ML20281A439

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ML20281A439
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Issue date: 10/01/2020
From: Michelle Beardsley
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Beardsley M
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Document 1 HRG Page 19 of 138 1 DRAFT 2 (05/27/2020) 2 DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT 3 Hazardous Materials and Waste Management Division 4 RADIATION CONTROL - LICENSING OF RADIOACTIVE MATERIAL 5 6 CCR 1007-1 PART 03 Commented [JJ1]:

EDITORIAL NOTE 1:

6 [Editors Notes follow the text of the rules at the end of this CCR Document.] These side margin comments as shown here are not part of the rule and are for information only with the intent to aid the 7 _________________________________________________________________________ reader in understanding the proposed changes in the draft regulations. All side margin comments will be removed prior to publication as a final rule.

8 Adopted by the Board of Health on May 17, 2017June 17, 2020; effective June 30, 2017August 14, 9 2020. EDITORIAL NOTE 2:

Except where otherwise indicated, proposed changes herein are derived from NRC Regulatory Action Tracking System 10 (RATS) 2018-1 to address changes made to 10 CFR Part 30, 32 and 35 which were amended in 2018.

11 [ * * * = Unaffected sections or text ]

NRC regulations may be found at:

https://www.nrc.gov/reading-rm/doc-collections/cfr/

12 EDITORIAL NOTE 3: This draft rule includes additional 13 * *

  • changes beyond those proposed in the rule presented to the Board of Health in March 2020. These additions/changes are highlighted in yellow and were added to address changes and 14 3.1.4.3 In accordance with Section 24-4-103(12.5)(c), CRS, updates associated with the documents incorporated by 15 https://www.colorado.gov/cdphe/radregs identifies where incorporated material is reference as proposed in Section 3.1.4.3.

16 available to the public on the internet at no cost. If the incorporated material is not 17 available on the internet at no cost to the public, copies of the incorporated material has Commented [JSJ2]: Adoption and effective dates are 18 been provided to the State Publications Depository and Distribution Center, also known tentative and subject to change, pending Board of Health 19 as the State Publications Library. The State Librarian at the State Publication Library meeting schedule, final adoption of the rule, and the Colorado Register publication dates.

20 retains a copy of the material and will make the copy available to the public.

Commented [JSJ3]: Provisions in section 3.1.4.3, are 21 3.1.4.3 Throughout this Part 3, federal regulations, state regulations, and standards or revised and enhanced for consistency with the Colorado Administrative Procedure Act (24-4-103(12.5)(a)(2), CRS) 22 guidelines of outside organizations have been adopted and incorporated by regarding documents incorporated by reference.

23 reference. Unless a prior version of the incorporated material is otherwise 24 specifically indicated, the materials incorporated by reference cited herein include 25 only those versions that were in effect as of the most recent effective date of this 26 Part 3 (August 2020), and not later amendments or editions of the incorporated 27 material.

28 3.1.4.4 Materials incorporated by reference are available for public inspection, and copies 29 (including certified copies) can be obtained at reasonable cost, during normal 30 business hours from the Colorado Department of Public Health and Environment, 31 Hazardous Materials and Waste Management Division, 4300 Cherry Creek Drive 32 South, Denver, Colorado 80246. Additionally, 33 https://www.colorado.gove/cdphe/radregs identifies where the incorporated federal 34 and state regulations are available to the public on the internet at no cost. A copy 35 of the materials incorporated in this Part is available for public inspection at the 36 state publications depository and distribution center.

37 3.1.4.5 Availability from Source Agencies or Organizations.

38 (1) All federal agency regulations incorporated by reference herein are 39 available at no cost in the online edition of the Code of Federal Regulations 40 (CFR) hosted by the U.S. Government Printing Office, online at 41 www.govinfo.gov.

Document 1 HRG Page 20 of 138 42 (2) All state regulations incorporated by reference herein are available at no 43 cost in the online edition of the Code of Colorado Regulations (CCR) 44 hosted by the Colorado Secretary of States Office, online at 45 https://www.sos.state.co.us/CCR/RegisterHome.do.

46 * *

  • 47 3.3.2.4 No person may, for purposes of commercial distribution, transfer radioactive material in Commented [JSJ4]: The reference to a specific CFR date is 48 the individual quantities set forth in Schedule 3B, knowing or having reason to believe removed in order to defer to the revised standard 49 that such quantities of radioactive material will be transferred to persons exempt under incorporation by reference language in section 3.1.4.

50 3.3.2 or equivalent regulations of NRC or any Agreement State except in accordance with 51 a specific license issued by NRC pursuant to Section 32.18 of 10 CFR Part 32 (January 52 1, 2015), which license states that the radioactive material may be transferred by the 53 licensee to persons exempt under 3.3.2 or the equivalent regulations of NRC or an 54 Agreement State.1 55 * *

  • 56 3.5.8.3 * *
  • Commented [JSJ5]: The reference to a specific CFR date is removed in order to defer to the revised standard 57 (1) * *
  • incorporation by reference language in section 3.1.4.

58 (2) * *

  • 59 (3) * *
  • 60 (4) * *

63 * *

  • 64 3.6.4.2 The general license in 3.6.4.1 applies only to radioactive material contained in devices Commented [JSJ6]: The reference to a specific CFR date is 65 which have been: removed in order to defer to the revised standard incorporation by reference language in section 3.1.4.

66 (1) Manufactured or initially transferred and labeled for distribution to persons 67 generally licensed in accordance with the specifications contained in a specific 68 license issued by:

69 (a) The Department pursuant to 3.12.4 or 70 (b) By NRC or an Agreement State4 4

71 Regulations under the Federal Food, Drug, and Cosmetic Act authorizing the use of radioactive control devices in food production 72 require certain additional labeling thereon which is found in 21 CFR 179.21 (April 1, 2012).

73 (2) Received from one of the specific licensees described in 3.6.4.2(1) or through a 74 transfer made under 3.6.4.3(8).

75 3.6.4.3 Any person who owns, receives, acquires, possesses, uses, owns, or transfers Commented [JSJ7]: The reference to a specific CFR date is 76 radioactive material in a device pursuant to the general license in 3.6.4.1: removed in order to defer to the revised standard incorporation by reference language in section 3.1.4.

77 (1) * *

  • 78 (2) * *
  • 79 (3) * *
  • Document 1 HRG Page 21 of 138 80 (4) * *
  • 81 (5) * *
  • 82 (6) * *
  • 83 (7) Shall not export the device except in accordance with 10 CFR Part 110 (January 84 1, 2015) and shall obtain written approval from NRC before transferring the 85 device to any other specific licensee not specifically identified in 3.6.4.3(8);

86 (8) * *

  • 87 (9) Shall transfer the device to another general licensee only:

88 (a) Where the device remains in use at a particular location.

89 In such case the transferor shall give the transferee a copy of this 90 regulation and any safety documents identified in the label on the device 91 and within 30 days of the transfer, report to the Department the 92 manufacturer's (or initial transferors) name and model number and serial 93 number of device transferred, the identity of the radionuclide(s) present 94 and assayed or calculated activity present, the transferees name and 95 mailing address for the location of use, and the name, title, and phone Commented [JSJ8]: Correction of typographical error by 96 number of the responsible individual identified by the transferee in adding a comma between name and title.

97 accordance with 3.6.4.3(12) to have knowledge of and authority to take 98 actions to ensure compliance with the appropriate regulations and 99 requirements; or 100 * *

  • 101 3.6.5.1 * *
  • Commented [JSJ9]: The reference to a specific CFR date is removed in order to defer to the revised standard 102 (1) * *
  • incorporation by reference language in section 3.1.4.

103 (2) Each device has been manufactured, assembled or imported in accordance with 104 a specific license issued by NRC or each device has been manufactured or 105 assembled in accordance with the specifications contained in a specific license 106 issued by the Department or any Agreement State to the manufacturer or 107 assembler of such device pursuant to licensing requirements equivalent to those 108 in Section 32.53 of 10 CFR Part 32 (January 1, 2015).

109 * *

  • 110 3.6.7.4 The general licenses in 3.6.7.1, 3.6.7.2, and 3.6.7.3 apply only to calibration or reference Commented [JSJ10]: The reference to a specific CFR date 111 sources which have been manufactured in accordance with the specifications contained is removed in order to defer to the revised standard 112 in a specific license issued to the manufacturer or importer of the sources by NRC incorporation by reference language in section 3.1.4.

113 pursuant to Section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70 114 (January 1, 2015) or which have been manufactured in accordance with the 115 specifications contained in a specific license issued to the manufacturer by the 116 Department or any Agreement State pursuant to licensing requirements equivalent to 117 those contained in Section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70 118 (January 1, 2015).

119 * *

  • Commented [JSJ11]: The reference to a specific CFR date 120 3.6.10.1 A general license is hereby issued to receive, acquire, possess, use, and transfer is removed in order to defer to the revised standard 121 strontium-90 contained in ice detection devices, provided each device contains incorporation by reference language in section 3.1.4.

Document 1 HRG Page 22 of 138 122 not more than 1.85 MBq (50 µCi) of strontium-90 and each device has been 123 manufactured or imported in accordance with a specific license issued by NRC or 124 each device has been manufactured in accordance with the specifications 125 contained in a specific license issued by the Department or an Agreement State 126 to the manufacturer of such device pursuant to licensing requirements equivalent 127 to those in Section 32.61 of 10 CFR Part 32 (January 1, 2015).

128 * *

  • 129 DECOMMISSIONING WARRANTY 130 3.9.5.2 The Department may require any licensee to furnish a decommissioning warranty in a Commented [JSJ12]: Here, and in subsequent sections -

131 dollar amount determined by the agencyDepartment as necessary to protect public where applicable - the more generic agency is replaced with 132 health and safety, to ensure corrective action during operation, to ensure Department for clarity and specificity.

133 decontamination and decommissioning of a facility and disposal of radioactive materials The model regulations of the Conference of Radiation Control 134 in the event of abandonment, default or inability of the licensee to meet the requirements Program Directors (CRCPD) Inc., on which this rule is partly 135 of the Act, these regulations, or the license. based, typically use the term agency in its model rules since the actual regulatory agency regulating sources of radiation varies from state to state. The intent is that each regulatory 136 3.9.5.3 The following specific licensees are required to furnish decommissioning warranties: agency will modify the language and specify its specific name or title.

137 (1) Each licensee authorized to possess and use greater than 370 MBq (10 mCi) of 138 source material in a readily dispersible form; and 139 (2) Each licensee authorized to possess and use radioactive material with a half-life 140 greater than 120 days, in quantities:

141 (a) Greater than 103 times the applicable quantity of Schedule 3B in 142 unsealed form. For a combination of isotopes if R divided by 103 is 143 greater than 1 (unity rule), where R is defined here as the sum of the 144 ratios of the quantity of each isotope to the applicable value in Schedule 145 3B.

146 (b) Greater than 1010 times the applicable quantity of Schedule 3B in sealed 147 sources or plated foils. For a combination of isotopes if R divided by 1010 148 is greater than 1 (unity rule), where R is defined in 3.9.5.3(2)(a).

149 (c) 370 Bq (0.01 µCi) shall be used as the Schedule 3B value for any alpha 150 emitting radionuclide not listed in Schedule 3B, or mixtures of alpha 151 emitters of unknown composition, for the purpose of determining if the 152 quantity of licensed radioactive material requires a decommissioning 153 warranty or a decommissioning funding plan as defined in 3.9.6.

154 (3) Former U.S. Atomic Energy Commission or NRC licensed facilities; 155 (4) Radioactive waste collection and/or processing licensees; 156 (5) Radioactive waste disposal licensees; 157 (6) Source material milling licensees; 158 (7) Ore refineries; and 159 (8) Other persons with, or applicants for, a specific license as determined by the 160 agencyDepartment.

161 * *

  • Document 1 HRG Page 23 of 138 162 3.9.6.3 Waste collectors and waste processors, as defined in Part 4, Appendix D, shall establish 163 an agencyDepartment-approved decommissioning funding plan to assure the availability 164 of funds for decommissioning activities conducted over the life of the licensed facility.

165 * *

  • 166 3.11.5 Specific licenses of broad scope are subject to the following conditions:

167 3.11.5.1 Unless specifically authorized, persons licensed pursuant to 3.11 shall not:

168 (1) Conduct tracer studies in the environment involving direct release of radioactive 169 material; 170 (2) Receive, acquire, own, possess, use; or transfer devices containing 3.7 PBq (100 171 kCi) or more of radioactive material in sealed sources used for irradiation of 172 materials; 173 (3) Conduct activities for which a specific license issued by the Department under Commented [JSJ13]: Provision is modified to correct a past 174 3.10, 3.12, or Parts 7, 14, and 18Part 3, 5, or 7 is required; or error in cross references, consistent with similar requirements in 10 CFR 33.17.

175 176 * *

  • 177 3.12.4.5 * *
  • Commented [JSJ14]: The reference to a specific CFR date is removed in order to defer to the revised standard 178 (1) *** incorporation by reference language in section 3.1.4.

179 (2) ***

180 (3) * *

  • 181 (a) Report the information specified in 3.12.4.5(2) to NRC for all transfers of 182 such devices to persons for use under NRC general license in Section 183 31.5 of 10 CFR Part 31 (January 1, 2015).

184 * *

  • 185 3.12.5.1 * *
  • Commented [JSJ15]: The reference to a specific CFR date is removed in order to defer to the revised standard incorporation by reference language in section 3.1.4.

186 (1) * *

  • 187 (2) The applicant satisfies the requirements of Sections 32.53, 32.54, 32.55, and 188 32.56 of 10 CFR Part 32 (January 1, 2015), or their equivalent.

189 * *

  • 190 3.12.6.1 * *
  • Commented [JSJ16]: The reference to a specific CFR date is removed in order to defer to the revised standard incorporation by reference language in section 3.1.4.

191 (1) * *

  • 192 (2) The applicant satisfies the requirements of Sections 32.57, 32.58, and 32.59 of 193 10 CFR Part 32 and Section 70.39 of 10 CFR Part 70 (January 1, 2015) or their 194 equivalent.

195 * *

  • Document 1 HRG Page 24 of 138 196 3.12.9.1 * *
  • Commented [JSJ17]: The reference to a specific CFR date is removed in order to defer to the revised standard incorporation by reference language in section 3.1.4.

197 (1) * *

  • 198 (2) The criteria of Sections 32.61, and 32.62 of 10 CFR Part 32 (January 1, 2015) 199 are met.

200 201 * *

  • 202 203 3.12.10 Manufacture, Preparation, or Transfer for Commercial Distribution of Radioactive Drugs for Commented [JSJ18]: A sentence is added to this provision, 204 Medical Use. consistent with 2018 amendments to 10 CFR 32.72.

NRC RATS 2018-1 205 3.12.10.1 An application for a specific license to manufacture, prepare, or transfer for NRC Compatibility B 206 commercial distribution radioactive drugs containing radioactive material for 207 use by persons authorized underfor medical use pursuant to Part 7 will be 208 approved if:

209 (1) The applicant satisfies the general requirements specified in 3.9; 210 (2) The applicant submits evidence that the applicant is at least one of the following:

211 (a) Registered or licensed with the U.S. Food and Drug Administration 212 (FDA) as the owner or operator of a drug establishment that engages in 213 the manufacture, preparation, propagation, compounding, or processing 214 of a drug under 21 CFR Part 207.20(a);

215 (b) Registered or licensed with the State Board of Pharmacy as a drug 216 manufacturer; 217 (c) Licensed as a pharmacy by the State Board of Pharmacy; 218 (d) Operating as a nuclear pharmacy within a Federal medical institution; or 219 (e) A Positron Emission Tomography (PET) drug production facility 220 registered with the State Board of Pharmacy.

221 (3) The applicant submits information on the radionuclide,; the chemical and 222 physical form,; the maximum activity per vial, syringe, generator, or other 223 container of the radioactive drug,; and the shielding provided by the packaging of 224 the radioactive material to show it is appropriate for safe handling and storage of 225 the radioactive drugs by medical use licensees; and 226 (4) The applicant has procedures to assure which commit to the following labeling Commented [JSJ19]: This provision parallels the 227 requirements: requirements in 10 CFR 32.72(a)(4)) to clarify that the applicant has procedures to address the specified labeling requirements. The radiation program wants to retain the ability 228 (a) A label shall beis affixed to each transport radiation shield, (whether it is to review procedures applicable to labeling.

229 constructed of lead, glass, plastic, or other material) of a radioactive drug 230 to be transferred for commercial distribution. NRC RATS 2018-1 NRC Compatibility B 231 (i) The label shallmust include the radiation symbol prescribed in 232 4.27 and the words CAUTION, RADIOACTIVE MATERIAL or 233 DANGER, RADIOACTIVE MATERIAL; the name of the

Document 1 HRG Page 25 of 138 234 radioactive drug or its abbreviation; and the quantity of 235 radioactivity at a specified date and time.

236 (ii) For radioactive drugs with a half-life greater than 100 days, the 237 time may be omitted.

238 (b) A label shall beis affixed to each syringe, vial, or other container used to 239 hold a radioactive drug to be transferred for commercial distribution. and 240 shall include:The label must include:

241 (i) The radiation symbol prescribed in 4.27 and the words 242 CAUTION, RADIOACTIVE MATERIAL or DANGER, 243 RADIOACTIVE MATERIAL; and 244 (ii) An identifier that ensures that the syringe, vial or other container 245 can be correlated with the information on the transport radiation 246 shield label.

247 3.12.10.2 A radioactive materials licensee who is also licensed by the State Board of 248 Pharmacy:A licensee described by 3.12.10.1(2)(c) or 3.12.10.1(2)(d):

249 (1) May prepare radioactive drugs for medical use, as defined in Part 1, Section 1.2 250 and Part 7, provided that the radioactive drug is prepared by either:

251 (a) An authorized nuclear pharmacist, as specified in 3.12.10.2(2) or 252 3.12.10.2(4), or 253 (b) An individual under the direct supervision of an authorized nuclear 254 pharmacist as specified in Part 7, Section 7.10; 255 (2) May allow a pharmacist to work as an authorized nuclear pharmacist if:

256 (a) This individual qualifies as an Authorized Nuclear Pharmacist as defined 257 in Part 7, Section 7.2; 258 (b) This individual meets the requirements specified in Part 7, Appendix 7C2 259 and Section 7.65, and the licensee has received a Department an 260 approved license amendment identifying this individual as an authorized 261 nuclear pharmacist; or 262 (c) This individual is designated as an authorized nuclear pharmacist in 263 accordance with 3.12.10.2(4).

264 (3) The actions authorized in 3.12.10.2(1) and 3.12.10.2(2) are permitted in spite of 265 more restrictive language in license conditions.

266 (4) May designate a pharmacist (as defined in Part 7, Section 7.2) as an authorized 267 nuclear pharmacist if:

268 (a) The individual was a nuclear pharmacist preparing only radioactive drugs 269 containing accelerator-produced radioactive material, and 270 (b) The individual practiced at a pharmacy at a Government agency or 271 Federally recognized Indian Tribe before November 30, 2007 or at all 272 other pharmacies before August 8, 2009, or an earlier date as noticed by 273 the NRC.

Document 1 HRG Page 26 of 138 274 (5) Shall provide to the Department: a copy of each individuals:

275 (a) A copy of each individuals Ccertification by a specialty board whose Commented [JSJ20]: The proposed changes are being 276 certification process has been recognized by the NRC or an Agreement made for consistency with the 2018 amendments to 10 CFR 277 State as specified in Part 7, Appendix 7C1 with the written attestation 32.72(b)(5)(i).

278 signed by a preceptor as required by Part 7, Appendix 7C, Section Consistent with other changes related to training and 279 7C2.2; or experience requirements in Part 7, the proposed rule removes the written attestation requirement for individuals wanting to 280 (b) The Department, NRC or Agreement State license that allows such be listed as an Authorized Nuclear Pharmacist whose board certification has been recognized by NRC or an Agreement 281 work, or State.

282 (c) NRC master materials licensee permit, or The proposed rule provides some regulatory relief for licensees since the current rule requires both the written attestation and board certification.

283 (d) The permit issued by a licensee or NRC master materials permittee of 284 broad scope or the authorization from a commercial nuclear pharmacy NRC RATS 2018-1 285 authorized to list its own authorized nuclear pharmacist, or NRC Compatibility B 286 (e) Documentation that only accelerator-produced radioactive materials 287 were used in the practice of nuclear pharmacy at a Government agency 288 or Federally recognized Indian Tribe before November 30, 2007 or at all 289 other locations of use before August 8, 2009, or an earlier date as 290 noticed by the NRC; and 291 (f) A copy of the State pharmacy licensure or registration, no later than 30 292 days after the date that the licensee allows, under 3.12.10.2(2)(a) and 293 3.12.10.2(2)(c), the individual to work as an authorized nuclear 294 pharmacist.

295 3.12.10.3 A licensee shall possess and use instrumentation to measure the radioactivity of Commented [JSJ21]: This provision formatted for 296 radioactive drugs. alignment.

297 (1) The licensee shall have procedures for use of the instrumentation.

298 (2) The licensee shall measure, by direct measurement or by combination of 299 measurements and calculations, the amount of radioactivity in dosages of alpha-,

300 beta- or photon-emitting radioactive drugs prior to transfer for commercial 301 distribution.

302 (3) In addition, the licensee shall:

303 (a) Perform tests before initial use, periodically, and following repair, on 304 each instrument for accuracy, linearity and geometry dependence, as 305 appropriate for the use of the instrument; and make adjustments when 306 necessary; and 307 (b) Check each instrument for constancy and proper operation at the 308 beginning of each day of use.

309 3.12.10.4 A licensee shall satisfy the labeling requirements in 3.12.10.1(4). Commented [JSJ22]: This is a new provision, added for consistency with the 2018 amendments to 10 CFR 32.72(d).

310 3.12.10.45 Nothing in this section relieves the licensee from complying with applicable FDA, The provision is added to clarify that the labeling requirements 311 Federal, and state requirements governing radioactive drugs. that applicants commit to are also applicable to current licensees. The language of the current rule lacks clarity in this 312 3.12.11 Reserved. regard.

NRC RATS 2018-1 313 3.12.12 Manufacture and Distribution of Sources or Devices Containing Radioactive Material for Medical NRC Compatibility B 314 Use.

Document 1 HRG Page 27 of 138 315 3.12.12.1 An application for a specific license to manufacture and distribute sources and 316 devices containing radioactive material to persons licensed pursuant to Part 7 for 317 use as a calibration, transmission, or reference source or for the uses listed in 318 Part 7, Sections 7.19, 7.40, 7.42, 7.48 and 7.62 will be approved if:

319 (1) The applicant satisfies the general requirements in 3.9 of this part; 320 (2) The applicant submits sufficient information regarding each type of source or 321 device pertinent to an evaluation of its radiation safety, including:

322 (a) The radioactive material contained, its chemical and physical form, and 323 amount, 324 (b) Details of design and construction of the source or device, 325 (c) Procedures for, and results of, prototype tests to demonstrate that the 326 source or device will maintain its integrity under stresses likely to be 327 encountered in normal use and accidents, 328 (d) For devices containing radioactive material, the radiation profile of a 329 prototype device, 330 (e) Details of quality control procedures to assure that production sources 331 and devices meet the standards of the design and prototype tests, 332 (f) Procedures and standards for calibrating sources and devices, 333 (g) Legend and methods for labeling sources and devices as to their 334 radioactive content, and 335 (h) Instructions for handling and storing the source or device from the 336 radiation safety standpoint; these instructions are to be included on a 337 durable label attached to the source or device or attached to a 338 permanent storage container for the source or device; provided, that 339 instructions which are too lengthy for such label may be summarized on 340 the label and printed in detail on a brochure which is referenced on the 341 label; 342 (3) The label affixed to the source or device, or to the permanent storage container 343 for the source or device, contains information on the radionuclide, quantity, and 344 date of assay, and a statement that the source or device is licensed by the 345 Department for distribution to persons licensed pursuant to Part 7, Sections 7.40 346 and 7.42 or under equivalent licenses of NRC or an Agreement State, provided 347 that such labeling for sources which do not require long term storage may be on 348 a leaflet or brochure which accompanies the source; 349 (4) The source or device has been registered in the Sealed Source and Device 350 Registry.

351 * *

  • 352 3.12.13.4 Each person licensed pursuant to 3.12.13.1 shall:

353 (1) * *

  • 354 (2) * *
  • Document 1 HRG Page 28 of 138 355 (3) * *
  • 356 (4) * *
  • 357 (5) * *
  • 358 (6) Report to NRC all transfers of industrial products or devices to persons for use 359 under NRC general license in Section 40.25 of 10 CFR Part 40 (January 1, 360 2010).

361 * *

  • 362 3.15.6 Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium- Commented [JSJ23]: A sentence is added to this provision, 363 99m generators or rubidium-82 from strontium-82/rubidium-82 generators shall test the generator consistent with 2018 amendments to 10 CFR 30.34.

364 eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, The language adds a reporting requirement for when a 365 respectively, in accordance with Part 7. The licensee shall record the results of each test and generator eluate exceeds specified values.

366 retain each record for 3 years after the record is made. The licensee shall report the results of 367 any test that exceeds the permissible concentration listed in Part 7, Section 7.33.1 at the NRC RATS 2018-1 368 time of generator elution, in accordance with Part 7, Section 7.33.5. NRC Compatibility B 369 * *

  • 370 3.16.2.7 Each licensee or person responsible for a facility or site which includes a non- Commented [JSJ24]: Language updated in this provision 371 exempt source of radiation or which may be contaminated by residual for consistency with other wording in Section 3.16.2.

372 radioactivity shall, no less than 30 days before vacating or relinquishing 373 possession or control of the facility or site, notify the agencyDepartment, in 374 writing, of the intent to vacate.

375 * *

  • 376 3.19 AgencyDepartment Action on Applications to Renew and Amend.

377 * *

  • 378 3.24.4 Each general licensee operating within the state under reciprocity in areas of exclusive federal Commented [JSJ25]: The reference to a specific CFR date 379 jurisdiction shall comply with the applicable provisions of 10 CFR 150.20 (January 1, 2013). is removed in order to defer to the revised standard incorporation by reference language in section 3.1.4.

380 381 * *

  • 382 383

Document 1 HRG Page 29 of 138 384 PART 3, SCHEDULE 3B: EXEMPT QUANTITIES (3.3.2) 385 ` * *

  • 386 [EDITORIAL NOTE - NO CHANGES TO MAIN BODY/TABLE OF SCHEDULE 3B]

387 Note 1: For purposes of 3.9.5.3(5)(a)(2)(a) and 3.9.5.3(5)(b)(2)(b) where there is involved a combination Commented [JSJ26]: Correction of cross-reference errors 388 of radionuclides, the limit for the combination should be derived as follows: in footnotes of Schedule 3B as item (5) does not exist.

389 Determine the amount of each radionuclide possessed and divide by 1,000 times the amount in 390 Schedule 3B for each of those radionuclides when not in combination. The sum of the ratios of those 391 quantities may not exceed 1.

392 Example:

Amount of Radionuclide A possessed +Amount of Radionuclide B possessed 1 1000 x Schedule 3B quantity for 1000 x Schedule 3B quantity for Radionuclide B Radionuclide A.

393 Note 2: To convert microcuries (µCi) to SI units of kilobecquerels (kBq), multiply the above values by 37.

394 Example: Zirconium-97 (10 µCi multiplied by 37 is equivalent to 370 kBq).

395 * *

  • 396 3C.12.1 Except for persons who manufacture, process, or produce self-luminous products Commented [JSJ27]: The reference to a specific CFR date 397 containing tritium, krypton-85, or promethium-147, any person is exempt from is removed in order to defer to the revised standard 398 these regulations to the extent that such person receives, possesses, uses, incorporation by reference language in section 3.1.4.

399 transfers, owns, or acquires tritium, krypton-85 or promethium-147 in self-400 luminous products manufactured, processed, produced, imported, or transferred 401 in accordance with a specific license issued by NRC pursuant to section 32.22 of 402 10 CFR Part 32 (January 1, 2015), which license authorizes the transfer of the 403 product to persons who are exempt from regulatory requirements.

404 * *

  • 405 3C.13.1 Except for persons who manufacture, process, produce, or initially transfer for 406 sale or distribution gas and aerosol detectors containing radioactive material, any 407 person is exempt from the requirements for a license set forth in the Act and from 408 the regulations in 3, 4, 5, 7, 10, 16, and 19 to the extent that such person 409 receives, possesses, uses, transfers, owns, or acquires radioactive material in 410 gas and aerosol detectors designed to protect health, safety, or property and 411 manufactured, processed, produced, or initially transferred in accordance with a 412 specific license issued by NRC18 pursuant to section 32.26 of 10 CFR Part 413 32(January 1, 2015), which license authorizes the initial transfer of the detectors 414 to persons who are exempt from regulatory requirements. This exemption also 415 covers gas and aerosol detectors manufactured or distributed before November 416 30, 2007, in accordance with a specific license issued by NRC or an Agreement 417 State under comparable provisions to 10 CFR Part 32.26 authorizing distribution 418 to persons exempt from regulatory requirements.

419 * *

  • 420 [EDITORIAL NOTE - NO CHANGES TO REMAINDER OF RULE FOLLOWING FOOTNOTES 421 OF SCHEDULE 3B]
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