ML20281A439
| ML20281A439 | |
| Person / Time | |
|---|---|
| Issue date: | 10/01/2020 |
| From: | Michelle Beardsley NRC/NMSS/DMSST |
| To: | |
| Beardsley M | |
| Shared Package | |
| ML20281A277 | List: |
| References | |
| Download: ML20281A439 (11) | |
Text
DRAFT 2 (05/27/2020) 1 DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT 2
Hazardous Materials and Waste Management Division 3
RADIATION CONTROL - LICENSING OF RADIOACTIVE MATERIAL 4
6 CCR 1007-1 PART 03 5
[Editors Notes follow the text of the rules at the end of this CCR Document.]
6 7
Adopted by the Board of Health on May 17, 2017June 17, 2020; effective June 30, 2017August 14, 8
2020.
9 10
[ * * * = Unaffected sections or text ]
11 12 13 3.1.4.3 In accordance with Section 24-4-103(12.5)(c), CRS, 14 https://www.colorado.gov/cdphe/radregs identifies where incorporated material is 15 available to the public on the internet at no cost. If the incorporated material is not 16 available on the internet at no cost to the public, copies of the incorporated material has 17 been provided to the State Publications Depository and Distribution Center, also known 18 as the State Publications Library. The State Librarian at the State Publication Library 19 retains a copy of the material and will make the copy available to the public.
20 3.1.4.3 Throughout this Part 3, federal regulations, state regulations, and standards or 21 guidelines of outside organizations have been adopted and incorporated by 22 reference. Unless a prior version of the incorporated material is otherwise 23 specifically indicated, the materials incorporated by reference cited herein include 24 only those versions that were in effect as of the most recent effective date of this 25 Part 3 (August 2020), and not later amendments or editions of the incorporated 26 material.
27 3.1.4.4 Materials incorporated by reference are available for public inspection, and copies 28 (including certified copies) can be obtained at reasonable cost, during normal 29 business hours from the Colorado Department of Public Health and Environment, 30 Hazardous Materials and Waste Management Division, 4300 Cherry Creek Drive 31 South, Denver, Colorado 80246. Additionally, 32 https://www.colorado.gove/cdphe/radregs identifies where the incorporated federal 33 and state regulations are available to the public on the internet at no cost. A copy 34 of the materials incorporated in this Part is available for public inspection at the 35 state publications depository and distribution center.
36 3.1.4.5 Availability from Source Agencies or Organizations.
37 (1)
All federal agency regulations incorporated by reference herein are 38 available at no cost in the online edition of the Code of Federal Regulations 39 (CFR) hosted by the U.S. Government Printing Office, online at 40 www.govinfo.gov.
41 Commented [JJ1]:
EDITORIAL NOTE 1:
These side margin comments as shown here are not part of the rule and are for information only with the intent to aid the reader in understanding the proposed changes in the draft regulations. All side margin comments will be removed prior to publication as a final rule.
EDITORIAL NOTE 2:
Except where otherwise indicated, proposed changes herein are derived from NRC Regulatory Action Tracking System (RATS) 2018-1 to address changes made to 10 CFR Part 30, 32 and 35 which were amended in 2018.
NRC regulations may be found at:
https://www.nrc.gov/reading-rm/doc-collections/cfr/
EDITORIAL NOTE 3: This draft rule includes additional 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 updates associated with the documents incorporated by reference as proposed in Section 3.1.4.3.
Commented [JSJ2]: Adoption and effective dates are tentative and subject to change, pending Board of Health meeting schedule, final adoption of the rule, and the Colorado Register publication dates.
Commented [JSJ3]: Provisions in section 3.1.4.3, are revised and enhanced for consistency with the Colorado Administrative Procedure Act (24-4-103(12.5)(a)(2), CRS) regarding documents incorporated by reference.
Document 1 HRG Page 19 of 138
(2)
All state regulations incorporated by reference herein are available at no 42 cost in the online edition of the Code of Colorado Regulations (CCR) 43 hosted by the Colorado Secretary of States Office, online at 44 https://www.sos.state.co.us/CCR/RegisterHome.do.
45 46 3.3.2.4 No person may, for purposes of commercial distribution, transfer radioactive material in 47 the individual quantities set forth in Schedule 3B, knowing or having reason to believe 48 that such quantities of radioactive material will be transferred to persons exempt under 49 3.3.2 or equivalent regulations of NRC or any Agreement State except in accordance with 50 a specific license issued by NRC pursuant to Section 32.18 of 10 CFR Part 32 (January 51 1, 2015), which license states that the radioactive material may be transferred by the 52 licensee to persons exempt under 3.3.2 or the equivalent regulations of NRC or an 53 Agreement State.1 54 55 3.5.8.3 * *
- 56 (1) 57 (2) 58 (3) 59 (4) 60 (5)
Shall not export such depleted uranium except in accordance with a license 61 issued by NRC pursuant to 10 CFR Part 110 (January 1, 2015).
62 63 3.6.4.2 The general license in 3.6.4.1 applies only to radioactive material contained in devices 64 which have been:
65 (1)
Manufactured or initially transferred and labeled for distribution to persons 66 generally licensed in accordance with the specifications contained in a specific 67 license issued by:
68 (a)
The Department pursuant to 3.12.4 or 69 (b)
By NRC or an Agreement State4 70 4 Regulations under the Federal Food, Drug, and Cosmetic Act authorizing the use of radioactive control devices in food production 71 require certain additional labeling thereon which is found in 21 CFR 179.21 (April 1, 2012).
72 (2)
Received from one of the specific licensees described in 3.6.4.2(1) or through a 73 transfer made under 3.6.4.3(8).
74 3.6.4.3 Any person who owns, receives, acquires, possesses, uses, owns, or transfers 75 radioactive material in a device pursuant to the general license in 3.6.4.1:
76 (1) 77 (2) 78 (3) 79 Commented [JSJ4]: 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.
Commented [JSJ5]: 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.
Commented [JSJ6]: 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.
Commented [JSJ7]: 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.
Document 1 HRG Page 20 of 138
(4) 80 (5) 81 (6) 82 (7)
Shall not export the device except in accordance with 10 CFR Part 110 (January 83 1, 2015) and shall obtain written approval from NRC before transferring the 84 device to any other specific licensee not specifically identified in 3.6.4.3(8);
85 (8) 86 (9)
Shall transfer the device to another general licensee only:
87 (a)
Where the device remains in use at a particular location.
88 In such case the transferor shall give the transferee a copy of this 89 regulation and any safety documents identified in the label on the device 90 and within 30 days of the transfer, report to the Department the 91 manufacturer's (or initial transferors) name and model number and serial 92 number of device transferred, the identity of the radionuclide(s) present 93 and assayed or calculated activity present, the transferees name and 94 mailing address for the location of use, and the name, title, and phone 95 number of the responsible individual identified by the transferee in 96 accordance with 3.6.4.3(12) to have knowledge of and authority to take 97 actions to ensure compliance with the appropriate regulations and 98 requirements; or 99 100 3.6.5.1 * *
- 101 (1) 102 (2)
Each device has been manufactured, assembled or imported in accordance with 103 a specific license issued by NRC or each device has been manufactured or 104 assembled in accordance with the specifications contained in a specific license 105 issued by the Department or any Agreement State to the manufacturer or 106 assembler of such device pursuant to licensing requirements equivalent to those 107 in Section 32.53 of 10 CFR Part 32 (January 1, 2015).
108 109 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 110 sources which have been manufactured in accordance with the specifications contained 111 in a specific license issued to the manufacturer or importer of the sources by NRC 112 pursuant to Section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70 113 (January 1, 2015) or which have been manufactured in accordance with the 114 specifications contained in a specific license issued to the manufacturer by the 115 Department or any Agreement State pursuant to licensing requirements equivalent to 116 those contained in Section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70 117 (January 1, 2015).
118 119 3.6.10.1 A general license is hereby issued to receive, acquire, possess, use, and transfer 120 strontium-90 contained in ice detection devices, provided each device contains 121 Commented [JSJ8]: Correction of typographical error by adding a comma between name and title.
Commented [JSJ9]: 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.
Commented [JSJ10]: 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.
Commented [JSJ11]: 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.
Document 1 HRG Page 21 of 138
not more than 1.85 MBq (50 µCi) of strontium-90 and each device has been 122 manufactured or imported in accordance with a specific license issued by NRC or 123 each device has been manufactured in accordance with the specifications 124 contained in a specific license issued by the Department or an Agreement State 125 to the manufacturer of such device pursuant to licensing requirements equivalent 126 to those in Section 32.61 of 10 CFR Part 32 (January 1, 2015).
127 128 DECOMMISSIONING WARRANTY 129 3.9.5.2 The Department may require any licensee to furnish a decommissioning warranty in a 130 dollar amount determined by the agencyDepartment as necessary to protect public 131 health and safety, to ensure corrective action during operation, to ensure 132 decontamination and decommissioning of a facility and disposal of radioactive materials 133 in the event of abandonment, default or inability of the licensee to meet the requirements 134 of the Act, these regulations, or the license.
135 3.9.5.3 The following specific licensees are required to furnish decommissioning warranties:
136 (1)
Each licensee authorized to possess and use greater than 370 MBq (10 mCi) of 137 source material in a readily dispersible form; and 138 (2)
Each licensee authorized to possess and use radioactive material with a half-life 139 greater than 120 days, in quantities:
140 (a)
Greater than 103 times the applicable quantity of Schedule 3B in 141 unsealed form. For a combination of isotopes if R divided by 103 is 142 greater than 1 (unity rule), where R is defined here as the sum of the 143 ratios of the quantity of each isotope to the applicable value in Schedule 144 3B.
145 (b)
Greater than 1010 times the applicable quantity of Schedule 3B in sealed 146 sources or plated foils. For a combination of isotopes if R divided by 1010 147 is greater than 1 (unity rule), where R is defined in 3.9.5.3(2)(a).
148 (c) 370 Bq (0.01 µCi) shall be used as the Schedule 3B value for any alpha 149 emitting radionuclide not listed in Schedule 3B, or mixtures of alpha 150 emitters of unknown composition, for the purpose of determining if the 151 quantity of licensed radioactive material requires a decommissioning 152 warranty or a decommissioning funding plan as defined in 3.9.6.
153 (3)
Former U.S. Atomic Energy Commission or NRC licensed facilities; 154 (4)
Radioactive waste collection and/or processing licensees; 155 (5)
Radioactive waste disposal licensees; 156 (6)
Source material milling licensees; 157 (7)
Ore refineries; and 158 (8)
Other persons with, or applicants for, a specific license as determined by the 159 agencyDepartment.
160 161 Commented [JSJ12]: Here, and in subsequent sections -
where applicable - the more generic agency is replaced with Department for clarity and specificity.
The model regulations of the Conference of Radiation Control Program Directors (CRCPD) Inc., on which this rule is partly 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 agency will modify the language and specify its specific name or title.
Document 1 HRG Page 22 of 138
3.9.6.3 Waste collectors and waste processors, as defined in Part 4, Appendix D, shall establish 162 an agencyDepartment-approved decommissioning funding plan to assure the availability 163 of funds for decommissioning activities conducted over the life of the licensed facility.
164 165 3.11.5 Specific licenses of broad scope are subject to the following conditions:
166 3.11.5.1 Unless specifically authorized, persons licensed pursuant to 3.11 shall not:
167 (1)
Conduct tracer studies in the environment involving direct release of radioactive 168 material; 169 (2)
Receive, acquire, own, possess, use; or transfer devices containing 3.7 PBq (100 170 kCi) or more of radioactive material in sealed sources used for irradiation of 171 materials; 172 (3)
Conduct activities for which a specific license issued by the Department under 173 3.10, 3.12, or Parts 7, 14, and 18Part 3, 5, or 7 is required; or 174 175 176 3.12.4.5 177 (1) 178 (2) 179 (3) 180 (a)
Report the information specified in 3.12.4.5(2) to NRC for all transfers of 181 such devices to persons for use under NRC general license in Section 182 31.5 of 10 CFR Part 31 (January 1, 2015).
183 184 3.12.5.1 185 (1) 186 (2)
The applicant satisfies the requirements of Sections 32.53, 32.54, 32.55, and 187 32.56 of 10 CFR Part 32 (January 1, 2015), or their equivalent.
188 189 3.12.6.1 190 (1) 191 (2)
The applicant satisfies the requirements of Sections 32.57, 32.58, and 32.59 of 192 10 CFR Part 32 and Section 70.39 of 10 CFR Part 70 (January 1, 2015) or their 193 equivalent.
194 195 Commented [JSJ13]: Provision is modified to correct a past error in cross references, consistent with similar requirements in 10 CFR 33.17.
Commented [JSJ14]: 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.
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.
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.
Document 1 HRG Page 23 of 138
3.12.9.1 196 (1) 197 (2)
The criteria of Sections 32.61, and 32.62 of 10 CFR Part 32 (January 1, 2015) 198 are met.
199 200 201 202 3.12.10 Manufacture, Preparation, or Transfer for Commercial Distribution of Radioactive Drugs for 203 Medical Use.
204 3.12.10.1 An application for a specific license to manufacture, prepare, or transfer for 205 commercial distribution radioactive drugs containing radioactive material for 206 use by persons authorized underfor medical use pursuant to Part 7 will be 207 approved if:
208 (1)
The applicant satisfies the general requirements specified in 3.9; 209 (2)
The applicant submits evidence that the applicant is at least one of the following:
210 (a)
Registered or licensed with the U.S. Food and Drug Administration 211 (FDA) as the owner or operator of a drug establishment that engages in 212 the manufacture, preparation, propagation, compounding, or processing 213 of a drug under 21 CFR Part 207.20(a);
214 (b)
Registered or licensed with the State Board of Pharmacy as a drug 215 manufacturer; 216 (c)
Licensed as a pharmacy by the State Board of Pharmacy; 217 (d)
Operating as a nuclear pharmacy within a Federal medical institution; or 218 (e)
A Positron Emission Tomography (PET) drug production facility 219 registered with the State Board of Pharmacy.
220 (3)
The applicant submits information on the radionuclide,; the chemical and 221 physical form,; the maximum activity per vial, syringe, generator, or other 222 container of the radioactive drug,; and the shielding provided by the packaging of 223 the radioactive material to show it is appropriate for safe handling and storage of 224 the radioactive drugs by medical use licensees; and 225 (4)
The applicant has procedures to assure which commit to the following labeling 226 requirements:
227 (a)
A label shall beis affixed to each transport radiation shield, (whether it is 228 constructed of lead, glass, plastic, or other material) of a radioactive drug 229 to be transferred for commercial distribution.
230 (i)
The label shallmust include the radiation symbol prescribed in 231 4.27 and the words CAUTION, RADIOACTIVE MATERIAL or 232 DANGER, RADIOACTIVE MATERIAL; the name of the 233 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.
Commented [JSJ18]: A sentence is added to this provision, consistent with 2018 amendments to 10 CFR 32.72.
NRC RATS 2018-1 NRC Compatibility B Commented [JSJ19]: This provision parallels the 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 to review procedures applicable to labeling.
NRC RATS 2018-1 NRC Compatibility B Document 1 HRG Page 24 of 138
radioactive drug or its abbreviation; and the quantity of 234 radioactivity at a specified date and time.
235 (ii)
For radioactive drugs with a half-life greater than 100 days, the 236 time may be omitted.
237 (b)
A label shall beis affixed to each syringe, vial, or other container used to 238 hold a radioactive drug to be transferred for commercial distribution. and 239 shall include:The label must include:
240 (i)
The radiation symbol prescribed in 4.27 and the words 241 CAUTION, RADIOACTIVE MATERIAL or DANGER, 242 RADIOACTIVE MATERIAL; and 243 (ii)
An identifier that ensures that the syringe, vial or other container 244 can be correlated with the information on the transport radiation 245 shield label.
246 3.12.10.2 A radioactive materials licensee who is also licensed by the State Board of 247 Pharmacy:A licensee described by 3.12.10.1(2)(c) or 3.12.10.1(2)(d):
248 (1)
May prepare radioactive drugs for medical use, as defined in Part 1, Section 1.2 249 and Part 7, provided that the radioactive drug is prepared by either:
250 (a)
An authorized nuclear pharmacist, as specified in 3.12.10.2(2) or 251 3.12.10.2(4), or 252 (b)
An individual under the direct supervision of an authorized nuclear 253 pharmacist as specified in Part 7, Section 7.10; 254 (2)
May allow a pharmacist to work as an authorized nuclear pharmacist if:
255 (a)
This individual qualifies as an Authorized Nuclear Pharmacist as defined 256 in Part 7, Section 7.2; 257 (b)
This individual meets the requirements specified in Part 7, Appendix 7C2 258 and Section 7.65, and the licensee has received a Department an 259 approved license amendment identifying this individual as an authorized 260 nuclear pharmacist; or 261 (c) This individual is designated as an authorized nuclear pharmacist in 262 accordance with 3.12.10.2(4).
263 (3)
The actions authorized in 3.12.10.2(1) and 3.12.10.2(2) are permitted in spite of 264 more restrictive language in license conditions.
265 (4)
May designate a pharmacist (as defined in Part 7, Section 7.2) as an authorized 266 nuclear pharmacist if:
267 (a)
The individual was a nuclear pharmacist preparing only radioactive drugs 268 containing accelerator-produced radioactive material, and 269 (b)
The individual practiced at a pharmacy at a Government agency or 270 Federally recognized Indian Tribe before November 30, 2007 or at all 271 other pharmacies before August 8, 2009, or an earlier date as noticed by 272 the NRC.
273 Document 1 HRG Page 25 of 138
(5)
Shall provide to the Department: a copy of each individuals:
274 (a)
A copy of each individuals Ccertification by a specialty board whose 275 certification process has been recognized by the NRC or an Agreement 276 State as specified in Part 7, Appendix 7C1 with the written attestation 277 signed by a preceptor as required by Part 7, Appendix 7C, Section 278 7C2.2; or 279 (b)
The Department, NRC or Agreement State license that allows such 280 work, or 281 (c)
NRC master materials licensee permit, or 282 (d)
The permit issued by a licensee or NRC master materials permittee of 283 broad scope or the authorization from a commercial nuclear pharmacy 284 authorized to list its own authorized nuclear pharmacist, or 285 (e)
Documentation that only accelerator-produced radioactive materials 286 were used in the practice of nuclear pharmacy at a Government agency 287 or Federally recognized Indian Tribe before November 30, 2007 or at all 288 other locations of use before August 8, 2009, or an earlier date as 289 noticed by the NRC; and 290 (f)
A copy of the State pharmacy licensure or registration, no later than 30 291 days after the date that the licensee allows, under 3.12.10.2(2)(a) and 292 3.12.10.2(2)(c), the individual to work as an authorized nuclear 293 pharmacist.
294 3.12.10.3 A licensee shall possess and use instrumentation to measure the radioactivity of 295 radioactive drugs.
296 (1)
The licensee shall have procedures for use of the instrumentation.
297 (2)
The licensee shall measure, by direct measurement or by combination of 298 measurements and calculations, the amount of radioactivity in dosages of alpha-,
299 beta-or photon-emitting radioactive drugs prior to transfer for commercial 300 distribution.
301 (3)
In addition, the licensee shall:
302 (a)
Perform tests before initial use, periodically, and following repair, on 303 each instrument for accuracy, linearity and geometry dependence, as 304 appropriate for the use of the instrument; and make adjustments when 305 necessary; and 306 (b)
Check each instrument for constancy and proper operation at the 307 beginning of each day of use.
308 3.12.10.4 A licensee shall satisfy the labeling requirements in 3.12.10.1(4).
309 3.12.10.45 Nothing in this section relieves the licensee from complying with applicable FDA, 310 Federal, and state requirements governing radioactive drugs.
311 3.12.11 Reserved.
312 3.12.12 Manufacture and Distribution of Sources or Devices Containing Radioactive Material for Medical 313 Use.
314 Commented [JSJ20]: The proposed changes are being made for consistency with the 2018 amendments to 10 CFR 32.72(b)(5)(i).
Consistent with other changes related to training and experience requirements in Part 7, the proposed rule removes the written attestation requirement for individuals wanting to be listed as an Authorized Nuclear Pharmacist whose board certification has been recognized by NRC or an Agreement State.
The proposed rule provides some regulatory relief for licensees since the current rule requires both the written attestation and board certification.
NRC RATS 2018-1 NRC Compatibility B Commented [JSJ21]: This provision formatted for alignment.
Commented [JSJ22]: This is a new provision, added for consistency with the 2018 amendments to 10 CFR 32.72(d).
The provision is added to clarify that the labeling requirements that applicants commit to are also applicable to current licensees. The language of the current rule lacks clarity in this regard.
NRC RATS 2018-1 NRC Compatibility B Document 1 HRG Page 26 of 138
3.12.12.1 An application for a specific license to manufacture and distribute sources and 315 devices containing radioactive material to persons licensed pursuant to Part 7 for 316 use as a calibration, transmission, or reference source or for the uses listed in 317 Part 7, Sections 7.19, 7.40, 7.42, 7.48 and 7.62 will be approved if:
318 (1)
The applicant satisfies the general requirements in 3.9 of this part; 319 (2)
The applicant submits sufficient information regarding each type of source or 320 device pertinent to an evaluation of its radiation safety, including:
321 (a)
The radioactive material contained, its chemical and physical form, and 322
- amount, 323 (b)
Details of design and construction of the source or device, 324 (c)
Procedures for, and results of, prototype tests to demonstrate that the 325 source or device will maintain its integrity under stresses likely to be 326 encountered in normal use and accidents, 327 (d)
For devices containing radioactive material, the radiation profile of a 328 prototype device, 329 (e)
Details of quality control procedures to assure that production sources 330 and devices meet the standards of the design and prototype tests, 331 (f)
Procedures and standards for calibrating sources and devices, 332 (g)
Legend and methods for labeling sources and devices as to their 333 radioactive content, and 334 (h)
Instructions for handling and storing the source or device from the 335 radiation safety standpoint; these instructions are to be included on a 336 durable label attached to the source or device or attached to a 337 permanent storage container for the source or device; provided, that 338 instructions which are too lengthy for such label may be summarized on 339 the label and printed in detail on a brochure which is referenced on the 340 label; 341 (3)
The label affixed to the source or device, or to the permanent storage container 342 for the source or device, contains information on the radionuclide, quantity, and 343 date of assay, and a statement that the source or device is licensed by the 344 Department for distribution to persons licensed pursuant to Part 7, Sections 7.40 345 and 7.42 or under equivalent licenses of NRC or an Agreement State, provided 346 that such labeling for sources which do not require long term storage may be on 347 a leaflet or brochure which accompanies the source; 348 (4)
The source or device has been registered in the Sealed Source and Device 349 Registry.
350 351 3.12.13.4 Each person licensed pursuant to 3.12.13.1 shall:
352 (1) 353 (2) 354 Document 1 HRG Page 27 of 138
(3) 355 (4) 356 (5) 357 (6)
Report to NRC all transfers of industrial products or devices to persons for use 358 under NRC general license in Section 40.25 of 10 CFR Part 40 (January 1, 359 2010).
360 361 3.15.6 Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-362 99m generators or rubidium-82 from strontium-82/rubidium-82 generators shall test the generator 363 eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, 364 respectively, in accordance with Part 7. The licensee shall record the results of each test and 365 retain each record for 3 years after the record is made. The licensee shall report the results of 366 any test that exceeds the permissible concentration listed in Part 7, Section 7.33.1 at the 367 time of generator elution, in accordance with Part 7, Section 7.33.5.
368 369 3.16.2.7 Each licensee or person responsible for a facility or site which includes a non-370 exempt source of radiation or which may be contaminated by residual 371 radioactivity shall, no less than 30 days before vacating or relinquishing 372 possession or control of the facility or site, notify the agencyDepartment, in 373 writing, of the intent to vacate.
374 375 3.19 AgencyDepartment Action on Applications to Renew and Amend.
376 377 3.24.4 Each general licensee operating within the state under reciprocity in areas of exclusive federal 378 jurisdiction shall comply with the applicable provisions of 10 CFR 150.20 (January 1, 2013).
379 380 381 382 383 Commented [JSJ23]: A sentence is added to this provision, consistent with 2018 amendments to 10 CFR 30.34.
The language adds a reporting requirement for when a generator eluate exceeds specified values.
NRC RATS 2018-1 NRC Compatibility B Commented [JSJ24]: Language updated in this provision for consistency with other wording in Section 3.16.2.
Commented [JSJ25]: 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.
Document 1 HRG Page 28 of 138
PART 3, SCHEDULE 3B: EXEMPT QUANTITIES (3.3.2) 384
`
385
[EDITORIAL NOTE - NO CHANGES TO MAIN BODY/TABLE OF SCHEDULE 3B]
386 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 387 of radionuclides, the limit for the combination should be derived as follows:
388 Determine the amount of each radionuclide possessed and divide by 1,000 times the amount in 389 Schedule 3B for each of those radionuclides when not in combination. The sum of the ratios of those 390 quantities may not exceed 1.
391 Example:
392 Amount of Radionuclide A possessed
+Amount of Radionuclide B possessed 1
1000 x Schedule 3B quantity for Radionuclide A.
1000 x Schedule 3B quantity for Radionuclide B Note 2: To convert microcuries (µCi) to SI units of kilobecquerels (kBq), multiply the above values by 37.
393 Example: Zirconium-97 (10 µCi multiplied by 37 is equivalent to 370 kBq).
394 395 3C.12.1 Except for persons who manufacture, process, or produce self-luminous products 396 containing tritium, krypton-85, or promethium-147, any person is exempt from 397 these regulations to the extent that such person receives, possesses, uses, 398 transfers, owns, or acquires tritium, krypton-85 or promethium-147 in self-399 luminous products manufactured, processed, produced, imported, or transferred 400 in accordance with a specific license issued by NRC pursuant to section 32.22 of 401 10 CFR Part 32 (January 1, 2015), which license authorizes the transfer of the 402 product to persons who are exempt from regulatory requirements.
403 404 3C.13.1 Except for persons who manufacture, process, produce, or initially transfer for 405 sale or distribution gas and aerosol detectors containing radioactive material, any 406 person is exempt from the requirements for a license set forth in the Act and from 407 the regulations in 3, 4, 5, 7, 10, 16, and 19 to the extent that such person 408 receives, possesses, uses, transfers, owns, or acquires radioactive material in 409 gas and aerosol detectors designed to protect health, safety, or property and 410 manufactured, processed, produced, or initially transferred in accordance with a 411 specific license issued by NRC18 pursuant to section 32.26 of 10 CFR Part 412 32(January 1, 2015), which license authorizes the initial transfer of the detectors 413 to persons who are exempt from regulatory requirements. This exemption also 414 covers gas and aerosol detectors manufactured or distributed before November 415 30, 2007, in accordance with a specific license issued by NRC or an Agreement 416 State under comparable provisions to 10 CFR Part 32.26 authorizing distribution 417 to persons exempt from regulatory requirements.
418 419
[EDITORIAL NOTE - NO CHANGES TO REMAINDER OF RULE FOLLOWING FOOTNOTES 420 OF SCHEDULE 3B]
421 Commented [JSJ26]: Correction of cross-reference errors in footnotes of Schedule 3B as item (5) does not exist.
Commented [JSJ27]: 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.
Document 1 HRG Page 29 of 138