| (i) all commercial distributions of such devices to
persons for use in accordance with the NRC general license in Title
10, CFR, §31.5 and all receipts of devices from general licensees
in areas under NRC jurisdiction including the following:
(I) identity of each general licensee by name and address;
(II) the type, model and serial number of device, and
serial number of sealed source commercially distributed;
(III) the quantity and type of radioactive material
contained in the device;
(IV) the date of transfer; or
(ii) if the licensee makes changes to a device possessed
in accordance with the general license in §289.251(f)(4)(H) of
this title, such that the label must be changed to update required
information, the report shall identify the licensee, the device, and
the changes to information on the device label;
(iii) in the case of devices not initially transferred
by the reporting licensee, the name of the manufacturer or initial
transferor;
(iv) if no commercial distributions have been made
to the NRC licensees during the reporting period; the report shall
so indicate;
(C) report to the department or any agreement state
all transfers of devices manufactured and commercially distributed
in accordance with this subsection for use in accordance with a general
license in that state's requirements equivalent to §289.251(f)(4)(H)
of this title and all receipts of devices from general licensees.
(i) The report shall:
(I) be submitted within 30 days after the end of each
calendar quarter in which such a device is commercially distributed
to the generally licensed person;
(II) clearly indicate the period covered by the report;
(III) clearly identify the specific licensee submitting
the report and include the license number of the specific licensee;
(IV) identify each general licensee by name and mailing
address for the location of use; if there is no mailing address for
the location of use an alternate address for the licensee shall be
submitted along with the information on the actual location of use;
(V) identify an individual by name, position, and phone
number who has knowledge of and authority to take required actions
to ensure compliance with the appropriate regulations and requirements;
(VI) include the type, model and serial number of the
device, and serial number of sealed source commercially distributed;
(VII) include the quantity and type of radioactive
material contained in the device; and
(VIII) include the date of receipt.
(ii) If one or more intermediate persons will temporarily
possess the device at the intended place of use before its possession
by the user, the report shall also include the same information for
both the intended user and each intermediate person, and clearly designate
the intermediate person(s).
(iii) If no commercial distributions have been made
to persons in the agreement state during the reporting period, the
report shall so indicate.
(iv) For 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, the date of receipt, and, in the case of devices not initially
transferred by the reporting licensee, the name of the manufacturer
or initial transferor; and
(D) make, maintain, and retain records required by
this paragraph for inspection by the department in accordance with
subsection (mm) of this section, including the name, address, and
the point of contact for each general licensee to whom the licensee
directly or through an intermediate person commercially distributes
radioactive material in devices for use in accordance with the general
license provided in §289.251(f)(4)(H) of this title, or equivalent
requirements of the NRC or any agreement state.
(i) The records shall include the following:
(I) the date of each commercial distribution;
(II) the isotope and the quantity of radioactivity
in each device commercially distributed;
(III) the identity of any intermediate person; and
(IV) compliance with the reporting requirements of
this subsection.
(ii) If no commercial distributions have been made
to persons generally licensed in accordance with §289.251(f)(4)(H)
of this title during the reporting period, the records shall so indicate.
(8) If a notification of bankruptcy has been made in
accordance with subsection (x)(6) of this section or the license is
to be terminated, each person licensed in accordance with this subsection
shall provide, upon request to the NRC and to any appropriate agreement
state, records of final disposition required in accordance with subsection
(y)(16)(A) of this section.
(9) Each device that is transferred after February
19, 2002, shall meet the labeling requirements in accordance with
paragraph (1)(C) - (E) of this subsection.
(m) Specific licenses for the manufacture, assembly,
repair, or initial transfer of luminous safety devices containing
tritium or promethium-147 for use in aircraft for distribution to
persons generally licensed in accordance with §289.251(f)(4)(B)
of this title. In addition to the requirements in subsection (e) of
this section, a specific license to manufacture, assemble, repair,
or initially transfer luminous safety devices containing tritium or
promethium-147 for use in aircraft, for distribution to persons generally
licensed in accordance with §289.251(f)(4)(B) of this title,
will be issued if the department approves the information submitted
by the applicant. The information shall satisfy the requirements of
Title 10, CFR, §§32.53, 32.54, 32.55, and 32.56, or their
equivalent.
(n) Specific licenses for the manufacture or initial
transfer of calibration sources containing americium-241 or radium-226
for commercial distribution to persons generally licensed in accordance
with §289.251(f)(4)(D) of this title.
(1) In addition to the requirements in subsection (e)
of this section, a specific license to manufacture or initially transfer
calibration sources containing americium-241, or radium-226 to persons
generally licensed in accordance with §289.251(f)(4)(D) of this
title will be issued if the department approves the information submitted
by the applicant. The information shall satisfy the requirements of
Title 10, CFR, §§32.57, 32.58, 32.59, and §70.39 or
their equivalent.
(2) Each person licensed in accordance with this subsection
shall perform a dry wipe test on each source containing more than
0.1 µCi (3.7 kilobecquerels (kBq)) of americium-241 or radium-226
before transferring the source to a general licensee in accordance
with §289.251(f)(4)(D) of this title or equivalent regulations
of the NRC or any agreement state. This test shall be performed by
wiping the entire radioactive surface of the source with a filter
paper with the application of moderate finger pressure. The radioactivity
on the filter paper shall be measured by using radiation detection
instrumentation capable of detecting 0.005 µCi (0.185 kBq) of
americium-241 or radium-226. If a source has been shown to be leaking
or losing more than 0.005 µCi (0.185 kBq) of americium-241 or
radium-226 by methods described in this paragraph, the source shall
be rejected and shall not be transferred to a general licensee in
accordance with §289.251(f)(4)(D) of this title or equivalent
regulations of the NRC or any agreement state.
(o) Specific licenses for the manufacture and commercial
distribution of sealed sources or devices containing radioactive material
for medical use. In addition to the requirements in subsection (e)
of this section, a specific license to manufacture and commercially
distribute sealed sources and devices containing radioactive material
to persons licensed in accordance with §289.256 of this title
for use as a calibration, transmission, or reference source or for
use of sealed sources listed in §289.256(q), (rr), (bbb), and
(ddd) of this title will be issued if the department approves the
following information submitted by the applicant:
(1) an evaluation of the radiation safety of each type
of sealed source or device including the following:
(A) the radioactive material contained, its chemical
and physical form, and amount;
(B) details of design and construction of the sealed
source or device;
(C) procedures for, and results of, prototype tests
to demonstrate that the sealed source or device will maintain its
integrity under stresses likely to be encountered in normal use and
accidents;
(D) for devices containing radioactive material, the
radiation profile of a prototype device;
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