Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 3 - RADIOACTIVE MATERIAL LICENSING › Section R9-7-306 - General License-Radioactive Material Other Than Source Material

Current through Register Vol. 30, No. 28, July 12, 2024
A. Certain
				measuring, gauging or controlling devices and certain devices for producing
				light or an ionized atmosphere.
1. This
				subsection grants a general license to a commercial or industrial firm; a
				research, educational or medical institution; an individual conducting
				business; or a state or local government agency to receive, acquire, possess,
				use, or transfer radioactive material contained in devices designed and
				manufactured for the purpose of detecting, measuring, gauging or controlling
				thickness, density, level, interface location, radiation, leakage, or
				qualitative or quantitative chemical composition, or for producing light or an
				ionized atmosphere, according to the provisions of
				10 CFR
				31.5(b), (c), and (d),
				(Revised January 1, 2013, incorporated by reference, and available under
				R9-7-101. The incorporated material
				contains no future editions or amendments.
2. A general licensee shall receive a device
				from one of the specific licensees described in this Section or through a
				transfer made under subsection (A)(4)(k).
3. A general license in subsection (A)(1)
				applies only to radioactive material contained in devices that have been
				manufactured or initially transferred and labeled in accordance with the
				requirements contained in:
a. A specific
				license issued under
				R9-7-311(A),
				or
b. An equivalent specific
				license issued by the NRC or another Agreement State.
c. An equivalent specific license issued by a
				State with rules or regulations comparable to this Section.
4. A person who acquires,
				receives, possesses, uses, or transfers radioactive material in a device
				licensed under subsection (A)(1) or through a transfer made under subsection
				(A)(4)(h), shall:
a. Ensure that all labels
				and safety statements affixed to a device at the time of receipt and bearing a
				statement that removal of the label is prohibited are maintained and not
				removed, and comply with all instructions and precautions on the
				labels.
b. Ensure that the device
				is tested for leakage of radioactive material and proper operation of the
				on-off mechanism and indicator, if any, at no longer than six-month intervals
				or at other intervals as specified on the label.
i. A general licensee need not test a device
				that contains only krypton for leakage of radioactive material; and
ii. A general licensee need not test a device
				for leakage of radioactive material if the device contains only tritium, not
				more than 3.7 mega-becquerels (100 microcuries) of other beta and/ or gamma
				emitting material, or 370 kilobec-querels (10 microcuries) of alpha emitting
				material, or the device is held in storage, in the original shipping container,
				before initial installation.
c. Ensure that the tests required by
				subsection (A)(4)(b) and other testing, installation, servicing, and removal
				from installation involving the radioactive material or its shielding or
				containment, are performed:
i. In accordance
				with the device label instructions, or
ii. By a person holding a specific license
				under R9-7-311(A) or in
				accordance with the provisions of a specific license issued by the NRC or an
				Agreement State which authorizes distribution of devices to persons generally
				licensed by the NRC or an Agreement State.
d. Maintain records of compliance with the
				requirements in subsections (A)(4)(b) and (c) that show the results of tests;
				the dates that required activities were performed, and the names of persons
				performing required activities involving radioactive material from the
				installation and its shielding or containment. The records shall be maintained
				for three years from the date of the recorded event or until transfer or
				disposal of the device.
e.
				Immediately suspend operation of a device if there is a failure of, or damage
				to, or any indication of a possible failure of or damage to, the shielding of
				the radioactive material or the on-off mechanism or indicator, or upon the
				detection of 185 becquerel (0.005 microcurie) or more of removable radioactive
				material.
i. A general licensee shall not
				operate the device until it has been repaired by the manufacturer or another
				person holding a specific license to repair this type of device that was issued
				by the Department under
				R9-7-311(A), the
				NRC, or an Agreement State which authorizes distribution of devices to persons
				generally licensed by the NRC or an Agreement State.
ii. If necessary the general licensee shall
				dispose of the device and any radioactive material from the device by transfer
				to a person authorized by a specific license to receive the radioactive
				material in the device or as otherwise approved by the Department.
iii. Within 30 days of an event governed by
				subsection (A)(4)(e) the general licensee shall furnish a report that contains
				a brief description of the event and the remedial action taken and, in the case
				of detection of 185 Becquerel (0.005 microcurie) or more of removable
				radioactive material or failure of or damage to a source likely to result in
				contamination of the general licensee's facility or the surrounding area, if
				applicable, a plan for ensuring that the general licensee's facility and
				surrounding area, if applicable, are acceptable for unrestricted use. The
				radiological criteria for unrestricted use in R9-7-452 may be used to prepare
				the plan, as determined by the Department, on a case-by-case basis.
f. Not abandon a device that
				contains radioactive material.
g.
				Not export a device that contains radioactive material except in accordance
				with 10 CFR 110, revised January 1, 2013, incorporated by reference, and
				available under
				R9-7-101. The incorporated material
				contains no future editions or amendments.
h. Transfer or dispose of a device that
				contains radioactive material only by export as authorized in subsection
				(A)(4)(g), transfer to another general licensee as authorized in subsection
				(A)(4)(k) or a person who is authorized to receive the device by a specific
				license issued by the Department, the NRC, or an Agreement State, or collection
				as waste if authorized by equivalent regulations of an Agreement State, or the
				NRC, or as otherwise approved under subsection (A)(4)(j).
i. Within 30 days after the transfer or
				export of a device to a specific licensee, furnish a report to the Department.
				The report shall:
i. Identify the device by
				manufacturer's (or initial transferor's) name, model number, and serial
				number;
ii. Provide the name,
				address, and license number of the person receiving the device (license number
				not applicable if exported); and
iii. Provide the date of transfer or
				export.
j. Obtain
				written Department approval before transferring a device to any other specific
				licensee that is not authorized in accordance with subsection
				(A)(4)(h).
k. Transfer a device to
				another general licensee only:
i. If the
				device remains in use at a particular location. The transferor shall provide
				the transferee with a copy of this Section, a copy of R9-7-443, R9-7-445, and
				R9-7-448 and any safety documents
				identified on the device label. Within 30 days of the transfer, the transferor
				shall report to the Department the manufacturer's (or initial transferor's)
				name; the model number and the serial number of the device transferred; the
				transferee's name and mailing address for the location of use; and the name,
				title, and telephone number of the responsible individual appointed by the
				transferee in accordance with subsection (A)(4)(n); or
ii. If the device is held in storage in the
				original shipping container at its intended location of use before initial use
				by a general licensee, and by a person that is not a party to the
				transaction.
l. Comply
				with the provisions of R9-7-443, R9-7-444, R9-7-445, R9-7-447, and R9-7-448 for
				reporting and notification of radiation incidents, theft or loss of licensed
				material, and is exempt from the other requirements of 9 A.A.C 7, Articles 4
				and 10.
m. Respond to written
				requests from the Department to provide information relating to the general
				license within 30 days from the date on the request, or a longer time period
				specified in the request. If the general licensee cannot provide the requested
				information within the specified time period, the general licensee shall
				request a longer period to supply the information before expiration of the time
				period, providing the Department with a written justification for the
				request.
n. Appoint an individual
				responsible for knowledge of applicable laws and possessing the authority to
				take actions required to comply with applicable radiation safety laws. The
				general licensee, through this individual, shall ensure the day-to-day
				compliance with applicable radiation safety laws. This provision does not
				relieve the general licensee of responsibility.
o. Register, in accordance with subsections
				(A)(4)(p) and (q), any device that contains at least 370 mega-becquerels (10
				millicuries) of cesium-137, 3.7 megabecquerels (0.1 millicuries) of
				strontium-90, 37 megabecquerels (1 millicurie) of cobalt-60, or 37
				megabecquerels (1 millicurie) of americium-241 or any other transuranic (i.e.,
				element with atomic number greater than uranium (92)), based on the activity
				indicated on the label. Each address for a location of use, as described under
				subsection (A)(4)(q)(iv), represents a separate general licensee and requires a
				separate registration and fee.
p.
				Register each device annually with the Department and pay the fee required by
				R9-7-1306, Category D4, if in possession of a device that meets the criteria in
				subsection (A)(4)(o). The general licensee shall register by verifying,
				correcting, and adding to the information provided in a request for
				registration received from the Department. The registration information shall
				be submitted to the Department within 30 days from the date on the request for
				registration. In addition, a general licensee holding devices meeting the
				criteria of subsection (A)(4)(o) is subject to the bankruptcy notification
				requirements in
				R9-7-313(D).
q. In registering a device, furnish the
				following information and any other registration information specifically
				requested by the Department:
i. Name and
				mailing address of the general licensee;
ii. Information about each device, including
				the manufacturer (or initial transferor), model number, serial number,
				radioisotope, and activity (as indicated on the label);
iii. Name, title, and telephone number of the
				responsible individual appointed by the general licensee under subsection
				(A)(4)(n);
iv. Address or location
				at which each device is used and stored. For a portable device, the address of
				the primary place of storage;
v.
				Certification by the responsible individual that the information concerning
				each device has been verified through a physical inventory and review of label
				information; and
vi. Certification
				by the responsible individual that the individual is aware of the requirements
				of the general license.
r. Report a change in mailing address for the
				location of use or a change in the name of the general licensee to the
				Department within 30 days of the effective date of the change. For a portable
				device, a report of address change is only required for a change in the
				device's primary place of storage.
s. Not use a device if the device has not
				been used for a period of two years. If a device with shutters is not being
				used, the general licensee shall ensure that the shutters are locked in the
				closed position. The testing required by subsection (A)(4)(b) need not be
				performed during a period of storage. However, if a device is put back into
				service or transferred to another person, and has not been tested during the
				required test interval, the general licensee shall ensure that the device is
				tested for leakage before use or transfer and that the shutter is tested before
				use. A device kept in standby for future use is excluded from the two-year time
				limit in this subsection if the general licensee performs a quarterly physical
				inventory regarding the standby devices.
5. A person that is generally licensed by an
				Agreement State with respect to a device that meets the criteria in subsection
				(A)(4)(o) is exempt from registration requirements if the device is used in an
				area subject to Department jurisdiction for a period less than 180 days in any
				calendar year. The Department does not request registration information from a
				general licensee if the device is exempted from licensing requirements in
				subsection (A)(4)(o).
6. The
				general license granted under subsection (A)(1) is subject to the provisions of
				9 A.A.C. 7, Articles 1, 3, 12, and 15, and A.R.S. §§
										30-654(B)(13),
				30-657(A) and
				(B),
				30-681, and
				30-685 through
				30-689.
7. The general license in subsection (A)(1)
				does not authorize the manufacture or import of devices containing byproduct
				material.