N. C. Regulations for Protection Against Radiation

15A NCAC 11 .0335          SPECIFIC LICENSES: PRODUCTS CONTAINING DEPLETED URANIUM

(a)  An application for a specific license to manufacture industrial products and devices containing depleted uranium for use pursuant to Rule .0307(e) of this Section or equivalent regulations of the U.S. Nuclear Regulatory Commission or an agreement state will be approved if:

(1)           the applicant satisfies the general requirements specified in Rule .0317 of this Section;

(2)           the applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards of the industrial product or device 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 any period of one calendar quarter a radiation dose in excess of ten percent of the limits specified in Rule .1604 of this Chapter; and

(3)           the applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass‑volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.

(b)  In the case of an industrial product or device whose unique benefits are questionable, the agency will approve an application for a specific license under this Rule only if the product or device is found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.

(c)  The agency may deny any application for a specific license under this Rule if the end use(s) of the industrial product or device cannot be reasonably foreseen.

(d)  Each person licensed pursuant to Paragraph (a) of this Rule 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;

(2)           label or mark each unit to:

(A)          identify the manufacturer of the product or device and the number of the license under which the product or device was manufactured, 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 are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or of an agreement state;

(3)           assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: "Depleted Uranium".

(e)  Each person, licensed under this Rule to distribute devices, shall furnish a copy of the general license contained in Section 40.25 of 10 CFR Part 40 to each person to whom he directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license contained in Rule .0307(e) of this Section, or equivalent regulations of the U.S. Nuclear Regulatory Commission or an agreement state.  The copy of Section 40.25 of 10 CFR Part 40 shall be accompanied by a note explaining that the use of the device is regulated by agreement states under requirements substantially the same as those in Section 40.25 of 10 CFR Part 40.  Alternatively, when transferring the devices to persons in a specific agreement state, a copy of that agreement state equivalent regulations shall be furnished.

(f)  Each person, licensed under this Rule to distribute devices, shall report to the agencies specified in Subparagraphs (f)(1),(2) and (3) of this Rule all transfers of the devices to persons generally licensed under the rules of those agencies.  Such reports shall identify each general licensee by name and address, an individual by name or position who may constitute a contact with the general licensee, the type and model number of the device transferred, and the quantity and type of radioactive material contained in the device.  If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the reports shall include identification of each intermediate person by name, address, contact and relationship to the intended user.  If no transfers have been made to generally licensed persons during the reporting period, the reports shall so indicate.  The reports shall cover each calendar quarter and shall be filed within 30 days thereafter.  The reports shall be submitted to:

(1)           the agency for devices transferred to persons generally licensed under Rule .0307(e) of this Section;

(2)           each agreement state for devices transferred to persons generally licensed under rules equivalent to Rule .0307(e) of this Section; and

(3)           the U.S. Nuclear Regulatory Commission for devices transferred to persons generally licensed under Section 40.25 of 10 CFR Part 40.

(g)  Each person, licensed under this Rule to distribute devices, shall maintain for agency inspection either copies of all reports required in Paragraph (f) of this Rule or a record containing substantially the same information.  Such copies or records of transfer shall be maintained for at least five years after the date of each transfer of a device to a generally licensed person.

History Note:        Authority G.S. 104E‑7; 104E‑10(b);

Eff. February 1, 1980;

Amended Eff. January 1, 1994.

NC Radiation Protection, 1645 Mail Service Center,
Raleigh, NC  27699-1645  919-571-4141  Fax  919-571-4148