Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part C - LICENSING OF RADIOACTIVE MATERIAL › GENERAL LICENSES › Section 144-220-C-6 - General licenses - radioactive material other than source material

Current through 2024-29, July 17, 2024
A. Reserved.
B. A general license is hereby issued to
					 receive title to and own special nuclear material without regard to quantity.
					 Notwithstanding any other provision of this Part, a general licensee under C.6
					 is not authorized to acquire, deliver, receive, possess, use, transfer, import,
					 or export special nuclear material, except as authorized in a specific
					 license.
C. Certain measuring,
					 gauging or controlling devices
(1) A general
					 license is hereby issued to commercial and industrial firms and to research,
					 educational and medical institutions, individuals in the conduct of their
					 business, and State or local government agencies to own, receive, acquire,
					 possess, use or transfer in accordance with the provision of C.6.C(2), (3),
					 (4), radioactive material, excluding special nuclear 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.
(2) The general license in C.6.C(1) applies
					 only to radioactive material contained in devices, which have been manufactured
					 and labeled in accordance with the specifications contained in a specific
					 license issued by the Agency pursuant to C.11.D or in accordance with the
					 specifications contained in a specific license issued by the U.S. Nuclear
					 Regulatory Commission or an Agreement State, which authorizes distribution of
					 devices to persons generally licensed by the U.S. Nuclear Regulatory Commission
					 or an Agreement State. Regulations under the Federal Food, Drug, and Cosmetic
					 Act authorizing the use of radioactive control devices in food production
					 require certain additional labeling thereon which is found in Section 179.21 of
					 the Code of Federal Regulations, Title 21. The devices must have been received
					 from one of the specific licensees described in C.6.C(2) or through a transfer
					 under C.6.C(3)(i)
(3) Any person
					 who owns, receives, acquires, possesses, uses, or transfers radioactive
					 material in a device pursuant to the general license in C.6.C(1) shall file
					 Agency Form HHE 861, Registration Certificate - Use of Fixed Measuring, Gauging
					 or Controlling Devices, Agency Form HHE 862, Registration Certificate - Use of
					 Portable Measuring, Gauging or Controlling Devices or Agency Form HHE 864,
					 Registration Certificate for use of Static Eliminators, Electron Capture
					 Devices, Gas Chromatographs, or Other Devices which Contain Radioactive
					 Material Under a General License with the Agency. The form shall be submitted
					 within 30 days after the first receipt or acquisition of such device or 30 days
					 after the effective date of this rule for devices acquired prior to the
					 effective date. The general licensee shall furnish such information as may be
					 required by that form as well as the annual fee referenced in Appendix A of
					 this Part and:
(a) 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) 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 MBq) of other beta and/or gamma emitting
					 material or 10 microcuries (0.37 MBq) 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) Shall assure that the tests required by
					 C.6.C(3)(b) 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 an applicable
					 specific license from the Agency, the U.S. Nuclear Regulatory Commission or an
					 Agreement State to perform such activities;
(d) Shall maintain records showing compliance
					 with the requirements of C.6.C(3)(b) and c. The records shall show the results
					 of tests. The records also shall show the dates of performance of, and the
					 names of persons performing, testing, installation, servicing, and removal from
					 installation concerning the radioactive material, its shielding or containment.
					 Records of tests for leakage of radioactive material required by C.6.C(3)(b)
					 shall be maintained for three years after the next required leak test is
					 performed or until the sealed source is transferred or disposed. Records of
					 tests of the on/off mechanism and indicator required by C.6.C(3)(b) shall be
					 maintained 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. Records which are required by C.6.C(3)(c) shall be maintained for a
					 period of three years from the date of the recorded event or until the device
					 is transferred or disposed;
(e)
					 Upon the occurrence of 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 microcurie
					 (185 Bq) or more removable radioactive material, shall immediately suspend
					 operation of the device until it has been repaired by the manufacturer or other
					 person holding an applicable specific license from the Agency, the U.S. Nuclear
					 Regulatory Commission or an Agreement State to repair such devices, or disposed
					 of by transfer to a person authorized by an applicable specific license to
					 receive the radioactive material contained in the device and, within 30 days,
					 furnish to the Agency a report containing a brief description of the event and
					 the remedial action taken, and, 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, a plan for ensuring
					 that the premises and environs are acceptable for unrestricted use, must be
					 furnished to the Agency;
(f) Shall
					 not abandon the device containing radioactive material;
(g) Shall not export the device containing
					 radioactive material except in accordance with 10 CFR Part 110 ;
(h)
(i)
					 Shall transfer or dispose of the device containing radioactive material only by
					 export as provided by paragraph (g) of this section, by transfer to another
					 general licensee as authorized in paragraph (i) of this section, or to a person
					 authorized to receive the device by a specific license issued under Part C,
					 that authorizes possession, use, waste collection, or equivalent regulations of
					 an Agreement State, or as otherwise approved under paragraph (h)(iii) of this
					 section.
(ii) Shall, within 30 days
					 after the transfer of a device to a specific licensee or export, furnish a
					 report to the Manager, Radiation Control Program. The report must contain:
(a) The identification of the device by
					 manufacturer's (or initial transferor's) name, model number, and serial
					 number;
(b) The name, address, and
					 license number of the person receiving the device (license number not
					 applicable if exported); and
(c)
					 The date of the transfer.
(iii) Shall obtain written Agency approval
					 before transferring the device to any other specific licensee not specifically
					 identified in paragraph (h)(i) of this section; 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:
(a) Verifies that the specific license
					 authorizes the possession and use, or applies for and obtains an amendment to
					 the license authorizing the possession and use;
(b) Removes, alters, covers, or clearly and
					 unambiguously augments the existing label (otherwise required by paragraph (a)
					 of this section) so that the device is labeled in compliance with Part D.1904;
					 however the manufacturer, model number, and serial number must be
					 retained;
(c) 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
(d) Reports the
					 transfer under paragraph (h)(ii) of this section.
(i) Shall transfer the device to
					 another general licensee only:
(a) Where the
					 device remains in use at a particular location. In such case the transferor
					 shall give the transferee a copy of this Section, a copy of Sections
					 10 CFR
					 31.2, C.25, D.2201, D.2202, and any safety
					 documents identified in the label on the device and within 30 days of the
					 transfer, report to the Agency: the manufacturer's (or initial transferor's)
					 name and model and serial number of device transferred, the name, address for
					 the location of use of the transferee, and the name and/or position of an
					 individual who may constitute a point of contact between the Agency and the
					 transferee; or
(b) Where the device
					 is held in storage in the original shipping container at its intended location
					 of use prior to initial use by a general licensee;
(j) Shall comply with the provisions of
					 D.2201. and D.2202. of this rule for reporting radiation incidents, theft, or
					 loss of licensed material, but shall be exempt from the other requirements of
					 Parts D and J of this rule;
(k)
					 Shall respond to written requests from the Agency 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
					 submitting a letter to the Radiation Control Program and provide written
					 justification as to why it cannot comply.
(l) 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)
(i) Shall register, in accordance with
					 C.6.C.(3)(m)(ii) and (iii), devices containing at least 370 MBq (10 mCi) of
					 cesium-137, 3.7 MBq (0.1 mCi) of strontium-90, 37 MBq (1 mCi) of cobalt- 60,
					 3.7 megabecquerels (0.1 millicurie) of radium-226, or 37 MBq (1 mCi) 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 paragraph
					 C.6.C.(3)(m)(iii)(d), represents a separate general licensee and requires a
					 separate registration and fee.
(ii)
					 If in possession of a device meeting the criteria of C.6.C(3)(m)(i), shall
					 register these devices annually with the Agency and shall pay the required fee.
					 Registration must be done by verifying, correcting and/or adding to the
					 information provided in a request for registration received from the Agency.
					 The registration information must be submitted to the Agency within 30 days of
					 the date of the request for registration or as otherwise indicated in the
					 request. In addition, a general license holding devices meeting the criteria of
					 C.6.C.(3)(m)(i) is subject to bankruptcy notification requirement in Part
					 C.
(iii) In registering devices,
					 shall furnish the following information and any other information specifically
					 requested by the Agency:
(a) Name and mailing
					 address of the general licensee.
(b) Information about each device: the
					 manufacturer (or initial transferor), model number, serial number, the
					 radioisotope and activity (as indicated on the label).
(c) Name, title, and telephone number of the
					 responsible person designated as a representative of the general licensee under
					 paragraph C.6.C(3)(l). of this section.
(d) Address or location at which the
					 device(s) are used and/or stored. For portable devices, the address of the
					 primary place of storage.
(e)
					 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.
(f) 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 an
					 Agreement State with respect to devices meeting the criteria in paragraph
					 C.6.C.(3)(m)(i) this section are not subject to registration requirements if
					 the devices are used in areas subject to Agency jurisdiction for a period fewer
					 than 180 days in any calendar year. The Agency will not request registration
					 information from such licensees.
(n) Shall report changes to the mailing
					 address for the location of use (including change in name of general licensee)
					 to the Radiation Control Program Manager 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) Shall not hold devices that are not in
					 use for longer than two years. If devices with shutters are not being used, the
					 shutter must be locked in the closed position. The testing required by
					 C.6.C(3)(c) 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 must 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 C.6.C(1) does not authorize the manufacture of devices
					 containing radioactive material.
(5) The general license provided in C.6.C(1)
					 is subject to the provisions of A.4 through A.9., C.14., C.21., C.22. and Part
					 L of this rule.