New Mexico Administrative Code › Title 20 - ENVIRONMENTAL PROTECTION › Chapter 3 - RADIATION PROTECTION › Part 3 - LICENSING OF RADIOACTIVE MATERIALS › Section 20.3.3.305 - GENERAL LICENSES - RADIOACTIVE MATERIAL OTHER THAN SOURCE MATERIAL

Current through Register Vol. 35, No. 13, July 16, 2024
A.
[RESERVED]
B.
Certain detecting, measuring, gauging or controlling devices and certain
				devices for producing light or an ionized atmosphere.
(1) A general license is hereby issued as
				required by Subparagraph (m) of Paragraph (3) of this Subsection to commercial
				and industrial firms and research, educational and medical institutions,
				individuals in the conduct of their business, and federal, state or local
				government agencies to receive, acquire, possess, use or transfer, in
				accordance with the provisions of Paragraphs (2), (3), and (4) of this
				subsection, byproduct 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, and the device has been registered in the sealed source and device
				registry.
(2) The general license in
				Paragraph (1) of this subsection applies only to byproduct material contained
				in devices which have been manufactured or initially transferred and labeled in
				accordance with the specifications contained in:
(a) a specific license issued by the
				department pursuant to Subsection E of
				20.3.3.315
				NMAC; or
(b) an equivalent specific
				license issued by the NRC or an agreement state; or
(c) an equivalent specific license issued by
				a state with provisions comparable to Subsection E of
				20.3.3.315
				NMAC. The devices must have been received from one of the specific licensees
				described in this paragraph, or through a transfer made under Subparagraph (h)
				of Paragraph (3) of this subsection.
(3) Any person who receives, acquires,
				possesses, uses or transfers byproduct material in a device pursuant to the
				general license in Paragraph (1) of this subsection shall comply with the
				following.
(a) The general licensee shall
				assure that all labels affixed to the device at the time of receipt and bearing
				a statement that removal of the label is prohibited are maintained thereon and
				shall comply with all instructions and precautions provided by such
				labels.
(b) The general licensee
				shall assure 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 such other intervals as are specified in the
				label; however:
(i) devices containing only
				krypton need not be tested for leakage of radioactive material; and
(ii) devices containing only tritium or not
				more than 100 microcuries (3.7 megabecquerels) of other beta or gamma emitting
				material or 10 microcuries (0.37 megabecquerel) of alpha emitting material and
				devices held in storage in the original shipping container prior to initial
				installation need not be tested for any purpose.
(c) The general licensee shall assure that
				the test required by Subparagraph (b) of Paragraph (3) of this subsection and
				other testing, installation, servicing and removal from installation involving
				the radioactive materials, its shielding or containment are performed:
(i) in accordance with the instructions
				provided by the labels; or
(ii) by
				a person holding a specific license pursuant to this part from the department,
				the NRC, or an agreement state to perform such activities.
(d) The general licensee shall maintain
				records showing compliance with the requirements of Subparagraphs (b) and (c)
				of Paragraph (3) of this subsection. The records must show the results of
				tests. The records must also show the dates of performance of, and the names of
				persons performing, testing, installing, servicing and removing from the
				installation radioactive material and its shielding or containment. The
				licensee shall retain these records as follows:
(i) each record of a test for leakage or
				radioactive material required by Subparagraph (b) of Paragraph (3) of this
				subsection shall be retained for three years after the next required leak test
				is performed or until the sealed source is transferred or disposed
				of;
(ii) each record of a test of
				the on-off mechanism and indicator required by Subparagraph (b) of Paragraph
				(3) of this subsection shall be retained for three years after the next
				required test of the on-off mechanism and indicator is performed or until the
				sealed source is transferred or disposed of; and
(iii) each record that is required by
				Subparagraph (c) of Paragraph (3) of this subsection shall be retained for 3
				years from the date of the recorded event or until the device is transferred or
				disposed of.
(e) The
				general licensee shall immediately suspend operation of the 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 0.005 microcuries (185 becquerels) or more
				removable radioactive material. The device may not be operated until it has
				been repaired by the manufacturer or other person holding a specific license to
				repair such devices that was issued pursuant to this part by the department,
				the NRC or an agreement state. The device and any radioactive material from the
				device, shall only be disposed of 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. A report shall be furnished to the
				department within 30 days containing a brief description of the event and the
				remedial action taken. In the case of detection of 0.005 microcurie or more
				removable radioactive material or failure of, or damage to, a source likely to
				result in contamination of the premises or the environs, the report shall
				include a plan for ensuring that the premises and environs are acceptable for
				unrestricted use. Under these circumstances, the criteria set out in Subsection
				B of
				20.3.4.426
				NMAC,
radiological criteria for unrestricted use
, shall be
				applicable, as determined by the department on a case-by-case basis.
(f) The general licensee shall not abandon
				the device containing radioactive material.
(g) The general licensee shall not export the
				device containing radioactive material except in accordance with 10 CFR
				110.
(h)
Device transfer
				requirements.
(i) The general licensee
				shall transfer or dispose of the device containing radioactive material only by
				export as provided by Subparagraph (g) of this paragraph, by transfer to
				another general licensee as authorized in Subparagraph (i) of this paragraph,
				or to a person authorized to receive the device by a specific license issued by
				the department pursuant under this part, or by a specific license issued by the
				department authorizing waste collection pursuant to this part, or equivalent
				provisions of the NRC or an agreement state, or as otherwise approved under
				Item (iii) of this subparagraph.
(ii) The general licensee shall within 30
				days after the transfer of a device to a specific licensee or export, furnish a
				report to the department at the address indicated in
				20.3.1.116 NMAC.
				The report shall contain the identification of the device by manufacturer's (or
				initial transferor's) name, model number and serial number; the name, address
				and license number of the person receiving the device (license number not
				applicable if exported); and the date of the transfer.
(iii) The general licensee shall obtain
				written department approval before transferring the device to any other
				specific licensee not specifically identified in Item (i) of this subparagraph.
				However, a holder of a specific license may transfer a device for possession
				and use under its own specific license without prior approval, if, the holder:
				verifies that the specific license authorizes the possession and use, or
				applies for and obtains amendment to the license authorizing the possession and
				use; removes, alters, covers, or clearly and unambiguously augments the
				existing label (otherwise required by Subparagraph (a) of this paragraph) so
				that the device is labeled in compliance with
				20.3.4.430
				NMAC, however, the manufacturer, model number, and serial number must be
				retained; obtains the manufacturer's or initial transferor's information
				concerning maintenance that would be applicable under the specific license
				(such as leak testing procedures); and reports the transfer under Item (ii) of
				this subparagraph.
(i)
				The general licensee shall transfer the device to another general licensee only
				if:
(i) the device remains in use at a
				particular location, in which case:
1) the
				transferor shall give the transferee a copy of this subsection (Subsection B of
				20.3.3.305 NMAC), a copy of Subsection F of
				20.3.3.317
				NMAC, a copy of
				20.3.3.326
				NMAC, a copy of
				20.3.4.451
				NMAC, a copy of
				20.3.4.452
				NMAC and any safety documents identified in the label of the device;
2) within 30 days of the transfer, the
				transferor shall report to the department at the address indicated in
				20.3.1.116 NMAC,
				stating 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 phone number of the
				responsible individual identified by the transferee in accordance with
				Subparagraph (l) of this paragraph to have knowledge of and authority to take
				actions to ensure compliance with the appropriate regulations and requirements;
				or
(ii) the device is
				held in storage by an intermediate person in the original shipping container at
				its intended location of use prior to initial use by a general
				licensee.
(j) The general
				licensee shall comply with the provisions of
				20.3.4.451
				NMAC and
				20.3.4.452
				NMAC for reporting radiation incidents, theft or loss of licensed material, but
				shall be exempt from the other requirements of 20.3.4 NMAC and 20.3.10
				NMAC.
(k) The general licensee
				shall respond to written requests from the department to provide information
				relating to the general license within 30 calendar days of the date of the
				request, or other time specified in the request. If the general licensee cannot
				provide the requested information within the allotted time, it shall, within
				that same time period, request a longer period to supply the information by
				providing the department with a written justification for the
				request.
(l) The general licensee
				shall appoint an individual responsible for having knowledge of the appropriate
				regulations and requirements and the authority for taking required actions to
				comply with appropriate regulations and requirements. The general licensee,
				through this individual, shall ensure the day-to-day compliance with
				appropriate regulations and requirements. This appointment does not relieve the
				general licensee of any of its responsibility in this regard.
(m)
Registration requirements.
(i) The general licensee shall register on a
				department registration form, in accordance with Items (ii) and (iii) of this
				subparagraph, devices containing at least 10 millicuries (370 megabecquerels)
				of cesium-137, 0.1 millicuries (3.7 megabecquerels) of strontium-90, 1
				millicurie (37 megabecquerels) of cobalt-60, 0.1 millicurie (3.7
				megabecquerels) of radium-226, 1 millicurie (37 megabecquerels) 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 of a location of use, as described under Item (iii) of this
				subparagraph, represents a separate general licensee and requires a separate
				registration.
(ii) If in possession
				of a device meeting the criteria of Item (i) of this subparagraph, the general
				licensee shall register these devices annually with the department.
				Registration shall be done by verifying, correcting or 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 of the date of the request for registration or as otherwise
				indicated in the request. In addition, a general licensee holding devices
				meeting the criteria of Item (i) of this Subparagraph is subject to the
				bankruptcy notification requirement in Subsection E of
				20.3.3.317
				NMAC.
(iii) In registering devices,
				the general licensee shall furnish the following information and any other
				information specifically requested by the department:
1) name and mailing address of the general
				licensee;
2) information about each
				device: the manufacturer (or initial transferor), model number, serial number,
				the radioisotope and activity (as indicated on the label);
3) name, title and telephone number of the
				responsible person designated as a representative of the general licensee under
				Subparagraph (l) of this paragraph;
4) address or location at which the device(s)
				are used or stored; for portable devices, the address of the primary place of
				storage;
5) certification by the
				responsible representative of the general licensee that the information
				concerning the device(s) has been verified through a physical inventory and
				checking of label information; and
6) certification by the responsible representative of the general
				licensee that they are aware of the requirements of the general
				license.
(iv) Persons
				generally licensed by the NRC and an agreement state with respect to devices
				meeting the criteria in Item (i) of this Subparagraph are not subject to
				registration requirements if the devices are used in areas subject to
				department jurisdiction for a period less than 180 days in any calendar year.
				The department will not request registration information from such licensees.
(n) The general licensee
				shall report changes to the mailing address for the location of use (including
				change in name of general licensee) to the department at the address indicated
				in
				20.3.1.116 NMAC,
				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.
(o) The general
				licensee shall not hold devices that are not in use for longer than 2 years. If
				devices with shutters are not being used, the shutter shall be locked in the
				closed position. The testing required by Subparagraph (b) of Paragraph (3) of
				this Subsection need not be performed during the period of storage only.
				However, when devices are put back into service or transferred to another
				person, and have not been tested within the required test interval, they shall
				be tested for leakage before use or transfer and the shutter tested before use.
				Devices kept in standby for future use are excluded from the two-year time
				limit if the general licensee performs quarterly physical inventories of these
				devices while they are in standby.
(4) The general license in Paragraph (1) of
				this subsection does not authorize the manufacture or import of devices
				containing radioactive material.