Ariz. Admin. Code § R9-7-311 - Special Requirements for a Specific License to Manufacture, Assemble, Repair, or Distribute Commodities, Products, or Devices that Contain Radioactive Material
A.
Licensing the manufacture and distribution of devices to persons generally
licensed under
R9-7-306(A).
1. The Department shall grant a specific
license to manufacture or distribute each device that contains radioactive
material, excluding special nuclear material, to persons generally licensed
under R9-7-306(A) or
equivalent regulations of the NRC, an Agreement State, or the Licensing State
if:
a. The applicant satisfies the
requirements of
R9-7-309;
b. The applicant submits sufficient
information relating to the design, manufacture, prototype testing, quality
control, labels, pro-posed uses, installation, servicing, leak testing,
operating and safety instructions, and potential hazards of the device to
provide reasonable assurance that:
i. The
device can be safely operated by persons not having training in radiological
protection;
ii. 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 any person will receive a dose in
excess of 10 percent of the limits specified in
R9-7-408; and
iii. Under accident conditions (such as fire
and explosion) associated with handling, storage, and use of the device, it is
unlikely that any person would receive an external radiation dose or dose
commitment in excess of the following organ doses:
(1) Whole body; head and trunk; active
blood-forming organs; gonads; or lens of eye: 150 mSv (15 rem);
(2) Hands and forearms; feet and ankles;
localized areas of skin averaged over areas no larger than 1 square centimeter;
2 Sv (200 rem);
(3) Other organs:
500 mSv (50 rem);
c. Each device bears a durable, legible,
clearly visible label or labels that contain in a clearly identified and
separate statement:
i. Instructions and
precautions necessary to assure safe installation, operating, and servicing of
the device (documents such as operating and service manuals may be identified
in the label and used to provide this information);
ii. The requirement, or lack of requirement,
for leak testing, or for testing any on-off mechanism and indicator, including
the maximum time interval for the testing, and the identification of
radioactive material by isotope, quantity of radioactivity, and date of
determination of the quantity; and
iii. The information called for in one of the
following statements in the same or substantially similar form:
The receipt, possession, use, and transfer of this device, Model _____, Serial No. _____, are subject to a general license or the equivalent and the regulations of the U.S. 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.
CAUTION - RADIOACTIVE MATERIAL
__________________________________
(name of manufacturer or distributor)
The receipt, possession, use and transfer of this device, Model _____, 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.
CAUTION - RADIOACTIVE MATERIAL
__________________________________
(name of manufacturer or distributor)
d. The model, serial number, and
name of manufacturer or distributor may be omitted from the label if the
information location is specified in labeling affixed to the device;
e. Each device with a separable source
housing that provides the primary shielding for the source also bears, on the
source housing, a durable label that provides the device model number and
serial number, the isotope and quantity, the words, "Caution-Radioactive
Material," the radiation symbol described in
R9-7-428, and the name of the
manufacturer or initial distributor;
f. Each device meets the criteria in
10 CFR
31.5(c)(13)(i) (revised
December 19, 2014, incorporated by reference, available under
R9-7-101, and containing no future
editions or amendments.) and bears a permanent (e.g., 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,
"CautionRadioactive Material," and, if practicable, the radiation symbol
described in
R9-7-428; and
g. The device has been registered in the
Sealed Source and Device Registry.
2. In the event the applicant desires that
the device undergo mandatory testing 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 application shall contain
sufficient information to demonstrate that the longer interval is justified by
performance characteristics of the device or similar de-vices 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 Department shall consider information
which includes, but is not limited to:
a.
Primary containment (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 under
R9-7-306(A), or
under equivalent regulations of the NRC or an Agreement State or 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 application shall include written instructions to be followed
by the general licensee, estimated calendar quarter doses associated with the
activity or activities, and bases for the estimates. The submitted information
shall demonstrate that performance of the 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 10 percent of the limits
specified in
R9-7-408.
4. A licensee authorized under subsection (A)
to distribute a device to a generally licensed person shall provide, if a
device that contains radioactive material is to be transferred for use under
the general license granted in
R9-7-306(A), the
name of each person that is licensed under subsection (A) and the information
specified in this subsection for each person to whom a device will be
transferred. The licensee shall provide this information before the device may
be transferred. In the case of transfer through another person, the licensee
shall provide the listed information to the intended user before initial
transfer to the other person.
a. The licensee
shall provide:
i. A copy of the general
license, issued under R9-7-306(A);
iii. A list of the services that can only be
performed by a specific licensee;
iv. Information on authorized disposal
options, including estimated costs of disposal; and
v. A list of civil penalties for improper
disposal.
b. The licensee
shall:
i. Report on a quarterly basis to the
responsible Agreement State or NRC all transfers of devices to persons for use
under a general license in accordance with
10 CFR
32.52, revised December 19, 2014,
incorporated by reference, available under
R9-7-101, and containing no future
editions or amendments;
ii.
Maintain all information concerning transfers and receipts of devices that
supports the reports required by subsection (A)(4)(b)(i); and
iii. Maintain records required by subsection
(A)(4)(b)(i) for a period of at least three years following the date of the
recorded event.
5. If radioactive material is to be
transferred in a device for use under an equivalent general license of the NRC
or another Agreement State, each person that is licensed under R9-7-304(B)
shall provide the information specified in this subsection to each person to
whom a device will be transferred. The licensee shall provide this information
before the device is transferred. In the case of transfer through another
person, the licensee shall provide the listed information to the intended user
before initial transfer to the other person. The licensee shall provide:
a. A copy of the Agreement State's
requirements that are equivalent to
R9-7-306(A),
R9-7-443, and
R9-7-445, and to A.R.S. §
30-657. If a copy of NRC
regulations is provided to a prospective general licensee in lieu of the
Agreement State's requirements, the licensee shall explain in writing that use
of the device is regulated by the Agreement State. If certain requirements do
not apply to a particular device, the licensee may omit the requirement from
the material provided;
b. A list of
the services that can only be performed by a specific licensee;
c. Information on authorized disposal
options, including estimated costs of disposal; and
d. The name, title, address, and telephone
number of the individual at the Agreement State regulatory agency who can
provide additional information.
6. A licensee may propose to the Department
an alternate method of informing the customer.
7. If a licensee has notified the Department
of bankruptcy under
R9-7-313(E) or is
terminating under
R9-7-319, the licensee shall
provide, upon request, to the Department, the NRC, or another Agreement State,
records of the disposition as required under A.R.S. §
30-657.
8. A licensee authorized to transfer a device
to a generally licensed person, shall comply with the following requirements:
a. The person licensed under subsection (A)
shall report all transfers of devices to persons for use under a general
license obtained under
R9-7-306(A), and
all receipts of devices from persons licensed under
R9-7-306(A) to the
Department, the NRC, or other affected Agreement State. The report shall be
submitted on a quarterly basis, in a clear and legible form, and contain the
following information:
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, the person licensed under
subsection (A) shall submit an alternate address for the general licensee,
along with information on the actual location of use;
ii. The name, title, and telephone number of
a person identified by the general licensee as having knowledge of and
authority to take required actions to ensure compliance with the applicable
laws;
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 intermediaries will
temporarily possess the device at the intended place of use before its
possession by the in-tended user, the report shall include the information
required of the general licensee in subsection (A)(4) for both the intended
user and each intermediary, clearly identifying the intended user and each
intermediary.
c. For devices
received from a general licensee, licensed under
R9-7-306(A), the
report shall include:
i. The identity of the
general licensee by name and address;
ii. The type, model number, and serial number
of the device received;
iii. The
date of receipt; and
iv. In the
case of a device not initially transferred by the reporting licensee, the name
of the manufacturer or initial transferor.
d. If the person licensed under subsection
(A) makes a change to a device possessed by a general licensee so that the
label must be changed to update required information, the report shall identify
the general licensee, the device, and the changes to information on the device
label.
e. The report shall cover a
calendar quarter, be filed within 30 days of the end of each calendar quarter,
and clearly indicate the period covered by the report.
f. The report shall clearly identify the
person licensed under subsection (A) submitting the report and include the
license number of the license.
g.
If no transfers are made to or from persons generally licensed under
R9-7-306(A) during
a reporting period, the person licensed under subsection (A) shall submit a
report indicating the lack of activity.
9. The licensee shall maintain records of all
transfers for Department inspection. Records shall be maintained for at least
three years after termination of the license to manufacture the generally
licensed devices regulated under R9-7-306(A).
B. The Department shall grant a specific
license to manufacture, assemble, repair, or initially transfer luminous safety
devices that contain tritium or promethium-147 for use in aircraft, for
distribution to persons generally licensed under
R9-7-306(B), if
the applicant satisfies:
1. The general
requirements specified in
R9-7-309; and
C. The Department shall grant a specific
license to manufacture or initially transfer calibration or reference sources
that contain americium-241, radium-226, or plutonium for distribution to
persons generally licensed under
R9-7-306(C) if the
applicant satisfies:
1. The general
requirements of
R9-7-309; and
D. The Department shall grant a specific
license to distribute radioactive material for use by a physician under the
general license in
R9-7-306(D) if:
1. The general requirements of
R9-7-309; and
E. The Department shall grant for a specific
license to manufacture or distribute radioactive material for use under the
general license of
R9-7-306(E) if:
1. The applicant satisfies the general
requirements specified in
R9-7-309.
2. The radioactive material is to be prepared
for distribution in prepackaged units of:
a.
Iodine-125 in units not exceeding 370 kBq (10 microcuries) each;
b. Iodine-131 in units not exceeding 370 kBq
(10 microcuries) each;
c. Carbon-14
in units not exceeding 370 kBq (10 microcuries) each;
d. Hydrogen-3 (tritium) in units not
exceeding 1.85 MBq (50 microcuries) each;
e. Iron-59 in units not exceeding 740 kBq (20
microcuries) each;
f. Cobalt-57 or
selenium-75 in units not exceeding 370 kilobecquerels (10 microcuries)
each;
g. Mock iodine-125 in units
not exceeding 1.85 kBq (50 nanocuries) of iodine-129 and 185 Bq (5 nanocuries)
of americium-241 each.
3.
Each prepackaged unit bears a durable, clearly visible label:
a. Identifying the radioactive contents as to
chemical form and radionuclide and indicating that the amount of radioactivity
does not exceed 370 kilobecquerels (10 microcuries) of iodine-125, iodine-131,
cobalt-57, selenium-75, or carbon-14; 1.85 mega-becquerels (50 microcuries) of
hydrogen-3 (tritium); 740 kilobecquerels (20 microcuries) of iron-59; or mock
iodine-125 in units not exceeding 1.85 kilobecquerels (0.05 microcurie) of
iodine-129 and 185 becquerels (0.005 microcurie) of americium-241 each;
and
b. Displaying the radiation
caution symbol described in
R9-7-428, the words, "CAUTION,
RADIOACTIVE MATERIAL," and the phrase "Not for Internal or External Use in
Humans or Animals."
4.
One of the following statements, or a substantially similar statement that
contains the information called for in the following statements appears on a
label affixed to each prepackaged unit or appears in a leaflet or brochure that
accompanies the package:
a. This radioactive
material may be received, acquired, possessed, and used only by physicians,
clinical laboratories or hospitals and only for in vitro clinical or laboratory
tests not involving internal or external administration of the material, or the
radiation from the radioactive material, to human beings or animals. Its
receipt, acquisition, possession, use, and transfer are subject to the
regulations and a general license of the U.S. Nuclear Regulatory Commission or
of a state with which the Commission has entered into an agreement for the
exercise of regulatory authority.
_____________________
Name of Manufacturer
b. This radioactive drug may be received,
acquired, possessed, and used only by physicians, clinical laboratories or
hospitals and only for in vitro clinical or laboratory tests not involving
internal or external administration of the material, or the radiation from the
radioactive material, to human beings or animals. Its receipt, acquisition,
possession, use and transfer are subject to the regulations and a general
license of a Licensing State.
_____________________
Name of Manufacturer
5. The label affixed to the unit, or the
leaflet or brochure that accompanies the package, contains adequate information
about the precautions to be observed in handling and storing the specified
radioactive material. In the case of the mock iodine-125 reference or
calibration source, the information accompanying the source must also contain
directions to the licensee regarding the waste disposal requirements set out in
R9-7-434.
F. The
Department shall grant for a specific license to manufacture and distribute ice
detection devices to persons generally licensed under
R9-7-306(F) if the
applicant satisfies:
1. The general
requirements of
R9-7-309; and
G. The Department shall grant a specific
license to manufacture, prepare, or transfer for commercial distribution
radioactive drugs that contain radioactive material for use by a person
authorized in accordance with Article 7 of this Chapter, if the applicant meets
all of the requirements in 10 CFR 30.32(j),
revised November 21, 2023, or
10 CFR
32.72, revised August 24, 2023, both
incorporated by reference, available under
R9-7-101, and containing no future
editions or amendments.
1. Authorization
under this Section to produce Positron Emission Tomography (PET) radioactive
drugs for noncommercial transfer to medical use licensees in its consortium
does not relieve the licensee from complying with applicable FDA, other
federal, and state requirements governing radioactive drugs.
2. Each licensee authorized under this
Section to produce PET radioactive drugs for noncommercial transfer to medical
use licensees in its consortium shall:
a.
Satisfy the labeling requirements in
R9-7-431 for each PET radioactive
drug transport radiation shield and each syringe, vial, or other container used
to hold a PET radioactive drug intended for noncommercial distribution to
members of its consortium,; and
b. Possess and use instrumentation to measure
the radioactivity of the PET radioactive drugs intended for noncommercial
distribution to members of its consortium and meet the procedural,
radioactivity measurement, instrument test, instrument check, and instrument
adjustment requirements in
R9-7-449.
3. A licensee that is a pharmacy authorized
under this Section to produce PET radioactive drugs for noncommercial transfer
to medical use licensees in its consortium shall require that any individual
who prepares PET radioactive drugs be an:
a.
Authorized nuclear pharmacist that meets the requirements in
R9-7-712, or
b. Individual under the supervision of an
authorized nuclear pharmacist as specified in R9-7-706.
4. A pharmacy, authorized under this Section
to produce PET radioactive drugs for noncommercial transfer to medical use
licensees in its consortium that allows an individual to work as an authorized
nuclear pharmacist, shall meet the requirements of
R9-7-712.
H. The Department shall grant a specific
license to manufacture and distribute generators or reagent kits that contain
radioactive material for preparation of radiopharmaceuticals by persons
licensed according to 9 A.A.C. 7, Article 7 if:
1. The applicant satisfies the general
requirements of
R9-7-309;
2. The applicant submits evidence that:
a. The generator or reagent kit is to be
manufactured, labeled and packaged according to the Federal Food, Drug, and
Cosmetic Act or the Public Health Service Act, a new drug application (NDA)
approved by the Food and Drug Administration (FDA), a biologic product license
issued by FDA, or a "Notice of Claimed Investigational Exemption for a New
Drug" (IND) that has been accepted by the FDA; or
b. The manufacture and distribution of the
generator or reagent kit are not subject to the Federal Food, Drug, and
Cosmetic Act and the Public Health Service Act;
3. The applicant submits information on the
radionuclide; chemical and physical form, packaging including maximum activity
per package, and shielding provided by the packaging of the radioactive
material contained in the generator or reagent kit;
4. The label affixed to the generator or
reagent kit contains information on the radionuclide, including quantity, and
date of assay; and
5. The label
affixed to the generator or reagent kit, or the leaflet or brochure that
accompanies the generator or reagent kit, contains:
a. Adequate information, from a radiation
safety standpoint, on the procedures to be followed and the equipment and
shielding to be used in eluting the generator or processing radioactive
material with the reagent kit; and
b. A statement that this generator or reagent
kit (as appropriate) is approved for use by persons licensed by the Department
under 9 A.A.C. 7, Article 7, or equivalent licenses of the U.S. Nuclear
Regulatory Commission or an Agreement State or Licensing State. The labels,
leaflets, or brochures required by this subsection supplement the labeling
required by FDA, and they may be separate from or, with the approval of FDA,
combined with the labeling required by FDA.
I. The Department shall grant a specific
license to manufacture and distribute sources and devices that contain
radioactive material to a person licensed in accordance with Article 7 of this
Chapter for use as a calibration, transmission, or reference source or for
medical purposes, if the applicant meets all of the requirements in
10 CFR
32.74, revised July 25, 2012, incorporated by
reference, available under
R9-7-101, and containing no future
editions or amendments.
J.
Requirements for license to manufacture and distribute industrial products
containing depleted uranium for mass volume applications.
1. The Department shall grant a specific
license to manufacture industrial products and devices that contain depleted
uranium for use under R9-7-305(F) or equivalent regulations of the NRC or
another Agreement State if:
a. The applicant
satisfies the general requirements in
R9-7-309;
b. The applicant submits sufficient
information relating to the design, manufacture, prototype testing, quality
control procedures, labeling or marking, proposed uses, and potential hazards
of the industrial product or device to provide reasonable assurance that
possession, use, or transfer of the depleted uranium in the product or device
is not likely to cause any individual to receive a radiation dose in excess of
10 percent of the limits specified in
R9-7-408; and
c. The applicant submits sufficient
information regarding the industrial product or device and the presence of
depleted uranium for a mass volume application in the product or device to
provide reasonable assurance that unique benefits will accrue to the public
because of the usefulness of the product or device.
2. In the case of an industrial product or
device whose unique benefits are questionable, the Department shall approve an
application for a specific license under this subsection only if the product or
device is found to combine a high degree of utility and low probability of
uncontrolled disposal and dispersal of significant quantities of depleted
uranium into the environment.
3.
The Department may deny any application for a specific license under this
subsection if the end use or uses of the industrial product or device cannot be
reasonably foreseen.
4. Each person
licensed under subsection (J)(1) shall:
a.
Maintain the level of quality control required by the license in the
manufacture of the industrial product or device and the installation of the
depleted uranium into the product or device;
b. Label or mark each unit to:
i. Identify the manufacturer of the product
or device, the number of the license under which the product or device was
manufactured or initially transferred, the fact that the product or device
contains depleted uranium, and the quantity of depleted uranium in each product
or device; and
ii. State that the
receipt, possession, use, and transfer of the product or device are subject to
a general license or the equivalent regulations of the U.S. Nuclear Regulatory
Commission or an Agreement State;
c. Assure that the depleted uranium, before
being installed in each product or device, has been impressed with the
following legend, clearly legible through any plating or other covering:
"Depleted Uranium";
d. Furnish a
copy of the general license contained in
R9-7-305(F) and a
copy of ARRA-23 to each person to whom depleted uranium in a product or device
is transferred for use under a general license contained in
R9-7-305(F);
or
e. Furnish a copy of the general
license contained in the NRC's or Agreement State's regulation equivalent to
R9-7-305(F) and a
copy of the NRC's or Agreement State's certificate, or alternatively, furnish a
copy of the general license contained in
R9-7-305(F) and a
copy of ARRA-23 to each person to whom depleted uranium in a product or device
is transferred for use under a general license of the NRC or an Agreement
State, with a document explaining that use of the product or device is
regulated by the NRC or an Agreement State under requirements substantially the
same as those in
R9-7-305(F);
f. Report to the Department all transfers of
industrial products or devices to persons for use under the general license in
R9-7-305(F). The report shall identify each general licensee by name and
address, an individual by name or position who serves as the point of contact
person for the general licensee, the type and model number of device
transferred, and the quantity of depleted uranium contained in the product or
device. The report shall be submitted within 30 days after the end of each
calendar quarter in which a product or device is transferred to the generally
licensed person. If no transfers have been made to persons generally licensed
under R9-7-305(F) during
the reporting period, the report shall so indicate;
i. Report to the U.S. Nuclear Regulatory
Commission all transfers of industrial products or devices to persons for use
under the NRC general license in
10 CFR
40.25; or
ii. Report to the responsible state agency
all transfers of devices manufactured and distributed under subsection
(J)(4)(f) for use under a general license in that state's regulations
equivalent to
R9-7-305(F);
iii. The report required in subsection
(J)(4)(f)(i) or (ii) shall identify each general licensee by name and address,
an individual by name or position who serves as the contact person for the
general licensee, the type and model number of the device transferred, and the
quantity of depleted uranium contained in the product or device. The report
shall be submitted within 30 days after the end of each calendar quarter in
which a product or device is transferred to the generally licensed
person;
iv. If no transfers have
been made to NRC licensees during the reporting period, this information shall
be reported to the NRC;
v. If no
transfers have been made to general licensees within a particular Agreement
State during the reporting period, this information shall be reported to the
responsible Agreement state agency; and
vi. Records showing the name, address, and
contact person for each general licensee to whom depleted uranium in industrial
products or devices is transferred for use under a general license provided in
R9-7-305(F) or equivalent regulations of the NRC or of another Agreement State
shall be maintained for a period of at least three years and show the date of
each transfer, the quantity of depleted uranium in each product or device
transferred, and compliance with the reporting requirements of this
Section.
K. A licensee who manufactures nationally
tracked sources, as defined in Article 4, shall:
1. Serialize the sources in accordance with
10 CFR
32.201, revised November 8, 2006,
incorporated by reference, available under
R9-7-101, and containing no future
editions or amendments; and
2.
Report manufacturing activities in accordance with
R9-7-454.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.