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 › SPECIFIC LICENSES › Section 144-220-C-11 - Special requirements for a specific license to manufacture, assemble, repair or distribute commodities, products or devices which contain radioactive material

Current through 2024-29, July 17, 2024
A. Licensing the
					 introduction of radioactive material into products in exempt concentrations.
No person may introduce radioactive material into a
						product or material knowing or having reason to believe that it will be
						transferred to persons exempt under C.3.A. or equivalent regulations of the
						NRC, or an Agreement State, except in accordance with a license issued under
						10 CFR
						32.11
B. Licensing the distribution of radioactive
					 material in exempt quantities. Authority to transfer possession or control by
					 the manufacturer, processor, or producer of any equipment, device, commodity,
					 or other product containing radioactive material whose subsequent possession,
					 use transfer, and disposal by all other persons are exempted from regulatory
					 requirements may be obtained only from the U.S. Nuclear Regulatory Commission,
					 Washington, D.C. 20555
C. Licensing
					 the incorporation of radioactive material into gas and aerosol detectors. An
					 application for a specific license authorizing the incorporation of radioactive
					 material into gas and aerosol detectors to be distributed to persons exempt
					 under C.3 will be approved if the application satisfies requirements equivalent
					 to those contained in Section 32.26 of 10 CFR Part 32 . The maximum quantity of
					 Radium-226 in each device shall not exceed 0.1 microcurie (3.7 kBq). NARM
					 radionuclides are found in Appendix B to Part C.
D. Licensing the manufacture and distribution
					 of devices to persons generally licensed under C.6.D.
(1) An application for a specific license to
					 manufacture or distribute devices containing radioactive material, excluding
					 special nuclear material, to persons generally licensed under C.6.D or
					 equivalent regulations of the U.S. Nuclear Regulatory Commission or an
					 Agreement State will be approved if:
(a) The
					 applicant satisfies the general requirements of C.8;
(b) 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:
(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 in one year a
					 dose in excess of 10 percent of the limits specified in D.6, 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:
Table D.1
Organ
Dose
Whole body; head and trunk; active blood-forming
								  organs; gonads; or lens of eye
15 rem (150 mSv)
Hands and forearms; feet and ankles; localized
								  areas of skin averaged over areas no larger than 1 square centimeter
200 rem (2 Sv)
Other organs
50 rem (500 mSv)
(c) Each device bears a durable, legible,
					 clearly visible label or labels approved by the Agency, which contain in a
					 clearly identified and separate statement:
(i)
					 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),
(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 such 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 the
					 following statement, as appropriate, in the same or substantially similar form:
The receipt, possession, use, and transfer of this
						device, Model_______, Serial No._______7 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 U.S. 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)
(d) 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 Part D.1901 of this rule,
					 and the name of the manufacturer or initial distributor.
(e) Each device meeting the criteria of Part
					 C 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, "
Caution-Radioactive
					 Material
,'' and, if practicable, the radiation symbol described in Part
					 D.1901 of this rule.