| (III) The model and serial number and name of manufacturer
or distributor may be omitted from this label provided they are elsewhere
stated in labeling affixed to the device.
(D) 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 number and serial
numbers, the isotope and quantity, the words, "Caution-Radioactive
Material," the radiation symbol described in §289.202(z) of this
title, and the name of the manufacturer or initial distributor.
(E) Each device meeting the criteria of §289.251(g)(1)
of this title, bears a permanent (for example, embossed, etched, stamped,
or engraved) label affixed to the source housing if separable, or
the device if the source housing is not separable, that includes the
words, "Caution-Radioactive Material," and, if practicable, the radiation
symbol described in §289.202(z) of this title.
(F) The device has been registered in the Sealed Source
and Device Registry.
(2) In the event the applicant desires that the device
be required to be tested at intervals longer than 6 months, either
for proper operation of the "on-off" mechanism and indicator, if any,
or for leakage of radioactive material, or for both, the applicant
shall include in the application sufficient information to demonstrate
that the longer interval is justified by performance characteristics
of the device or similar devices and by design features that have
a significant bearing on the probability or consequences of radioactive
material leakage from the device or failure of the "on-off" mechanism
and indicator. In determining the acceptable interval for the test
for radioactive material leakage, the department will consider information
that includes the following:
(A) primary containment (sealed source capsule);
(B) protection of primary containment;
(C) method of sealing containment;
(D) containment construction materials;
(E) form of contained radioactive material;
(F) maximum temperature withstood during prototype
tests;
(G) maximum pressure withstood during prototype tests;
(H) maximum quantity of contained radioactive material;
(I) radiotoxicity of contained radioactive material;
and
(J) operating experience with identical devices or
similarly designed and constructed devices.
(3) In the event the applicant desires that the general
licensee in accordance with §289.251(f)(4)(H) of this title or
in accordance with equivalent regulations of the NRC or any agreement
state, be authorized to mount the device, collect the sample to be
analyzed by a specific licensee for radioactive material leakage,
perform maintenance of the device consisting of replacement of labels,
rust and corrosion prevention, and for fixed gauges, repair and maintenance
of sealed source holder mounting brackets, test the "on-off" mechanism
and indicator, or remove the device from installation, the applicant
shall include in the application written instructions to be followed
by the general licensee, estimated annual doses associated with such
activity or activities, and bases for such estimates. The submitted
information shall demonstrate that performance of such activity or
activities by an individual untrained in radiological protection,
in addition to other handling, storage, and use of devices in accordance
with the general license, is unlikely to cause that individual to
receive an annual dose in excess of ten percent of the limits specified
in §289.202(f) of this title.
(4) Before the device may be transferred, each person
licensed in accordance with this subsection to commercially distribute
devices to generally licensed persons shall furnish:
(A) a copy of the general license in §289.251(f)(4)(H)
of this title to each person to whom the licensee directly commercially
distributes radioactive material in a device for use in accordance
with the general license in §289.251(f)(4)(H) of this title;
(B) a copy of the general license in the NRC's or any
agreement state's regulation equivalent to §289.251(f)(4)(H)
of this title, or alternatively, a copy of the general license in §289.251(f)(4)(H)
of this title to each person to whom the licensee directly commercially
distributes radioactive material in a device for use in accordance
with the general license of the NRC or any agreement state. If certain
requirements of the regulations do not apply to the particular device,
those requirements may be omitted. If a copy of the general license
in §289.251(f)(4)(H) of this title is furnished to such a person,
it shall be accompanied by an explanation that the use of the device
is regulated by the NRC or any agreement state in accordance with
requirements substantially the same as those in §289.251(f)(4)(H)
of this title;
(C) a copy of §289.251(g) of this title;
(D) a list of the services that can only be performed
by a specific licensee;
(E) information on acceptable disposal options including
estimated costs of disposal;
(F) the name or position, address, and phone number
of a contact person at the department, the NRC, or any agreement state,
from which additional information may be obtained; and
(G) an indication that it is the NRC's policy to issue
high civil penalties for improper disposal if the device is commercially
distributed to a general licensee of the NRC.
(5) An alternative approach to informing customers
may be submitted by the licensee for approval by the department.
(6) In the case of a transfer through an intermediate
person, each licensee who commercially distributes radioactive material
in a device for use in accordance with the general license in §289.251(f)(4)(H)
of this title, shall furnish the information in paragraph (4) of this
subsection to the intended user before the initial transfer to the
intermediate person.
(7) Each person licensed in accordance with this subsection
to commercially distribute devices to generally licensed persons shall:
(A) report to the department all commercial distributions
of devices to persons for use in accordance with the general license
in §289.251(f)(4)(H) of this title and all receipts of devices
from general licensees licensed in accordance with §289.251(f)(4)(H)
of this title.
(i) The report shall:
(I) cover each calendar quarter;
(II) be filed within 30 days thereafter;
(III) be submitted on a form prescribed by the department
or in a clear and legible report containing all of the data required
by the form;
(IV) clearly indicate the period covered by the report;
(V) clearly identify the specific licensee submitting
the report and include the license number of the specific licensee;
(VI) 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 general licensee
shall be submitted along with information on the actual location of
use;
(VII) identify an individual by name, title, and phone
number who has knowledge of and authority to take required actions
to ensure compliance with the appropriate regulations and requirements;
(VIII) identify the type, model and serial number of
device, and serial number of sealed source commercially distributed;
(IX) identify the quantity and type of radioactive
material contained in the device; and
(X) include the date of transfer.
(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 information in accordance
with paragraph (7)(A)(i) of this subsection 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 generally licensed in accordance with §289.251(f)(4)(H)
of this title 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.
(B) report the following to the NRC to include covering
each calendar quarter to be filed within 30 days thereafter, clearly
indicating the period covered by the report, the identity of the specific
licensee submitting the report, and the license number of the specific
licensee:
Cont'd... |
