 3.014.14 includes specific provisions that apply to certain specifically licensed items.

031.05CERTIFICATE OF REGISTRATION. After completion of the evaluation, the Department issues a certificate of registration to the person making the request. 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.

031.06LIMITATION. The person submitting the request for evaluation and registration of safety information about the product must manufacture and distribute the product according to:

(A) The statements and representations, including quality control program, contained in the request; and

(B) The provisions of the registration certificate.

031.07AUTHORITY TO MANUFACTURE OR INITIALLY DISTRIBUTE A SEALED SOURCE OR DEVICE TO SPECIFIC LICENSEES. 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 no more than:

(i) 37 MBq (1 mCi), for beta or gamma emitting radionuclides; or

(ii)0.37 MBq (10 µCi), for alpha emitting radionuclides;

(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

(i) The intended recipients are licensed under 180 NAC 3-013, U.S. Nuclear Regulatory Commission (NRC) 10 CFR 33 or comparable provisions of an Agreement State;

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

(iii) The sources and devices are to be built to the unique specifications of the particular recipient and contain no more than 740 GBq (20 Ci) of tritium or 7.4 GBq (200 mCi) of any other radionuclide.

031.08ADDITIONAL REVIEW. After the certificate is issued, the Department may conduct additional review as it determines is necessary to ensure compliance with current regulatory standards. In conducting its review, the Department will complete its evaluation according to criteria specified in 180 NAC 3-031. The certificate holder must provide any additional information requested by the Department.

180 Neb. Admin. Code, ch. 3, § 031

Amended effective 6/15/2021