| 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:
(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.
Cont'd... |
