No. 41992 (Amendment): Rule R313-19. Requirements of General Applicability to Licensing of Radioactive Material

(Amendment)

DAR File No.: 41992
Filed: 08/01/2017 04:56:08 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The proposed changes incorporate corresponding revisions made by the U.S. Nuclear Regulatory Commission (NRC) in a final rule published in the Federal Register on 05/29/2013 (78 FR 32310) under the title of Distribution of Source Material to Exempt Persons and to General Licensees and Revision of General License and Exemptions. As an Agreement State with the NRC for the radioactive materials program in Utah, the proposed changes are made in order to maintain regulatory compatibility with the federal radioactive materials regulations and our agreement state status with the NRC. Changes are proposed in selected sections of Rules R313-12, R313-19, R313-21, and R313-22 in order to incorporate all of the corresponding revisions issued under NRC's final rule promulgated on 05/29/2013. Additional proposed changes not directly associated with NRC's final rule are being made to update noted references and citations. (EDITOR'S NOTE: A proposed amendment to Rule R313-12 is under Filing No. 41991, a proposed amendment to Rule R313-21 is under Filing No. 41993, and a proposed amendment to Rule R313-22 in under Filing No. 41994 in this issue, August 15, 20017, of the Bulletin.)

Summary of the rule or change:

On 07/13/2017, the Waste Management and Radiation Control Board authorized the proposed changes to be published for public review and comment. Proposed changes to Rules R313-12, R313-19, R313-21, and R313-22 reflect those revisions made by the NRC to selected sections of 10 CFR Part 40, as promulgated on 05/29/2013 (78 FR 32310). The majority of the changes are required to retain regulatory compatibility for the radioactive materials program, other proposed changes provide added clarification or correct textual errors. Specifically, incorporating the revisions promulgated by the NRC into the appropriate sections of Rule R313-19 require the initial distribution of source material to exempt persons or to general licensees be explicitly authorized by a specific license and institute new reporting requirements to provide timely information on the types and quantities of source material distributed for use either under exemption or by general licensees. In addition, the rule modifies the existing possession and use requirements of the general license for small quantities of source material to better align the requirements with current health and safety standards. The regulatory amendments will create a regulatory framework for the initial distribution of source material to inform the Division, in the event of any manufacturer or distributor of source material becomes licensed in Utah, of what types and quantities of products containing source material are distributed for use under the exemptions from licensing and to identify persons using significant quantities of source material under the general license in Section R313-21-21. It will also ensure that general licensees under Section R313-21-21 are informed of applicable regulations before they obtain source material. Also, the proposed rule changes revise, clarify, or delete certain source material exemptions from licensing to make the exemptions more risk informed. The NRC's final rule and the associated proposed rule changes in the Utah radiation control rules also affect the possession and use of source material under a general license or an applicable license exemption. Proposed changes in the Exemptions section (R313-19-13) are being made to be compatible with the corresponding NRC regulations of 10 CFR 40.13 as promulgated on 05/29/2013 (78 FR 32310) regarding the distribution of certain quantities of source material (radioactive material containing uranium and/or thorium). The associated dates noted in the proposed changes in Section R313-19-13 are proposed to be 10/16/2017 based on the Waste Management and Radiation Control Board's action, during their scheduled meeting on 10/12/2017 to set the effective date of the rule changes as 10/16/2017. The edition date of the two incorporations by reference in Section R313-19-50 to Appendix B of 10 CFR Part 20 are updated from 2010 to 2017.

Statutory or constitutional authorization for this rule:

• Section 19-3-104
• Section 19-6-104

This rule or change incorporates by reference the following material:

• Updates 10 CFR Part 20, Appendix B, published by Government Printing Office, 01/01/2017

Anticipated cost or savings to:

the state budget:

The primary focus of the proposed rule changes is directed to manufacturers and distributors of radioactive source material (containing by definition a certain quantity of uranium or thorium). There are no state agencies that manufacture or distribute radioactive source material to either entities exempt from radioactive materials licensing requirements or to radioactive materials general licensees. However, state academic institutions that may possess or use radioactive source material for research or other academic-related purposes beyond the proposed quantity limit may need to apply for and receive a specific licenses. Any costs associated with the specific license application process and subsequent implementation procedures are unique to each licensing action and are therefore not quantifiable. However, additional information regarding a cost-benefit analysis associated with the NRC's final rule issued on 05/29/2013 (74 FR 32310) can be found in NRC's regulatory analysis document for this final rule (ADAMS Accession No. ML13079A302). A copy of this analysis is available from the Division of Waste Management and Radiation Control Web site at https://deq.utah.gov/Divisions/dwmrc/index.htm.

local governments:

The primary focus of the proposed rule changes is directed to manufacturers and distributors of radioactive source material (containing by definition a certain quantity of uranium or thorium). There are no local governments that manufacture or distribute radioactive source material to either entities exempt from radioactive materials licensing requirements or to radioactive materials general licensees. Additional information regarding a cost-benefit analysis associated with the NRC's final rule issued on 05/29/2013 (74 FR 32310) can be found in NRC's regulatory analysis document for this final rule (ADAMS Accession No. ML13079A302). A copy of this analysis is available from the Division of Waste Management and Radiation Control Web site at https://deq.utah.gov/Divisions/dwmrc/index.htm.

small businesses:

The primary focus of the proposed rule changes is directed to manufacturers and distributors of radioactive source material (containing by definition a certain quantity of uranium or thorium). There are no small business in Utah that manufacture or distribute radioactive source material to either entities exempt from radioactive materials licensing requirements or to radioactive materials general licensees. However, a small business that may possess or use radioactive source material for commercial, operational, research, development, or other business-related purposes beyond the proposed quantity limit may need to apply for and receive a specific licenses. Any costs associated with the specific license application process and subsequent implementation procedures are unique to each licensing action and are therefore not quantifiable. Additional information regarding a cost-benefit analysis associated with the NRC's final rule issued on 05/29/2013 (74 FR 32310) can be found in NRC's regulatory analysis document for this final rule (ADAMS Accession No. ML13079A302). A copy of this analysis is available from the Division of Waste Management and Radiation Control Web site at https://deq.utah.gov/Divisions/dwmrc/index.htm.

persons other than small businesses, businesses, or local governmental entities:

The primary focus of the proposed rule changes is directed to manufacturers and distributors of radioactive source material (containing by definition a certain quantity of uranium or thorium). There are no other entities in Utah that currently manufacture or distribute radioactive source material to either entities exempt from radioactive materials licensing requirements or to radioactive materials general licensees. However, a person that may possess or use radioactive source material for commercial, operational, research, development, or other business-related purposes beyond the proposed quantity limit may need to apply for and receive a specific licenses. Any costs associated with the specific license application process and subsequent implementation procedures are unique to each licensing action and are therefore not quantifiable. Additional information regarding a cost-benefit analysis associated with the NRC's final rule issued on 05/29/2013 (74 FR 32310) can be found in NRC's regulatory analysis document for this final rule (ADAMS Accession No. ML13079A302). A copy of this analysis is available from the Division of Waste Management and Radiation Control Web site at https://deq.utah.gov/Divisions/dwmrc/index.htm.

Compliance costs for affected persons:

The primary focus of the proposed rule changes is directed to manufacturers and distributors of radioactive source material (containing by definition a certain quantity of uranium or thorium). There are no entities in Utah that manufacture or distribute radioactive source material to either entities exempt from radioactive materials licensing requirements or to radioactive materials general licensees. However, a business or person that may possess or use radioactive source material for commercial, operational, research, development, or other business-related purposes beyond the proposed quantity limit may need to apply for and receive a specific licenses. Any costs associated with the specific license application process and subsequent implementation procedures are unique to each licensing action and are therefore not quantifiable. Additional information regarding a cost-benefit analysis associated with the NRC's final rule issued on 05/29/2013 (74 FR 32310) can be found in NRC's regulatory analysis document for this final rule (ADAMS Accession No. ML13079A302). A copy of this analysis is available from the Division of Waste Management and Radiation Control Web site at https://deq.utah.gov/Divisions/dwmrc/index.htm.

Comments by the department head on the fiscal impact the rule may have on businesses:

The primary focus of the proposed rule changes is directed to manufacturers and distributors of radioactive source material (containing by definition a certain quantity of uranium or thorium). There are no entities in Utah that manufacture or distribute radioactive source material to either entities exempt from radioactive materials licensing requirements or to radioactive materials general licensees. However, a business or person that may possess or use radioactive source material for commercial, operational, research, development, or other business-related purposes beyond the proposed quantity limit may need to apply for and receive a specific licenses. Any costs associated with the specific license application process and subsequent implementation procedures are unique to each licensing action and are therefore not quantifiable. Additional information regarding a cost-benefit analysis associated with the NRC's final rule issued on 05/29/2013 (74 FR 32310) can be found in NRC's regulatory analysis document for this final rule (ADAMS Accession No. ML13079A302). A copy of this analysis is available from the Division of Waste Management and Radiation Control Web site at https://deq.utah.gov/Divisions/dwmrc/index.htm.

Alan Matheson, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Environmental Quality
Waste Management and Radiation Control, RadiationRoom Second Floor
195 N 1950 W
SALT LAKE CITY, UT 84116-4880

Direct questions regarding this rule to:

• Rusty Lundberg at the above address, by phone at 801-536-4257, by FAX at 801-536-0222, or by Internet E-mail at [e-mail]
• Thomas Ball at the above address, by phone at 801-536-0251, by FAX at , or by Internet E-mail at [e-mail]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

09/15/2017

This rule may become effective on:

10/16/2017

Authorized by:

Scott Anderson, Director

RULE TEXT

R313. Environmental Quality, Waste Management and Radiation Control, Radiation.

R313-19. Requirements of General Applicability to Licensing of Radioactive Material.

R313-19-13. Exemptions.

(1) Source material.

(a) A person is exempt from Rules R313-19, R313-21, and R313-22 to the extent that the person receives, possesses, uses, owns, or transfers source material in a chemical mixture, compound, solution or alloy in which the source material is by weight less than 1/20 of one percent (0.05 percent) of the mixture, compound, solution, or alloy.

(b) A person is exempt from Rules R313-19, R313-21, and R313-22 to the extent that the person receives, possesses, uses or transfers unrefined and unprocessed ore containing source material; provided, that, except as authorized in a specific license, such person shall not refine or process the ore.

(c) A person is exempt from the requirements in Rules R313-15, R313-18, R313-19, R313-21, and R313-22 to the extent that the person receives, possesses, uses or transfers:

(i) any quantities of thorium contained in:

(A) incandescent gas mantles,

(B) vacuum tubes,

(C) welding rods,

(D) electric lamps for illuminating purposes: provided that, each lamp does not contain more than 50 milligrams of thorium,

(E) germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting provided that each lamp does not contain more than two grams of thorium,

(F) rare earth metals and compounds, mixtures, and products containing not more than 0.25 percent by weight thorium, uranium, or any combination of these, or

(G) personnel neutron dosimeters provided that each dosimeter does not contain more than 50 milligrams of thorium;

(ii) source material contained in the following products:

(A) glazed ceramic tableware manufactured before October 16, 2017, provided that the glaze contains not more than 20 percent by weight source material[,];

(B) piezoelectric ceramic containing not more than two percent by weight source material[,]; or

(C) glassware containing not more than two percent by weight source material or, for glassware manufactured before October 16, 2017, not more than ten percent by weight source material, but not including commercially manufactured glass brick, pane glass, ceramic tile, or other glass or ceramic used in construction;

(iii) photographic film, negatives and prints containing uranium or thorium;

(iv) a finished product or part fabricated of, or containing, tungsten-thorium or magnesium-thorium alloys, provided that the thorium content of the alloy does not exceed four percent by weight and that this exemption shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of the product or part;

(v) uranium contained in counterweights installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of the counterweights, provided that:

[(A) the counterweights are manufactured in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission authorizing distribution by the licensee pursuant to 10 CFR Part 40,]

[(B)](A) each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "DEPLETED URANIUM",

[(C)](B) each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED",

[(D)](C) The requirements specified in Subsections R313-19-13(1)(c)(v)[(B)](A) and [(C)](B) need not be met by counterweights manufactured prior to December 31, 1969, provided that such counterweights were manufactured under a specific license issued by the Atomic Energy Commission and were[are] impressed with the legend, "CAUTION - RADIOACTIVE MATERIAL - URANIUM", as previously required by the rules in effect on June 30, 1969, and

(E) the exemption contained in Subsection R313-19-13(1)(c)(v) shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such counterweights other than repair or restoration of any plating or other covering;

(vi) natural or depleted uranium metal used as shielding constituting part of a shipping container which is conspicuously and legibly impressed with the legend "CAUTION - RADIOACTIVE SHIELDING - URANIUM" and the uranium metal is encased in mild steel or equally fire resistant metal of minimum wall thickness of one eighth inch (3.2 mm);

(vii) thorium or uranium contained in or on finished optical lenses and mirrors, provided that each lens or mirror does not contain more than 10 percent by weight thorium or uranium or, for lenses manufactured before October 16, 2017, [does not contain more than] 30 percent by weight of thorium, and that this exemption shall not be deemed to authorize either:

(A) the shaping, grinding, or polishing of a lens or manufacturing processes other than the assembly of such lens into optical systems and devices without alteration of the lens, or

(B) the receipt, possession, use, or transfer of thorium contained in contact lenses, or in spectacles, or in eyepieces in binoculars or other optical instruments;

[(viii) uranium contained in detector heads for use in fire detection units, provided that each detector head contains not more than 0.005 microcurie (185.0 Bq) of uranium; or]

[(ix)](viii) thorium contained in a finished aircraft engine part containing nickel-thoria alloy, provided that:

(A) the thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide), and

(B) the thorium content in the nickel-thoria alloy does not exceed four percent by weight.

(ix) No person may initially transfer for sale or distribution a product containing source material to persons exempt under Subsection R313 - 19 - 13(1)(c), or equivalent regulations of an Agreement State, unless authorized by a license issued under 10 CFR 40.52 to initially transfer such products for sale or distribution.

(A) A person initially distributing source material in products covered by the exemptions in this Subsection R313 - 19 - 13(1)(c) before (Utah effective date to be set by the Board), without specific authorization may continue such distribution for one year beyond this date. Initial distribution may also be continued until the director takes final action on a pending application for license or license amendment to specifically authorize distribution submitted no later than one year beyond this date.

(B) A person authorized to manufacture, process, or produce these materials or products containing source material by an Agreement State, and a person who imports finished products or parts, for sale or distribution must be authorized by a license issued under 10 CFR 40.52 for distribution only and are exempt from the requirements of Rules R313 - 15 and R313 - 18 and Subsections R313-22-33(1)(a) and (b).

(d) The exemptions in Subsection R313-19-13(1)(c) do not authorize the manufacture of any of the products described.

(2) Radioactive material other than source material.

(a) Exempt concentrations.

(i) Except as provided in Subsection R313-19-13(2)(a)(iii) a person is exempt from Rules R313-19, R313-21 and R313-22 to the extent that the person receives, possesses, uses, transfers, owns or acquires products or materials containing:

(A) radioactive material introduced in concentrations not in excess of those listed in Section R313-19-70, or

(B) diffuse sources of natural occurring radioactive materials containing less than 15 picocuries per gram radium-226.

(ii) A manufacturer, processor, or producer of a product or material is exempt from the requirements for a license set forth in Rules R313-19, R313-21 and R313-22 and Rules R313-32, R313-34, R313-36, and R313-38 to the extent that the person transfers:

(A) radioactive material contained in a product or material in concentrations not in excess of those specified in R313-19-70; and

(B) introduced into the product or material by a licensee holding a specific license issued by the U.S. Nuclear Regulatory Commission authorizing the introduction.

(C) The exemption in R313-19-13-2(a)(ii)(A) and R313-19-13-2(a)(ii)(B) does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

(iii) A person may not introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under Subsection R313-19-13(2)(a)(i) or equivalent regulations of a Licensing State, the U.S. Nuclear Regulatory Commission or an Agreement State, except in accordance with a specific license issued pursuant to Subsection R313-22-75(1).

(b) Exempt quantities.

(i) Except as provided in Subsections R313-19-13(2)(b)(ii) through (iv) a person is exempt from these rules to the extent that the person receives, possesses, uses, transfers, owns, or acquires radioactive material in individual quantities which do not exceed the applicable quantity set forth in Section R313-19-71.

(ii) Subsection R313-19-13(2)(b) does not authorize the production, packaging or repackaging of radioactive material for purposes of commercial distribution, or the incorporation of radioactive material into products intended for commercial distribution.

(iii) A person may not, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in Section R313-19-71, knowing or having reason to believe that the quantities of radioactive material will be transferred to persons exempt under Subsection R313-19-13(2)(b) or equivalent regulations of a Licensing State, the U.S. Nuclear Regulatory Commission or an Agreement State, except in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission, pursuant to 10 CFR Part 32 or by the Director pursuant to Subsection R313-22-75(2), which license states that the radioactive material may be transferred by the licensee to persons exempt under Subsection R313-19-13(2)(b) or the equivalent regulations of a Licensing State, the U.S. Nuclear Regulatory Commission or an Agreement State.

(iv) A person who possesses radioactive material received or acquired prior to September 25, 1971, under the general license formerly provided in 10 CFR Part 31.4 or equivalent regulations of a State is exempt from the requirements for a license set forth in Rule R313-19 to the extent that the person possesses, uses, transfers or owns radioactive material. This exemption does not apply for diffuse sources of radium-226.

(v) No person may, for purposes of producing an increased radiation level, combine quantities of radioactive material covered by this exemption so that the aggregate quantity exceeds the limits set forth in R313-19-71, except for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise provided by these rules.

(c) Exempt items.

(i) Certain items containing radioactive material. Except for persons who apply radioactive material to, or persons who incorporate radioactive material into the following products, a person is exempt from these rules to the extent that person receives, possesses, uses, transfers, owns or acquires the following products:

(A) Timepieces or hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified levels of radiation:

(I) 25 millicuries (925.0 MBq) of tritium per timepiece;

(II) five millicuries (185.0 MBq) of tritium per hand;

(III) 15 millicuries (555.0 MBq) of tritium per dial. Bezels when used shall be considered as part of the dial;

(IV) 100 microcuries (3.7 MBq) of promethium-147 per watch or 200 microcuries (7.4 MBq) of promethium-147 per any other timepiece;

(V) 20 microcuries (0.74 MBq) of promethium-147 per watch hand or 40 microcuries (1.48 MBq) of promethium-147 per other timepiece hand;

(VI) 60 microcuries (2.22 MBq) of promethium-147 per watch dial or 120 microcuries (4.44 MBq) of promethium-147 per other timepiece dial. Bezels when used shall be considered as part of the dial;

(VII) the radiation dose rate from hands and dials containing promethium-147 will not exceed, when measured through 50 milligrams per square centimeter of absorber:

for wrist watches, 0.1 millirad (1.0 uGy) per hour at ten centimeters from any surface;

for pocket watches, 0.1 millirad (1.0 uGy) per hour at one centimeter from any surface;

for other timepieces, 0.2 millirad (2.0 uGy) per hour at ten centimeters from any surface;

(VIII) one microcurie (37.0 kBq) of radium-226 per timepiece in timepieces manufactured prior to November 30, 2007.

(B)(I) Static elimination devices which contain, as sealed source or sources, radioactive material consisting of a total of not more than 18.5 MBq (500 uCi) of polonium-210 per device.

(II) Ion generating tubes designed for ionization of air that contain, as a sealed source or sources, byproduct material consisting of a total of not more than 18.5 MBq (500 uCi) of polonium-210 per device or of a total of not more than 1.85 GBq (50 mCi) of hydrogen-3 (tritium) per device.

(III) Such devices authorized before October 23, 2012 for use under the general license then provided in 10 CFR 31.3 (January 1, 2012) or equivalent regulations of the Commission or an Agreement State and manufactured, tested, and labeled by the manufacturer in accordance with the specifications contained in a specific license issued by the Commission or Agreement State.

(C) Precision balances containing not more than one millicurie (37.0 MBq) of tritium per balance or not more than 0.5 millicurie (18.5 MBq) of tritium per balance part manufactured before June 9, 2010.

(D) Marine compasses containing not more than 750 millicuries (27.8 GBq) of tritium gas and other marine navigational instruments containing not more than 250 millicuries (9.25 GBq) of tritium gas manufactured before June 9, 2010.

(E) Ionization chamber smoke detectors containing not more than 1 microcurie (37 kBq) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.

(F) Electron tubes, including spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes, and other completely sealed tubes that are designed to conduct or control electrical currents; provided that each tube does not contain more than one of the following specified quantities of radioactive material:

(I) 150 millicuries (5.55 GBq) of tritium per microwave receiver protector tube or ten millicuries (370.0 MBq) of tritium per any other electron tube;

(II) one microcurie (37.0 kBq) of cobalt-60;

(III) five microcuries (185.0 kBq) of nickel-63;

(IV) 30 microcuries (1.11 MBq) of krypton-85;

(V) five microcuries (185.0 kBq) of cesium-137;

(VI) 30 microcuries (1.11 MBq) of promethium-147;

(VII) one microcurie (37.0 kBq) of radium-226;

and provided further, that the radiation dose rate from each electron tube containing radioactive material will not exceed one millirad (10.0 uGy) per hour at one centimeter from any surface when measured through seven milligrams per square centimeter of absorber.

(G) Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided that:

(I) each source contains no more than one exempt quantity set forth in Section R313-19-71; and

(II) each instrument contains no more than ten exempt quantities. For purposes of this requirement, an instrument's source(s) may contain either one type or different types of radionuclides and an individual exempt quantity may be composed of fractional parts of one or more of exempt quantities in Section R313-19-71, provided that the sum of the fractions shall not exceed unity;

(III) for purposes of Subsection R313-19-13(2)(c)(i)(G), 0.05 microcurie (1.85 kBq) of americium-241 is considered an exempt quantity under Section R313-19-71.

(ii) Self-luminous products containing radioactive material.

(A) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147, and except as provided in R313-19-13(2)(c)(ii)(C), any person is exempt from the regulations in R313-15, R313-19, R313-21, R313-22, R313-32, R313-34, R313-36, and R313-38 to the extent that such a person receives, possesses, uses, transfers, owns, or acquires tritium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, produced, or initially transferred in accordance with a specific license issued pursuant to 10 CFR 32.22 (2015), which license authorizes the initial transfer of the product for use.

(B) Any person who desires to manufacture, process, or produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147 for use under R313-19-13(2)(c)(ii)(A), should apply for a license under 10 CFR 32.22 (2015) and for a certificate of registration in accordance with 10 CFR 32.210 (2015).

(C) The exemption in R313-19-13(2)(c)(ii)(A) does not apply to tritium, krypton-85, or promethium-147 used in products primarily for frivolous purposes or in toys or adornments.

(D) Radium-226. A person is exempt from these rules, to the extent that such person receives, possesses, uses, transfers, or owns articles containing less than 0.1 microcurie (3.7 kBq) of radium-226 which were acquired prior to the effective date of these rules.

(iii) Gas and aerosol detectors containing radioactive material.

(A) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution gas and aerosol detectors containing radioactive material, any person is exempt from the regulations in parts R313-18, R313-15, R313-19, R313-21, R313-22, R313-32, R313-34, R313-36, and R313-38 to the extent that such person receives, possesses, uses, transfers, owns, or acquires byproduct material in gas and aerosol detectors designed to protect health, safety, or property, and manufactured, processed, produced, or initially transferred in accordance with a specific license issued under 10 CFR 32.26 (2015), which license authorizes the initial transfer of the product for use under this section. This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007, in accordance with a specific license issued by a State under comparable provisions to 10 CFR 32.26 (2015) authorizing distribution to persons exempt from regulatory requirements.

(B) Any person who desires to manufacture, process, or produce gas and aerosol detectors containing byproduct material, or to initially transfer such products for use under paragraph (a)of this section, should apply for a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to 10 CFR Part 32.26 (2015) and for a certificate of registration in accordance with R313-22-210 or equivalent regulations of an Agreement State.

(iv) Capsules containing carbon-14 urea for "in vivo" diagnostic use for humans.

(A) Except as provided in Subsection R313-19-13(2)(c)(iv)(B), any person is exempt from the requirements in Rules R313-19 and R313-32 provided that the person receives, possesses, uses, transfers, owns, or acquires capsules containing 37 kBq (1 uCi) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for "in vivo" diagnostic use for humans.

(B) Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to Rule R313-32.

(C) Nothing in Subsection R313-19-13(2)(c)(iv) relieves persons from complying with applicable United States Food and Drug Administration, other Federal, and State requirements governing receipt, administration, and use of drugs.

(v) Certain industrial devices.

(A) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing radioactive material 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 an ionized atmosphere, any person is exempt from the regulations in parts R313-18, R313-15, R313-18, R313-15, R313-19, R313-21, R313-22, R313-32, R313-34, R313-36, and R313-38 to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material, in these certain detecting, measuring, gauging, or controlling devices and certain devices for producing an ionized atmosphere, and manufactured, processed, produced, or initially transferred in accordance with a specific license issued under 10 CFR 32.30 (2015), which license authorizes the initial transfer of the device for use under this rule. This exemption does not cover sources not incorporated into a device, such as calibration and reference sources.

(B) Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing byproduct material for use under R313-19-13(2)(c)(v)(A), should apply for a license under 10 CFR 32.30 (2015) and for a certificate of registration in accordance with R313-22-210.

(vi) With respect to Subsections R313-19-13(2)(b)(iii), R313-19-13(2)(c)(i), (iii) and (iv), the authority to transfer possession or control by the manufacturer, processor, or producer of equipment, devices, commodities, or other products containing byproduct material whose subsequent possession, use, transfer, and disposal by other persons is exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

 

R313-19-50. Reporting Requirements.

(1) Licensees shall notify the Director as soon as possible but not later than four hours after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits or releases of licensed material that could exceed regulatory limits. Events may include fires, explosions, toxic gas releases, etc.

(2) The following events involving licensed material require notification of the Director by the licensee within 24 hours:

(a) an unplanned contamination event that:

(i) requires access to the contamination area, by workers or the public, to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area;

(ii) involves a quantity of material greater than five times the lowest annual limit on intake specified in Appendix B of 10 CFR 20.1001 through 20.2402 [(2010)](2017), which is incorporated by reference, for the material; and

(iii) has access to the area restricted for a reason other than to allow radionuclides with a half-life of less than 24 hours to decay prior to decontamination; or

(b) an event in which equipment is disabled or fails to function as designed when:

(i) the equipment is required by rule or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident;

(ii) the equipment is required by rule or license condition to be available and operable; and

(iii) no redundant equipment is available and operable to perform the required safety function; or

(c) an event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body; or

(d) an unplanned fire or explosion damaging licensed material or a device, container, or equipment containing licensed material when:

(i) the quantity of material involved is greater than five times the lowest annual limit on intake specified in Appendix B of 10 CFR 20.1001 through 20.2402 [(2010)](2017), which is incorporated by reference, for the material; and

(ii) the damage affects the integrity of the licensed material or its container.

(3) Preparation and submission of reports. Reports made by licensees in response to the requirements of Section R313-19-50 must be made as follows:

(a) For radioactive materials, other than special nuclear material, licensees shall make reports required by Subsections R313-19-50(1) and (2) by telephone to the Director. To the extent that the information is available at the time of notification, the information provided in these reports must include:

(i) the caller's name and call back telephone number;

(ii) a description of the event, including date and time;

(iii) the exact location of the event;

(iv) the radionuclides, quantities, and chemical and physical form of the licensed material involved; and

(v) available personnel radiation exposure data.

(b) For special nuclear materials, licensees shall make reports required by Subsections R313-19-50(1) and (2) by telephone to the Director. To the extent that the information is available at the time of notification, the information provided in these reports must include:

(i) the caller's name, position title, and call-back telephone number;

(ii) the date, time, and exact location of the event; and

(iii) a description of the event, including:

(A) radiological or chemical hazards involved, including isotopes, quantities, and chemical and physical form of any material released; and

(B) actual or potential health and safety consequences to the workers, the public, and the environment, including relevant chemical and radiation data for actual personnel exposures to radiation or radioactive materials or hazardous chemicals produced from radioactive materials (e.g., level of radiation exposure, concentration of chemicals, and duration of exposure).

(c) Written report for materials other than special nuclear materials. A licensee who makes a report required by Subsections R313-19-50(1) or (2) shall submit a written follow-up report within 30 days of the initial report. Written reports prepared pursuant to other rules may be submitted to fulfill this requirement if the reports contain all of the necessary information and the appropriate distribution is made. These written reports shall be sent to the Director. The report shall include the following:

(i) A description of the event, including the probable cause and the manufacturer and model number, if applicable, of equipment that failed or malfunctioned;

(ii) the exact location of the event;

(iii) the radionuclides, quantities, and chemical and physical form of the licensed material involved;

(iv) date and time of the event;

(v) corrective actions taken or planned and results of evaluations or assessments; and

(vi) the extent of exposure of individuals to radiation or radioactive materials without identification of individuals by name.

(d) Written report for special nuclear material. A licensee who makes a report required by Subsections R313-19-50(1) or (2) shall submit a written follow-up report within 30 days of the initial report. Written reports prepared pursuant to other rules may be submitted to fulfill this requirement if the reports contain all of the necessary information and the appropriate distribution is made. These written reports shall be sent to the Director. The report shall include the following:

(i) the complete applicable information required by Subsection R313-19-50(3)(b);

(ii) the probable cause of the event, including all factors that contributed to the event and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned; and

(iii) corrective actions taken or planned to prevent occurrence of similar or identical events in the future and the results of any evaluations or assessments.

 

KEY: licenses, reciprocity, transportation, exemptions

Date of Enactment or Last Substantive Amendment: [June 10, 2016]2017

Notice of Continuation: July 1, 2016

Authorizing, and Implemented or Interpreted Law: 19-3-104; [19-6-107]19-6-104

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