(4) Licensing the manufacture and
distribution of devices to persons generally licensed under Subsection
R313-21-22(4).
(a) An application for a specific license to
manufacture or distribute devices containing radioactive material, excluding
special nuclear material, to persons generally licensed under Subsection
R313-21-22(4)
or equivalent regulations of the Nuclear Regulatory Commission, an Agreement
State or a Licensing State will be approved if:
(i) the applicant satisfies the general
requirements of Section
R313-22-33;
(ii) the applicant submits sufficient
information relating to the design, manufacture, prototype testing, quality
control, labels, proposed uses, installation, servicing, leak testing,
operating and safety instructions, and potential hazards of the device to
provide reasonable assurance that:
(A) the
device can be safely operated by persons not having training in radiological
protection,
(B) under ordinary
conditions of handling, storage and use of the device, the radioactive material
contained in the device will not be released or inadvertently removed from the
device, and it is unlikely that a person will receive in one year, a dose in
excess of ten percent of the annual limits specified in Subsection
R313-15-201(1),
and
(C) under accident conditions,
such as fire and explosion, associated with handling, storage and use of the
device, it is unlikely that a person would receive an external radiation dose
or dose commitment in excess of the following organ doses:
TABLE |
Whole body; head and trunk; gonads; or lens of
eye |
active blood-forming organs 150.0 mSv (15
rems) |
Hands and forearms;
feet and ankles;
localized areas of skin averaged over areas no
larger than one square centimeter |
2.0 Sv (200 rems) |
Other organs |
500.0 mSv (50 rems); and |
(iii) each device bears a durable, legible,
clearly visible label or labels approved by the Director, which contain in a
clearly identified and separate statement:
(A) instructions and precautions necessary to
assure safe installation, operation and servicing of the device; documents such
as operating and service manuals may be identified in the label and used to
provide this information,
(B) the
requirement, or lack of requirement, for leak testing, or for testing an
"on-off" mechanism and indicator, including the maximum time interval for
testing, and the identification of radioactive material by radionuclide,
quantity of radioactivity, and date of determination of the quantity,
and
(C) the information called for
in one of the following statements, as appropriate, in the same or
substantially similar form:
(I) "The receipt,
possession, use and transfer of this device, Model No. ........, Serial No.
............, are subject to a general license or the equivalent, and the
regulations of the Nuclear Regulatory Commission or a state with which the
Nuclear Regulatory Commission has entered into an agreement for the exercise of
regulatory authority. This label shall be maintained on the device in a legible
condition. Removal of this label is prohibited." The label shall be printed
with the words "CAUTION -RADIOACTIVE MATERIAL" and the name of the manufacturer
or distributor shall appear on the label. The model, serial number, and name of
the manufacturer or distributor may be omitted from this label provided the
information is elsewhere specified in labeling affixed to the device.
(II) "The receipt, possession, use and
transfer of this device, Model No. ........, Serial No. ............., are
subject to a general license or the equivalent, and the regulations of a
Licensing State. This label shall be maintained on the device in a legible
condition. Removal of this label is prohibited." The label shall be printed
with the words "CAUTION - RADIOACTIVE MATERIAL" and the name of the
manufacturer or distributor shall appear on the label. The model, serial
number, and name of the manufacturer or distributor may be omitted from this
label provided the information is elsewhere specified in labeling affixed to
the device.
(iv) 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
number, the isotope and quantity, the words, "Caution-Radioactive Material,"
the radiation symbol described in Section
R313-15-901, and
the name of the manufacturer or initial distributor.
(v) Each device meeting the criteria of
Subsection
R313-21-22(4)(c)(xiii)(A),
bears a permanent label, for example, embossed, etched, stamped, or engraved,
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 Section
R313-15-901.
(vi) The device has been registered in the
Sealed Source and Device Registry.
(b) In the event the applicant desires that
the device be required to be tested at intervals longer than six 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 a longer interval is
justified by performance characteristics of the device or similar devices and
by design features which have a significant bearing on the probability or
consequences of leakage of radioactive material from the device or failure of
the "on-off" mechanism and indicator. In determining the acceptable interval
for the test for leakage of radioactive material, the Director will consider
information which includes, but is not limited to:
(i) primary containment, or source
capsule;
(ii) protection of primary
containment;
(iii) method of
sealing containment;
(iv)
containment construction materials;
(v) form of contained radioactive
material;
(vi) maximum temperature
withstood during prototype tests;
(vii) maximum pressure withstood during
prototype tests;
(viii) maximum
quantity of contained radioactive material;
(ix) radiotoxicity of contained radioactive
material; and
(x) operating
experience with identical devices or similarly designed and constructed
devices.
(c) In the event
the applicant desires that the general licensee under Subsection
R313-21-22(4),
or under equivalent regulations of the Nuclear Regulatory Commission, an
Agreement State or a Licensing State be authorized to install the device,
collect the sample to be analyzed by a specific licensee for leakage of
radioactive material, service the device, 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 calendar quarter doses associated with this activity or activities,
and basis for these estimates. The submitted information shall demonstrate that
performance of this activity or activities by an individual untrained in
radiological protection, in addition to other handling, storage, and use of
devices under the general license, is unlikely to cause that individual to
receive a dose in excess of ten percent of the annual limits specified in
Subsection
R313-15-201(1).
(d)
(i) If
a device containing radioactive material is to be transferred for use under the
general license contained in Subsection
R313-21-22(4),
each person that is licensed under Subsection R313-22-75(4) shall provide the
information specified in Subsections R313-22-75(4)(d)(i)(A) through (E) to each
person to whom a device is to be transferred. This information must be provided
before the device may be transferred. In the case of a transfer through an
intermediate person, the information must also be provided to the intended user
prior to initial transfer to the intermediate person. The required information
includes:
(A) a copy of the general license
contained in Subsection
R313-21-22(4);
if Subsections
R313-21-22(4)(c)(ii)
through (iv) or
R313-21-22(4)(c)(xiii)
do not apply to the particular device, those paragraphs may be
omitted;
(B) a copy of Sections
R313-12-51,
R313-15-1201,
and
R313-15-1202;
(C) a list of services that can only be
performed by a specific licensee;
(D) Information on acceptable disposal
options including estimated costs of disposal; and
(E) An indication that the Director's policy
is to issue civil penalties for improper disposal.
(ii) If radioactive material is to be
transferred in a device for use under an equivalent general license of the
Nuclear Regulatory Commission, an Agreement State, or Licensing State, each
person that is licensed under Subsection R313-22-75(4) shall provide the
information specified in Subsections R313-22-75(4)(d)(ii)(A) through (D) to
each person to whom a device is to be transferred. This information must be
provided before the device may be transferred. In the case of a transfer
through an intermediate person, the information must also be provided to the
intended user prior to initial transfer to the intermediate person. The
required information includes:
(A) A copy of
an Agreement State's or Licensing State's regulations equivalent to Sections
R313-12-51,
R313-15-1201,
R313-15-1202,
and Subsection
R313-21-22(4)
or a copy of
10
CFR 31.5, 10 CFR 31.2,
10 CFR
30.51, 10 CFR 20.2201, and
10 CFR
20.2202. If a copy of the Nuclear Regulatory
Commission regulations is provided to a prospective general licensee in lieu of
the Agreement State's or Licensing State's regulations, it shall be accompanied
by a note explaining that use of the device is regulated by the Agreement State
or Licensing State; if certain paragraphs of the regulations do not apply to
the particular device, those paragraphs may be omitted;
(B) A list of services that can only be
performed by a specific licensee;
(C) Information on acceptable disposal
options including estimated costs of disposal; and
(D) The name or title, address, and phone
number of the contact at the Nuclear Regulatory Commission, Agreement State, or
Licensing State from which additional information may be obtained.
(iii) An alternative approach to
informing customers may be proposed by the licensee for approval by the
Director.
(iv) Each device that is
transferred after February 19, 2002 must meet the labeling requirements in
Subsection R313-22-75(4)(a)(iii).
(v) If a notification of bankruptcy has been
made under Section
R313-19-34
or the license is to be terminated, each person licensed under Subsection
R313-22-75(4) shall provide, upon request, to the Director, the Nuclear
Regulatory Commission, or an appropriate Agreement State or Licensing State,
records of final disposition required under Subsection
R313-22-75(4)(d)(vii)(H).
(vi) Each
person licensed under Subsection R313-22-75(4) to initially transfer devices to
generally licensed persons shall comply with the requirements of Subsections
R313-22-75(4)(d)(vi) and (vii).
(A) The person
shall report all transfers of devices to persons for use under the general
license under Subsection
R313-21-22(4)
and all receipts of devices from persons licensed under Subsection
R313-21-22(4)
to the Director. The report must be submitted on a quarterly basis on Form 653,
"Transfers of Industrial Devices Report" as prescribed by the Nuclear
Regulatory Commission, or in a clear and legible report containing all of the
data required by the form.
(B) The
required information for transfers to general licensees includes:
(I) The identity of 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 alternative address for the general
licensee shall be submitted along with information on the actual location of
use.
(II) The name, title, and
phone number of the person identified by the general licensee as having
knowledge of and authority to take required actions to ensure compliance with
the appropriate regulations and requirements;
(III) The date of transfer;
(IV) The type, model number, and serial
number of device transferred; and
(V) The quantity and type of radioactive
material contained in the device.
(C) 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 must include the same information for both
the intended user and each intermediate person, and clearly designate the
intermediate persons.
(D) For
devices received from a Subsection
R313-21-22(4)
general licensee, the report must 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.
(E) If the licensee
makes changes to a device possessed by a Subsection
R313-21-22(4)
general licensee, such that the label must be changed to update required
information, the report must identify the general licensee, the device, and the
changes to information on the device label.
(F) The report must cover each calendar
quarter, must be filed within 30 days of the end of the calendar quarter, and
must clearly indicate the period covered by the report.
(G) The report must clearly identify the
specific licensee submitting the report and include the license number of the
specific licensee.
(H) If no
transfers have been made to or from persons generally licensed under Subsection
R313-21-22(4)
during the reporting period, the report must so indicate.
(vii) The person shall report all transfers
of devices to persons for use under a general license in the Nuclear Regulatory
Commission's, an Agreement State's, or Licensing State's regulations that are
equivalent to Subsection
R313-21-22(4)
and all receipts of devices from general licensees in the Nuclear Regulatory
Commission's, Agreement State's, or Licensing State's jurisdiction to the
Nuclear Regulatory Commission, or to the responsible Agreement State or
Licensing State agency. The report must be submitted on Form 653, "Transfers of
Industrial Devices Report" as prescribed by the Nuclear Regulatory Commission,
or in a clear and legible report containing all of the data required by the
form.
(A) The required information for
transfers to general licensee includes:
(I)
The identity of 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
alternative address for the general licensee shall be submitted along with
information on the actual location of use.
(II) The name, title, and phone number of the
person identified by the general licensee as having knowledge of and authority
to take required actions to ensure compliance with the appropriate regulations
and requirements;
(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 place of use before its
possession by the user, the report must include the same information for both
the intended user and each intermediate person, and clearly designate the
intermediate persons.
(C) For
devices received from a general licensee, the report must 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.
(D) 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 must identify the general licensee, the
device, and the changes to information on the device label.
(E) The report must cover each calendar
quarter, must be filed within 30 days of the end of the calendar quarter, and
must clearly indicate the period covered by the report.
(F) The report must clearly identify the
specific licensee submitting the report and must include the license number of
the specific licensee.
(G) If no
transfers have been made to or from a Nuclear Regulatory Commission licensee,
or to or from a particular Agreement State or Licensing State licensee during
the reporting period, this information shall be reported to the Nuclear
Regulatory Commission or the responsible Agreement State or Licensing State
agency upon request of the agency.
(H) The person shall maintain all information
concerning transfers and receipts of devices that supports the reports required
by Subsection R313-22-75(4)(d)(vii). Records required by Subsection
R313-22-75(4)(d)(vii)(H) must be maintained for a period of three years
following the date of the recorded event.