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{{#Wiki_filter: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]:
{{#Wiki_filter: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:
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.
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.
8 Adopted by the Board of Health on May 17, 2017June 17, 2020; effective June 30, 2017August 14, 9 2020.                                                                                                            EDITORIAL NOTE 2:
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.
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.
11                                            [ * * * = Unaffected sections or text ]
NRC regulations may be found at:
NRC regulations may be found at:
https://www.nrc.gov/reading-rm/doc-collections/cfr/
https://www.nrc.gov/reading-rm/doc-collections/cfr/
12 EDITORIAL NOTE 3: This draft rule includes additional 13                                                                  * *
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.
* 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.
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.
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.
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.
20                      retains a copy of the material and will make the copy available to the public.
Document 1 HRG Page 19 of 138
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.
(2)
46                                                               * *
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.
* 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.
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 * *
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 (1) 57 (2) 58 (3) 59 (4) 60 (5)
* 56          3.5.8.3 * *
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).
* Commented [JSJ5]: The reference to a specific CFR date is removed in order to defer to the revised standard 57                      (1)       * *
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:
* incorporation by reference language in section 3.1.4.
65 (1)
58                      (2)       * *
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:
* 59                      (3)       * *
68 (a)
* 60                      (4)       * *
The Department pursuant to 3.12.4 or 69 (b)
* 61                      (5)       Shall not export such depleted uranium except in accordance with a license 62                                  issued by NRC pursuant to 10 CFR Part 110 (January 1, 2015).
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).
63                                                               * *
72 (2)
* 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.
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).
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:
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:
69                                  (a)     The Department pursuant to 3.12.4 or 70                                  (b)     By NRC or an Agreement State4 4
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.
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).
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.
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).
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.
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.
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.
77                      (1)       * *
Document 1 HRG Page 20 of 138
* 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).
(4) 80 (5) 81 (6) 82 (7)
128                                                * *
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);
* 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 -
85 (8) 86 (9)
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.
Shall transfer the device to another general licensee only:
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.
87 (a)
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:
Where the device remains in use at a particular location.
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.
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 * *
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).
* 101 (1) 102 (2)
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.
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).
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.
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).
161                                                * *
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.
* 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.
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.
165                                                  * *
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.
* 166 3.11.5 Specific licenses of broad scope are subject to the following conditions:
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.
167        3.11.5.1         Unless specifically authorized, persons licensed pursuant to 3.11 shall not:
Document 1 HRG Page 21 of 138
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.
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).
236                        (ii)     For radioactive drugs with a half-life greater than 100 days, the 237                                time may be omitted.
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.
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:
135 3.9.5.3 The following specific licensees are required to furnish decommissioning warranties:
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.
136 (1)
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):
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)
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:
Each licensee authorized to possess and use radioactive material with a half-life 139 greater than 120 days, in quantities:
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:
140 (a)
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).
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.
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.
145 (b)
266          (4) May designate a pharmacist (as defined in Part 7, Section 7.2) as an authorized 267              nuclear pharmacist if:
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).
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.
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


Document 1                                                          HRG                                                Page 26 of 138 274                (5)  Shall provide to the Department: a copy of each individuals:
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.
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).
164 165 3.11.5 Specific licenses of broad scope are subject to the following conditions:
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.
166 3.11.5.1 Unless specifically authorized, persons licensed pursuant to 3.11 shall not:
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.
167 (1)
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.
Conduct tracer studies in the environment involving direct release of radioactive 168 material; 169 (2)
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.
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)
297                (1)   The licensee shall have procedures for use of the instrumentation.
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)
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-,
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).
300                      beta- or photon-emitting radioactive drugs prior to transfer for commercial 301                      distribution.
183 184 3.12.5.1 185 (1) 186 (2)
302                (3)  In addition, the licensee shall:
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.
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.
188 189 3.12.6.1 190 (1) 191 (2)
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).
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.
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.
194 195 Commented [JSJ13]: Provision is modified to correct a past error in cross references, consistent with similar requirements in 10 CFR 33.17.
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.
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


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:
3.12.9.1 196 (1) 197 (2)
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:
The criteria of Sections 32.61, and 32.62 of 10 CFR Part 32 (January 1, 2015) 198 are met.
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.
199 200 201 202 3.12.10 Manufacture, Preparation, or Transfer for Commercial Distribution of Radioactive Drugs for 203 Medical Use.
351                                            * *
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:
* 352  3.12.13.4 Each person licensed pursuant to 3.12.13.1 shall:
208 (1)
353          (1)   * *
The applicant satisfies the general requirements specified in 3.9; 209 (2)
* 354          (2)   * *
The applicant submits evidence that the applicant is at least one of the following:
* Document 1                                                                HRG                                            Page 28 of 138 355                  (3)     * *
210 (a)
* 356                  (4)      * *
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);
* 357                  (5)      * *
214 (b)
* 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).
Registered or licensed with the State Board of Pharmacy as a drug 215 manufacturer; 216 (c)
361                                                      * *
Licensed as a pharmacy by the State Board of Pharmacy; 217 (d)
* 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.
Operating as a nuclear pharmacy within a Federal medical institution; or 218 (e)
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.
A Positron Emission Tomography (PET) drug production facility 219 registered with the State Board of Pharmacy.
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                                                      * *
220 (3)
* 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.
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)
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.
The applicant has procedures to assure which commit to the following labeling 226 requirements:
375                                                      * *
227 (a)
* 376 3.19  AgencyDepartment Action on Applications to Renew and Amend.
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.
377                                                      * *
230 (i)
* 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.
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.
380 381                                                      * *
Commented [JSJ18]: A sentence is added to this provision, consistent with 2018 amendments to 10 CFR 32.72.
* 382 383
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


Document 1                                                             HRG                                                 Page 29 of 138 384 PART 3, SCHEDULE 3B: EXEMPT QUANTITIES (3.3.2) 385                           `                          * *
radioactive drug or its abbreviation; and the quantity of 234 radioactivity at a specified date and time.
* 386                  [EDITORIAL NOTE - NO CHANGES TO MAIN BODY/TABLE OF SCHEDULE 3B]
235 (ii)
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.
For radioactive drugs with a half-life greater than 100 days, the 236 time may be omitted.
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.
237 (b)
392 Example:
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:
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.
240 (i)
393 Note 2: To convert microcuries (µCi) to SI units of kilobecquerels (kBq), multiply the above values by 37.
The radiation symbol prescribed in 4.27 and the words 241 CAUTION, RADIOACTIVE MATERIAL or DANGER, 242 RADIOACTIVE MATERIAL; and 243 (ii)
394 Example: Zirconium-97 (10 µCi multiplied by 37 is equivalent to 370 kBq).
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.
395                                                     * *
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):
* 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.
248 (1)
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.
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:
404                                                     * *
250 (a)
* 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.
An authorized nuclear pharmacist, as specified in 3.12.10.2(2) or 251 3.12.10.2(4), or 252 (b)
419                                                     * *
An individual under the direct supervision of an authorized nuclear 253 pharmacist as specified in Part 7, Section 7.10; 254 (2)
* 420          [EDITORIAL NOTE - NO CHANGES TO REMAINDER OF RULE FOLLOWING FOOTNOTES 421          OF SCHEDULE 3B]}}
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}}

Latest revision as of 17:32, 29 November 2024

Co Part 3 Redline Strikeout
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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

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