ML22243A213
| ML22243A213 | |
| Person / Time | |
|---|---|
| Issue date: | 08/30/2022 |
| From: | Office of Nuclear Material Safety and Safeguards |
| To: | State of NM, Environment Dept |
| Poy S | |
| Shared Package | |
| ML22243A198 | List: |
| References | |
| Download: ML22243A213 (68) | |
Text
1 TITLE 20 ENVIRONMENTAL PROTECTION 2 CHAPTER 3 RADIATION PROTECTION 3 PART 3 LICENSING OF RADIOACTIVE MATERIAL 4
5 20.3.3.1 ISSUING AGENCY: Environmental Improvement Board.
6 [20.3.3.1 NMAC - Rp, 20.3.3.1 NMAC, 4/30/2009]
7 8 20.3.3.2 SCOPE:
9 A. This part provides for the licensing of radioactive material. Except for persons exempt as 10 provided in this part, no person shall manufacture, produce, receive, possess, use, own, transfer or acquire 11 radioactive material except as authorized in a specific or general license issued pursuant to the requirements in this 12 part.
13 B. In addition to the requirements of this part, all licensees are subject to the requirements of 20.3.1 14 NMAC, 20.3.4 NMAC, 20.3.10 NMAC and 20.3.16 NMAC.
15 C. The requirements of this part are in addition to, and not in substitution for, other requirements of 16 this chapter. In any conflict between a requirement in this part and a specific requirement in another part of this 17 chapter, the specific requirement governs.
18 [20.3.3.2 NMAC - Rp, 20.3.3.2 NMAC, 4/30/2009]
19 20 20.3.3.3 STATUTORY AUTHORITY: Sections 74-1-9, 74-3-5 and 74-3-9 NMSA 1978.
21 [20.3.3.3 NMAC - Rp, 20.3.3.3 NMAC, 4/30/2009]
22 23 20.3.3.4 DURATION: Permanent.
24 [20.3.3.4 NMAC - Rp, 20.3.3.4 NMAC, 4/30/2009]
25 26 20.3.3.5 EFFECTIVE DATE: April 30, 2009, unless a later date is cited at the end of a section.
27 [20.3.3.5 NMAC - Rp, 20.3.3.5 NMAC, 4/30/2009]
28 29 20.3.3.6 OBJECTIVE: This part sets forth rules applicable to all persons in the state of New Mexico 30 governing licensing of radioactive material under the act, and exemptions from the licensing requirements.
31 [20.3.3.6 NMAC - Rp, 20.3.3.6 NMAC, 4/30/2009]
32 33 20.3.3.7 DEFINITIONS:
34 A. Alert means events that may occur, are in progress, or have occurred that could lead to a r elease 35 of radioactive material but that the release is not expected to require a response by offsite response organizations to 36 protect persons offsite.
37 B. Principal activities means activities authorized by the license which are essential to achieving 38 the purpose(s) for which the license was issued or amended. Storage during which no licensed material is accessed 39 for use or disposal and activities incidental to decontamination or decommissioning are not principal activities.
40 C. Site area emergency means events that may occur, are in progress, or have occurred that could 41 lead to a significant release of radioactive material and that could require a response by offsite response 42 organizations to protect persons offsite.
43 D. Indian Tribe means an Indian or Alaska native Tribe, band, nation, pueblo, village, or 44 community that the secretary of the interior acknowledges to exist as an Indian Tribe pursuant to the Federally 45 Recognized Indian Tribe List Act of 1994, 25 U.S.C. 479a.
46 E. Tribal official means the highest ranking individual that represents Tribe leadership, such as 47 the chief, president, or Tribal council leadership.
48 F. Unrefined and unprocessed ore means ore in its natural form prior to any processing, such as 49 grinding, roasting or beneficiating, or refining. Processing does not include sieving or encapsulation of ore or 50 preparation of samples for laboratory analysis.
51 [20.3.3.7 NMAC - N, 04/30/2009; A, 06/13/2017; A, 8/10/2021]
52 53 20.3.3.8 to 20.3.3.300 [RESERVED]
54 55 20.3.3.301 EXEMPTIONS - UNIMPORTANT QUANTITIES OF SOURCE MATERIAL:
56 A. Any person is exempt from the requirements in this part to the extent that such person receives,
20.3.3 NMAC 1 1 possesses, uses, transfers or delivers source material in any chemical mixture, compound, solution or alloy in which 2 the source material is by weight less than one twentieth of one percent of the mixture, compound, solution or alloy.
3 The exemption contained in this subsection does not include byproduct material as defined in Paragraph (2) of 4 Subsection F of 20.3.1.7 NMAC.
5 B. Any person is exempt from the requirements in this part to the extent that such person receives, 6 possesses, uses or transfers unrefined and unprocessed ore containing source material; provided that, except as 7 authorized in a specific license, such person shall not refine or process such ore.
8 C. Any person is exempt from the requirements for a license set forth in the Radiation Protection Act, 9 NMSA 1978, Sections 74 1 through 16 and from the regulations in this part and in 10 CFR Parts 19, 20, and 21 to 10 the extent that such person receives, possesses, uses or transfers:
11 (1) any quantities of thorium contained in:
12 (a) incandescent gas mantles; 13 (b) vacuum tubes; 14 (c) welding rods; 15 (d) electric lamps for illuminating purposes; provided, that each lamp does not 16 contain more than 50 milligrams of thorium; 17 (e) germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting; 18 provided, that each lamp does not contain more than two grams of thorium; 19 (f) rare earth metals and compounds, mixtures and products containing not more 20 than one fourth of one percent by weight, thorium, uranium or any combination of these; or 21 (g) personnel neutron dosimeter s; provided, that each dosimeter does not contain 22 more than 50 milligrams of thorium; 23 (2) source material contained in the following products:
24 (a) glazed ceramic tableware manufactured before August 27, 2013, provided that 25 the glaze does not contain m ore than twenty percent by weight source material; 26 (b) glassware, containing not more than two percent by weight source material or, 27 for glassware manufactured before August 27, 2013, ten percent by weight source material; but not including 28 commercially manufactured glass brick, pane glass, ceramic tile or other glass, glass enamel or ceramic used in 29 construction; 30 (c) glass enamel or glass enamel frit containing not more than ten percent by weight 31 source material imported or ordered for importation into the United States, or initially distributed by manufacturers 32 in the United States, before July 25, 1983 (On July 25, 1983, the exemption of glass enamel frit was suspended. The 33 exemption was eliminated on September 11, 1984); or 34 (d) piezoelectric ceramic containing not more than two percent by weight source 35 material; 36 (3) photographic film, negatives and prints containing uranium or thorium; 37 (4) any finished product or part fabricated of, or containing, tungsten or magnesium -thorium 38 alloys, provide d that the thorium content of the alloy does not exceed four percent by weight and that this exemption 39 shall not be deemed to authorize the chemical, physical or metallurgical treatment or processing of any such product 40 or part; 41 (5) uranium contained in counterweights installed in aircraft, rockets, projectiles and 42 missiles, or stored or handled in connection with installation or removal of such counterweights; provided, that:
43 (a) each counterweight has been impressed with the following legend clearly legible 44 through any plating or other covering: depleted uranium. (the requirements specified in Subparagraphs (a) and (b) 45 of this paragraph need not be met by counterweights manufactured prior to December 31, 1969; provided, that such 46 counterweights are impressed with the legend, caution - radioactive material - uranium);
47 (b) each counterweight is durably and legibly labeled or marked with the 48 identification of the manufacturer and the statement: unauthorized alterations prohibited; (the requiremen ts 49 specified in Subparagraphs (a) and (b) of this paragraph need not be met by counterweights manufactured prior to 50 December 31, 1969; provided, that such counterweights are impressed with the legend, caution - radioactive 51 material - uranium);
52 (c) the exemption contained in this paragraph shall not be deemed to authorize the 53 chemical, physical or metallurgical treatment or processing of such counterweights other than repair or restoration of 54 any plating or other covering; and 55 (d) consistent with 10 CFR 40.56, the counterweights are not manufactured for 56 military purpose using Australian-obligated source material;
20.3.3 NMAC 2 1 (6) natural or depleted uranium metal used as shielding constituting part of any shipping 2 container which is conspicuously and legibly im pressed with the legend, caution - radioactive shielding - uranium 3 and the uranium metal is encased in mild steel or equally fire resistant metal of minimum wall thickness of one-4 eighth of an inch (3.2 millimeters);
5 (7) thorium or uranium contained in or on finished optical lenses and mirrors, provided that 6 each lens or mirror does not contain more than ten percent by weight of thorium or uranium or, for lenses 7 manufactured before August 27, 2013, thirty percent by weight of thorium; and that the exempt ion contained in this 8 paragraph does not authorize either:
9 (a) the shaping, grinding or polishing of such lens or mirror or manufacturing 10 processes other than the assembly of such lens or mirror into optical systems and devices without any alternation of 11 the lens; or 12 (b) the receipt, possession, use or transfer of uranium or thorium contained in 13 contact lenses, spectacles, eyepieces in binoculars or other optical instruments; 14 (8) uranium contained in detector heads for use in fire detection units, provided that each 15 detector head contains not more than 0.005 microcurie of uranium; or 16 (9) thorium contained in any finished aircraft engine part containing nickel -thoria alloy, 17 provided, that:
18 (a) the thorium is dispersed in the nickel -thoria alloy in the form of finely divided 19 thoria (thorium-dioxide); and 20 (b) the thorium content in the nickel -thoria alloy does not exceed four percent by 21 weight.
22 D. No person may initially transfer for sale or distribution a product containing source material to 23 persons exempt in accordance with 10 CFR 40.13(c), or equivalent regulations of an agreement state, unless 24 authorized by a license issued pursuant to 10 CFR 40.52 to initially transfer such products for sale or distribution.
25 (1) Persons initially distributing source material in products covered by the exemptions in 26 this paragraph 10 CFR 40.13(c) before August 27, 2013, without specific authorization may continue such 27 distribution for 1 year beyond this date. Initial distribution may also be continued until the NRC commission takes 28 final action on a pending application for license or license amendment to specifically authorize distribution 29 submitted no later than 1 year beyond this date.
30 (2) Persons authorized to manufacture, process, or produce these mate rials or products 31 containing source material by an agreement state, and persons who import finished products of parts, for sale or 32 distribution must be authorized by a license issued pursuant to 10 CFR 40.52 for distribution only and are exempt 33 from the requirements of 10 CFR 19 and 10 CFR 20, and 10 CFR 40.32(b) and (c).
34 E. The exemptions in Subsection C of this section do not authorize the manufacture of any of the 35 products described.
36 [20.3.3.301 NMAC - Rp, 20.3.3.301 NMAC, 4/30/2009; A, 8/10/2021]
37 [Editorial Note:
38 1On July 25, 1983, the exemption of glass enamel or glass enamel frit was suspended. The exemption was 39 eliminated on September 11, 1984.
40 2The requirements specified in Subsection C(5)(a) and (b) of this section need not be met by counterweights 41 manufactured prior to Dec. 31, 1969, provided that such counterweights were manufactured under a specific license 42 issued by the atomic energy commission and were impressed with the legend required by 10 CFR 40.13(c)(5)(ii) in 43 effect on June 30, 1969.]
44 45 20.3.3.302 EXEMPTIONS - RADIOACTIVE MATERIAL OTHER THAN SOURCE MATERIAL:
46 A. Exempt concentrations.
47 (1) Except as provided in Paragraphs (3) and (4) of this subsection, any person is exempt 48 from the license requirements in this part to the extent that such person receives, possesses, uses, transfers, owns or 49 acquires products or materials containing radioactive material in concentrations not in excess of those listed in 50 20.3.3.329 NMAC.
51 (2) This subsection shall not be deemed to author ize the import of radioactive material or 52 products containing radioactive material.
53 (3) A manufacturer, processor or producer of a product or material is exempt from the 54 license requirements in this part to the extent that they transfer radioactive material contained in a product or 55 material in concentrations not in excess of those specified in 20.3.3.329 NMAC and introduced into the product or 56 material by a licensee holding a specific license issued by the NRC expressly authorizing such introduction. Thi s
20.3.3 NMAC 3 1 exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug or 2 other commodity or product designed for ingestion or inhalation by, or application to, a human being.
3 (4) No person may introduce radioa ctive material into a product or material knowing or 4 having reason to believe that it will be transferred to persons exempt under this subsection or equivalent regulations 5 of the NRC or an agreement state, except in accordance with a specific license issued pursuant to Paragraph (1) of 6 Subsection A of 20.3.3.315 NMAC.
7 B. Exempt quantities.
8 (1) Except as provided in Paragraphs (3) through (5) of this subsection, any person is exempt 9 from the license requirements in this part to the extent that such person receives, possesses, uses, transfers, owns or 10 acquires radioactive material in individual quantities each of which does not exceed the applicable quantity set forth 11 in 20.3.3.330 NMAC.
12 (2) Any person who possesses byproduct material received or acquired prior to September 13 25, 1971 under the general license then provided in 10 CFR 31.4 or similar general license of an agreement state, is 14 exempt from the requirements for a license set forth in this part to the extent that such person possesses, uses, 15 transfers or owns byproduct material.
16 (3) This subsection does not authorize for the purposes of commercial distribution the 17 production, packaging, repackaging or transfer of radioactive material or the incorporation of radioactive material 18 into products inte nded for commercial distribution.
19 (4) No person may, for purposes of commercial distribution, transfer radioactive material in 20 the individual quantities set forth in 20.3.3.330 NMAC, knowing or having reason to believe that such quantities of 21 radioactive material will be transferred to persons exempt under this subsection or equivalent regulations of the 22 NRC or an agreement state, except in accordance with a specific license issued by the NRC pursuant to 10 CFR 23 32.18 which license states that the radioact ive material may be transferred by the licensee to persons exempt under 24 this subsection or the equivalent regulations of the NRC or an agreement state.
25 (5) No person may, for purposes of producing an increased radiation level, combine 26 quantities of radioactive material covered by this exemption so that the aggregate quantity exceed the limits set forth 27 in 20.3.3.330 NMAC, except for radioactive material combined within a device placed in use before May 3, 1999, or 28 as otherwise permitted by the rules in this chapter.
29 C. Exempt items.
30 (1) Certain items containing radioactive material. Any person who desires to apply 31 byproduct material to, or to incorporate byproduct material into, the products exempted in this paragraph, or who 32 desires to initially transfer for sale or distribution such products containing byproduct material, shall apply for a 33 specific license to NRC pursuant to 10 CFR 32.14, which license states that the product may be distributed by the 34 licensee to persons exempt from the regulations pur suant to this paragraph or equivalent NRC or agreement state 35 regulations. Except for persons who apply radioactive material to, or persons who incorporate radioactive material 36 into, the following products, or persons who initially transfer for sale or dist ribution (specifically licensed by NRC 37 pursuant to 10 CFR 32.14) the following products containing radioactive material, any person is exempt from the 38 license requirements in this part to the extent that such person receives, possesses, uses, transfers, ow ns or acquires 39 the following products:
40 (a) timepieces or hands or dials containing not more than the following specified 41 quantities of radioactive material and not exceeding the following specified levels of radiation:
42 (i) 25 millicuries (925 megabe cquerels) of tritium per timepiece; 43 (ii) 5 millicuries (185 megabecquerels) of tritium per hand; 44 (iii) 15 millicuries (555 megabecquerels) of tritium per dial (bezels when 45 used shall be considered as part of the dial);
46 (iv) 100 microcuries (3.7 megabecquerels) of promethium -147 per watch 47 hand or 200 microcuries (7.4 megabecquerels) of promethium -147 per any other timepiece; 48 (v) 20 microcuries (0.74 megabecquerel) of promethium -147 per watch 49 hand or 40 microcuries (1.48 megabecquerels) of promethium -147 per other timepiece hand; 50 (vi) 60 microcuries (2.22 megabecquerels) of promethium -147 per watch 51 dial or 120 microcuries (4.44 megabecquerels) of promethium -147 per other timepiece dial (bezels when used shall 52 be considered as part of the di al);
53 (vii) the levels of radiation from hands and dials containing promethium -147 54 shall not exceed, when measured through 50 milligrams per square centimeter of absorber: 1) for wrist watches, 0.1 55 millirad (1 milligray) per hour at 10 centimeters from any surface; 2) for pocket watches, 0.1 millirad (1 milligray) 56 per hour at 1 centimeter from any surface; or 3) for any other timepiece, 0.2 millirad (2 milligray) per hour at 10
20.3.3 NMAC 4 1 centimeters from any surface; or 2 (viii) 1 microcurie (37 kilobecquerels) of radium-226 per timepiece in intact 3 timepieces manufactured prior to November 30, 2007; 4 (b) Static elimination device. Devices designed for use as static eliminators which 5 contain, as a sealed source or sources, byproduct material consisting of a total of not more than 500 microcuries 6 (18.5 megabecquerels) of polonium -210 per device.
7 (c) Ion generating tube. Devices designed for ionization of air which contain, as a 8 sealed source or sources, byproduct material consisting of a tot al of not more than 500 microcuries (18.5 9 megabecquerels) of polonium -210 per device or a total of not more than 50 millicuries (1.85 gigabecquerels) of 10 hydrogen-3 (tritium) per device.
11 (d) precision balances containing not more than 1 millicurie (37 me gabecquerels) of 12 tritium per balance or not more than 0.5 millicurie (18.5 megabecquerels) of tritium per balance part manufactured 13 before December 17, 2007; 14 (e) [RESERVED];
15 (f) marine compasses containing not more than 750 millicuries (27.8 16 gigabecquerels) of tritium gas and other marine navigational instruments containing not more than 250 millicuries 17 (9.25 gigabecquerels) of tritium gas manufactured before December 17, 2007; 18 (g) ionization chamber smoke detectors containing not more than 1 microcurie (37 19 kilobecquerels) of americium -241 per detector in the form of a foil and designed to protect life and property from 20 fires; 21 (h) electron tubes; provided, that each tube does not contain more than one of the 22 following specified quantities of radi oactive material (for purposes of this exemption, electron tubes include spark 23 gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwaves tubes, indicator tubes, pick-up 24 tubes, radiation detection tubes and any other completely s ealed tube that is designed to conduct or control electrical 25 currents):
26 (i) 150 millicuries (5.55 gigabecquerels) of tritium per microwave receiver 27 protector tube or 10 millicuries (370 megabecquerels) of tritium per any other electron tube; 28 (ii) 1 microcurie (37 kilobecquerels) of cobalt -60; 29 (iii) 5 microcuries (185 kilobecquerels) of nickel -63; 30 (iv) 30 microcuries (1.11 megabecquerels) of krypton-85; 31 (v) 5 microcuries (185 kilobecquerels) of cesium -137; 32 (vi) 30 microcuries (1.11 me gabecquerels) of promethium -147; and 33 provided further, that the levels of radiation from each electron tube containing radioactive materials do not exceed 34 1 millirad (10 milligray) per hour at 1 centimeter from any surface when measured through 7 milligram s per square 35 centimeter of absorber; and 36 (i) ionizing radiation measuring instruments containing, for purposes of internal 37 calibration or standardization, one or more sources of radioactive material; provided, that:
38 (i) each source contains no more than one exempt quantity set forth in 39 20.3.3.330 NMAC; 40 (ii) each instrument contains no more than ten exempt quantities; for this 41 requirement, an instrument's source(s) may contain either one type or different types of radionuclides and an 42 individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in 43 20.3.3.330 NMAC provided that the sum of such fractions shall not exceed unity; and 44 (iii) for purposes of this subparagraph, 0.05 microcurie (1.85 45 kilobecquerels) of americium -241 is considered an exempt quantity under 20.3.3.330 NMAC.
46 (2) Self-luminous products containing tritium, krypton-85, promethium-147 or radium -
47 226.
48 (a) Except for persons who manufacture, process, produce, or initially t ransfer for 49 sale or distribution self-luminous products containing tritium, krypton-85, promethium -147 or radium -226, and 50 except as provided in Subparagraph (c) of this paragraph, any person is exempt from the license requirements in this 51 part to the extent that such person receives, possesses, uses, transfers, owns or acquires tritium, krypton -85, 52 promethium-147 or radium -226 in self-luminous products manufactured, processed, produced or initially transferred 53 in accordance with a specific license issued b y the NRC pursuant to 10 CFR 32.22 which license authorizes the 54 initial transfer of the product for use under this paragraph.
55 (b) Any person who desires to manufacture, process or produce, or initially transfer 56 for sale or distribution self-luminous products containing tritium, krypton -85 or promethium -147 for use pursuant to
20.3.3 NMAC 5 1 Subparagraph (a) of this paragraph, shall apply to NRC for a license pursuant to 10 CFR 32.22, and for a certificate 2 of registration in accordance with 10 CFR 32.210.
3 (c) The exemption in this paragraph does not apply to tritium, krypton -85, promethium -147 or radium -226 4 used in products primarily for frivolous purposes or in toys or adornments.
5 (3) Radium-226 acquired previously. Any person is exempt from the licensing 6 requirements in this part to the extent that such person possesses, uses or transfers, articles containing less than 0.1 7 microcurie (3.7 kilobecquerels) of radium -226 which were acquired prior to May 3, 1995 (the date when these rules 8 were codified).
9 (4) Gas and aer osol detectors containing radioactive material.
10 (a) Except for persons who manufacture, process, produce or initially transfer for 11 sale or distribution gas and aerosol detectors containing byproduct material, any person is exempt from the licensing 12 requirements in this part to the extent that such person receives, possesses, uses, transfers, owns or acquires 13 byproduct material, in gas and aerosol detectors designed to protect life or property, and manufactured, processed, 14 produced or initially transferred in accordance with a specific license issued by the NRC, pursuant to 10 CFR 32.26, 15 which license authorizes the initial transfer of the product for use under this paragraph. This exemption also covers 16 gas and aerosol detectors manufactured or distributed before November 30, 2007 in accordance with a specific 17 license issued by the department, agreement state or non-agreement state under comparable provisions to 10 CFR 18 32.26 authorizing distribution to persons exempt from regulatory requirements.
19 (b) Any person who desires to manufacture, process or produce gas and aerosol 20 detectors containing byproduct material, or to initially transfer such products for use pursuant to Subparagraph (a) of 21 this paragraph, shall apply for a license to the NRC pursuant to 10 CFR 32.26 and for a certificate of registration in 22 accordance with 10 CFR 32.210.
23 (5) Certain industrial devices.
24 (a) Except for persons who manufacture, process, produce, or initially transfer for 25 sale or distribution industrial devices containing byproduct material designed and manufactured for the purpose of 26 detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or 27 qualitative or quantitative chemical composition, or for producing an ionize d atmosphere, any person is exempt from 28 the requirements for a license set forth in section 81 of the Atomic Energy Act of 1954, as amended and from the 29 regulations in 10 CFR parts 19, 20, 21, 30 through 36, and 39 to the extent that such person receives, possesses, 30 uses, transfers, owns, or acquires byproduct material, in these certain detecting, measuring, gauging, or controlling 31 devices and certain devices for producing an ionized atmosphere, and manufactured, processed, produced, or 32 initially transferred in accordance with a specific license issued under 10 CFR 32.30 of this chapter, which license 33 authorizes the initial transfer of the device for use under this section. This exemption does not cover sources not 34 incorporated into a device, such as calibr ation and reference sources.
35 (b) Any person who desires to manufacture, process, produce, or initially transfer 36 for sale or distribution industrial devices containing byproduct material for use under subparagraph (a) of this 37 paragraph, should apply for a license under 10 CFR 32.30 and for a certificate of registration in accordance with 10 38 CFR 32.210.
39 D. Radioactive drug - capsules containing carbon-14 urea for in vivo diagnostic use for 40 humans.
41 (1) Except as provided in Paragraphs (2) and (3) of this subsection, any person is exempt 42 from the requirements for a license set forth in this part and 20.3.7 NMAC provided that such person receives, 43 possesses, uses, transfers, owns or acquires capsules containing 1microcurie (37 kilobecquerels) carbon -14 urea 44 (allowing for nominal variation that may occur during the manufacturing process) each, for in vivo diagnostic use 45 for humans.
46 (2) Any person who desires to use the capsules for research involving human subjects shall 47 apply for and receive a specif ic license pursuant to 20.3.7 NMAC.
48 (3) Any person who desires to manufacture, prepare, process, produce, package, repackage 49 or transfer for commercial distribution such capsules shall apply for and receive a specific license by NRC pursuant 50 to 10 CFR 32.21.
51 (4) Nothing in this section relieves persons from complying with applicable FDA, other 52 federal and state requirements governing receipt, administration and use of drugs.
53 [20.3.3.302 NMAC - Rp, 20.3.3.302 NMAC, 4/30/2009; A, 6/30/2011; A, 8/10/2021]
54 55 20.3.3.303 TYPES OF LICENSES: Licenses for radioactive materials are of two types: general and 56 specific.
20.3.3 NMAC 6 1 A. General License. A general license is provided by regulation, grants authority to a person for 2 certain activities involving radioactive material, and is effective without the filing of an application with the 3 department or the issuance of a licensing document to a particular person. However, registration with the 4 department may be required by the particular general license.
5 B. Specific License. A specific license is issued by the department to a named person who has filed 6 an application for the license under the specific licensing provisions of 20.3.3 NMAC, 20.3.5 NMAC, 20.3.7 7 NMAC, 20.3.12 NMAC, 20.3.13 NMAC, 20.3.14 NMAC and 20.3.15 NM AC.
8 [20.3.3.303 NMAC - Rp, 20.3.3.303 NMAC, 4/30/2009]
9 10 20.3.3.304 GENERAL LICENSES - SOURCE MATERIAL:
11 A. General license to receive title to source material or byproduct material (as defined in 12 Paragraph (2) of Subsection F of 20.3.1.7 NMAC). A general license is hereby issued authorizing the receipt of 13 title to source material or byproduct material (as defined in Paragraph (2) of Subsection F of 20.3.1.7 NMAC) 14 without regard to quantity. This general license does not authorize any person to receive, pos sess, deliver, use or 15 transfer source material or byproduct material (as defined in Paragraph (2) of Subsection F of 20.3.1.7 NMAC).
16 B. Small quantities of source material.
17 A general license is hereby issued authorizing commercial and industrial firms; research, educational, and medical 18 institutions; and federal, state, and local government agencies to receive, possess, use, and transfer uranium and 19 thorium, in their natural isotopic concentrations and in the form of depleted uranium, for research, development, 20 educational, commercial, or operational purposes in the following forms and quantities:
21 (1) No more than 1.5 kg (3.3 lb) of uranium and thorium in dispersible forms (e.g., gaseous, 22 liquid, powder, etc.) at any one time. Any material processed by th e general licensee that alters the chemical or 23 physical form of the material containing source material must be accounted for as a dispersible form. A person 24 authorized to possess, use, and transfer source material under Subsection B of this section may not receive more 25 than a total of 7 kg (15.4 lb) of uranium and thorium in any one calendar year. Persons possessing source material in 26 excess of these limits as of August 27, 2013, may continue to possess up to 7 kg (15.4 lb) of uranium and thorium at 27 any one time for one year beyond this date, or until the department takes final action on a pending application 28 submitted on or before August 27, 2014, for a specific license for such material and receive up to 70 kg (154 lb) of 29 uranium or thorium in any one cal endar year until December 31, 2014, or until the department takes final action on a 30 pending application submitted on or before August 27, 2014, for a specific license for such material; and 31 (2) No more than a total of 7 kg (15.4 lb) of uranium and thori um at any one time. A person 32 authorized to possess, use, and transfer source material under Subsection B of this section may not receive more 33 than a total of 70 kg (154 lb) of uranium and thorium in any one calendar year. A person may not alter the chemica l 34 or physical form of the source material possessed under this paragraph unless it is accounted for under the limits of 35 Subsection B(1) of this section; or 36 (3) No more than 7 kg (15.4 lb) of uranium, removed during the treatment of drinking water, 37 at any one time. A person may not remove more than 70 kg (154 lb) of uranium from drinking water during a 38 calendar year under Subsection B of this section; or 39 (4) No more than 7 kg (15.4 lb) of uranium and thorium at laboratories for the purpose of 40 determining the concentration of uranium and thorium contained within the material being analyzed at any one time.
41 A person authorized to possess, use, and transfer source material under Subsection B of this section may not receive 42 more than a total of 70 kg (154 lb) of source material in any one calendar year.
43 C. Any person who receives, possess, uses, or transfers source material pursuant to the general 44 license in Subsection B of this section:
45 (1) is prohibited from administering source material, or the radiat ion 46 therefrom, either externally or internally, to human beings except as may be authorized by the department in a 47 specific license; 48 (2) shall not abandon such source material. Source material may be disposed of as follows:
49 (a) A cumulative total of 0.5 kg (1.1 lb) of source material in a solid, non-50 dispersible form may be transferred each calendar year, by a person authorized to receive, possess, use, and transfer 51 source material under a general license to persons receiving the material for permanent disposal.
52 (b) The recipient of source material transferred under the provisions of this section 53 is exempt from the requirements to obtain a license under this part to the extent the source material is permanently 54 disposed. This provision does not apply to any person who is in possession of source material under a specific 55 license issued under this chapter or in accordance with 20.3.4.433 NMAC.
56 (3) is subject to the provisions in accordance with 10 CFR 40.1 through 40.10, 10 CFR
20.3.3 NMAC 7 1 40.41(a) through (e), 10 CFR 40.46, 10 CFR 40.51, 10 CFR 40.56, 10 CFR 40.60 through 40.63, 10 CFR 40.71, 10 2 CFR 40.81, and the equivalent regulations in 20.3.3 NMAC; and 3 (4) shall not export such source material except in accordance with 10 CFR 110.
4 D. Any person who receives, possesses, uses, or transfers source material in accordance with 5 subsection B of this section shall conduct activities so as to minimize contamination of the facility and the 6 environment. When activities involving such source mater ial are permanently ceased at any site, if evidence of 7 significant contamination is identified, the general licensee shall notify the department by an appropriate method 8 listed in 20.3.1.116 NMAC about such contamination and may consult with the department as to the appropriateness 9 of sampling and restoration activities to ensure that any contamination or residual source material remaining at the 10 site where source material was used under this general license is not likely to result in exposures that exceed the 11 limits in 20.3.4.426.B NMAC.
12 E. Any person who receives, possesses, uses, or transfers source material in accordance with the 13 general license granted in Subsection B of this section is exempt from the provisions of 20.3.10 NMAC, and 20.3.4 14 NMAC to the extent that such receipt, possession, use, and transfer are within the terms of this general license, 15 except that such person shall comply with the provisions of 20.3.4.426.A NMAC and 20.3.4.433 NMAC to the 16 extent necessary to meet the provisions of 20.3. 3.304.B NMAC. However, this exemption does not apply to any 17 person who also holds a specific license issued under 20.3.3 NMAC.
18 F. No person may initially transfer or distribute source material to persons generally licensed under 19 Paragraph (1) and (2) Subs ection B of this section, or equivalent regulations of an agreement state, unless authorized 20 by a specific license in accordance with 10 CFR 40.54 or equivalent provisions of an agreement state. This 21 prohibition does not apply to analytical laboratories r eturning processed samples to the client who initially provided 22 the sample. Initial distribution of source material to persons generally licensed by Subsection A of this section 23 before August 27, 2013, without specific authorization may continue for 1 year beyond this date. Distribution may 24 also be continued until the NRC takes final action on a pending application for a license or license amendment to 25 specifically authorize distribution submitted on or before August 27, 2014.
26 G. Depleted uranium in industrial products and devices.
27 (1) A general license is hereby issued to receive, acquire, possess, use or transfer, in 28 accordance with the provisions in Paragraphs (2), (3), (5) and (6) of this subsection, depleted uranium contained in 29 industrial products or devices for the purpose of providing a concentrated mass in a small volume of the product or 30 device.
31 (2) The general license in Paragraph (1) of this subsection applies only to industrial products 32 or devices which have been manufactured or initially tr ansferred either in accordance with a specific license issued 33 to the manufacturer of the products or devices pursuant to Subsection L of 20.3.3.315 NMAC or in accordance with 34 a specific license issued by the NRC or an agreement state which authorizes manu facture of the products or devices 35 for distribution to persons generally licensed by the NRC or an agreement state.
36 (3) Persons who receive, acquire, possess or use depleted uranium pursuant to the general 37 license established by Paragraph (1) of this subsection shall file a form, registration certificate - use of depleted 38 uranium under general license, with the department. The form shall be submitted within 30 days after the first 39 receipt or acquisition of such depleted uranium. The general licensee shall furnish on the registration form the 40 following information and such other information as may be required by that form:
41 (a) name and address of the general licensee; 42 (b) a statement that the general licensee has developed and will maintain procedures 43 designed to establish physical control over the depleted uranium described in Paragraph (1) of this subsection and 44 designed to prevent transfer of such depleted uranium in any form, including metal scrap, to persons not authorized 45 to receive the depleted uranium; and 46 (c) name and title, address and telephone number of the individual duly authorized 47 to act for and on behalf of the general licensee in supervising the procedures identified in Subparagraph (b) of this 48 paragraph.
49 (4) The general licensee possessing or using depleted uranium under the general license 50 established by Paragraph (1) of this subsection shall report in writing to the department any changes in information 51 furnished by them in the form registration certificate-use of depleted uranium under general license. The report 52 shall be submitted within 30 days after the effective date of such change.
53 (5) A person, who receives, acquires, possesses or uses depleted uranium pursuant to the 54 general license established by Paragraph (1) of this subsection:
55 (a) shall not introduce such depleted uranium, in any form, into a chemical, physical 56 or metallurgical treatment or process, except a treatment or process for repair or restoration of any plating or other
20.3.3 NMAC 8 1 covering of the depleted uranium; 2 (b) shall not abandon such depleted uranium; 3 (c) shall transfer or dispose of such depleted uranium only by transfer in accordance 4 with the provisions of 20.3.3.323 NMAC; in the case where the transferee receives the depleted uranium pursuant to 5 the general license established by Paragraph (1) of this subsection, the transferor shall furnish the transferee a copy 6 of this subsection and a copy of the registration form; in cases where the transferee receives the depleted uranium 7 pursuant to a general license contained in the NRC or agreement state's regulation equivalent to this subsection, 8 Subsection C of 20.3.3.304 NMAC, the transferor shall furnish the transferee a copy of this subsection and a copy of 9 the registration form accompanied by a note explaining that use of the product or device is regulated by the NRC or 10 agreement state under requirements substantially the sa me as those in this subsection; 11 (d) shall report in writing, within 30 days of any transfer, to the department the 12 name and address of the person receiving the depleted uranium pursuant to such transfer; and 13 (e) shall not export such depleted uranium except in accordance with a license 14 issued by the NRC pursuant to 10 CFR 110.
15 (6) Any person receiving, acquiring, possessing, using or transferring depleted uranium 16 pursuant to the general license established by Paragraph (1) of this subsection is exem pt from the requirements of 17 20.3.4 NMAC and 20.3.10 NMAC with respect to the depleted uranium covered by that general license.
18 [20.3.3.304 NMAC - Rp, 20.3.3.304 NMAC, 4/30/2009; A, 8/10/2021]
19 20 20.3.3.305 GENERAL LICENSES - RADIOACTIVE MATERIAL OTHER THAN SOURCE 21 MATERIAL:
22 A. [Reserved]
23 B. Certain detecting, measuring, gauging or controlling devices and certain devices for 24 producing light or an ionized atmosphere.
25 (1) A general license is hereby issued as required by Subparagraph (m) of Paragraph (3) of 26 this subsection to commercial and industrial firms and research, educational and medical institutions, individuals in 27 the conduct of their business, and federal, state or local government agencies to receive, acquire, possess, use or 28 transfer, in accordance with the provisions of Paragraphs (2), ( 3), and (4) of this subsection, byproduct material 29 contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling 30 thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, 31 or for producing light or an ionized atmosphere, and the device has been registered in the sealed source and device 32 registry.
33 (2) The general license in Paragraph (1) of this subsectio n applies only to byproduct material 34 contained in devices which have been manufactured or initially transferred and labeled in accordance with the 35 specifications contained in:
36 (a) a specific license issued by the department pursuant to Subsection E of 37 20.3.3.315 NMAC; or 38 (b) an equivalent specific license issued by the NRC or an agreement state; or 39 (c) an equivalent specific license issued by a state with provisions comparable to 40 Subsection E of 20.3.3.315 NMAC. The devices must ha ve been received from one of the specific licensees 41 described in this paragraph, or through a transfer made under Subparagraph (h) of Paragraph (3) of this subsection.
42 (3) Any person who receives, acquire s, possesses, uses or transfers byproduct material in a 43 device pursuant to the general license in Paragraph (1) of this subsection shall comply with the following.
44 (a) The general licensee shall assure that all labels affixed to the device at the time 45 of receipt and bearing a statement that removal of the label is prohibited are maintained thereon and shall comply 46 with all instructions and precautions provided by such labels.
47 (b) The general licensee shall assure that the device is tested for leakage of 48 radioactive material and proper operation of th e on-off mechanism and indicator, if any, at no longer than six month 49 intervals or at such other intervals as are specified in the label; however:
50 (i) devices containing only krypton need not be tested for leakage of 51 radioactive material; and 52 (ii) devices containing only tritium or not more than 100 microcuries (3.7 53 megabecquerels) of other beta or gamma emitting material or 10 microcuries (0.37 megabecquerel) of alpha 54 emitting material and devices held in storage in the original shipping container prior to initial installation need not 55 be tested for any purpose.
56 (c) The general licensee shall assure that the test required by Subparagraph (b) of
20.3.3 NMAC 9 1 Paragraph (3) of this subsection and other testing, installation, servicing and removal from installati on involving the 2 radioactive materials, its shielding or containment are performed:
3 (i) in accordance with the instructions provided by the labels; or 4 (ii) by a person holding a specific license pursuant to this part from the 5 department, the NRC, or an agreement state to perform such activities.
6 (d) The general licensee shall maintain records showing compliance with the 7 requirements of Subparagraphs (b) and (c) of Paragraph (3) of this subsection. The records must show the results of 8 tests. The records must also show the dates of performance of, and the names of persons performing, testing, 9 installing, servicing and removing from the installation radioactive material and its shielding or containment. The 10 licensee shall retain these records as foll ows:
11 (i) each record of a test for leakage or radioactive material required by 12 Subparagraph (b) of Paragraph (3) of this subsection shall be retained for three years after the next required leak test 13 is performed or until the sealed source is transferred or disposed of; 14 (ii) each record of a test of the on -off mechanism and indicator required by 15 Subparagraph (b) of Paragraph (3) of this subsection shall be retained for three years after the next required test of 16 the on-off mechanism and indicator is performed or until the sealed source is transferred or disposed of; and 17 (iii) each record that is required by Subparagraph (c) of Paragraph (3) of 18 this subsection shall be retained for 3 years from the date of the recorded event or until the device is transferred or 19 disposed of.
20 (e) The general licensee shall immediately suspend operation of the device if there 21 is a failure of, or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive 22 material or the on-off mechanism or indicator, or upon the detection of 0.005 microcuries (185 becquerels) or more 23 removable radioactive material. The device may not be operated until it has been repaired by the manufacturer or 24 other person holding a specific licens e to repair such devices that was issued pursuant to this part by the department, 25 the NRC or an agreement state. The device and any radioactive material from the device, shall only be disposed of 26 by transfer to a person authorized by a specific license to receive the radioactive material in the device, or as 27 otherwise approved by the department. A report shall be furnished to the department within 30 days containing a 28 brief description of the event and the remedial action taken. In the case of detection of 0.005 microcurie or more 29 removable radioactive material or failure of, or damage to, a source likely to result in contamination of the premises 30 or the environs, the report shall include a plan for ensuring that the premises and environs are acceptable for 31 unrestricted use. Under these circumstances, the criteria set out in Subsection B of 20.3.4.426 NMAC, radiological 32 criteria for unrestricted use, shall be applicable, as determined by the department on a case-by-case basis.
33 (f) The general licensee shall not abandon the device containing radioactive 34 material.
35 (g) The general licensee shall not export the device containing radioactive material 36 except in accordance with 10 CFR 110.
37 (h) Device transfer requirements.
38 (i) The general licensee shall transfer or dispose of the device containing 39 radioactive material only by export as provided by Subparagraph (g) of this paragraph, by transfer to another general 40 licensee as authorized in Subparagraph (i) of this paragraph, or to a person authorized to r eceive the device by a 41 specific license issued by the department pursuant under this part, or by a specific license issued by the department 42 authorizing waste collection pursuant to this part, or equivalent provisions of the NRC or an agreement state, or a s 43 otherwise approved under Item (iii) of this subparagraph.
44 (ii) The general licensee shall within 30 days after the transfer of a device 45 to a specific licensee or export, furnish a report to the department at the address indicated in 20.3.1.116 NMAC. The 46 report shall contain the identification of the device by manufacturers (or initial transferors) name, model number 47 and serial number; the name, address and license number of the person receiving the device (license number not 48 applicable if exported); and the date of the transfer.
49 (iii) The general licensee shall obtain written department approval before 50 transferring the device to any other specific licensee not specifically identified in Item (i) of this subparagraph.
51 However, a holder of a specific license may transfer a device for possession and use under its own specific license 52 without prior approval, if, the holder: verifies that the specific license authorizes the possession and use, or applies 53 for and obtains amendment to the license authori zing the possession and use; removes, alters, covers, or clearly and 54 unambiguously augments the existing label (otherwise required by Subparagraph (a) of this paragraph) so that the 55 device is labeled in compliance with 20.3.4.430 NMAC, however, the manufac turer, model number, and serial 56 number must be retained; obtains the manufacturers or initial transferors information concerning maintenance that
20.3.3 NMAC 10 1 would be applicable under the specific license (such as leak testing procedures); and reports the transfer under Item 2 (ii) of this subparagraph.
3 (i) The general licensee shall transfer the device to another general licensee only if:
4 (i) the device remains in use at a particular location, in which case: 1) the 5 transferor shall give the transferee a copy of this subsection (Subsection B of 20.3.3.305 NMAC), a copy of 6 Subsection F of 20.3.3.317 NMAC, a copy of 20.3.3.326 NMAC, a copy of 20.3.4.451 NMAC, a copy of 20.3.4.452 7 NMAC and any safety documents identified in the label of the device; 2) within 30 days of the transfer, the 8 transferor shall report to the department at the address indicated in 20.3.1.116 NMAC, stating the manufacturers (or 9 initial transferors) name, the model number and the serial number of the device transferred, the transferees name 10 and mailing address for the location of use, and the name, title and phone number of the responsible individual 11 identified by the transferee in accordance with Subparagraph (l) of this paragraph to have knowledge of and 12 authority to take actions to ensure compliance with the appropriate regulations and requirements; or 13 (ii) the device is held in storage by an intermediate person in the original 14 shipping container at its intended location of use prior to initial use by a general licensee.
15 (j) The general licensee shall comply with the provisions of 20.3.4.451 NMAC and 16 20.3.4.452 NMAC for reporting radiation incidents, theft or loss of licensed material, but shall be exempt from the 17 other requirements of 20.3.4 NMAC and 20.3.10 NMAC.
18 (k) The general licensee shall respond to written requests from the department to 19 provide information relating to the general license within 30 calendar days of the date of the request, or other time 20 specified in the request. If the general licensee cannot provide the requested information within the allotted time, it 21 shall, within that same time period, request a longer period to supply the information by providing the department 22 with a written justification for the request.
23 (l) The general licensee shall appoint an i ndividual responsible for having 24 knowledge of the appropriate regulations and requirements and the authority for taking required actions to comply 25 with appropriate regulations and requirements. The general licensee, through this individual, shall ensure the day -to-26 day compliance with appropriate regulations and requirements. This appointment does not relieve the general 27 licensee of any of its responsibility in this regard.
28 (m) Registration requirements.
29 (i) The general licensee shall register on a department registration form, in 30 accordance with Items (ii) and (iii) of this subparagraph, devices containing at least 10 millicuries (370 31 megabecquerels) of cesium-137, 0.1 millicuries (3.7 megabecquerels) of strontium -90, 1 millicurie (37 32 megabecquerels) of cobalt-60, 0.1 millicurie (3.7 megabecquerels) of radium -226, 1 millicurie (37 megabecquerels) 33 of americium-241 or any other transuranic (i.e., element with atomic number greater than uranium (92)), based on 34 the activity indicated on the label. Each address of a location of use, as described under Item (iii) of this 35 subparagraph, represents a separate general licensee and requires a separate registration.
36 (ii) If in possession of a device meeting the criteria of Item (i) of this 37 subparagraph, the general licensee shall register these devices annually with the department. Registration shall be 38 done by verifying, correcting or adding to the information provided in a request for registration received from the 39 department. The registration information shall be submitted to the department within 30 days of the date of the 40 request for registration or as otherwise indicated in the request. In addition, a general licensee holding devices 41 meeting the criteria of Item (i) of this subparagraph is subject to the bankruptcy notification requirement in 42 Subsection E of 20.3.3.317 NMAC.
43 (iii) In registering devices, the general licensee shall furnish the following 44 information and any other information specifically requested by the department: 1) name and mailing a ddress of the 45 general licensee; 2) information about each device: the manufacturer (or initial transferor), model number, serial 46 number, the radioisotope and activity (as indicated on the label); 3) name, title and telephone number of the 47 responsible person designated as a representative of the general licensee under Subparagraph (l) of this paragraph; 4) 48 address or location at which the device(s) are used or stored; for portable devices, the address of the primary place of 49 storage; 5) certification by the responsible representative of the general licensee that the information concerning the 50 device(s) has been verified through a physical inventory and checking of label information; and 6) certification by 51 the responsible representative of the general license e that they are aware of the requirements of the general license.
52 (iv) Persons generally licensed by the NRC and an agreement state with 53 respect to devices meeting the criteria in Item (i) of this subparagraph are not subject to registration requirements if 54 the devices are used in areas subject to department jurisdiction for a period less than 180 days in any calendar year.
55 The department will not request registration information from such licensees.
56 (n) The general licensee shall report changes to t he mailing address for the location
20.3.3 NMAC 11 1 of use (including change in name of general licensee) to the department at the address indicated in 20.3.1.116 2 NMAC, within 30 days of the effective date of the change. For a portable device, a report of address change i s only 3 required for a change in the devices primary place of storage.
4 (o) The general licensee shall not hold devices that are not in use for longer than 2 5 years. If devices with shutters are not being used, the shutter shall be locked in the closed position. The testing 6 required by Subparagraph (b) of Paragraph (3) of this subsection need not be performed during the period of storage 7 only. However, when devices are put back into service or transferred to another person, and have not been tested 8 within the required test interval, they shall be tested for leakage before use or transfer and the shutter tested before 9 use. Devices kept in standby for future use are excluded from the two-year time limit if the general licensee 10 performs quarterly physical inve ntories of these devices while they are in standby.
11 (4) The general license in Paragraph (1) of this subsection does not authorize the 12 manufacture or import of devices containing radioactive material.
13 C. Luminous safety devices for use in aircraft.
14 (1) A general license is hereby issued to own, receive, acquire, possess and use tritium or 15 promethium-147 contained in luminous safety devices for use in aircraft, provided:
16 (a) each device contains not more than 10 curies (370 gigabecquerels) of tritium or 17 300 millicuries (11.1 gigabecquerels) of promethium -147; 18 (b) each device has been manufactured, assembled or initially transferred in 19 accordance with a license issued under the provisions 10 CFR 32.53 or manufactured or assembled in accordance 20 with a specific license issued by the NRC];
21 (c) quality assurance procedures are in place that are sufficient to ensure 22 compliance with 10 CFR 32.55; and 23 (d) prototypes of the device have been subjected to and have satisfactorily passed 24 the tests required in 10 CFR 32.53(e) and outlined in Subsection C(2) of this section.
25 (2) The applicant shall subject at least five prototypes of the device to tests as follows:
26 (a) the devices are subjected to tests that adequately take into account the 27 individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely 28 affect the effective containment of tritium or promethium-147, such as temperature, moisture, absolute pressure, 29 water immersion, vibration, shock, and weathering; 30 (b) the devices are inspected for evidence of physical damage and for loss of tritium 31 or promethium-147, after each stage of testing, using methods of inspection adequate for determining compliance 32 with the criteria in subparagraph C(2) of this section; and 33 (c) the device designs are rejected for which the following has been detected for any 34 unit; a leak resulting in a loss of one tenth of one percent or more of the original amount of tritium or promethium -
35 147 from the device; or surface contamination of tritium or promethium -147 on the device of more than 2,200 36 disintegrations per minute per 100 square centimeters of surface area; or any other evidence of physical damage.
37 (3) Each person licensed under 10 CFR 32.55 or Subsection C of 20.3.3.305 NMAC shall 38 visually inspect each device and shall reject any that has an observable physical defect that could adversely affect 39 containment of the tritium or promethium -147.
40 (4) Each person licensed under 10 CFR 32.53 or Sub section C of 20.3.3.305 shall:
41 (a) maintain quality assurance systems in the manufacture of the luminous safety 42 device in a manner sufficient to provide reasonable assurance that the safety -related components of the distributed 43 devices are capable of performing their intended functions; and 44 (b) subject inspection lots to acceptance sampling procedures, by procedures 45 specified in Subparagraph C(2) of this section and in the license issued under 10 CFR 32.53 or Subsection C of 46 20.3.3.305 NMAC to provide at least ninety-five percent confidence that the lot tolerance percent defective of five 47 percent will not be exceeded.
48 (5) The licensee shall subject each inspection lot to:
49 (a) tests that adequately take into account the individual, aggregate, and c umulative 50 effects of environmental conditions expected in service that could adversely affect the effective containment of 51 tritium or promethium-147, such as absolute pressure and water immersion; and 52 (b) inspection for evidence of physical damage, cont ainment failure, or loss of 53 tritium or promethium-147 after each stage of testing, using methods of inspection adequate for applying the 54 following criteria for defective:
55 (i) a leak resulting in a loss of one tenth of one percent or more of the 56 original amount of tritium or promethium-147 from the device;
20.3.3 NMAC 12 1 (ii) levels of radiation in excess of 5 microgray (0.5 millirad) per hour at 2 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber, if the 3 device contains promethium -147; and 4 (iii) any other criteria specified in the license issued under 10 CFR 32.53 or 5 Subsection C of 20.3.3.305 NMAC.
6 (6) No person licensed under 10 CFR 32.53 or Subsection C of 20.3.3.305 NMAC shall 7 transfer to persons general ly licensed pursuant to 10 CFR 31.7 or under an equivalent general license of an 8 agreement state:
9 (a) any luminous safety device tested and found defective under any condition of a 10 license issued under Subsection C of this section, unless the defective luminous safety device has been repaired or 11 reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or 12 (b) any luminous safety device contained within any lot that has been sampled and 13 rejected as a result of the procedures in Subsection C(4)(b) of this section, unless a procedure for defining sub-lot 14 size, independence, and additional testing procedures is contained in the license issued under 10 CFR 32.53 or 15 Subsection C of 20.3.3.305 NMAC and each individual sub -lot is sampled, tested, and accepted in accordance with 16 Subsection C(2) of this section and any other criteria that may be required as a condition of the license issued under 17 10 CFR 32.53 or Subsection C of 20.3.3.305 NMAC.
18 (7) Persons who own, receive, acquire, possess or use luminous safety devices pursuant to 19 this general license are exempt from the requirements of 20.3.4 NMAC and 20.3.10 NMAC except that they shall 20 comply with the reporting and notification provisions of 20.3.4. 451 NMAC and 20.3.4.452 NMAC.
21 (8) This general license does not authorize the manufacture, assembly, repair or import of 22 luminous safety containing tritium or promethium -147.
23 (9) This general license does not authorize the export of luminous safety devices containing 24 tritium or promethium-147.
25 (10) This general license does not authorize the ownership, receipt, acquisition, possession or 26 use of promethium -147 contained in instrument dials.
27 D. Calibration and reference sources.
28 (1) A general license is hereby issued to those persons listed in this paragraph to own, 29 receive, acquire, possess, use and transfer, in accordance with the provisions of Paragraphs (4) and (5) of this 30 subsection americium-241 in the form of calibration or reference sources.
31 (a) Any person who holds a specific license issued by the department which 32 authorizes them to receive, possess, use and transfer radioactive material.
33 (b) Any government agency, as defined in 20.3.1.7 NMAC, which holds a specific 34 license issued pursua nt to this chapter which authorizes it to receive, possess, use and transfer radioactive material.
35 (2) A general license is hereby issued to those persons listed below to receive title to, own, 36 acquire, deliver, receive, possess, use and transfer in acco rdance with the provisions of Paragraph (4) and (5) 37 plutonium in the form of calibration or reference sources.
38 (a) Any person who holds a specific license issued by the department which 39 authorizes them to receive, possess, use and transfer radioactive m aterial.
40 (b) Any government agency, as defined in 20.3.1.7 NMAC, which holds a specific 41 license issued pursuant to 20.3 NMAC which authorizes it to receive, possess, use and transfer radioactive material.
42 (c) Any person who holds a specific license i ssued by the NRC or an agreement 43 state which authorizes them to receive, possess, use and transfer special nuclear material.
44 (3) A general license is hereby issued to receive, possess, use and transfer radium -226 in the 45 form of calibration or reference s ources in accordance with Paragraphs (4) and (5) of this subsection to any person 46 who holds a specific license issued by the department which authorizes them to receive, possess, use and transfer 47 radioactive material.
48 (4) The general licenses in Paragrap hs (1), (2) and (3) of this subsection apply only to 49 calibration or reference sources which have been manufactured or initially transferred in accordance with the 50 specifications contained in a specific license issued the department pursuant to Subsection G of 20.3.3.315 NMAC 51 or in accordance with the specifications contained in a specific license issued by the NRC or an agreement state 52 pursuant to equivalent licensing requirements which authorizes the manufacturer of the sources for distribution to 53 persons generally licensed by the NRC or an agreement state.
54 (5) The general licenses provided in Paragraphs (1), (2) and (3) of this subsection are subject 55 to the provisions of Subsection F of 20.3.3.317 NMAC. In addition, persons who receive, acquire, possess, use or 56 transfer one or more calibration or reference sources pursuant to these general licenses:
20.3.3 NMAC 13 1 (a) shall not possess at any one time, at any one location of storage or use, more 2 than 5 microcuries (185 kilobecquerels) of americium -241, 5 microcuries (185 kilobecquerels) of plutonium and 5 3 microcuries (185 kilobecquerels) of radium -226 in such sources; 4 (b) shall not receive, possess, use or transfer such source unless the source, or the 5 storage container, bears a label which includes the fol lowing statement or a substantially similar statement which 6 contains the information called for in the following statement:
7 The receipt, possession, use and transfer of this source, model ________, serial number _________, are subject to a 8 general license and the regulations of the United States nuclear regulatory commission or of a state with which the 9 commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.
10 Caution - radioactive material - this source contains [describe one of the following radioactive materials 11 americium-241, plutonium or radium -226 as appropriate]. Do not touch radioactive portion of this source.
12 ______________________________
13 (name of manufacturer or initial transferor) 14 (c) shall not transfer, abandon or dispose of such source except by transfer to a 15 person authorized by a license issued by the department, the NRC or an agreement state to receive the source; 16 (d) shall store such source, except when the source is being used, in a closed 17 container adequately designated and constructed to contain americium -241, plutonium or radium -226 which might 18 otherwise escape during storage; and 19 (e) shall not use such source for any purpose other than the calibration of radiation 20 detectors or the standardization of other sources.
21 (6) These general licenses do not authorize the manufacture or import of calibration or 22 reference sources containing americium -241, plutonium or radium -226.
23 E. General license to install devices generally licensed in Subsection B of 20.3.3.305 NMAC.
24 Any person who holds a specific license issued by the NRC or an agreement state authorizing the holder to 25 manufacture, install or service a device described in Subsection B of this section within such agreement state i ssuing 26 the specific license or within a location subject to NRC jurisdiction, is hereby granted a general license to install and 27 service such device in this state; provided, that:
28 (1) the device has been manufactured, labeled, installed and serviced in accordance with 29 applicable provisions of the specific license issued to such person by the NRC or an agreement state; and 30 (2) such person assures that any labels required to be affixed to the device under regulations 31 of the NRC or agreement state which licensed manufacture of the device bear a statement that removal of the label is 32 prohibited.
33 F. General license for use of radioactive material for certain in -vitro clinical or laboratory 34 testing.
35 (1) A general license is hereby issued to any phys ician, veterinarian in the practice of 36 veterinary medicine, clinical laboratory or hospital to receive, acquire, possess, transfer or use, for any of the 37 following stated tests, in accordance with the provisions of Paragraphs (2) through (6) of this subsec tion, the 38 following radioactive materials in prepackaged units, each for use for in-vitro clinical or laboratory tests not 39 involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or 40 animals:
41 (a) iodine-125, in units not exceeding 10 microcuries (370 kilobecquerels) each; 42 (b) iodine-131, in units not exceeding 10 microcuries (370 kilobecquerels) each; 43 (c) carbon-14, in units not exceeding 10 microcuries (370 kilobecquerels) each; 44 (d) hydrogen-3, in units not exceeding 50 microcuries (1.85 megabecquerels) each; 45 (e) iron-59, in units not exceeding 20 microcuries (740 kilobecquerels) each; 46 (f) cobalt-57, in units not exceeding 10 microcuries (370 kilobecquerels) each; 47 (g) selenium-75, in units not exceeding 10 microcuries (370 kilobecquerels) each; 48 and 49 (h) mock iodine -125 for use as reference or calibration sources not to exceed 0.05 50 microcurie (1.85 kilobecquerels) of iodine -129 and 0.005 microcurie (1.85 becquerels) of americium -241 each.
51 (2) No person shall receive, acquire, possess, use or transfer radioactive material pursuant to 52 the general license established by Paragraph (1) of this subsection unless that person 53 (a) has filed a form, registration certificate -in vitro testing with radioactive 54 material under general license, with the department and received from the department a validated copy of the 55 registration certificate with a registration number assigned. The physician, clinical laboratory or hospital shall 56 furnish on the registration certificate the following information and such other information as may be required by the
20.3.3 NMAC 14 1 form:
2 (i) name and address of the physician, clinical laboratory or hospital; 3 (ii) the location of use; and 4 (iii) a statement that the physician, veterinarian, clinical laboratory or 5 hospital has appropriate radiation measuring instruments to carry out in vitro clinical or laboratory tests with 6 radioactive material as authorized under the general license in Paragraph (1) of this subsect ion and that such tests 7 will be performed only by personnel competent in the use of such instruments and in the handling of the radioactive 8 material; or 9 (b) has a license that authorizes the medical use of radioactive material that was 10 issued under 20.3.7 NMAC.
11 (3) A person who receives, acquires, possesses or uses radioactive material pursuant to the 12 general license established by Paragraph (1) of this subsection shall comply with the following:
13 (a) the general licensee shall not possess at any one time, pursuant to the general 14 license in Paragraph (1) of this subsection at any one location of storage or use, a total amount of iodine -125, iodine -
15 131, iron-59, cobalt-57 or selenium -75 in excess of 200 microcuries (7.4 megabecquerels);
16 (b) the general licensee shall store the radioactive material, until used, in the 17 original shipping container or in a container providing equivalent radiation protection; 18 (c) the general licensee shall use the radioactive material only for the uses 19 authorized by Pa ragraph (1) of this subsection; 20 (d) the general licensee shall neither transfer the radioactive material except by 21 transfer to a person authorized to receive it pursuant to a license issued by the department, the NRC or an agreement 22 state, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as 23 received from the supplier; and 24 (e) the general licensee shall dispose of mock iodine reference or calibration 25 sources in accordance with 20.3.4.433 NMAC.
26 (4) The general licensee shall not receive, acquire, possess or use radioactive material 27 pursuant to Paragraph (1) of this subsection:
28 (a) except as prepackaged units which are labeled in accordance with the provisions 29 of a specific license issued under Subsection H of 20.3.3.315 NMAC, or in accordance with the provisions of a 30 specific license issued by the NRC or an agreement state, or labeled before November 30, 2007 in accordance with 31 the provisions of a specific license issued by a state with compar able provisions to Subsection H of 20.3.3.315 32 NMAC, which authorizes the manufacture and distribution of iodine -125, iodine -131, carbon-14, hydrogen -3 33 (tritium), iron-59, cobalt-57, selenium -75, or mock iodine -125 for distribution to persons generally lice nsed by the 34 NRC, the agreement state or the state with comparable provisions to Subsection H of 20.3.3.315 NMAC; and 35 (b) unless the following statement, or a substantially similar statement, which 36 contains the information called for in the following sta tement appears on a label affixed to each prepackaged unit or 37 appears in a leaflet or brochure which accompanies the package:
38 This radioactive material shall be received, acquired, possessed and used only by physicians, veterinarians in the 39 practice of veterinary medicine, clinical laboratories or hospitals and only for in-vitro clinical or laboratory tests 40 not involving internal or external administration of the material, or the radiation therefrom, to human beings or 41 animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of 42 the U.S. nuclear regulatory commission or of a State with which the commission has entered into an agreement for 43 the exercise of regulatory authority.
44 ________________________________
45 (name of manufacturer) 46 (5) The general licensee possessing or using radioactive material under the general license of 47 Paragraph (1) of this subsection shall report in writing to the department, any changes in the information furnished 48 by them in the certificate -in-vitro testing with radioactive material under general license form. The report shall be 49 furnished within 30 days after the effective date of such change.
50 (6) Any person using radioactive material pursuant to the general license of Paragraph (1) of 51 this subsection is exem pt from the requirements of 20.3.4 NMAC and 20.3.10 NMAC with respect to radioactive 52 material covered by that general license except that such person using a mock iodine -125 shall comply with the 53 provisions of 20.3.4.433 NMAC, 20.3.4.451 NMAC and 20.3.4.452 NMAC.
54 G. General license for strontium 90 in ice detection devices.
55 (1) A general license is hereby issued to own, receive, acquire, possess, use and transfer 56 strontium-90 contained in ice detection devices, provided each device contains not more than 50 microcuries (1.85
20.3.3 NMAC 15 1 megabecquerels) of strontium-90 and each device has been manufactured or initially transferred in accordance with 2 a specific license issued by the department, the NRC or an agreement state, which authorizes manufacture of the ice 3 detection devices for distribution to persons generally licensed by the department, NRC or an agreement state.
4 (2) Persons who own, receive, acquire, possess, use or transfer strontium -90 contained in ice 5 detection devices pursuant to the general license in Paragraph (1) of this subsection:
6 (a) shall, upon occurrence of visually observable damage, such as a bend or crack or 7 discoloration from overheating, to the device, discontinue use of the device until it has been inspected, tested for 8 leakage and repaired by a person holding a specific license from the department, the NRC or an agreement state to 9 manufacture or service such devices; or shall dispose of the device pursuant to the provisions of 20.3.4.433 NMAC; 10 (b) shall assure that all labels affixed to the device at the time of receipt, and which 11 bear a statement which prohibits removal of the labels, are maintained thereof; and 12 (c) are exempt from the requirement of 20.3.4 NMAC and 20.3.10 NMAC except 13 that such persons shall comply with the provis ions of 20.3.4.433 NMAC, 20.3.4.451 NMAC and 20.3.4.452 NMAC.
14 (3) This general license does not authorize the manufacture, assembly, disassembly, repair or 15 import of strontium-90 in ice detection devices.
16 H. General license for certain items and self -luminous products containing radium-226.
17 (1) A general license is hereby issued to any person to acquire, receive, possess, use or 18 transfer, in accordance with the provisions of Paragraphs (2), (3) and (4) of this subsection, radium -226 contained in 19 the following products manufactured prior to November 30, 2007.
20 (a) Antiquities originally intended for use by the general public. For the purposes 21 of this paragraph, antiquities mean products originally intended for use by the general public and distributed in the 22 late 19th and early 20th centuries, such as radium emanator jars, revigators, radium water jars, radon generators, 23 refrigerator cards, radium bath salts and healing pads.
24 (b) Intact timepieces containing greater than 0.037 megabecquerel (1 micro curie),
25 non-intact timepieces, and timepiece hands and dials no longer installed in timepieces.
26 (c) Luminous items installed in air, marine or land vehicles.
27 (d) All other luminous products, provided that no more than 100 items are used or 28 stored at the same location at any one time.
29 (e) Small radium sources containing no more than 1 microcurie (0.037 30 megabecquerel) of radium-226. For the purposes of this paragraph, small radium sources means discrete survey 31 instrument check sources, sources contained in radiation measuring instruments, sources used in educational 32 demonstrations (such as cloud chambers and spinthariscopes), electron tubes, lightning rods, ionization sources, 33 static eliminators or as designated by the department or NRC.
34 (2) Persons who acquire, receive, possess, use or transfer byproduct material under the 35 general license issued in Paragraph (1) of this subsection are exempt from the provisions of 20.3.3.325 NMAC, 36 20.3.3.326 NMAC, 20.3.4 NMAC and 20.3.10 NMAC to the extent that the receipt, possession, use or transfer of 37 radioactive material is within the terms of the general license; provided, however, that this exemption shall not be 38 deemed to apply to any such person specifically licensed under this chapter.
39 (3) Any person who acquires, receives, possesses, uses or transfers radioactive material in 40 accordance with the general license in Paragraph (1) of this section shall:
41 (a) notify the department should there be any indication of possible damage to the 42 product so that i t appears it could result in a loss of the radioactive material. A report containing a brief description 43 of the event, and the remedial action taken, must be furnished to the department at the address specified in 44 20.3.1.116 NMAC within 30 days of the eve nt; 45 (b) not abandon products containing radium -226; the product, and any radioactive 46 material from the product, may only be disposed of according to 20.3.4.437 NMAC or by transfer to a person 47 authorized by a specific license to receive the radium -226 in the product or as otherwise approved by the 48 department; 49 (c) not export products containing radium -226 except in accordance with 10 CFR 50 110; 51 (d) dispose of products containing radium -226 at a disposal facility authorized to 52 dispose of radioactive mat erial in accordance with any federal or state solid or hazardous waste law, including the 53 Solid Waste Disposal Act, as authorized under the Energy Policy Act, by transfer to a person authorized to receive 54 radium-226 by a specific license issued under this part, or equivalent regulations of the NRC, an agreement state or 55 as otherwise approved by the department or NRC; 56 (e) respond to written requests from the department to provide information relating
20.3.3 NMAC 16 1 to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the 2 general licensee cannot provide the requested information within the allotted time, it shall, within that same time 3 period, request a longer period to supply the information by providing t he department a written justification for the 4 request.
5 (4) The general license in Paragraph (1) of this section does not authorize the manufacture, 6 assembly, disassembly, repair or import of products containing radium -226, except when timepieces may be 7 disassembled and repaired.
8 I. General license to own radioactive material. A general license is hereby issued to receive title 9 to and own radioactive material without regard to quantity. Notwithstanding any other provision of this chapter, a 10 general licensee under this subsection is not authorized to acquire, deliver, manufacture, produce, transfer, receive, 11 possess, use, import or export radioactive material, except as authorized in a specific license.
12 [20.3.3.305 NMAC - Rp, 20.3.3.305 NMAC, 04/30/2009; A, 8/10/2021 ]
13 14 20.3.3.306 TRANSPORTATION OF RADIOACTIVE MATERIAL:
15 A. Except as specified in Subsection D of this section, the regulations of the United States NRC set 16 forth in 10 CFR 71 are hereby incorporated by reference.
17 B. Shipment and transport of radioactive material shall be in accordance with the provisions of 18 Subsection A of this section.
19 C. The following modifications are made to the incorporated federal regulations in this section:
20 (1) commission means the NRC except a specified in subsection (4) below; 21 (2) act means the Radiation Protection Act, Sections 74-3-1 through 74-3-16 NMSA 1978; 22 and 23 (3) byproduct material means radioactive material as defined in 20.3.1.7 NMAC.
24 (4) all reference in 10 CFR 71 to commission are changed to department as follows:
25 71.17(a), 71.17(b), 71.21, 71.91(b), 71.91(c), 71.91(d), 71.101(c)(1), 71.106(a), 71.106(a)(1), 71.106(b) and 26 71.106(b)(1).
27 (5) all reference in 10 CRF 71 to certificate holder, applicant and applicant for a 28 certificate of compliance (COC) apply to the NRC as follows 71.91(c), 71.91(d), 71.101(a), 71.101(b), 71.103(a) 29 and 71.135.
30 D. The following provisions contained in 10 CFR 71 are applicable to the NRC and not incorporated 31 in this section: 71.11, 71.14(b), 71.19, 71.31, 71.33, 71.35, 71.37, 71.38, 71.39, 71.41, 71.43, 71.45, 71.51, 71.55, 32 71.59, 71.61, 71.63, 71.64, 71.65, 71.70,71.71, 71.73, 71.74, 71.75, 71.77, 71.85(a) -(c), 71.91(b),71.101(c)(2), (d),
33 and (e), 71.107, 71.109, 71.111, 71.113, 71.115, 71.117, 71.119, 71.121, 71.123, and 71.125.
34 [20.3.3.306 NMAC - Rp, 20.3.3.306 NMAC & 20.3.3.325 NMAC, 04/30/2009; A, 6/30/2011; A, 8/1 0/2021]
35 36 20.3.3.307 FILING APPLICATION FOR SPECIFIC LICENSES:
37 A. Except where otherwise determined by the department, applicati ons for specific licenses shall be 38 filed in duplicate on a form prescribed by the department ( application for a radioactive material license) in 39 accordance with the instructions to the form. Additional copies of the application may be required by the 40 department. Information contained in previous application, statements or reports filed with the department may be 41 incorporated by reference, provided that the reference is clear and specific.
42 B. The department may at any time after the filing of the original application, and before the 43 expiration of the license, require further statements in order to enable the department to determine whether the 44 application shall be granted or denied or whether a license shall be modified or revoked.
45 C. Each application shall be signed by the applicant or licensee or a person duly authorized to act for 46 and on their behalf.
47 D. An application for a license may include a request for a license authorizing more than one activity, 48 provided that the application specifies the additional activities for which licenses are requested and complies with 49 the requirements in this chapter as to applications for such licenses. In such cases, annual fees for all types of 50 activities authorized by the license may be charged as determined by 20.3.1 6 NMAC.
51 E. An application for a specific license of category 1 and category 2 quantities of radioactive material 52 shall comply with 10 CFR 37. The licensee shall comply with 10 CFR 37 except as follows:
53 (1) any reference to the commission or NRC shall be deemed a reference to the department; 54 (2) 10 CFR 37.5 definitions of agreement state, byproduct material, commission and person 55 shall not be applicable; 56 (3) 10 CFR 37.7, 10 CFR 37.9, 10 CFR 37.11(a) and (b), 10 CFR 37.13, 10 CFR 37.27(c),
20.3.3 NMAC 17 1 10 CFR 37.105, and 10 CFR 37.107 shall not be applicable; and 2 (4) the license required report of events or notification in 10 CFR 37.45, 10 CFR 37.57, 10 3 CFR 71, 10 CFR 37.77(a) through (d), and 10 CFR 37.81 shall use the following address when applicable: New 4 Mexico Environment Department/RCB, P.O. Box 5469, Santa Fe, NM 87502-5469.
5 F. An application for a specific license to use radioactive material in the form of a sealed source or in 6 a device that contains the sealed source must identify the source and (or) the device by manufacturer name and 7 model number as registered with the sealed source and device registry.
8 (1) Except as provided in Paragraph (2), (3) and (4) of this Subsection, an application for a 9 specific license to use byproduct material in the fo rm of a sealed source or in a device that contains the sealed source 10 must either:
11 (a) identify the source or device by manufacturer and model number registered with 12 the NRC pursuant to 10 CFR 32.210, with an agreement state, or for a source or a device containing radium -226 or 13 accelerator-produced radioactive material with a state under provisions comparable to 10 CFR 32.210; or 14 (b) contain the information identified in 10 CFR 32.210(c).
15 (2) For sources or devices manufactured before October 23, 201 2 that are not registered with 16 the NRC under 10 CFR 32.210 or with an agreement state, and for which the applicant is unable to provide all 17 categories of information specified in 10 CFR 32.210(c), the application must include:
18 (a) all available information identified in 10 CFR 32.210(c) concerning the source, 19 and, if applicable, the device; and 20 (b) sufficient additional information to demonstrate that there is reasonable 21 assurance that the radiation safety properties of the source or device are adequate to protect health and minimize 22 danger to life and property. Such information must include a description of the source or device, a description of 23 radiation safety features, the intended use and associated operating experience, and the results of a recent leak test.
24 (3) For sealed sources and devices allowed to be distributed without registration of safety 25 information in accordance with 10 CFR 32.210(g)(1), the applicant may supply only the manufacturer, model 26 number, and radionuclide and quantity.
27 (4) If it is not feasible to identify each sealed source and device individually, the applicant 28 may propose constraints on the number and type of sealed sources and devices to be used and the conditions under 29 which they will be used, in lieu of identif ying each sealed source and device.
30 G. As provided by 20.3.3.311 NMAC, certain applications for a new or renewal specific license must 31 contain a proposed decommissioning funding plan or a certification of financial assurance for decommissioning.
32 H. An application for a license to receive and possess radioactive material for the conduct of any 33 activity which the department has determined pursuant to Subpart A of 10 CFR 51 will significantly affect the 34 quality of the environment shall be filed at least nine months prior to commencement of construction of the plant or 35 facility in which the activity will be conducted and shall be accompanied by an environmental impact report 36 required pursuant to Subpart A of 10 CFR 51.
37 I. None of the following applications shall be accepted for review unless it is accompanied by an 38 environmental impact report, submitted by the applicant, that specifically addresses the short -term and long-term 39 environmental, radiological and public health and safety aspects of the applications and alternatives to the proposed 40 action:
41 (1) an initial application for a radioactive material license for a commercial radioactive waste 42 disposal site license; 43 (2) the first renewal of any such license not previously accompanied by an environmental 44 impact report; 45 (3) an application for an amendment to an existing license that may result in additional 46 significant impacts from radiation on the environment or public health or safety beyond those impacts addressed in 47 the existing license and accompanyin g documents; and 48 (4) any other application that the secretary determines may have significant impacts from 49 radiation on the environment or public health or safety.
50 J. The application for a radioactive material license for a commercial radioactive waste disposal site, 51 or for any renewal thereof, or for an amendment thereto as described in Paragraph (3) of Subsection H of this 52 section, shall demonstrate that the activity for which such license is requested will comply with all laws and 53 regulations enforcea ble by the department.
54 K. An application from a medical facility or educational institution to produce PET radioactive drugs 55 for noncommercial transfer to licensees in its consortium authorized for medical use under 20.3.7 NMAC shall 56 include:
20.3.3 NMAC 18 1 (1) a request for authorization for the production of PET radionuclides or evidence of an 2 existing license issued under 20.3.3 NMAC or under equivalent NRC or agreement state requirements for a PET 3 radionuclide production facility within its consortium from which it receives PET radionuclides; 4 (2) evidence that the applicant is qualified to produce radioactive drugs for medical use by 5 meeting one of the criteria in Subparagraph (b) of Paragraph (1) of Subsection J of 20.3.3.315 NMAC; 6 (3) identification of individual(s) authorized to prepare the PET radioactive drugs if the 7 applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear 8 pharmacist as specified in Subparagraph (b) of Paragraph (2) of Subsection J of 20.3.3.315 NMAC; and 9 (4) information identified in Subparagraph (c) of Paragraph (1) of Subsection J of 20.3.3.315 10 NMAC on the PET drugs to be non-commercially transferred to members of its consortium.
11 L. An application for a specific license to transfer source material under this section.
12 (1) An application for a specific license to initially transfer source material for use under 13 20.3.3.307 NMAC, will be approved if:
14 (a) the applicant satisfies the general requirements specified in this section; and 15 (b) the applicant submits adequate information on, and the department approves the 16 methods to be used for quality control, labeling, and providing safety instructions to recipients.
17 (2) Each person licensed under this section shall label the immediate container of each 18 quantity of source material with the type of source material and quantity of material and the words, radioactive 19 material.
20 (3) Each person licensed under this section shall ensure that the quantities and concentrations 21 of source material are as labeled and indicated in any transfer records.
22 (4) Each person licensed under this section shall provide the information specified in this 23 paragraph to each person to whom source material is transferred for use under this section. This information must 24 be transferred before the source material is transferred for the first time in each calendar year to the particular 25 recipient. The required information includes:
26 (a) a copy of Subsection B of 20.3.3.304.B NMAC and 10 CFR 40.51 or equivalent 27 regulations under Subsection L of 20.3.3.307 NMAC; and 28 (b) appropriate radiation safety precautions and instructions relating to handling, 29 use, storage, and disposal of the material.
30 (5) Each person licensed under this s ection shall report transfers as follows:
31 (a) File a report with the department under 20.3.1.116 NMAC. The report shall 32 include the following information:
33 (i) The name, address, and license number of the person who transferred 34 the source material; and 35 (ii) For each general licensee under 10 CFR 40.22 or 20.3.3.304 NMAC to 36 whom greater than 50 grams (0.11 lb) of source material has been transferred in a single calendar quarter, the name 37 and address of the general licensee to whom source material is distributed; a responsible agent, by name and/or 38 position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and 39 quantity of source material transferred; and 40 (iii) The total quantity of eac h type and physical form of source material 41 transferred in the reporting period to all such generally licensed recipients.
42 (b) File a report with each responsible agreement state agency that identifies all 43 persons, operating under the provisions equival ent to 10 CFR 40.22, to whom greater than 50 grams (0.11 lb) of 44 source material has been transferred within a single calendar quarter. The report shall include the following 45 information specific to those transfers made to the agreement state:
46 (i) The name, address, and license number of the person who transferred 47 the source material; 48 (ii) The name and address of the general licensee to whom source material 49 was distributed; a responsible agent, by name and/or position and phone number, of the genera l licensee to whom 50 the material was sent; and the type, physical form, and quantity of source material transferred; and 51 (iii) The total quantity of each type and physical form of source material 52 transferred in the reporting period to all such generally licensed recipients within the Agreement State.
53 (c) Submit each report by January 31 of each year covering all transfers for the 54 previous calendar year. If no transfers were made to persons generally licensed under 10 CFR 40.22 or equivalent 55 agreement state provisions during the current period, a report shall be submitted to the NRC indicating so. If no 56 transfers have been made to general licensees in a particular agreement state during the reporting period, this
20.3.3 NMAC 19 1 information shall be reported to the res ponsible agreement state agency upon request of the agency.
2 (d) Each person licensed under 20.3.3.304 NMAC shall maintain all information 3 that supports the reports required by this section concerning each transfer to a general licensee for a period of o ne 4 year after the event is included in a report to the NRC or to an agreement state agency.
5 [20.3.3.307 NMAC - Rp, 20.3.3.307 NMAC, 04/30/2009; A, 8/1 0/2021]
6 7 20.3.3.308 GENERAL REQUIREMENTS FOR THE ISSUANCE OF SPECIFIC LICENSES:
8 A. An application for a s pecific license shall be approved if all of the following requirements are met.
9 (1) The application is for a purpose authorized by the act.
10 (2) The applicant is qualified by training and experience to use the material for the purpose 11 requested in accordance with the provisions in this chapter and in such a manner as to minimize the danger to public 12 health and safety or property.
13 (3) The applicant's proposed equipment, facilities and procedures are adequate to minimize 14 danger to public health and safet y or property.
15 (4) The applicant satisfies the requirements in this section, and any special requirements in 16 20.3.3.307 NMAC and 20.3.3.309 NMAC, 20.3.3.313 NMAC, 20.3.3.314 NMAC or 20.3.3.315 NMAC.
17 B. Upon a determination that an application meets the requirements of the act and the 20.3 NMAC, 18 the department will issue a specific license authorizing the possession and use of radioactive material.
19 C. The secretary may deny an application if an applicant:
20 (1) fails to demonstrate that the requirements of the act and 20.3 NMAC have been 21 addressed; 22 (2) fails to meet the requirements for completeness and accuracy of information in 23 20.3.1.123 NMAC; 24 (3) has demonstrated deliberate misconduct as described in 20.3.1.122 NMAC; and 25 (4) fails to respond to a request for additional information within 30 days from the date of the 26 request, or within such other time as may be specified in the request for information.
27 [20.3.3.308 NMAC - Rp, 20.3.3.308 NMAC, 4/30/2009; A, 6/13/2017]
28 20.3.3.309 REQUIREMENTS FOR EMERGENCY RESPONSE PLANS FOR CERTAIN 29 LICENSEES:
30 A. Each application to possess radioactive materials in unsealed forms, on foils or plated sources, or 31 sealed in glass in excess of the quantities in 20.3.3.333 NMAC (Schedule E - Quantities of Radioactive Materials 32 Requiring Consideration of the Need for an Emergency Plan for Responding to a Release), must contain either:
33 (1) an evaluation showing that the maximum dose to a person offsite due to a release of 34 radioactive materials would not exceed 1 rem effective dose equivalent or 5 rems (50 millisieverts) to the thyroid; or 35 (2) an emergency plan for responding to a release of radioactive material.
36 B. One or more of the following factors may be used to support an evaluation submitted under 37 Paragraph (1) of Subsection A of this section:
38 (1) the radioactive material is physically separated so that only a portion could be involved in 39 an accident; 40 (2) all or part of the radioactive material is not subject to release during an accident because 41 of the way it is stored or packaged; 42 (3) the release fraction in the respirable size range would be lower than the release fraction 43 shown in 20.3.3.333 NMAC of this part due to the chemical or physical form of the material; 44 (4) the solubility of the radioactive material would reduce the dose received; 45 (5) facility design or engineered safety features in the facility would cause the release 46 fraction to be lower than shown in 20.3.3.333 NMAC; 47 (6) other factors appropriate for the specific facility; or 48 (7) operating restrictions or procedures would prevent a release fraction as large as that 49 shown in 20.3.3.333 NMAC.
50 C. An emergency plan for responding to a release of radioactive material submitted under Paragraph 51 (2) of Subsection A of this section must include the following information.
52 (1) Facility description: a brief description of the licensee's facility and area near the site.
53 (2) Types of accidents: an identification of each type of radioactive materials accident for 54 which protective actions may be needed.
55 (3) Classification of accidents: a system for classifying each accident as alert or site 56 area emergencies.
20.3.3 NMAC 20 1 (4) Detection of accidents: identification of the means of detecting each type of accident in 2 a timely manner.
3 (5) Mitigation of consequences: a brief description of the means and equipment for 4 mitigating the consequences of each type of accident, including those provided to protect workers onsite, and a 5 description of the program for maintaining the equipment.
6 (6) Assessment of releases: a brief description of the methods and equipment to assess 7 releases of radioactive materials.
8 (7) Responsibilities: a brief description of the responsibilities of licensee personnel should 9 an accident occur, including identification of personnel responsible for promptly notifying offsite response 10 organizations and the secretary; also responsibilities for developing, maintaining, and updating the plan.
11 (8) Notification and coordination: a commitment to and a brie f description of the means to 12 promptly notify offsite response organizations and request offsite assistance, including medical assistance for the 13 treatment of contaminated injured onsite workers when appropriate. A control point must be established. The 14 notification and coordination must be planned so that unavailability of some personnel, parts of the facility, and 15 some equipment will not prevent the notification and coordination. The licensee shall also commit to notify the 16 secretary immediately and en sure notification of other appropriate offsite response organizations and not later than 17 one hour after the licensee declares an emergency.
18 (9) Information to be communicated: a brief description of the types of information 19 regarding facility status, radioactive releases and, if necessary, recommended protective actions.
20 (10) Training: a brief description of the frequency, performance objectives and plans for the 21 training that the licensee will provide workers on how to respond to an emergency including any special instructions 22 and orientation tours the licensee would offer to fire, police, medical and other emergency personnel. The training 23 shall familiarize personnel with site-specific emergency procedures. Also, the training shall thoroughly prepare site 24 personnel for their responsibilities in the event of accident scenarios postulated as most probable for the specific site, 25 including the use of team training for such scenarios.
26 (11) Safe shutdown: a brief description of the mea ns of restoring the facility to a safe 27 condition after an accident.
28 (12) Exercises: provisions for conducting quarterly communications checks with offsite 29 response organizations and biennial onsite exercises to test response to simulated emergencies. Q uarterly 30 communications checks with offsite response organizations must include the check and update of all necessary 31 telephone numbers. The licensee shall invite offsite response organizations to participate in the biennial exercises.
32 Participation of offsite response organizations in biennial exercises, although recommended, is not required.
33 Exercises must use accident scenarios postulated as most probable for the specific site and the scenarios shall not be 34 known to most exercise participants. The licensee shall critique each exercise using individuals not having direct 35 implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, 36 emergency procedures, facilities, equipment and training of personnel and overall effectiveness of the response.
37 Deficiencies found by the critiques must be corrected.
38 (13) Hazardous chemicals: a certification that the applicant has met its responsibilities under 39 the Emergency Planning and Community Right -to-Know Act (title III, pub. l. 99 -499), if applicable to the 40 applicant's activities at the proposed place of use of the radioactive material.
41 D. The licensee shall allow the offsite response organizations expected to respond in case of an 42 accident 60 days to comment on the licensee's emergency plan before submitting it in final form to the department.
43 The licensee shall provide any comments received within the 60 days to the department with the emergency plan.
44 [20.3.3.309 NMAC - Rp, 20.3.3.309 NMAC, 4/30/2009]
45 46 20.3.3.310 PUBLIC NOTICE, PARTICIPATION AND HEARING:
47 A. Within 60 days following:
48 (1) initial receipt of a new license application, or each additional submission of information 49 by the applicant, the secretary will either accept the application for a new license for a review and give notice 50 pursuant to Subsection B of this section, or notify the applicant in writing of any deficiencies in the application that 51 must be corrected in order for the application to be accepted for review; 52 (2) a license amendment or license renewal application requesting a change of the location 53 where radioactive material will be stored or used, the secretary will issue notices pursuant to Subsection B of this 54 section; 55 (3) a license amendment or license renewal applicat ion requesting a change of principal 56 activity, the secretary will issue notices pursuant to Subsection B of this section.
20.3.3 NMAC 21 1 B. Notices. The secretary shall give a notice of acceptance of a new application, license amendment 2 or renewal license application described in Subsection A of this section:
3 (1) to the applicant, by certified mail; and 4 (2) to the public, by the publication of a notice in at least one newspaper of general 5 circulation in the area of the proposed activity in the license application, and in other newspapers as deemed 6 appropriate by the secretary; 7 (3) the secretary shall make a good faith effort to notify of acceptance of a new application, 8 license amendment or renewal license application described in of Subsection A of this section by first-class mail:
9 (a) any local, state, Indian Tribal government or federal government agency that the 10 secretary determines may be significantly affected or interested; and 11 (b) any other person who, prior to such notice, has requested in writing such notices.
12 C. The notice specified in Paragraph (2) of Subsection B of this section shall include:
13 (1) the name and address of the applicant; 14 (2) the location of the proposed activity; 15 (3) a brief description of the procedures to be followed by the secretary in making a final 16 determination; 17 (4) a brief description of the proposed activity; 18 (5) the time within which written comments and requests for public hearings will be 19 accepted; and 20 (6) the means by which interested persons may obtain further information; 21 (7) the following sample notice satisfies the requirements of this section:
22 23 PUBLIC NOTICE 24 The New Mexico Environment Department (the Department) has received an application for a Radioactive Material 25 License from__________ __________________________________________(company name and address) for 26 ___________________________(proposed activity) to be located at ____________________________(location).
27 During the early part of the evaluation period, the Department will review and comment upon the application. The 28 NMED may, at its discretion, retain consultants to assist it in its evaluation of the application. Relevant comments 29 and questions received by the NMED from various agencies and interested parties will be forwarded to the applicant 30 for its response. Correspondence associated with the application will be on file with the Radiation Control Bureau 31 and will be available for inspection by the applicant and any other interested parties.
32 The Department has required the applican t to provide complete plans and other materials addressing, among other 33 things, the public health, safety and environmental aspects of the proposed activity.
34 The Department will analyze the license application carefully. During this analysis, the application will be reviewed 35 to ensure that there are no deficiencies, that the application meets all applicable requirements and that there is no 36 reason to believe that the operation will violate any laws or regulations. If the Department is so satisfied, it will 37 issue a Radioactive Material License, to expire in five years.
38 The activities of all licensees are inspected periodically to assure compliance with regulations and license 39 conditions.
40 The application is available for review at NMEDs offices of the Radiation Control Bureau in Santa Fe, New 41 Mexico.
42 It is anticipated that the review period will require about _________ months. Written comments and requests for 43 public hearing will be accepted for _________ days after publication of this notice.
44 Written comments regarding this license application should be directed to Radiation Control Bureau, En vironment 45 Department, P.O. Box 5469, Santa Fe, New Mexico 87502-5469.
46 D. The department shall maintain all licensees administrative record, which shall be available for 47 public inspection at the department office in Santa Fe.
48 E. Public comment period.
49 (1) Following the notice pursuant to Subsections B and C of this section and prior to ruling 50 on any new application, or amendment request or renewal license application of the type described in Subsection A 51 of this section, the secretary shall allow for a period of at least 30 days during which written comments or questions 52 about the license application may be submitted by any interested person. If the secret ary determines that the 53 questions are relevant to the requirements in 20.3.3.307 NMAC, 20.3.3.308 NMAC and any specific requirements 54 for the type of license requested, the secretary shall require the applicant to answer them.
55 (2) Following the notice of acceptance of the license application pursuant to Subsections A 56 through C of this section and prior to ruling on any application required to be accompanied by an environmental
20.3.3 NMAC 22 1 report pursuant to Subsection H of 20.3.3.307 NMAC, the secretary shall allow a period of at least 60 days during 2 which written comments or questions may be submitted by any interested person. If the secretary determines that 3 the questions are relevant to the considerations enumerated in Subsection H of 20.3.3.307 NMAC or 20.3.3.308 4 NMAC, the secretary shall require the applicant to answer them.
5 The secretary may allow an additional written comment period upon submission of additional information to the 6 license application, amendment request or renewal license application described by Subsection A of this section by 7 the applicant, or upon request by members of the public. A written request for a hearing may be made by the 8 members of the public within the time period specified in the public notice described in Subsection C of this sect ion.
9 F. If the secretary determines that there is significant public interest, or that there is a need to resolve 10 issues not resolvable in writing, the secretary shall order a public hearing be held to provide guidance on any issue 11 relevant to the license proceeding. Notice of the public hearing shall be given at least 30 days prior to the hearing to 12 the persons and in the manner specified in Subsection C of 20.1.4.200 NMAC. Any such public hearing shall be 13 conducted pursuant to the hearing procedures in 20.1.4 NMAC.
14 [20.3.3.310 NMAC - Rp, 20.3.3.310 NMAC, 4/30/2009; A, 6/13/2017; A, 8/1 0/2021]
15 16 20.3.3.311 FINANCIAL ASSURANCE AND RECORD KEEPING FOR DECOMMISSIONING:
17 A. Decommissioning funding plan required.
18 (1) Each applicant for a specific license authorizing the possession and use of unsealed 19 radioactive material (except source material which is subject to Paragraph (3) of this subsection) of half -life greater 20 than 120 days in quantities exceeding 100,000 (1E+5) times the applicable quantit ies set forth in 20.3.3.338 NMAC, 21 shall submit a decommissioning funding plan as described in Subsection E of this section. The decommissioning 22 funding plan must also be submitted when a combination of radioisotopes is involved if R divided by 100,000 23 (1E+5) is greater than 1 (unity rule), where R is defined here as the sum of the ratios of the quantity of each 24 radioisotope to the applicable value in 20.3.3.338 NMAC.
25 (2) Each applicant for a specific license authorizing the possession and use of sealed s ources 26 or plated foils of half -life greater than 120 days and in quantities exceeding 10 12 (1E+12) times the applicable 27 quantities set forth in 20.3.3.338 NMAC (or when a combination of radioisotopes is involved if R, as defined in 28 Paragraph (1) of this subsection, divided by 10 12 is greater than 1), shall submit a decommissioning funding plan as 29 described in Subsection E of this section.
30 (3) Each applicant for a specific license authorizing the possession and use of more than 100 31 (1E+2) millicuries of source material in a readily dispersible form shall submit a decommissioning funding plan as 32 described in Subsection E of this section.
33 B. Each applicant for a specific license authorizing possession and use of radioactive material of half -
34 life greater than 120 days and in quantities specified in Subsection D of this section shall either:
35 (1) submit a decommissioning funding plan as described in Subsection E of this section; or 36 (2) submit a certification that financial assurance for decommissioning has been provided in 37 the amount prescribed by Subsection D of this section using one of the methods described in Subsection F of this 38 section; for an applicant, this certification may state that the appropriate assurance will be obtained after the 39 application has been approved and the license issued but prior to the receipt of licensed material; if the applicant 40 defers execution of the financial instrument until after the license has been issued, a signed original of the financial 41 instrument obtained to satisfy the requirements of Subsection F of this section must be submitted to the department 42 before receipt of licensed material; if the applicant does not defer execution of the financial instrument, the applicant 43 shall submit to the department, as part of the ce rtification, a signed original of the financial instrument obtained to 44 satisfy the requirements of Subsection F of this section.
45 C. Financial assurance for holders of specific license. Each holder of a specific license issued 46 before the effective date of these regulations which is of a type described in Subsection A or B of this section shall 47 provide financial assurance for decommissioning in accordance with the criteria set forth in this section.
48 (1) Each holder of a specific license issued before the effective date of these regulations, and 49 of a type described in Subsection A of this section shall submit a decommissioning funding plan as described in 50 Subsection E of this section.
51 (2) Each holder of a specific license issued before the effective date of these regulations, and 52 of a type described in Subsection B of this section shall submit a decommissioning funding plan as described in 53 Subsection E of this section, or a certification of financial assurance for decommissioning in accordance with the 54 criteria set forth in Subsection D of this section.
55 (3) Any licensee who has submitted an application before the effective date of these 56 regulations for renewal of license in accordance with 20.3.3.319 NMAC shall provide financial assurance for
20.3.3 NMAC 23 1 decommissioning in accordance with Subsections A and B of this section.
2 (4) Waste collectors and waste processors, as defined in 20.3.4.466 NMAC, must provide 3 financial assurance in an amount based on a decommissioning funding plan as described in Subsection E of this 4 section. The decommissioning funding plan must include the cost of disposal of the maximum amount (in curies) of 5 radioactive material permitted by license, and the cost of disposal of the maximum quantity, by volume, of 6 radioactive material which could be present at the licensee's facility at any time, in addition to the cost to remediate 7 the licensee's site to meet the license termination criteria of 20.3.4.426 NMAC.
8 D. Required amounts of financial assurance for decommissioning by quantity of material.
9 Licensees exceeding the upper bounds of this subsection must base financial assurance on a decommissioning 10 funding plan as described in Subsection E of this section.
11 (1) Greater than 10,000 (1E+4) but less than or equal to 100,000 (1E+5) times the ap plicable 12 quantities of 20.3.3.338 NMAC, in unsealed form. (For a combination of radioisotopes, if R as defined in 13 Subsection A of this section, divided by 10,000 (1E+4) is greater than 1 but R divided by 100,000 (1E+5) is less 14 than or equal to 1): at least equal to $1,125,000.
15 (2) Greater than 1,000 (1E+3) but less than or equal to 10,000 (1E+4) times the applicable 16 quantities of 20.3.3.338 NMAC, in unsealed form. (For a combination of radioisotopes, if R, as defined in 17 Subsection A of this section, di vided by 1,000 (1E+3) is greater than 1 but R divided by 10,000 (1E+4) is less than 18 or equal to 1): at least equal to $225,000.
19 (3) Greater than 1010 (1E+10) but less than or equal to 10 12 (1E+12) times the applicable 20 quantities of 20.3.3.338 NMAC, in s ealed sources or plated foils. (For a combination of radioisotopes, if R, as 21 defined in Subsection A of this section, divided by 10 10 is greater than 1, but R divided by 10 12 is less than or equal 22 to 1): at least equal to $113,000.
23 (4) For source material, greater than 10 millicuries but less than or equal to 100 millicuries:
24 at least equal to $225,000.
25 E. Decommissioning funding plan.
26 (1) Each decommissioning funding plan must be submitted for review and approval and must 27 contain a detailed cost estimate for decommissioning in an amount reflecting:
28 (a) the cost of an independent contractor to perform all decommissioning activities; 29 (b) the cost of meeting the 20.3.4.426.B NMAC criteria for unrestricted use, 30 provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of 20.3.4.426.C NMAC, 31 the cost estimate may be based on meeting the 20.3.4.426.C NMAC department approved criteria; 32 (c) the volume of onsite subsurface material containing residual radioactivity that 33 will require remediation to meet the criteria for license termination; 34 (d) an adequate contingency factor with identification of and justification for using 35 the key assumptions contained in the decommissioning cost estimate; 36 (e) a description of the method of assuring funds for decommissioning from 37 20.3.3.311.F NMAC including means for adjusting cost estimates and associated funding levels periodically over 38 the life of the facility; 39 (f) a certification by the licensee that financial assurance for decommissioning has 40 been provided in the amount of the cost estimate for decommissioning; and 41 (g) a signed original of the financial instrument obtained to satisfy the requirement 42 of Subsection F of this section (unless a previously submitted and accepted financial instrument continues to cover 43 the cost estimate for decommissioning).
44 (2) At the time of license renewal and at intervals not to exceed three years, the 45 decommissioning funding plan must be resubmitted with adjustments as necessary to account for changes in costs 46 and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be 47 done until the updated decommissioning funding plan is approved. The decommissioning funding plan m ust update 48 the information submitted with the original or prior approved plan, and must specifically consider the effect of the 49 following events on decommissioning costs:
50 (a) spills of radioactive material producing additional residual radioactivity in onsite 51 subsurface material; 52 (b) waste inventory increasing above the amount previously estimated; 53 (c) waste disposal costs increasing above the amount previously estimated; 54 (d) facility modifications; 55 (e) changes in authorized possession limits ;
56 (f) actual remediation costs that exceed the previous cost estimate;
20.3.3 NMAC 24 1 (g) onsite disposal; and 2 (h) use of a settling pond.
3 F. Methods of financial assurance. Financial assurance for decommissioning must be provided by 4 one or more of the followi ng methods.
5 (1) Prepayment. Prepayment is the deposit prior to the start of operation into an account 6 segregated from licensee assets and outside the licensee's administrative control of cash or liquid assets such that the 7 amount of funds would be suffi cient to pay decommissioning costs. Prepayment may be in the form of a trust, 8 escrow account, government fund, certificate of deposit or deposit of government securities.
9 (2) A surety method, insurance or other guarantee method. These methods guarantee 10 that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit or 11 line of credit. A parent company guarantee of funds for decommissioning costs based on a financial test may be 12 used if the guarantee and te st are as contained in 20.3.3.334 NMAC. A parent company guarantee may not be used 13 in combination with other financial methods to satisfy the requirements of this section. For commercial corporations 14 that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial 15 test may be used if the guarantee and test are as contained in 20.3.3.335 NMAC. For commercial companies that do 16 not issue bonds, a guarantee of funds by the applicant or licensee for decommissi oning costs may be used if the 17 guarantee and test are as contained in 20.3.3.336 NMAC. For nonprofit entities, such as colleges, universities and 18 nonprofit hospitals, a guarantee of funds by the applicant or licensee may be used if the guarantee and test are as 19 contained in 20.3.3.337 NMAC. A guarantee by the applicant or licensee may not be used in combination with any 20 other financial methods to satisfy the requirements of this section or in any situation where the applicant or licensee 21 has a parent company holding majority control of the voting stock of the company. Any surety method or insurance 22 used to provide financial assurance for decommissioning must contain the following conditions.
23 (a) The surety method or insurance must be open-ended or, if written for a specified 24 term, such as five years, must be renewed automatically unless 90 days or more prior to the renewal date, the issuer 25 notifies the department, the beneficiary, and the licensee of its intention not to renew. The surety method or 26 insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration 27 without proof of forfeiture if the licensee fails to provide a replacement acceptable to the department within 30 da ys 28 after receipt of notification of cancellation.
29 (b) The surety method or insurance must be payable to a trust established for 30 decommissioning costs. The trustee and trust must be acceptable to the department. An acceptable trustee includes 31 an appropriate state or federal government agency or an entity which has the authority to act as a trustee and whose 32 trust operations are regulated and examined by a federal or state agency.
33 (c) The surety method or insurance must remain in effect until the depa rtment has 34 terminated the license.
35 (3) An external sinking fund in which deposits are made at least annually, coupled with 36 a surety method or insurance, the value of which may decrease by the amount being accumulated in the 37 sinking fund. An external sin king fund is a fund established and maintained by setting aside funds periodically in 38 an account segregated from licensee assets and outside the licensee's administrative control in which the total 39 amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected.
40 An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or 41 deposit of government securities. The surety or insurance provisions must be as s tated in Paragraph (2) of this 42 subsection.
43 (4) In the case of federal, state or local government licensees, a statement of intent containing 44 a cost estimate for decommissioning or an amount based on Subsection D of this section, and indicating that funds 45 for decommissioning will be obtained when necessary.
46 (5) When a governmental entity is assuming c ustody and ownership of a site, an arrangement 47 that is deemed acceptable by such governmental entity.
48 G. Record keeping requirements. Each person licensed under this part or Parts 5, 7, 12, 13 and 15 49 of this chapter shall keep records of information important to the decommissioning of the facility in an identified 50 location until the site is released for unrestricted use. Before licensed activities are tran sferred or assigned in 51 accordance with 20.3.3.317 NMAC, licensees shall transfer all records described in this paragraph to the new 52 licensee. In this case, the new licensee will be responsible for maintaining these records until the license is 53 terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these 54 records and their locations may be used. Information the department considers important to decommissioning 55 consists of:
56 (1) records of spills or other unusual occurrences involving the spread of contamination in
20.3.3 NMAC 25 1 and around the facility, equipment or site; these records may be limited to instances when contamination remains 2 after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to 3 inaccessible areas as in the case of possible seepage into porous materials such as concrete; these records must 4 include any known information on identification of involved nuclides, quantities, forms and concentrations; 5 (2) as-built drawings and modifications of structures and equipment in restricted areas where 6 radioactive materials are used or stored, and of locations of possible inaccessible contamination such as buried pipes 7 which may be subject to contamination; if requi red drawings are referenced, each relevant document need not be 8 indexed individually; if drawings are not available, the licensee shall substitute appropriate records of available 9 information concerning these areas and locations; 10 (3) except for areas containing only sealed sources (provided the sources have not leaked or 11 no contamination remains after any leak) or radioactive materials having only half -lives of less than 65 days, a list 12 contained in a single document and updated every two years, of the following:
13 (a) all areas designated and formerly designated restricted areas as defined in 14 20.3.4.7 NMAC; 15 (b) all areas outside of restricted areas that require documentation under Paragraph 16 (1) of this subsection; 17 (c) all areas outside of restricted areas where current and previous wastes have been 18 buried as documented under 20.3.4.448 NMAC; and 19 (d) all areas outside of restricted areas that contain material such that, if the license 20 expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in 21 20.3.4.426 NMAC, or apply for approval for disposal under 20.3.4.434 NMAC; and 22 (4) records of the cost estimate performed for the decommissioning funding plan or of the 23 amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding 24 plan or certification is used.
25 [20.3.3.311 NMAC - Rp, 20.3.3.311 NMAC, 4/30/2009; A, 6/13/2017]
26 27 20.3.3.312 [RESERVED]
28 29 20.3.3.313 SPECIAL REQUIREMENTS FOR ISSUANCE OF CERTAIN SPECIFIC LICENSES FOR 30 RADIOACTIVE MATERIAL:
31 A. Industrial radiographic operations. In addition to the requirements set forth in 20.3.3.307 32 NMAC and 20.3.3.308 NMAC, a specific license for use of sealed sources in industrial radiography will be issued if 33 the applicant or licensee meets the specific requirements in 20.3.5 NMAC.
34 B. Medical use of radioactive materials. In addition to the requirements set forth in 20.3.3.307 35 NMAC and 20.3.3.308 NMAC, a specific license for use of sealed sources and unsealed radioactive materials for 36 medical use will be issued if the applicant or licensee meets the specific requirements in 20.3.7 NMAC.
37 C. Well logging operations and subsurface tracer studies. In addition to the requirements set forth 38 in 20.3.3.307 NMAC and 20.3.3.308 NMAC, a specific license for use of sealed sources in wireline service 39 operations, including mineral -logging, radioactive markers or subsurface tracer studies will be issued if the applicant 40 or licensee meets the specific req uirements in 20.3.12 NMAC.
41 D. Land disposal of radioactive waste. In addition to the requirements set forth in 20.3.3.308 42 NMAC, a specific license for any method of land disposal of low -level radioactive waste will be issued if the 43 applicant or licensee meets the specific requirements in 20.3.13 NMAC.
44 E. Naturally occurring radioactive materials in the oil and gas industry. In addition to the 45 requirements set forth in 20.3.3.308 NMAC, a specific license for use of naturally occurring radioactive materia ls 46 (NORM) in the gas and oil industry will be issued if the applicant or licensee meets the specific requirements in 47 20.3.14 NMAC.
48 F. Irradiators. In addition to the requirements set forth in 20.3.3.307 NMAC and 20.3.3.308 49 NMAC, a specific license for use of sealed sources in irradiators will be issued if the applicant or licensee meets the 50 specific requirements in 20.3.15 NMAC.
51 [20.3.3.313 NMAC - Rp, 20.3.3.313 NMAC, 4/30/2009; A, 6/13/2017]
52 53 20.3.3.314 SPECIAL REQUIREMENTS FOR SPECIFIC LICENSES OF BROAD SCOPE: This 54 section prescribes requirements for the issuance of specific licenses of broad scope for radioactive material (broad 55 licenses) and certain regulations governing holders of such licenses.
56 A. Types of specific licenses of broad scope.
20.3.3 NMAC 26 1 (1) A type A specific license of broad scope is a specific license authorizing receipt, 2 acquisition, ownership, possession, use and transfer of any chemical or physical form of the radioactive material 3 specified in the license, but not exceeding quantities s pecified in the license, for purposes authorized by the act. The 4 quantities specified are usually in the multicurie range.
5 (2) A type B specific license of broad scope is a specific license authorizing receipt, 6 acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material 7 specified in 20.3.3.332 NMAC, for purposes authorized by the act. The possession limit for a type B broad license, 8 if only one radionuclide is possessed thereunder, is the quantity spec ified for that radionuclide in c olumn I of 9 20.3.3.332 NMAC. If two or more radionuclides are possessed thereunder, the possession limit for each is 10 determined as follows: for each radionuclide determine the ratio of the quantity possessed to the applicable quantity 11 specified in c olumn I of 20.3.3.332 NMAC, for that radionuclide. The sum of the ratios for all radionuclides 12 possessed under the license shall not exceed unity.
13 (3) A type C specific license of broad scope is a specific license authorizing receipt, 14 acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material 15 specified in 20.3.3.332 NMAC, for any purposes authorized by the act. The possession limit for a type C broad 16 license, if only one radi onuclide is possessed thereunder, is the quantity specified for that radionuclide in c olumn II 17 of 20.3.3.332 NMAC. If two or more radionuclides are possessed thereunder, the possession limit is determined for 18 each as follows:
19 (a) for each radionuclide determine the ratio of the quantity possessed to the 20 applicable quantity specified in Column II of 20.3.3. 332 NMAC, for the radionuclide; and 21 (b) the sum of the ratios for all radionuclides possessed under the license shall not 22 exceed unity.
23 B. Requirements for the issuance of a type A specific license of broad scope. An application for a 24 type A specific license of broad scope will be approved if the following requirements are met.
25 (1) The applicant satisfies the general requirements specified in 20.3.3.307 NMAC and 26 20.3.3.308 NMAC.
27 (2) The applicant has engaged in a reasonable number of activities involving the use of 28 radioactive materials.
29 (3) The applicant has established administrative controls and provisions relating to 30 organization and management, procedures, record keeping, material control, material accounting and management 31 review that are necessary to assure safe operations, including:
32 (a) the establishment of a radiation safety committee composed of such persons as a 33 radiation safety officer, a representative of management, and persons trained and experienced in the safe use of 34 radioactive material; 35 (b) the appointment of a radiation safety officer who is qualified by training and 36 experience in radiation protection and who is available for advice and assistance on radiation safety matters; and 37 (c) the establishment of appropriate administrative procedures to assure:
38 (i) control of procurement and use of radioactive material; 39 (ii) completion of safety evaluations of proposed uses of radioactive 40 material which take into consideration such matters as the adequacy of facilities and equipment, training and 41 experience of the user and the operating or handling procedures; and 42 (iii) review, approval and re cording by the radiation safety committee of 43 safety evaluation of proposed uses prepared in accordance with Item (ii) of this subparagraph prior to use of the 44 radioactive material.
45 C. Requirements for the issuance of a type B specific license of broad sco pe. An application for a 46 type B specific license of broad scope will be approved if the following requirements are met.
47 (1) The applicant satisfies the general requirements specified in 20.3.3.307 NMAC and 48 20.3.3.308 NMAC.
49 (2) The applicant has established administrative controls and provisions relating to 50 organization and management, procedures, record keeping, material control, material accounting and management 51 review that are necessary to assure safe operations, including:
52 (a) the appointment of a radiation safety officer who is qualified by training and 53 experience in radiation protection and who is available for advice and assistance on radiation safety matters; and 54 (b) the establishment of appropriate administrative procedures to assure:
55 (i) control of procurement and use of radioactive material; 56 (ii) completion of safety evaluations of proposed uses of radioactive
20.3.3 NMAC 27 1 materials which take into consideration such matters as the adequacy of facilities and equipment, training and 2 experience of the user, and the operating or handling procedures; and 3 (iii) review, approval and recording by the radiation safety officer of safety 4 evaluations of proposed uses prepared in accordance with Item (ii) of this subparagraph.
5 D. Requirements for the issuance of a type C specific license of broad scope. An application for a 6 type C specific license of broad scope will be approved if the following requirements are met.
7 (1) The applicant satisfies the general requirements specified in 20.3.3.307 NMAC and 8 20.3.3.308 NMAC.
9 (2) The applicant submits a statement that radioactive material will be used only by, or under 10 the direct supervision of, individuals who have received:
11 (a) a college degree at the bachelor level, or equivalent training and experi ence, in 12 the physical or biological sciences or in engineering; and 13 (b) at least 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of training and experience in the safe handling of radioactive 14 materials, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection 15 instrumentation and biological hazards of exposure to radiation appropriate to the type and forms of radioactive 16 material to be used.
17 (3) The applicant has established administrative controls and provisions relating to 18 procurement of radioactive material, procedures, record keeping, material control, material accounting and 19 management review necessary to assure safe operations.
20 E. Conditions of specific licenses of broad scope.
21 (1) Unless specifically authorized pursuant to other parts of this chapter, persons licensed 22 under this section shall not:
23 (a) conduct tracer studies in the environment involving direct release of radioactive 24 material; 25 (b) receive, acquire, own, possess, use, transfer or import devices containing 26 100,000 curies or more of radioactive material in sealed sources used for irradiation of material; 27 (c) conduct activities for which a specific license issued by the department under 28 20.3.5 NMAC, 20.3.7 NMAC or 20.3.3.315 NMAC is required; or 29 (d) add or cause the addition of radioactive material to any food, beverage, 30 cosmetic, drug or other product designed for ingestion or inhalation by, or application to, a human being.
31 (2) Each type A specific license of broad scope issued under this section sha ll be subject to 32 the condition that radioactive material possessed under the license shall only be used by, or under the direct 33 supervision of, individuals approved by the licensee's radiation safety committee.
34 (3) Each type B specific license of broad scope issued under this section shall be subject to 35 the condition that radioactive material possessed under the license shall only be used by, or under the direct 36 supervision of, individuals approved by the licensee's radiation safety officer.
37 (4) Each type C specific license of broad scope issued under this section shall be subject to 38 the condition that radioactive material possessed under the license shall only be used by, or under the direct 39 supervision of, individuals who satisfy the requirement s of Paragraph (2) of Subsection D of this section.
40 [20.3.3.314 NMAC - Rp, 20.3.3.314 NMAC, 4/30/2009; A, 6/13/2017]
41 42 20.3.3.315 SPECIAL REQUIREMENTS FOR A SPECIFIC LICENSE TO MANUFACTURE, 43 ASSEMBLE, REPAIR OR DISTRIBUTE COMMODITIES, PRODUCTS OR DEVICES WHICH 44 CONTAIN RADIOACTIVE MATERIAL:
45 A. Introduction of radioactive material in exempt concentrations into products or materials.
46 (1) Licensing. A specific license authorizing the introduction of radioactive material into a 47 product or material owned by or i n the possession of the licensee or another and the transfer of ownership or 48 possession of the product or material containing the radioactive material to be transferred to persons exempt under 49 Paragraph (1) of Subsection A of 20.3.3.302 NMAC will be issued by NRC pursuant to 10 CFR 32.11.
50 (2) Prohibition of introduction. No person may introduce radioactive material into a 51 product or material knowing or having reason to believe that it will be transferred to persons exempt under 52 Subsection A of 20.3.3.302 NMAC or equivalent regulations of the NRC or an agreement state, except in 53 accordance with a license issued by NRC pursuant to 10 CFR 32.11.
54 B. Radioactive material in exempt quantities or in certain items.
55 (1) Manufacture, distribution and transfer of exempt quantities of byproduct material.
56 An application for a specific license to manufacture, process, produce, package, repackage or transfer exempt
20.3.3 NMAC 28 1 quantities of byproduct material for commercial distribution to persons exempt pursuant to Subsection B of 2 20.3.3.302 NMAC or the equivalent regulations of the NRC or an agreement state shall be issued by NRC pursuant 3 to 10 CFR 32.18.
4 (2) Certain items containing byproduct material. An application for a specific license to 5 apply byproduct material to, or to incorporate byproduct material into, the products specified in Paragraph (1) of 6 Subsection C of 20.3.3.302 NMAC or to initially transfer for sale or distribution such products containing byproduct 7 material for use pursuant to Paragraph (1) of Subsection C of 20.3.3.302 NMAC to persons exempt from 20.3 8 NMAC shall be submitted to NRC pursuant to 10 CFR 32.14.
9 (3) Except as specified in Paragraphs (1) and (2) of this subsection, in addition to the 10 requirements set forth in 20.3.3.308 NMAC, an application for a specific license to manufacture, process, produce, 11 package, repackage or initially transfer naturally occurring or accelerator produced radioactive material (NARM) in 12 exempt quantities as specified in 20.3.3.330 NMAC of this part to persons exempt from licensing pursuant to 13 Subsection B of 20.3.3.302 NMAC will be approved if:
14 (a) the radioactive material is not contained in any food, beverage, cosmetic, drug 15 or other commodity designed for ingestion or inhalation by, or application to, a human being; 16 (b) the radioactive material is in the form of processed chemical elements, 17 compounds, mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or 18 similar substances, identified as radioactive and to be used for i ts radioactive properties, but is not incorporated into 19 any manufactured or assembled commodity, product or device intended for commercial distribution; and 20 (c) the applicant submits copies of prototype labels and brochures and the 21 department approves s uch labels and brochures.
22 (4) The license issued under Paragraph (3) of Subsection B of this subsection is subject to the 23 following conditions:
24 (a) no more than 10 exempt quantities shall be sold or transferred in any single 25 transaction; however, an e xempt quantity may be composed of fractional parts of one or more of the exempt quantity 26 provided the sum of the fractions shall not exceed unity; 27 (b) each exempt quantity shall be separately and individually packaged; no more 28 than 10 such packaged exem pt quantities shall be contained in any outer package for transfer to persons exempt 29 pursuant to Subsection B of 20.3.3.302 NMAC; the outer package shall be such that the dose rate at the external 30 surface of the package does not exceed 0.5 millirem per hou r; 31 (c) the immediate container of each quantity or separately packaged fractional 32 quantity of radioactive material shall bear a durable and legible label which:
33 (i) identifies the radionuclide and the quantity of radioactivity; and 34 (ii) bears the words radioactive material ; and 35 (d) in addition to the labeling information required by Subparagraph (c) of this 36 paragraph, the label affixed to the immediate container, or an accompanying brochure shall 37 (i) state that the contents are exempt fr om these regulations; 38 (ii) bear the words radioactive material - not for human use - introduction 39 into foods, beverages, cosmetics, drugs or medicinal product, or into products manufactured for commercial 40 distribution is prohibited - exempt quantities shall not be combined; and 41 (iii) set forth appropriate additional radiation safety precautions and 42 instructions relating to the handling, use, storage and disposal of the radioactive material.
43 (5) Each person licensed under Subsection B of 20.3.3.315 NMAC shall maintain records 44 identifying, by name and address, each person to whom radioactive material is transferred for use under Subsection 45 B of 20.3.3.302 NMAC and stating the kinds and quantities of radioactive material transferred. An annual summa ry 46 report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the 47 department. Each report shall cover the year ending June 30 and shall be filed within 30 days thereafter. If no 48 transfers of radioactiv e material have been made pursuant to Subsection B of 20.3.3.315 NMAC, during the report 49 period, the report shall so indicate.
50 C. Licensing of byproduct material by NRC.
51 (1) Gas and aerosol detectors. An application for a specific license to manufacture, process 52 or produce gas and aerosol detectors containing byproduct material and designed to protect life or property from 53 fires and airborne hazards, or to initially transfer such products for use pursuant to Paragraph (4) of Subsection C of 54 20.3.3.302 NMAC or equivalent regulations of the NRC or an agreement state, shall be submitted to NRC pursuant 55 to 10 CFR 32.26.
56 (2) Self-luminous products. An application for a specific license to manufacture, process or
20.3.3 NMAC 29 1 produce self-luminous products containing tritium, krypton -85, promethium-147 or radium-226, or to initially 2 transfer such products for use pursuant to Paragraph (2) of Subsection C of 20.3.3.302 NMAC or equivalent 3 regulations of the NRC or an agree ment state, shall be submitted to NRC pursuant to 10 CFR 32.22 and for 4 distribution submit to the NRC pursuant to 10 CFR 32.53.
5 (3) Capsules containing carbon-14. An application for a specific license to manufacture, 6 prepare, process, produce, package, repackage or transfer for commercial distribution capsules containing 1 7 microcurie (37 kilobecquerels) carbon-14 urea (allowing for nominal variation that may occur during the 8 manufacturing process) each for in vivo diagnostic use, to persons exempt from licensing under Subsection D of 9 20.3.3.302 NMAC or the equivalent regulations of the NRC or an agreement state shall be submitted to NRC 10 pursuant to 10 CFR 32.21.
11 D. [RESERVED]
12 E. Licensing the manufacture and distribution of devices to persons generally licensed under 13 Subsection B of 20.3.3.305 NMAC.
14 (1) Requirements for approval of a license application. An application for a specific 15 license to manufacture or initially transfer devices containing radioactive material to persons generally licensed 16 under Subsection B of 20.3.3.305 NMAC or equivalent regulations of the NRC or an agreement state will be 17 approved if:
18 (a) the applicant satisfies the general requirements of 20.3.3.308 NMAC; 19 (b) the applicant submits sufficient information relating to the design, manufacture, 20 prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety 21 instructions and potenti al hazards of the device to provide reasonable assurance that:
22 (i) the device can be safely operated by persons not having training in 23 radiological protection; 24 (ii) under ordinary conditions of handling, storage and use of the device, 25 the radioactive material contained in the device will not be released or inadvertently removed from the device, and it 26 is unlikely that any person will receive in one year a dose in excess of ten percent of the limits specified in 27 Subsection A of 20.3.4.405 NMAC; and 28 (iii) under accident conditions (such as fire and explosion) associated with 29 handling, storage and use of the device, it is unlikely that any person would receive an external radiation dose or 30 dose commitment in excess of the following organ doses: 1) whole body, head and trunk, active blood -forming 31 organs, gonads or lens of eye: 15 rems (150 millisieverts); 2) hands and forearms, feet and ankles, and localized 32 areas of skin averaged over areas no larger than 1 square centimeter: 200 rems (2 sieverts); and 3) other organs: 50 33 rems (500 millisieverts);
34 (c) each device bears a durable, legible, clearly visible label or labels approved by 35 the department, which contain in a clearly identified and separate statement:
36 (i) instructions and precautions nec essary to assure safe installation, 37 operation and servicing of the device (documents such as operating and service manuals may be identified in the 38 label and used to provide this information);
39 (ii) the requirement, or lack of requirement, for leak test ing, or for testing 40 any on-off mechanism and indicator, including the maximum time interval for such testing, and the identification of 41 radioactive material by isotope, quantity of radioactivity; and date of determination of the quantity; and 42 (iii) the information called for in the following statement in the same or 43 substantially similar form:
44 The receipt, possession, use and transfer of this device model ___________, serial number ____________, are 45 subject to general license or the equivalent and the r egulations of the United States nuclear regulatory commission 46 or a state with which the nuclear regulatory commission has entered into an agreement for the exercise of 47 regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is 48 prohibited. The model, serial number, and name of manufacturer or distributor may be omitted from this label 49 provided this information is specified elsewhere in labeling affixed.
50 Caution-radioactive material 51 ___________________________________;
52 (name of manufacturer or distributor) 53 (d) each device having a separable source housing that provides the primary 54 shielding for the source also bears, on the source housing, a durable label containing the device model number and 55 serial number, the isotope and quantity, the words, caution-radioactive material, the radiation symbol described in 56 20.3.4.427 NMAC, and the name of the manufacturer or initial distributor; and
20.3.3 NMAC 30 1 (e) each device meeting the criteria of Item (i) in Subparagraph (m) of Paragraph 2 (3) of Subsection B of 20.3.3.305 NMAC, bears a permanent (e.g., embossed, etched, stamped or engraved) label 3 affixed to the source housing if separable, or the device if the source housing is not separable, that includes the 4 words, caution-radioactive material, and, if practicable, the radiation symbol described in 20.3.4.427 NMAC.
5 (f) The device has been registered in the Sealed Source and Device Registry.
6 (2) Requests for lengthening of test intervals: In the event the applicant desires that the 7 device be required to be tested at longer intervals than six months, either for proper operation of the on-off 8 mechanism and indicator, if any, or for leakage of radioactive material or for both, the applicant shall include in its 9 application sufficient information to demonstrate that such longer interval is justified by performance characteristics 10 of the device or similar devices and by design features which have a significant bearing on the probability or 11 consequences of leakage of radioa ctive material from the device or failure of the on -off mechanism and indicator. In 12 determining the acceptable interval for the test for leakage of radioactive material, the department will consider 13 information which includes, but is not limited to:
14 (a) primary containment (source capsule);
15 (b) protection of primary containment; 16 (c) method of sealing containment; 17 (d) containment construction materials; 18 (e) form of contained radioactive material; 19 (f) maximum temperature withstood during prototype test; 20 (g) maximum pressure withstood during prototype test; 21 (h) maximum quantity of contained radioactive material; 22 (i) radiotoxicity of contained radioactive material; and 23 (j) operating experience with identical devices or similarly designed and 24 constructed devices.
25 (3) Authorizations for general licensees to perform certain activities. In the event the 26 applicant desires that the general licensee under Subsection B of 20.3.3.305 NMAC, or under equivalent regulations 27 of the NRC or an agreement state, be authorized to install the device, collect the sample to be analyzed by a specific 28 licensee for leakage of radioactive material, service the device, test the on -off mechanism and indicator or remove 29 the device from installation, the applicant shall include in its application written instructions to be followed by the 30 general licensee, estimated calendar quarter doses associated with such activity or activities and the bases for such 31 estimates. The submitted information must demonstrate that performance of such activity or activities by an 32 individual untrained in radiological protection, in addition to other handling, storage and use of devices under the 33 general license, is unlikely to cause that individual to receive a yearly do se in excess of ten percent of the limits 34 specified in Subsection A of 20.3.4.405 NMAC.
35 (4) Transfer provisions:
36 (a) [Reserved]
37 (b) If radioactive material is to be transferred in a device for use under an equivalent 38 general license of the NRC or an agreement state, each person that is licensed under this subsection shall provide the 39 information specified in this subparagraph to each person to whom a device is to be transferred. This information 40 shall be provided before the device may be transferred. In the case of a transfer through an intermediate person, the 41 information shall also be provided to the intended user prior to initial transfer to the intermediate person. The 42 required information includes:
43 (i) a copy of the NRCs or agreement state s regulations equivalent to 44 Subsection B of 20.3.3.305 NMAC, Subsection F of 20.3.3.317 NMAC, 20.3.3.326 NMAC, 20.3.4.451 NMAC, and 45 20.3.4.452 NMAC or a copy of 10 CFR Sections 31.5, 31.2, 30.51, 20.2201 and 20.2202; if a copy of the NRC 46 regulations is pro vided to a prospective general licensee in lieu of the agreement states regulations, it shall be 47 accompanied by a note explaining that use of the device is regulated by the agreement state; if certain paragraphs of 48 the regulations do not apply to the part icular device, those paragraphs may be omitted; 49 (ii) a list of the services that can only be performed by a specific licensee; 50 (iii) information on acceptable disposal options including estimated costs of 51 disposal; and 52 (iv) the name or title, address and phone number of the contact at the 53 agreement state regulatory agency from which additional information may be obtained.
54 (c) An alternative approach to informing customers may be proposed by the 55 licensee for approval by the department.
56 (d) Each device shall meet the labeling requirements in Subparagraphs (c) through
20.3.3 NMAC 31 1 (e) of Paragraph (1) of this S ubsection.
2 (e) If a notification of bankruptcy is submitted under Subsection E of 20.3.3.317 3 NMAC of this part and each specific licensee or the license is to be terminated, each person licensed under 4 Paragraph (1) of this subsection shall provide, upon request, to the department, NRC and any agreement state, 5 records of final disposition required under 10 CFR30.34(h).
6 (5) Material transfer reports and records: Each person licensed under 20.3.3.305 NMAC 7 of this subsection to initially transfer devices to generally licensed persons shall comply with the requirements of 8 this section.
9 (a) The person shall report to the department in accordance with 20.3.1.116 NMAC, 10 all transfers of such devices to persons for use under the general license in Subsection B of 20.3.3.305 NMAC and 11 all receipts of devices from persons licensed under Subsection B of 20.3.3.305 NMAC. The report shall be clear and 12 legible, submitted on a quarterly basis containing all of the following data.
13 (i) The required information for transfers to general licensees includes: 1) 14 the identity of each general licensee by name and mailing address for the location of use; if there is no mailing 15 address for the location of use, an alternate address for the general licensee shall be submitted along with 16 information on the actual location of use; 2) the name, title and phone number of the person identified by the general 17 licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate 18 regulations and requirements; 3) the date of transfer; 4) the type, model number, and serial number of the device 19 transferred; and 5) the quantity and type of radioactive material contained in the device.
20 (ii) If one or more intermediate persons will temporarily possess the device 21 at the intended place of use before its possession by the user, the report shall include the same information for both 22 the intended user and each intermediate person, and clearly designate the intermediate person(s).
23 (iii) For devices received from a person licensed pursuant to Subsection B 24 of 20.3.3.305 NMAC, the report shall include the identity of the general licensee by name and address, the type, 25 model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially 26 transferred by the reporting licensee, the name of the manufacturer or initial transferor.
27 (iv) If the licensee makes changes to a device possessed by a person 28 licensed pursuant to Subsection B of 20.3.3.305 NMAC, such that the label must be changed to update required 29 information, the report shall identify the general licensee, the device and the changes to informat ion on the device 30 label.
31 (v) The report shall cover each calendar quarter, shall be filed within 30 32 days of the end of the calendar quarter, and shall clearly indicate the period covered by the report.
33 (vi) The report shall clearly identify the specific licensee submitting the 34 report and include the license number of the specific licensee.
35 (vii) If no transfers have been made to or from persons generally licensed 36 under Subsection B of 20.3.3.305 NMAC during the reporting period, the report shall so indicate.
37 (b) The person shall report all transfers of devices to persons for use under a general 38 license under NRCs or an agreement states regulations that are equivalent to Subsection B of 20.3.3.305 NMAC, 39 and all receipts of devices from general licensees in the NRCs or agreement states jurisdiction, to the responsible 40 NRC or agreement state agency. The report shall be clear and legible, containing all of the data required as 41 described below.
42 (i) The required information for transfers to general licensees includes: 1) 43 the identity of each general licensee by name and mailing address for the location of use; if there is no mailing 44 address for the location of use, an alternate address for the general licensee shall be submitted along with 45 information on the actual location of use; 2) the name, title and phone number of the person identified by the general 46 licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate 47 regulations and requirements; 3) the date of transfer; 4) the type, model number and serial number of the device 48 transferred; and 5) the quantity and type of radioactive material contained in the device.
49 (ii) If one or more intermediate persons will temporarily possess the device 50 at the intended place of use before its possession by the user, the report shall include the same information for both 51 the intended user and each intermediate person, and clearly designate the intermediate person(s).
52 (iii) For devices received from a general licensee, the report shall include 53 the identity of the general licensee by name and address, the type, model number, serial number of the device 54 received, the date of receipt, and, in the case of devices not initially transferred by the repor ting licensee, the name 55 of the manufacturer or initial transferor.
56 (iv) If the licensee makes changes to a device possessed by a general
20.3.3 NMAC 32 1 licensee, such that the label must be changed to update required information, the report shall identify the general 2 licensee, the device and the changes to information on the device label.
3 (v) The report shall cover each calendar quarter, shall be filed within 30 4 days of the end of the calendar quarter, and shall clearly indicate the period covered by the report.
5 (vi) The report shall clearly identify the specific licensee submitting the 6 report and must include the license number of the specific licensee.
7 (vii) If no transfers have been made to or from NRC or a particular 8 agreement state during the reporting period, this information shall be reported to NRC or the responsible agreement 9 state agency upon request of the agency.
10 (c) The person shall maintain all information concerning transfers and receipts of 11 devices that supports the reports required by Subparagraphs (a) and (b) of this paragraph. Records required by this 12 paragraph shall be maintained for a period of three years following the date of the recorded event.
13 F. Special requirements for the manufacture, assembly, repair or initial transfer of lu minous 14 safety devices for use in aircraft. An application for a specific license to manufacture, assemble, repair or initially 15 transfer luminous safety devices containing tritium or promethium -147 for use in aircraft, for distribution to persons 16 generally licensed under Subsection C of 20.3.3.305 NMAC will be approved subject to the following conditions:
17 (1) the applicant satisfies the general requirements specified in 20.3.3.308 NMAC; 18 (2) the applicant satisfies the requirements of 10 CFR 32.53, 10 CF R 32.54, 10 CFR 32.55 19 and 10 CFR 32.56 or their equivalent; 20 (3) each person licensed under 10 CFR 32.53 shall file an annual report with the director, 21 office of Nuclear Materials Safety and Safeguards, ATTN: document control desk/GLTS by an appropriate m ethod 22 listed in 10 CFR 30.6(a) which must state the total quantity of tritium or promethium -147 transferred to persons 23 generally licensed under 10 CFR 31.7. The report must identify each general licensee by name, state the kinds and 24 number of luminous devi ces transferred, and specify the quantity of tritium or promethium -147 in each kind of 25 device. Each report must cover the year ending June 30 and must be filed within 30 days thereafter. If no transfers 26 have been made to persons generally licensed under 10 CFR 31.7 during the reporting period, the report must so 27 indicate; and 28 (4) each person licensed under 10 CFR 32.53 shall report annually all transfers of devices to 29 persons for use under a general license in an agreement states regulations that are equ ivalent to 10 CFR 31.7 of this 30 paragraph to the responsible agreement state agency. The report must state the total quantity of tritium or 31 promethium-147 transferred, identify each general licensee by name, state the kinds and numbers of luminous 32 devices transferred, and specify the quantity of tritium or promethium -147 in each kind of device. If no transfers 33 have been made to a particular agreement state during the reporting period, this information must be reported to the 34 responsible agreement state agen cy upon request of the agency.
35 G. Special requirements for license to manufacture or initially transfer calibration or reference 36 sources containing americium-241, plutonium or radium-226 for distribution to persons generally licensed 37 under Subsection D of 20.3.3.305 NMAC. An application for a specific license to manufacture or initially transfer 38 calibration or reference sources containing americium -241, plutonium or radium -226 for distribution to persons 39 generally licensed under Subsection D of 20.3.3.305 NMAC will be approved subject to the following conditions:
40 (1) the applicant satisfies the general requirements of 20.3.3.307 NMAC and 20.3.3.308 41 NMAC, and 42 (2) the applicant satisfies the requirements of 10 CFR 32.57, 10 CFR 32.58, 10 CFR 32.59 43 and 10 CFR 70.39 or their equivalent.
44 H. Manufacture and distribution of radioactive material for certain in-vitro clinical or 45 laboratory testing under general license. An application for a specific license to manufacture or distribute 46 radioactive material for use under the general license of Subsection F of 20.3.3.305 NMAC will be approved if:
47 (1) the applicant satisfies the general requirements specified in 20.3.3.307 NMAC and 48 20.3.3.308 NMAC; 49 (2) the radioactive material is to be prepared for distribution in prepackaged units of:
50 (a) iodine-125 in units not exceeding 10 microcuries (370 kilobecquerels) each; 51 (b) iodine-131 in units not exceeding 10 microcuries (370 kilobecquerels) each; 52 (c) carbon-14 in units not exceeding 10 microcuries (370 kilobecquerels) each; 53 (d) hydrogen-3 (tritium) in units not exceeding 50 microcuries (1.85 54 megabecquerels) each; 55 (e) iron-59 in units not exceeding 20 microcuries (740 kilobecquerels) each; 56 (f) cobalt-57 in units not exceeding 10 microcuries (370 kilobecquerels) each;
20.3.3 NMAC 33 1 (g) selenium-75 in units not exceeding 10 microcuries (370 kilobecquerels) each; or 2 (h) mock iodine -125 reference or calibration sources in units not exceeding 0.05 3 microcurie (1.85 kilobecquerels) of iodine -129 and 0.005 microcurie (185 becquerels) of americium -241 each; 4 (3) each prepackaged unit bears a durable, clearly visible label:
5 (a) identifying the radioactive contents as to chemical form and radionuclide, and 6 indicating that the amount of radioactivity does not exceed 10 microcuries (370 kilobecquerels) of iodine -125, 7 iodine-131, carbon-14, cobalt-57 or selenium -75; 50 microcuries (1.85 megabecquerels) of hydrogen-3 (tritium); 20 8 microcuries (740 kilobecquerels) of iron -59; or 0.05 microcurie (1.85 kilobecquerels) of iodi ne-129 and 0.005 9 microcurie (185 becquerels) of americium -241; and 10 (b) displaying the radiation caution symbol described in Paragraph (1) of Subsection 11 A of 20.3.4.427 NMAC and the words, caution, radioactive material and not for internal or external use in 12 humans or animals ;
13 (4) the following statement, or a substantially similar statement which contains the 14 information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a 15 leaflet or brochure which accompanies the package:
16 This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians, clinical 17 laboratories or hospitals and only for in-vitro clinical or laboratory tests not involving internal or external 18 administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, 19 possession, use, and transfer are subject to the regulations and a general license of the United States nuclear 20 regulatory commission or of a state with which the NRC has entered into an agreement for the exercise of 21 regulatory authority.
22 _________________________________
23 (name of manufacturer) ; and 24 (5) the label affixed to the unit, or the leaflet or brochure which accompanies the package, 25 contains adequate information as to the precautions to be observed in handling, storing and disposal of such 26 radioactive material; in the case of the mock iodine-125 reference or calibration source, the information 27 accompanying the source must als o contain directions to the licensee regarding the waste disposal requirements set 28 out in 20.3.4.433 NMAC.
29 I. Licensing the manufacture and distribution of ice detection devices. An application for a 30 specific license to manufacture and distribute ice detection devices to persons generally licensed under Subsection G 31 of 20.3.3.305 NMAC will be approved subject to the following conditions:
32 (1) the applicant satisfies the general requirements of 20.3.3.307 NMAC and 20.3.3.308 33 NMAC; and 34 (2) the criteria of 10 CFR 32.61 and 32.62 are met.
35 J. Manufacture, preparation or transfer for commercial distribution of radioactive drugs 36 containing byproduct [radioactive] material for medical use under 20.3.7 NMAC.
37 (1) An application for a specific license to manufacture, prepare or transfer for commercial 38 distribution, radioactive material for use by persons authorized pursuant to 20.3.7 NMAC will be approved if the 39 following conditions are met.
40 (a) The applicant satisfies the general requirements specified in 20.3.3.307 NMAC 41 and 20.3.3.308 NMAC; 42 (b) The applicant submits evidence that the applicant is at least one of the 43 following:
44 (i) registered with the FDA as the owner or operat or of a drug 45 establishment that engages in the manufacture, preparation, propagation, compounding or processing of a drug under 46 21 CFR 207.20(a);
47 (ii) registered or licensed with a state agency as a drug manufacturer; 48 (iii) licensed as a pharmacy b y a state board of pharmacy; 49 (iv) operating as a nuclear pharmacy within a federal medical institution; or 50 (v) a PET drug production facility registered with a state agency.
51 (c) The applicant submits information on the radionuclide; the chemical and 52 physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the 53 shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive 54 drugs by medical use licensees.
55 (d) The applicant [satisfies] commits to the following labeling requirements.
56 (i) A label is affixed to each transport radiation shield, whether it is
20.3.3 NMAC 34 1 constructed of lead, glass, plastic or other material, of a radioactive drug to be t ransferred for commercial 2 distribution; the label must include the radiation symbol and the words caution, radioactive material or danger, 3 radioactive material ; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a 4 specified date and time. For radioactive drugs with a half -life greater than 100 days, the time may be omitted; and 5 (ii) A label is affixed to each syringe, vial or other container used to hold a 6 radioactive drug to be transferred for commercial dist ribution; the label must include the radiation symbol and the 7 words caution, radioactive material or danger, radioactive material and an identifier that ensures that the 8 syringe, vial or other container can be correlated with the information on the tra nsport radiation shield label.
9 (2) A licensee described by Items (iii) or (iv) of Subparagraph (b) of Paragraph (1) of this 10 subsection:
11 (a) may prepare radioactive drugs for medical use, as defined in 20.3.7.7 NMAC, 12 provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, as specified in 13 Subparagraphs (b) and (d) of this paragraph, or an individual under the supervision of an authorized nuclear 14 pharmacist as specified in Subsection F of 20.3.7.702 NMAC; 15 (b) may allow a pharmacist to work as an authorized nuclear pharmacist if:
16 (i) the individual qualifies as an authorized nuclear pharmacist as defined 17 in 20.3.7.7 NMAC; 18 (ii) the individual meets the requirements specified in Subsection C of 19 20.3.7.714 NMAC, incorporating 10 CFR 35.55(b) and Subsection E of 20.3.7.714 NMAC, incorporating 10 CFR 20 35.59, and the licensee has received an approved license amendment identifying this individual as an authorized 21 nuclear pharmacist; or 22 (iii) the individual is designa ted as an authorized nuclear pharmacist in 23 accordance with Subparagraph (d) of this paragraph; 24 (c) may conduct the actions authorized in Subparagraphs (a) and (b) of this 25 paragraph in spite of more restrictive language in license conditions; 26 (d) may designate a pharmacist (as defined in 20.3.7.7 NMAC) as an authorized 27 nuclear pharmacist if:
28 (i) the individual was a nuclear pharmacist preparing only radioactive 29 drugs containing accelerator-produced radioactive material, and 30 (ii) the individual practiced at a pharmacy at a government agency or 31 federally recognized Indian T ribe before November 30, 2007, or at all other pharmacies in non-licensing states, as 32 defined in 20.3.1.7 NMAC, before August 8, 2009, or an earlier date as noticed by the NRC; 33 (e) may designate a pharmacist (as defined in 20.3.7.7 NMAC) as an authorized 34 nuclear pharmacist if the individual is identified as of May 3, 1995, as an authorized user in a nuclear pharmacy 35 license issued by the department under this part; and 36 (f) shall provide to the commission a copy of 37 (i) each individuals certification by a specialty board whose certification 38 process has been recognized by the [ department, NRC] Commission or agreement state as specified in [Subsection C 39 of 20.3.7.714 NMAC, incorporating 10 CFR 35.55(a), with the written attestation signed by a preceptor as re quired 40 by Subsection C of 20.3.7.714 NMAC, incorporating 10 CFR 35.55(b)(2)] 10 CFR 35.55(a); or 41 (ii) the [department, NRC] Commission or agreement state license, or 42 (iii) [the permit issued by a NRC] Commission master material licensee 43 permit, or 44 (iv) the permit issued by a [ department, NRC or agreement state licensee, or 45 NRC] licensee or Commission master materials permittee of broad scope, or the authorization from a commercial 46 nuclear pharmacy authorized to list its own authorized nuclear pharmacist, or 47 (v) documentation that only accelerator -produced radioactive materials 48 were used in the practice of nuclear pharmacy at a government agency or federally recognized Indian Tribe before 49 November 30, 2007, or at all other pharmacies in non-licensing states, as defined in 20.3.1.7 NMAC, before August 50 8, 2009, or an earlier date as noticed by the NRC; and 51 (vi) the state pharmacy licensure or registration, no later than 30 days after 52 the date that the licensee allows, under Items (i) and (i ii) of Subparagraph (b) of this paragraph, the individual to 53 work as an authorized nuclear pharmacist.
54 (3) A licensee shall possess and use instrumentation to measure the radioactivity of 55 radioactive drugs. The licensee shall have procedures for use of t he instrumentation. The licensee shall measure, by 56 direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of
20.3.3 NMAC 35 1 alpha, beta or photon emitting radioactive drugs prior to transfer for commercial distributi on. In addition, the 2 licensee shall:
3 (a) perform tests before initial use, periodically and following repair, on each 4 instrument for accuracy, linearity and geometry dependence, as appropriate for the use of the instrument; and make 5 adjustments when nec essary; and 6 (b) check each instrument for constancy and proper operation at the beginning of 7 each day of use.
8 (4) [Nothing in this section relieves the licensee from complying with applicable FDA, or 9 other federal and state requirements governing radioactive drugs ] A licensee shall satisfy the labeling requirements 10 in paragraph J(1)(d) of this section.
11 (5) Nothing in this section relieves the licensee from complying with applicable FDA, or 12 other federal and state requirements governing radioactive drugs.
13 14 K. Manufacture and distribution of sources or devices containing radioactive material for 15 medical use. An application for a specific license to manufacture and distribute sources and devices containing 16 radioactive material to persons licensed pursuant to 20.3.7 NMAC for use as a calibration, transmission or reference 17 source or for the uses listed in 20.3.7.710 NMAC, 20.3.7.711 NMAC and 20.3.7.712 NMAC will be approved if:
18 (1) the applicant satisfies the general requirements in 20.3.3.307 NMAC and 20.3.3.308 19 NMAC; and 20 (2) the applicant satisfies the requirements in 10 CFR 32.74.
21 L. Requirements for license to manufacture and distribute industrial products containing 22 depleted uranium for mass-volume applications.
23 (1) An application for a specific license to manufacture industrial products and devices 24 containing depleted uranium for use pursuant to Subsection E of 20.3.3.304 NMAC or equivalent regulations of the 25 NRC or an agreement state will be approved if:
26 (a) the applicant satisfies the general requirements specified in 20.3.3.307 NMAC 27 and 20.3.3.308 NMAC; 28 (b) the applicant submits sufficient information relating to the design, manufacture, 29 prototype testing, quality control procedures, labeling and marking, proposed uses, an d potential hazards of the 30 industrial product or device to provide reasonable assurance that possession, use, or transfer of the depleted uranium 31 in the product or device is not likely to cause any individual to receive in one year a radiation dose in exce ss of ten 32 percent of the limits specified in Subsection A of 20.3.4.405 NMAC; and 33 (c) the applicant submits sufficient information regarding the industrial product or 34 device and the presence of depleted uranium for a mass -volume application in the product or device to provide 35 reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or 36 device.
37 (2) In the case of an industrial product or device whose unique benefits are questionable, the 38 department will approve an application for a specific license under this subsection only if the product or device is 39 found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant 40 quantities of depleted uranium into the environment.
41 (3) The department may deny application for a specific license under this subsection if the 42 end use of the industrial product or device cannot be reasonably foreseen.
43 (4) Each person licensed pursuant to this subsection shall:
44 (a) maintain the level of quality control required by the license in the manufacture 45 of the industrial product or device, and in the installation of the depleted uranium into the product or device; 46 (b) label or mark each unit to:
47 (i) identify the manufacturer or initial transferor of the product or device 48 and the number of the license under which the product or device was manufactured or initially transferred, the fact 49 that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or 50 device; and 51 (ii) state that the receipt, possession, use and transfer of the product or 52 device are subject to a general license or the equivalent and the regulations of the NRC or of an agreement state; 53 (c) assure that the depleted uranium before being installed in each product or device 54 has been impressed with the following legend clearly legible through any plating or other covering: depleted 55 uranium; 56 (d) furnish a copy of the general license contained in Subsection C of 20.3.3.304
20.3.3 NMAC 36 1 NMAC and a copy of the department form to each person to whom they transfer depleted uranium in a product or 2 device for use pursuant to the general license contained in Subsection C of 20.3.3.304 NMAC; or furnish a copy of 3 the general license contained in the NRC or agreement state's regulation equivalent to Subsection C of 20.3.3.304 4 NMAC and a copy of the NRC or agreement state's certificate; or alternatively, furnish a copy of the general license 5 contained in Subsection C of 20.3.3.304 NMA C and a copy of department form to each person to whom they 6 transfer depleted uranium in a product or device for use pursuant to the general license of the NRC or an agreement 7 state, with a note explaining that use of the product or device is regulated by the NRC or an agreement state under 8 requirements substantially the same as those in Subsection C of 20.3.3.304 NMAC; 9 (e) report to the department all transfers of industrial products or devices to persons 10 for use under the general license in Subsection C of 20.3.3.304 NMAC; such report shall identify each general 11 licensee by name and address, an individual by name and (or) position who may constitute a point of contact 12 between the department and the general licensee, the type and model number of device t ransferred, and the quantity 13 of depleted uranium contained in the product or device; the report shall be submitted within 30 days after the end of 14 each calendar quarter in which such a product or device is transferred to the generally licensed person; if n o transfers 15 have been made to persons generally licensed under Subsection C of 20.3.3.304 NMAC during the reporting period, 16 the report shall so indicate; 17 (f) report to the director of the office of nuclear material safety and safeguards, by 18 an appropria te method listed in 10 CFR 40.5 all transfers of industrial products or devices to persons for use under 19 the U.S. nuclear regulatory commission general license in 10 CFR 40.25; the report shall contain all information 20 described in Subparagraph (e) of this paragraph; 21 (g) report to the responsible state agency all transfers of devices manufactured and 22 distributed pursuant to Subsection L of 20.3.3.315 NMAC for use under a general license in that agreement state's 23 regulations equivalent to Subsection C of 2 0.3.3.304 NMAC; the report shall contain all information described in 24 Subparagraph (e) of this paragraph; 25 (h) keep records showing the name, address and point of contact for each general 26 licensee to whom they transfer depleted uranium in industrial prod ucts or devices for use pursuant to the general 27 license provided in Subsection C of 20.3.3.304 NMAC or equivalent regulations of the NRC or of an agreement 28 state; the records shall be retained for three years and show the date of each transfer, the quantit y of depleted 29 uranium in each product or device transferred and compliance with the report requirements of this subsection.
30 M. Licensing the manufacture, assembly, repair or distribution of commodities, products or 31 devices which contain radioactive material other than those enumerated above. The department shall require 32 substantially the same information as required for licensing of similar items by 10 CFR Part 32 not specifically 33 named in this section.
34 N. Serialization of nationally tracked sources. Each licensee who manufactures a nationally 35 tracked source, as defined in 20.3.4.7 NMAC, after February 6, 2007 shall assign a unique serial number to each 36 nationally tracked source. Serial numbers must be composed only of alpha -numeric characters.
37 [20.3.3.315 NMAC - Rp, 20.3.3.315 NMAC, 04/30/2009; A, 8/1 0/2021]
38 39 40 20.3.3.316 ISSUANCE OF SPECIFIC LICENSES:
41 A. Upon a determination that an application meets the requirements of the act and 20.3 NMAC, the 42 department will issue a specific license authorizing the proposed activity in such form and containing such 43 conditions and limitations as it deems appropriate or necessary to effectuate the purposes of the act.
44 B. The department may incorporate in any license at the time of issuance, or thereaft er by license 45 amendment, rule, regulation, or order, such additional requirements and conditions with respect to the licensee's 46 receipt, possession, use and transfer of radioactive material subject to this part as it deems appropriate or necessary 47 in order to:
48 (1) minimize danger to public health and safety or property; or 49 (2) require reports and the keeping of records, or to provide for inspections of activities 50 under the license as may be appropriate or necessary; or 51 (3) prevent loss or theft of mat erial subject to this chapter.
52 C. The department may request, and the licensee shall provide, additional information after the 53 license has been issued to enable the department to determine whether the license shall be modified in accordance 54 with 20.3.3.32 2 NMAC.
55 [20.3.3.316 NMAC - Rp, 20.3.3.316 NMAC, 4/30/2009]
56
20.3.3 NMAC 37 1 20.3.3.317 TERMS AND CONDITIONS OF LICENSES:
2 A. Each license issued pursuant to the requirements in this part shall be subject to all the provisions 3 of the act, now or hereafter in effect, and to all rules, regulations and orders of the board or department.
4 (1) No right to the special nuclear material shall be conferred by the license except as defined 5 by the license; 6 (2) Neither the license nor any right under the license shall be assigned or otherwise 7 transferred in violation of the provisions of 20.3.3.317 NMAC; 8 (3) The license shall be subject to and the licensee shall observe, all applicable rules, 9 regulations, and orders of the department.
10 B. No license issued or granted under this part nor any right under a license issued pursuant to this 11 part shall be transferred, assigned, or in any manner disposed of, either voluntarily, or involuntarily, directly or 12 indirectly, through transfer of control of any license to any person unless the department shall, after securing full 13 information, find that the transfer is in accordance with the provisions of the act, and shall give its consent in 14 writing. An application for transfer of license must include:
15 (1) the identity, technical and financial qualifications of the proposed transferee; and 16 (2) financial assurance for decommissioning information required by 20.3.3.311 NMAC.
17 C. Each person licensed by the department pursuant to this part shall confine their use and possession 18 of material licensed to the locations and purposes authorized in the license. Except as otherwise provided in the 19 license, a license issued pursuant to the rules in this part shall carry with it the right to receive, acquire, own and 20 possess radioactive material. Preparation for shipment and transport of radioactive material shall be in accordance 21 with the provisions of 20.3.3.306 NMAC, incorporating 10 CFR 71.
22 D. Each license issued pursuant to the regulations in this part shall be deemed to contain the 23 applicable provisions set forth in the act and 20.3 NMAC, whether or not these provisions are expressly set forth in 24 the license.
25 E. Filing for bankruptcy.
26 (1) Each general licensee that is required to register by Paragraph (m) of Subsection B of 27 20.3.3.305 NMAC and each specific licensee shall notify the department and appropriate NRC Regional 28 Administrator in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy 29 under any chapter of title 11 (bankruptcy) of the United States Code by or against:
30 (a) the licensee; 31 (b) an entity (as that term is defined in 11 U.S.C. 101(15)) controlling the licensee 32 or listing the license or licensee as property of the estate; or 33 (c) an affiliate (as that term is defined in 11 U.S.C. 101(2)) of the licensee.
34 (2) The notification must indicate:
35 (a) the bankruptcy court in which the petition for bankruptcy was filed; and 36 (b) the date of the filing of the petition.
37 F. The general licenses provided in this part are subject t o the provisions in 20.3.1 NMAC, Paragraph 38 (4) of Subsection A of 20.3.3.302 NMAC, Subsection A of 20.3.3.317 NMAC, 20.3.3.322 NMAC, 20.3.3.323 39 NMAC, 20.3.3.326 NMAC, 20.3.4 NMAC and 20.3.10 NMAC unless indicated otherwise by a particular provision 40 of the general license.
41 G. Licensees required submitting emergency plans by 20.3.3.309 NMAC shall follow the emergency 42 plan approved by the department. The licensee may change the approved plan without department approval only if 43 the changes do not decrease the effectiveness of the plan. The licensee shall furnish the change to the department 44 and to affected offsite response organizations prior to the effective date of the change. Proposed changes that 45 decrease, or potentially decrease, the effectiveness of th e approved emergency plan may not be implemented without 46 prior application to and prior approval by the department.
47 H. Security requirements for portable gauges. Each portable gauge licensee shall use a minimum 48 of two independent physical controls that f orm tangible barriers to secure portable gauges from unauthorized 49 removal, whenever portable gauges are not under the control and constant surveillance of the licensee.
50 I. Generators. Each licensee preparing technetium -99m radiopharmaceuticals from molybdenum -
51 99/technetium -99m generators or rubidium -82 from strontium -82/rubidium-82 generators shall test the generator 52 eluates for molybdenum -99 breakthrough or strontium -82 and strontium -85 contamination, respectively, in 53 accordance with 20.3.7.706 NMAC of t his chapter. The licensee shall record the results of each test and retain each 54 record for 3 years after the record is made. The licensee shall report the results of any test that exceeds the 55 permissible concentration listed in 10 CFR 35.204(a) at the tim e of generator elution, in accordance with 10 CFR 56 35.3204.
20.3.3 NMAC 38 1 J. PET drugs for non-commercial distribution.
2 (1) Authorization under Subsection J of 20.3.3.307 NMAC to produce PET radioactive drugs 3 for non-commercial transfer to medical use licensees in its consortium does not relieve the licensee from complying 4 with applicable FDA, or other federal and state requirements governing radioactive drugs.
5 (2) Each licensee authorized under Subsection J of 20.3.3.307 NMAC to produce PET 6 radioactive drugs for non-commercial transfer to medical use licensees in its consortium shall:
7 (a) satisfy the labeling requirements in Subparagraph (d) of Paragraph (1) of 8 Subsection J of 20.3.3.315 NMAC for each PET radioactive drug transport radiation shield and each syringe, vial or 9 other container used to hold a PET radioactive drug intended for non-commercial distribution to members of its 10 consortium; and 11 (b) possess and use instrumentation to measure the radioactivity of the PET 12 radioactive drugs intended for non-commercial distribution to members of its consortium and meet the procedural, 13 radioactivity measurement, instrument test, instrument check and instrument adjustment requirements in Paragraph 14 (3) of Subsection J of 20.3.3.315 NMAC.
15 (3) A licensee that is a pharmacy authorized under Subsection J of 20.3.3.307 NMAC to 16 produce PET radioactive drugs for non-commercial transfer to medical use licensees in its consortium shall require 17 that any individual that prepares PET radioactive drugs shall be:
18 (a) an authorized nuclear pharmacist that meets the requirements in Subparagraph 19 (b) of Paragraph (2) of Subsection J of 20.3.3.315 NMAC; or 20 (b) an individual under the supervision of an authorized nuclear pharmacist as 21 specified in Subsection F of 20.3.7.702 NMAC.
22 (4) A pharmacy, authorized under Subsection J of 20.3.3.307 NMAC to produce PET 23 radioactive drugs for non-commercial transfer to medical use licensees in its consortium that allows an individual to 24 work as an authorized nuclear pharmacist, shall meet the requirements of Subparagraph (e) of Paragraph (2) of 25 Subsection J of 20.3.3.315 NMAC.
26 [20.3.3.317 NMAC - Rp, 20.3.3.317 NMAC, 4/30/2009; A, 6/30/2011; A, 6/13/2017]
27 28 20.3.3.318 EXPIRATION AND TERMINATION OF LICENSES AND DECOMMISSIONING OF 29 SITES AND SEPARATE BUILDINGS OR OUTDOOR AREAS:
30 A. The term of a specific license is five years unless the department granted a different term. Except 31 as provided in Subsection B of this section, each specific license expires at the end of the day on the expiration date 32 stated in the license unless the licensee has filed an application for renewal under 20.3.3.319 NMAC not less than 30 33 days before the expiration date stated in the existing license. If an application for renewal has been filed at least 30 34 days before the expiration date stated in the existing license, the existing license expires at the end of the day on 35 which the department makes a final determination to deny the renewal application or, if the determination states an 36 expiration date, the expiration date stated in the determination.
37 B. If the licensee failed to pay outstanding annual fees to the department as required by 20.3.16 38 NMAC, the specific license expires at the end of the day on the expiration date stated in the license. The licensee 39 shall follow the requirements in Subsection F through [ M] L of this section for termination of the specific license, or 40 apply for a license pursuant to 20.3.3.307 NMAC after the outstanding annual fee(s) has been paid.
41 C. Each specific license revoked by the department expires at the end of the day on the date of the 42 department's final determination to revoke the license, or on the expiration date stated in the determination, or as 43 otherwise provided by department order.
44 D. Expiration of the specific license does not relieve the licensee from the requirements in 20.3 45 NMAC. All license provisions continue in effect, beyond the expiration date if necessary, with respect to possession 46 of radioactive material until the department notifies the licensee in writing that the license is terminated. During this 47 time, the licensee shall:
48 (1) limit actions involving radioactive material to those related to decommissioning; and 49 (2) continue to control entry to restricted areas until they are suitable for release in 50 accordance with department requirements.
51 E. Within 60 days of the occurrence of any of the following, each licensee shall provide notification 52 to the department in writing of such occurrence, and either begin decommissioning its site, or any separate building 53 or outdoor area that contains residual radioactivity so that the building or outdoor area is suitable for release in 54 accordance with department requirements, or submit within 12 months of notification a decommissioning plan, if 55 required by Subsection H of this section, and begin decommissioning upon approval of that plan if:
56 (1) the license has expired or has been revoked pursuant to Subsections A, B or C of this
20.3.3 NMAC 39 1 section; or 2 (2) the licensee has decided to permanently cease principal activities, as def ined in 20.3.3.7 3 NMAC, at the entire site or in any separate building or outdoor area that contains residual radioactivity such that the 4 building or outdoor area is unsuitable for release in accordance with department requirements; or 5 (3) no principal ac tivities under the license have been conducted for a period of 24 months; 6 or 7 (4) no principal activities have been conducted for a period of 24 months in any separate 8 building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for 9 release in accordance with department requirements.
10 F. Coincident with the notification required by Subsection E of this section, the licensee shall 11 maintain in effect all decommissioning financial assurances established by the licensee pursuant to 20.3.3.311 12 NMAC in conjunction with a license issuance or renewal or as required by this section. The amount of the financial 13 assurance must be increased, or may be decreased, as appropriate, to cover the detailed cost estimate f or 14 decommissioning established pursuant to Subparagraph (e) of Paragraph (4) of Subsection H of this section.
15 G. The department may grant a request to extend the time periods established in Subsection E of this 16 section, if the department determines that this relief is not detrimental to the public health and safety and is 17 otherwise in the public interest. The request must be submitted no later than 30 days before notification pursuant to 18 Subsection E of this section. The schedule for decommissioning set forth in Subsection E of this section may not 19 commence until the department has made a determination on the request.
20 H. Decommissioning Plan.
21 (1) A decommissioning plan must be submitted if required by license condition or if the 22 procedures and activities necessary to carry out decommissioning of the site or separate building or outdoor area 23 have not been previously approved by the department and these procedures could increase potential health and 24 safety impacts to workers or to the public, such as in a ny of the following cases:
25 (a) procedures would involve techniques not applied routinely during cleanup or 26 maintenance operations; 27 (b) workers would be entering areas not normally occupied where surface 28 contamination and radiation levels are signific antly higher than routinely encountered during operation; 29 (c) procedures could result in significantly greater airborne concentrations of 30 radioactive materials than are present during operation; or 31 (d) procedures could result in significantly greater releases of radioactive material to 32 the environment than those associated with operation.
33 (2) The department may approve an alternate schedule for submittal of a decommissioning 34 plan required pursuant to Subsection E of this section if the department determines that the alternative schedule is 35 necessary to the effective conduct of decommissioning operations and presents no undue risk from radiation to the 36 public health and safety and is otherwise in the public interest.
37 (3) Procedures, such as those listed in Paragraph (1) of this subsection, with potential health 38 and safety impacts may not be carried out prior to approval of the decommissioning plan.
39 (4) The proposed decommissioning plan for the site or separate building or outdo or area 40 must include:
41 (a) a description of the conditions of the site or separate building or outdoor area 42 sufficient to evaluate the acceptability of the plan; 43 (b) a description of planned decommissioning activities; 44 (c) a description of methods used to ensure protection of workers and the 45 environment against radiation hazards during decommissioning; 46 (d) a description of the planned final radiation survey; 47 (e) an updated detailed cost estimate for decommissioning, comparison of that 48 estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds 49 for completion of decommissioning; and 50 (f) for decommissioning plans calling for completion of decommissioning later than 51 24 months aft er plan approval, the plan shall include a justification for the delay based on the criteria in Subsection J 52 of this section.
53 (5) The proposed decommissioning plan will be approved by the department if the 54 information therein demonstrates that the decomm issioning will be completed as soon as practicable and that the 55 health and safety of workers and the public will be adequately protected.
56 I. Deadline for Decommissioning.
20.3.3 NMAC 40 1 (1) Except as provided in Subsection J of this section, licensees shall complete 2 decommissioning of the site or separate building or outdoor area as soon as practicable but no later than 24 months 3 following the initiation of decommissioning.
4 (2) Except as provided in Subsection J of this section, when decommissioning involves the 5 entire site, the licensee shall request license termination as soon as practicable but no later than 24 months following 6 the initiation of decommissioning.
7 J. The department may approve a request for an alternative schedule for completion of 8 decommissioning of the site or separate building or outdoor area, and license termination if appropriate, if the 9 department determines that the alternative is warranted by consideration of the following:
10 (1) whether it is technically feasible to complete decommissioning within the allotted 24 -
11 month period; 12 (2) whether sufficient waste disposal capacity is available to allow completion of 13 decommissioning within the allotted 24-month period; 14 (3) whether a significant volume reduction in wastes requiring disposal will be achieved by 15 allowing short -lived radionuclides to decay; 16 (4) whether a significant reduction in radiation exposure to workers can be achieved by 17 allowing short -lived radionuclides to decay; and 18 (5) other site-specific factors which the department may consider appropriate on a case-by-19 case basis, such as the regulatory requirements of other government agencies, lawsuits, ground -water treatment 20 activities, monitored natural ground-water restoration, actions that could result in more environmental harm than 21 deferred cleanup, and other factors beyond the control of the licensee.
22 K. As the final step in decommissioning, the licensee shall:
23 (1) certify the disposition of all licensed material, including accumulated wastes, by 24 submitting a completed c ertificate - disposition of radioactive material form or equivalent information; and 25 (2) conduct a radiation survey of the premises where the licensed activities were carried out 26 and submit a report of the results of this survey, unless the licensee demonstrat es in some other manner that the 27 premises are suitable for release in accordance with the criteria for decommissioning in 20.3.4.426 NMAC; the 28 licensee shall, as appropriate:
29 (a) report levels of gamma radiation in units of millisievert (microroentgen) per 30 hour3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> at one meter from surfaces, and report levels of radioactivity, including alpha and beta, in units of 31 megabecquerels (disintegrations per minute or microcuries) per 100 square centimeters, removable and fixed, for 32 surfaces, megabecquerels (microcu ries) per milliliter for water, and becquerels (picocuries) per gram for solids such 33 as soils or concrete; and 34 (b) specify the survey instrument(s) used and certify that each instrument is 35 properly calibrated and tested.
36 L. Specific licenses, including expired licenses, will be terminated by written notice to the licensee 37 when the department determines that:
38 (1) radioactive material has been properly disposed; 39 (2) reasonable effort has been made to eliminate residual radioactive contamination, if 40 present; and 41 (3) a radiation survey has been performed which demonstrates that the premises are suitable 42 for release in accordance with the criteria for decommissioning in 20.3.4.426 NMAC; or other information 43 submitted by the licensee is sufficient to demonstrate that the premises are suitable for release in accordance with 44 the criteria for decommissioning in 20.3.4.426 NMAC; and 45 (4) records required by Subsections D and F of 20.3.3.326 NMAC, have been received by the 46 department.
47 [20.3.3.318 NMAC - Rp, 20.3.3.318 NMAC, 4/30/2009]
48 49 20.3.3.319 RENEWAL OF LICENSES:
50 A. Applications for renewal of specific licenses shall be filed in accordance with 20.3.3.307 NMAC 51 not less than 30 days before the expiration date stated in the existing license.
52 B. In any case in which a licensee, not less than 30 days prior to expiration of their existing license, 53 has filed an application in proper form for renewal or for a new license authorizing the same activities, such existing 54 license shall not expire until the application has been finally determined by the department.
55 C. An application for renewal of a license shall be approved if the department determines that the 56 requirements of this part have been satisfied, and the licensee has paid any outstanding annual fee(s) purs uant to
20.3.3 NMAC 41 1 20.3.16 NMAC.
2 [20.3.3.319 NMAC - Rp, 20.3.3.319 NMAC and 20.3.3.321 NMAC, 4/30/2009 ]
3 4 20.3.3.320 AMENDMENT OF LICENSES AT REQUEST OF LICENSEE:
5 A. An license amendment may be requested by filing a form prescribed by the department pursuant to 6 20.3.3.307 NMAC which shall specify the proposed amendment and the grounds for the amendment.
7 B. Supporting documentation (e.g. training records, certificates, procedures, etc.) shall be submitted 8 with the amendment, or provided upon request by the department within 30 days from the date of the request or 9 other time as may be specified in the request. Failure to provide the appropriate supporting documentation within 10 the prescribed time frame will be grounds for denial of the amendment.
11 C. A request for a license amendment shall be approved if the department determines that the 12 requirements of this part have been satisfied, and the licensee has pai d any outstanding annual fee(s) pursuant to 13 20.3.16 NMAC.
14 [20.3.3.320 NMAC - Rp, 20.3.3.320 NMAC and 20.3.3.321 NMAC, 4/30/2009 ]
15 16 20.3.3.321 [RESERVED]
17 18 20.3.3.322 MODIFICATION, SUSPENSION AND REVOCATION OF LICENSES:
19 A. The terms and conditions of all lic enses shall be subject to amendment or modification by the 20 department by reason of amendments to the act, or by reason of rules, regulations and orders issued by the board or 21 department.
22 B. Any license may be modified, suspended or revoked, in whole or in part by the department, for 23 any material false statement in the application or any statement of fact required under provisions of the act; or 24 because of conditions revealed by such application or statement of fact or any report, record, or inspection or other 25 means which would warrant the department to refuse to grant a license on an original application; or for violation of, 26 or failure to observe any of the terms and conditions of the act, conditions of the license, or of any rule, regulation, 27 or order of the board or department; or the department determines that existing conditions constitute a substantial 28 threat to the public health and safety or the environment.
29 C. Except in cases of willfulness or those in which the public health, interest or safety r equires 30 otherwise, no license shall be modified, suspended, or revoked unless, prior to the institution of proceedings 31 therefore, facts or conduct which may warrant such actions shall have been called to the attention of the licensee in 32 writing and the licensee shall have been accorded an opportunity to demonstrate or achieve compliance with all 33 lawful requirements.
34 [20.3.3.322 NMAC - Rp, 20.3.3.322 NMAC, 4/30/2009]
35 36 20.3.3.323 TRANSFER OF MATERIAL:
37 A. No licensee shall transfer radioactive material except as authorized by this section.
38 B. Except as otherwise provided in their license and subject to the provisions of Sections C and D 39 this section any licensee may transfer radioactive material:
40 (1) to the department after receiving prior approval from the department; 41 (2) to the agency in any agreement state which regulates radioactive material pursuant to an 42 agreement under Section 274 of the Atomic Energy Act; 43 (3) to the United States department of energy; 44 (4) to any person exempt from the Radiation Protection Act to the extent permitted under 45 such exemptions; or to any person in the NRC jurisdiction or an agreement state, subject to the jurisdiction of that 46 state, who has been exempted from the licensing requirements and regulations of the NRC or the agreement state, to 47 the extent permitted under such exemption; 48 (5) to any person authorized to receive such material under terms of a general license or a 49 specific license or equivalent licensing document issued by the department, the NRC or an agreeme nt state; or 50 (6) as otherwise authorized by the department in writing.
51 C. Before transferring radioactive material to a specific licensee of the department, the NRC or an 52 agreement state, or to a general licensee who is required to register with the dep artment, the NRC or an agreement 53 state prior to receipt of the radioactive material, the licensee transferring the material shall verify that the transferee's 54 license authorizes the receipt of the type, form and quantity of radioactive material to be trans ferred.
55 D. The following methods for the verification required by Subsection C of this section are acceptable:
56 (1) the transferor may have in their possession, and read, a current copy of the transferee's
20.3.3 NMAC 42 1 specific license or registration certificate; 2 (2) the transferor may have in their possession a written certification by the transferee that 3 they are authorized by license or registration certificate to receive the type, form and quantity of radioactive material 4 to be transferred, specifying the licen se or registration certificate number, issuing agency and expiration date; 5 (3) for emergency shipments, the transferor may accept oral certification by the transferee 6 that they are authorized by license or registration certificate to receive the type, fo rm and quantity of radioactive 7 material to be transferred, specifying registration certificate number, issuing agency and expiration date; provided 8 that the oral certification is confirmed in writing within 10 days; 9 (4) the transferor may obtain other sources of information compiled by a reporting service 10 from official records of the department, the NRC or an agreement state as to the identity of licensees and the scope 11 and expiration dates of licenses and registration; or 12 (5) when none of the m ethods of verification described in Paragraphs (1) to (4) of this 13 subsection are readily available or when a transferor desires to verify that information received by one of such 14 methods is correct or up-to-date, the transferor may obtain and record confir mation from the department, the NRC or 15 an agreement state that the transferee is licensed to receive the radioactive material.
16 [20.3.3.323 NMAC - Rp, 20.3.3.323 NMAC, 4/30/2009]
17 18 20.3.3.324 RECIPROCAL RECOGNITION OF LICENSES:
19 A. Provided that the requirem ents of this section have been met, any person who holds a specific 20 license from the NRC or an agreement state, and issued by the regulatory authority having jurisdiction where the 21 licensee maintains an office for directing the licensed activity and at whi ch radiation safety records are normally 22 maintained, is hereby granted a general license to conduct the activities authorized in such licensing document 23 within the state of New Mexico for a period not in excess of 180 days in any calendar year provided tha t:
24 (1) the licensing document does not limit the activity authorized by such document to 25 specified installations or locations; 26 (2) the out-of-state licensee notifies the department in writing at least three business days 27 prior to engaging in such activ ity, filing a form, reciprocity application - proposed activities; such notification shall 28 indicate the location of work, period of work, and type, manufacturer name and model number of radioactive 29 material to be brought within the state, the clients name and address, and shall be accompanied by a copy of the 30 pertinent licensing document and application fee as determined by 20.3.16 NMAC charged once for each calendar 31 year; if, for a specific case, the three-day period would impose an undue hardship on the out -of-state licensee, they 32 may, upon application to the department, obtain permission to proceed sooner; the department may waive the 33 requirements for filing additional written notifications during the calendar year following the receipt of the initial 34 notification from a person engaging in activities under the general license provided in this section; 35 (3) the out-of-state licensee complies with all applicable provisions of 20.3 NMAC, all 36 provisions of the act, now or hereafter in effect, and orders of t he board or department and with all the terms and 37 conditions of their licensing document, except any such terms and conditions which may be inconsistent with 38 requirements in this chapter; 39 (4) the out-of-state licensee supplies such other information as t he department may request; 40 and 41 (5) the out-of-state licensee shall not transfer or dispose of radioactive material possessed or 42 used under the general license provided in this section except by transfer to a person specifically licensed by the 43 department, an agreement state or by the NRC to receive such material.
44 B. Notwithstanding the provisions of Subsection A of this section, any person who holds a specific 45 license issued by the NRC or an agreement state authorizing the holder to manufacture, transfer, install or service a 46 device described in Paragraph (1) of Subsection B of 20.3.3.305 NMAC within areas subject to the jurisdiction of 47 the licensing body is hereby granted a general license to install, transfer, demonstrate or service such a device in thi s 48 state provided that:
49 (1) such person shall file a report with the department within 30 days after the end of each 50 calendar quarter in which any device is transferred to or installed in this state; each such report shall identify each 51 general license to whom such device is transferred by name and address, the type of device transferred, and the 52 quantity and type of radioactive material contained in the device; 53 (2) the device has been manufactured, labeled, installed and serviced in accordance with 54 applicable provisions of the specific license issued to such person by the NRC or an agreement state; 55 (3) such person shall assure that any labels required to be affixed in the device under 56 regulations of the authority which licensed manufacture of the devic e bear a statement that removal of this label is
20.3.3 NMAC 43 1 prohibited ; and 2 (4) the holder of the specific license shall furnish to each general licensee to whom they 3 transfer such device or on whose premises they install such device a copy of the general license contained in 4 Subsection B of 20.3.3.305 NMAC.
5 C. The department may withdraw, limit or qualify its acceptance of any specific license or equivalent 6 licensing document issued by another department, or any product distributed pursuant to such licens ing document, 7 upon determining that such action is necessary in order to prevent undue hazard to public health and safety or 8 property.
9 D. Reciprocity in Areas of Exclusive Federal Jurisdiction:
10 (1) Before radioactive material can be used at temporary jo bsites at any federal facility, the 11 jurisdictional status of the jobsites shall be determined. If a temporary jobsite is under exclusive federal jurisdiction, 12 the general license authorized under Subsection A of this section is subject to all the rules, r egulations, orders and 13 fees of the NRC.
14 (2) Authorizations for use of radioactive materials in areas of exclusive federal jurisdiction 15 shall be obtained from the NRC by:
16 (a) filing an NRC form 241 in accordance with 10 CFR 150.20(b); or 17 (b) applying for a specific NRC license.
18 E. Reciprocity in Other States:
19 (1) Before radioactive material can be used at a temporary jobsite in another state, 20 authorization shall be obtained from the state if it is an agreement state or from NRC for any non-agreement state, 21 either by filing for reciprocity or applying for a specific license.
22 (2) The general license authorized under Subsection A of this section is subject to all the 23 rules, regulations, orders and fees of the agreement state, or those of the NRC for any non-agreement state.
24 [20.3.3.324 NMAC - Rp, 20.3.3.324 NMAC, 4/30/2009]
25 26 20.3.3.325 REPORTING REQUIREMENTS:
27 A. Immediate Report. Each licensee shall notify the department as soon as possible but not later 28 than 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> after the discovery of an event that prevents immediate protective actions necessary to avoid exposures 29 to radiation or radioactive materials that could exceed regulatory limits or releases of licensed material that could 30 exceed regulatory limits (events may include fires, explosions, t oxic gas releases, etc.).
31 B. Twenty-Four Hour Report. Each licensee shall notify the department within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the 32 discovery of any of the following events involving licensed material.
33 (1) An unplanned contamination event that:
34 (a) requires access to the contaminated area, by workers or the public, to be 35 restricted for more than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> by imposing additional radiological controls or by prohibiting entry into the area; 36 (b) involves a quantity of material greater than five times the lowest annual limit on 37 intake specified in 20.3.4.461 NMAC for the material; and 38 (c) has access to the area restricted for a reason other than to allow radioactive 39 material with a half-life of less than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> to decay prior to decontamination.
40 (2) An event in which equipment is disabled or fails to function as designed when:
41 (a) the equipment is required by regulation or license condition to prevent releases 42 exceeding regulatory limits, to prevent exposures to radiation and radioactive materia ls exceeding regulatory limits, 43 or to mitigate the consequences of an accident; 44 (b) the equipment is required to be available and operable when it is disabled or 45 fails to function; and 46 (c) no redundant equipment is available and operable to perform t he required safety 47 function.
48 (3) An event that requires unplanned medical treatment at a medical facility of an individual 49 with spreadable radioactive contamination on the individual's clothing or body.
50 (4) An unplanned fire or explosion damaging any l icensed material or any device, container 51 or equipment containing licensed material when:
52 (a) the quantity of material involved is greater than five times the lowest annual 53 limit on intake specified in 20.3.4.461 NMAC for the material; and 54 (b) the damage affects the integrity of the licensed material or its container.
55 C. Preparation and Submission of Reports. Reports made by licensees in response to the 56 requirements of this section must be made as follows.
20.3.3 NMAC 44 1 (1) Licensees shall make reports required by Subsections A and B of this section by 2 telephone to the department. To the extent that the information is available at the time of notification, the 3 information provided in these reports must include:
4 (a) the caller's name and call back telephone n umber; 5 (b) a description of the event, including date and time; 6 (c) the exact location of the event; 7 (d) the radioactive material, quantities and chemical and physical form of the 8 licensed material involved; and 9 (e) any personnel radiation exposure data available; 10 (2) Written report. Each licensee who makes a report required by Subsections A and B of 11 this section shall submit a written follow-up report within 30 days of the initial report. Written reports prepared 12 pursuant to other regulations may be submitted to fulfill this requirement if the reports contain all of the necessary 13 information and the appropriate distribution is made. These written reports must be sent to the department at the 14 address in 20.3.1.116 NMAC. The re ports must include the following:
15 (a) a description of the event, including the probable cause and the manufacturer 16 and model number (if applicable) of any equipment that failed or malfunctioned; 17 (b) the exact location of the event; 18 (c) the radioactive material, quantities and chemical and physical form of the 19 licensed material involved; 20 (d) date and time of the event; 21 (e) corrective actions taken or planned and the results of any evaluations or 22 assessments; and 23 (f) the extent of exposure of individuals to radiation or to radioactive materials 24 without identification of individuals by name.
25 [20.3.3.325 NMAC - Rp, 20.3.3.312 NMAC, 4/30/2009]
26 27 20.3.3.326 RECORDS: Each person who receives radioactive material pursuant to a license and the 28 regulations in this part and parts 20.3.5 NMAC, 20.3.7 NMAC, 20.3.12 NMAC, 20.3.13 NMAC, 20.3.14 NMAC 29 and 20.3.15 NMAC is subject to the requirements of this section.
30 A. The licensee shall keep records showing the receipt, transfer and disposal of the radioactive 31 material as follows.
32 (1) The licensee shall retain each record of receipt of radioactive material as long as the 33 material is possessed and for three years following tr ansfer or disposal of the material.
34 (2) The licensee who transferred the material shall retain each record of transfer for three 35 years after each transfer unless a specific requirement in another part of the regulations in this chapter dictates 36 otherwise.
37 (3) The licensee who disposed of the material shall retain each record of disposal of 38 radioactive material until the department terminates each license that authorizes disposal of the material.
39 B. The licensee shall retain each record required by appl icable parts of 20.3 NMAC or by license 40 condition for the period specified by the applicable regulation or license condition. If a retention period is not 41 otherwise specified by regulation or license condition, the record shall be retained until the depar tment terminates 42 each license that authorizes the activity that is subject to the recordkeeping requirement.
43 C. Records Format and Retention Period.
44 (1) Records which must be maintained pursuant to 20.3 NMAC may be the original or a 45 reproduced copy or m icroform if such reproduced copy or microform is duly authenticated by authorized personnel 46 and the microform is capable of producing a clear and legible copy after storage for the period specified by 20.3 47 NMAC. The record may also be stored in electronic media with the capability for producing legible, accurate and 48 complete records during the required retention period. Records such as letters, drawings, specifications, shall 49 include all pertinent information such as stamps, initials and signatures. The licensee shall maintain adequate 50 safeguards against tampering with and loss of records.
51 (2) If there is a conflict between the retention period in 20.3 NMAC, license condition or 52 other written department approval or authorization pertaining to the retent ion period for the same type of record, the 53 retention period specified in 20.3 NMAC for such records shall apply unless the department, pursuant to Subsection 54 A of 20.3.1.107 NMAC, has granted a specific exemption from the record retention requirements spe cified in 20.3 55 NMAC.
56 D. Prior to license termination, each licensee authorized to possess radioactive material with a half -
20.3.3 NMAC 45 1 life greater than 120 days, in an unsealed form, shall forward the following records to the department:
2 (1) records of disposal of licensed material made under Sections 434 (including burials 3 authorized before January 28, 1981), 435, 436 and 437 of 20.3.4 NMAC; and 4 (2) records required by Paragraph (4) of Subsection B of 20.3.4.442 NMAC.
5 E. If licensed activities are transferred or assigned in accordance with Subsection B of 20.3.3.317 6 NMAC, each licensee authorized to possess radioactive material, with a half -life greater than 120 days, in an 7 unsealed form, shall transfer the following records to the new licensee and the new licensee will be responsible for 8 maintaining these records until the license is terminated:
9 (1) records of disposal of licensed material made under Sections 434 (including burials 10 authorized before January 28, 1981), 435, 436 and 437 of 20.3.4 NMAC; 11 (2) records required by Paragraph (4) of Subsection B of 20.3.4.442 NMAC; and 12 (3) the records required under Subsection G of 20.3.3.311 NMAC.
13 F. Prior to license termination, each licensee shall forward the records required by Subsection G of 14 20.3.3.311 NMAC t o the department.
15 [20.3.3.326 NMAC - Rp, 20.3.3.300 NMAC, 4/30/2009]
16 17 20.3.3.327 [RESERVED]
18 19 20.3.3.328 [RESERVED]
20 21 20.3.3.329 SCHEDULE A - EXEMPT CONCENTRATIONS:
22 A. Table 339.1.
TABLE 329.1 Element Isotope Column I Gas Column II Liquid (Atomic Number) Concentration and Solid Concentration microcurie/milliliter1 microcurie/milliliter2 Antimony (51) Sb-122 3x10-4 Sb-124 2x10-4 Sb-125 1x10-3 Argon (18) Ar-37 1x10-3 Ar-41 4x10-7 Arsenic (33) As-73 5x10-3 As-74 5x10-4 As-76 2x10-4 As-77 8x10-4 Barium (56) Ba-131 2x10-3 Ba-140 3x10-4 Beryllium (4) Be-7 2x10-2 Bismuth (83) Bi-206 4x10-4 Bromine (35) Br-82 4x10-7 3x10-3 Cadmium (48) Cd-109 2x10-3 Cd-115m 3x10-4 Cd-115 3x10-4 Calcium (20) Ca-45 9x10-5 Ca-47 5x10-4 Carbon (6) C-14 1x10-6 8x10-3 Cerium (58) Ce-141 9x10-4 Ce-143 4x10-4 Ce-144 1x10-4 Cesium (55) Cs-131 2x10-2 Cs-134m 6x10-2 Cs-134 9x10-5 Chlorine (17) Cl-38 9x10-7 4x10-3
20.3.3 NMAC 46 TABLE 329.1 Element Isotope Column I Gas Column II Liquid (Atomic Number) Concentration and Solid Concentration microcurie/milliliter1 microcurie/milliliter2 Chromium (24) Cr-51 2x10-2 Cobalt (27) Co-57 5x10-3 Co-58 1x10-3 Co-60 5x10-4 Copper (29) Cu-64 3x10-3 Dysprosium (66) Dy-165 4x10-3 Dy-166 4x10-4 Erbium (68) Er-169 9x10-4 Er-171 1x10-3 Europium (63) Eu-152 6x10-4 (T 1/2 = 9.2 h)
Eu-155 2x10-3 Fluorine (9) F-18 2x10-6 8x10-3 Gadolinium (64) Gd-153 2x10-3 Gd-159 8x10-4 Gallium (31) Ga-72 4x10-4 Germanium (32) Ge-71 2x10-2 Gold (79) Au-196 2x10-3 Au-198 5x10-4 Au-199 2x10-3 Hafnium (72) Hf-181 7x10-4 Hydrogen (1) H-3 5x10-6 3x10-2 Indium (49) In-113m 1x10-2 In-114m 2x10-4 Iodine (53) I-126 3x10-9 2x10-5 I-131 3x10-9 2x10-5 I-132 8x10-8 6x10-4 I-133 1x10-8 7x10-5 I-134 2x10-7 1x10-3 Iridium (77) Ir-190 2x10-3 Ir-192 4x10-4 Ir-194 3x10-4 Iron (26) Fe-55 8x10-3 Fe-59 6x10-4 Krypton (36) Kr-85m 1x10-6 Kr-85 3x10-6 Lanthanum (57) La-140 2x10-4 Lead (82) Pb-203 4x10-3 Lutetium (71) Lu-177 1x10-3 Manganese (25) Mn-52 3x10-4 Mn-54 1x10-3 Mn-56 1x10-3 Mercury (80) Hg-197m 2x10-3 Hg-197 3x10-3 Hg-203 2x10-4 Molybdenum (42) Mo-99 2x10-3 Neodymium (60) Nd-147 6x10-4
20.3.3 NMAC 47 TABLE 329.1 Element Isotope Column I Gas Column II Liquid (Atomic Number) Concentration and Solid Concentration microcurie/milliliter1 microcurie/milliliter2 Nd-149 3x10-3 Nickel (28) Ni-65 1x10-3 Niobium (Columbium) (41) Nb-95 1x10-3 Nb-97 9x10-3 Osmium (76) Os-185 7x10-4 Os-191m 3x10-2 Os-191 2x10-3 Os-193 6x10-4 Palladium (46) Pd-103 3x10-3 Pd-109 9x10-4 Phosphorous (15) P-32 2x10-4 Platinum (78) Pt-191 1x10-3 Pt-193m 1x10-2 Pt-197m 1x10-2 Pt-197 1x10-3 Potassium (19) K-42 3x10-3 Praseodymium (59) Pr-142 3x10-4 Pr-143 5x10-4 Promethium (61) Pm-147 2x10-3 Pm-149 4x10-4 Rhenium (75) Re-183 6x10-3 Re-186 9x10-4 Re-188 6x10-4 Rhodium (45) Rh-103m 1x10-1 Rh-105 1x10-3 Rubidium (37) Rb-86 7x10-4 Ruthenium (44) Ru-97 4x10-3 Ru-103 8x10-4 Ru-105 1x10-3 Ru-106 1x10-4 Samarium (62) Sm-153 8x10-4 Scandium (21) Sc-46 4x10-4 Sc-47 9x10-4 Sc-48 3x10-4 Selenium (34) Se-75 3x10-3 Silicon (14) Si-31 9x10-3 Silver (47) Ag-102 1x10-3 Ag-110m 3x10-4 Ag-111 4x10-4 Sodium (11) Na-24 2x10-3 Strontium (38) Sr-85 1x10-3 Sr-89 1x10-4 Sr-91 7x10-4 Sr-92 7x10-4 Sulfur (16) S-35 9x10-8 6x10-4 Tantalum (73) Ta-182 4x10-4 Technetium (43) Tc-96m 1x10-1
20.3.3 NMAC 48 TABLE 329.1 Element Isotope Column I Gas Column II Liquid (Atomic Number) Concentration and Solid Concentration microcurie/milliliter1 microcurie/milliliter2 Tc-96 1x10-3 Tellurium (52) Te-125m 2x10-3 Te-127m 6x10-4 Te-127 3x10-3 Te-129m 3x10-4 Te-131m 6x10-4 Te-132 3x10-4 Terbium (65) Tb-160 4x10-4 Thallium (81) Tl-200 4x10-3 Tl-201 3x10-3 Tl-202 1x10-3 Tl-204 1x10-3 Thulium (69) Tm-170 5x10-4 Tm-171 5x10-3 Tin (50) Sn-113 9x10-4 Sn-125 2x10-4 Tungsten (Wolfram) (74) W-181 4x10-3 W-187 7x10-4 Vanadium (23) V-48 3x10-4 Xenon (54) Xe-131m 4x10-6 Xe-133 3x10-6 Xe-135 1x10-6 Ytterbium (70) Yb-175 1x10-3 Yttrium (39) Y-90 2x10-4 Y-91m 3x10-2 Y-91 3x10-4 Y-92 6x10-4 Y-93 3x10-4 Zinc (30) Zn-65 1x10-3 Zn-69m 7x10-4 Zn-69 2x10-2 Zirconium (40) Zr-95 6x10-4 Zr-97 2x10-4 Beta or gamma emitting 1x10-10 1x10-6 radioactive material not listed above with half-life less than 3 years.
1 Table 329.1 notes:
2 1 values are given in column I only for those materials normally used as gases; 3 2 microcuries per gram for solids.
4 B. Notes.
5 (1) Many radioisotopes disintegrate into isotopes which are also radioactive. In expressing 6 the concentrations in Subsection A the activity stated is that of the parent isotope and takes into account the 7 daughters.
8 (2) For purposes of 20.3.3.302 NMAC where there is involved a combination of isotopes, the 9 limit for the combination shall be derived as follows: determine for each isotope in the product the ratio between the 10 concentration present in the product and the exem pt concentration established in Subsection A of this section for the 11 specific isotope when not in combination. The sum of such ratios may not exceed 1 (i.e., unity). Example:
12 (concentration of isotope A in product) / (exempt concentration of isotope A ) + (concentration of isotope B in
20.3.3 NMAC 49 1 product) / (exempt concentration of isotope B) <1.
2 (3) The values in this table are presented in scientific notation. In this notation, a value of 3 3 x 10-4 represents a value of 3E-4 or 0.0003.
4 (4) To convert microcuries to SI units of kilobecquerels multiply the above values by 37.
5 For example: Zirconium-97 of 2x10-4 microcurie multiplied by 37 is equivalent to 0.0074 kilobecquerel or 7.4 6 becquerels.
7 [20.3.3.329 NMAC - Rp, 20.3.3.329 NMAC, 4/30/2009]
8 9 20.3.3.330 SCHEDULE B - EXEMPT QUANTITIES:
10 TABLE 330.1 Radioactive Material Acronym Microcuries Antimony-122 (Sb-122) 100 Antimony-124 (Sb-124) 10 Antimony-125 (Sb-125) 10 Arsenic-73 (As-73) 100 Arsenic-74 (As-74) 10 Arsenic-76 (As-76) 10 Arsenic-77 (As-77) 100 Barium-131 (Ba-131) 10 Barium-133 (Ba-133) 10 Barium-140 (Ba-140) 10 Bismuth-210 (Bi-210) 1 Bromine-82 (Br-82) 10 Cadmium-109 (Cd-109) 10 Cadmium-115m (Cd-115m) 10 Cadmium-115 (Cd-115) 100 Calcium-45 (Ca-45) 10 Calcium-47 (Ca-47) 10 Carbon-14 (C-14) 100 Cerium-141 (Ce-141) 100 Cerium-143 (Ce-143) 100 Cerium-144 (Ce-144) 1 Cesium-129 (Cs-129) 100 Cesium-131 (Cs-131) 1,000 Cesium-134m (Cs-134m) 100 Cesium-134 (Cs-134) 1 Cesium-135 (Cs-135) 10 Cesium-136 (Cs-136) 10 Cesium-137 (Cs-137) 10 Chlorine-36 (Cl-36) 10 Chlorine-38 (Cl-38) 10 Chromium-51 (Cr-51) 1,000 Cobalt-57 (Co-57) 100 Cobalt-58m (Co-58m) 10 Cobalt-58 (Co-58) 10 Cobalt-60 (Co-60) 1 Copper-64 (Cu-64) 100 Dysprosium-165 (Dy-165) 10 Dysporsium-166 (Dy-166) 100 Erbium-169 (Er-169) 100 Erbium-17 (Er-171) 100 Europium-152(9.2h) (Eu-152) 100
20.3.3 NMAC 50 TABLE 330.1 Radioactive Material Acronym Microcuries Europium-152(13y) (Eu-152) 1 Europium-154 (Eu-154) 1 Europium-155 (Eu-155) 10 Fluorine-18 (F-18) 1,000 Gadolinium-153 (Gd-153) 10 Gadolinium-159 (Gd-159) 100 Gallium-67 (Ga-67) 100 Gallium-72 (Ga-72) 10 Germanium-68 (Ge-68) 10 Germanium-71 (Ge-71) 100 Gold-195 (Au-195) 10 Gold-198 (Au-198) 100 Gold-199 (Au-199) 100 Hafnium-181 (Hf-181) 10 Holmium-166 (Ho-166) 100 Hydrogen-3 (H-3) 1,000 Indium-111 (In-111) 100 Indium-113m (In-113m) 100 Indium-114m (In-114m) 10 Indium-115m (In-115m) 100 Indium-115 (In-115) 10 Iodine-123 (I-123) 100 Iodine-125 (I-125) 1 Iodine-126 (I-126) 1 Iodine-129 (I-129) 0.1 Iodine-131 (I-131) 1 Iodine-132 (I-132) 10 Iodine-133 (I-133) 1 Iodine-134 (I-134) 10 Iodine-135 (I-135) 10 Iridium-192 (Ir-192) 10 Iridum-194 (Ir-194) 100 Iron-52 (Fe-52) 10 Iron-55 (Fe-55) 100 Iron-59 (Fe-59) 10 Krypton-85 (Kr-85) 100 Krypton-87 (Kr-87) 10 Lanthanum-140 (La-140) 10 Lutetium-177 (Lu-177) 100 Manganese-52 (Mn-52) 10 Manganese-54 (Mn-54) 10 Manganese-56 (Mn-56) 10 Mercury-197m (Hg-197m) 100 Mercury-197 (Hg-197) 100 Mercury-203 (Hg-203) 10 Molybdenum-99 (Mo-99) 100 Neodymium-147 (Nd-147) 100 Neodymium-149 (Nd-149) 100 Nickel-59 (Ni-59) 100 Nickel-63 (Ni-63) 10
20.3.3 NMAC 51 TABLE 330.1 Radioactive Material Acronym Microcuries Nickel-65 (Ni-65) 100 Niobium-93m (Nb-93m) 10 Niobium-95 (Nb-95) 10 Niobium-97 (Nb-97) 10 Osmium-185 (Os-185) 10 Osmium-191m (Os-191m) 100 Osmium-191 (Os-191) 100 Osmium-193 (Os-193) 100 Palladium-103 (Pd-103) 100 Palladium-109 (Pd-109) 100 Phosphorus-32 (P-32) 10 Platinum-191 (Pt-191) 100 Platinum-193m (Pt-193m) 100 Platinum-193 (Pt-193) 100 Platinum-197m (Pt-197m) 100 Platinum-197 (Pt-197) 100 Polonium-210 (Po-210) 0.1 Potassium-42 (K-42) 10 Potassium-43 (K-43) 10 Praseodymium-142 (Pr-142) 100 Praseodymium-143 (Pr-143) 100 Promethium-147 (Pm-147) 10 Promethium-149 (Pm-149) 10 Rhenium-186 (Re-186) 100 Rhenium-188 (Re-188) 100 Rhodium-103m (Rh-103m) 100 Rhodium-105 (Rh-105) 100 Rubidium-81 (Rb-81) 10 Rubidium-86 (Rb-86) 10 Rubidium-87 (Rb-87) 10 Ruthenium-97 (Ru-97) 100 Ruthenium-103 (Ru-103) 10 Ruthenium-105 (Ru-105) 10 Ruthenium-106 (Ru-106) 1 Samarium-151 (Sm-151) 10 Samarium-153 (Sm-153) 100 Scandium-46 (Sc-46) 10 Scandium-47 (Sc-47) 100 Scandium-48 (Sc-48) 10 Selenium-75 (Se-75) 10 Silicon-31 (Si-31) 100 Silver-105 (Ag-105) 10 Silver-110m (Ag-110m) 1 Silver-111 (Ag-111) 100 Sodium-22 (Na-22) 10 Sodium-24 (Na-24) 10 Strontium-85 (Sr-85) 10 Strontium-89 (Sr-89) 1 Strontium-90 (Sr-90) 0.1 Strontium-91 (Sr-91) 10
20.3.3 NMAC 52 TABLE 330.1 Radioactive Material Acronym Microcuries Strontium-92 (Sr-92) 10 Sulphur-35 (S-35) 100 Tantalum-182 (Ta-182) 10 Technetium-96 (Tc-96) 10 Technetium-97m (Tc-97m) 100 Technetium-97 (Tc-97) 100 Technetium-99m (Tc-99m) 100 Technetium-99 (Tc-99) 10 Tellurium-125m (Te-125m) 10 Tellurium-127m (Te-127m) 10 Tellurium-127 (Te-127) 100 Tellurium-129m (Te-129m) 10 Tellurium-129 (Te-129) 100 Tellurium-131m (Te-131m) 10 Tellurium-132 (Te-132) 10 Terbium-160 (Tb-160) 10 Thallium-200 (T1-200) 100 Thallium-201 (T1-201) 100 Thallium-202 (T1-202) 100 Thallium-204 (T1-204) 10 Thulium-170 (Tm-170) 10 Thulium-171 (Tm-171) 10 Tin-113 (Sn-113) 10 Tin-125 (Sn-125) 10 Tungsten-181 (W-181) 10 Tungsten-185 (W-185) 10 Tungsten-187 (W-187) 100 Vanadium-48 (V-48) 10 Xenon-131m (Xe-131m) 1,000 Xenon-133 (Xe-133) 100 Xenon-135 (Xe-135) 100 Ytterbium-175 (Yb-175) 100 Yttrium-87 (Y-87) 10 Yttrium-88 (Y-88) 10 Yttrium-90 (Y-90) 10 Yttrium-91 (Y-91) 10 Yttrium-92 (Y-92) 100 Yttrium-93 (Y-93) 100 Zinc -65 (Zn -65) 10 Zinc -69m (Zn -69m) 100 Zinc -69 (Zn -69) 1,000 Zirconium -93 (Zr-93) 10 Zirconium -95 (Zr-95) 10 Zirconium -97 (Zr-97) 10 Any radioactive material not listed above 0.1 other than alpha emitting radioactive material 1 Table 330.1 note: to convert microcuries to SI units of kilobecquerels multiply the above values by 37. For 2 example: Zirconium-97 of 10 microcuries multiplied by 37 is equivalent to 370 kilobecquerels.
3 [20.3.3.330 NMAC - Rp, 20.3.3.330 NMAC, 4/30/2009]
4 5 20.3.3.331 [RESERVED]
20.3.3 NMAC 53 1 [20.3.3.331 NMAC - Rp, 20.3.3.331 NMAC, 4/30/2009; Repealed, 6/30/2011]
2 3 20.3.3.332 SCHEDULE D - RADIOACTIVE MATERIAL QUANTITIES FOR BROAD SCOPE 4 LICENSES:
5 A. Table 332.1 TABLE 332.1 Radioactive Material Column I Column II curies curies Antimony-122 1 0.01 Antimony-124 1 0.01 Antimony-125 1 0.01 Arsenic-73 10 0.1 Arsenic-74 1 0.01 Arsenic-76 1 0.01 Arsenic-77 10 0.1 Barium-131 10 0.1 Barium-140 1 0.01 Beryllium-7 10 0.1 Bismuth-210 0.1 0.001 Bromine-82 10 0.1 Cadmium-109 1 0.01 Cadmium-115m 1 0.01 Cadmium-115 10 0.1 Calcium-45 1 0.01 Calcium-47 10 0.1 Carbon-14 100 1.0 Cerium-141 10 0.1 Cerium-143 10 0.1 Cerium-144 0.1 0.001 Cesium-131 100 1.0 Cesium-134m 100 1.0 Cesium-134 0.1 0.001 Cesium-135 1 0.01 Cesium-136 10 0.1 Cesium-137 0.1 0.001 Chlorine-36 1 0.01 Chlorine-38 100 1.0 Chromium-51 100 1.0 Cobalt-57 10 0.1 Cobalt-58m 100 1.0 Cobalt-58 1 0.01 Cobalt-60 0.1 0.001 Copper-64 10 0.1 Dysprosium-165 100 1.0 Dysprosium-166 10 0.1 Erbium-169 10 0.1 Erbium-171 10 0.1 Europium-152 (9.2 h) 10 0.1 Europium-152 (13 y) 0.1 0.001 Europium-154 0.1 0.001 Europium-155 1 0.01 Fluorine-18 100 1.0 Gadolinium-153 1 0.01
20.3.3 NMAC 54 TABLE 332.1 Radioactive Material Column I Column II curies curies Gadolinium-159 10 0.1 Gallium-72 10 0.1 Germanium-71 100 1.0 Gold-198 10 0.1 Gold-199 10 0.1 Hafnium-181 1 0.01 Holmium-166 10 0.1 Hydrogen-3 100 1.0 Indium-113m 100 1.0 Indium-114m 1 0.01 Indium-115m 100 1.0 Indium-115 1 0.01 Iodine-125 0.1 0.001 Iodine-126 0.1 0.001 Iodine-129 0.1 0.01 Iodine-131 0.1 0.001 Iodine-132 10 0.1 Iodine-133 1 0.01 Iodine-134 10 0.1 Iodine-135 1 0.01 Iridium-192 1 0.01 Iridium-194 10 0.1 Iron-55 10 0.1 Iron-59 1 0.01 Krypton-85 100 1.0 Krypton-87 10 0.1 Lanthanum-140 1 0.01 Lutetium-177 10 0.1 Manganese-52 1 0.01 Manganese-54 1 0.01 Manganese-56 10 0.1 Mercury-197m 10 0.1 Mercury-197 10 0.1 Mercury-203 1 0.01 Molybdenum-99 10 0.1 Neodymium-147 10 0.1 Neodymium-149 10 0.1 Nickel-59 10 0.1 Nickel-63 1 0.01 Nickel-65 10 0.1 Niobium-93 1 0.01 Niobium-95 1 0.01 Niobium-97 100 1.0 Osmium-185 1 0.01 Osmium-191m 100 1.0 Osmium-191 10 0.1 Osmium-193 10 0.1 Palladium-103 10 0.1 Palladium-109 10 0.1
20.3.3 NMAC 55 TABLE 332.1 Radioactive Material Column I Column II curies curies Phosphorus-32 1 0.01 Platinum-191 10 0.1 Platinum-193m 100 1.0 Platinum-193 10 0.1 Platinum-197m 100 1.0 Platinum-197 10 0.1 Polonium-210 0.01 0.0001 Potassium-42 1 0.01 Praseodymium-142 10 0.1 Praseodymium-143 10 0.1 Promethium-147 1 0.01 Promethium-149 10 0.1 Radium-226 0.01 0.0001 Rhenium-186 10 0.1 Rhenium-188 10 0.1 Rhodium-103m 1,000 10.0 Rhodium-105 10 0.1 Rubidium-86 1 0.01 Rubidium-87 1 0.01 Ruthenium-97 100 1.0 Ruthenium-103 1 0.01 Ruthenium-105 10 0.1 Ruthenium-106 0.1 0.001 Samarium-151 1 0.01 Samarium-153 10 0.1 Scandium-46 1 0.01 Scandium-47 10 0.1 Scandium-48 1 0.01 Selenium-75 1 0.01 Silicon-31 10 0.1 Silver-105 1 0.01 Silver-110m 0.1 0.001 Silver-111 10 0.1 Sodium-22 0.1 0.001 Sodium-24 1 0.01 Strontium-85m 1,000 10.0 Strontium-85 1 0.01 Strontium-89 1 0.01 Strontium-90 0.01 0.0001 Strontium-91 10 0.1 Strontium-92 10 0.1 Sulphur-35 10 0.1 Tantalum-182 1 0.01 Technetium-96 10 0.1 Technetium-97m 10 0.1 Technetium-97 10 0.1 Technetium-99m 100 1.0 Technetium-99 1 0.01 Tellurium-125m 1 0.01
20.3.3 NMAC 56 TABLE 332.1 Radioactive Material Column I Column II curies curies Tellurium-127m 1 0.01 Tellurium-127 10 0.1 Tellurium-129m 1 0.01 Tellurium-129 100 1.0 Tellurium-131m 10 0.1 Tellurium-132 1 0.01 Terbium-160 1 0.01 Thallium-200 10 0.1 Thallium-201 10 0.1 Thallium-202 10 0.1 Thallium-204 1 0.01 Thulium-170 1 0.01 Thulium-171 1 0.01 Tin-113 1 0.01 Tin-125 1 0.01 Tungsten-181 1 0.01 Tungsten-185 1 0.01 Tungsten-187 10 0.1 Vanadium-48 1 0.01 Xenon-131m 1,000 10.0 Xenon-133 100 1.0 Xenon-135 100 1.0 Ytterbium-175 10 0.1 Yttrium-90 1 0.01 Yttrium-91 1 0.01 Yttrium-92 10 0.1 Yttrium-93 1 0.01 Zinc -65 1 0.01 Zinc -69m 10 0.1 Zinc -69 100 1.0 Zirconium -93 1 0.01 Zirconium -95 1 0.01 Zirconium -97 1 0.01 Any radioactive material other than source 0.1 0.001 material, special nuclear material, or alpha emitting radioactive material not listed above 1 B. Note. To convert curies to SI units of gigabecquerels, multiply the above values by 37. For 2 example: Zirconium-97 (Column II) of 0.01 curie multiplied by 37 is equivalent to 0.37 gigabecquerel.
3 [20.3.3.332 NMAC - Rp, 20.3.3.332 NMAC, 4/30/2009]
4 5 20.3.3.333 SCHEDULE E - QUANTITIES OF RADIOACTIVE MATERIALS REQUIRING 6 CONSIDERATION OF THE NEED FOR AN EMERGENCY PLAN FOR RESPONDING TO A RELEASE:
7 A. Table 333.1 TABLE 333.1 Radioactive Material Release Quantity Fraction (Curies)
Actinium-228 0.001 4,000 Americium-241 0.001 2 Americium-242 0.001 2
20.3.3 NMAC 57 TABLE 333.1 Radioactive Material Release Quantity Fraction (Curies)
Americium-243 0.001 2 Antimony-124 0.01 4,000 Antimony-126 0.01 6,000 Barium-133 0.01 10,000 Barium-140 0.01 30,000 Bismuth-207 0.01 5,000 Bismuth-210 0.01 600 Cadmium-109 0.01 1,000 Cadmium-113 0.01 80 Calcium-45 0.01 20,000 Californium-252 0.001 9 (20 mg)
Carbon-14 (Non CO2) 0.01 50,000 Cerium-141 0.01 10,000 Cerium-144 0.01 300 Cesium-134 0.01 2,000 Cesium-137 0.01 3,000 Chlorine-36 0.5 100 Chromium-51 0.01 300,000 Cobalt-60 0.001 5,000 Copper-64 0.01 200,000 Curium-242 0.001 60 Curium-243 0.001 3 Curium-244 0.001 4 Curium-245 0.001 2 Europium-152 0.01 500 Europium-154 0.01 400 Europium-155 0.01 3,000 Gadolinium-153 0.01 5,000 Germanium-68 0.01 2,000 Gold-198 0.01 30,000 Hafnium-172 0.01 400 Hafnium-181 0.01 7,000 Holmium-166m 0.01 100 Hydrogen-3 0.5 20,000 Iodine-125 0.5 10 Iodine-131 0.5 10 Indium-114m 0.01 1,000 Iridium-192 0.001 40,000 Iron-55 0.01 40,000 Iron-59 0.01 7,000 Krypton-85 1.0 6,000,000 Lead-210 0.01 8 Manganese-56 0.01 60,000 Mercury-203 0.01 10,000 Molybdenum-99 0.01 30,000 Neptunium-237 0.001 2 Nickel-63 0.01 20,000 Niobium-94 0.01 300 Phosphorus-32 0.5 100
20.3.3 NMAC 58 TABLE 333.1 Radioactive Material Release Quantity Fraction (Curies)
Phosphorus-33 0.5 1,000 Polonium-210 0.01 10 Potassium-42 0.01 9,000 Promethium-145 0.01 4,000 Promethium-147 0.01 4,000 Radium-226 0.001 100 Ruthenium-106 0.01 200 Samarium-151 0.01 4,000 Scandium-46 0.01 3,000 Selenium-75 0.01 10,000 Silver-110m 0.01 1,000 Sodium-22 0.01 9,000 Sodium-24 0.01 10,000 Strontium-89 0.01 3,000 Strontium-90 0.01 90 Sulfur-35 0.5 900 Technetium-99 0.01 10,000 Technetium-99m 0.01 400,000 Tellurium-127m 0.01 5,000 Tellurium-129m 0.01 5,000 Terbium-160 0.01 4,000 Thulium-170 0.01 4,000 Tin-113 0.01 10,000 Tin-123 0.01 3,000 Tin-126 0.01 1,000 Titanium-44 0.01 100 Vanadium-48 0.01 7,000 Xenon-133 1.0 900,000 Yttrium-91 0.01 2,000 Zinc -65 0.01 5,000 Zirconium -93 0.01 400 Zirconium -95 0.01 5,000 Any other beta-gamma emitter.01 10,000 Mixed fission products.01 1,000 Mixed corrosion products.01 10,000 Contaminated equipment beta-gamma.001 10,000 Irradiated material, any form other.01 1,000 than solid. noncombustible Irradiated material solid, noncombustible.001 10,000 Mixed radioactive waste, beta-gamma.01 1,000 Packaged mixed waste, beta-gamma.001 10,000 Any other alpha emitter.001 2 Contaminated equipment alpha.0001 20 Packaged waste, alpha1.0001 20 1 Table 333.1 note:
2 1 waste packaged in Type B containers does not require an emergency plan.
3 B. Notes.
4 (1) To convert curies to SI units of gigabecquerels, multiply the above values by 37.
5 Example: Zirconium-95 of 5000 curies multiplied by 37 is equivalent to 185,000 gigabecquerels or 185 6 terabecquerels.
20.3.3 NMAC 59 1 (2) For combinations of radioactive materials, consideration of the need for an emergency 2 plan is required if the sum of the ratios of the quantity of each radioactive material authorized to the quantity listed 3 for that material in table 333.1 exceeds one.
4 [20.3.3.333 NMAC - Rp, 20.3.3.333 NMAC, 4/30/2009]
5 6 20.3.3.334 CRITERIA RELATING TO USE OF FINANCIAL TESTS AND PARENT COMPANY 7 GUARANTEES FOR PROVIDING REASONABLE ASSURANCE OF FUNDS FOR 8 DECOMMISSIONING:
9 A. Introduction. An applicant or licensee may provide reasonable assurance of the availability of 10 funds for decommissioning based on obtaining a parent company guarantee that funds will be available for 11 decommissioning costs and on a demonstration that the parent company passes a financial test. This section 12 establishes criteria for passing the financial test and for obtaining the parent company guarantee.
13 B. Financial Test.
14 (1) To pass the financial test, the parent company must meet the criteria of eith er 15 Subparagraphs (a) or (b) of this paragraph.
16 (a) The parent company must have:
17 (i) two of the following three ratios: a ratio of total liabilities to net worth 18 less than 2.0; a ratio of the sum of net income plus depreciation, depletion and amort ization to total liabilities greater 19 than 0.1; and a ratio of current assets to current liabilities greater than 1.5; 20 (ii) net working capital and tangible net worth each at least six times the 21 current decommissioning cost estimates (or prescribed amou nt if a certification is used);
22 (iii) tangible net worth of at least $10 million; and 23 (iv) assets located in the United States amounting to at least 90 percent of 24 total assets or at least six times the current decommissioning cost estimates (or prescribed amount if a certification is 25 used);
26 (b) The parent company must have:
27 (i) a current rating for its most recent bond issuance of AAA, AA, A or 28 BBB as issued by Standard and Poor's or Aaa, Aa, A or Baa as issued by Moody's; 29 (ii) tangible net worth at least six times the current decommissioning cost 30 estimate (or prescribed amount if a certification is used);
31 (iii) tangible net worth of at least $10 million; and 32 (iv) assets located in the United States amounting to at least 90 percent of 33 total assets or at least six times the current decommissioning cost estimates for the total of all facilities or parts 34 thereof (or prescribed amount if certification is used).
35 (2) The parent company's independent certified public acc ountant must have compared the 36 data used by the parent company in the financial test, which is derived from the independently audited, year end 37 financial statements for the latest fiscal year, with the amounts in such financial statement. In connection wi th that 38 procedure the licensee shall inform the department within 90 days of any matters coming to the auditor's attention 39 which cause the auditor to believe that the data specified in the financial test shall be adjusted and that the company 40 no longer pas ses the test.
41 (3) After the initial financial test, the parent company must repeat the passage of the test 42 within 90 days after the close of each succeeding fiscal year.
43 (4) If the parent company no longer meets the requirements of Subsection A of this section, 44 the licensee must send notice to the department of intent to establish alternate financial assurance as specified in this 45 section. The notice must be sent by certified mail within 90 days after the end of the fiscal year for which the year 46 end financial data show that the parent company no longer meets the financial test requirements. The licensee must 47 provide alternate financial assurance within 120 days after the end of such fiscal year.
48 C. Parent Company Guarantee. The terms of a parent com pany guarantee which an applicant or 49 licensee obtains must provide the following.
50 (1) The parent company guarantee will remain in force unless the guarantor sends notice of 51 cancellation by certified mail to the licensee and the department; cancellation m ay not occur, however, during the 52 120 days beginning on the date of receipt of the notice of cancellation by both the licensee and the department, as 53 evidenced by the return receipts.
54 (2) If the licensee fails to provide alternate financial assurance as specified in the 55 departments regulations within 90 days after receipt by the licensee and department of a notice of cancellation of 56 the parent company guarantee from the guarantor, the guarantor will provide such alternative financial assurance in
20.3.3 NMAC 60 1 the name of the licensee.
2 (3) The parent company guarantee and financial test provisions must remain in effect until 3 the department has terminated the license.
4 (4) If a trust is established for decommissioning costs, the trustee and trust must be 5 acceptable to the department; an acceptable trustee includes an appropriate state or federal government agency or an 6 entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a federal 7 or state agency.
8 [20.3.3.334 NMAC - Rp, 20.3.3.334 NMAC, 4/30/2009]
9 10 20.3.3.335 CRITERIA RELATING TO USE OF FINANCIAL TESTS AND SELF-GUARANTEES 11 FOR PROVIDING REASONABLE ASSURANCE OF FUNDS FOR DECOMMISSIONING:
12 A. Introduction. An applicant or licensee may provide reasonable assurance of the availability of 13 funds for decommissioning based on furnishing its own guarantee that funds will be available for decommissioning 14 costs and on a demonstration that the company passes the financial test of Subsection B of this section. The terms of 15 the self-guarantee are in Subsection C of this section. This section establishes criteria for passing the financial test 16 for the self guarantee and establishes the terms for a self -guarantee.
17 B. Financial Test.
18 (1) To pass the financial test, a company must meet all of the following criteria:
19 (a) tangible net worth at least 10 times the total current decommissioning cost 20 estimate for the total of all facilities or parts thereof (or the current amount required if certification is used) for all 21 decommissioning activities for which the company is responsible as self -guaranteeing licensee and as parent-22 guarantor; 23 (b) assets located in the United States amounting to at least 90 percent of total assets 24 or at least 10 times the total current decommissioning cost estimate for the total of all facilities of parts thereof (or 25 the current amount required if certification is used) for all decommissioning activities for which the company is 26 responsible as self-guaranteeing licensee and as parent-guarantor; and 27 (c) a current rating for its most recent bond issuance of AAA, AA or A as issued by 28 Standard and Poors, or Aaa, Aa or A as issued by Moodys.
29 (2) To pass the financial test, a company must meet all of the following additional 30 requirements:
31 (a) the company must have at least one class of equity securities registered under 32 the Securities Exchange Act; 33 (b) the company's independent certified public accountant must have compared the 34 data used by the company in the financial test which is derived from the independently audited, year -end financial 35 statements for the latest fiscal year, with the amounts in such financial statement; in connection with that procedure, 36 the licensee shall inform the department within 90 days of any matters coming to the attention of the auditor that 37 cause the auditor to believe that the data specified in the financial test shall be adjusted and that the company no 38 longer passes the test; and 39 (c) after the initial financial test, the company must repeat passage o f the test within 40 90 days after the close of each succeeding fiscal year.
41 (3) If the licensee no longer meets the requirements of Paragraph (1) of Subsection B of this 42 section, the licensee must send immediate notice to the department of its intent to establish alternate financial 43 assurance as specified in the department's regulations within 120 days of such notice.
44 C. Company Self-Guarantee. The terms of a self -guarantee which an applicant or licensee 45 furnishes must provide the following.
46 (1) The guarantee will remain in force unless the licensee sends notice of cancellation by 47 certified mail to the department; cancellation may not occur, however, during the 120 days beginning on the date of 48 receipt of the notice of cancellation by the department, as evidenced by the return receipt.
49 (2) The licensee shall provide alternative financial assurance as specified in 20.3.3.311 50 NMAC within 90 days following receipt by the department of a notice of cancellation of the guarantee.
51 (3) The guarantee and financial test provisions must remain in effect until the department has 52 terminated the license or until another financial assurance method acceptable to the department has been put in 53 effect by the licensee.
54 (4) The licensee will promptly forward to the department and the licensee's independent 55 auditor all reports covering the latest fiscal year filed by the licensee with the securities and exchange commission 56 pursuant to the requirements of Section 13 of the Securities and Exchange Act.
20.3.3 NMAC 61 1 (5) If, at any time, the licensee's most recent bond issuance ceases to be rated in any category 2 of A or above by either Standard and Poors or Moodys, the licensee will provide notice in writing of such fact to 3 the department within 20 days after publication of the change by the rating service. If the licensee's most recent 4 bond issuance ceases to be rated in any category of A or above by both Standard and Poors and Moodys, the 5 licensee no longer meets the requirements of Paragraph (1) of Subsection B of this section.
6 (6) The applicant or licensee must provide to the department a written guarantee (a written 7 commitment by a corporate officer) which states that the licensee will fund and carry out the required 8 decommissioning activities or, upon issuance of an order b y the department, the licensee will set up and fund a trust 9 in the amount of the current cost estimates for decommissioning.
10 [20.3.3.335 NMAC - Rp, 20.3.3.335 NMAC, 4/30/2009]
11 12 20.3.3.336 CRITERIA RELATING TO USE OF FINANCIAL TESTS AND SELF-GUARANTEES 13 FOR PROVIDING REASONABLE ASSURANCE OF FUNDS FOR DECOMMISSIONING BY 14 COMMERCIAL COMPANIES THAT HAVE NO OUTSTANDING RATED BONDS:
15 A. Introduction. An applicant or licensee may provide reasonable assurance of the availability of 16 funds for decommissioning based on furnishing its own guarantee that funds will be available for decommissioning 17 costs and on a demonstration that the company passes the financial test of Subsection B of this section. The terms of 18 the self-guarantee are in Subsection C of this section. T his section establishes criteria for passing the financial test 19 for the self guarantee and establishes the terms for a self -guarantee.
20 B. Financial Test.
21 (1) To pass the financial test, a company must meet the following criteria:
22 (a) tangible net wor th greater than $10 million, or at least 10 times the total current 23 decommissioning cost estimate (or the current amount required if certification is used), whichever is greater, for all 24 decommissioning activities for which the company is responsible as se lf-guaranteeing licensee and as parent-25 guarantor; 26 (b) assets located in the United States amounting to at least 90 percent of total assets 27 or at least 10 times the total current decommissioning cost estimate (or the current amount required if certification is 28 used) for all decommissioning activities for which the company is responsible as self -guaranteeing licensee and as 29 parent-guarantor; and 30 (c) a ratio of cash flow divided by total liabilities greater than 0.12 and a ratio of 31 total liabilities divided by net worth less than 1.5.
32 (2) In addition, to pass the financial test, a company must meet all of the following 33 requirements:
34 (a) the company's independent certified public accountant must have compared the 35 data used by the company in the financ ial test which is derived from the independently audited, year-end financial 36 statements for the latest fiscal year, with the amounts in such financial statement; in connection with that procedure, 37 the licensee shall inform the department within 90 days of any matters coming to the attention of the auditor that 38 cause the auditor to believe that the data specified in the financial test shall be adjusted and that the company no 39 longer passes the test; 40 (b) after the initial financial test, the company must repeat passage of the test within 41 90 days after the close of each succeeding fiscal year; and 42 (c) if the licensee no longer meets the requirements of Paragraph (1) of Subsection 43 B of this section, the licensee must send immediate notice to the department of its intent to establish alternate 44 financial assurance as specified in 20.3.3.311 NMAC; the notice must be sent by certified mail, return receipt 45 requested, within 90 days after the end of the fiscal year for which the year end financial data show that the licensee 46 no longer meets the financial test requirements; the licensee must provide alternative financial assurance within 120 47 days after the end of such fiscal year.
48 C. Company Self-Guarantee. The terms of a self -guarantee which an applicant or lice nsee 49 furnishes must provide the following.
50 (1) The guarantee will remain in force unless the licensee sends notice of cancellation by 51 certified mail to the department; cancellation may not occur until alternative financial assurance mechanism is in 52 place.
53 (2) The licensee shall provide alternative financial assurance as specified in 20.3.3.311 54 NMAC within 90 days following receipt by the department of a notice of cancellation of the guarantee.
55 (3) The guarantee and financial test provisions must remai n in effect until the department has 56 terminated the license or until another financial assurance method acceptable to the department has been put in
20.3.3 NMAC 62 1 effect by the licensee.
2 (4) The applicant or licensee must provide to the department a written guarantee (a written 3 commitment by a corporate officer) which states that the licensee will fund and carry out the required 4 decommissioning activities or, upon issuance of an order by the department, the licensee will set up and fund a trust 5 in the amount of the cur rent cost estimates for decommissioning.
6 [20.3.3.336 NMAC - N, 4/30/2009]
7 8 20.3.3.337 CRITERIA RELATING TO USE OF FINANCIAL TESTS AND SELF-GUARANTEE 9 FOR PROVIDING REASONABLE ASSURANCE OF FUNDS FOR DECOMMISSIONING BY 10 NONPROFIT COLLEGES, UNIVERSITIES AND HOSPITALS:
11 A. Introduction. An applicant or licensee may provide reasonable assurance of the availability of 12 funds for decommissioning based on furnishing its own guarantee that funds will be available for decommissioning 13 costs and on a demonstration that the applicant or licensee passes the financial test of Subsection B of this section.
14 The terms of the self-guarantee are in Subsection C of this section. This section establishes criteria for passing the 15 financial test for the self-guarantee and establishes the terms for a self -guarantee.
16 B. Financial Test.
17 (1) For colleges and universities, to pass the financial test a college or university must meet 18 either the criteria in Subparagraph (a) or the criteria in Subparagraph (b) of this paragraph.
19 (a) For applicants or licensees that issue bonds, a current rating for its most recent 20 uninsured, uncollateralized and unencumbered bond issuance of AAA, AA or A as issued by Standard and Poors or 21 Aaa, Aa or A as issued by Moodys.
22 (b) For applicants or licensees that do not issue bonds, unrestricted endowment 23 consisting of assets located in the United States of at least $50 million, or at least 30 times the total current 24 decommissioning cost estimate (or the current amount required if certification is used), whichever is greater, for all 25 decommissioning activities for which the college or university is responsible as a self -guaranteeing licensee.
26 (2) For hospitals, to pass the financial test a hospital must meet either the criteria in 27 Subparagraph (a) or the criteria in Subparagraph (b) of this paragraph.
28 (a) For applicants or licensees that issue bonds, a current rating for its most recent 29 uninsured, uncollateralized, and unencumbered bond issuance of AAA, AA or A as issued by Standard and Poors or 30 Aaa, Aa or A as issued by Moodys.
31 (b) For applicants or licensees that do not issue bonds, all the following tests must 32 be met:
33 (i) total revenues less total expenditures divided by total revenues must be 34 equal to or greater than 0.04; 35 (ii) long term debt divided by net fixed assets must be less than or equal to 36 0.67; 37 (iii) current assets and depreciation fund divided by current liabilities must 38 be greater than or equal to 2.55; and 39 (iv) operating revenues must be at least 100 times the total current 40 decommissioning cost estimate (or the current amount required if certification is used) for all decommissioning 41 activities for which the hospital is responsible as a self-guaranteeing license.
42 (3) In addition, to pass the f inancial test, a licensee must meet all the following requirements:
43 (a) the licensee's independent certified public accountant must have compared the 44 data used by the licensee in the financial test, which is required to be derived from the independently audited year 45 end financial statements, based on United States generally accepted accounting practices, for the latest fiscal year, 46 with the amounts in such financial statement; in connection with that procedure, the licensee shall inform the 47 department within 90 days of any matters coming to the attention of the auditor that cause the auditor to believe that 48 the data specified in the financial test shall be adjusted and that the licensee no longer passes the test; 49 (b) after the initial financial test, the licensee must repeat passage of the test within 50 90 days after the close of each succeeding fiscal year; and 51 (c) if the licensee no longer meets the requirements of Subsection B of this section, 52 the licensee must send notice to the department of its i ntent to establish alternative financial assurance as specified 53 in 20.3.3.311 NMAC; the notice must be sent by certified mail, return receipt requested, within 90 days after the end 54 of the fiscal year for which the year end financial data show that the lic ensee no longer meets the financial test 55 requirements; the licensee must provide alternate financial assurance within 120 days after the end of such fiscal 56 year.
20.3.3 NMAC 63 1 C. Self-Guarantee. The terms of a self -guarantee which an applicant or licensee furnishes mu st 2 provide the following.
3 (1) The guarantee shall remain in force unless the licensee sends notice of cancellation by 4 certified mail and return receipt requested, to the department. Cancellation may not occur unless an alternative 5 financial assurance mechanism is in place.
6 (2) The licensee shall provide alternative financial assurance as specified in the 20.3.3.311 7 NMAC within 90 days following receipt by the department of a notice of cancellation of the guarantee.
8 (3) The guarantee and financial test provisions must remain in effect until the department has 9 terminated the license or until another financial assurance method acceptable to the department has been put in 10 effect by the licensee.
11 (4) The applicant or licensee must provide to the departme nt a written guarantee (a written 12 commitment by a corporate officer or officer of the institution) which states that the licensee will fund and carry out 13 the required decommissioning activities or, upon issuance of an order by the department, the licensee will set up and 14 fund a trust in the amount of the current cost estimates for decommissioning.
15 (5) If, at any time, the licensee's most recent bond issuance ceases to be rated in any category 16 of A or above by either Standard and Poors or Moodys, the lic ensee shall provide notice in writing of such fact to 17 the department within 20 days after publication of the change by the rating service.
18 [20.3.3.337 NMAC - N, 4/30/2009]
19 20 20.3.3.338 QUANTITIES FOR USE WITH DECOMMISSIONING AND QUANTITIES OF 21 LICENSED MATERIAL REQUIRING LABELING:
22 A. Table 338.1 TABLE 338.1 Radioactive Material Microcuries1 Americium-241 0.01 Antimony-122 100 Antimony-124 10 Antimony-125 10 Arsenic-73 100 Arsenic-74 10 Arsenic-76 10 Arsenic-77 100 Barium-131 10 Barium-133 10 Barium-140 10 Bismuth-210 1 Bromine-82 10 Cadmium-109 10 Cadmium-115m 10 Cadmium-115 100 Calcium-45 10 Calcium-47 10 Carbon-14 100 Cerium-141 100 Cerium-143 100 Cerium-144 1 Cesium-131 1,000 Cesium-134m 100 Cesium-134 1 Cesium-135 10 Cesium-136 10 Cesium-137 10 Chlorine-36 10 Chlorine-38 10
20.3.3 NMAC 64 TABLE 338.1 Radioactive Material Microcuries1 Chromium-51 1,000 Cobalt-58m 10 Cobalt-58 10 Cobalt-60 1 Copper-64 100 Dysprosium-165 10 Dysprosium-166 100 Erbium-169 100 Erbium-171 100 Europium-152 (9.2 h) 100 Europium-152 (13 yr) 1 Europium-154 1 Europium-155 10 Florine-18 1,000 Gadolinium-153 10 Gadolinium-159 100 Gallium-72 10 Germanium-71 100 Gold-198 100 Gold-199 100 Hafnium-181 10 Holmium-166 100 Hydrogen-3 1,000 Indium-113m 100 Indium-114m 10 Indium-115m 100 Indium-115 10 Iodine-125 1 Iodine-126 1 Iodine-129 0.1 Iodine-131 1 Iodine-132 10 Iodine-133 1 Iodine-134 10 Iodine-135 10 Iridium-192 10 Iridium-194 100 Iron-55 100 Iron-59 10 Krypton-85 100 Krypton-87 10 Lanthanum-140 10 Lutetium-177 100 Manganese-52 10 Manganese-54 10 Manganese-56 10 Mercury-197m 100 Mercury-197 100 Mercury-203 10 Molybdenum-99 100
20.3.3 NMAC 65 TABLE 338.1 Radioactive Material Microcuries1 Neodymium-147 100 Neodymium-149 100 Nickel-59 100 Nickel-63 10 Nickel-65 100 Niobium-93m 10 Niobium-95 10 Niobium-97 10 Osmium-185 10 Osmium-191m 100 Osmium-191 100 Osmium-193 100 Palladium-103 100 Palladium-109 100 Phosphorus-32 10 Platinum-191 100 Platinum-193m 100 Platinum-193 100 Platinum-197m 100 Platinum-197 100 Plutonium-239 0.01 Polonium-210 0.1 Potassium-42 10 Praseodymium-142 100 Praseodymium-143 100 Promethium-147 10 Promethium-149 10 Radium-226 0.01 Rhenium-186 100 Rhenium-188 100 Rhodium-103m 100 Rhodium-105 100 Rubidium-86 10 Rubidium-87 10 Ruthenium-97 100 Ruthenium-103 10 Ruthenium-105 10 Ruthenium-106 1 Samarium-151 10 Samarium-153 100 Scandium-46 10 Scandium-47 100 Scandium-48 10 Selenium-75 10 Silicon-31 100 Silver-105 10 Silver-110m 1 Silver-111 100 Sodium-22 1 Sodium-24 10
20.3.3 NMAC 66 TABLE 338.1 Radioactive Material Microcuries1 Strontium-89 1 Strontium-90 0.1 Strontium-91 10 Strontium-92 10 Sulfur-35 100 Tantalum-182 10 Technetium-96 10 Technetium-97m 100 Technetium-97 100 Technetium-99m 100 Technetium-99 10 Tellurium-125m 10 Tellurium-127m 10 Tellurium-127 100 Tellurium-129m 10 Tellurium-129 100 Tellurium-131m 10 Tellurium-132 10 Terbium-160 10 Thallium-200 100 Thallium-201 100 Thallium-202 100 Thallium-204 10 Thorium (natural)2 100 Thulium-170 10 Thulium-171 10 Tin-113 10 Tin-125 10 Tungsten-181 10 Tungsten-185 10 Tungsten-187 100 Uranium (natural)3 100 Uranium-233 0.01 Uranium-234 0.01 Uranium-235 0.01 Vanadium-48 10 Xenon-131m 1,000 Xenon-133 100 Xenon-135 100 Ytterbium-175 100 Yttrium-90 10 Yttrium-91 10 Yttrium-92 100 Yttrium-93 100 Zinc-65 10 Zinc-69m 100 Zinc-69 1,000 Zirconium-93 10 Zirconium-95 10 Zirconium-97 10
20.3.3 NMAC 67 TABLE 338.1 Radioactive Material Microcuries1 Any alpha emitting radionuclide not listed 0.01 above or mixtures of alpha emitters of unknown composition Any radionuclide other than alpha 0.1 emitting radionuclides, not listed above or mixtures of beta emitters of unknown composition 1 Table 338.1 notes:
2 1 to convert microcurie to kilobecquerels, multiply the microcurie value by 37; 3 2 based on alpha disintegration rate of Th-232, Th-230 and their daughter products; 4 3 based on alpha disintegration rate of U -238, U-234 and U -235.
5 B. Note. Where a combination of isotopes in known amounts is involved, the limit for the 6 combination shall be derived as follows: determine, for each isotope in the combination, the ratio between the 7 quantity present in the combination and the limit otherwise established for the specific isotope when not in 8 combination. The sum of such ratios for all the isotopes in the combination may not exceed "1" (i.e. unity).
9 [20.3.3.338 NMAC - Rp, 20.3.4.465 NMAC, 4/30/2009]
10 11 HISTORY OF 20.3.3 NMAC:
12 Pre-NMAC History: The material in this p art was derived from that previously filed as follows:
13 EIB 73-2, Regulations for Governing the Health and Environmental Aspects of Radiation filed on 7/9/ 1973; 14 EIB 73-2, Amendment 1, Regulations for Governing the Health and Environmental Aspects of Radiati on filed on 15 4/17/1978; 16 EIB RPR-1, Radiation Protection Regulations filed on 4/21/ 1980; 17 EIB RPR-1, Amendment 1, Radiation Protection Regulations filed on 10/13/ 1981; 18 EIB RPR-1, Amendment 2, Radiation Protection Regulations filed on 12/15/ 1982; and 19 EIB RPR-1, Radiation Protection Regulations filed on 3/10/ 1989.
20 21 History of Repealed Material:
22 20.3.3 NMAC, Licensing of Radioactive Material (filed 03/15/2004) repealed 4/30/2009.
23 24 Other History: EIB RPR 1, Radiation Protection Regulations (filed 3/10/1989) renumbered and reformatted to 20 25 NMAC 3.1; Radioactive Materials and Radiation Machines, effect ive 5/3/1995; 26 20 NMAC 3.1; Radioactive Materials and Radiation Machines (filed 4/3/1995) internally renumbered, reforma tted 27 and replaced by 20 NMAC 3.1, Radioactive Materials and Radiation Machines, effective 7/30/1999.
28 20 NMAC 3.1.Subpart 3, Licensing of Radioactive Material (filed 6/17/1999), reformatted, amended and replaced 29 by 20.3.3 NMAC, Licensing of R adioactive Material, effective 4/15/2004.
30 20.3.3 NMAC, Licensing of Radioactive Material (filed 3/15/2004) replaced by 20.3.3 NMAC, Licensing of 31 Radioactive Material, effective 4/30/2009.
20.3.3 NMAC 68