ML19238A296
| ML19238A296 | |
| Person / Time | |
|---|---|
| Issue date: | 04/26/2019 |
| From: | Michelle Beardsley NRC/NMSS/DMSST |
| To: | |
| BEARDSLEY M | |
| Shared Package | |
| ML19238A290 | List: |
| References | |
| Download: ML19238A296 (15) | |
Text
DPH-16-001 Source Material Distribution and General License Revisions Final Regulations April 26, 2019 Page 1 of 15 TITLE 17, California Code of Regulations Division 1, Chapter 5, Subchapter 4.0.
Group 2. Licensing of Radioactive Materials Article 3. Exemptions Amend Section 30181 to read as follows:
§ 30181. Products Containing and Quantities of Source Material.
(a)
No change to text.
(b) A person is exempt from the requirements for a license specified in section 30190 and sections 30191 through 30237, and from Group 3 of this subchapter, to the extent that such 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 such ore. Unrefined and unprocessed ore means ore in its natural form prior to any processing, such as grinding, roasting or beneficiating, or refining. Processing does not include sieving or encapsulation of ore or preparation of samples for laboratory analysis.
(c) Subject to subsection (g), aA person is exempt from the requirements for a license specified in section 30190 and sections 30191 through 30237, and from Group 3 of this subchapter, to the extent that such person receives, possesses, uses, or transfers:
(1) The following items or materials containing thorium or uranium:
(A) Incandescent gas mantles, vacuum tubes, welding rods, or electric lamps for illuminating purposes, which do not contain more than 50 milligrams of thorium per item; (B) Germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting, which do not contain more than 2 grams of thorium per item; (C) Rare earth metals and compounds, mixtures, and products, which do not contain more than 0.25 percent by weight of thorium, uranium, or any combination of these two radioactive materials; or (D) Neutron-detecting dosimeters, which do not contain more than 50 milligrams of thorium per dosimeter.
(1) Any quantities of thorium contained in:
DPH-16-001 Source Material Distribution and General License Revisions Final Regulations April 26, 2019 Page 2 of 15 (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, compounds, mixtures, or products, provided the metal, compound, mixture or product does not contain more than 0.25 percent by weight of thorium or uranium, any combination of these; or (G) Personnel neutron dosimeters, provided that each dosimeter does not contain more than 50 milligrams of thorium.
(2) Source material contained in the following products:
(A) Glazed ceramic tableware manufactured before August 27, 2013, provided that the glaze contains not more than 20 percent by weight source material; (B)
No change to text.
(C) Glassware containing not more than two percent by weight source material, or for glassware manufactured before August 27, 2013, 10 percent by weight source material, but not including commercially manufactured glass brick, pane glass, ceramic tile, or other glass or ceramic used in construction; (D)
No change to text.
(3)
No change to text.
(4)
No change to text.
(5) Subject to subsection (d), counterweights which contain uranium and which are designed for installation installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of such counterweights, provided that the following requirements are met:
(A) The counterweights or manufacture in accordance with a specific license issued by the Department;
DPH-16-001 Source Material Distribution and General License Revisions Final Regulations April 26, 2019 Page 3 of 15 (B)(A) Each counterweight manufactured on or after December 31, 1969 has been impressed with the following legend clearly legible through any plating or other covering: Depleted Uranium; and (C)(B) Each counterweight manufactured on or after December 31, 1969 is durably and legibly labeled or marked with the identification of the manufacturer, and the statement: Unauthorized Alterations Prohibited; and (C) The requirements specified in paragraphs (A) and (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 impressed with the legend required pursuant to section 40.13(c)(5)(ii) in title 10, Code of Federal Regulations, Part 40 (10 CFR 40) in effect on June 30, 1969.
(6)
No change to text.
(7) Subject to subsection (e), finished optical lenses and mirrors containing thorium or uranium, provided that each lens or mirror does not contain more than 10 percent by weight thorium or uranium, or for lenses manufactured before August 27, 2013, 30 percent by weight of thorium.
(8)
No change to text.
(d)
No change to text.
(e) The exemption contained in subsection (c)(7) shall not be deemed to authorize either:
(1) The shaping, grinding or polishing of such lens or mirrors or manufacturing processes, other than the assembly of such lens or mirrors into optical systems and devices without any alteration of the lens or mirrors; or (2) The receipt, possession, use, or transfer, of thorium contained in contact lenses, or in spectacles, or in eyepieces in binoculars or other optical instruments.
(f)
No change to text.
(g) A person is exempt from the requirements for a license specified in section 30190 and sections 30191 through 30237, and from Group 3 of this subchapter, to the extent that such person receives, possesses, uses, or transfers detector heads, used in
DPH-16-001 Source Material Distribution and General License Revisions Final Regulations April 26, 2019 Page 4 of 15 fire detection units, which contain uranium, provided that each detector head contains not more than 0.005 microcurie of uranium. This exemption does not authorize the manufacture of any detector head containing uranium.
(g) Except as provided in paragraphs (1) and (2), a person may not initially transfer for sale or distribution a product containing source material to persons exempt under subsection (c), or equivalent Nuclear Regulatory Commission (NRC) or Agreement State provisions, unless authorized by a specific license issued by the NRC under 10 CFR 40.52 to initially transfer such products for sale or distribution. Nothing in this subsection may be construed to incorporate by reference 10 CFR 40.52.
(1) Persons initially distributing source material in products specified in subsection (c), without a specific license issued by the NRC under 10 CFR 40.52 before October 1, 2019 may continue such distributions for one year beyond this date. These initial distributions may be continued until the NRC takes final action on a pending application, for a specific license or amendment authorizing distribution, submitted no later than one year beyond this date.
(2) Persons approved by the Department under section 30194 to manufacture, process, or produce, for sale or distribution any product specified in subsection (c) shall also be authorized by a specific license issued by NRC under 10 CFR 40.52 to distribute these products.
Note: Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code.
Reference:
Sections 114965, 114970, 115000, 115060, 115165, 115230, 115235, 131050, 131051 and 131052, Health and Safety Code.
Article 4. Licenses Amend Section 30191 to read as follows:
§ 30191 General Licenses Source Material (a) A general license is hereby issued to commercial firms, educational institutions, and medical institutions and government agencies, authorizing the possession, use, and transfer of not more than 15 pounds of source material at any one
DPH-16-001 Source Material Distribution and General License Revisions Final Regulations April 26, 2019 Page 5 of 15 time for research, development, educational, commercial or operational purposes.
Persons authorized to possess, use, or transfer source material pursuant to this general license may not receive more than a total of 150 pounds of source material in any one calendar year. With respect to such source material, any person shall be exempt from the provisions of Group 3 of this subchapter, except for sections 30254 and 30293(a),
unless such person also possesses source material under a specific license.
(a) A general license is hereby issued to commercial and industrial firms, to research, educational, and medical institutions, and to government agencies, authorizing the receipt, possession, use, and transfer of uranium and thorium, in their natural isotopic concentrations and in the form of depleted uranium, for research, development, educational, commercial, or operational purposes, in the following forms and quantities:
(1) No more than 1.5 kilograms (kg) (3.3 lb.) of uranium and thorium in dispersible forms (e.g., gaseous, liquid, powder, etc.) at any one time. Any material processed by a general licensee that alters the chemical or physical form of the material containing source material must be accounted for as a dispersible form. A person authorized to possess, use, and transfer source material under this paragraph may not receive more than a total of 7 kg (15.4 lb.) of uranium and thorium in any one calendar year. Persons possessing source material in excess of these limits as of October 1, 2019 may continue to possess up to 7 kg of uranium and thorium at any one time for one year beyond this date, or until the Department takes final action on a pending application submitted on or before October 1, 2020 for a specific license for such material; and may continue to receive up to 70 kg (154 lb) of uranium or thorium in any one calendar year until December 31, 2020 or until the Department takes final action on a pending application submitted on or before October 1, 2020 for a specific license for such material; and (2) No more than a total of 7 kg of uranium and thorium at any one time. A person authorized to possess, use, and transfer source material under this paragraph may not receive more than a total of 70 kg of uranium and thorium in any one calendar year. A person may not alter the chemical or physical form of the source material
DPH-16-001 Source Material Distribution and General License Revisions Final Regulations April 26, 2019 Page 6 of 15 possessed under this paragraph unless it is accounted for under the limits of paragraph (1); or (3) No more than 7 kg of uranium, removed during the treatment of drinking water, at any one time. A person may not remove more than 70 kg of uranium from drinking water during a calendar year under this paragraph; or (4) No more than 7 kg of uranium and thorium, at laboratories for the purpose of determining the concentration of uranium and thorium contained within the material being analyzed, at any one time. A person authorized to possess, use, and transfer source material under this paragraph may not receive more than a total of 70 kg of source material in any one calendar year.
(b) A general license described in subsection (a) shall not authorize human use, or the use in any device or article which is intended to be placed on or in the human body, or the use of any instrument or apparatus (including component parts and accessories thereto) intended for human use.
(b) Any person who receives, possesses, uses, or transfers source material in accordance with the general license in subsection (a):
(1) Is prohibited from administering source material, or the radiation therefrom, either externally or internally, to human beings except as may be authorized by a specific license for medical use under section 30195.
(2) Shall not abandon such source material. Source material may be disposed of as follows:
(A) A cumulative total of 0.5 kg (1.1 lb.) of source material, in a solid non-dispersible form, may be transferred each calendar year by a person authorized to receive, possess, use, and transfer source material under this general license, to persons receiving the material for permanent disposal. The recipient of source material transferred under the provisions of this paragraph is exempt from the requirements to obtain a specific license under this Article to the extent that the source material is permanently disposed. This provision does not apply to any person who is in possession of source material under a specific license issued under section 30194; or
DPH-16-001 Source Material Distribution and General License Revisions Final Regulations April 26, 2019 Page 7 of 15 (B) In accordance with section 20.2001 in title 10, Code of Federal Regulations, Part 20 (10 CFR 20), incorporated by reference in section 30253.
(3) Is subject to the requirements in sections 30105, 30190(d), 30205, 30210, 30254(a), 30275, 30293, and 30295.
(4) Shall not export such source material except in accordance with an export license issued by Nuclear Regulatory Commission (NRC) pursuant to 10 CFR 110.
This requirement may not be construed to incorporate by reference 10 CFR 110.
(c) Any person who receives, possesses, uses, or transfers source material in accordance with the general license in subsection (a) shall conduct activities so as to minimize contamination of the facility and the environment. When activities involving such source material are permanently ceased at any site, if evidence of significant contamination is identified, the general licensee shall notify the Department about such contamination, shall consult with the Department as to appropriate sampling and restoration activities, and shall, with respect to any contamination or residual source material remaining at the site, comply with paragraphs (1), (2) and (3) of subsection (k) of section 30256.
(d) Any person who receives, possesses, uses, or transfers source material in accordance with the general license in subsection (a) is exempt from the requirements in Articles 1, 2, and 3 of Group 3 of this subchapter to the extent that such receipt, possession, use, transfer, and disposal are within the terms of this general license, except that such person shall comply with the provisions of 10 CFR 20.2001, incorporated by reference in section 30253, and section 30256(k) to the extent necessary to meet the provisions of subsections (b)(2) and (c) of this section. However, this exemption does not apply to any person who also holds a specific license issued under section 30194.
(e) No person may initially transfer or distribute source material to persons generally licensed under this section or equivalent NRC or Agreement State provisions, unless authorized by a specific license issued in accordance with section 30202. This prohibition does not apply to analytical laboratories returning processed samples to the client who initially provided the sample. Initial distribution of source material to persons
DPH-16-001 Source Material Distribution and General License Revisions Final Regulations April 26, 2019 Page 8 of 15 generally licensed under this section before October 1, 2019 without specific authorization, may continue for one year beyond this date. Distribution may also be continued until the Department takes final action on a pending application for license or license amendment to specifically authorize distribution, submitted on or before October 1, 2020.
Note: Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code.
Reference:
Sections 114965, 114970, 114985(g), 115000, 115060, 115165, 115230, 115235, 131050, 131051 and 131052, Health and Safety Code.
Amend Section 30192.6 to read as follows:
§ 30192.6. General Licenses - Depleted Uranium.
(a)
No Change to Text.
(b) The general license issued pursuant to subsection (a) applies only to industrial products or devices which have been manufactured or initially transferred and labeled in accordance with a specific license authorizing distribution to general licensees,issued pursuant to section 30201, an equivalent specific license issued by an Agreement State other than this State, or a specific license issued by the United States Nuclear Regulatory Commission (NRC) under section 40.34 of title 10, Code of Federal Regulations, Part 40.
(c)
No Change to Text (d)
No Change to Text.
Note: Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code.
Reference:
Sections 114965, 114970, 114985(g), 115060, 115165, 115230, 115235, 131050, 131051 and 131052, Health and Safety Code.
Adopt Section 30201, within Article 4. Licenses, to read as follows:
§ 30201. Requirements and Conditions for License to Manufacture or Distribute Products or Devices Containing Depleted Uranium.
DPH-16-001 Source Material Distribution and General License Revisions Final Regulations April 26, 2019 Page 9 of 15 (a) In addition to the requirements set forth in section 30194, a specific license to manufacture industrial products or devices containing depleted uranium, or to initially transfer such products or devices for use under section 30192.6 or equivalent Nuclear Regulatory Commission (NRC) or Agreement State provisions, will be issued only if the applicant submits information regarding:
(1) The design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards, of the industrial product or device, so as to provide reasonable assurance that possession, use, or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in one year a radiation dose in excess of 10 percent of the annual limits specified in title 10 Code of Federal Regulations, Part 20 (10 CFR 20) section 20.1201(a), incorporated by reference in section 30253; and (2) The industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device, so as to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.
(b) Each person licensed under subsection (a) shall:
(1) Maintain the level of quality control required by the license in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device; and (2) Label or mark each product and device to:
(A) Identify the manufacturer or initial transferor of the product or device and the number of the license under which the product or device was manufactured or initially transferred, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and (B) State that the receipt, possession, use, and transfer of the product or device is subject to the general license requirements in section 30192.6 or 10 CFR 40.25 or the applicable Agreement State requirements equivalent to 10 CFR 40.25; and
DPH-16-001 Source Material Distribution and General License Revisions Final Regulations April 26, 2019 Page 10 of 15 (3) Assure that the depleted uranium, before being installed in each product or device, has been impressed with the legend, "Depleted Uranium," clearly legible through any plating or other covering; and (4) Furnish a copy of sections 30108.1 and 30192.6 or equivalent NRC or Agreement State provisions, as appropriate, to each person to whom depleted uranium is transferred for use pursuant to the general license contained in section 30192.6 or equivalent NRC or Agreement State provisions.
(5) Report to the Department all transfers of industrial products or devices for use under the general license in section 30192.6. Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the Department and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter. If no transfers have been made during the reporting period to persons generally licensed under section 30192.6, the report shall so indicate; (6) Report to NRC all transfers of industrial products or devices for use under the general license in 10 CFR 40.25. Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between NRC and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device.
The report shall be submitted within 30 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person. If no transfers have been made during the reporting period to a person generally licensed under 10 CFR 40.25, this information shall be reported to NRC.
(7) Report to the responsible Agreement State agency all transfers of industrial products or devices for use under the general license in the Agreement State regulation equivalent to 10 CFR 40.25. Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or
DPH-16-001 Source Material Distribution and General License Revisions Final Regulations April 26, 2019 Page 11 of 15 device. The report shall be submitted within 30 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person.
If no transfers have been made during the reporting period to a particular Agreement State, this information shall be reported to the responsible Agreement State agency; (8) Keep records showing the name, address, and a point of contact for each general licensee to whom the individual transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in section 30192.6 or equivalent regulations of NRC or an Agreement State. The records shall be retained for three years from the date of transfer and must show the date of each transfer, the quantity of depleted uranium in each product or device transferred, a copy of each report provided pursuant to paragraphs (5), (6) and (7), and the date of the reports submittal.
Note: Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code.
Reference:
Sections 114965, 114970, 114985(g), 115000, 115060, 115165, 115230, 115235, 131050, 131051 and 131052, Health and Safety Code.
Adopt Section 30202, within Article 4. Licenses, to read as follows:
§ 30202. Requirements and Conditions for a License to Distribute Source Material to General Licensees.
(a) In addition to the requirements set forth in section 30194, a specific license to initially transfer source material for use under section 30191 or equivalent Nuclear Regulatory Commission (NRC) or Agreement State provisions will be issued only if the applicant submits information on, and the Department approves, the methods to be used for quality control, labeling, and providing safety instructions to recipients.
(b) Each person licensed under subsection (a) shall:
(1) Label the immediate container of each quantity of source material with the type of source material and quantity of material and the words, "radioactive material";
(2) Ensure that the quantities and concentrations of source material are as labeled and indicated in any transfer records;
DPH-16-001 Source Material Distribution and General License Revisions Final Regulations April 26, 2019 Page 12 of 15 (3) Provide the following information to each person to whom source material is transferred for use under section 30191 or equivalent NRC or Agreement State provisions. This information shall be provided to the transferee before the source material is transferred for the first time in each calendar year to the particular recipient.
(A) A copy of sections 30191 and 30210 or equivalent NRC or Agreement State provisions, and any regulation those provisions cite; and (B) Appropriate radiation safety precautions and instructions relating to handling, use, storage, and disposal of the material.
(4) Be subject to section 30202.1.
Note: Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code.
Reference:
Sections 114965, 114970, 114985(g), 115000, 115060, 115165, 115230, 115235, 131050, 131051 and 131052, Health and Safety Code.
Adopt Section 30202.1, within Article 4. Licenses, to read as follows:
§ 30202.1 Reports Required for Distributing Source Material under Section 30202.
(a) Each person licensed pursuant to section 30202 shall report transfers as follows:
(1) File a report with the Department. The report shall include the following information:
(A) The name, address, and license number of the person who transferred the source material; (B) For each general licensee under section 30191 or equivalent Nuclear Regulatory Commission (NRC) or Agreement State provisions to whom greater than 50 grams (0.11 lb) of source material has been transferred in a single calendar quarter, the name and address of the general licensee to whom source material is distributed; a responsible agent, by name and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred; and
DPH-16-001 Source Material Distribution and General License Revisions Final Regulations April 26, 2019 Page 13 of 15 (C) The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients.
(2) File a report with the NRC and each responsible Agreement State agency that identifies all persons, operating under provisions equivalent to section 30191, to whom greater than 50 grams of source material has been transferred within a single calendar quarter. The report shall contain and provide the following information specific to those transfers made to the NRC or Agreement State being reported to:
(A) The name, address, and license number of the person who transferred the source material; and (B) The name and address of the general licensee to whom source material was distributed; a responsible agent, by name and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred.
(C) The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients within the Agreement State or under NRC jurisdiction, as appropriate.
(3) Submit each report required by paragraphs (1) and (2) by January 31 of each year, covering all transfers for the previous calendar year. If no transfers were made to persons generally licensed under section 30191 or equivalent NRC or Agreement State provisions during the previous calendar year, a report indicating that no transfers were made shall be submitted to the Department. If no transfers have been made to general licensees under the jurisdiction of the NRC or a particular Agreement State during the reporting period, this information shall be reported to the responsible agency upon their request.
(b) Each person licensed pursuant to section 30202 shall maintain all information that supports the reports required by this section concerning each transfer to a general licensee for a period of one year after the event is included in a report to the Department, an Agreement State agency, or the NRC.
Note: Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code.
DPH-16-001 Source Material Distribution and General License Revisions Final Regulations April 26, 2019 Page 14 of 15
Reference:
Sections 114965, 114970, 114985(g), 115000, 115060, 115165, 115230, 115235, 131050, 131051 and 131052, Health and Safety Code.
Group 3. Standards for Protection Against Radiation Article 3.1. Records and Notification Amend Section 30293 to read as follows:
§ 30293 Records.
(a) through (d)
No change to Text.
(e) Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than 120 days, in an unsealed form, or source material in an unsealed form, or special nuclear material shall, if requested by the Department, forward the following records to the Department:
(1) Records of disposal of licensed material made under Title 10, Code of Federal Regulations (10 CFR 20), sections 20.2002, 20.2003, 20.2004, 20.2005, incorporated by reference in section 30253; and (2) Records required by Title 10, Code of Federal Regulations10 CFR 20 section 20.2103(b)(4), incorporated by reference in section 30253.; and (3) If the specific license authorized possession of special nuclear material, records required by section 30256(a).
(f) If licensed activities are transferred or assigned in accordance with section 30194(c), each licensee authorized to possess radioactive material, with a half-life greater than 120 days, in an unsealed form, or source material in an unsealed form, or special nuclear material shall transfer the following records to the new licensee, and the new licensee will be responsible for maintaining these records until the license is terminated:
(1) Records of disposal of licensed material made under Title 10, Code of Federal Regulations,10 CFR 20 sections 20.2002, 20.2003, 20.2004, 20.2005, incorporated by reference in section 30253; and
DPH-16-001 Source Material Distribution and General License Revisions Final Regulations April 26, 2019 Page 15 of 15 (2) Records required by Title 10, Code of Federal Regulations,10 CFR 20 section 20.2103(b)(4), incorporated by reference in section 30243.30253; and (3) If the specific license authorized possession of special nuclear material, records required by section 30256(a).
(g) Prior to license termination, each licensee shall, if requested by the Department, forward the records required by section 30256(a) to the Department.
Note: Authority cited: Sections 100275 and 115000, Health and Safety Code.
Reference:
Sections 114965, 114970, 115105, 115110, 115230 and 115235, Health and Safety Code.