15A NCAC 11 .0310          GENERAL LICENSES: MANUFACTURE, TRANSFER, INSTALL GENERALLY LICENSED DEVICES

Any person who is authorized to manufacture, install or service a device described in Rule .0309 of this Section pursuant to a specific license issued by the agency, the U.S. Nuclear Regulatory Commission or an agreement state is hereby granted a general license to install and service the device described in Rule .0309, provided the following requirements are met:

(1)           The person shall file a report with the agency within 30 days after the end of each calendar quarter in which any device is transferred to or installed in this state.  Each report shall identify each general licensee, to whom the device is transferred by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device;

(2)           The device is manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to the person by the U.S. Nuclear Regulatory Commission or an agreement state;

(3)           The person shall assure that any labels satisfy the requirements in Rule .0309 of this Section and shall furnish to each general licensee, to whom he transfers a device or on whose premises he installs a device, a copy of the general license contained in Rule .0309 of this Section;

(4)           The person shall ensure that each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model and serial number, the isotope and quantity, the words "Caution: Radioactive Material," the radiation symbol described in Rule .1623 of this Chapter, and the name of the manufacturer or initial transferor;

(5)           The person shall ensure that each device meeting the criteria of Rule .0309 of this Chapter bears a permanently embossed, etched, stamped or engraved label affixed to the source housing, if separable, or the device if the source housing is not separable.  The label shall include the words, "Caution: Radioactive Materials," and, if space and accessibility permit, the radiation symbol described in Rule .1623 of this Chapter;

(6)           If a device is to be transferred for use under the general license granted in Rule .0309(c)(12) of this Chapter, each person that is licensed under this Rule shall provide the following information to each person to whom the device is being transferred prior to the device being transferred.  In the case of a transfer through an intermediate person, the information shall also be provided to the intended user prior to the initial transfer to the intermediate person.  The required information includes:

(a)           a copy of the general license document referenced in Rule .0306 of this Chapter or if no license document is issued, a copy of the letter issued by the agency indicating a license exists in accordance with Rule .0309 of this Chapter.  If the prospective general licensee is in the jurisdiction of the Nuclear Regulatory Commission or another Agreement State, the notification shall include a statement advising the person receiving the device of the agency that has jurisdiction over the device;

(b)           a copy of Rule .0309 of this Section.  If the prospective general licensee is in the jurisdiction of the Nuclear Regulatory Commission or another Agreement State, the notification of transfer shall include the name or title, address, and telephone number of the contact at the proper regulatory agency that has jurisdiction over the person receiving the device;

(c)           a list of services, as provided by the manufacturer, that can be performed only by a specific licensee;

(d)           information on acceptable disposal options, including estimated cost of disposal; and

(e)           a statement that loss or improper disposal of the device may result in formal enforcement actions.

(7)           Each device transferred after January 1, 2005 shall meet the labeling requirements;

(8)           Each person specifically licensed to initially transfer generally licensed devices to other persons shall comply with the requirements of this Paragraph.

(a)           The person shall report, on a quarterly basis, all transfers of devices to persons for use under a general license and all receipts of devices from generally licensed persons. For devices transferred for use under the general license granted in Rule .0309(c)(12) of this Chapter, the reports shall be provided to the agency at the address listed in Rule .0111.  For devices transferred outside the jurisdiction of the agency, the reports shall be provided to the Nuclear Regulatory Commission or to the Agreement State which has jurisdiction over the general licensee.  The information shall be provided either on the Nuclear Regulatory Commission's Form 653 "Transfers of Industrial Devices Report" or in a clear and legible report that contains all of the information required by the form.  The required information includes:

(i)            the identity of each general licensee by name and mailing address for the location of use. If there is no mailing address at the location of use, an alternate address for the general licensee shall be submitted along with the information on the actual location of use;

(ii)           the name, title and telephone number of the person identified by the general licensee as having knowledge of, and authority to ensure compliance with, these rules;

(iii)          the date of transfer;

(iv)          the type, model number, and serial number of the device transferred; and

(v)           the quantity and type of radioactive material contained in the device.

(b)           If one or more intermediate persons will temporarily possess the device at the intended use location prior to its use by the end user, the report shall include the same information for both the intended end user and each intermediate person, and designate the intermediate person(s).

(c)           If the licensee makes changes to a device possessed by a general licensee such that the label must be changed to update required information, the report shall identify the general licensee, the device, and the changes to the information on the label.

(d)           The report shall cover a calendar quarter and must be filed within 30 days of the end of the calendar quarter.  The report shall identify the period covered by the report.

(e)           The report shall identify the specific licensee submitting the report and include the license number of the specific licensee.

(f)            In providing information on devices received from a general licensee, the report shall include the identity of the general licensee by name and address, the type, model number and serial number of the device received, and, in the case of devices not initially transferred by the licensee submitting the report, the name of the manufacturer or initial transferor.

(g)           If no transfers have been made to or from persons generally licensed during the reporting period, the report shall so indicate.

(9)           The person providing the reports shall maintain all information concerning the transfers and receipts of devices required by this Rule for a period of three years following the date of the recorded event.

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

Eff. February 1, 1980;

Amended Eff. January 1, 2005.