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§ 30201. Requirements and Conditions for License to Manufacture or Distribute Products or Devic...

17 CA ADC § 30201Barclays Official California Code of Regulations

Barclays California Code of Regulations
Title 17. Public Health
Division 1. State Department of Health Services (Refs & Annos)
Chapter 5. Sanitation (Environmental) (Refs & Annos)
Subchapter 4. Radiation
Group 2. Licensing of Radioactive Materials
Article 4. Licenses
17 CCR § 30201
§ 30201. Requirements and Conditions for License to Manufacture or Distribute Products or Devices Containing Depleted Uranium.
(a) In addition to the requirements set forth in section 30194, a specific license to manufacture industrial products or devices containing depleted uranium, or to initially transfer such products or devices for use under section 30192.6 or equivalent Nuclear Regulatory Commission (NRC) or Agreement State provisions, will be issued only if the applicant submits information regarding:
(1) The design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards, of the industrial product or device, so as to provide reasonable assurance that possession, use, or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in one year a radiation dose in excess of 10 percent of the annual limits specified in title 10 Code of Federal Regulations, Part 20 (10 CFR 20) section 20.1201(a), incorporated by reference in section 30253; and
(2) The industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device, so as to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.
(b) Each person licensed under subsection (a) shall:
(1) Maintain the level of quality control required by the license in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device; and
(2) Label or mark each product and device to:
(A) Identify the manufacturer or initial transferor of the product or device and the number of the license under which the product or device was manufactured or initially transferred, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and
(B) State that the receipt, possession, use, and transfer of the product or device is subject to the general license requirements in section 30192.6 or 10 CFR 40.25 or the applicable Agreement State requirements equivalent to 10 CFR 40.25; and
(3) Assure that the depleted uranium, before being installed in each product or device, has been impressed with the legend, “Depleted Uranium,” clearly legible through any plating or other covering; and
(4) Furnish a copy of sections 30108.1 and 30192.6 or equivalent NRC or Agreement State provisions, as appropriate, to each person to whom depleted uranium is transferred for use pursuant to the general license contained in section 30192.6 or equivalent NRC or Agreement State provisions.
(5) Report to the Department all transfers of industrial products or devices for use under the general license in section 30192.6. Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the Department and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter. If no transfers have been made during the reporting period to persons generally licensed under section 30192.6, the report shall so indicate;
(6) Report to NRC all transfers of industrial products or devices for use under the general license in 10 CFR 40.25. Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between NRC and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person. If no transfers have been made during the reporting period to a person generally licensed under 10 CFR 40.25, this information shall be reported to NRC.
(7) Report to the responsible Agreement State agency all transfers of industrial products or devices for use under the general license in the Agreement State regulation equivalent to 10 CFR 40.25. Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person. If no transfers have been made during the reporting period to a particular Agreement State, this information shall be reported to the responsible Agreement State agency;
(8) Keep records showing the name, address, and a point of contact for each general licensee to whom the individual transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in section 30192.6 or equivalent regulations of NRC or an Agreement State. The records shall be retained for three years from the date of transfer and must show the date of each transfer, the quantity of depleted uranium in each product or device transferred, a copy of each report provided pursuant to paragraphs (5), (6) and (7), and the date of the report's submittal.

Credits

Note: Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 114985(g), 115000, 115060, 115165, 115230, 115235, 131050, 131051 and 131052, Health and Safety Code.
History
1. New section filed 8-7-2019; operative 10-1-2019 (Register 2019, No. 32).
This database is current through 4/26/24 Register 2024, No. 17.
Cal. Admin. Code tit. 17, § 30201, 17 CA ADC § 30201
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